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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 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, 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. and B.):

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

B.    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. and B.):

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

B.    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

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
  • 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
  • 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
  • Genotropin
  • 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 LAMA/LABA

  • Stiolto Respimat
  • Anoro Ellipta
  • Bevespi Aerosphere

Inhaled Long-Acting Muscarinic

  • Spiriva
  • 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
  • Insulin Lispro
  • 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

  • Abilify Mycite
  • Seroquel XR
  • aripiprazole
  • 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/Lotemax SM
  • Dexamethasone
  • Inveltys

Ophthalmic NSAIDs

  • Acuvail
  • Nevanac
  • Ilevro
  • Prolensa

Ophthalmic Prostaglandins

  • Xelpros
  • 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

 

  • Praluent
  • 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

 

  • Albuterol Sulfate [Brand]
  • 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 buccal tabs [Brand]
  • Fentanyl Citrate
  • Subsys

Weight Loss Products

  • Qsymia
  • Belviq/XR
  • Contrave ER

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
  • Atripla [new starts only]
  • Symtuza [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
  • desoximetasone
  • Fenoprofen calcium capsules [Brand]
  • Fenortho
  • Nalfon
  • Zorvolex
  • Diclofenac
  • Meloxicam
  • Indomethacin
  • Naprelan CR
  • Diclofenac epolamine [Brand]
  • Flector
  • Berinert
  • Ruconest
  • Cortifoam
  • Uceris (foam)
  • hydrocortisone
  • Noctiva
  • desmopressin
  • Siklos
  • Droxia
  • Lucemyra
  •  clonidine
  • luliconazole [Brand]
  • Luzu
  • ciclopirox
  • Butrans
  • Belbuca
  • Buprenorphine patch 
  • Kapspargo Sprinkle
  • Bystolic
  • Metoprolol succinate
  • Minolira ER
  • Solodyn
  • Minocycline ER [generic]
  • Pifeltro [new starts only]
  • efavirenz
  • Tolsura
  • itraconazole
  • Apadaz
  • Benzhydrocodone-Acetaminophen [Brand]
  • hydrocodone w/ acetaminophen
  •  clocortolone pivalate [Brand]
  • betamethasone valerate
  • fluocinolone acetonide
  • triamcinolone acetonide
  • Prezcobix [new starts only]
  • Prezista
  • Kaletra
  • Prolia
  • alendronate
  • Tymlos
  • Forteo
  • lidocaine-tetracaine [Brand]
  • lidocaine cream
  • lidocaine/prilocaine cream
  • Dutoprol
  • metoprolol succinate er-hctz [Brand]
  • metoprolol tartrate/hydrochlorothiazide
  • metoprolol succinate ER
  • Veltassa
  • Lokelma
  • Kisqali [new starts only]
  • Kisqali Femara Co-Pack [new starts only]
  • Ibrance
  • Verzenio
  • topiramate er [Brand]
  • topiramate
  • Qudexy XR
  • Ingrezza
  • tetrabenazine
  • Austedo

**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-0752-012
Effective Date Begin: 08/01/2019
Effective End Begin: 08/31/2019
Original Date: 07/01/2018
Review Date: 05/01/2019


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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