5.01.605 Medical Necessity Criteria for Pharmacy Edits · Medical Necessity Criteria for Pharmacy Edits Effective Date: May 1, 2018 Last Revised: April 17, 2018 Replaces: N/A

PHARMACY UTILIZATION MANAGEMENT GUIDELINE ndash 501605

Medical Necessity Criteria for Pharmacy Edits

Effective Date May 1 2018

Last Revised April 17 2018

Replaces NA

This policy has been revised Click

here to view the upcoming

changes

RELATED GUIDELINES POLICIES

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Disorders

501529 Opioid Analgesics

501541 Medical Necessity Exception Criteria for Closed Formulary Benefits and

for Dispense as Written (DAW) Exception Reviews

501547 Medical Necessity Criteria and Dispensing Quantity Limits for Exchange

Formulary Benefits

501552 Hetliozreg (tasimelteon)

Select a hyperlink below to be directed to that section

COVERAGE GUIDELINE | CODING | RELATED INFORMATION

EVIDENCE REVIEW | REFERENCES | HISTORY

infin Clicking this icon returns you to the hyperlinks menu above

Introduction

Pharmacy prior authorization helps members receive the most appropriate therapy The

program also helps reduce unnecessary prescription drug use waste and error Before a

medication can be covered certain medical criteria need to be met This helps ensure

medications are safe and effective for a particular condition while offering the greatest value

This policy describes coverage criteria for drugs in the planrsquos pharmacy prior authorization

program

Note The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria The

rest of the policy uses specific words and concepts familiar to medical professionals It is intended for

providers A provider can be a person such as a doctor nurse psychologist or dentist A provider also can

be a place where medical care is given like a hospital clinic or lab This policy informs them about when a

service may be covered

Page | 2 of 37 infin

Index of Drugs Drug Classes and Disease States

The medications in the following hyperlink table are affected by the Companyrsquos Pharmacy Prior

Authorization program

Drug Class Indications Individual Agents

ADHD Drugs brands ADHD Adzenys ER Adzenys XR-ODTtrade Aptensio XRtrade

Cotempla XR-ODT Daytranareg DyanaveltradeXR Evekeo

Mydayis Quillichew ERtradeQuillivant XRreg Ritalin LAreg

10mg 60mg Vyvansereg Zenzeditrade

Angiotensin II Receptor Blockers brands Hypertension

Cardiovascular

Disease Diabetes

Edarbireg Edarbyclorreg TevetenHCTreg

Anti-hypertensivediuretic Edema

hypertension

severe heart failure

Carospirreg

Antipsychotics (2nd

Gen ldquoAtypicalsrdquo)

brands

Psychoses Bipolar

Disorder MDD etc

Fanaptreg Latudareg Rexultireg Saphrisreg Versacloztrade

Vraylarreg Nuplazidreg Abilify MyCitereg

Brand Oral Antibiotics Acne Rosacea

Infections

Solodynreg Xyrosa Minolira Acticlate Adoxa Avidoxy

Doryx Doryx MPC Doxycycline IR-DR Minocin

Monodox Morgidox Oracea and Targadox Ximino

Constipation IBS-C CIC OIC Amitizareg Linzessreg Movantikreg

Corticosteroids Duchenne Muscular

Dystrophy (DMD)

Emflazatrade (deflazacort)

Guanylate cyclase-C Agonists CIC IBS-C Trulancereg

Heart Failure Heart Failure Corlanorreg Entrestoreg

Homozygous Familial

Hypercholesterolemia

HoFH Juxtapidreg Kynamrotrade

Hypnotics non-benzodiazepine brands Insomnia Edluarreg Rozeremreg Zolpimisttrade Belsomrareg

Intranasal corticosteroid products brands Allergic Rhinitis Beconase AQreg Omnarisreg Qnaslreg Ticanasetrade

Ticaspraytrade Veramystreg Zetonnareg

Nitrogen scavenging agents Urea Cycle Disorder Ravictitrade

Nonsteroidal Anti-inflammatory Drugs

(NSAIDs)

Pain and

Inflammation

Cambiareg Duexisreg Vimovoreg

Ophthalmic Prostaglandin Analogs

brands

Glaucoma Lumiganreg Travatan Zreg Vyzultatrade and Zioptanreg

Rho Kinase Inhibitor Elevated intraocular Rhopressareg



pressure

Statins Hyperlipidemia Flolipid Livaloreg Nikita Zypitamag

Tardive Dyskinesia Tardive Dyskinesia Ingrezza Austedo

Testosterone Replacement Low Testosterone Axironreg Fortestareg Natestotrade Testimreg Testosterone

gel Vogelxotrade

Topical Antibiotic Impetigo Xepitrade

Tryptophan Hydroxylase Inhibitor Carcinoid

Syndrome Diarrhea

Xermeloreg

Xyremreg Narcolepsy Xyremreg

Coverage Guideline

Pharmacy Benefit Drugs

Drug Medical Necessity

Stimulants for ADHD and other psychiatric conditions

Brand Brand stimulants for ADHD and other psychiatric

conditions may be considered medically necessary when

Patient failed a previous adequate trial of a generic

stimulant agent

OR

A suitable generic alternative is not currently available

OR

Patient failed a previous adequate trial of an oral stimulant

agent (brand or generic) and is or will be placed on a

transdermal brand stimulant

Vyvansetrade (lisdexamfetamine

dimesylate)

Vyvansetrade (lisdexamfetamine dimesylate) may be

considered medically necessary for the treatment of Binge

Eating Disorder (BED) without requiring a trial of or a

contraindication to a generic stimulant when medical

records show that ALL of the DSM-5 criteria below for BED

are met

1 Recurrent episodes of binge eating An episode of binge



Drug Medical Necessity eating is characterized by both of the following

o Eating in a discrete period of time (for example within

any 2-hour period) an amount of food that is definitely

larger than most people would eat in a similar period of

time under similar circumstances

o A sense of lack of control over eating during the

episode (for example a feeling that one cannot stop

eating or control what or how much one is eating)

2 The binge-eating episodes are associated with three (or

more) of the following

o Eating much more rapidly than normal

o Eating until feeling uncomfortably full

o Eating large amounts of food when not feeling

physically hungry

o Eating alone because of feeling embarrassed by how

much one is eating

o Feeling disgusted with oneself depressed or very guilty

afterwards

3 Marked distress regarding binge eating is present

4 The binge eating occurs on average at least once a week

for three months

5 The binge eating is not associated with the recurrent use of

inappropriate compensatory behavior (for example

purging) and does not occur exclusively during the course

of Anorexia Nervosa Bulimia Nervosa or

AvoidantRestrictive Food Intake Disorder


considered medically necessary for the treatment of ADHD

without requiring a trial of or a contraindication to a

generic stimulant when the individual has a history of drug

abuse or dependence

Angiotensin II receptor blockers (ARBs)

Brand angiotensin II receptor

blockers

Brand Angiotensin II receptor blockers that are not

available generically may be considered medically



Drug Medical Necessity necessary for the treatment of cardiovascular disease and

diabetes when the patient has failed a trial of a generic

ARB due to intolerance or inadequate response

Antipsychotics second generation

Brand second generation

antipsychotics

Brand second generation antipsychotics (SGAs formerly

known as atypicals) except Rexultireg (brexpiprazole) and

Abilify MyCiteregmay be considered medically necessary

when the patient has failed a trial of one generic SGA

Rexultireg (brexpiprazole) Rexultireg (brexpiprazole) may be considered medically

necessary when the patient has failed a trial of aripiprazole

Latudareg (lurasidone HCL) Latudareg (lurasidone HCL) may be considered medically

necessary for the treatment of bipolar depression without

trial and failure of a generic second generation

antipsychotic

Nuplazidreg (pimavanserin) Nuplazidreg (pimavanserin) may be considered medically

necessary for the treatment of hallucinations and delusions

associated with Parkinsonrsquos disease psychosis

Note Nuplazid is not subject to the criteria of other brand name second

generation antipsychotics outlined above and its use is restricted to

patients with Parkinsonrsquos disease psychosis only

Abilify MyCitereg Abilify MyCitereg may be considered medically necessary

when the patient has met all of the following criteria

Documentation of low medication adherence (lt80)

AND

Trial and failure of an injectable depot antipsychotic (eg

Risperdal Consta Invega Sustenna and Invega Trinza Abilify

Maintena etc)

Constipation

Amitizareg (lubiprostone) Amitizareg (lubiprostone) may be considered medically

necessary for the following labeled indications

Females at least 18 years of age with Irritable Bowel

Syndrome with constipation (IBC-C)

Adults with Chronic Idiopathic Constipation (CIC)

Adults with Opioid-Induced Constipation (OIC) with



Drug Medical Necessity chronic non-cancer pain

All other uses of lubiprostone are considered

investigational

Linzessreg (linaclotide) Linzessreg (linaclotide) may be considered medically


Adults with irritable bowel syndrome with constipation

(IBC-C)

Adults with chronic idiopathic constipation (CIC)

All other uses of linaclotide are considered investigational

Movantikreg (naloxegol) Movantikreg (naloxegol) may be considered medically


Adults with opioid-induced constipation (OIC) with chronic

non-cancer pain including patients with chronic pain

related to prior cancer or its treatment who do not require

frequent (eg weekly) opioid dosage escalation

All other uses of naloxegol are considered investigational

Trulancereg (plecanatide) Trulancereg (plecanatide) may be considered medically

necessary for the treatment of adult patients with chronic

idiopathic constipation (CIC) when patient has had at least

3-months trial and treatment failure or intolerance of at

least 3 of the following drugs

Bisacodyl lactulose polyethylene glycol docusate sodium

senna-sennosides or sodium phosphate enema

Trulancereg (plecanatide) may be considered medically

necessary for the treatment of adult patients with irritable

bowel syndrome with constipation (IBS-C)

Corticosteroids

Emflazatrade (deflazacort) Emflazatrade (deflazacort) may be considered medically

necessary for the following labeled indication

Treatment of Duchenne Muscular Dystrophy (DMD) in

patients 5 years of age and older who have had an



Drug Medical Necessity adequate trial and treatment failure due to the lack of

response or increase in adverse events with prednisone

Initial approval can be granted for a period of 6 months

Further re-authorization would require documentation of

continued clinical response measured by improvement of

muscle strength as compared to the baseline andor

diminished loss of muscle strength

Adequate trial is defined as 3 continuous months of therapy

Heart Failure Agents

Corlanorreg (ivabradine) Corlanorreg (ivabradine) may be considered medically

necessary when ALL of the following criteria are met

Patient has a diagnosis of stable symptomatic heart failure

Patient has normal sinus rhythm with a resting heart rate of

ge70 beats per minute

Patient has a left ventrical ejection fraction (LVEF) le 35

Previous therapy with a beta blocker was ineffective or not

tolerated

Per the package insert stable symptomatic heart failure is defined as NYHA

Class II to IV

All other uses of ivabradine are considered investigational

Entrestoreg(sacubitrilvalsartan) Entrestoreg (sacubitrilvalsartan) may be considered

medically necessary when ALL of the following criteria are

met

Patient has a diagnosis of chronic heart failure (NYHA Class

II to IV) with reduced ejection fraction of 40 or less

Entresto is prescribed by or in consultation with a

cardiologist or a cardiac care specialist

Patient is 18 years or older

All other uses of sacubitrilvalsartan are considered

investigational




Homozygous Familial Hypercholesterolemia Agents

Kynamrotrade (mipomersen) and

Juxtapidreg (lomitapide)

Kynamrotrade (mipomersen) and Juxtapidreg (lomitapide) may

be considered medically necessary as adjunctive therapy to

lower low-density cholesterol (LDL) apolipoprotein B total

cholesterol and non-HDL cholesterol in patients with

homozygous familial hypercholesterolemia (HoFH)

All other uses of mipomersen and lomitapide are

considered investigational

Anti-hypertensivediuretic

Carospirreg (spironolactone

liquid)

Carospirreg (spironolactone) may be considered medically

necessary for the following indications when medical

records show clinical necessity for a liquid (eg trouble

swallowing etc)

Severe heart failure (NYHA class III-IV) and have a LVEF lt35

OR

Used as add-on therapy for the treatment of hypertension

OR

Edema

Hypnotics

Non-benzodiazepine hypnotic

agents (branded single source)

Non-benzodiazepine hypnotic agents (branded single

source) may be considered medically necessary for

treatment of insomnia when the patient has failed a trial of

generic eszopiclone zolpidem or zaleplon unless such

therapy would be inappropriate

Intranasal Brand Corticosteroid Products

Intranasal brand corticosteroid

products (eg Beconase AQreg

Qnaslreg Omnarisreg Ticanase

trade Ticaspraytrade Veramystreg

Zetonnareg)

Intranasal brand corticosteroid products (eg Beconase

AQreg Omnarisreg Qnaslreg Ticanase trade Ticaspraytrade

Veramystreg Zetonnareg) may be considered medically

necessary for the treatment of allergic rhinitis when the

patient has failed a trial of at least one generic intranasal

corticosteroid

Nitrogen Scavenging Agents

Ravictitrade (glycerol Ravictitrade (glycerol phenylbutyrate) may be considered



Drug Medical Necessity phenylbutyrate) medically necessary for the treatment of Urea Cycle

Disorder when the patient has failed a trial of Buphenylreg

that was ineffective or not tolerated (sodium

phenylbutyrate)

Statins

Livaloreg (pitavastatin)

Nikitatrade(pitavastatin)

Zypitamagtrade (pitavastatin)

Livaloreg (pitavastatin) Nikita (pitavastatin) and

Zypitamagtrade (pitavastatin) may be considered medically

necessary for the treatment of hyperlipidemia when patient

has had at least 3-months trial and treatment failure or

intolerance of any 2 of the following generic drugs

Atorvastatin simvastatin lovastatin pravastatin

rosuvastatin or fluvastatin

Flolipid (simvastatin liquid) Flolipid (simvastatin) may be considered medically


has documentation in the form of medical records of the

following

At least a 3 month trial and treatment failure of 2 generic

statins (atorvastatin simvastatin lovastatin pravastatin

rosuvastatin or fluvastatin)

OR

Documentation that liquid is clinically necessary (eg trouble

swallowing etc)

Tryptophan Hydroxylase Inhibitor

Xermeloreg (telotristat ethyl) Xermeloreg (telotristat ethyl) may be considered medically

necessary for use in adult patients after failure of control of

carcinoid-induced diarrhea following an adequate course

(ge3 months) of dose escalation with octreotide-LAR to a

maximum of 30 to 60mgmonth

Must be used in combination with long-acting synthetic

somatostatin analogue (SSA)

Nonsteroidal Anti-inflammatory Drugs (NSAIDs) and Combinations

The following brand NSAIDs may be considered medically necessary when the patient has

failed a trial of ALL of the indicated alternatives (see criteria below for details)

Note Documentation in the form of chart notesmedical records must be provided with every prior authorization

review for the agents described below



Drug Medical Necessity Cambiareg (diclofenac

potassium for oral solution)

Cambiareg (diclofenac potassium for oral solution) may be

considered medically necessary when the patient has failed

a trial of generic diclofenac AND 2 other generic NSAIDs

Duexisreg (ibuprofen +

famotidine)

Duexisreg (ibuprofen + famotidine) may be considered

medically necessary when the patient has failed a trial of

generic ibuprofen IN COMBINATION with generic

famotidine AND 2 other regimens COMBINING an NSAID

with either a PPI or an H2 Antagonist

Vimovoreg (naproxen +

esomeprazole magnesium)

Vimovoreg (naproxen + esomeprazole magnesium) may be


a trial of generic naproxen IN COMBINATION

esomeprazole magnesium AND 2 other regimens

COMBINING and NSAID with a PPI


Brand Ophthalmic

Prostaglandin Analogs (eg

Lumiganreg Travatan Zreg

Vyzultatrade and Zioptanreg)

Brand Ophthalmic Prostaglandin Analogs (eg Lumiganreg

Travatan Zreg Vyzultatradeand Zioptanreg) may be considered

medically necessary to reduce intraocular pressure in

patients with glaucoma when the patient has failed trial of

generic bimatoprost or latanoprost

Brand Oral Antibiotics

Xyrosareg (doxycycline) Xyrosareg (doxycycline) may be considered medically

necessary for the treatment of rosacea when patient has

had at least 3-months trial and treatment failure of the

following drugs (documentation required in the form of

medical records)

Generic doxycycline

AND

Generic minocycline

Acticlatereg (doxycycline)

Adoxa (doxycycline)

Avidoxy (doxycycline)

Doryxreg (doxycycline)

Doryxreg MPC (doxycycline)

Doxycycline IR-DR

Minocinreg (minocycline)

Minolirareg (minocycline

Acticlate Adoxa Avidoxy Doryx Doryx MPC Doxycycline

IR-DR Minocin Minolira Monodox Morgidox Oracea

Solodyn Targadox and Ximino may be considered

medically necessary in patients who have had at least a 3

months trial and treatment failure of the following drugs

(documentation required in the form of medical records)

Generic doxycycline



Drug Medical Necessity hydrochloride extended-

release)Monodoxreg

(doxycycline)

Morgidoxreg (doxycycline)

Oraceareg (doxycycline)

Solodynreg (extended-release

minocycline)

Targadoxtrade (doxycycline)

Ximino trade(extended release

minocycline)

AND

Generic minocycline

Tardive Dyskinesia Medications

Ingrezzatrade (valbenazine) Ingrezzatrade may be considered medically necessary when

patient has a diagnosis of DRBA (dopamine receptor

blocking agents)-induced tardive dyskinesia (initial

authorization of 3 months)

Reauthorization criteria

Improvement as measured by a decrease in AIMS

(abnormal involuntary movement scale) score or

documentation in the form of medical records of

improvement in involuntary movements

Austedotrade (deutetrabenazine) Austedotrade may be considered medically necessary when

patient has one of the following diagnoses (initial


DRBA-induced tardive dyskinesia

OR

Chorea associated with Huntingtonrsquos disease






Testosterone Replacement Products

Nonpreferred Testosterone

Replacement agents

Nonpreferred Testosterone Replacement agents may be




Drug Medical Necessity a trial of generic testosterone gel (1) AND Androgel

(162)

Nonpreferred Testosterone Replacement agents include

Axironreg (testosterone topical solution)

Fortestareg (testosterone gel)

Testimreg (testosterone gel)

Testosterone 1 gel (brand name)

Vogelxotrade (testosterone gel)

Xyremreg

Xyremreg (sodium oxybate) Xyremreg (sodium oxybate) may be considered medically


Treatment of cataplexy in narcolepsy patients when

confirmatory or diagnostic diagnosis of narcolepsy has

been documented by a sleep study

OR

Treatment of excessive daytime sleepiness in narcolepsy

patients when ALL of the following conditions are met

o Confirmatory or diagnostic diagnosis of narcolepsy has


AND

o Prior therapy with a stimulant medication (eg

methylphenidate) was ineffective not tolerated or

contraindicated

AND

o Prior therapy with modafinil (Provigilreg) or armodafinil

(Nuvigilreg) was ineffective not tolerated or

contraindicated

Note Requirement trial with a stimulant and

modafinilarmodafinil may be waived if medical records

show symptoms consistent with cataplexy

Quantity dispensed is not more than 9 grams per day



Drug Medical Necessity Doses greater than 9 grams per day are not supported by

clinical evidence and therefore are considered not

medically necessary

All other uses of Xyremreg (sodium oxybate) are considered

investigational

Medical records showing diagnosis suggestive of

narcolepsy is not considered confirmatory or diagnostic of

narcolepsy

Further reauthorization would require

A sleep study confirming diagnosis of narcolepsy

AND

Documentation of continued clinical response

Note An adequate trial of a medication means

A therapeutic dose of the medication (ie a dose that usually works)

is taken for a period that is long enough to get a positive response

A trial that was stopped because medication was not tolerated due

to a severe adverse response is considered adequate regardless of

whether or not the medicine was taken for the recommended length

of time to get a positive response

Medication dosage and duration to achieve a therapeutic response

while taking a trial of medication will vary based on the specific

medication the condition being treated and the age andor size of

the patient in some cases

Rho Kinase Inhibitor

Rhopressareg (Netarsudil) Rhopressareg (Netarsudil) may be considered medically

necessary to reduce intraocular pressure in patients with

open-angle glaucoma or ocular hypertension when the

patient has failed trial of two ophthalmic beta-blockers (eg

timolol betaxolol) AND two ophthalmic prostaglandins

(eg latanoprost bimatoprost)

Topical Antibiotic



Drug Medical Necessity Xepitrade (Ozenoxacin) Xepitrade (Ozenoxacin) may be considered medically necessary

to treat impetigo when the patient has failed a trial of

mupirocin

Coding

NA

Related Information

This policy applies to all pharmacy benefit contracts that include Pharmacy Prior Authorization

Edits

The Companyrsquos Pharmacy Prior Authorization program is a set of electronic ldquosmart editsrdquo

designed to improve the quality of pharmacy care for our members and promote appropriate

and cost-effective drug therapies

The goals of this program are

To improve the quality of pharmacotherapy and its outcomes

To promote the appropriate and cost-effective use of medications and

To ensure the appropriate length of drug therapy for each patient

This policy briefly describes each edit and sets forth the clinical criteria upon which the

computerized edit logic is based The medications included in the Pharmacy Prior Authorization

are listed within the Index of Drugs table at the beginning of the policy Additional Prior

Authorization drugs are contained in other medical policies (see Related GuidelinesPolicies)


Benefit Application

This policy is managed through the Pharmacy benefit

Evidence Review

Brand ADHD Agents

Stimulant drugs for ADHD fall into two categories methylphenidate-based products and

amphetamines Within each category pharmacokinetic profile is the primary differentiating

characteristic A wide variety of generic medications are currently available to meet the needs of

most patients

Angiotensin II Receptor Blockers

All ARBs are indicated for treatment of hypertension (HTN) as monotherapy or in combination

with other anti-HTN agents These agents have demonstrated efficacy comparable to

angiotensin-converting enzyme inhibitors (ACEIs) in lowering diastolic (DBP) and systolic blood

pressure (SBP) in randomized clinical trials Studies comparing various ARBs to beta-blockers

diuretics and calcium channel blockers (CCBs) demonstrated comparable efficacy in lowering

SBP and DBP ARBs have favorable drug interaction and adverse reaction profiles compared to

ACEIs In general there is no a priori reason to prefer one ARB over another

Second Generation Antipsychotics (SGA)

Bipolar depression

The other established medications for the treatment of bipolar depression are more problematic

for the following reasons

Symbyax The fixed dose combination makes dose adjustments difficult and olanzapine

metabolic side-effects are considerably more problematic than Latudareg or Seroquel XRreg


Lithium Multiple daily dosing needed plus small window between therapeutic and toxic

serum levels plus more problematic side-effects plus augmentation with a SGA

antipsychotic is not infrequently needed

Lamotrigine Multiple daily dosing needed plus risk of SJ syndrome (and have to dc with

any rash even if eventually not SJ syndrome) plus sub-optimal efficacy for acute depressive

symptoms

Immediate-release quetiapine Multiple daily dosing needed plus more sedating that

Latuda plus XR formulation has a ldquosmootherrdquo clinical effect

Parkinsonrsquos Disease Psychosis

Psychotic symptoms in Parkinsons disease (PD) are relatively common and in addition to

creating a disturbance in patients daily lives have consistently been shown to be associated

with poor outcome Our understanding of the pathophysiology of psychosis in PD has expanded

dramatically over the past 15 years from an initial interpretation of symptoms as dopaminergic

drug adverse effects to the current view of a complex interplay of extrinsic and disease-related

factors PD psychosis has unique clinical features namely that it arises within a context of a clear

sensorium and retained insight there is relative prominence of visual hallucinations and

progression occurs over time PD psychosis tends to emerge later in the disease course and

disease duration represents one risk factor for its development The use of anti-PD medications

(particularly dopamine receptor agonists) has been the most widely identified risk factor for PD

psychosis Other risk factors discussed in the literature include older age disease severity sleep

disturbance cognitive impairment dementia andor depression

Traditionally treatment begins with a search for correctable infectious toxic and metabolic

aetiologies If symptoms persist anti-Parkinsons disease medications are slowly reduced

However withdrawal of these drugs usually worsens parkinsonism and is often not tolerated

Certain atypical antipsychotics can be used to treat psychosis without compromising motor

function The choice of atypical antipsychotic is largely based on ease of use and adverse effect

profile as most have comparable efficacy in improving psychosis

At the time of this update Nuplazid is the first FDA-approved treatment for hallucinations and

delusions associated with Parkinsonrsquos disease psychosis


Constipation

Linzessreg (linaclotidein)

The efficacy and safety of Linzessreg (linaclotidein) irritable bowel syndrome with constipation

(IBS-C) was established in one Phase IIb and two Phase III clinical trials One additional Phase IIb

and two Phase III trials evaluated linaclotide in chronic idiopathic constipation (CIC) In the Phase

III clinical trials for IBS-C for the first of four co-primary endpoints a greater proportion of

patients treated with linaclotide 290mcg once daily compared to placebo achieved the US Food

and Drug Administration (FDA)-recommended definition of response (336 and 337 for

linaclotide vs 210 and 139 for placebo plt00001 for both) Linaclotide was also statistically

significantly superior to placebo for all three of the additional co-primary endpoints in both

trials as well as all pre-specified secondary endpoints in both trials In the phase III clinical trials

in CIC patients a greater proportion of patients in the linaclotide 145mcg group vs placebo

achieved the primary endpoint of an increase of ge 1 complete spontaneous bowel movement

(CSBM) from baseline and ge 3 CSBMs in ge912 weeks in both trials (160 vs 60 plt001 for

trial 01 and 212 vs 33 plt0001 for trial 303) Linaclotide was statistically significantly

superior to placebo for all pre-specified secondary endpoints in both trials

Amitiza (lubiprostone)

The efficacy and safety of Amitiza (lubiprostone) was established in 2 double-blinded placebo-

controlled trials in patients with chronic idiopathic constipation (CIC) comparing lubiprostone

24 mcg twice daily with placebo for 4 weeks The primary endpoint was spontaneous bowel

movement (SBM) frequency Patients treated with Amitiza had a higher frequency of SBMs

during each week of therapy Lubiprostone demonstrated increases in the of patients with

SBMs in the first 24 hours (567 vs 369 in Study 1 and 629 vs 319 in Study 2) Time to

first SBM was shorter with lubiprostone than placebo Signs and symptoms related to

constipation were also improved with lubiprostone versus placebo The results were consistent

in subpopulation analyses for gender race and elderly patients (ge 65 years of age) During a 7-

week randomized withdrawal study patients who received lubiprostone during the treatment

period were randomized to receive either placebo or to continue treatment with lubiprostone In

lubiprostone patients randomized to placebo SBM frequency rates returned toward baseline

within 1 week and did not result in worsening compared to baseline Patients continued on

lubiprostone maintained response to therapy over the additional 3 weeks of treatment

The efficacy of lubiprostone in the treatment of opioid-induced constipation was assessed in

three randomized double-blinded placebo-controlled studies Patients had been receiving


stable opioid therapy for at least 30 days prior and continued during the 12-week treatment

period Baseline mean oral morphine equivalent daily doses (MEDDs) were 99 mg and 130 mg

for placebo-treated and lubiprostone-treated patients in Study 1 237 mg and 265 mg in Study 2

and 330 mg and 373 mg in Study 3 The Brief Pain Inventory-Short Form (BPI-SF) was

administered at baseline and monthly In Study 1 ldquooverall respondersrdquo were 271 in the

lubiprostone group vs 189 with placebo (treatment difference = 82 p-value = 003)

Examination of gender and race subgroups did not identify differences in response to

lubiprostone among these subgroups In Study 2 overall response rates were 243 in the

lubiprostone group and 154 with placebo In Study 3 ldquooverall respondersrdquo were 153 in the

lubiprostone group vs 130 with placebo Two double-blinded placebo-controlled studies

demonstrated similar results in women with IBS-C Insufficient men were enrolled in this study

Trulancetrade (plecanatide)

Trulancetrade (plecanatide) is a peptide analog of uroguanylin the endogenous agonist that binds

and activates guanylate cyclase-C receptors expressed in the epithelial lining of the GI mucosa It

is indicated for the treatment of chronic idiopathic constipation It is the first drug to successfully

meet new more stringent FDA criteria defining primary efficacy endpoints The new criteria

evaluates the durability of the response requiring patients to be complete spontaneous bowel

movement responders in 3 of the last 4 treatment weeks in addition to 9 of the 12 weeks The

phase III trials showed that treatment groups were superior to placebo groups in both primary

and secondary endpoints There are no serious safety concerns with plecanatide with the most

common side effect being diarrhea Due to the risk of dehydration it is not recommended for

children less than 18 years old There has been no comparative analysis or cost-effectiveness

analysis done yet Given the limited therapies specifically labeled for CIC plecanatide provides

another option for patients with CIC

Cushingrsquos Disease

The preferred treatment for Cushingrsquos disease is surgery specifically transsphenoidal surgery

(TSS) Surgery results in long-term remission rates of 60-90 with a recurrence risk of 26

within 10-years Poor outcomes are seen with larger tumor size and repeat surgeries Patients

with persistent disease after surgery can be treated with pituitary irradiation however months

to years of treatment may be required before an effect is seen Bilateral adrenalectomy may also

be performed however the pituitary adenoma remains in situ negative feedback effects of

cortisol are lost and replacement gluco- and mineralocorticoids are required


Medical therapy is used with unsuccessful surgery patients without an adenoma image on MRI

those undergoing radiotherapy which is not yet effective patients with severe complications of

Cushingrsquos and with those ineligible for surgery Cushingrsquos disease can be treated with drugs

which target the adenoma in the pituitary adrenal-blocking drugs or those which block

glucocorticoid receptors Drugs which target the pituitary include pasireotide and the dopamine

agonists bromocriptine and cabergoline Cabergoline is a dopamine agonist which targets

dopamine receptor subtype 2 (D2R) which is expressed in 80 of ACTH-secreting pituitary

adenomas Adrenal-targeting drugs include ketoconazole metopirone and mitotane These

agents act by inhibiting steroid formation Ketoconazolersquos actions are linked to inhibition of CYP

450 enzymes Mitotane is typically effective in gt50 of cases while ketoconazole and

metoprione are effective in approximately 50 of patients Mifepristone is the only agent

available which blocks glucocorticoid receptors more specifically the cortisol and progesterone

receptors4 However each of these agents with the exception of pasireotide has been

evaluated in a small number of patients All except pasireotide and mifepristone are not FDA

indicated for Cushingrsquos disease or syndrome Mifepristone is FDA indicated for patients with

Cushingrsquos syndrome with diabetes or glucose intolerance that require glycemic control

Although several different guidelines address the diagnosis of Cushingrsquos disease few address

medical treatment The European Neuroendocrine Association and the Pituitary Society last

published a consensus statement in 2008 which discussed therapy options as described above

The guidelines emphasized the importance of surgery as a first line option but did not

recommend any particular medical therapy above another

Byettareg Bydureonreg (exenatide) and Victozareg (liraglutide)

Byettareg is the first of a new class of antidiabetic agents known as incretin mimetics that mimic

the actions of a naturally occurring incretin hormone glucagon-like peptide 1 (GLP-1) Byettareg

is indicated for use in combination with maximal doses of metformin a sulfonylurea or a

thiazolidinedione to improve glycemic control in patients with type 2 diabetes

Byettareg stimulates glucose-dependent insulin secretion improves first-phase insulin response

suppresses postprandial glucagons secretion slows gastric emptying suppresses appetite and

reduces body weight The most common adverse events seen with exenatide therapy include

hypoglycemia (mild) and nausea which improves after several weeks of use

Byettareg typically achieves more modest A1c reduction (average 1) but patients do not gain

weight in fact two-year follow-up data showed that patients were able to lose five to 10


pounds per year and weight loss continued at the two-year follow-up point Trials in

combination with insulin are ongoing

Victozareg (liraglutide) acts by the same mechanism as exenatide A1c reduction in clinical trials

was comparable to the weekly Bydureonreg (exenatide) and somewhat greater than twice daily

Byettareg however rigorous head-to-head comparisons among these agents are not available

Non-benzodiazepine Hypnotics Agents (Branded Single Source)

There are clear pharmacokinetic differences between zaleplon zolpidem eszopiclone and

benzodiazepines for the treatment of insomnia Among the non-benzodiazepine agents

zolpidem seems to have optimal pharmacokinetics and is therefore recommended as a

preferred agent Current evidence does not clearly demonstrate any advantage among zaleplon

eszopiclone and zolpidem in efficacy

Januviatrade (sitagliptin) and Other DPP4 Inhibitors

Januviatrade (sitagliptin) is the first of a new class of antidiabetic agents known as DPP-4 inhibitors

that decrease the rate of clearance of endogenous incretins It is indicated as an adjunct to diet

and exercise to improve glycemic control in patients with type 2 diabetes mellitus as

monotherapy or in combination with metformin or a thiazolidinedione when a single agent

alone does not provide adequate glycemic control Sitagliptin should not be used in patients

with type 1 diabetes or for the treatment of diabetic ketoacidosis as it would not be effective in

these settings

Sitagliptin stimulates glucose-dependent insulin secretion improves first-phase insulin response


reduces body weight The most common adverse events seen with sitagliptin therapy include


Sitagliptin typically achieves more modest A1c reduction (average 1) but patients do not gain

weight in fact two-year follow-up data showed that patients were able to lose 5-10 pounds per

year and weight loss continued at the two-year follow-up point Trials in combination with

insulin are ongoing

Other agents in this class approved by the FDA include Nesinareg (alogliptin) Onglyzareg

(saxagliptin) and Tradjentareg (linagliptin) Galvus (vildagliptin) was approved in Europe but is not


currently available in the US Clinical trial results are similar for all these agents without direct

comparisons Combinations of DPP4 inhibitors with metformin sulfonylureas and pioglitazone

are also available

Solodynreg (minocycline HCl USP)

Extended-release Solodynreg tablets are available in eight strengths (45 mg 55 mg 65 mg 80

mg 90 mg 105 mg 115 mg and 135 mg) for more precise weight-based dosing of Solodynreg

that narrows the actual dose ranges toward the target of 1 mgkgday for patients with non-

nodular moderate to severe inflammatory acne 12 years and older weighing 99-300 lbs In

clinical trials of the 45 mg 90 mg and 135 mg strengths with 1038 patients Solodynreg

demonstrated efficacy in a low dose (1 mgkgday) There was no evidence of improved efficacy

with 2 mgkgday and 3 mgkgday5 Higher doses of Solodynreg have not been shown to be of

additional benefit in the treatment of inflammatory lesions of acne and may be associated with

more acute vestibular adverse events Clinical studies also showed that Solodynreg tablets were

well-tolerated with an adverse event profile similar to placebo

In a Phase II dose-response study of 233 subjects with the 45 mg 90 mg and 135 mg strengths

1 mgkgday extended-release Solodynreg tablets provided statistically significant inflammatory

lesion reduction vs placebo (n=114 568 vs 394 p=0015) In two Phase III clinical studies

with the 45 mg 90 mg and 135 mg strengths the mean percent improvement in inflammatory

lesions was greater in patients treated with Solodynreg tablets than with placebo (Study 1 n=451

431 vs 317 p=0001 Study 2 n=473 458 vs 308 plt0001 respectively) There was no

evidence of improved efficacy with 2 mgkgday and 3 mgkgday No head-to-head data are

reported The manufacturersrsquo trials are all unpublished and placebo-controlled making it

impossible to assess comparative effectiveness

Adverse reactions reported in the clinical trials of Solodynreg were not statistically different from

placebo1 No comparative data versus other forms of minocycline or doxycycline were found A

recent review article recommends doxycycline as a first choice oral tetracycline for acne patients

due to the overall lower side effect profile


Many studies have assessed efficacy of Livaloreg (pitavastatin) in reducing LDL-C and

influencing lipid parameters and reducing cardiovascular risk especially to assess pitavastatin

versus other HMG-CoA reductase inhibitors Although head to head studies are still lacking a


meta-analyses reported that pitavastatin has similar cumulative probability of reducing the

risk of CHD mortality as rosuvastatin and all-cause mortality as atorvastatin and simvastatin

Specific data in Japanes patients are available Although pitavastatin shares the same side

effects as other agents in its class there is evidence of fewer drug interactions than some

others due to its being mainly metabolized through glucuronidation Pitavastatin is available

by brand only suggesting a higher cost over all the other commonly used agents within the

same class There is no evidence of clinical superiority in the majority of patients

Xyremreg (sodium oxybate)

Xyremreg (sodium oxybate) is a CNS depressant The mechanism of action of Xyrem in the

treatment of narcolepsy is unknown Sodium oxybate is the sodium salt of gamma

hydroxybutyrate (GHB) an endogenous compound and metabolite of the neurotransmitter

GABA Abuse or misuse of illicit GHB is associated with CNS adverse reactions including seizure

respiratory depression decreased consciousness coma and death It is hypothesized that the

therapeutic effects of Xyrem on cataplexy and excessive daytime sleepiness are mediated

through GABAB actions at noradrenergic and dopaminergic neurons as well as at

thalamocortical neurons Xyrem is a Schedule III controlled substance Because of its

abusediversion potential it is only available from a single pharmacy through a limited

distribution scheme the Xyrem Success Program Both prescribers and patients must be

registered in this program to obtain the drug Serious side effects observed in patients taking

Xyrem include hallucinations agitation severe confusion abnormal thinking sleep disturbances

and depression In 2011 Jazz Pharmaceuticals the manufacturer was cited for failure to

properly submit adverse event reports to the FDA

Sodium oxybate is eliminated by cytosolic metabolism and exhibits saturable kinetics This has

not been studied in children under 18 and data in elderly populations are limited Clearance was

reduced by more than half in patients with cirrhosis both Childrsquos Class A and C

The efficacy of Xyrem in the treatment of cataplexy was evaluated in two 4-week randomized

double-blind placebo-controlled multicenter parallel-group trials n=136 and 55 respectively

The high percentages of concomitant stimulant use in these studies make it impossible to assess

the efficacy and safety independent of stimulant use Doses of 6-9 g per night resulted in

statistically significant reductions in frequency of cataplexy attacks The 3 g per night dose had

little effect Overall the evidence supporting this indication is of low quality

The efficacy of Xyrem in the treatment of excessive daytime sleepiness in patients with

narcolepsy was evaluated in an 8-week randomized double-blind placebo-controlled trial

n=228 Most of these patients were also being treated with CNS stimulants Statistically


significant improvements in Epworth Sleepiness Scale Scores were seen with 6 and 9 g doses A

second multicenter randomized double-blind placebo-controlled parallel-group trial evaluated

222 patients on modafinil at baseline who were randomized to placebo Xyrem modafinil or

Xyrem plus modafinil Xyrem dose was 6g per night for 4 weeks followed by 9g per night for 4

weeks Modafinil was continued in the modafinil groups at the patientrsquos prior dose A statistically

significant improvement in in the Maintenance of Wakefulness Test score from baseline at Week

8 was seen in the Xyrem and Xyrem plus modafinil groups compared to placebo The trial was

not designed to compare Xyrem with modafinil

Studies have been conducted to demonstrate the efficacy of Xyrem in fibromyalgia patients

however all of these have been placebo-controlled In 2010 FDA rejected an application for use

in fibromyalgia FDA panel members expressed serious concerns about the potential for abuse

and diversion of sodium oxybate This concern was felt to outweigh any benefits that might

accrue and is supported by the lack of any head-to-head comparison with alternative

treatments for fibromyalgia none of which have the level of abuse potential seen with Xyrem

The manufacturer is currently conducting clinical trials in a number of other diseases including

Parkinsonrsquos schizophrenia chronic insomnia obstructive sleep apnea PTSD Alzheimerrsquos and

essential tremor

Corlanorreg (ivabradine)

Corlanorreg (ivabradine) is the first in a new class of medications which block hyperpolarization-

activated cyclic nucleotide-gated (HCN) channels Selectively inhibiting if current in the sinoatrial

node reduces the spontaneous pacemaker activity of the sinus node which results in heart rate

reduction without affecting ventricular repolarization or contractility It has been approved in

Europe since 2005 to reduce heart failure hospitalizations in patients with NYHA class II-IV heart

failure who have an LVEF 35 resting heart rate 70 bpm and either have a contraindication to

beta blockers or are on maximal tolerated therapy The FDA approved it based on results from a

randomized double-blind international trial 6558 patients were randomized to receive

ivabradine (n=3241) or placebo (n=3260) Over a median follow-up of 23 months ivabradine

resulted in a significant reduction in a composite of time for first HF hospitalization or CV death

(245) compared to placebo (287) plt0001) Ivabradine was associated with an improved

HRQOL


Entrestoreg (valsartansacubitril)

Entrestoreg (valsartansacubitril or LCZ696) was granted fast track approval by the FDA for heart

failure with reduced ejection fraction (HFrEF) based on the results of the PARADIGM HF trial

which randomized 8441 patients to receive LCZ696 200mg twice daily (n=4187) or enalapril

10mg twice daily (n=4212) LCZ696 was superior to enalapril at reducing the composite

endpoint of cardiovascular death and first heart failure hospitalization (HR 080 95 CI 073-

087 plt0001) When assessed individually both components of the composite occurred in a

lower proportion of patients in the LCZ696 arm (plt0001 for both) All-cause mortality occurred

in 17 of the LCZ696 group compared to 198 in the enalapril arm (plt0001) A 29 reduction

in recurrent hospitalizations was seen with LCZ696 (p=0001) Due to the statistically significant

reduction in the primary endpoint the study was prematurely stopped The phase II

PARAMOUNT trial has shown beneficial results with LCZ696 compared to valsartan in patients

who have heart failure with preserved ejection fraction LCZ696 significantly reduced NT-proBNP

at 12 weeks (ratio of change LCZ696valsartan 077 95 CI 064-092 p=0005)

Xermeloreg (telotristat ethyl)

Xermeloreg (telotristat ethyl) is a novel oral tryptophan hydroxylase (TPH) inhibitor currently

indicated for the symptomatic treatment of inadequately controlled carcinoid-induced diarrhea

in combination with long-acting SSA therapy in adult patients4 Unlike SSAs which may slow

tumor progression and provide relief of carcinoid-induced diarrhea and flushing56 evidence for

the efficacy of telotristat ethyl is limited to the symptomatic relief of carcinoid-induced diarrhea

and has not been studied in the context of disease progression1-3 In the pivotal phase III study1

treatment with telotristat ethyl 250 mg PO TID was associated with a small reduction in mean

daily BMs compared to placebo (NS) Moreover this finding is confounded by a lack of

comparable key baseline characteristics (lower daily BM frequency for placebo than the

telotristat ethyl 250 mg arm [p lt005]) and unclear method of statistical analyses which limits

the interpretation of results Results differed between the preplanned intention-to-treat (ITT)

analysis (-143 BMsday) and the post-hoc per-protocol analysis (-17 BMsday) the latter was

used to demonstrate the treatment benefit associated with telotristat ethyl 250 mg PO TID In

relation to safety GI disorders were the most commonly reported AEs1-3 Currently there is no

real-world evidence for the comparative effectiveness of telotristat ethyl in patients with

inadequately treated carcinoid-induced diarrhea As of March 2017 the National Comprehensive

Cancer Network (NCCN) guidelines for neuroendocrine tumors (NETs) recommend octreotide

150-250 μg SC TID or octreotide long-acting repeatable (LAR) 20-30 mg IM Q4W for symptom

control of carcinoid-induced diarrhea with an increase in dose andor frequency as needed5


Ingrezzatrade (valbenazine) and Austedotrade (deutetrabenazine)

Ingrezzatrade (valbenazine) is a FDA-approved VMAT2 inhibitor indicated for tardive dyskinesia

(TD) The treatment landscape consists of strategies with either limited evidence to support or

refute their efficacy or with the magnitude of the risk outweighing the benefit1

In one phase II (KINECT II) and one phase III (KINECT III) clinical trial valbenazine (VBZ)

demonstrated a reduction in the severity of tardive dyskinesia as shown by Abnormal

Involuntary Movement Scale (AIMS) score23 These trials consistently demonstrated positive

results but it remains unclear what constitutes as a clinically significant change in the AIMS

score

In addition although no conclusions on long-term efficacy can be drawn from the small 6-week

duration trials a durable improvement in AIMS score was observed in a 48-week extension

study Furthermore after VBZ was discontinued the TD worsened Both findings suggest long-

term maintenance of improvement in TD with VBZ

KINECT II and KINECT III had similar safety profiles for VBZ and the drug appears to be well-

tolerated23 However a movement disorder like TD is chronic and requires long-term

management Therefore it is important to have a sufficient amount and duration of safety data

Until that data is available VBZ should be utilized with caution

Austedotrade (deutetrabenazine) is a FDA-approved VMAT2 inhibitor indicated for tardive

dyskinesia and chorea associated with Huntingtonrsquos disease Efficacy of Austedo in the treatment

of chorea associated with Huntingtonrsquos disease was established primarily in study 1 a

randomized double-blind placebo-controlled trial in 90 patients with Huntingtonrsquos disease

Primary efficacy endpoint was the Total Maximal Chorea score Total Maximal Chorea scores for

patients receiving Austedo improved approximately 44 units from baseline compared to 19

units in the placebo group Efficacy of Austedo in the treatment of tardive dyskinesia was

established in two 12 week randomized double-blind placebo-controlled trials in 335 patients

with tardive dyskinesia caused by dopamine receptor antagonists The Abnormal Involuntary

Movement Scale (AIMS) was the primary efficacy measure AIMS score showed statistically

significant improvement of 32-33 units compared to 14 units in placebo

References


1 US Modafinil in Narcolepsy Multicenter Study Group Randomized trial of modafinil as a treatment for the excessive daytime

somnolence of narcolepsy Neurology 2000 541166-1175

2 Drover D Comparative pharmacokinetics and pharmacodynamics of short-acting hypnosedatives Clinical Pharmacokinetics

2004 43227-238

3 Michelson D Faries D Wernicke J et al Atomoxetine in the Treatment of children and adolescents with attention-

deficithyperactivity disorder A randomized placebo-controlled dose-response study Pediatrics 2001 108(5)1

4 Michelson D Adler L Spencer T et al Atomoxetine in adults with ADHD two randomized placebo-controlled studies Biol

Psychiatry 2003 53112-120

5 Kratochvil CJ Heiligenstein JH Dittman R et al Atomoxetine and methylphenidate treatment in children with ADHD A

prospective randomized open-label trial J Am Acad Child Adolesc Psychiatry 2002 41(7)776

6 Nussbaum A Stroup TS Paliperidone for Schizophrenia Cochrane Database Syst Rev 2008 Apr 16(2)CD006369

7 Komossa K Rummel-Kluge C Schwarz S etal Risperidone versus Other Atypical Antipsychotics for Schizophrenia Cochrane

Database Syst Rev 2011 Jan 19(1)CD006626

8 Komossa K Rummel-Kluge C Hunger H et al Olanzapine versus Other Atypical Antipsychotics for Schizophrenia Cochrane

Database Syst Rev 2010 Mar 17(3)CD006654

9 Komossa K Rummel-Kluge C Hunger H et al Ziprasidone versus Other Atypical Antipsychotics for Schizophrenia Cochrane

Database Syst Rev 2009 Oct 7(4)CD006627

10 Komossa K Rummel-Kluge C Schmid F et al Aripiprazole versus Other Atypical Antipsychotics for Schizophrenia Cochrane


11 Cranney A Tugwell P Adachi J et al Meta-analysis of therapies for postmenopausal osteoporosis III Meta-analysis of

risedronate for the treatment of postmenopausal osteoporosis Endocr Rev 200223517-523

12 Bonnick SL Harris ST Kendler DL et al Management of osteoporosis in postmenopausal women 2010 position statement of

the North American Menopause Society Menopause 201017(1)25-54

13 Cummings SR Black DM Thompson DE et al Alendronate reduces the risk of vertebral fractures in women without pre-existing

vertebral fractures results from the Fracture Intervention Trial JAMA 19982802077-2082

14 Liberman UA Weiss SR Broll J et al Effect of oral alendronate on bone mineral density and the incidence of fractures in

postmenopausal osteoporosis N Engl J Med 1995333 1437-1443

15 MacLean C Newberry S Maglione M et al Systematic review comparative effectiveness of treatments to prevent fractures in

men and women with low bone density or osteoporosis Ann Intern Med 2008148197-213

16 Bolland MJ Grey AB Gamble GD Reid IR Effect of osteoporosis treatment on mortality a meta-analysis J Clin Endocrinol

Metab 2010951174-1181

17 Wells GA Cranney A Peterson J et al Alendronate for the primary and secondary prevention of osteoporotic fractures in

postmenopausal women Cochrane Database of Systematic Reviews 2008 Issue 1 Art NoCD00115 DOI

10100214651858CD001155pub2

18 Jamal SA Bauer DC Ensrud KE et al Alendronate treatment in women with normal to severely impaired renal function an

analysis of the Fracture Intervention Trial J Bone Miner Res 200722503-508

19 Vakil N and Fennerty MB Systematic review direct comparative trials of the efficacy of proton pump inhibitors in the

management of gastro-oesophageal reflux disease and peptic ulcer disease Aliment Pharmacol Ther 2003 18 559ndash568

20 Ford CN Evaluation and management of laryngopharyngeal reflux JAMA 2005 2941534-1540

21 McDonagh MS Carson S Thakurta S Drug Class Review Proton Pump Inhibitors Drug Effectiveness Review Project Oregon

Evidence-based Practice Center Oregon Health amp Science University June 2009 Availabe online at

httpwwwohsueduxdresearchcenters-institutesevidence-based-practice-centerdrug-effectiveness-review-

projectuploadPPI_-final-report_update-5_version-4_unshaded_09_Maypdf Accessed April 2018


22 Zanchetti A Omboni S Di Biagio C Candesartan cilexetil and enalapril are of equivalent efficacy in patients with mild to

moderate hypertension J Hum Hypertens 1997 11(supp 2) S57 S59

23 Gradman AH Arcuri KE Goldberg AI et al A randomized placebo-controlled double blind parallel study of various doses of

losartan potassium compared with enalapril maleate in patients with essential hypertension Hypertension 1995 251345-1350

24 Stumpe KO Hawirtg D Hoglund C et al Comparison of the angiotensin II receptor antagonist irbesartan with atenolol for

treatment of hypertension Blood Press 1998 (1) 31-37

25 Corea L Cardoni O Fogari R et al Valsartan a new angiotensin II antagonist for the treatment of essential hypertension A

comparative study of the efficacy and safety against amlodipine Clin Pharmacol Ther 1996 60(3)341-346

26 Dormandy JA Charbonnel B Eckland DJA et al The PROactive investigators Secondary prevention of macrovascular events in

patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial in Macrovascular Events) a

randomized controlled trial Lancet 20053661279-1289

27 DeFronzo RA Ratner RE Han J et al Effects of exenatide (exendin-4) on glycemic control and weight control over 30 weeks in

metformin-treated patients with type 2 diabetes Diabetes Care 200528(5)1092-100

28 Buse JB Henry RR Han J et al Effects of exenatide (exendin-4) on glycemic control over 30 weeks in sulfonylurea-treated

patients with type 2 diabetes Diabetes Care 200427(11)2628-35

29 Kendall DM Riddle MC Rosenstock J et al Effects of exenatide (exendin-4) on glycemic control over 30 weeks in patients with

type 2 diabetes treated with metformin and a sulfonylurea Diabetes Care 200528(5)1083-91

30 Heine RJ Van Gall LF Johns D et al Exenatide versus insulin glargine in patients with suboptimally controlled type 2 diabetes a

randomized trial Ann Intern Med 2005143(8)559-69

31 Aschner P Kipnes MS Lunceford JK et al Effect of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy on glycemic

control in patients with type 2 diabetes Diabetes Care In press Merck internal data

32 Raz I Hanefeld M Xu L et al Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy in patients

with type 2 diabetes mellitus Diabetologia In press Merck internal data

33 Charbonnel B Karasik A Liu J et al Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing

metformin therapy in patients with type 2 diabetes inadequately controlled on metformin alone Diabetes Care In press Merck

internal data

34 Oliver TN Update on anti-emetics for chemotherapy-induced emesis Intern Med J 200535(8)478-81 Review

35 Package inserts for acyclovir famciclovir and valacyclovir

36 Manual of Clinical Psychopharmacology 6th edition Schatzberg Cole and DeBattista American Psychiatric Publishing 2007

(7th edition due out in 2010)

37 Evidence-Based Psychopharmacology Stein Lerer and Stahl (editors) Cambridge University Press 2005

38 AACE Diabetes Mellitus Clinical Practice Guidelines Task Force AACE Medical Guidelines for Clinical Practice for Developing a

Diabetes Mellitus Comprehensive Care Plan 2011 Available at httpswwwaacecomfilesdm-guidelines-ccppdf Accessed

April 2018

39 Reviewed and recommended by the Pharmacy and Therapeutics Committee May 15 2007

40 Package insert Nuvigil (armodafinil)

41 Littleton ET Hobart JC Palace J Modafinil for multiple sclerosis fatigue does it work Clin Neurol Neurosurg 2010

Jan112(1)29-31

42 Kumar R Approved and investigational uses of modafinil an evidence-based review Drugs 200868(13)1803-39

43 SOLODYN Tablets Package Insert Scottsdale AZ Medicis The Dermatology Company August 2010 Data on file with the

manufacturer (Unpublished)


44 Kircik LH Doxycycline and minocycline for the management of acne a review of efficacy and safety with emphasis on clinical

implications J Drugs Dermatol 20109(11)1407-1411

45 Simonart T Dramaix M De Maertelaer V Efficacy of tetracyclines in the treatment of acne vulgaris A review Br J Dermatol

2008158208-216

46 Package insert Xyrem (sodium oxybate) Jazz Pharmaceuticals

47 FDA warning letter to Jazz Pharmaceuticals October 11 2011 Available at httpwaybackarchive-

itorg799320161023100631httpwwwfdagovICECIEnforcementActionsWarningLetters2011ucm275565htm

Accessed April 2018

48 Mc Millen M FDA Panel Rejects Xyrem as Fibromyalgia Treatment Advisory Panel Members Worry About Potential for Abuse of

Drug Thatrsquos Similar to GHB WebMD Health News August 20 2010 Available at

httpwwwwebmdcomfibromyalgianews20100820fda-panel-rejects-xyrem-as-fibromyalgia-treatment20

Accessed April 2018

49 ClinicalTrialsgov Available at httpclinicaltrialsgovct2resultsterm=xyrem Accessed April 2018

50 Van der Pas R de Herder WW Hofland LJ Feelders RA Recent developments in drug therapy for Cushingrsquos disease Drugs 2013

June 5 [Epub ahead of print]

51 Castinetti F Moragne I Conte-Devolx B and Brue T Cushingrsquos disease Orpahnet J Rare Dis 2012741-50

52 Hammer GD Tyrell JB Lamborn KR et al Transsphenoidal microsurgery for Cushingrsquos disease initial outcome and long-term

results J Clin Endocrinol Metab 200489(12)6348-6357

53 Dekkers OM Biermasz NR Pereira AM et al Mortality in patients treated for Cushingrsquos disease is increased compared with

patients treated for nonfunctioning pituitary macroadenoma J Clin Endocrinol Metab 200792(3)976-981

54 Fleseriu M Petersenn S Medical management of Cushingrsquos disease what is the future Pituitary 201215330-341

55 Niemann LK Biller BM Findling JW et al The diagnosis of Cushingrsquos syndrome an Endocrine Society Clinical Practice Guideline

J Clin Endocrinol Metab 2008931526-1540

56 Biller BM Grossman AB Stewart PM et al Treatment of adrenocorticotropin-dependent Cushingrsquos syndrome a consensus

statement J Clin Endocrinol Metab 2008932454-2462

57 Product information for Amitiza (lubiprostone) Takeda Pharmaceuticals Available at httpwwwamitizacom Accessed April

2018

58 Product information for Linzess (linaclotide) July 2014 Forest Pharmaceuticals Available at httpwwwlinzesscom Accessed

February 2018

59 Product information for Nuplazid (pimavanserin) April 2016 Acadia Pharmaceuticals San Diego CA Available at

httpswwwnuplazidcompdfNUPLAZID_Prescribing_Informationpdf Accessed April 2018

60 Product information for Emflazareg(deflazacort) February 2017 Marathon Pharmaceuticals LLC Northbrook IL Available at

httpsemflazacomwp-contentuploads201710Prescribing-Informationpdf Accessed April 2018

61 Package insert Ingrezza (valbenazine) Neurocrine Biosciences Inc)

62 Bhidayasiri R Fahn S Weiner WJ et al Evidence-based guideline treatment of tardive syndromes report of the Guideline

Development Subcommittee of the American Academy of Neurology Neurology 201381(5)463-9

63 Hauser RA Factor SA Marder SR et al KINECT 3 A Phase 3 Randomized Double-Blind Placebo-Controlled Trial of Valbenazine

for Tardive Dyskinesia Am J Psychiatry 2017 appiajp201716091037

64 Obrien CF Jimenez R Hauser RA et al NBI-98854 a selective monoamine transport inhibitor for the treatment of tardive

dyskinesia A randomized double-blind placebo-controlled study Mov Disord 201530(12)1681-7

65 Pacage Insert Austedo (deutetrabenazine) (Auspex Pharmaceuticals Inc)


History

Date Comments 121305 Add to Prescription Drug Section - New Policymdasheffective January 1 2006

080806 Replace Policy - Policy reviewed with literature search by Pharmacy and Therapeutic

Committee on July 25 2006 Policy statement updated with exenatide and

thiazolindinediones added as medically necessary Policy Guidelines and Rationale

sections updated references added

050807 Replace Policy - Policy statement for exenatide updated with additional criteria Policy

Guidelines updated to reflect addition to policy statement Reviewed by PampT on March

27 2007

061207 Replace Policy - Policy statement on coverage criteria for exenatide (Byettareg)

sitagliptin and esomeprazole (Nexiumreg) expanded medically necessary indications for

5HTR3R antagonists Actiqreg and Fentoratrade added to policy statement Policy

Guidelines updated and Rationale updated references added


Committee on May 15 2007Policy statement updated to include Pregabalin as either

medically necessary or investigational under the criteria Acyclovir famciclovir and

valacyclovir as medically necessary under criteria References added

040808 Replace Policy - Policy updated with literature search by Pharmacy Policy statement

was updated to include fibromyalgia as a medically necessary indication under

Pregabalin References added


updated to include the use of leukotrience modifiers for the treatment of allergic

rhinitis refractory to nasal corticosteroids under the medically necessary indication


updated to delete medically necessary and investigational statements relating to

Pregabalin Pregabalin statements moved to PR501521


updated with addition of Nuvigil Reference added

020910 Replace Policy - Policy updated with literature search by Pharmacy No change to the

policy statement Policy guidelines section updated

030910 Replace Policy - Policy updated with literature search Policy statement updated with

medically necessary indications for provigil and nuvigil when all criteria are met New

diabetes drugs also added to medically necessary statement References added



Date Comments medically necessary indication added for Leukotriene modifiers References added

060810 Replace Policy - Policy updated with literature search Pantoprazole added to policy

guidelines Reference added

081010 Replace Policy - Policy updated with the addition of 300mcg strength to Fentora

Buccals (new strength available) in policy guideline bolding of the beginning of

paragraph in policy guidelines for antivirals and the addition of HAS in sentence for

leukotriences in policy guidelines and a paragraph formatting in rationalesource

020811 Replace Policy - Reference to COX II inhibitors and transmucosal fentanyl citrate

removed from the Policy statements and entirety of the policy and are now discussed

in 501529 References removed

061311 Replace Policy - Policy updated based on review by PampT May 2011 List of point-of-

sale program drugs updated antiemetics removed from the list and the medically

necessary policy statement has been removed from the Policy section The medically

necessary policy statement on non-benzodiazepine hypnotic drugs has been updated

to include zaleplon as one of the agents required for failed trial Rationale updated

Phased-in additional changes are August - Solodynreg (extended-release minocycline)

considered medically necessary for the treatment of inflammatory lesions of acne

following a failed trial of any generic tetracycline product eg doxycycline or

minocycline September - Nonpreferred atypical antipsychotics considered medically

necessary for labeled indications following failed trial of a preferred atypical

antipsychotic agent AND orally-administered brand Bisphosphonate products

considered medically necessary for treatment of osteoporosis following a failed a trial

of generic alendronate October - Nonpreferred ARBs considered medically necessary

for the treatment of cardiovascular disease and diabetes following failed trial of a

preferred ARB Policy Guidelines updated for the October phase indicating preferred

ARB allowable for patients unable to tolerate nonpreferred ARBs

080111 Replace Policy - Preapproved edits for August implementation added to policy policy

published

091011 Replace Policy ndash Preapproved edits for September implementation added to policy

September - Nonpreferred atypical antipsychotics considered medically necessary for

labeled indications following failed trial of a preferred atypical antipsychotic agent

AND orally-administered brand Bisphosphonate products considered medically

necessary for treatment of osteoporosis following a failed a trial of generic

alendronate

090711 Replace Policy ndash Policy updated and published with final changes originally scheduled

for October The changes are as follows and carry the effective date of 9711

Nonpreferred ARBs considered medically necessary for the treatment of cardiovascular

disease and diabetes following failed trial of a preferred ARB Policy Guidelines

updated for the October phase indicating preferred ARB allowable for patients unable

to tolerate nonpreferred ARBs Description section updated Atelviatrade (risendronate

sodium delayed release) added to the list of biophosphates included in the Pharmacy


Date Comments Point-of-Sale program

022712 Replace policy Policy updated with an additional policy statement indicating brand

ophthalmic prostaglandin analogs as medically necessary to reduce intraocular

pressure in patients with glaucoma when the patient has failed trial of generic

latanoprost Sitagliptin and simvastatin (Juvisynctrade) added to the approved medically

necessary medications to treat type 2 diabetes within the category of incretin mimetics

or DPP4 inhibitors Edarbireg added to the list of ARBs approved for medically necessary

treatment of CV and diabetes Reviewed by PampT on January 24 2012

033012 Minor update Valtuma (aliskirenvalsartan) no longer covered by this policy it was

removed

041012 Replace policy Policy updated with a new medically necessary policy statement for

Intranasal brand corticosteroid products (eg Beconase AQreg Nasonexreg Rhinocort

Aquareg Omnarisreg Veramystreg) for allergic rhinitis when the patient has failed a trial

of at least one generic intranasal corticosteroid Newly approved brand and POS drugs

added to policy

050812 Qnaslreg added to the list in intranasal steroids within the Policy section Statins were

removed from the policy

053012 Minor update irbesartan and irbesartanHCT added to the list of nonpreferred

angiotensin II receptor blockers approved as medically necessary when a preferred

medication has failed and lansoprazole added to the list of proton pump inhibits

approved as medically necessary for treatment of acid peptic diseases

073112 Minor update Two updates were made to the Policy Guidelines 1 an additional bullet

point under the limitations of coverage for modafinil (Provigilreg) or armodafinil

(Nuvigilreg) was added indicating therapy with Nuvigilreg will be approved ONLY when

the prescriber has documented an adverse reaction or intolerance to generic modafinil

or Provigil 2 clarification was added to the paragraph on non-benzodiazepines

hypnotic agents (branded single source) pointing out zolpidem or zaleplon as

examples of generic agents requiring a trial failure for approval These edits are

effective as of 8112 for prior authorization and were approved by PampT May 2012

100912 Replace Policy ndash Policy section revised Abilify has been added with 2 medically

necessary statements There is now a double-step edit requiring the use of metformin

unless contraindicated the use of any two generics or a generic and an insulin must be

tried

112612 Update Related Policies Add 501529

031113 Replace policy Policy updated with the following 1) Brand non-insulin agents for the

treatment of type 2 diabetes and TZDrsquos combined ndash remove THIAZOLIDINEDIONES

(TZD) language and slight change in the Brand non-insulin products language (There

will be one Diabetic Agent Policy) Second generation antipsychotics (SGA) - Paragraph

added to further clarify the SGA prior authorization criteria Bisphosphonates -

Addition of new medication BINOSTOreg and remove BONIVAreg Angiotensin receptor

blockers - move DIOVAN HCTreg from preferred to non-preferred list and addition of 2


Date Comments new generics to preferred list Proton Pump Inhibitors ndash increase the number of failed

trials to at least two of the listed medications before this class of drug would be

approved for medical necessity in treating GERD esophagitis or ulcer 2) Policy

updated with medically necessary indications for Abilifyreg with or without the failure

of a generic SGA removing criteria of the need for a legitimate medical reason to

avoid the potential weight gain or metabolic effects of other SGAs and for concern

about potential QT prolongation with ziprasidone psychotic disorder or psychotic

symptoms Schizoaffective Disorder Bipolar Disorders disorders with subtle psychotic

thinking (eating disorders Post Traumatic Stress Disorder personality disorders)

severe agitation or Autism or Autism Spectrum Disorders augmentation of

antidepressant medication for depressive disorders when at least two antidepressants

medications have failed for the augmentation of an anxiolytic for Generalized Anxiety

Disorder when at least two anxiolytic medications have failed and at least one of which

is or was an SSRI and for the augmentation of medication for Obsessive Compulsive

Disorder when there have been at least two failed trials of medications for OCD

031513 Replace policy Added ibrandronate to the Bisphosphonates within the Policy section

removed text in Brand Non-Insulin Agents within the Description

041113 Minor update Clarification made in Description section brand SGAs bullet now

preceded by including but not limited to

051313 Replace policy Policy updated with two new policy statements 1) Non-Preferred

Combination Beta-2 Agonist Corticosteroid Inhalers Advair Diskusreg (fluticasone

propionate salmeterol) and Advair HFAreg (fluticasone propionate salmeterol) may

be considered medically necessary after the trial and falure of at least one Preferred

Combination Beta-2 AgonistCorticosteroid Inhalers (these have been defined) 2)

Nonpreferred Testosterone Replacement agents (examples provided) may be

considered medically necessary when the patient has failed a trial of the preferred

agent Androgelreg (testosterone gel) Policy Guidelines section updated with coverage

criteria of newly added agents which have also been listed in the Description section


070813 Replace policy Policy section updated with Breo Elliptatrade (fluticasone furoate

vilanterol) as an added product to the list of non-preferred combination beta-2

agonistcorticosteroid inhalers approved following trial and failure of at least on

preferred product Clarification was added to the policy that it is managed through the

memberrsquos pharmacy benefit this is now listed in the header and within the coding

section

081213 Replace policy Policy updated with the addition of crofelemer as medically necessary

for symptomatic relief of non-infectious diarrhea in adult patients with HIVAIDS The

leukotriene modifier edit has been removed from the Policy section as Singular went

generic The policy statement for brand ADHD drugs has been updated to indicate all

brand ADHD drugs are subject to review and may be approved when a generic has

failed is not available or is inappropriate as outlined Travoprost is now added to the

list of generics which must be tried and failed for a patient to qualify for coverage for


Date Comments brand ophthalmic prostaglandin analogs Policy section reorganized for clarification

with a table added to outline specifically those medications addressed in this policy

which are subject to the Companyrsquos Pharmacy Prior Authorization program

090913 Replace policy Xyremreg added to Policy section with a medically necessary indication

for treating narcolepsy when diagnosed through a sleep study Rational section

updated in support of this addition

101413 Replace policy Policy section updated with addition of Homozygous Familial

Hypercholesterolemia Agents Mipomersen (Kynamrotrade) and lomitapide (Juxtapidreg)

considered medically necessary as adjunctive therapy to lower low-density cholesterol

(LDL) apolipoprotein B total cholesterol and non-HDL cholesterol Policy Guidelines

section also updated Change title to policy 201503

120413 Replace policy Policy updated with medical necessity criteria for brand stimulant and

brand non-stimulant ADHD drugs Seroquel XRreg (quetiapine fumarate) added as

medically necessary in the treatment of depressive disorders when criteria are met

and Latudareg (lurasidone HCL) and Seroquel XRreg (quetiapine fumarate) added as

medically necessary to treat bi-polar disorder Rationale section updated

031014 Annual review Policy section updated to reflect expansion of brand stimulants and

non-stimulants previously only addressing ADHD to now include other psychiatric

conditions

041414 Interim review Policy updated with the addition of Abilifyreg (aripiprazole) as medically

necessary for the augmentation of medication for OCD (without trial and failure of at

least one generic SGA) when criteria are met Versacloztrade (clozapine) Oral solution as

medically necessary for Schizoaffective Disorder and bipolar disorder when trial and

failure criteria are met and Versacloztrade (clozapine) Oral solution as medically

necessary for patients who require a liquid formulation instead of a pill

051214 Interim review Policy updated with the addition of a new drug Hetlioz now included

in the hypnotics category Lunesta was removed from this same category as it is now

available generically Eszopiclone has been added as a qualifier for coverage of a

brand name hypnotic drug


081114 Interim review Testosterone gel Vogelxotrade added to the list of medically necessary

agents for testosterone replacement therapy Amitizareg Linzesstrade added to treat

constipation treatment of Cushingrsquos removed (addressed in another policy)

References 50 ndash 56 added

090814 Interim review Jardiancereg added to the list of approved drugs within the category of

non-insulin antidiabetic agents brands as listed on the drug class table A policy

statement was added to indicate that the use of two or more branded non-stimulant

medications for ADHD or other psychiatric conditions is considered to be not

medically necessary Another policy statement was added to clarify that the

simultaneous use of two or more stimulant medications for ADHD or other psychiatric

conditions is considered to be not medically necessary except when a short-acting


Date Comments stimulant is used to provide coverage for an additional few hours after a long-acting

stimulant wears off

101314 Interim update Removed all multisource brand medications as this policy will now

only target SSB medications Also cleaned up the formatting for superscript so that all

were the same

111014 Interim update Policy section updated with the addition of a medically necessary

statement for nitrogen scavenging agents

120814 Interim update Additional drugs added to the Non-Insulin Antidiabetic Agents brands

section of the Policy section

122214 Interim update Belsomrareg added to the list of non-benzodiazepine hypnotic brand

drugs Approved by PampT November 2014 Related Policy 1101504 updated it is

renumbered to 601522

012815 Annual review Policy updated with the addition of 2 proton pump medications to

support recent edits Aciphex and Zegerid

021015 Minor update Policy converted to UM Guideline Modafinil criterion removed

requiring trial of two or more standard antidepressant medications that need to be

stopped due to triggering or worsening hypomania or mania as related to fatigue

andor sleepiness

031015 Annual review Updated criteria for ARB and PPI and added some additional language

on the ADHD guidelines Drugs that will no longer require a PA review removed from

the policy

041415 Interim update Natesto added to the list of Testosterone therapy agents A not

medically necessary policy statement for branded non-stimulants for psychiatric

conditions for which there is no credible published scientific evidence of efficacy or

effectiveness

052715 Interim Update Added verbiage about additional formulary alternative needing to be

tried for MSB medications and removed requirement for MedWatch form for both

MSB and DAW reviews Dosage information on Xyrem added

060915 Interim update Policy update with a new ADHD drug Aptension XR criteria added for

Vyvanse regarding drug abuse or dependence Removed Intuniv and criter for Fulyzaq

since the PA is being removed

071415 Interim update Glyxambi added to miscellaneous brand anti-diabetics Fulyzaq

removed to align with PA edit removal Xalatan removed and bimtoprost added to the

qualifier list for ophthalmic prostaglandin analogs

091415 Interim update Added new strength of Riatlin LA (60 mg) added Rexulti (new drug)

Removed the following edit retired AdvairBreo Ellipta Abilify and PPIs

101315 Interim Update Update step table Removed - line in table for diabetic medication

combination products that include metformin Provigil and modafinil from drug target

table criteria information for modafinil and Provigil as they are no longer requiring


Date Comments prior authorization Updated ndash criteria section for Nuvigil to add indication for Shift

Work Sleep Disorder as being covered with prior trial of modafinil or Provigil

indications for sleep apnea narcolepsy and idiopathic hypersomnia to require prior

trial of modafinil or Provigil depression criteria to include requirement of trial of

modafinil or Provigil Added ndash Sentence to indicate all other used of Nuvigil other than

those called out in the policy will be considered investigational

111015 Interim Update Removed indication of Type 2 diabetes from the Non-Insulin

Antidiabetic Agents criteria

021816 Annual Review Policy updated with edits effective March 1 2016 ndash ADHD Straterra

removed Vyvanse added coverage for Binge Eating Disorder Brand SGA removed

diagnosis requirement added requirement of generic apiprzaole for Rexulti only

Constipation removed OTC trial from Linzess added OIC diagnosis for Amitizia and

criteria for Movantik Heart Failure added criteria for Corlanor and Entresto Non-

Insulin Antidiabetic removed diagnosis requirement of DSM Type 2 NSAIDs and

Combinations added Criteria for Cambia Duexis and Vimovo

040116 Minor update approved March 8 2016 DyanaveltradeXR added to the list of ADHD brand

drugs

050116 Minor update to policy approved April 12 2016 The following medications have been

addedAdzenys XR-ODT Quillichew ER Ticanase Aloglipton-Pioglitazone generic

testosterone to preferred agents for Testosterone Replacement Products The

following drugs were removed Invega Intermezzo and Nasonex

060116 Minor update approved May 10 2016 Clarification on the criteria for Entrestoreg

070116 Interim Update approved June 14 2016 Addition of a new agent Nuplazid and its

criteria to the policy (PA to label) Description section was also updated to include a

summary of Parkinsonrsquos Disease Psychosis Removal of Nuvigil from the policy due to a

generic release

090116 Interim Update approved August 9 2016 Ticaspraytrade added to the list of brand nasal

corticosteroids

100116 Interim Update approved September 13 2016 Removal of the diabetes criteria (please

see ldquoPharmacotherapy of Type I and Type II Diabetes Mellitusrdquo policy for a set of new

criteria)

110116 Interim review approved October 11 2016 Insulin criteria put back in the policy due

to staggered Prior-Authorization (PA) roll out Will be in place until 1117 when all

Lines of Business are switched over to the same PA edit then please refer to the policy

501569 Language change for hypnotic agents

120116 Interim review approved November 8 2016 Due to Benicar and BenicarHCT going

generic removed drug names from the brand ARB criteria

010117 Interim review approved December 13 2016 Due to Seroquel XR going generic

removed drug name from the brand second generation anti-psychotic criteria


Date Comments 030117 Annual review approved February 14 2017 Removed travoprost from alternatives for

brand-name ophthalmic drops due to drug no longer being available on the market

031517 Interim review approved February 15 2017 Added a new agent to the policy ndash

Emflazareg (deflazacort) ndash considered medically necessary to treat Duchenne Muscular

Dystrophy (DMD) in patients 5 years of age and older per labeled indication Policy

effective date will be March 15 2017

040117 Interim review approved March 14 2017 Removed Focalin XR from the list of drugs

requiring a prior authorization added chart notes requirement for Vimovo Duexis and

Cambia updated criteria for deflazacort

060117 Interim Review approved May 16 2017 Policy moved into new format Updated

coverage criteria for Entrestoreg

070117 Interim Review approved June 22 2017 Removed criteria for non-insulin diabetic

drugs Added criteria for Xyrosareg Minolirareg Livaloreg Trulancereg and Xermeloreg

Added summary statements for Livaloreg Trulancereg and Xermeloreg

080117 Interim Review approved July 25 2017 Update ADHD drugs (add Mydayis) update

reauthorization criteria for Xyrem

090117 Interim Review approved August 22 2017 Added the drug Zypitamag and Updated

ADHD drugs (add Cotempla XR-ODT)

091517 Interim Review approved September 12 2017 effective September 15 2017 Added

Flolipid and Nikita added brand oral acne products updated Solodyn Xyrosa amp

Minolara criteria added Ingrezza amp Austedo added Carospir

110117 Interim Review approved October 3 2017 Updated oral acne antibiotics criteria and

updated brand testosterone products criteria

120117 Interim Update approved November 9 2017 Added criteria for Ximinotrade

010118 Interim Update approved December 6 2017 Added statement that Entrestoreg is

considered investigational in pediatric patients (under age 18) Added Abilify MyCite

and Vyzulta Removed 201503 from Related Policies as it was archived

030118 Interim Review approved February 27 2018 Added Adzenys ER under the Individual

Agent column for the drug class of ADHD Drugs brands Criteria for Xyrem was

updated Criteria for Trulance and Movantik were updated due to FDA label

expansions

050118 Annual Review approved April 17 2018 Added criteria for Rhopressa and Xepi Added

note that this policy has been updated and included link to policy that becomes

effective August 3 2018

Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The

Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and

local standards of practice Since medical technology is constantly changing the Company reserves the right to review


and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit

booklet or contact a member service representative to determine coverage for a specific medical service or supply

CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera

All Rights Reserved

Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when

determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to

the limits and conditions of the member benefit plan Members and their providers should consult the member

benefit booklet or contact a customer service representative to determine whether there are any benefit limitations

applicable to this service or supply This medical policy does not apply to Medicare Advantage

037338 (07-2016)

Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race color national origin age disability or sex Premera does not exclude people or treat them differently because of race color national origin age disability or sex Premera bull Provides free aids and services to people with disabilities to communicate

effectively with us such as bull Qualified sign language interpreters bull Written information in other formats (large print audio accessible

electronic formats other formats) bull Provides free language services to people whose primary language is not

English such as bull Qualified interpreters bull Information written in other languages

If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ

(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي

مھمة قد تكون ھناك تواريخ Premera Blue Cross خالل من التغطية التي تريد الحصول عليھا للمساعدة أو الصحية تغطيتك على للحفاظ معينة تواريخ في إجراء التخاذ تحتاج اإلشعار وقد ھذا فياتصل تكلفة أية دون تكبد بلغتك والمساعدة ھذه المعلومات على يحق لك الحصول التكاليف دفع في (TTY 800-842-5357) 1471-722-800بـ

中文 (Chinese) 本通知有重要的訊息本通知可能有關於您透過 Premera Blue Cross 提交的

申請或保險的重要訊息本通知內可能有重要日期您可能需要在截止日期

之前採取行動以保留您的健康保險或者費用補貼您有權利免費以您的母

語得到本訊息和幫助請撥電話 800-722-1471 (TTY 800-842-5357)

Oromoo (Cushite) Beeksisni kun odeeffannoo barbaachisaa qaba Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandarsquoa Guyyaawwan murteessaa tarsquoan beeksisa kana keessatti ilaalaa Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandarsquoa Kaffaltii irraa bilisa haala tarsquoeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu Lakkoofsa bilbilaa 800-722-1471 (TTY 800-842-5357) tii bilbilaa Franccedilais (French) Cet avis a dimportantes informations Cet avis peut avoir dimportantes informations sur votre demande ou la couverture par lintermeacutediaire de Premera Blue Cross Le preacutesent avis peut contenir des dates cleacutes Vous devrez peut-ecirctre prendre des mesures par certains deacutelais pour maintenir votre couverture de santeacute ou daide avec les coucircts Vous avez le droit dobtenir cette information et de lrsquoaide dans votre langue agrave aucun coucirct Appelez le 800-722-1471 (TTY 800-842-5357) Kreyogravel ayisyen (Creole) Avi sila a gen Enfogravemasyon Enpogravetan ladann Avi sila a kapab genyen enfogravemasyon enpogravetan konsegravenan aplikasyon w lan oswa konsegravenan kouvegraveti asirans lan atravegrave Premera Blue Cross Kapab genyen dat ki enpogravetan nan avi sila a Ou ka gen pou pran kegravek aksyon avan segraveten dat limit pou ka kenbe kouvegraveti asirans sante w la oswa pou yo ka ede w avegravek depans yo Se dwa w pou resevwa enfogravemasyon sa a ak asistans nan lang ou pale a san ou pa gen pou peye pou sa Rele nan 800-722-1471 (TTY 800-842-5357) Deutsche (German) Diese Benachrichtigung enthaumllt wichtige Informationen Diese Benachrichtigung enthaumllt unter Umstaumlnden wichtige Informationen bezuumlglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung Sie koumlnnten bis zu bestimmten Stichtagen handeln muumlssen um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten Sie haben das Recht kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten Rufen Sie an unter 800-722-1471 (TTY 800-842-5357) Hmoob (Hmong) Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj Hu rau 800-722-1471 (TTY 800-842-5357) Iloko (Ilocano) Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo Tumawag iti numero nga 800-722-1471 (TTY 800-842-5357) Italiano (Italian) Questo avviso contiene informazioni importanti Questo avviso puograve contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross Potrebbero esserci date chiave in questo avviso Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente Chiama 800-722-1471 (TTY 800-842-5357)

日本語 (Japanese) この通知には重要な情報が含まれていますこの通知にはPremera Blue Cross の申請または補償範囲に関する重要な情報が含まれている場合があ

りますこの通知に記載されている可能性がある重要な日付をご確認くだ

さい健康保険や有料サポートを維持するには特定の期日までに行動を

取らなければならない場合がありますご希望の言語による情報とサポー

トが無料で提供されます800-722-1471 (TTY 800-842-5357)までお電話

ください 한국어 (Korean) 본 통지서에는 중요한 정보가 들어 있습니다 즉 이 통지서는 귀하의 신청에 관하여 그리고 Premera Blue Cross를 통한 커버리지에 관한 정보를 포함하고 있을 수 있습니다 본 통지서에는 핵심이 되는 날짜들이 있을 수 있습니다 귀하는 귀하의 건강 커버리지를 계속 유지하거나 비용을 절감하기 위해서 일정한 마감일까지 조치를 취해야 할 필요가 있을 수 있습니다 귀하는 이러한 정보와 도움을 귀하의 언어로 비용 부담없이 얻을 수 있는 권리가 있습니다 800-722-1471 (TTY 800-842-5357) 로 전화하십시오

ລາວ (Lao) ແຈງການນມຂມນສາຄນ ແຈງການນອາດຈະມຂມນສາຄນກຽວກບຄາຮອງສະໝກ ຫ ຄວາມຄມຄອງປະກນໄພຂອງທານຜານ Premera Blue Cross ອາດຈະມວນທສາຄນໃນແຈງການນ ທານອາດຈະຈາເປນຕອງດາເນນການຕາມການດເວລາສະເພາະເພອຮກສາຄວາມຄມຄອງປະກນສຂະພາບ ຫ ຄວາມຊວຍເຫອເລອງຄາໃຊຈາຍຂອງທານໄວ ທານມສດໄດຮບຂມນນ ແລະ ຄວາມຊວຍເຫອເປນພາສາຂອງທານໂດຍບເສຍຄາ ໃຫໂທຫາ 800-722-1471 (TTY 800-842-5357) ភាសាែខមរ (Khmer)

េសចកត ជនដណងេនះមានពតមានយាងសខាន េសចកត ជនដណងេនះរបែហល

ជាមានពតមានយាងសខានអពទរមងែបបបទ ឬការរាបរងរបសអនកតាមរយៈ

Premera Blue Cross របែហលជាមាន កាលបរេចឆទសខានេនៅកន ងេសចកត ជន

ដណងេនះ អនករបែហលជារតវការបេញចញសមតថភាព ដលកណតៃថងជាកចបាស

នានា េដើមបនងរកសាទកការធានារាបរងសខភាពរបសអនក ឬរបាកជនយេចញៃថល

អនកមានសទធទទលពតមានេនះ នងជនយេនៅកន ងភាសារបសអនកេដាយមនអស

លយេឡើយ សមទរសពទ 800-722-1471 (TTY 800-842-5357)

ਪਜਾਬੀ (Punjabi)

ਇਸ ਨਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ ਇਸ ਨਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤਹਾਡੀ ਕਵਰਜ ਅਤ ਅਰਜੀ ਬਾਰ ਮਹਤਵਪਰਨ ਜਾਣਕਾਰੀ ਹ ਸਕਦੀ ਹ ਇਸ ਨਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹ ਸਕਦੀਆ ਹਨ ਜਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰਖਣੀ ਹਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵਚ ਮਦਦ ਦ ਇਛਕ ਹ ਤਾ ਤਹਾਨ ਅਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾ ਕ ਝ ਖਾਸ ਕਦਮ ਚ ਕਣ ਦੀ ਲੜ ਹ ਸਕਦੀ ਹ ਤਹਾਨ

ਮਫ਼ਤ ਿਵਚ ਤ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵਚ ਜਾਣਕਾਰੀ ਅਤ ਮਦਦ ਪਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ਕਾਲ

800-722-1471 (TTY 800-842-5357)

(Farsi) فارسی فرم درباره مھم اطالعات ممکن است حاوی اعالميه اين ميباشد مھم اطالعات یوحا اعالميه اين

در مھم ھای تاريخ به باشد Premera Blue Crossشما از طريق ای بيمه پوشش يا و تقاضابيمه تان يا کمک در پرداخت ھزينه پوشش حقظ برای است ممکن شما نماييد توجه اعالميه اين

حق شما خاصی احتياج داشته باشيد انجام کارھای مشخصی برای ھای تاريخ به درمانی تانھای نماييد برای کسب رايگان دريافت طور به خود زبان به را کمک و اطالعات اين که داريد را اين

تماس )800-842-5357تماس باشماره TTY(کاربران 800-722-1471 اطالعات با شماره نماييدبرقرار

Polskie (Polish) To ogłoszenie może zawierać ważne informacje To ogłoszenie może zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez Premera Blue Cross Prosimy zwroacutecic uwagę na kluczowe daty ktoacutere mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminoacutew w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami Macie Państwo prawo do bezpłatnej informacji we własnym języku Zadzwońcie pod 800-722-1471 (TTY 800-842-5357) Portuguecircs (Portuguese) Este aviso conteacutem informaccedilotildees importantes Este aviso poderaacute conter informaccedilotildees importantes a respeito de sua aplicaccedilatildeo ou cobertura por meio do Premera Blue Cross Poderatildeo existir datas importantes neste aviso Talvez seja necessaacuterio que vocecirc tome providecircncias dentro de determinados prazos para manter sua cobertura de sauacutede ou ajuda de custos Vocecirc tem o direito de obter esta informaccedilatildeo e ajuda em seu idioma e sem custos Ligue para 800-722-1471 (TTY 800-842-5357)

Romacircnă (Romanian) Prezenta notificare conține informații importante Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin Premera Blue Cross Pot exista date cheie icircn această notificare Este posibil să fie nevoie să acționați pacircnă la anumite termene limită pentru a vă menține acoperirea asigurării de sănătate sau asistența privitoare la costuri Aveți dreptul de a obține gratuit aceste informații și ajutor icircn limba dumneavoastră Sunați la 800-722-1471 (TTY 800-842-5357) Pусский (Russian) Настоящее уведомление содержит важную информацию Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через Premera Blue Cross В настоящем уведомлении могут быть указаны ключевые даты Вам возможно потребуется принять меры к определенным предельным срокам для сохранения страхового покрытия или помощи с расходами Вы имеете право на бесплатное получение этой информации и помощь на вашем языке Звоните по телефону 800-722-1471 (TTY 800-842-5357) Farsquoasamoa (Samoan) Atonu ua iai i lenei farsquoasilasilaga ni farsquoamatalaga e sili ona taua e tatau ona e malamalama i ai O lenei farsquoasilasilaga o se fesoasoani e farsquoamatala atili i ai i le tulaga o le polokalame Premera Blue Cross ua e tau fia maua atu i ai Farsquoamolemole ia e iloilo farsquoalelei i aso farsquoapitoa olorsquoo iai i lenei farsquoasilasilaga taua Masalo o lersquoa iai ni feau e tatau ona e faia ao lersquoi aulia le aso ua tarsquoua i lenei farsquoasilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olorsquoo e iai i ai Olorsquoo iai iate oe le aia tatau e maua atu i lenei farsquoasilasilaga ma lenei farsquomatalaga i legagana e te malamalama i ai aunoa ma se togiga tupe Vili atu i le telefoni 800-722-1471 (TTY 800-842-5357) Espantildeol (Spanish) Este Aviso contiene informacioacuten importante Es posible que este aviso contenga informacioacuten importante acerca de su solicitud o cobertura a traveacutes de Premera Blue Cross Es posible que haya fechas clave en este aviso Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura meacutedica o ayuda con los costos Usted tiene derecho a recibir esta informacioacuten y ayuda en su idioma sin costo alguno Llame al 800-722-1471 (TTY 800-842-5357) Tagalog (Tagalog) Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross Maaaring may mga mahalagang petsa dito sa paunawa Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos Tumawag sa 800-722-1471 (TTY 800-842-5357) ไทย (Thai)

ประกาศนมขอมลสาคญ ประกาศนอาจมขอมลทสาคญเกยวกบการการสมครหรอขอบเขตประกนสขภาพของคณผาน Premera Blue Cross และอาจมกาหนดการในประกาศน คณอาจจะตองดาเนนการภายในกาหนดระยะเวลาทแนนอนเพอจะรกษาการประกนสขภาพของคณหรอการชวยเหลอทมคาใชจาย คณมสทธทจะไดรบขอมลและความชวยเหลอนในภาษาของคณโดยไมมคาใชจาย โทร 800-722-1471 (TTY 800-842-5357) Український (Ukrainian) Це повідомлення містить важливу інформацію Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross Зверніть увагу на ключові дати які можуть бути вказані у цьому повідомленні Існує імовірність того що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того щоб зберегти Ваше медичне страхування або отримати фінансову допомогу У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові Дзвоніть за номером телефону 800-722-1471 (TTY 800-842-5357) Tiếng Việt (Vietnamese) Thocircng baacuteo nagravey cung cấp thocircng tin quan trọng Thocircng baacuteo nagravey coacute thocircng tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quyacute vị qua chương trigravenh Premera Blue Cross Xin xem ngagravey quan trọng trong thocircng baacuteo nagravey Quyacute vị coacute thể phải thực hiện theo thocircng baacuteo đuacuteng trong thời hạn để duy trigrave bảo hiểm sức khỏe hoặc được trợ giuacutep thecircm về chi phiacute Quyacute vị coacute quyền được biết thocircng tin nagravey vagrave được trợ giuacutep bằng ngocircn ngữ của migravenh miễn phiacute Xin gọi số 800-722-1471 (TTY 800-842-5357)


Index of Drugs Drug Classes and Disease States

The medications in the following hyperlink table are affected by the Companyrsquos Pharmacy Prior

Authorization program


ADHD Drugs brands ADHD Adzenys ER Adzenys XR-ODTtrade Aptensio XRtrade

Cotempla XR-ODT Daytranareg DyanaveltradeXR Evekeo

Mydayis Quillichew ERtradeQuillivant XRreg Ritalin LAreg

10mg 60mg Vyvansereg Zenzeditrade

Angiotensin II Receptor Blockers brands Hypertension

Cardiovascular

Disease Diabetes

Edarbireg Edarbyclorreg TevetenHCTreg

Anti-hypertensivediuretic Edema

hypertension

severe heart failure

Carospirreg

Antipsychotics (2nd

Gen ldquoAtypicalsrdquo)

brands

Psychoses Bipolar

Disorder MDD etc

Fanaptreg Latudareg Rexultireg Saphrisreg Versacloztrade

Vraylarreg Nuplazidreg Abilify MyCitereg

Brand Oral Antibiotics Acne Rosacea

Infections

Solodynreg Xyrosa Minolira Acticlate Adoxa Avidoxy

Doryx Doryx MPC Doxycycline IR-DR Minocin

Monodox Morgidox Oracea and Targadox Ximino

Constipation IBS-C CIC OIC Amitizareg Linzessreg Movantikreg

Corticosteroids Duchenne Muscular

Dystrophy (DMD)

Emflazatrade (deflazacort)

Guanylate cyclase-C Agonists CIC IBS-C Trulancereg

Heart Failure Heart Failure Corlanorreg Entrestoreg

Homozygous Familial

Hypercholesterolemia

HoFH Juxtapidreg Kynamrotrade

Hypnotics non-benzodiazepine brands Insomnia Edluarreg Rozeremreg Zolpimisttrade Belsomrareg

Intranasal corticosteroid products brands Allergic Rhinitis Beconase AQreg Omnarisreg Qnaslreg Ticanasetrade

Ticaspraytrade Veramystreg Zetonnareg

Nitrogen scavenging agents Urea Cycle Disorder Ravictitrade

Nonsteroidal Anti-inflammatory Drugs

(NSAIDs)

Pain and

Inflammation

Cambiareg Duexisreg Vimovoreg


brands

Glaucoma Lumiganreg Travatan Zreg Vyzultatrade and Zioptanreg

Rho Kinase Inhibitor Elevated intraocular Rhopressareg



pressure




gel Vogelxotrade



Syndrome Diarrhea

Xermeloreg


Coverage Guideline







stimulant agent

OR


OR





dimesylate)






are met

















physically hungry


much one is eating


afterwards



for three months










abuse or dependence



blockers










antipsychotics










antipsychotic










AND



Maintena etc)

Constipation











investigational




(IBC-C)




















Corticosteroids























tolerated


Class II to IV




met







investigational
















liquid)




swallowing etc)


OR


OR

Edema

Hypnotics













Zetonnareg)






corticosteroid








phenylbutyrate)

Statins














following




OR


swallowing etc)






















famotidine)














Brand Ophthalmic














medical records)

Generic doxycycline

AND

Generic minocycline


Adoxa (doxycycline)




Doxycycline IR-DR









Generic doxycycline




release)Monodoxreg

(doxycycline)




minocycline)



minocycline)

AND

Generic minocycline















OR









Replacement agents






(162)







Xyremreg






OR





AND



contraindicated

AND



contraindicated









medically necessary


investigational



narcolepsy



AND




















Topical Antibiotic





mupirocin

Coding

NA

Related Information


Edits













Benefit Application


Evidence Review

Brand ADHD Agents




most patients










Bipolar depression











symptoms

























Constipation






















































































































these settings








insulin are ongoing






are also available

















































































essential tremor













HRQOL













































score




















References





2004 43227-238



























Metab 2010951174-1181



10100214651858CD001155pub2




































internal data








April 2018




Jan112(1)29-31








2008158208-216




Accessed April 2018




Accessed April 2018















2018


February 2018














History








27 2007






















































published






alendronate


















removed





added to policy


















tried












































section



























conditions

























stimulant wears off



were the same













andor sleepiness



the policy




effectiveness
































drugs









generic release


corticosteroids



criteria)








































expansions











All Rights Reserved






037338 (07-2016)






























800-722-1471 (TTY 800-842-5357)










pressure




gel Vogelxotrade



Syndrome Diarrhea

Xermeloreg


Coverage Guideline







stimulant agent

OR


OR





dimesylate)






are met

















physically hungry


much one is eating


afterwards



for three months










abuse or dependence



blockers










antipsychotics










antipsychotic










AND



Maintena etc)

Constipation











investigational




(IBC-C)




















Corticosteroids























tolerated


Class II to IV




met







investigational
















liquid)




swallowing etc)


OR


OR

Edema

Hypnotics













Zetonnareg)






corticosteroid








phenylbutyrate)

Statins














following




OR


swallowing etc)






















famotidine)














Brand Ophthalmic














medical records)

Generic doxycycline

AND

Generic minocycline


Adoxa (doxycycline)




Doxycycline IR-DR









Generic doxycycline




release)Monodoxreg

(doxycycline)




minocycline)



minocycline)

AND

Generic minocycline















OR









Replacement agents






(162)







Xyremreg






OR





AND



contraindicated

AND



contraindicated









medically necessary


investigational



narcolepsy



AND




















Topical Antibiotic





mupirocin

Coding

NA

Related Information


Edits













Benefit Application


Evidence Review

Brand ADHD Agents




most patients










Bipolar depression











symptoms

























Constipation






















































































































these settings








insulin are ongoing






are also available

















































































essential tremor













HRQOL













































score




















References





2004 43227-238



























Metab 2010951174-1181



10100214651858CD001155pub2




































internal data








April 2018




Jan112(1)29-31








2008158208-216




Accessed April 2018




Accessed April 2018















2018


February 2018














History








27 2007






















































published






alendronate


















removed





added to policy


















tried












































section



























conditions

























stimulant wears off



were the same













andor sleepiness



the policy




effectiveness
































drugs









generic release


corticosteroids



criteria)








































expansions











All Rights Reserved






037338 (07-2016)






























800-722-1471 (TTY 800-842-5357)























physically hungry


much one is eating


afterwards



for three months










abuse or dependence



blockers










antipsychotics










antipsychotic










AND



Maintena etc)

Constipation











investigational




(IBC-C)




















Corticosteroids























tolerated


Class II to IV




met







investigational
















liquid)




swallowing etc)


OR


OR

Edema

Hypnotics













Zetonnareg)






corticosteroid








phenylbutyrate)

Statins














following




OR


swallowing etc)






















famotidine)














Brand Ophthalmic














medical records)

Generic doxycycline

AND

Generic minocycline


Adoxa (doxycycline)




Doxycycline IR-DR









Generic doxycycline




release)Monodoxreg

(doxycycline)




minocycline)



minocycline)

AND

Generic minocycline















OR









Replacement agents






(162)







Xyremreg






OR





AND



contraindicated

AND



contraindicated









medically necessary


investigational



narcolepsy



AND




















Topical Antibiotic





mupirocin

Coding

NA

Related Information


Edits













Benefit Application


Evidence Review

Brand ADHD Agents




most patients










Bipolar depression











symptoms

























Constipation






















































































































these settings








insulin are ongoing






are also available

















































































essential tremor













HRQOL













































score




















References





2004 43227-238



























Metab 2010951174-1181



10100214651858CD001155pub2




































internal data








April 2018




Jan112(1)29-31








2008158208-216




Accessed April 2018




Accessed April 2018















2018


February 2018














History








27 2007






















































published






alendronate


















removed





added to policy


















tried












































section



























conditions

























stimulant wears off



were the same













andor sleepiness



the policy




effectiveness
































drugs









generic release


corticosteroids



criteria)








































expansions











All Rights Reserved






037338 (07-2016)






























800-722-1471 (TTY 800-842-5357)















antipsychotics










antipsychotic










AND



Maintena etc)

Constipation











investigational




(IBC-C)




















Corticosteroids























tolerated


Class II to IV




met







investigational
















liquid)




swallowing etc)


OR


OR

Edema

Hypnotics













Zetonnareg)






corticosteroid








phenylbutyrate)

Statins














following




OR


swallowing etc)






















famotidine)














Brand Ophthalmic














medical records)

Generic doxycycline

AND

Generic minocycline


Adoxa (doxycycline)




Doxycycline IR-DR









Generic doxycycline




release)Monodoxreg

(doxycycline)




minocycline)



minocycline)

AND

Generic minocycline















OR









Replacement agents






(162)







Xyremreg






OR





AND



contraindicated

AND



contraindicated









medically necessary


investigational



narcolepsy



AND




















Topical Antibiotic





mupirocin

Coding

NA

Related Information


Edits













Benefit Application


Evidence Review

Brand ADHD Agents




most patients










Bipolar depression











symptoms

























Constipation






















































































































these settings








insulin are ongoing






are also available

















































































essential tremor













HRQOL













































score




















References





2004 43227-238



























Metab 2010951174-1181



10100214651858CD001155pub2




































internal data








April 2018




Jan112(1)29-31








2008158208-216




Accessed April 2018




Accessed April 2018















2018


February 2018














History








27 2007






















































published






alendronate


















removed





added to policy


















tried












































section



























conditions

























stimulant wears off



were the same













andor sleepiness



the policy




effectiveness
































drugs









generic release


corticosteroids



criteria)








































expansions











All Rights Reserved






037338 (07-2016)






























800-722-1471 (TTY 800-842-5357)












investigational




(IBC-C)




















Corticosteroids























tolerated


Class II to IV




met







investigational
















liquid)




swallowing etc)


OR


OR

Edema

Hypnotics













Zetonnareg)






corticosteroid








phenylbutyrate)

Statins














following




OR


swallowing etc)






















famotidine)














Brand Ophthalmic














medical records)

Generic doxycycline

AND

Generic minocycline


Adoxa (doxycycline)




Doxycycline IR-DR









Generic doxycycline




release)Monodoxreg

(doxycycline)




minocycline)



minocycline)

AND

Generic minocycline















OR









Replacement agents






(162)







Xyremreg






OR





AND



contraindicated

AND



contraindicated









medically necessary


investigational



narcolepsy



AND




















Topical Antibiotic





mupirocin

Coding

NA

Related Information


Edits













Benefit Application


Evidence Review

Brand ADHD Agents




most patients










Bipolar depression











symptoms

























Constipation






















































































































these settings








insulin are ongoing






are also available

















































































essential tremor













HRQOL













































score




















References





2004 43227-238



























Metab 2010951174-1181



10100214651858CD001155pub2




































internal data








April 2018




Jan112(1)29-31








2008158208-216




Accessed April 2018




Accessed April 2018















2018


February 2018














History








27 2007






















































published






alendronate


















removed





added to policy


















tried












































section



























conditions

























stimulant wears off



were the same













andor sleepiness



the policy




effectiveness
































drugs









generic release


corticosteroids



criteria)








































expansions











All Rights Reserved






037338 (07-2016)






























800-722-1471 (TTY 800-842-5357)


























tolerated


Class II to IV




met







investigational
















liquid)




swallowing etc)


OR


OR

Edema

Hypnotics













Zetonnareg)






corticosteroid








phenylbutyrate)

Statins














following




OR


swallowing etc)






















famotidine)














Brand Ophthalmic














medical records)

Generic doxycycline

AND

Generic minocycline


Adoxa (doxycycline)




Doxycycline IR-DR









Generic doxycycline




release)Monodoxreg

(doxycycline)




minocycline)



minocycline)

AND

Generic minocycline















OR









Replacement agents






(162)







Xyremreg






OR





AND



contraindicated

AND



contraindicated









medically necessary


investigational



narcolepsy



AND




















Topical Antibiotic





mupirocin

Coding

NA

Related Information


Edits













Benefit Application


Evidence Review

Brand ADHD Agents




most patients










Bipolar depression











symptoms

























Constipation






















































































































these settings








insulin are ongoing






are also available

















































































essential tremor













HRQOL













































score




















References





2004 43227-238



























Metab 2010951174-1181



10100214651858CD001155pub2




































internal data








April 2018




Jan112(1)29-31








2008158208-216




Accessed April 2018




Accessed April 2018















2018


February 2018














History








27 2007






















































published






alendronate


















removed





added to policy


















tried












































section



























conditions

























stimulant wears off



were the same













andor sleepiness



the policy




effectiveness
































drugs









generic release


corticosteroids



criteria)








































expansions











All Rights Reserved






037338 (07-2016)






























800-722-1471 (TTY 800-842-5357)























liquid)




swallowing etc)


OR


OR

Edema

Hypnotics













Zetonnareg)






corticosteroid








phenylbutyrate)

Statins














following




OR


swallowing etc)






















famotidine)














Brand Ophthalmic














medical records)

Generic doxycycline

AND

Generic minocycline


Adoxa (doxycycline)




Doxycycline IR-DR









Generic doxycycline




release)Monodoxreg

(doxycycline)




minocycline)



minocycline)

AND

Generic minocycline















OR









Replacement agents






(162)







Xyremreg






OR





AND



contraindicated

AND



contraindicated









medically necessary


investigational



narcolepsy



AND




















Topical Antibiotic





mupirocin

Coding

NA

Related Information


Edits













Benefit Application


Evidence Review

Brand ADHD Agents




most patients










Bipolar depression











symptoms

























Constipation






















































































































these settings








insulin are ongoing






are also available

















































































essential tremor













HRQOL













































score




















References





2004 43227-238



























Metab 2010951174-1181



10100214651858CD001155pub2




































internal data








April 2018




Jan112(1)29-31








2008158208-216




Accessed April 2018




Accessed April 2018















2018


February 2018














History








27 2007






















































published






alendronate


















removed





added to policy


















tried












































section



























conditions

























stimulant wears off



were the same













andor sleepiness



the policy




effectiveness
































drugs









generic release


corticosteroids



criteria)








































expansions











All Rights Reserved






037338 (07-2016)






























800-722-1471 (TTY 800-842-5357)













phenylbutyrate)

Statins














following




OR


swallowing etc)






















famotidine)














Brand Ophthalmic














medical records)

Generic doxycycline

AND

Generic minocycline


Adoxa (doxycycline)




Doxycycline IR-DR









Generic doxycycline




release)Monodoxreg

(doxycycline)




minocycline)



minocycline)

AND

Generic minocycline















OR









Replacement agents






(162)







Xyremreg






OR





AND



contraindicated

AND



contraindicated









medically necessary


investigational



narcolepsy



AND




















Topical Antibiotic





mupirocin

Coding

NA

Related Information


Edits













Benefit Application


Evidence Review

Brand ADHD Agents




most patients










Bipolar depression











symptoms

























Constipation






















































































































these settings








insulin are ongoing






are also available

















































































essential tremor













HRQOL













































score




















References





2004 43227-238



























Metab 2010951174-1181



10100214651858CD001155pub2




































internal data








April 2018




Jan112(1)29-31








2008158208-216




Accessed April 2018




Accessed April 2018















2018


February 2018














History








27 2007






















































published






alendronate


















removed





added to policy


















tried












































section



























conditions

























stimulant wears off



were the same













andor sleepiness



the policy




effectiveness
































drugs









generic release


corticosteroids



criteria)








































expansions











All Rights Reserved






037338 (07-2016)






























800-722-1471 (TTY 800-842-5357)
















famotidine)














Brand Ophthalmic














medical records)

Generic doxycycline

AND

Generic minocycline


Adoxa (doxycycline)




Doxycycline IR-DR









Generic doxycycline




release)Monodoxreg

(doxycycline)




minocycline)



minocycline)

AND

Generic minocycline















OR









Replacement agents






(162)







Xyremreg






OR





AND



contraindicated

AND



contraindicated









medically necessary


investigational



narcolepsy



AND




















Topical Antibiotic





mupirocin

Coding

NA

Related Information


Edits













Benefit Application


Evidence Review

Brand ADHD Agents




most patients










Bipolar depression











symptoms

























Constipation






















































































































these settings








insulin are ongoing






are also available

















































































essential tremor













HRQOL













































score




















References





2004 43227-238



























Metab 2010951174-1181



10100214651858CD001155pub2




































internal data








April 2018




Jan112(1)29-31








2008158208-216




Accessed April 2018




Accessed April 2018















2018


February 2018














History








27 2007






















































published






alendronate


















removed





added to policy


















tried












































section



























conditions

























stimulant wears off



were the same













andor sleepiness



the policy




effectiveness
































drugs









generic release


corticosteroids



criteria)








































expansions











All Rights Reserved






037338 (07-2016)






























800-722-1471 (TTY 800-842-5357)











release)Monodoxreg

(doxycycline)




minocycline)



minocycline)

AND

Generic minocycline















OR









Replacement agents






(162)







Xyremreg






OR





AND



contraindicated

AND



contraindicated









medically necessary


investigational



narcolepsy



AND




















Topical Antibiotic





mupirocin

Coding

NA

Related Information


Edits













Benefit Application


Evidence Review

Brand ADHD Agents




most patients










Bipolar depression











symptoms

























Constipation






















































































































these settings








insulin are ongoing






are also available

















































































essential tremor













HRQOL













































score




















References





2004 43227-238



























Metab 2010951174-1181



10100214651858CD001155pub2




































internal data








April 2018




Jan112(1)29-31








2008158208-216




Accessed April 2018




Accessed April 2018















2018


February 2018














History








27 2007






















































published






alendronate


















removed





added to policy


















tried












































section



























conditions

























stimulant wears off



were the same













andor sleepiness



the policy




effectiveness
































drugs









generic release


corticosteroids



criteria)








































expansions











All Rights Reserved






037338 (07-2016)






























800-722-1471 (TTY 800-842-5357)











(162)







Xyremreg






OR





AND



contraindicated

AND



contraindicated









medically necessary


investigational



narcolepsy



AND




















Topical Antibiotic





mupirocin

Coding

NA

Related Information


Edits













Benefit Application


Evidence Review

Brand ADHD Agents




most patients










Bipolar depression











symptoms

























Constipation






















































































































these settings








insulin are ongoing






are also available

















































































essential tremor













HRQOL













































score




















References





2004 43227-238



























Metab 2010951174-1181



10100214651858CD001155pub2




































internal data








April 2018




Jan112(1)29-31








2008158208-216




Accessed April 2018




Accessed April 2018















2018


February 2018














History








27 2007






















































published






alendronate


















removed





added to policy


















tried












































section



























conditions

























stimulant wears off



were the same













andor sleepiness



the policy




effectiveness
































drugs









generic release


corticosteroids



criteria)








































expansions











All Rights Reserved






037338 (07-2016)






























800-722-1471 (TTY 800-842-5357)












medically necessary


investigational



narcolepsy



AND




















Topical Antibiotic





mupirocin

Coding

NA

Related Information


Edits













Benefit Application


Evidence Review

Brand ADHD Agents




most patients










Bipolar depression











symptoms

























Constipation






















































































































these settings








insulin are ongoing






are also available

















































































essential tremor













HRQOL













































score




















References





2004 43227-238



























Metab 2010951174-1181



10100214651858CD001155pub2




































internal data








April 2018




Jan112(1)29-31








2008158208-216




Accessed April 2018




Accessed April 2018















2018


February 2018














History








27 2007






















































published






alendronate


















removed





added to policy


















tried












































section



























conditions

























stimulant wears off



were the same













andor sleepiness



the policy




effectiveness
































drugs









generic release


corticosteroids



criteria)








































expansions











All Rights Reserved






037338 (07-2016)






























800-722-1471 (TTY 800-842-5357)












mupirocin

Coding

NA

Related Information


Edits













Benefit Application


Evidence Review

Brand ADHD Agents




most patients










Bipolar depression











symptoms

























Constipation






















































































































these settings








insulin are ongoing






are also available

















































































essential tremor













HRQOL













































score




















References





2004 43227-238



























Metab 2010951174-1181



10100214651858CD001155pub2




































internal data








April 2018




Jan112(1)29-31








2008158208-216




Accessed April 2018




Accessed April 2018















2018


February 2018














History








27 2007






















































published






alendronate


















removed





added to policy


















tried












































section



























conditions

























stimulant wears off



were the same













andor sleepiness



the policy




effectiveness
































drugs









generic release


corticosteroids



criteria)








































expansions











All Rights Reserved






037338 (07-2016)






























800-722-1471 (TTY 800-842-5357)









Benefit Application


Evidence Review

Brand ADHD Agents




most patients










Bipolar depression











symptoms

























Constipation






















































































































these settings








insulin are ongoing






are also available

















































































essential tremor













HRQOL













































score




















References





2004 43227-238



























Metab 2010951174-1181



10100214651858CD001155pub2




































internal data








April 2018




Jan112(1)29-31








2008158208-216




Accessed April 2018




Accessed April 2018















2018


February 2018














History








27 2007






















































published






alendronate


















removed





added to policy


















tried












































section



























conditions

























stimulant wears off



were the same













andor sleepiness



the policy




effectiveness
































drugs









generic release


corticosteroids



criteria)








































expansions











All Rights Reserved






037338 (07-2016)






























800-722-1471 (TTY 800-842-5357)














symptoms

























Constipation






















































































































these settings








insulin are ongoing






are also available

















































































essential tremor













HRQOL













































score




















References





2004 43227-238



























Metab 2010951174-1181



10100214651858CD001155pub2




































internal data








April 2018




Jan112(1)29-31








2008158208-216




Accessed April 2018




Accessed April 2018















2018


February 2018














History








27 2007






















































published






alendronate


















removed





added to policy


















tried












































section



























conditions

























stimulant wears off



were the same













andor sleepiness



the policy




effectiveness
































drugs









generic release


corticosteroids



criteria)








































expansions











All Rights Reserved






037338 (07-2016)






























800-722-1471 (TTY 800-842-5357)









Constipation






















































































































these settings








insulin are ongoing






are also available

















































































essential tremor













HRQOL













































score




















References





2004 43227-238



























Metab 2010951174-1181



10100214651858CD001155pub2




































internal data








April 2018




Jan112(1)29-31








2008158208-216




Accessed April 2018




Accessed April 2018















2018


February 2018














History








27 2007






















































published






alendronate


















removed





added to policy


















tried












































section



























conditions

























stimulant wears off



were the same













andor sleepiness



the policy




effectiveness
































drugs









generic release


corticosteroids



criteria)








































expansions











All Rights Reserved






037338 (07-2016)






























800-722-1471 (TTY 800-842-5357)





























































































these settings








insulin are ongoing






are also available

















































































essential tremor













HRQOL













































score




















References





2004 43227-238



























Metab 2010951174-1181



10100214651858CD001155pub2




































internal data








April 2018




Jan112(1)29-31








2008158208-216




Accessed April 2018




Accessed April 2018















2018


February 2018














History








27 2007






















































published






alendronate


















removed





added to policy


















tried












































section



























conditions

























stimulant wears off



were the same













andor sleepiness



the policy




effectiveness
































drugs









generic release


corticosteroids



criteria)








































expansions











All Rights Reserved






037338 (07-2016)






























800-722-1471 (TTY 800-842-5357)




























































these settings








insulin are ongoing






are also available

















































































essential tremor













HRQOL













































score




















References





2004 43227-238



























Metab 2010951174-1181



10100214651858CD001155pub2




































internal data








April 2018




Jan112(1)29-31








2008158208-216




Accessed April 2018




Accessed April 2018















2018


February 2018














History








27 2007






















































published






alendronate


















removed





added to policy


















tried












































section



























conditions

























stimulant wears off



were the same













andor sleepiness



the policy




effectiveness
































drugs









generic release


corticosteroids



criteria)








































expansions











All Rights Reserved






037338 (07-2016)






























800-722-1471 (TTY 800-842-5357)



























these settings








insulin are ongoing






are also available

















































































essential tremor













HRQOL













































score




















References





2004 43227-238



























Metab 2010951174-1181



10100214651858CD001155pub2




































internal data








April 2018




Jan112(1)29-31








2008158208-216




Accessed April 2018




Accessed April 2018















2018


February 2018














History








27 2007






















































published






alendronate


















removed





added to policy


















tried












































section



























conditions

























stimulant wears off



were the same













andor sleepiness



the policy




effectiveness
































drugs









generic release


corticosteroids



criteria)








































expansions











All Rights Reserved






037338 (07-2016)






























800-722-1471 (TTY 800-842-5357)











are also available

















































































essential tremor













HRQOL













































score




















References





2004 43227-238



























Metab 2010951174-1181



10100214651858CD001155pub2




































internal data








April 2018




Jan112(1)29-31








2008158208-216




Accessed April 2018




Accessed April 2018















2018


February 2018














History








27 2007






















































published






alendronate


















removed





added to policy


















tried












































section



























conditions

























stimulant wears off



were the same













andor sleepiness



the policy




effectiveness
































drugs









generic release


corticosteroids



criteria)








































expansions











All Rights Reserved






037338 (07-2016)






























800-722-1471 (TTY 800-842-5357)




























































essential tremor













HRQOL













































score




















References





2004 43227-238



























Metab 2010951174-1181



10100214651858CD001155pub2




































internal data








April 2018




Jan112(1)29-31








2008158208-216




Accessed April 2018




Accessed April 2018















2018


February 2018














History








27 2007






















































published






alendronate


















removed





added to policy


















tried












































section



























conditions

























stimulant wears off



were the same













andor sleepiness



the policy




effectiveness
































drugs









generic release


corticosteroids



criteria)








































expansions











All Rights Reserved






037338 (07-2016)






























800-722-1471 (TTY 800-842-5357)

























essential tremor













HRQOL













































score




















References





2004 43227-238



























Metab 2010951174-1181



10100214651858CD001155pub2




































internal data








April 2018




Jan112(1)29-31








2008158208-216




Accessed April 2018




Accessed April 2018















2018


February 2018














History








27 2007






















































published






alendronate


















removed





added to policy


















tried












































section



























conditions

























stimulant wears off



were the same













andor sleepiness



the policy




effectiveness
































drugs









generic release


corticosteroids



criteria)








































expansions











All Rights Reserved






037338 (07-2016)






























800-722-1471 (TTY 800-842-5357)




















































score




















References





2004 43227-238



























Metab 2010951174-1181



10100214651858CD001155pub2




































internal data








April 2018




Jan112(1)29-31








2008158208-216




Accessed April 2018




Accessed April 2018















2018


February 2018














History








27 2007






















































published






alendronate


















removed





added to policy


















tried












































section



























conditions

























stimulant wears off



were the same













andor sleepiness



the policy




effectiveness
































drugs









generic release


corticosteroids



criteria)








































expansions











All Rights Reserved






037338 (07-2016)






























800-722-1471 (TTY 800-842-5357)

















score




















References





2004 43227-238



























Metab 2010951174-1181



10100214651858CD001155pub2




































internal data








April 2018




Jan112(1)29-31








2008158208-216




Accessed April 2018




Accessed April 2018















2018


February 2018














History








27 2007






















































published






alendronate


















removed





added to policy


















tried












































section



























conditions

























stimulant wears off



were the same













andor sleepiness



the policy




effectiveness
































drugs









generic release


corticosteroids



criteria)








































expansions











All Rights Reserved






037338 (07-2016)






























800-722-1471 (TTY 800-842-5357)












2004 43227-238



























Metab 2010951174-1181



10100214651858CD001155pub2




































internal data








April 2018




Jan112(1)29-31








2008158208-216




Accessed April 2018




Accessed April 2018















2018


February 2018














History








27 2007






















































published






alendronate


















removed





added to policy


















tried












































section



























conditions

























stimulant wears off



were the same













andor sleepiness



the policy




effectiveness
































drugs









generic release


corticosteroids



criteria)








































expansions











All Rights Reserved






037338 (07-2016)






























800-722-1471 (TTY 800-842-5357)


































internal data








April 2018




Jan112(1)29-31








2008158208-216




Accessed April 2018




Accessed April 2018















2018


February 2018














History








27 2007






















































published






alendronate


















removed





added to policy


















tried












































section



























conditions

























stimulant wears off



were the same













andor sleepiness



the policy




effectiveness
































drugs









generic release


corticosteroids



criteria)








































expansions











All Rights Reserved






037338 (07-2016)






























800-722-1471 (TTY 800-842-5357)












2008158208-216




Accessed April 2018




Accessed April 2018















2018


February 2018














History








27 2007






















































published






alendronate


















removed





added to policy


















tried












































section



























conditions

























stimulant wears off



were the same













andor sleepiness



the policy




effectiveness
































drugs









generic release


corticosteroids



criteria)








































expansions











All Rights Reserved






037338 (07-2016)






























800-722-1471 (TTY 800-842-5357)









History








27 2007






















































published






alendronate


















removed





added to policy


















tried












































section



























conditions

























stimulant wears off



were the same













andor sleepiness



the policy




effectiveness
































drugs









generic release


corticosteroids



criteria)








































expansions











All Rights Reserved






037338 (07-2016)






























800-722-1471 (TTY 800-842-5357)




































published






alendronate


















removed





added to policy


















tried












































section



























conditions

























stimulant wears off



were the same













andor sleepiness



the policy




effectiveness
































drugs









generic release


corticosteroids



criteria)








































expansions











All Rights Reserved






037338 (07-2016)






























800-722-1471 (TTY 800-842-5357)


















removed





added to policy


















tried












































section



























conditions

























stimulant wears off



were the same













andor sleepiness



the policy




effectiveness
































drugs









generic release


corticosteroids



criteria)








































expansions











All Rights Reserved






037338 (07-2016)






























800-722-1471 (TTY 800-842-5357)











































section



























conditions

























stimulant wears off



were the same













andor sleepiness



the policy




effectiveness
































drugs









generic release


corticosteroids



criteria)








































expansions











All Rights Reserved






037338 (07-2016)






























800-722-1471 (TTY 800-842-5357)



























conditions

























stimulant wears off



were the same













andor sleepiness



the policy




effectiveness
































drugs









generic release


corticosteroids



criteria)








































expansions











All Rights Reserved






037338 (07-2016)






























800-722-1471 (TTY 800-842-5357)










stimulant wears off



were the same













andor sleepiness



the policy




effectiveness
































drugs









generic release


corticosteroids



criteria)








































expansions











All Rights Reserved






037338 (07-2016)






























800-722-1471 (TTY 800-842-5357)

























drugs









generic release


corticosteroids



criteria)








































expansions











All Rights Reserved






037338 (07-2016)






























800-722-1471 (TTY 800-842-5357)







































expansions











All Rights Reserved






037338 (07-2016)






























800-722-1471 (TTY 800-842-5357)












All Rights Reserved






037338 (07-2016)






























800-722-1471 (TTY 800-842-5357)








037338 (07-2016)






























800-722-1471 (TTY 800-842-5357)

























800-722-1471 (TTY 800-842-5357)








Documents

5.01.605 Medical Necessity Criteria for Pharmacy Edits · Medical Necessity Criteria for Pharmacy Edits Effective Date: May 1, 2018 Last Revised: April 17, 2018 Replaces: N/A