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General Non-Formulary Request Criteria – Delaware – NSF
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
      • 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, a targeted NSF contraceptive may be approved if a member meets one 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 alternative listed in the Contraceptive category in Table 1 below.

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

When a benefit, an antibiotic, anti-viral, or anti-fungal may be approved if a member meets the following criteria:

A.    The member has tried and failed one 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, a combination product may be approved if a member meets the following criteria:

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

IV.   All Other Targeted Medications

When a benefit, the requested medication will be approved if a member meets all of the following criteria (A. and B. or C.):

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

B.    For targeted medications listed in Table 1 below, the member must have tried and failed two alternative products, if available, listed in the last column in the corresponding category.

C.    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

    Acne Combo w/ Antibiotics

    • Aktipak
    • Veltin
    • Acanya
    • Onexton

    Acne - Oral

    • Doxycycline IR-DR
    • doxycycline
    • Oracea

    Acne Vulgaris

    • Plixda
    • Epiduo
    • adapalene

    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
    • Freestyle
    • Precision
    • Truetrack
    • True Metrix

    + All Others Except One Touch

    • One Touch Ultra
    • One Touch Verio

    Calcitonin Gene-Related Peptide (CGRP) Inhibitors

    • Ajovy
    • Aimovig
    • Emgality

    Chorionic Gonadotropins

    • Pregnyl
    • Chorionic gonadotropin
    • Novarel
    • Ovidrel

    Colchicine Products

    • Colchicine

     

    • Colcrys
    • Mitigare

    Contraceptives

    • Minastrin 24 FE
    • Lo Loestrin FE
    • Natazia
    • Nuvaring
    • Taytulla
    • Safyral

    Direct-Acting Antivirals for Hepatitis C

    • Daklinzia
    • Mavyret
    • Olysio
    • Sovaldi

    *See products required in policy J-820

    DPP4 Inhibitors

    • Alogliptin
    • Alogliptin-Metformin
    • Kazano
    • Kombiglyze XR
    • Nesina
    • Onglyza
    • Januvia
    • Janumet, Janumet XR
    • Jentadueto, Jentadueto XR
    • Tradjenta

    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

    Filgrastim Products

    • Neupogen
    • Nivestym
    • Granix
    • Zarxio

    Follitropins

    • Follistim AQ
    • Bravelle
    • Gonal-F

    Glucagon-Like Peptide-1 Agonists

    • Adlyxin
    • Bydureon
    • Byetta
    • Tanzeum
    • Trulicity
    • Victoza
    • Ozempic

    GnRH Antagonists

    • Ganirelix Acetate
    • Cetrotide

    Growth Hormones

    • Omnitrope
    • Saizen
    • Nutropin
    • Zomacton
    • Humatrope
    • Genotrpoin
    • Norditropin

    HMG-CoA Reductase Inhibitors

    • Altoprev
    • Zypitamag
    • Livalo
    • Lovastatin
    • atorvastatin

    Hylauronic Acid Derivatives**

    • Gel-One
    • Gelsyn
    • Genvisc
    • Hyalgan
    • Hymovis
    • Supartz
    • Synvisc
    • Visco-3
    • Euflexxa
    • Monovisc
    • Orthovisc

    Inflammatory Bowel

    • Asacol
    • Delzicol
    • Dipentum
    • Apriso
    • Pentasa

    Inhaled Long-Acting Muscarinic

    • Spiriva HandiHaler
    • Spiriva Respimat
    • Incruse Ellipta
    • Tudorza Pressair

    Insulin Other - Human

    • Humulin R
    • Novolin R

    Insulin Other- NPH

    • Humulin N
    • Novolin N

    Insulin Other -Combo

    • Humulin
    • Novolin

    Insulin Rapid Acting

    • Humalog
    • Admelog
    • Apidra
    • Novolog
    • Fiasp

    Long Acting Beta Agonist (nebulized)

    • Brovana
    • Perforomist

    Narcotic Analgesics- Oral

    • Embeda
    • Oxycodone HCl ER
    • Oxycontin
    • Opana ER
    • Hysingla ER
    • Nucynta ER
    • Xtampza ER

    Nasal Steroids

    • Beconase
    • Omnaris
    • Zetonna
    • fluticasone propionate
    • QNASL

    Novel Psychotropics

    • Seroquel XR
    • Latuda
    • quetiapine ER

    Ophthalmic Anti-Allergy

    • Alocril
    • Alomide
    • Emadine
    • Alrex
    • Bepreve
    • Pazeo

    Ophthalmic Anti-Inflammatory

    • Flarex
    • FML Forte
    • FML S.O.P
    • Maxidex
    • Pred Mild
    • Lotemax
    • dexamethasone

    Ophthalmic NSAIDs

    • Acuvail
    • Nevanac
    • Ilevro
    • Prolensa

    Ophthalmic Prostaglandins

    • Zioptan
    • Lumigan
    • Travatan Z

    Other Ophthalmic Drugs for Glaucoma

    • Timoptic
    • Istalol
    • Alphagan P
    • Combigan

    Otic Antibiotic

    • Cetraxal
    • Ciprodex
    • Otovel

    Pancreatic Enzymes- EC

    • Pancreaze DR
    • Pertyze DR
    • Creon
    • Zenpep

    PCSK9 Inhibitors

     

    • Praulent
    • Repatha

    Phosphate Binders

    • Fosrenol packet
    • Renagel
    • Phoslyra
    • Velphoro

    PPIs

    • Aciphex
    • Protonix suspension
    • Prilosec DR suspension
    • Zegerid
    • Nexium Rx packet
    • omeprazole
    • pantoprazole

     

    Progesterones- Vaginal/Infertility

    • Endometrin Suppository
    • Crinone

    Pulmonary Anti-Inflammatory

    • Alvesco
    • ArmonAir
    • Arnuity
    • Asmanex
    • Flovent
    • Pulmicort Inhaler
    • Qvar

    Short Acting Inhaled Bronchodilators

     

    • Proventil
    • Levalbuterol
    • Xopenex HFA
    • Proair
    • Ventolin

    Somatostatin Analogs

    • Signifor LAR
    • Sandostatin LAR
    • Somatuline
    •  

    Topical Actinic Keratosis

    • Fluorouracil
    • Zyclara
    • Imiquimod [Brand]

     

    • Carac
    • Picato

    Transmucosal Fentanyl Analgesics

    • Abstral
    • Lazanda
    • Fentora
    • Fentanyl Citrate
    • Subsys

    Weight Loss Products

    • Qsymia
    • Contrave ER
    • Belviq/XR

     

    Miscellaneous Categories

     

    • Emflaza
    • prednisone
    • Evzio
    • Naloxone HCl
    • Narcan
    • Glumetza
    • Metformin ER (generic to Glucophage XR)
    • Gocovri ER
    • Osmolex ER
    • Amantadine HCl
    • Lyrica CR
    • Gralise
    • Lyrica

     

    • Duzallo
    • Zurampic
    • Allopurinol
    • Mitigare

     

    • Xadago
    • Rasagiline
    • selegiline

     

    • Lupron Depot Ped
    • Eligard
    • Firmagon

     

    • Xerese
    • Zovirax
    • acyclovir

     

    • Atripla [new starts only]
    • Symtuza [new starts only]
    • Destrigo [new starts only]
    • Biktarvy
    • Complera
    • Genvoya
    • Odefsey
    • Stribild
    • Symfi/Symfi Lo

     

    • Topicort Spray
    • Verdeso
    • Desonide
    • desoximetasone

     

    • Fenoprofen calcium capsules [Brand]
    • Fenortho
    • Nalfon
    • Diclofenac
    • Meloxicam
    • Indomethacin
    • Naprelan CR

     

    • Berinert
    • Ruconest

     

    • Cortifoam
    • Uceris (foam)
    • hydrocortisone

     

    • Noctiva
    • desmopressin

     

    • Siklos
    • Droxia

     

    • Lucemyra
    • clonidine

     

    • luliconazole [Brand]
    • Luzu
    • ciclopirox

     

    • Butrans
    • Belbuca
    • Buprenorphine patch

     

    • Orilissa
    • Lupron Depot
    • Synarel
    • Zoladex

     

    • Kapspargo Sprinkle
    • Bystolic
    • Metoprolol succinate

     

    • Minolira ER
    • minocycline ER [Brand]
    • Solodyn
    • minocycline ER [generic]

     

    • Pifeltro
    • efavirenz

    **Must be a covered benefit.

     



    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-0752-002
    Effective Date Begin: 01/01/2019
    Effective End Begin: 01/06/2019
    Original Date: 07/01/2018
    Review Date: 11/07/2018


    References:

    1. Truven Health Analytics Micromedex Solutions. Available at: www.micromedexsolutions.com. Accessed June 11, 2018.
    2. American Society of Health-System Pharmacists. AHFS Drug Information. Available at: http://www.ahfsdruginformation.com/. Accessed June 11, 2018.
    3. Clinical Pharmacology. Elsevier. Gold Standard. Available at: http://www.clinicalpharmacology-ip.com/default.aspx. Accessed June 11, 2018.

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    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.



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