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-1049

 

Biologics- Other

 

 

 

 

 

Cosentyx

Kevzara

Kineret

Olumiant

Orencia

Siliq

*See products required in policy J-1049

 

 

 

 

 

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

Suprep

 

Buprenorphine/Naloxone Products

 

Bunavail

 

buprenorphine-naloxone

Zubsolv

Chorionic Gonadotropins

 

Pregnyl

Chorionic gonadotropin

Novarel

Ovidrel

Colchicine Products

 

colchicine capsules [brand]

 

Mitigare

colchicine tablets

Colony Stimulating Factors- Filgrastim Products

 

 

 

Granix

Neupogen

 

 

 

Nivestym

Zarxio

 

 

 

Colony Stiulating Factors- Pegfilgrastim Products

Neulasta

Udenyca

Fulphila

Ziextenzo

Contraceptives

 

 

 

Phexxi

Twirla

 

 

Eluryng

Xulane

Lo Loestrin Fe

Taytulla

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

Jentadueto, Jentadueto XR

Kazano

Kombiglyze XR

Nesina

Onglyza

Tradjenta

Januvia

Janumet, Janumet XR

 

 

 

 

 

 

 

DPP4/SGLT2 Inhibitor Combinations

 

 

Qtern

 

 

 

Glyxambi

Steglujan

Trijardy XR

 

Epinephrine Auto-Injector System

 

Epinephrine auto-injector [Brand]

Auvi-Q

 epinephrine auto-injector

Epipen/Epipen Jr.

Erythroid Stimulants

 

 

Aranesp

Epogen

Mircera

Procrit

Retacrit

 

Estrogen Transdermal

 

Elestrin

Estrogel

Divigel

estradiol patch

Estrogen Modifiers for Vaginal Symptoms

 

Femring

Intrarosa

 

estradiol

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

 

 

 

 

Humatrope

Nutropin

Omnitrope

Saizen, Saizenprep

Zomacton

Genotropin

Norditropin

 

 

 

Helicobacter pylori

 

Pylera

Helidac

lansoprazole-amoxicillin-clarithromcyin

Talicia

Hyaluronic Acid Derivatives**

 

 

 

 

 

 

 

 

 

 

 

Durolane

Gel-One

Gelsyn

Genvisc

Hyalgan

Hymovis

Sodium Hyaluronate 1% Syringe [Brand]

Supartz

Synvisc

Triluron

Trivisc

Visco-3

Euflexxa

Monovisc

Orthovisc

IBS-C and Chronic Constipation

Amitiza

Linzess

Trulance

Inflammatory Bowel

 

Dipentum

 

mesalamine ER

Pentasa

Inhaled LAMA/LABA

 

 

Duaklir Pressair

 

 

Anoro Ellipta

Bevespi Aerosphere

Stiolto Respimat

Inhaled Long-Acting Muscarinic

 

Tudorza Pressair

 

Incruse Ellipta

Spiriva, Spiriva Respimat

Insulin Basal

 

 

 

Semglee

 

 

 

Lantus

Levemir

Toujeo

Tresiba

Insulin Other - Human

Humulin R

Novolin R

Insulin Other- NPH

Humulin N

Novolin N

Insulin Other -Combo

Humulin

Novolin

Insulin Rapid Acting

 

 

 

 

 

 

Admelog

Apidra

Humalog

Insulin Aspart

Insulin Lispro

 

Lyumjev

Novolog

Fiasp

Long Acting Beta Agonist Inhalers

Striverdi Respimat

Serevent Diskus

Methotrexate Auto-Injectors

Otrexup

Rasuvo

Narcotic Analgesics- Oral

 

 

Morphabond ER

Oxycodone HCl ER

Oxycontin

Hysingla ER

Nucynta ER

Xtampza ER

Nasal Steroids

 

 

Beconase

Omnaris

Zetonna

fluticasone propionate

QNASL

Novel Psychotropics

 

 

Caplyta

aripiprazole

Latuda

quetiapine ER

Ophthalmic Anti-Allergy

 

 

 

Alocril

Alomide

Lastacaft

Pazeo

 

azelastine

olopatadine

Zerviate

Ophthalmic Anti-Inflammatory

 

 

 

FML Forte

FML S.O.P

Maxidex

Pred Mild

dexamethasone

Lotemax/Lotemax SM

Inveltys

Ophthalmic NSAIDs

 

 

Acuvail

Nevanac

Bromsite

Ilevro

Prolensa

Ophthalmic Prostaglandins

 

Xelpros

Lumigan

Zioptan

Ophthalmic Quinolone Antibiotics

 

Ciloxan

 

Besivance

ciprofloxacin

levofloxacin

Other Ophthalmic Drugs for Glaucoma

 

Timoptic

 

 

Alphagan P

Azopt

Combigan

Otic Antibiotic

 

Ciprofloxacin-fluocinolone [Brand]

 

ciprofloxacin-dexamethasone

Otovel

Pancreatic Enzymes- EC

 

 

Pertyze

 

 

Creon

Pancreaze

Zenpep

PCSK9 Inhibitors

Praluent

Repatha

Potassium Binders

Veltassa

Lokelma

PPIs

 

 

 

 

Aciphex Sprinkle

Prilosec suspension

Rabeprazole [Brand]

esomeprazole strontium 49.3 mg [brand]

omeprazole

pantoprazole

Progesterones

Crinone

Endometrin

Pulmonary Anti-Inflammatory

 

 

 

 

Armonair Digihaler

 

 

 

 

Arnuity Ellipta

Asmanex

Flovent

Pulmicort Flexhaler

Qvar Redihaler

Pulmonary Anti-Inflammatory/Beta-agonist

 

 

 

 

 

AirDuo Digihaler

AirDuo Respiclick

budesonidep-formoterol [Brand]

Fluticasone-salmeterol [brand]

 

 

 

Advair

Breo Ellipta

Dulera

fluticasone-salmeterol

Symbicort

Wixela

Short Acting Inhaled Bronchodilators

 

 

 

 

Albuterol Sulfate [Brand]

Levalbuterol [brand]

Proair Digihaler

Proair Respiclick

Ventolin

Xopenex HFA

albuterol sulfate HFA

Somatostatin Analogs

 

Mycapssa

Signifor LAR

Sandostatin LAR

Somatuline Depot

Topical Actinic Keratosis

 

 

 

 

Carac

Fluorouracil  [Brand]

Imiquimod [Brand]

Zyclara

 

fluorouracil

imiquimod

Picato

Miscellaneous Categories

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Emflaza

prednisone

 Evzio

Naloxone auto-injector [brand]

naloxone HCL

Narcan

 Glumetza

metformin ER (generic to Glucophage XR)

 Gocovri ER

amantadine HCL

Lyrica CR

gabapentin

pregabalin

Xadago 

Zelapar

rasagiline

selegiline

Delstrigo [new starts only]

Stribild [new starts only]

Complera [new starts only]

Rukobia [new starts only]

Biktarvy

Genvoya

Odefsey

efavirenz/lamivudine/TDF

 

Verdeso

desonide

desoximtasone

Fenoprofen calcium capsules [Brand]

Fenortho

Nalfon

Zorvolex

Relafen DS

Tivorbex

Vivlodex

Zipsor

indomethacin 20 mg capsules [Brand]

ketorolac nasal spray [Brand]

diclofenac capsule [Brand]

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

Inderal XL

Innopran XL

Kapspargo Sprinkle

Bystolic

metoprolol succinate

propranolol ER

minocycline ER capsules [brand]

Ximino

minocycline ER tablets

 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

Epiduo Forte

adapalene-benzyl peroxide

clindamycin phosphate

Onexton

tretinoin

Doryx 80 mg

Doxycycline hyclate 80 mg [brand]

Doxycycline IR-DR [brand]

 

doxycycline

Oracea 

Altoprev

Ezallor

 

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

Ecoza

Sulconazole Nitrate [brand]

Xolegel

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

 

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

Isturisa

Signifor

Qinlock [New starts only]

imatinib

Stivarga

Sutent

Fintepla

Diacomit

Epidiolex

Cystadrops

Cystaran

Upneeq

Not applicable

Inqovi [new starts only]

Onureg [new starts only]

*see criteria in policy J-1002

Xatmep

methotrexate

Aptiom

carbamazepine

oxcarbazepine

topiramate

Vimpat

Calquence [New starts only]

Imbruvica

Venclexta

Firdapse

Ruzurgi

Mytesi

diphenoxylate w/ atropine

loperamide

Pregenna

Trinaz

prenatal plus

preplus

Quazepam

estazolam

lorazepam

Retin-A Micro Pump

tretinoin

Firvanq

vancomycin

Nucynta

oxycodone

hydrocodone w/ acetaminophen

tramadol

Proctofoam-HC

Hc pramoxine

pramoxine w/ hydrocortisone

Ongentys

entacapone
Gimoti Nasal Spray metoclopramide tablet
Lampit Benznidazole
Alkindi Sprinkles hydrocortisone tablet
Hemady dexamethasone tablet

**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-0752-026
Effective Date Begin: 01/15/2021
Effective End Begin: 02/28/2021
Original Date: 07/01/2018
Review Date: 10/07/2020


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.