Idaho Medicaid Drug Utilization Review Program

Idaho Medicaid Drug Utilization Review Program

18 April 2013

1

ADURS (American Drug Utilization Review Society)

February 21-23, 2013Scottsdale, Arizona

Representatives present from 40 state Medicaid programs109 total participants

2

ADURSRound Table presentations from state

Medicaid representatives

Recurrent IssuesOpioid therapy for non-malignant painPsychotropic medications in childrenSuboxone therapy

3

ADURSOpening Session

Health Care Reform: How States are Responding

Speaker was from the National Conference of State Legislatures

4

ADURSContinuing Education Topics

Collaborative Care – How to increase safe use of psychotropic medications in children and adolescents.

Hemophilia 101

Medicaid Fraud and Abuse

Managed Care Medicaid5

ADURSContinuing Education Topics

Carving the Prescription Benefit Back In to Medicaid

340(b) Programs

New Drugs 2013

6

Follow-up to Previous ReviewsAtopic DermatitisP&T Committee Narcotic Analgesic

Studies

7

Atopic DermatitisThe P&T Committee requested a DUR on this drug

class to include patterns of use, presence or absence of step up therapy from steroids, specialty of prescribers and geographic region differences of prescribing patterns. The DUR should include an educational piece on risks of these agents compared to risks from steroids since many practitioners seem to be using these agents to spare patients from steroid exposure.

DUR completed April 2012 and it was felt that the medications were being used appropriately based on the data presented and these findings were presented to the P&T Committee.

8

Atopic Dermatitis

9

The P&T Committee asked at their October 2012 meeting for the DUR Board to look at how frequently these medications were being filled.

A review of paid claims between 10/01/2011 and 10/01/2012 was done.

Atopic Dermatitis

10

Conclusions:Overall only 13 of the 436 patients (3%) filled

their Elidel/Protopic more than once every other month.

Of those 13 patients, 7/13 were filling prescriptions for topical steroids at least as often as prescriptions for Elidel/Protopic.

For the 6 patients with no or infrequent topical steroid fills over the same time period, should any action be taken (e.g. send a DUR letter asking for chart notes)?

Atopic DermatitisEducational Document included in the Packet

11

Atopic Dermatitis

12

More than 6 claims for Elidel or Protopic in one yearPatient Number

Patient Age (years) Drug

# Claims for Elidel/Protopic

# Claims for Topical Steroid Prescriber

Diagnosis in Electronic Profile

64 15 Elidel 11 24 Dermatologist atopic dermatitis

269 14 Elidel 11 11 P.A.atopic dermatitis, eczema

201 9 Elidel 11 3 Family Medicine No derm diagnosis

5 38 Protopic 10 0 Family Medicine No derm diagnosis

2 65 Elidel 9 15 N.P. eczema

196 9 Protopic 9 9 Dermatologistatopic dermatitis, eczema

8 61 Protopic 9 0 Family Medicine eczema, psoriasis

127 12 Elidel 9 0 Pediatrics No derm diagnosis

73 13 Elidel 8 8 Family Medicine eczema

156 10 Protopic 8 8 Allergistatopic dermatitis, eczema

75 41 Protopic 8 1 Family Medicineatopic dermatitis, eczema

203 10 Elidel 7 11 Dermatologist eczema

399 4 Elidel 7 0 Pediatricsatopic dermatitis, eczema

Atopic Dermatitis#201

9 year old male11 Elidel claims in one year; only 3 topical

steroid claims in the same time periodStill filling Elidel monthly.Family Medicine prescriber; no derm diagnosis

in electronic profile.Send letter.

13

Atopic Dermatitis#5

39 yr male10 Protopic claims in one year/ no topical

steroid claims in the same time period.Family Medicine prescriber; only derm

diagnosis is ICD-9 757.39 specified skin anomalies.

Protopic last filled 12-20-12 so do NOT send letter as not currently receiving it.

14

Atopic Dermatitis#8

60 year old female9 Protopic claims in one year; no steroid

claims.Family Medicine prescriber; diagnosis –

eczema.Patient died in 2012 (pulmonary hypertension)

so do not send letter.

15


13 yr male9 Elidel claims in one year; no topical steroids.

Last paid claim for topical steroid was in 2006. Elidel last filled 1-17-13.

Pediatric prescriber; no derm diagnosis in electronic profile.

Send letter.

16


41yr female8 Protopic claims; 1 steroid claim.Family Medicine; atopic dermatitis/eczema.Protopic was last filled 11-29-12 so do not send

letter.

17


7 Elidel claims in one year; zero steroid claims.Pediatrics; atopic dermatitis/eczema.Elidel last filled 9-19-12 so do not send letter.

18

Atopic DermatitisComments/Questions?

19

P&T Committee Narcotic Analgesic Studies

20

Narcotic Analgesic UpdateParticipants Receiving Over 500 mg

Morphine Equivalents per Day

21

Original Review

Generated profiles for the top 150 recipients by total narcotic claim count from the recipients who had at least one narcotic claim in each of the 24 months of the period ending December 2011

Time Period: May 1, 2011 through December 31, 2011

All profiles were hand reviewed by Idaho Medicaid Pharmacists

22

Daily Morphine Equivalents

23

Lowest = 10 mgHighest = 2421 mg

0-99100 - 199200-299300-399400-499500-599600-699700-799800-899900-999

1000-10991100-11991200-12991300-1399

2000 or More

0 5 10 15 20 25 30 35 40 45

Daily Morphine Equivalents

Number of participants

Daily Morphine Equivalents (mg)

Average = 256 mg equivalents

Participants Receiving Over 500 Morphine Equivalents in 2011 StudyOriginal study 5/1/2011 – 12/31/2011

30 participants > 500 morphine mg equivalents

Follow-up study of these 30 participants 6/1/2012-11/30/2012

24

Data on 30 Original ParticipantsCharacteristic Number of PatientsOriginal participants still meeting threshold (> 500 mg MS equivalents)

6

Ineligible or Inactive for Idaho Medicaid

2

Deceased 5Incarcerated 1Current dose < 500 mg MS equivalents

16

25

Follow-up RequestLetter (see packet) sent 2/13/2013Included patient medication profile and Board of

Pharmacy controlled substance reportRequested Chart Notes and Documentation for

most recent 6 monthsEvaluation and monitoring of pain reliefEvaluation for improvement in daily functionPotential misuse/abuseCurrent treatment planPain contract Random urine screen results

26

Participant Review5 of 6 participants’ prescribers returned

documentationCase Presentations

Top User no longer receiving: Chris JohnsonMost complex user: Jane GennrichRemaining 4 users: Tami Eide

27

Current Interventions/Outcomes StudiesZolpidem High DoseMigraine Prevention

Prophylaxis Utilization in Chronic Triptan UtilizersBotulinumtoxin ProductsTestosterone enanthate/cypionate (injectable)Psychotropic Medications in Foster Children

Two (2) or more concomitant stimulant medications long-acting plus short-acting ok

28

Zolpidem High DoseOn January 10, 2013 the United States Food and

Drug Administration (FDA) notified the public of new information regarding the safety of certain drugs that contain zolpidem. (See packet for copy of Drug Safety Announcement)The NEW immediate release zolpidem dose for

women is being lowered from 10 mg to 5 mg.The NEW extended release zolpidem dose for

women is being lowered from 12.5 mg to 6.25 mg.For men, the new labeling recommends that the

same lower doses be considered (zolpidem immediate release 5 mg or zolpidem ER 6.25 mg).

29

Zolpidem High DoseA report was run looking at paid claims between

October 1, 2012, and December 31, 2012, to identify the number of Idaho Medicaid recipients who had received zolpidem:

30

Zolpidem Paid Claims 10/01/2012 – 12/31/2012

Male ≥2 per day Female ≥2 per day Prescribers

Ambien 5mg 63 10 223 33 209

Ambien 10mg 457 1514 879

Ambien CR 6.25mg 0 0 0

Ambien CR 12.5mg 19 47 44

Zolpidem High DosePatients were selected if they had doses above the

NEW recommended doses.

Letters were sent to 877 prescribers about 1,984 patients on 1/18/2013.

As of 4/16/2013, 246 responses have been received (28% response rate.)

See packet for copy of the letter.

31

Zolpidem High DoseCriteria Paragraph

On January 10, 2013, the Food and Drug Administration (FDA) published a safety announcement regarding the popular insomnia medication zolpidem (trade names Ambien, Ambien CR, Edluar, Zolpimist). The announcement included two important messages: First, the FDA provided new, lower bedtime dosing recommendations on zolpidem

immediate and extended release products. Next, the FDA reminded the public about safety concerns around driving or

performing other activities requiring alertness the morning after use. The risk of next-morning impairment is highest for women, who may

eliminate the medication more slowly. Impairment is also greater in those taking the extended release formulation (Ambien CR/zolpidem ER). Manufacturers will be revising the product labeling to reflect the following: 1. The NEW immediate release zolpidem dose in women is being lowered from 10 mg

to 5 mg.2. The NEW extended release zolpidem dose in women is being lowered from 12.5 mg

to 6.25 mg.3. For men, the new labeling will recommend the same lower doses be considered

(zolpidem 5 mg or zolpidem ER 6.25 mg). 32

Zolpidem High Dose:Note that providers may choose more than one

selection per response.

Reviewed and have or will modify the treatment126

Will use this information in care of future patients120

Information clinically useful: plan to monitor113

Reviewed and do not believe adjustment is needed72

Attempted to modify therapy unsuccessfully15

Not my patient, never has been5

33

Zolpidem High Dose: Comments of Interest“Patient is stable” (numerous similar responses)“will discuss with patient”“chronic sleep disorder. Pt. with chronic sleep problem

nightly and does not sleep without zolpidem”“dose was initially changed, had worsening of symptoms

and strongly favored higher dose”“attempts made to lower dosage or taper off without

success. The pt listed are long term complicated pts and to effectively recess her has been reviewed previously. Thanks”

“lower doses do not help. I still treat patients not studies.”

34

Zolpidem High Dose: Comments of Interest“He has multiple sclerosis. Ambien was discontinued.

Where is the form for why my patient was abruptly stopped on Advair which had been effective and helpful for the pt, why was my input not important then.”

“I will change my prescribing habits. Have only given 1 dose.”

“I’m the physician. Waste of my time.”“I already know.”“Will change dose to Ambien 5mg”“Patient has not responded to a lower dose”“I did not prescriber this medicine to my knowledge”“Both patients were (are) pregnant”

35

Zolpidem High Dose: Comments of Interest“tolerates well, has taken since April 2009”“The benefits outweigh the risks”“I will attempt to modify therapy with pts as

recommended”“But the patient is a male, not female”“He tolerates the current dose without side effects”“address at their next visit. Had already heard about the

FDA announcement”“I am not an Idaho Provider. This is not my patient.”

36

Zolpidem High Dose

37

Zolpidem Paid Claims

Male >1 per day Female >1 per day Prescribers MAXQTY

Month/Year 12/12 3/13 12/12 3/13 12/12 3/13 12/12 3/13 12/12 3/13

Ambien 5mg 38 55 3 4 118 271 15 19 102 150 Q02Ambien

10mg 305 301 7 10 1010 823 51 30 639 558 Q02Ambien CR

6.25mg 0 0 0 8 0 8 Q01Ambien CR

12.5mg 17 11 38 34 35 33 Q01

Payment Amount to Pharmacy: 12/12 - $25,787; 3/13 - $24,555

Zolpidem High DoseThoughts/Comments?

38

Migraine PreventionIdaho Medicaid paid over $770,000 worth of

pharmacy claims for the Triptan class of medication in 2012.

There were more than 7,200 claims paid for in 2012.

The question the Idaho DUR Board is beginning to investigate is “Are these medications being used appropriately and are recipients getting the appropriate treatment for the prevention of migraines?” 39

Migraine PreventionEpidemiology

Migraines affect approximately 11% of the adult populations in Western Countries.

In the United States, more than 30 million people have at least 1 migraine per year.

Gender Before puberty more common in boys than girls. In people over 12 years of age, the prevalence

increases in both males and females peaking at age 30-40 years.

The ratio of female-to-male increases from 2.5:1 at puberty to 3.5:1 at age 40.

40

Migraine Prevention: recipients with paid triptan claim between 1/1/2012 and 12/31/2012

Gender (Idaho Medicaid Population)

Overall Average Age: 35 (range 4 – 78)

Average Age Females: 35 (range 6 – 68)

Average Age Males: 31 (range 4 – 78)

41


Female194982%

Male41818%

Unique Recipients (Idaho Medicaid Popu-lation)

42


Female614385%

Male110815%

Claims (Idaho Medicaid Population)

43


44

Female 667532

86%

Male 105894 14%

Amount Paid at POS (Idaho Medicaid Population)

Migraine PreventionEpidemiology

Race Caucasians > African Americans > Asians

Geography Americas > Europe/Middle East > Asia > Africa

Economic ImpactEstimated at more than $2.5 billion per year in

cost of medical care (Direct costs)Estimated at more than $13 billion per year in

loss of productive time (Indirect costs).

45

Migraine PreventionMedical Diagnosis (based on direct

questionnaires)1989 – 38% of sufferers1999 – 48% of sufferers

PrognosisChronic condition with severity and frequency

diminishing with advancing age.Treatment

AbortivePreventative

46

Migraine PreventionPreventative Therapy

Taken in absence of headache with the goal of reducing the frequency and severity of the migraine, make acute attacks respond better to abortive therapy, and ultimately improve the patient’s quality of life.

3 primary classes of medications that are effective: antiepileptics, antidepressants, and antihypertensives.

Botulinum toxin A will be discussed in greater detail in slides to follow.

Please refer to handout in packet regarding the evidenced based guideline update .

47

Migraine PreventionIdaho Medicaid Numbers

In 2012 there were 5,022 unique recipients with a Migraine Diagnosis in their electronic medical record.

Of these 5,022 recipients, 1,258 had a triptan claim in their profile. Side note: In 2012 there were 2,367 unique

recipients with a triptan claimOf these 1,258 recipients, 281 (22%) had a

claim for one of the Level A Medications as described in the Evidence-based guideline update.

48

Migraine PreventionNext Steps???

49

Migraine PreventionReferences

http://www.neurology.org/content/78/17/1337.full.html http://www.neurology.org/content/78/17/1346.full.html http://www.neurology.org/content/63/12/2215.full.html http://emedicine.medscape.com/article/114256-overview http://www.medscape.com/viewarticle/429665_print

50

http://www.neurology.org/content/78/17/1337.full.html



http://emedicine.medscape.com/article/114256-overview

http://www.medscape.com/viewarticle/429665_print

Botulinumtoxin ProductsBotulinumtoxin products are excluded from

coverage by the outpatient pharmacy prescription drug program – these medications are only administered by health care professionals and are not safe for patients to pick up and “brown bag” to the doctor’s office.

Botulinumtoxin products are currently payable on the medical side using the J codes listed on a future slide.

There are four commercially available products at this time; they are not therapeutically equivalent and they have different dosages and different FDA approved indications. 51

Botulinumtoxin ProductsWhile Idaho Medicaid does not cover medications

for cosmetic uses (e.g. wrinkles), at this time there is no diagnosis verification or medical review for J0585, J0586, or J0587 to assure that the botulinumtoxin is being prescribed for a medical diagnosis rather than for a cosmetic indication.

Therefore, the Pharmacy Unit at Idaho Medicaid has done a DUR (Drug Utilization Review) project evaluating diagnoses of patients who have paid claims for botulinumtoxin in the past 3 months.

52

Botulinumtoxin ProductsProcedure Code

Trade Name

Generic Name and Billing Units

Prior Authorizati

on Required?

# Claims 12/01/2011

– 11/30/2012

$ for claims

12/01/2011 –

11/30/2012

J0585 Botox onabotulinumtoxin A, 1 unit

NO 478 $405,615

J0586 Dysport

abobotulinumtoxin A, 5 units

NO 21 $14,286

J0587 Myobloc

rimabotulinumtoxin B, 100 units

NO 23 $11,133

J0588 Xeomin

incobotulinumtoxin A, 1 unit

YES (as of August 2012)

3 (prior to August 2012)

$647

TOTALS 525 $431,681

53

Botulinumtoxin ProductsTrade Name


FDA approved indications

Botox onabotulinumtoxin A, 1 unit

Urinary incontinenceMigrainesSpasticityCervical dystoniaHyperhidrosisBlepharospasmStrabismusOveractive bladder (new – January 2013)Cosmetic (not covered by Idaho Medicaid)

54

Botulinumtoxin ProductsTrade Name


FDA approved indications

Dysport abobotulinumtoxin A, 5 units

Cervical dystoniaCosmetic (not covered by Idaho Medicaid)

Myobloc rimabotulinumtoxin B, 100 units

Cervical dystonia

Xeomin incobotulinumtoxin A, 1 unit

Cervical dystoniaBlepharospasm

55

Botulinumtoxin ProductsPatients with paid claims for botulinumtoxin

between 10/01/2012-12/31/2012: 98Diagnoses

Cerebral Palsy: 49 42 children, 7 adults

Cervical dystonia, torsion dystonia, or upper limb spasticity: 28

Traumatic brain injury/intracranial hemorrhage with muscle spasms: 12

Migraines: 5Misc: 4 (details on next slide)

56

Botulinumtoxin ProductsDiagnoses

Misc: 4 Patient #7 – dysphagia Patient #20 – spina bifida Patient #91 – closed fracture of vertebral column,

muscle spasm Patient #77 - blepharospasm

57

Botulinumtoxin ProductsMIGRAINES

References Botulinum Toxin A Treatment for Chronic Headache

and Chronic Migraine. Center for Evidence-based Policy: Medicaid Evidence-based Decisions Project. Oregon Health & Science University. February 2012.

Botox Prescribing Information. Allergan, Inc. Revised 01/2013.

58


General Conclusions from Medicaid Evidence-based Decisions Project Overall, the evidence for the effectiveness of BTX-A on

chronic migraine is inconsistent, with the studies that do show a benefit finding the improvement small and potentially clinically insignificant.

59


General Conclusions from Medicaid Evidence-based Decisions Project Key Question 1: Does BTX-A reduce the

frequency, severity, or duration of chronic headaches of migraines? The largest available study (N=1384) evaluated

onaBTX-A and found a small but statistically significant decrease in the mean number of headache days per month (-8.4 versus -6.6) and in the mean number of migraine days/month (-8.2 versus -6.2). Although statistically significant, the small size of the treatment effect relative to placebo suggests that this may not be clinically significant.

60


General Conclusions from Medicaid Evidence-based Decisions Project Key Question 2: Does BTX-A improve qualify of

life in patients who have chronic headaches or migraines? Only three trials assessed any aspect of QOL (quality of

life) in the treatment of chronic tension type headache. The smallest found significant improvement in QOL in the treatment group compared to placebo at both 30 and 90 days. A second trial found some reductions on affective distress outcomes compared to placebo at four weeks, but these were not sustained at eight weeks. The third found no significant difference between treatment and placebo groups in sleep duration.

61

Botulinumtoxin ProductsMigraine patient #6

58 year old femaleLong history (many years) of migraines2010: 20 ER visits/office visits specifically for migrainesJan 1- Sep 30, 2011: 11 ER visits/office visits specifically

for migrainesBotox started: 9/30/2011Receiving Botox approximately every 3 months: 1/20/12,

4/13/12, 7/5/12, 11/02/12No ER visits/office visits for migraines Oct 1 – Dec 31,

20118 ER visits/office visits for migraines in 2012Has been on verapamil and nadolol 2010 – presentOne paid claim for triptan 7/19/2010 62


51 year old female2010: 9 ER/office visits specifically for migrainesJan 1 – Sep 30, 2011: 7 ER/office visits specifically for

migrainesBotox started: 9/30/2011Receiving Botox approximately every 3 months since

then2 more ER/office visits for migraines Oct 1 – Dec 31,

20119 ER/office visits specifically for migraines in 2012Has been on propranolol 2010 – present

63

Botulinumtoxin ProductsMigraine patient #18, con’t

Received prior authorization request for Botox in February 2013 – prescriber states “she has had an excellent response to Botox” but ER visits have not changed between 2010 and 2012.

Also received prior authorization request for Maxalt in August 2012 (which was approved) but was only filled once. Request stated “Patient has been using Maxalt since 2008 with good results” but even though patient has been on Medicaid since 2008, she has only one paid claim for Maxalt in 2012.

64


24 year old femaleHistory of viral meningitis as well as physical abuse with

injury to neck/upper backProphylactic medications tried – divalproex and

amitriptylineRescue medications used – tramadol described as being

effective, also filling hydrocodone/acetaminophen (no triptans)

Botox given 10/08/2012 and 12/20/2012.No ER visits for migraines either before or after Botox

therapy.

65


48 year old maleBotox given 7-05-12 and 12-07-124 office visits specifically for migraines in 2010; 1 office

visit and 1 ER visit in 2011 for migraines3 office visits for migraines in 2012 prior to Botox; none

afterwardsTriptan was approved for patient back in 2007 but only

filled once.Other medical history – has pacemaker.

66

Botulinumtoxin ProductsMigraine Patient #87

36 year old female.Botox given 10-11-2012 (only once).Also has diagnosis of cervicalgia with frequent physical

therapy appointmentsOn topiramate and sumatriptan regularly.No ER visits for migraines.

67


Have been receiving prior authorization requests for Botox for migraines as it has been assumed by some physicians that prior authorization is required.

In general, insufficient documentation is being sent especially quantifying the number of migraines per month and the duration of headache/migraine per day.

Inadequate description of success/failure of both prophylactic and abortive medications to treat migraines.

68

Botulinumtoxin ProductsRecommendations for Botox used for chronic

headaches/migrainesRequire prior authorization for botulinumtoxin for

treatment of chronic headaches and migraines. Prior authorization form has been created (see copy in your packet). Implementation date would be July 1, 2013.

Therapeutic criteria:1. Quantification of headaches/migraines prior to

botulinumtoxin therapy. Botox is FDA approved for the treatment of 15 or more chronic headaches per month with each headache lasting at least 4 hours. Per package insert: Safety and efficacy has not been established for prophylaxis of episodic migraine (14 headache days or fewer per month).

69


headaches/migrainesTherapeutic criteria:

2. What has been tried prior to botulinumtoxin – including prophylactic therapy and treatment of migraines.

a) Should prophylactic trials of at least one or two agents be required ?

b) Documentation of fills of abortive medications at least monthly for the previous three months ?

70


headaches/migrainesTherapeutic criteria: If approved, initial approval would be for two

injections (given 3 months apart). This duration was used in the clinical studies that the FDA reviewed to approve Botox for chronic headaches. Idaho Medicaid would then require additional documentation including quantification of migraines after botulinumtoxin therapy as well as utilization of migraine treatment medications (e.g. triptans), ER utilization, office visits for migraines, and any adverse reactions to Botox.

Sample Prior Authorization form for Botox for Migraines/Chronic Headaches included in packet.

71

Botulinumtoxin ProductsCEREBRAL PALSY

Botox is injected into spastic or stiff muscles where it blocks transmission between the nerves and the affected muscles which relaxes the muscle and reduces stiffness. Once the muscles are relaxed, therapists are able to stretch the muscles. Children under the age of six respond best to this treatment as it is especially effective in children who have not developed fixed joint contractures. Benefits of therapy include improvement in range of motion, tolerance to wearing braces, and developmental improvements in crawling, standing, and gait. Duration of effect is typically four months. Side effects include flu-like symptoms and weakness of the legs.

72

Botulinumtoxin ProductsDYSTONIAS

Dystonias are involuntary muscle contractions that cause repetitive movements or distorted postures.

Cervical dystonia – contractions cause the head to twist and turn to one side or pull forward or backward

Blepharospasm – involuntary spasms causing eyelids to close

73

Botulinumtoxin ProductsTREATMENT OF OVERACTIVE BLADDER OR

URINARY INCONTINENCEBotox is approved for treatment in adults who have an

inadequate response to or are intolerant to anticholinergic medications.

There were no patients receiving Botox for this indication during the three months of this DUR.

74

Botulinumtoxin ProductsTREATMENT OF MUSCLE SPASMS s/p

MAJOR HEAD TRAUMANo specific FDA indication for this situation. Treatment of cervical dystonia or upper limb spasticity

does not specify etiology of dystonia or spasticity.

75

Botulinumtoxin Products

76

Botulinumtoxin ProductsBotulinumtoxin – Recommendations for

other indications besides chronic headaches/migrainesOveractive bladderUrinary incontinenceUpper limb spasticityCervical dystoniaSevere axillary hyperhidrosisBlepharospasmStrabismus

77

Botulinumtoxin Products1. Require prior authorization for all

botulinumtoxin products ?

2. Grandfather current patients vs. request chart notes to document effectiveness and safety of current therapy ? Same decision for all indications ?

3. Proposed implementation date: July 1, 2013

78

Testosterone Injection DUR

79

Injectable Testosterone DURTopical formulation of testosterone requires a prior authorizationDiagnosis of Testicular hypo function

(hypogonadism)Idaho Medicaid does not authorize payment

of medications for sexual dysfunctionInitial requests are approved for 3 months

with follow-up lab results.

80

Injectable Testosterone DURInjectable testosterone does not require a prior authorizationAppropriate use per diagnosis not evaluated

Multiple medical non-FDA indicated usesControlled substance with potential for abuse

Performance enhancer

81

Injectable Testosterone DURQuestions:

Are testosterone injections being prescribed appropriately?

Are there duplicative treatments between outpatient pharmacy benefit and medical benefit (J-codes)?

82

Testosterone DUREvaluated injectable testosterone use in 2012

Testosterone cypionateTestosterone Enanthate

Compared prescriptions and medical procedure codes with common diagnosis for use

257.2 Testicular Hypo function 257.9 Testicular Dysfunction Unspecified

83

Testosterone DUR2012 ResultsAge: 0- 75 years Average of 41 yearsAverage days supply: 28 days ( range: 14-34 daysAverage dispensed quantity: 4 mls (range: 1-10 mls)The most prescribed: Testosterone cypionate 200mg vial

Pharmacy Data:Total 152 clients with 532 claims4 femaleMedical Data:Total 104 clients with 533 claims6 femaleDuplicative Data:Total of 15 clients with both Pharmacy and Medical claims

5 clients had pharmacy/medical claims on the same dates84

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10

20

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50

60

70

80

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100

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120 113

18

5 5 2 1 1 1 1 1 1 1 1 1

Testosterone Injection by Diagnosis N= 152 (Rx)C

lient

s

85

0

10

20

30

40

50

60

70

80

90

10091

4 2 1 1 1 1 1 1 1

Testosterone Injection by Diagnosis N=104 (Medical)C

lient

s

86

Total Rx clients on patches Patches only History of Both0

20

40

60

80

100

120113

93

20

Topical Testosterone C

lient

87

Testosterone DURConclusions

Pharmacy15.7% of clients without a documented diagnosis or unapproved

diagnosis

Medical7.6% of clients without a documented diagnosis or unapproved

diagnosis33% of clients with duplicative claims noted between medical and

pharmacy claims for the same billing dates.

Prior Authorization of injectable testosterone for therapeutic diagnosis may be required to evaluate appropriate use and maintain consistency across the two programs

88

Foster Children Psychotropic Drugs Red Flags

4/18/2013

89

Red FlagsFive (5) or more psychotropic medications prescribed

concomitantly (reviewed August 2012)Two (2) or more concomitant antidepressants

(reviewed October 2013)Two (2) or more concomitant antipsychotic

medications (current)Two(2) or more concomitant stimulant medications

long-acting plus short-acting okThree (3) or more concomitant mood stabilizer

medicationsPsychotropic polypharmacy (2 or more agents) for a

given mental disorder prescribed before utilizing psychotropic monotherapy 90

91

Implementation of Red Flags

Retroacti

ve Evaluatio

n

Identify outliers

Profile

Review

DUR Board Intervention• Targ

eted education

Re-evaluation• indi

viduals

• overall

Further

Action

Point of service edits• Informa

tional (soft) – pharmacist override

• Hard Stop

ADHD Drugs Anti-depressants Mood Stabilizers Atypical Antipsychotics0%

5%

10%

15%

20%

25%

30%

35%

40%

36%

23%

13%

21%

9%

6%

0%

4%

Percent of Foster and Non-Foster Children Psychotropics by Drug Class

Calendar Year 2011

% Foster Children% Non-foster Children

Total foster =2785Total Non-Foster = 106,024

92

Foster Children ADHD Drug Therapy Focus

4/18/2013

93

Study Methodology

Children in Foster Care ages 0-17

Claims review of any foster child receiving an ADHD Drug between 11/1/2012 and 1/31/2013

94

Stimulants Included amphetamine salt combo Adderall XR (amphetamine salt

combo extended release) dexmethylphenidate Focalin XR

(dexmethylphenidate extended release)

dextroamphetamine IR/ER Procentra (dextroamphetamine) Vyvanse (lisdexamfetamine) Metadate CD (methylphenidate) Methylin Chew tabs

(methylphenidate) methylphenidate ER (Concerta

generic) Methylin solution

(methylphenidate) methylphenidate IR methylphenidate ER (Ritalin SR

generic) methylphenidate ER (Ritalin LA

generic) Daytrana (methylphenidate) Quillivant XR (methylphenidate)

95

Non-Stimulants Included Strattera (atomoxetine) Clonidine Kapvay (clonidine extended release) Guanfacine Intuniv (guanfacine extended release)

96

Methodology Limitations“Snap-Shot” in time – did not include drug

and dose changes before or after except as noted below

Excluded from analysis any child that did not have 2 continuous months of stable (same) drug therapyException: if less than two months because of

new start between 12/24/2012 and 1/31/2013 then following month was looked at in electronic record for evaluation of continuation

No medical history or profile review completed

97

Final Evaluation Numbers

759 children in original data pull

187 with less than 2 months of any drug

572 evaluated

98

Treatment Patterns

*12 children’s therapy counted in 2-4 different entities included an IR/ER combination of one of the entities, not counted here

One Drug with One Dose

IR and ER Dosage Forms (same drug class)*

Same Chemical Entitiy with More than One Strength

Two Different Chemical Entities

Three Different Chemical Entities

Four Different Chemical Entities

390

33

20

109

19

1

Number of Children in Different Pharmacotherapy Categories

99

One Drug/One Dose SummaryStimulants (67% of patients)

Most Used Stimulants 49 % methylphenidate ER 26% amphetamine salt combination ER

11 % received only an IR formulationNon-Stimulants (33% of patients)

atomoxetine (Strattera) 22%clonidine IR 32%guanfacine IR 30%guanfacine ER (Intuniv) 15%

100

Mixture of ER and IR Dosage Forms45 total patients (including 12 counted

elsewhere)

methylphenidate ER plus IR 47%

dexmethylphenidate XR plus IR 18%

amphetamine salt combo XR plus IR11%

Combo of different chemical entities24%

101

Same Chemical Entity with More than One StrengthTotal Patients = 22

Stimulants = 20 Methylphenidate ER 16/20 (80%)

Non-stimulants = 2Dosing

36% exceeded daily dose guidelines 7/16 methylphenidate ER patients 1 lisdexamfetamine (Vyvanse) patient

102

Summary of Two Different Chemical Entities109 patients

61% ER stimulant and IR non-stimulant Most common

methylphenidate ER with clonidine methylphenidate ER with guanfacine

16% ER stimulant and ER non-stimulant Most common

Vyvanse (lisdexamfetamine) with Intuniv (guanfacine) methylphenidate ER with Intuniv Adderall XR (amphetamine salt combo) with Intuniv

The dose was maximized for one or both of the agents in 18 patients ( 17%)

103

Summary of Three Different Chemical Entities19 patients had three different chemical entities

6 patients had an ER stimulant + ER non-stimulant + IR non-stimulant 4 included a combination of clonidine plus Intuniv

(guanfacine ER)5 patients had an ER stimulant plus 2 IR non-

stimulants All of these included guanfacine + Strattera

(atomoxetine) Dose was maximized in one or all agents in only 3

patients

104

Patient with Four Different Chemical Entitiesdexmethylphenidate IR 5 mg dailydexmethylphenidate XR 15 mg dailyclonidine 0.2 mg dailyguanfacine 5 mg daily atomoxetine 40 mg daily

105

Duplicate TherapyTwo different long-acting stimulants = 5 patients

dexmethylphenidate ER + Daytrana (methylphenidate) = 1dexmethylphenidate ER + methylphenidate ER = 1Vyvanse (lisdexamfetamine) + methylphenidate ER = 2

Two different short-acting stimulants = 1 patientTwo different long-acting non-stimulants = 1 patientTwo different short-acting non-stimulants = 12 patients

clonidine + atomoxetine = 6guanfacine + atomoxetine = 5clonidine + guanfacine = 1

Three different non-stimulants = 1 patientclonidine + guanfacine + atomoxetine

TOTAL = 20 patients

106

Next Steps? Profile and medical history review of

outliers? Evaluation of number and specialty of

prescribers? Other

107

Proposed Studies for Next Quarter:P&T Committee Narcotic Analgesic

Studies – Next StepsUse of Psychotropic Medications in Foster

Children – Next StepsThree (3) or more concomitant mood stabilizer

medicationsHepatitis C AgentsAntipsychotic Indication Evaluation- Hold

for FutureAAP and DVTs- Hold for future

108

P&T Committee Narcotic Analgesic Studies – Next Steps

109

Use of Psychotropic Medications in Foster Children The U.S. Government Accountability Office

released the results from a study that they performed examining the rates of psychotropic medications for foster and nonfoster children in 2008.

It was determined that HHS Guidance Could Help States Improve Oversight of Psychotropic Prescriptions.

110

ADHD Drugs Anti-depressants Mood Stabilizers Atypical Antipsychotics0%

5%

10%

15%

20%

25%

30%

35%

40%

36%

23%

13%

21%

9%

6%

0%

4%

Percent of Foster and Non-Foster Children Psychotropics by Drug Class

Calendar Year 2011

% Foster Children% Non-foster Children

Total foster =2785Total Non-Foster = 106,024

111

Use of Psychotropic Medications in Foster Children: Next StepsThree (3) or more concomitant mood stabilizer

medications

112

Hepatitis C AgentsIncivek and Victrelis

Review past 6 months of data for usage Are patients that started on therapy continuing

therapy? Will be requesting chart notes to determine why

patients discontinued therapy (e.g. intolerable side effects vs. non-responders to therapy based on viral counts) vs. non-compliance.

Will look for trends in patients that discontinued therapy (e.g. does rate vary between practices or geographically)

Are patients on TRIPLE therapy with ribavirin and interferon? Check for adherence to all three medications.

Audit for checking viral counts at appropriate time intervals

113

Hepatitis C AgentsIncivek and Victrelis

Look at quarterly trends in usage since Incivek/Victrelis were approved by the FDA in May 2011 as patients were not started on double therapy (ribavirin/interferon) as the specialists were waiting for triple therapy to be available.

In the future an all oral regimen is going to be available for treatment of Hepatitis C so there may be patient “warehousing” again.

114

Antipsychotic Indication Evaluation- Hold for Future

115

AAP and DVTs- Hold for future

116

Prospective DUR ReportHistory Errors:

• DD – drug-to-drug• PG – drug to pregnancy• TD – therapeutic

duplication• ER – early refill• MC – drug-to-disease

Non-History Errors:• PA – drug-to-age• HD – high dose• LD – low dose• SX – drug-to-gender

117

Prospective DUR ReportIdaho Medicaid ProgramProDUR Message Report

March-13

ProDUR ProDUR Message MessageMessage Severity Count Amount

Drug To Drug 1 1,696 $464,457.99 2 14,228 $2,471,750.95 3 73,113 $12,541,653.63Drug To Gender 1 220 $76,867.77 2 2,699 $319,980.77Drug To Known Disease 1 68,820 $10,040,216.19 2 242,531 $44,050,971.97 3 305,006 $52,254,965.87Drug To Pregnancy 1 100 $1,348.97 2 25 $840.03 A 8 $106.64 B 104 $11,723.20 C 204 $18,054.61 D 24 $2,068.05 X 50 $1,416.20Duplicate Therapy 0 119,918 $35,587,342.92Min Max 0 32,097 $6,412,192.38Too Soon Clinical 0 22,077 $4,131,301.25ALL 882,920 $168,387,259.39 Total Number of Claims with Messages 215,450 Average ProDUR Message Per Claim 4.10

118

DUR Spring NewsletterCopy of Winter Newsletter in packetBrainstorm for new topics

119

Medicaid Update

120

Documents

Idaho Medicaid Drug Utilization Review Program