Pharmacy Policy Bulletin

General Non-Formulary Request Criteria – Delaware – National Select Formulary
Number: J-0752 Category: Formulary
Line(s) of Business:

Commercial
Healthcare Reform
Medicare

Benefit(s):

Not Applicable

Region(s):

All
Delaware
New York
Pennsylvania
West Virginia

Additional Restriction(s):

Formulary: NSF



Drugs Products
  • All products not covered on the formulary due to being a targeted NSF Drug
    • See Table 1 below
FDA-Approved Indications:
  • See individual product information


Background:
  • This policy defines the criteria under which coverage for a NSF targeted medication will be considered for coverage under the prescription drug benefit.This policy is to be used in conjunction with other utilization management policies for the requested medication, if applicable, based on the member's benefit.For specific categories of products, additional criteria apply as outlined in the approval criteria.
  • Definitions:
    • 'Tried and failed' will include the following situations:
      • The use of a formulary medication at recommended doses for an adequate duration without achievement of desired therapeutic goal
      • There is a documented drug interaction with the preferred drug(s)
      • There is a documented adverse drug experiences (i.e., side effects, adverse drug reaction) with the preferred drug(s) or the prescriber attests that the individual would have adverse drug reactions with the preferred drug(s)
      • The preferred drug(s) is expected to be ineffective or less effective, based on known, relevant physical or mental characteristics of the individual and the known characteristics of the prescription drug regimen.
      • The individual is currently stable on the requested medication AND the prescribing physician attests that a change to another preferred product would not be in the individual’s best interest because of a likely adverse event or mental harm to the individual


Approval Criteria

I.  Contraceptives

When a benefit, coverage of a targeted NSF contraceptive may be approved if a member meets one (1) of the following criteria (A. or B.):

A.  The prescribing physician indicates that the drug is medically necessary.

B.  The member has tried and failed one (1) alternative listed in the Contraceptive category in Table 1 below.

 

II.  Antibiotics, Anti-virals, and Anti-fungals

When a benefit, coverage of an antibiotic, anti-viral, or anti-fungal may be approved if a member meets the following criteria (A. and B.):

A.  The medication must be used for an FDA approved indication.

B.  The member has tried and failed one (1) alternative with the same route of administration listed in the last column of Table 1 below for the corresponding antibiotic, anti-viral, or anti-fungal category.

 

III.  Combination Medications

When a benefit, coverage of a combination product may be approved if a member meets the following criteria (A. and B.):

A.  The medication must be used for an FDA approved indication.

B.  The member has tried and failed two (2) alternative products, if available, from the corresponding category listed in the last column of Table 1 below with one (1) being in the same specific class as at least one (1) ingredient in the requested combination product

 

IV.  All Other Targeted Medications

When a benefit, coverage of a targeted medication may be approved if a member meets all of the following criteria (A. and B.):

A.  The medication must be used for a FDA approved indication.

B.  The member meets one (1) of the following criteria (1. or 2.):

1.  The member has tried and failed all the alternative products, if available, listed in the last column in the corresponding category in Table 1 below.

2.  For targeted multisource brands NOT listed below, the member must have tried and failed the generic product.

 

Table 1. NSF Targeted Medications and Therapeutic Alternatives for Specific Therapeutic Categories

Category

Targeted Products

Alternative Products

Anticoagulants

Pradaxa

Savaysa

Eliquis

Xarelto

Beta Interferons

Extavia

Avonex

Betaseron

Plegridy

Rebif

Biologics- Injectable TNF

Cimzia

Simponi

*See products required in policy J-558

Biologics- Other

Kineret

Orencia

Siliq

Taltz

Olumiant

*See products required in policy J-558

Blood Glucose Monitors and Test Strips

Accu-Chek

Breeze

Contour

Truetrack

True Metrix

+ All Others not listed as preferred

One Touch Ultra

One Touch Verio

Freestyle

Precision Xtra

Bowel Evacuants

Osmoprep

Clenpiq

Prepopik

Suprep

Chorionic Gonadotropins

Pregnyl

Chorionic gonadotropin

Novarel

Ovidrel

Colchicine Products

colchicine capsules

 

Colcrys

Mitigare

colchicine tablets

Colony Stimulating Factors- Filgrastim Products

Granix

Neupogen

Nivestym

Zarxio

Direct-Acting Antivirals for Hepatitis C

Mavyret

Sovaldi

ledipasvir-sofosbuvir [Brand]

sofosbuvir-velpatasvir [Brand]

*See products required in policy J-820

DPP4 Inhibitors

Alogliptin

Alogliptin-Metformin

Alogliptin-Pioglitazone

Kazano

Kombiglyze XR

Nesina

Onglyza

Januvia

Janumet, Janumet XR

Jentadueto, Jentadueto XR

Trajenta

Epinephrine Auto-Injector System

Epinephrine auto-injector (non-Mylan)

Auvi-Q

 Epinephrine auto-injector (Mylan)

Epipen/Epipen Jr.

Erythroid Stimulants

Aranesp

Epogen

Mircera

Procrit

Retacrit

Estrogen Transdermal

Estrogel

Divigel

estradiol patch

Estrogen Modifiers for Vaginal Symptoms

Femring

Estring

Premarin

Estrogen/Progestin Combination Patches

Climara Pro

Combipatch

Factor VIII Recombinant Products

Nuwiq

Recombinate

Xyntha, Xyntha Solofuse

Advate

Adynovate

Afstyla

Eloctate

Jivi

Kogenate FS

Kovaltry

Novoeight

Esperoct

Follitropins

Follistim AQ

Gonal-F

Glucagon-Like Peptide-1 Agonists

Adlyxin

Bydureon

Byetta

Trulicy

Victoza

Ozempic

Growth Hormones

Omnitrope

Saizen

Nutropin

Zomacton

Humatrope

Genotropin

Norditropin

Helicobacter pylori

Pylera

Helidac

lansoprazole-amoxicillin-clarithromcyin

Talicia

Hyaluronic Acid Derivatives**

Gel-One

Gelsyn

Genvisc

Hyalgan

Hymovis

Supartz

Synvisc

Triluron

Visco-3

Sodium Hyaluronate 1% Syringe [Brand]

Trivisc

Euflexxa

Monovisc

Orthovisc

Inflammatory Bowel

Dipentum

 

Apriso

Pentasa

Inhaled LAMA/LABA

Duaklir Pressair

Anoro Ellipta

Bevespi Aerosphere

Stiolto Respimat

Inhaled Long-Acting Muscarinic

Tudorza Pressair

Incruse Ellipta

Spiriva

Spiriva Respimat

Insulin Other - Human

Humulin R

Novolin R

Insulin Other- NPH

Humulin N

Novolin N

Insulin Other -Combo

Humulin

Novolin

Insulin Rapid Acting

Humalog

Insulin Lispro

Admelog

Apidra

Insulin Aspart

Novolog

Fiasp

Long Acting Beta Agonist Inhalers

Striverdi Respimat

Serevent Diskus

Narcotic Analgesics- Oral

Embeda

Oxycodone HCl ER

Oxycontin

Hysingla ER

Nucynta ER

Xtampza ER

Nasal Steroids

Beconase

Omnaris

Zetonna

fluticasone propionate

QNASL

Novel Psychotropics

Seroquel XR

aripiprazole

Latuda

quetiapine ER

Ophthalmic Anti-Allergy

Alocril

Alomide

Alrex

Bepreve

Pazeo

Ophthalmic Anti-Inflammatory

FML Forte

FML S.O.P

Maxidex

Pred Mild

Lotemax/Lotemax SM

Dexamethasone

Inveltys

Ophthalmic NSAIDs

Acuvail

Nevanac

Ilevro

Prolensa

Ophthalmic Prostaglandins

Xelpros

Lumigan

Travatan Z

Zioptan

Other Ophthalmic Drugs for Glaucoma

Timoptic

Alphagan P

Combigan

Otic Antibiotic

Cetraxal

Ciprofloxacin-fluocinolone [Brand]

Ciprodex

Otovel

Pancreatic Enzymes- EC

Pancreaze DR

Pertyze DR

 

Creon

Zenpep

PCSK9 Inhibitors

Praluent

Repatha

Potassium Binders

Veltassa

Lokelma

PPIs

Aciphex

Protonix suspension

Prilosec DR suspension

Zegerid

Rabeprazole [Brand]

esomeprazole strontium 49.3 mg [brand]

Nexium Rx packet

omeprazole

pantoprazole

Pulmonary Anti-Inflammatory/Beta-agonist

budesonidep-formoterol [Brand]

Symbicort

Advair HFA

Breo Ellipta

Dulera

Short Acting Inhaled Bronchodilators

 

Albuterol Sulfate [Brand]

Proventil

Levalbuterol

Xopenex HFA

Proair Digihaler

Proair HFA/Respiclick

Ventolin

Somatostatin Analogs

Signifor LAR

Sandostatin LAR

Somatuline

Topical Actinic Keratosis

Fluorouracil  [Brand]

Zyclara

Imiquimod [Brand]

Carac

 

Picato

Miscellaneous Categories

 

Emflaza

prednisone

 Evzio

naloxone auto-injector

Naloxone HCL

Narcan

 Glumetza

Metformin ER (generic to Glucophage XR)

 Gocovri ER

Amantadine HCL

Lyrica CR

Gralise

Lyrica

Xadago 

Rasagiline

selegiline

Atripla [new starts only]

Delstrigo [new starts only]

Stribild [new starts only]

Complera [new starts only]

Biktarvy

Genvoya

Odefsey

Symfi/Symfi Lo

 Topicort Spray

Verdeso

Desonide

desoximtasone

Fenoprofen calcium capsules [Brand]

Fenortho

Nalfon

Zorvolex

Relafen DS

Tivorbex

Vivlodex

Zipsor

indomethacin 20 mg capsules

ketorolac nasal spray

Diclofenac

Meloxicam

Indomethacin

Naprelan CR

Diclofenac epolamine [Brand]

Pennsaid

Flector

 Berinert

Ruconest

 Cortifoam

Uceris (foam)

hydrocortisone

Noctiva

desmopressin

Nocdurna

Siklos

Oxbryta

Droxia

hydroxyurea

Lucemyra

clonidine

luliconazole [Brand]

Luzu

ciclopirox

Butrans

Belbuca

Buprenorphine patch

Kapspargo Sprinkle

Bystolic

Metoprolol succinate

minocycline ER capsules [brand]

Ximino

Minocycline ER tablets [generic]

 Pifeltro [new starts only]

efavirenz

Tolsura

itraconazole

Apadaz

Benzphydrocodone-Acetaminophen [Brand]

hydrocodone w/ acetaminophen

clocortolone pivalate [Brand]

betamethasone valerate

fluocinolone acetonide

triamcinolone acetonide

Prezcobix [new starts only]

Prezista

Kaletra

Prolia

Evenity

alendronate

Tymlos

Forteo

lidocaine-tetracaine [Brand]

lidocaine cream

lidocaine/prilocaine cream

Dutoprol

 

metoprolol tartrate/hydrochlorothiazide

metoprolol succinate ER

Kisqali [new starts only]

Kisqali Femara Co-Pack [new starts only]

Piqray [new starts only]

Ibrance

Verzenio

topiramate er [Brand]

topiramate

Qudexy XR

Ingrezza

tetrabenazine

Austedo

Aspirin-Omeprazole DR [Brand]

Yosprala

aspirin

omeprazole

esomeprazole magnesium

lansoprazole

pantoprazole sodium

rabeprazole sodium

 

Xpovio [new starts only]

Pomalyst

Revlimid

Thalomid

 

Katerzia 1 Mg/ML Suspension  

amlodipine besylate

Inrebic [new starts only]

Jakafi

Drizalma Sprinkle

Fetzima

venlafaxine ER

desvenlafaxine ER

duloxetine

Ozobax

baclofen

tizanidine

Veltin

Onexton

Doxycycline IR-DR [brand]

 

doxycycline

Oracea 

Altoprev

Ezallor

simvastatin suspension [Brand]

Livalo

Lovastatin

Atorvastatin

simvastatin

rosuvastatin

Lazanda

Fentora

Fentanyl citrate buccal tabs [Brand]

Subsys

Fentanyl Citrate

 

Akynzeo

Emend solution

aprepitant

Varubi

Epaned

Qbrelis

enalapril

lisinopril

Mulpleta

Doptelet

Sitavig

acyclovir

valacyclovir

famciclovir

Sulconazole Nitrate

ciclopirox

econazole nitrate

ketoconazole

naftifine hcl

oxiconazole nitrate

calcipotriene 0.005% foam [Brand]

calcipotriene

calcitriol

amphetamine ER suspension

dextroamphetamine sulfate ER

dextroamphetamine-amphet ER

Dyanavel XR

Mydayis

Quillichew ER

Quillivant XR

Vyvanse

Jatenzo

testosterone (topical, generic)

Androderm

 

Palforzia

*see criteria in policy J-246.

 

Clindagel

Clindamycin phosphate gel [brand]

clindamycin phosphate gel

erythromycin gel

Amzeeq

 

Doral

estazolam

lorazepam

 

Korlym

ketoconazole

Lysodren

Signifor

 

Procysbi

Cystagon

 

Tavalisse

Doptelet

Promacta

Nplate

 

Zelapar

rasagaline

selegiline

 

Isturisa

Signifor

 

Qinlock [New starts only]

imatinib

Stivarga

Sutent

 

Fintepla

Diacomit

Epidiolex

**Must be a covered benefit.

 

V.  An exception to some or all of the criteria above may be granted for select members and/or circumstances based on state and/or federal regulations.

 



Limitations of Coverage

I.      Coverage of a medication for disease states outside of their FDA-approved indications should be denied based on the lack of clinical data to support their effectiveness and safety in other conditions.

II.     This policy is to be used in conjunction with other utilization management policies for the requested medication, if applicable, based on the member's benefit



Authorization Duration

 

  • If approved, up to a 12 month authorization may be granted.


Automatic Approval Criteria
None


Version: J-0752-022
Effective Date Begin: 09/01/2020
Effective End Begin: 10/14/2020
Original Date: 07/01/2018
Review Date: 06/03/2020


References:

  1. Truven Health Analytics Micromedex Solutions. Available at: www.micromedexsolutions.com. Accessed May 21, 2020.
  2. American Society of Health-System Pharmacists. AHFS Drug Information. Available at: http://www.ahfsdruginformation.com/. Accessed May 21, 2020.
  3. Clinical Pharmacology. Elsevier. Gold Standard. Available at: http://www.clinicalpharmacology-ip.com/default.aspx. Accessed May 21, 2020.

 

 





Pharmacy policies do not constitute medical advice, nor are they intended to govern physicians' prescribing or the practice of medicine. They are intended to reflect Highmark's coverage and reimbursement guidelines. Coverage may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its pharmacy policy at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the pharmacy policies is prohibited; however, limited copying of pharmacy policies is permitted for individual use.