Enterprise P&T Committee Meeting Minutes - AmeriHealth ...€¦ · 1. Add a quantity limit of 1 mL per 30 days for Aimovig 70 mg/mL Autoinjector (NDC 55513‐0841‐01), and 2 mL

Enterprise P&T Meeting Committee Meeting Minutes

February 4, 2019

Voting Members Present

Kirton Caton, MD Rogers Elebra, PharmD Chris Meny, PharmD Andrew Peterson, PharmD Wayne Weart, PharmD

Donald Beam, MD Gus, Geraci, MD Jay Messeroff, RPh Eric Peters, PharmD Rani Whitfield. MD

John Floyd Brinley, MD Glenn Hamilton, MD Kendra Michael, MD David Petkash, MD Rodney Wise, MD

William Burnham, MD Jeffrey Kreitman, PharmD Betty Muller Jeanine Plante, PharmD

Don Cooper, RPh Markus Kruesi, MD Lavdena Orr, MD Kirby Smith, MD

Excused Voting Members

Christopher Anypas, PharmD Jen Devinney, PharmD Karen Jordan, MD

David Batluck, DO Lily Higgins, MD Susan McAllister, MD

Invited Guests Present

Linda Albandoz, NCPhT - PRx Tracey Davis, PharmD Lanaye Lawyer, MD Patty Oaster, Administrative-

PRx

Melwyn Wendt, PharmD

Dustin Brookshire, Compliance

Manager

Fury Fecondo, PharmD Shalis. Lightner,

Pharmacy Manager

Brian O'Meara,

Administrative- PRx

Eric Weiss, PharmD

Patrick DeHoratius, PharmD-PRx Monica Guerriero, PharmD Lauren Megargell, PharmD-PRx Devon Trumbower, PharmD-

PRx

Kathleen Clement,

Administrative- PRx

April Holley, PharmD LDH Holly Moreau, PharmD Kyle Viator, Market

President

Michael Colvin, PharmD Paul Knecht, PharmD Michelle Murphy, PharmD

Pharmacy Director

Calla Vodoor – PharmD Prx

Issue Discussion Conclusion/Results Vote Action/ Person Responsible

1. Call to Order The meeting was called to order at 6:07 PM EST.

Dr. Burnham welcomed all external and internal

participants.

Informational Only

Dr. William Burnham

2. Conflict of Interest Disclosure

No conflicts announced

Informational Only

Dr. William Burnham

5. Review of last P&T Minutes

Jay Messeroff asked if there were any corrections or updates

to the minutes from August 06, 2018 PT meeting

Minutes approved

as presented

Unanimous

Jay Messeroff

6. Review and Approval of December Proxy Minutes

Minutes approved

as presented

Unanimous

Jay Messeroff

7. Old Business PerformRx

PerformRx

8. New Business

Fluphenazine

PerformRx makes the following recommendation:

For KF/AHC/AHNE/ : Make no changes to the formulary status of fluphenazine

at this time

Committee

approved as

recommended

Unanimous

. PerformRx will update the

criteria and formulary/PDL

with any changes

Choline product

additions to

formulary


KF/AHC/ /AHN: Add Choline citrate 650mg tablet and Choline SR

300mg tablet to the formulary.

Committee

approved as

recommended

Unanimous

PerformRx will update the


with any changes.

9. Drug Reviews

Therapeutic Class

Calcitonin Gene-

related Peptide

(CGRP) Inhibitors

with PA Criteria


KF/AHC/AHNE/ : 1. Add a quantity limit of 1 mL per 30 days for Aimovig

70 mg/mL Autoinjector (NDC 55513‐0841‐01), and 2 mL

per 30 days for Aimovig 140 mg dose Autoinjector 2 pack

(NDC 55513‐0841‐02)

a. Cost per month of treatment is equivalent for both

dose strengths only when the appropriate product is

dispensed. PerformRx recommends adding quantity

limits to ensure the appropriate product is dispensed.

2. Add Ajovy (fremanezumab‐vfrm) 225 mg/1.5 mL (GCN

45306) subcutaneous solution prefilled syringe to the

Specialty Tier with prior authorization.

3. Add Emgality 120 mg/mL Pen (GCN 40418, 40419) to

the Specialty Tier with prior authorization.

4. Update the prior authorization criteria to prefer Emgality

over the other agents in this class.

5. Approve the Calcitonin Gene‐Related Peptide (CGRP)

Receptor Antagonist criteria

a) Add Ajovy and Emgality to criteria

b) Prefer Emgality to other agents in this class.

c) Add age restriction according to package insert. d) Add references.

Committee

approved as

recommended

Unanimous



with any changes.

First Generation

Antihistamines

PerformRx makes the following recommendations:

KF/AHC/AHNE/ 1. Remove carbinoxamine 4 mg/5 ml liquid (GCN 14949)

in an effort to align formularies within this class and

due to the availability of more cost effective alternatives

available within this class on the formulary

2. Remove chlorpheniramine (Chlorphen SR®) 12 mg

tablet, ER (OTC) (GCN 46541) in an effort to align

formularies within this class and due to a lack of

utilization and due to the availability of more cost

effective alternatives available within this class on the

formulary.

3. Remove chlorpheniramine (EdChloped Jr.®) 2 mg/5 ml

syrup (OTC) (GCN

46503) in an effort to align formularies within this

class and due to a lack of utilization and the

availability

of more cost effective alternatives available within

this class on the formulary.

4. Remove diphenhydramine 12.5 mg chewable tablet

(OTC) (GCN 46060) in an effort to align formularies

within this class and due to a lack of utilization and due

to the availability of more cost effective alternatives

available within this class on the formulary.

5. Remove diphenhydramine 12 mg/5 mL prefilled spoon

(OTC) (GCN 28478) in an effort to align formularies

within this class and due to a lack of utilization and the

availability of more cost effective alternatives available

within this class available on the formulary.

Committee

approved as

recommended

Unanimous



with any changes.

Platelet

Aggregation

Inhibitors


KF/AHC/AHNE/ No changes are recommended at this time

Committee

approved as

recommended

Unanimous



with any changes.

Benign Prostatic

Hyperplasia


KF/AHC/AHNE/ : No changes are recommended at this time

Committee

approved as

recommended

Unanimous



with any changes.

Pulmonary Arterial

Hypertension with

PA Criteria


KF/AHC/AHNE : No changes to the formulary status of the medications

in this class

Approve the prior authorization criteria with the

changes recommended:

1. Add Tyvaso, Adempas and Ventavis to the initial 28

day approval as these medications require titration as

well

2. Streamline language for appropriate dosing

3. Clarify patient’s weight is only required for

medications with weight based dosing

4. Add Tyvaso and Ventavis to section requiring PDE-

5 and Letairis prior to approving these therapies.

Letairis and PDE-5 are recommended as first line

therapies for functional class 2 and 3 and are less

costly than the alternative therapies.

5. Combine functional class 2 and 3 requirements as

these classes are treated with the same therapies

Committee

approved as

recommended

Unanimous



with any changes.

Cystic Fibrosis

with PA Criteria


KF/AHC/AHNE/ Add sodium chloride for inhalation (Hyper‐Sal®,

Pulmosal™) 7% vial for nebulization to the

formulary. This is a low cost medication

recommended for all Cystic Fibrosis patients

regardless of severity and therefore should be

available without prior authorization as all prior

authorization requests are currently being approved.

Remove acetylcysteine 100 mg/ml and 200mg/ml vial

from the formulary. Due to the high cost of

acetylcysteine and insufficient evidence to

recommend for or against chronic use of inhaled or

oral acetylcysteine, PerformRx is recommending

removing this from the formulary. Additionally, there

is little to no utilization of this medication.

Approve the prior authorization criteria with no

changes.

Committee

approved as

recommended

Unanimous



with any changes.

Single Product

Reviews:

Methergine PerformRx makes the following

recommendation: KF/AHC/AHN/

No changes recommended

Committee

approved as

recommended

Unanimous

No Changes

New Products Reviews

PerformRx recommends to keep the following product remain non-formulary

KF/AHC/AHN/ Abilify Mycite

Aemcolo

Albuminex

Altreno

Arakoda

Bryhali

Cequa

Clorotekal

Demerol (PF) Carpuject

Epidiolex

Firdapse

Gamifant

Gleolan

Glyrx-PF

Inveltys

Lexette

Minolira

Nocdurna

Nuzyra

Omegaven

Committee

approved as

recommended

Unanimous



with any changes

Omnipaque

Oxervate

Panzyga

Promacta

Qbrexza

Recovi

Seysara

Siklos

Sympazan

Tegsedi

Tiglutik

Tirosint

Tolsura

Tresiba

Ultomiris

Xelpros

Xepi

Xerava

Xofluza

Xolair

Xyosted

Yupelri

Yutiq

Zortress

Ztlido

PerformRx recommends to keep the following products non-formulary and use drug specific PA criteria for

KF/AHC/AHN/ Actemra ACTPen

Ajovy

Azedra

Copiktra

Daurismo

Dupixent

Granix

Jivi

Khapzory

Libtayo

Lorbrena

Lumoxiti

Nivestym

Talzenna

Udenyca

Vitrakvi

Vizimpro

Xospata

PerformRx recommends to remain non- formulary for

KF/AHC/AHN/ Delstrigo

Pifeltro

PerformRx recommends to add to Specialty Tier and use drug specific PA criteria for:

KF/AHC/AHNE/ Arikayce

PerformRx recommends to add to specialty tier as preferred agent with drug specific PA criteria

KF/AHC/AHNE/

Emgality SQ Syringe

Embality SQ Pen

PerformRx recommends to add to Formulary with a quantity limit of 60 tablets per 30 days

KF/AHC/AHNE/ Xarelto

9. Prior Authorization Criteria Review

.

Prior Authorization

Criteria Annual

Review

Alpha-1 Proteinase

Inhibitors


KF/AHC/AHN/ Approve the Alpha‐1 Proteinase Inhibitors (Human)

criteria for with the following changes

1. Addition of references

2. Listing preferred and non‐preferred agents to

enhance visibility

Unanimous

Tabled for next meeting

DDAVP PerformRx makes the following recommendation:

KF/AHC/AHNE/ Retire the DDAVP criteria

Remove prior authorization requirement from

desmopressin tablets and nasal spray/solution

Add a quantity limit of 90 tablets per 30 day for

desmopressin 0.1 mg tablets and a quantity limit of

180 tablets per 30 days for desmopressin 0.2 mg

tablets. Add a quantity limit of 15 mL per 30 days for

desmopressin 0.01% intranasal solution

Lower the minimum age limit for desmopressin

tablets to 4 years of age

Committee

approved as

recommended

Unanimous



with any changes.

Diclegis PerformRx makes the following recommendation:

KF/AHC/AHN/ Add references Age restrictions according to package insert Clarify language Add Pyridoxine (vitamin B6) 25 mg tablet to the ACLA

formulary to ensure access to first line treatment for nausea and vomiting in pregnancy

.

Committee

approved as

recommended

Unanimous



with any changes.

Emflaza PerformRx makes the following recommendations: KF/AHC/AHNE/ Add references

Clarify when calcium and vitamin D supplementation is

required’

Add additional diagnostic confirmatory tests to align

with updated guidelines

Remove requirement for baseline behavioral health

evaluation

Committee

approved as

recommended

Unanimous



with any changes.

Eosinophilic

Asthma Agents PerformRx makes the following recommendations:

KF/AHC/AHNE/ Addition of black box warning notification

Add references

Add Dupixent to drugs

Specified age restriction

Specified exclusion criteria prohibiting the use of

multiple monoclonal antibodies for the treatment of

asthma

Committee

approved as

recommended

Unanimous



with any changes.

Gonadotropin

Releasing

Hormone Agonists

(GNRH)

PerformRx makes the following recommendations: KF/AHC/AHN/ Add references

Co‐preferring Zoladex, Lupron Depot, and Lupron

Depot‐Ped

Reformatted drug names

Remove Gonadotropin Releasing Hormone Antagonist

Firmagon from drug list

Add Lupaneta Pack to drug list

Committee

approved as

recommended

Unanimous



with any changes

Growth Hormones

PerformRx makes the following

recommendations: KF/AHC/AHN/ Genotropin removed due availability of Genotropin

Miniquick

Add specific criteria for growth failure in pediatrics

with CKD

Modify wording to specify all genetic diseases require

confirmatory testing

Separate adult and pediatric growth hormone deficiency

criteria

Committee

approved as

recommended

Unanimous



with any changes

Modify pediatric growth hormone deficiency criteria to

require GF‐1 and IGFBP‐3 together with severe

clinical/auxological features or, in their absence, GH

stimulation test

Remove requirement for 2 standard deviations below

mean for age in regard to height and bone age.

Hepsera PerformRx makes the following recommendations: KF/AHC/AHN/ Retire the Hepsera criteria and list as non-

formulary/Prior Authorization Required Medication

Ensure appropriate use and utilization of formulary

alternatives.

Committee

approved as

recommended

Unanimous



with any changes.

Hyaluronic Acid

Derivatives PerformRx makes the following recommendation:

KF/AHC/AHN/ Remove reference to capsaicin

List preferred and non-preferred agents to enhance

visibility

Add of TriVisc to non-preferred agents

Committee

approved as

recommended

Unanimous



with any changes.

Add references

Injectable

Bisphosphonates &

Skeletal Related

Events

PerformRx makes the following recommendation: KF/AHC/AHN/ Modification to title

Require documentation of calcium and vitamin D

supplementation

Clarify CrCl requirements

Clarify use of denosumab and morbidity

Add endocrinologist to prescriber restrictions

.

Committee

approved as

recommended

Unanimous



with any changes.

KF/AHC/AHN/ Remove Kynamro from the criteria as it has been

withdrawn from the market in the U.S

Add documentation of LDL level pre‐treatment in order

to assess efficacy for reauthorization

Add ezetimibe as a prerequisite requirement as it is

indicated for this diagnosis and has shown to be

efficacious

With the removal of Kynamro, Juxtapid is specifically

indicated for homozygous familial

hypercholesterolemia and therefore the diagnostic

criteria has been updated to reflect this

Ocaliva PerformRx makes the following recommendation: KF/AHC/AHN/ Removal of liver biopsy and ultrasound of the liver as

this is no longer required for diagnosis according to the

2018 AASLD guidelines

Minor language changes for clarification and ease of

review

Remove lipid panel requirements as decreases in HDL

due to Ocaliva should lead to consideration of benefits

vs risks and whether the medication should be

continued. Decreases do not warrant a denial of therapy

as this is not a contraindication and should be monitored

by and decided on by the prescriber.

Remove ALT/AST monitoring parameters and instead

require that patient does not have complete biliary

obstruction as this warrants permanent discontinuation

of therapy

Committee

approved as

recommended

Unanimous



with any changes

Opioid

Dependence

Agents

PerformRx makes the following recommendation: KF/AHC/AHN/ Remove requirement for negative pregnancy test

Remove requirement of monotherapy for pregnant

patients. New trial data show no difference in outcomes

between dual therapy vs monotherapy. Additionally,

buprenorphine monotherapy has shown a higher

potential for misuse. Choice of therapy should be

decided on by the provider.

Remove counseling requirements under reauthorization

section as new SAMHSA guidelines state that

counseling has not shown any added benefit and should

not be mandatory.

Remove urine drug screen requirements. ASAM

guidelines recommend utilizing urine drug screens as a

tool to support recovery rather than deny therapy.

Committee

approved as

recommended

Unanimous



with any changes.

Opioid containing

products PerformRx makes the following recommendation:

KF/AHC/AHN Add separate criteria for opioid cough and cold

products to differentiate from opioids requested for pain

Add criteria for reauthorization requests when doses

have increased since initial approval

Add non formulary statement into re-authorization

criteria

Committee

approved as

recommended

Unanimous



with any changes.

Proprotein

Convertase

Subtilisin/Kexin 9

(PCSK9)

PerformRx makes the following recommendation: KF/AH/AHN Add trial of ezetimibe into Familial

Hypercholesterolemia section as a cost effective

alternative prior to treatment with a PCSK9 and in the

primary and secondary hyperlipidemia section as

recommended in the 2018 ACC/AHA guidelines

Changing criteria for “extreme risk” section to include

criteria for “high risk” and “very high risk” categories

according to 2018 ACC/AHA guidelines

Remove old treatment algorithm

Committee

approved as

recommended

Unanimous



with any changes.

Spinraza PerformRx makes the following recommendation: KF/AHC/AHN/ Clarify that the first 5 dose approval is for initial requests

and the reauthorization approval will be for 3

maintenance doses allowing for one year of therapy.

Remove the lab parameters as these do not warrant a

denial of therapy.

Committee

approved as

recommended

Unanimous



with any changes.

Hepatitis C PerformRx makes the following recommendation:

KF/AHC/AHN/ : Add the newly approved generic Epclusa

(sofosbuvir/velpatasvir) and generic Harvoni

(ledipasvir/sofosbuvir) as preferred products

Update treatment summary charts to align with new AASLD guidelines and to include additional preferred

agents

Remove Zepatier dosing from renal impairment

treatment summary due to the addition of generic Epclusa

(sofosbuvir/velpatasvir) and generic Harvoni

(ledipasvir/sofosbuvir) which are preferred produc

Remove Vosevi from the genotype 3 treatment

experienced summary due to Vosevi being alternative

treatment and due to the addition of the preferred generic

Epclusa product for this subset of patients.

.

Committee

approved as

recommended

Unanimous



with any changes.

Specialty

Biological Agents


Crohn’s Disease:

KF/AHC/AHN/ Stream the preferred vs non-preferred biologic language Move Inflectra to non-preferred. Add Pentasa as an option for prerequisite therapy as it is

indicated for Crohn’s Disease

Remove new member criteria, allowing physician

attestation for new members who have taken

conventional therapy already, and adding in more

detailed continuation of therapy/grandfathering

provisions.

Change language of preferred TNF to preferred

“biologic” agent as many of our criteria now have

multiple mechanisms of actions in the preferred product

category.

Committee

approved as

recommended

Unanimous



with any changes.

Ulcerative Colitis:

KF/AHC/AHN/ Streamlining preferred vs non-preferred biologic

language.

Move Inflectra to non-preferred.





provisions




category.

Psoriasis:

KF/AHC/AHN/ Streamline preferred vs non-preferred biologic

language.

Move Inflectra to non-preferred

Move Cosentyx and Taltz to preferred





provisions.

Change pre-requisites from one TNF to trial of two

preferred medications with different mechanisms of

action.




category.

Approve requirement of only 1 pre-requisite

alternatives and 1 preferred biologic agent for ACLA to

align with state requirements

Polyarticular Juvenile Idiopathic Arthritis: KF/AHC/AHN/ Streamline preferred vs non-preferred biologic language





provisions.


"biologic" agent as many of our criteria now have

multiple mechanisms of actions in the preferred

product category

Approve requirement of only 1 pre-requisite alternative

and 1 preferred biologic agent for ACLA to align with

state requirements.

Systemic Juvenile Idiopathic Arthritis:

KF/AHC/AHN/ Streamline preferred vs non-preferred biologic language


attestation for new members who have taken NSAID

therapy already, and adding in more detailed continuation

of therapy/grandfathering provisions.

Addition of non-preferred biologic request criteria

Remove pediatric rheumatologist as rheumatologist in

general will capture this requirement.

Add more detailed continuation of therapy and

grandfathering provisions.

FDA (if no indication specific criteria) and NON-FDA Approved Medically Accepted Indications

KF/AHC/AHN/ Streamline preferred vs non-preferred biologic language


Move Cosentyx, Taltz and Kevzara to preferred





provisions.

Change pre-requisites to trial of three preferred

medications with different mechanisms of action.




category


and 1 preferred biologic agent to align with state

requirements

Rheumatoid KF/AHC/AHN/ Streamline preferred vs non-preferred biologic language


Move Kevzara to preferred





provisions.

Change pre-requisites to trial of two preferred

medications with different mechanisms of action.




category


and 1 preferred biologic agent to align with state

requirements

Ankylosing Spondylitis KF/AHC/AHN/ Streamline preferred vs non-preferred biologic language


Move Cosentyx to preferred





provisions


medications with different mechanisms of action




category



state requirements

Psoriatic Arthritis (PsA) KF/AHC/AHN/ Streamline preferred vs non-preferred biologic language


Move Cosentyx and Taltz to preferred





provisions


medications with different mechanisms of action




category



state requirements

Second Generation

Antihistamines PerformRx recommends approving the criteria for

with the following changes: KF/AHC/AHN/ Remove allegra (fexofenadine) from first line agents

and making non-formulary

Add 30 mg to Allegra (fexofenadine) as a non-

formulary agent for clarity

Committee

approved as

recommended

Unanimous



with any changes.

Prior Authorization New Criteria:

Novoeight PerformRx makes the following recommendation: KF/AHC/AHN/ Approve the newly created criteria

Committee

approved as

recommended

Unanimous



with any changes.

Orilissa


KF/AHC/AHN/ AHDE: Approve the new Orlissa criteria

Committee

approved as

recommended

Unanimous



with any changes.

10. Recalls

There were several recalls in which members and providers

were notified.

Teva all Amlodipine/Valsartan Combination Tablets

and Amlodipine/Valsartan/Hydrochlorothiazide

Combination Tablets

Aurobindo 80 Lots of Amlodipine Valsartan Tablets,

Valsartan HCTZ Tablets, and Valsartan Tablets

Prinston Pharmaceutical- Irbesartan and Irbesartan

HCTZ Tablets

Torrent Pharmaceuticals recall of Losartan Potassium

Tablets

Sandoz recall of one lot of Losartan Potassium and

Hydrochlorothiazide

Mylan recall of 15 Lots of Valsartan Tablets,

Amlodipine and Valsartan Tablets, and Valsartan and

Hydrochlorothiazide Tablets

Informational

Melissa

Jeff Kreitman

Affected members

who had prescriptions filled

for these

products were all notified

11. Adjournment

The meeting adjourned at 7:18 PM EST

N/A

William

Burnham

The next meeting April 29,

2019 from 6:00 PM‐ 8:00

PM.

________________________________ __4/18/2019_____________

Dr. Glenn Hamilton, MD - Chair Date

Documents

Enterprise P&T Committee Meeting Minutes - AmeriHealth ...€¦ · 1. Add a quantity limit of 1 mL per 30 days for Aimovig 70 mg/mL Autoinjector (NDC 55513‐0841‐01), and 2 mL