sign in sign up
<<
Home , Balsalazide, Ciclesonide, Clocortolone pivalate, Levamlodipine, Vibegron

Drug and Biologic Coverage Policy

Effective Date ...... 10/1/2021 Next Review Date… ...... 10/1/2022 Coverage Policy Number ...... 1601

Drugs/Biologics Not Covered Unless Approved Under Medical Necessity Review Employer Group Plans: Standard, Performance, or Legacy List

Table of Contents Related Coverage Resources

Overview ...... 1 Coverage Policy ...... 1 General Background ...... 18 Off Label Uses ...... 19 References ...... 19

INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations.

Overview This policy supports employer group plan Prescription Drug Lists that require medical necessity exceptions for non-covered drugs.

Coverage Policy

Coverage for non-covered drugs varies across plans and may require the use of preferred products in addition to the medical necessity criteria listed in the tables below. Refer to the customer’s benefit plan document for coverage details.

Non-covered drugs are considered medically necessary when the following criteria are met: (1) where an A-rated generic is available and (2) for covered alternatives 1. Documentation that individual has tried the bioequivalent generic product AND cannot take due to a formulation difference in the inactive ingredient(s) [for example, difference in dyes, fillers, preservatives]

Page 1 of 19 Coverage Policy Number: 1601

between the brand and the bioequivalent generic product which, per the prescribing physician, would result in a significant allergy or serious adverse reaction.

2. When there is documentation of ONE of the following: a. The individual has had inadequate efficacy to the number of covered alternatives according to the table below OR b. The individual has a contraindication according to FDA label, significant intolerance, or is not a candidate* for the covered alternatives according to the table below

*Note: Not a candidate due to being subject to a warning per the prescribing information (labeling), having a disease characteristic, individual clinical factor[s], other attributes/conditions, or is unable to administer and requires this dosage formulation)

Note: Receipt of sample product does not satisfy any criteria requirements for coverage.

Employer Group Standard, Performance, and Legacy Non-Covered Products and Preferred Covered Alternatives: Therapeutic Drug or Clinical Coverage Criteria/Covered Alternative Drug Category Biologic Anti-diuretic and DDAVP® BOTH of the following: vasopressor hormone (desmopressin • desmopressin nasal solution (generic for DDAVP) agents acetate 0.01% • desmopressin tablets nasal solution)

Anti-infective agents: Tolsura Treatment of ONE of the following fungal infections: antifungals (itraconazole • Blastomycosis 65mg capsules) • Histoplasmosis • Aspergillosis in individuals intolerant or refractory to therapy Anti-infective agents: Mepron® ONE of the following: antiprotozoals (atovaquone • Prevention or treatment of Pneumocystis jiroveci pneumonia 750 mg/ 5 ml (PCP) in adults or individuals 13 years of age and older oral suspension) BOTH of the following: o atovaquone oral suspension (generic for Mepron) o trimethoprim/ sulfamethoxazole (TMP-SMX) • Prevention or treatment of Toxoplasma gondii encephalitis (TE) in adults or adolescents BOTH of the following: o atovaquone oral suspension (generic for Mepron) o ONE of the following: . trimethoprim/sulfamethoxazole (TMP-SMX) . pyrimethamine . sulfadiazine Anti-infective agents: Sitavig® BOTH of the following: antivirals (acyclovir 50 mg • Documented diagnosis of recurrent herpes labialis buccal tablet) • Documented inability to use acyclovir capsules and tablets Anti-infective agents: EryPed 400 BOTH of the following: Macrolides (erythromycin • erythromycin suspension (generic for EryPed) 400 mg/5 ml • erythromycin ethylsuccinate 400 mg tablets suspension) and Alvesco® ALL of the following: Respiratory: Inhalers, () • Flovent® Diskus OR Flovent HFA () • Qvar® OR Qvar® Redihaler™ (beclomethasone) ArmonAir® • Pulmicort Flexhaler™ ()

Page 2 of 19 Coverage Policy Number: 1601

Therapeutic Drug or Clinical Coverage Criteria/Covered Alternative Drug Category Biologic Digihaler™ (fluticasone)

Arnuity™ Ellipta® (fluticasone)

Asmanex®/HFA () Asthma and Seebri™ EFFECTIVE through 12/31/2021 Respiratory: Inhalers, Neohaler® • Incruse® Ellipta® (umeclidinium) Long Acting (glycopyrrolate) EFFECTIVE 1/1/2022 Tudorza® ONE of the following: Pressair® • Incruse® Ellipta® (umeclidinium) (aclidinium) • Spiriva (tiotropium) Spiriva® EFFECTIVE through 12/31/2021* HandiHaler® Spiriva Handihaler and Spiriva Respimat 2.5 mcg/actuation: (tiotropium) For COPD: • Incruse® Ellipta® (umeclidinium) Spiriva® Respimat® Spiriva Respimat 1.25 mcg/actuation: (tiotropium) For the add-on treatment of uncontrolled asthma and BOTH of the following: . Individual is 6 years of age or older . a high-dose inhaled (ICS) AND another controller therapy such as a long-acting beta- (LABA)

*Spiriva/Respimat covered as a preferred brand on 1/1/2022. Asthma and Striverdi® BOTH of the following: Respiratory: Inhalers, Respimat® • Arcapta™ Neohaler® () Long-Acting Beta () • Serevent Diskus® () Asthma and Zyflo® ( BOTH of the following: Respiratory: 600 mg tablets) • zileuton extended-release tablet (generic for Zyflo CR) Leukotriene modifiers • ONE of the following: o o Asthma and Elixophyllin BOTH of the following: Respiratory: ( 80 o theophylline solution (generic for Elixophyllin) derivatives mg/15 ml o theophylline extended release capsules or tablets solution) Calcium Channel Conjupri® ALL of the following: Blockers (CCBs) (levamlodipine) • • • LA • Calcium Channel Consensi® Documented inability to use amlodipine and celecoxib as Blockers (amlodipine/cele separate agents (CCBs)/Non-Steroidal coxib tablet) Anti-inflammatories (NSAIDs)

Page 3 of 19 Coverage Policy Number: 1601

Therapeutic Drug or Clinical Coverage Criteria/Covered Alternative Drug Category Biologic Cardiovascular: Yosprala™ ALL of the following: Antithrombotic (aspirin delayed • Individual is at risk of developing aspirin associated gastric Agents release/omepraz ulcers defined as EITHER of the following ole 81 mg – 40 o 55 years of age or older mg tablets and o Documented history of gastric ulcers 325 – 40 mg • Individual requires aspirin for secondary prevention of tablets) cardiovascular and cerebrovascular events defined as ONE of the following: o Previous ischemic stroke or transient ischemia of the brain due to fibrin platelet emboli o Previous myocardial infarction or unstable pectoris o Chronic stable angina pectoris o History of revascularization procedure (coronary artery bypass graft or percutaneous transluminal coronary angioplasty) when there is pre-existing condition for which aspirin is already indicated • Documented intolerance to immediate release (including enteric coated) aspirin Cardiovascular: Edecrin® ALL of the following: Diuretics (ethacrynic acid • bumetanide 25 mg tablets) • furosemide • torsemide ethacrynic acid (ethacrynic acid 25 mg tablets) Cardiovascular: Multaq EFFECTIVE 1/1/2022 Other (dronedarone EITHER of the following: 400 mg tablets) • Individual is currently receiving dronedarone (Multaq) • TWO of the following: o o disopyramide o o o o o /AF Cardiovascular: Edarbi EFFECTIVE 1/1/2022 Renin Inhibitors (azilsartan) FIVE of the following: • candesartan • irbesartan • losartan • olmesartan • telmisartan • valsartan Edarbyclor EFFECTIVE 1/1/2022 (azilsartan/ FIVE of the following: chlorthalidone) • candesartan/hydrochlorothiazide • irbesartan/ hydrochlorothiazide • losartan/hydrochlorothiazide • olmesartan/hydrochlorothiazide • telmisartan/hydrochlorothiazide • valsartan/hydrochlorothiazide

Page 4 of 19 Coverage Policy Number: 1601

Therapeutic Drug or Clinical Coverage Criteria/Covered Alternative Drug Category Biologic Cardiovascular: Cardizem CD BOTH of the following: Vasodilators ( 120 • diltiazem ER capsules (generic for Cardizem CD) mg, 180 mg, • Diltiazem extended-release 24-hour capsules OR tablets 240 mg, 300 (for example: generic Cardizem LA tablets, generic Dilacor mg, and 360 mg XR capsules, or generic Tiazac capsules) extended release capsules) GoNitro™ BOTH of the following: (nitroglycerin • nitroglycerin sublingual tablets sublingual • nitroglycerin sublingual spray powder) Isordil® Documented inability to use two tablets of isosorbide dinitrate 20 Titradose™ mg tablets (isosorbide dinitrate 40 mg tablet) Lowering Antara® BOTH of the following: (fenofibrate 30 • fenofibrate 43 mg, 67 mg, or 130 mg capsules mg and 90 mg • ALL of the following: ® capsules) o fenofibric acid (Trilipix ) ® ® o fenofibrate (Tricor /Lofibra ) ® o gemfibrozil (Lopid ) Fenoglide® BOTH of the following: (fenofibrate 40 • fenofibrate 48 mg or 120 mg tablets mg and 120 mg • ALL of the following: ® tablets) o fenofibric acid (Trilipix ) ® ® o fenofibrate (Tricor /Lofibra ) ® o gemfibrozil (Lopid ) ApexiCon® E FIVE of the following: (Topical) ( • 0.1% cream, lotion, ointment diacetate) • dipropionate, augmented 0.05% cream, 0.05% cream foam, gel, ointment • betamethasone dipropionate 0.05% cream, ointment • 0.1 % ointment • betamethasone valerate 0.12% foam • propionate 0.05% cream, foam, gel, lotion, ointment, shampoo • 0.25% cream, ointment • desoximetasone 0.05% cream, gel • 0.05% cream, gel, ointment, solution • fluocinonide 0.1% cream • fluocinonide-E 0.05% cream • 0.005% ointment • halobetasol propionate 0.05% cream, ointment • mometasone furoate 0.1% ointment • acetonide 0.1% ointment • 0.5% cream, ointment Cordran® FIVE of the following: (flurandrenolide) • dipropionate 0.05% cream, ointment 0.05% cream, • betamethasone dipropionate 0.05% lotion, spray lotion, ointment • betamethasone valerate 0.1% cream, lotion

Page 5 of 19 Coverage Policy Number: 1601

Therapeutic Drug or Clinical Coverage Criteria/Covered Alternative Drug Category Biologic • pivalate 0.1% cream Cordran® SP • 0.05% cream, lotion, ointment (flurandrenolide) • acetonide 0.025% cream, ointment 4 mcg/sq cm • 0.01% cream, oil, solution tape • fluticasone propionate 0.05% cream • valerate 0.2% cream, ointment • mometasone furoate 0.1% cream, lotion, solution • 0.1% cream, ointment • triamcinolone acetonide 0.025% cream • triamcinolone acetonide 0.05% ointment • triamcinolone acetonide 0.1% lotion Impoyz® FIVE of the following: (clobetasol • amcinonide 0.1% cream, lotion, ointment propionate) • betamethasone dipropionate, augmented 0.05% cream, 0.025% cream foam, gel, ointment • betamethasone dipropionate 0.05% cream, ointment • betamethasone valerate 0.1 % ointment • betamethasone valerate 0.12% foam • 0.05% cream, foam, gel, lotion, ointment, shampoo • desoximetasone 0.25% cream, ointment • desoximetasone 0.05% cream, gel • fluocinonide 0.05% cream, gel, ointment, solution • fluocinonide 0.1% cream • fluocinonide-E 0.05% cream • fluticasone propionate 0.005% ointment • halobetasol propionate 0.05% cream, ointment • mometasone furoate 0.1% ointment • triamcinolone acetonide 0.1% ointment • triamcinolone acetonide 0.5% cream, ointment Locoid® FIVE of the following: (hydrocortisone • alclometasone dipropionate 0.05% cream, ointment butyrate) 0.1% • betamethasone dipropionate 0.05% lotion, spray lotion • betamethasone valerate 0.1% cream, lotion • 0.1% cream ® Locoid • desonide 0.05% cream, lotion, ointment Lipocream • fluocinolone acetonide 0.025% cream, ointment (hydrocortisone • fluocinolone acetonide 0.01% cream, oil, solution butyrate) 0.1% • fluticasone propionate 0.05% cream lipid cream • 0.2% cream, ointment • mometasone furoate 0.1% cream, lotion, solution • prednicarbate 0.1% cream, ointment • triamcinolone acetonide 0.025% cream • triamcinolone acetonide 0.05% ointment • triamcinolone acetonide 0.1% lotion Olux™ FIVE of the following: ( • amcinonide 0.1% ointment propionate) • betamethasone dipropionate, augmented 0.05% cream, 0.05% cream, foam, gel, ointment foam, gel, lotion, • betamethasone dipropionate 0.05% cream, ointment

Page 6 of 19 Coverage Policy Number: 1601

Therapeutic Drug or Clinical Coverage Criteria/Covered Alternative Drug Category Biologic ointment, • clobetasol propionate 0.05% cream, foam, gel, lotion, shampoo ointment, shampoo • desoximetasone 0.25% cream, ointment Olux™-E • desoximetasone 0.05% gel (clobetasone • fluocinonide 0.05% cream, gel, ointment, solution propionate) • fluocinonide 0.1% cream 0.05% foam • halobetasol propionate 0.05% cream, ointment • triamcinolone acetonide 0.5% ointment Pandel® FIVE of the following: (hydrocortisone • amcinonide 0.1% cream, lotion probutate) 0.1% • betamethasone valerate 0.1% cream • betamethasone valerate 0.12% foam, ointment • desoximetasone 0.05% cream • fluocinolone acetonide 0.025% ointment • fluocinonide-E 0.05% cream • fluticasone propionate 0.005% ointment • hydrocortisone valerate 0.2% ointment • mometasone furoate 0.1% cream, lotion, ointment, solution • prednicarbate 0.1% ointment • triamcinolone acetonide 0.05% ointment • triamcinolone acetonide 0.5% cream • triamcinolone acetonide 0.1% ointment Psorcon® FIVE of the following: (diflorasone • amcinonide 0.1% cream, lotion, ointment diacetate) • betamethasone dipropionate, augmented 0.05% cream, 0.05% cream lotion • betamethasone dipropionate 0.05% cream, ointment • betamethasone valerate 0.1 % ointment • betamethasone valerate 0.12% foam • desoximetasone 0.25% cream, ointment • desoximetasone 0.05% cream, gel • fluocinonide 0.05% cream, gel, ointment, solution • fluocinonide-E 0.05% cream • fluticasone propionate 0.005% ointment • mometasone furoate 0.1% ointment • triamcinolone acetonide 0.1% ointment • triamcinolone acetonide 0.5% cream, ointment Tridesilon™ FIVE of the following: (desonide) • alclometasone dipropionate 0.05% cream, ointment 0.05% cream • betamethasone dipropionate 0.05% lotion, spray • betamethasone valerate 0.1% cream, lotion • clocortolone pivalate 0.1% cream • desonide 0.05% cream, lotion, ointment • fluocinolone acetonide 0.025% cream, ointment • fluocinolone acetonide 0.01% cream, oil, solution • fluticasone propionate 0.05% cream • hydrocortisone valerate 0.2% cream, ointment • mometasone furoate 0.1% cream, lotion, solution • prednicarbate 0.1% cream, ointment • triamcinolone acetonide 0.025% cream • triamcinolone acetonide 0.05% ointment

Page 7 of 19 Coverage Policy Number: 1601

Therapeutic Drug or Clinical Coverage Criteria/Covered Alternative Drug Category Biologic • triamcinolone acetonide 0.1% lotion Corticosteroids Cortifoam® ONE of the following: (Rectal Formulations) (hydrocortisone • Colocort (hydrocortisone) 100 mg/60 mL rectal enema acetate) 10% • hydrocortisone 100 mg/60 mL rectal enema aerosol foam

Dermatologic: Actinic Diclofenac 3% BOTH of the following: Keratosis, Topical topical gel • Diagnosis of actinic keratoses • ALL of the following topical therapies: Solaraze o 5-fluorouracil cream (fluorouracil 0.5%, Fluoroplex 1%, (diclofenac) 3% Tolak 4%, Efudex 5%) topical gel o 5-fluorouracil solution (2% or 5%) o Imiquimod 5% cream Dermatologic: Anti- Aldara® BOTH of the following: neoplastics, Topical (imiquimod 5% • imiquimod 5% cream (generic for Aldara) cream) • ONE of the following: o For actinic keratosis: ALL of the following topical therapies: . 5-fluorouracil cream (fluorouracil 0.5% cream, Fluoroplex 1%, Tolak 4%, Efudex 5%) . 5-fluorouracil solution (2% or 5%)

o For superficial basal cell carcinoma: . topical 5-fluorouracil 5% (cream or solution)

o For external genital and perianal warts (Condylomata acuminata): BOTH of the following topical therapies: . podofilox 0.5% (solution, Condylox gel) . Veregen (sinecatechins) 15% ointment Carac® BOTH of the following: (fluorouracil • fluorouracil 0.5% cream (generic for Carac) 0.5% cream) • ALL of the following topical therapies: o 5-fluorouracil cream (Fluoroplex 1%, Tolak 4%, Efudex 5%) o 5-fluorouracil solution (2% or 5%) o imiquimod 5% cream Condylox® BOTH of the following: (podofilox) 0.5% • For the topical treatment of anogenital warts (external topical gel genital warts and perianal warts) • BOTH of the following: o imiquimod 5% cream o podofilox 0.5% solution Klisyri® BOTH of the following: (tirbanibulin) • Diagnosis of Actinic Keratosis • BOTH of the following: o 5-fluorouracil 0.5% cream OR 5-fluorouracil solution (2% or 5%) o imiquimod 5% cream Zyclara® ALL of the following topical therapies: (imiquimod 2.5% • 5-fluorouracil cream (flurouracil 0.5% cream, Fluoroplex 1%, cream pump) Tolak 4%, Efudex 5%) • 5-fluorouracil solution (2% or 5%)

Page 8 of 19 Coverage Policy Number: 1601

Therapeutic Drug or Clinical Coverage Criteria/Covered Alternative Drug Category Biologic • imiquimod 5% cream Zyclara® ONE of the following: (imiquimod • For actinic keratosis: ALL of the following topical therapies: 3.75% cream o 5-fluorouracil cream (flurouracil 0.5% cream, Fluoroplex pump, and 1%, Tolak 4%, Efudex 5%) 3.75% cream) o 5-fluorouracil solution (2% or 5%) o imiquimod 5% cream

• For external genital and perianal warts (Condylomata acuminata): ALL of the following topical therapies: o imiquimod 5% cream o podofilox 0.5% (solution, Condylox gel) o Veregen (sinecatechins) 15% ointment Dermatologic: Enstilar® FIVE generic prescription-strength topical corticosteroid Anti-psoriatic agents, (calcipotriene products (for example, alclometasone, betamethasone topical 0.005% / dipropionate, desonide, fluocinolone, fluticasone, mometasone, betamethasone triamcinolone) AND a calcipotriene-containing product (for 0.064% foam) example, calcipotriene cream) Sorilux™ BOTH of the following: (calcipotriene • ONE of the following: calcipotriene cream, ointment, solution 0.005% foam) • tazarotene cream Taclonex® FIVE generic prescription-strength topical corticosteroid (calcipotriene products (for example, alclometasone, betamethasone 0.005%/ dipropionate, desonide, fluocinolone, fluticasone, mometasone, betamethasone triamcinolone) AND a calcipotriene-containing product (e.g., 0.064% calcipotriene cream) ointment and suspension) Tazorac® For the treatment of plaque psoriasis and BOTH of the following: (tazarotene • tazarotene (generic for Tazorac) 0.05% cream, • calcipotriene gel) Wynzora® • FIVE generic prescription-strength topical corticosteroid (calcipotriene/ products (e.g., alclometasone, betamethasone dipropionate, betamethasone desonide, fluocinolone, fluticasone , mometasone, dipropionate triamcinolone) AND a calcipotriene-containing product (e.g., 0.005%/ 0.064% calcipotriene cream) topical cream) Dermatologic: Local 3% BOTH of the following: anesthetics, topical lotion • lidocaine 3% cream • lidocaine 5% ointment Lido-K (lidocaine 3% lotion) Dermatologic: Clobex® BOTH of the following: Steroidal Anti- (clobetasol • clobetasol lotion (generic for Clobex lotion) inflammatory, Topical 0.05%) lotion • FOUR dosage forms of clobetasol 0.05%: liquid spray, shampoo, solution, ointment, cream, gel, or foam Clobex® BOTH of the following: (clobetasol • clobetasol lotion (generic for Clobex liquid spray) 0.05%) liquid • FOUR dosage forms of clobetasol 0.05%: lotion, shampoo, spray solution, ointment, cream, gel, or foam Clobex® BOTH of the following:

Page 9 of 19 Coverage Policy Number: 1601

Therapeutic Drug or Clinical Coverage Criteria/Covered Alternative Drug Category Biologic (clobetasol • clobetasol lotion (generic for Clobex shampoo) 0.05%) • FOUR dosage forms of clobetasol 0.05%: lotion, liquid shampoo spray, solution, ointment, cream, gel, or foam Cutivate® BOTH of the following: (fluticasone • fluticasone (generic for Cutivate) 0.05% lotion) • FOUR of the following:

o betamethasone o clocortolone o desoximetasone o fluocinonide o flurandrenolide o hydrocortisone o mometasone o prednicarbate o triamcinolone Halog ALL of the following: ( • betamethasone cream 0.1% cream) • clobetasol cream • fluocinonide cream • halobetasol cream • triamcinolone cream Halog ALL of the following: (halcinonide • betamethasone ointment 0.1% ointment) • clobetasol ointment • fluocinonide ointment • halobetasol ointment • triamcinolone ointment Halog ALL of the following: (halcinonide • betamethasone cream/gel/lotion/ointment 0.1% solution) • clobetasol cream/ointment • fluocinonide cream/gel/ointment/solution • halobetasol cream/ointment • triamcinolone cream/ointment Impeklo™ ALL of the following (clobetasol • clobetasol 0.05% lotion propionate • betamethasone diproprionate augmented 0.05% (gel, 0.05% lotion) ointment, or lotion) • 0.05% ointment • fluocinonide 0.1% cream • halobetasol propionate 0.05% (cream or ointment) Lexette® EFFECTIVE through 12/31/2021 (halobetasol ALL of the following: propionate • Individual is 18 years of age and older 0.05% foam) • Treatment of plaque psoriasis • halobetasol (generic for Lexette) halobetasol • FOUR of the following: propionate o betamethasone dipropionate, augmented 0.05% (gel, 0.05% foam lotion and ointment) o clobetasol propionate 0.05% (cream, foam, gel, lotion, ointment, shampoo, solution, spray) o diflorasone diacetate 0.05% (ointment) o fluocinonide 0.1% (cream)

Page 10 of 19 Coverage Policy Number: 1601

Therapeutic Drug or Clinical Coverage Criteria/Covered Alternative Drug Category Biologic o halobetasol propionate 0.05% (cream and ointment)

EFFECTIVE 1/1/2022 FIVE of the following: • amcinonide 0.1% ointment • betamethasone dipropionate, augmented 0.05% cream, foam, gel, ointment • betamethasone dipropionate 0.05% cream, ointment • clobetasol propionate 0.05% cream, foam, gel, lotion, ointment, shampoo • desoximetasone 0.25% cream, ointment • desoximetasone 0.05% gel • fluocinonide 0.05% cream, gel, ointment, solution • fluocinonide 0.1% cream • halobetasol propionate 0.05% cream, ointment • triamcinolone acetonide 0.5% ointment Kenalog® EFFECTIVE through 12/31/2021* (triamcinolone BOTH of the following: acetonide 0.147 • triamcinolone solution (generic for Kenalog) mg/gm aerosol • ALL of the following: triamcinolone acetonide cream, lotion solution) and ointment

EFFECTIVE 1/1/2022 triamcinolone FIVE of the following: acetonide 0.147 • Amcinonide 0.1% cream, lotion mg/gm aerosol • Betamethasone valerate 0.1% solution • Betamethasone valerate 0.12% foam, ointment • Desoximetasone 0.05% cream • Fluocinolone acetonide 0.025% ointment • Fluocinonide-E 0.05% cream • Fluticasone propionate 0.005% ointment • Hydrocortisone valerate 0.2% ointment • Mometasone furoate 0.1% cream, lotion, ointment, solution • Prednicarbate 0.1% ointment • Triamcinolone acetonide 0.05% ointment • Triamcinolone acetonide 0.5% cream • Triamcinolone acetonide 0.1% ointment Sernivo™ ALL of the following: (betamethasone • betamethasone dipropionate 0.05% ointment dipropionate • betamethasone dipropionate 0.05% cream 0.05% emulsion) • betamethasone dipropionate 0.05% lotion • augmented betamethasone dipropionate 0.05% gel • betamethasone valerate 0.12% foam Trianex® EFFECTIVE through 12/31/2021* (augmented ALL of the following: triamcinolone • triamcinolone acetonide cream acetonide 0.05% • triamcinolone acetonide lotion ointment) • triamcinolone acetonide ointment EFFECTIVE 1/1/2022 FIVE of the following:

Page 11 of 19 Coverage Policy Number: 1601

Therapeutic Drug or Clinical Coverage Criteria/Covered Alternative Drug Category Biologic augmented • Amcinonide 0.1% cream, lotion triamcinolone • Betamethasone valerate 0.1% acetonide • Betamethasone valerate 0.12% foam, ointment 0.05% ointment • Desoximetasone 0.05% cream • Fluocinolone acetonide 0.025% ointment • Fluocinonide-E 0.05% cream • Fluticasone propionate 0.005% ointment • Hydrocortisone valerate 0.2% ointment • Mometasone furoate 0.1% cream, lotion, ointment, solution • Prednicarbate 0.1% ointment • Triamcinolone acetonide 0.05% ointment • Triamcinolone acetonide 0.5% cream • Triamcinolone acetonide 0.1% ointment Ultravate® FIVE of the following: (halobetasol • betamethasone dipropionate, augmented 0.05% ointment propionate • betamethasone dipropionate, augmented 0.05% lotion 0.05% lotion) • clobetasol propionate 0.05% cream • clobetasol propionate 0.05% lotion • clobetasol propionate 0.05% ointment • halobetasol propionate 0.05% cream • halobetasol propionate 0.05% ointment Vanos® BOTH of the following: (fluocinonide • fluocinonide cream (generic for Vanos) 0.1% cream) • fluocinonide 0.05% solution, ointment, cream, and gel Verdeso® ALL of the following: (desonide • fluocinolone body oil 0.05% foam) • fluticasone lotion • topical hydrocortisone Diabetes: Insulins Novolog Mix • Humalog® Mix 75/25 70/30® (70% insulin aspart protamine/30% insulin aspart)

Novolin 70/30® • Humulin® 70/30 (70% NPH, human insulin isophane/30% regular human insulin) Novolin N® • Humulin® N (insulin, NPH human recombinant isophane) Novolin R® • Humulin R (insulin, regular, human recombinant) Diabetes: Test Strips AccuChek® • Documented inability to use BOTH One Touch Ultra® AND One Touch Verio® due to a physical limitation that makes

Page 12 of 19 Coverage Policy Number: 1601

Therapeutic Drug or Clinical Coverage Criteria/Covered Alternative Drug Category Biologic EasyTouch® utilization of the One Touch product not accurate, safe or for BluLink® other reason not medically appropriate (e.g. manual dexterity, visual impairment, or use of a insulin pump with a Freestyle® dedicated meter)

Contour®

FORA® TN'G Advance Pro Epinephrine Self- Auvi-Q® Individual weighs 16.5 to 33 pounds (7.5 to 15 kg). Administered (epinephrine) Injectables 0.1 mg auto- injector Auvi-Q® EITHER of the following: (epinephrine) • Documented inability to obtain generic epinephrine auto- 0.3 mg, 0.15 mg injector auto-injector • Individual or his/her caregiver is blind or significantly visually-impaired EpiPen® or Documented inability to obtain generic epinephrine auto-injector. EpiPen Jr. (epinephrine) 0.3 mg, 0.15 mg auto-injector Symjepi® Documented inability to obtain generic epinephrine auto-injector. (epinephrine) 0.3 mg, 0.15 mg pre-filled syringe Gallstone Dissolution Reltone™ ONE of the following: Agent (ursodiol) 200 • (generic) ursodiol 250 mg tablet mg, 400 mg • (generic) ursodiol 500 mg tablet capsule Gastrointestinal Asacol® HD BOTH of the following: Agents: (mesalamine) • mesalamine (generic for Asacol HD) • FOUR of the following: ™ o Apriso (mesalamine) o balsalazide ® o Lialda (mesalamine) ® o Pentasa (mesalamine) o Colazal® BOTH of the following: (balsalazide) • balsalazide (generic for Colazal) • ALL of the following: ™ o Apriso (mesalamine) ® o Lialda (mesalamine) ® o Pentasa (mesalamine) o sulfasalazine Delzicol® BOTH of the following: (mesalamine) • mesalamine (generic for Delzicol) • FOUR of the following: ™ o Apriso (mesalamine) o balsalazide ® o Lialda (mesalamine) ® o Pentasa (mesalamine)

Page 13 of 19 Coverage Policy Number: 1601

Therapeutic Drug or Clinical Coverage Criteria/Covered Alternative Drug Category Biologic o sulfasalazine Dipentum® FIVE of the following: () • Apriso™ (mesalamine) • balsalazide • generic mesalamine • Lialda® (mesalamine) • Pentasa® (mesalamine) • sulfasalazine Hyperlipidemia Niacor (niacin EFFECTIVE 1/1/2022 Agents 500 mg tablet) Documentation that individual has tried ONE niacin extended- release tablet product and cannot take due to a formulation niacin 500 mg difference in the inactive ingredient(s) [for example, difference in tablet dyes, fillers, preservatives] between the brand and a covered alternative product which, per the prescribing physician, would result in a significant allergy or serious adverse reaction. Hormones: oral Alkindi® • Individual is 17 years of age or younger corticosteroids Sprinkle oral • Documented diagnosis of adrenocortical insufficiency granules • Attestation that the individual is unable to swallow (hydrocortisone) hydrocortisone tablets (generic for Cortef) dexamethason ALL of the following: e 1.5 mg tablets o 1.5 mg tablets o tablet therapy pack Dxevo 11 Day o BOTH of the following: Dose Pack o hydrocortisone (dexamethasone o methylprednisolone tablets 1.5 mg tablets)

TaperDex 6 Day, 7 Day and 12 Day Pack (dexamethasone 1.5 mg tablets) Rayos® BOTH of the following: ( 1 o prednisone 1 mg, 2.5 mg, or 5 mg tablets mg, 2 mg, and 5 o ALL of the following: mg delayed o dexamethasone tablets release tablets) o hydrocortisone tablets o methylprednisolone tablets

Immunosuppressant Otrexup™ ALL of the following: Agents – (methotrexate) • generic oral or injectable methotrexate Methotrexate injection for • Rasuvo (methotrexate) solution for injection Injections subcutaneous • Reditrex (methotrexate) solution for injection use Rasuvo™ ONE of the following: (methotrexate) • (generic) oral methotrexate injection for • (generic) injectable methotrexate subcutaneous use Reditrex™ ONE of the following: (methotrexate) • (generic) oral methotrexate • (generic) injectable methotrexate

Page 14 of 19 Coverage Policy Number: 1601

Therapeutic Drug or Clinical Coverage Criteria/Covered Alternative Drug Category Biologic injection for subcutaneous use Laxative, Osmotic Kristalose® EFFECTIVE 1/1/2022 (lactulose) • lactulose oral solution packet)

lactulose packet Psychotherapeutic Versacloz® BOTH of the following: Drugs: Atypical ( 50 • clozapine 25 mg, 50 mg, 100 mg, or 200 mg tablets Antipsychotics mg/ml • clozapine 12.5 mg, 25 mg, 100 mg, 150 mg, or 200 mg suspension) orally disintegrating tablets Psychotherapeutic Ativan® BOTH of the following: Drugs: () o lorazepam (generic for Ativan) Benzodiazepines o TWO of the following: o alprazolam o clonazepam o diazepam o oxazepam o temazepam Psychotherapeutic Parnate® BOTH of the following: Drugs: (tranylcypromine • tranylcypromine (generic for Parnate) Monoamine oxidase sulfate 10 mg • ONE of the following: inhibitors tablets) o Marplan o selegiline (oral formulations only) o phenelzine Psychotherapeutic Cymbalta® BOTH of the following: Drugs: SNRIs (duloxetine) • duloxetine (generic for Cymbalta) delayed release • ONE of the following: capsules o citalopram o desvenlafaxine succinate ER o escitalopram o fluoxetine o fluvoxamine o paroxetine o sertraline o venlafaxine ER Psychotherapeutic Lexapro® BOTH of the following: Drugs: SSRIs (escitalopram) • escitalopram (generic for Lexapro) tablets • ONE of the following: o citalopram o fluoxetine o fluvoxamine o paroxetine o sertraline

Page 15 of 19 Coverage Policy Number: 1601

Therapeutic Drug or Clinical Coverage Criteria/Covered Alternative Drug Category Biologic Pexeva® ONE of the following: (paroxetine • Individual is currently taking Pexeva mesylate) 10 • Individual has suicidal ideation mg, 20 mg, 30 • BOTH of the following: mg, and 40 mg o paroxetine hydrochloride 10 mg, 20 mg, 30 mg, or 40 tablets mg tablets o ONE of the following: . citalopram . escitalopram . fluoxetine . fluvoxamine . sertraline Psychotherapeutic Anafranil™ BOTH of the following: Drugs: Tricyclic ( • clomipramine (generic for Anafranil) 25 mg, 50 mg • ONE of the following: and 75 mg o capsules) o o bupropion SR/XL o citalopram o desvenlafaxine succinate ER o o duloxetine o escitalopram o fluoxetine o fluvoxamine o o o paroxetine o sertraline o venlafaxine ER Pamelor™ BOTH of the following: (nortriptyline 10 • nortriptyline (generic for Pamelor) mg, 25 mg. 50 • ONE of the following: mg, and 75 mg o amitriptyline capsules) o amoxapine o bupropion SR/XL o citalopram o clomipramine o desvenlafaxine succinate ER o doxepin o duloxetine o escitalopram o fluoxetine o fluvoxamine o imipramine o paroxetine o sertraline o venlafaxine ER Renal and Detrol® BOTH of the following: Genitourinary Agents () • tolterodine (generic for Detrol) • ALL of the following: o ER o / oxybutynin ER

Page 16 of 19 Coverage Policy Number: 1601

Therapeutic Drug or Clinical Coverage Criteria/Covered Alternative Drug Category Biologic o o trospium / trospium ER Detrol LA® BOTH of the following: (tolterodine) • tolterodine ER (generic for Detrol LA) • ALL of the following: o darifenacin ER o oxybutynin/ oxybutynin ER o solifenacin o trospium / trospium ER Ditropan XL® BOTH of the following: (oxybutynin) • oxybutynin ER (generic for Ditropan XL) • ALL of the following: o darifenacin ER o solifenacin o tolterodine / tolterodine ER o trospium / trospium ER Gelnique 10% ALL of the following: gel (oxybutynin • darifenacin ER chloride • oxybutynin / oxybutynin ER metered-dose • solifenacin pump, sachet) • tolterodine / tolterodine ER • trospium / trospium ER Gemtesa® ONE of the following: (vibegron) • Individual is 66 years of age or older • Individual is 65 years of age or younger AND ALL of the following: o darifenacin ER o oxybutynin / oxybutynin ER o solifenacin o tolterodine / tolterodine ER o trospium / trospium ER Myrbetriq® ONE of the following: () • Individual is 66 years of age or older • Individual is 65 years of age or younger AND ALL of the following: o darifenacin ER o oxybutynin / oxybutynin ER o solifenacin o tolterodine / tolterodine ER o trospium / trospium ER Oxytrol® • oxybutynin syrup, extended release tablets or tablets (oxybutynin transdermal system)

Toviaz® ALL of the following: () • darifenacin ER • oxybutynin / oxybutynin ER • solifenacin • tolterodine / tolterodine ER • trospium / trospium ER

Page 17 of 19 Coverage Policy Number: 1601

Therapeutic Drug or Clinical Coverage Criteria/Covered Alternative Drug Category Biologic Vesicare® BOTH of the following: (solifenacin) • solifenacin (generic for Vesicare) tablets • ALL of the following: o darifenacin ER o oxybutynin / oxybutynin ER o tolterodine / tolterodine ER o trospium / trospium ER Vesicare LS™ ONE of the following: (solfenacin • Individual is 4 years of age or younger succ.) 5 mg / 5 • Individual is 5 years of age or older AND ALL of the mL oral following: suspension o darifenacin ER o oxybutynin / oxybutynin ER o solifenacin o tolterodine / tolterodine ER o trospium / trospium ER

General Background

A patient must document the failure of or intolerance to any Covered Alternative Drug(s) before Cigna will approve coverage for the identified drug. A “Covered Alternative Drug” is a drug or biologic in the same therapeutic class that can be expected to have equivalent clinical efficacy and safety when administered to patients under the conditions specified in the FDA-approved product information (Label). The number of Covered Alternative Drugs may vary by employer group plan and Prescription Drug Lists (e.g. “closed” versus “open” formulary plan designs).

Authorized Generics: From the US Food and Drug Administration: An “authorized generic drug” is a listed drug as that has been approved by the FDA’s rules (under subsection 505(c)) and is marketed, sold, or distributed directly or indirectly to retail class of trade with either labeling, packaging (other than repackaging as the listed drug in blister packs, unit doses, etc.), product code, labeler code, trade name, or trade mark that differs from that of the listed drug.

A generic drug is the same as a brand-name drug in dosage, safety, strength, quality, the way it works, the way it is taken and the way it should be used. FDA requires generic drugs have the same high quality, strength, purity and stability as brand-name drugs. Not every brand-name drug has a generic drug. When new drugs are first made they have drug patents. Most drug patents are protected for 20 years. The patent, which protects the company that made the drug first, doesn't allow anyone else to make and sell the drug. When the patent expires, other drug companies can start selling a generic version of the drug. But, first, they must test the drug and the FDA must approve it.

The FDA’s generic drug approval process does not require the drug sponsor to repeat costly animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness. Generic drugs must establish the following for approval: • contain the same active ingredients as the innovator drug(inactive ingredients may vary) • be identical in strength, dosage form, and route of administration • have the same use indications • be bioequivalent • meet the same batch requirements for identity, strength, purity, and quality • be manufactured under the same strict standards of FDA's good manufacturing practice regulations required for innovator products

Page 18 of 19 Coverage Policy Number: 1601

Off Label Uses

The American Hospital Formulary Service supports the following off label uses: • Mepron for the prevention or treatment of Toxoplasma gondii encephalitis (TE) in adults or adolescent

Fluticasone delivered via swallowed multi-dose inhaler formulation or swallowed budesonide aqueous solution are recommended for treatment of eosinophilic esophagitis by the American College of Gastroenterology guidelines for esophageal eosinophilia and eosinophilic esophagitis. No other topical therapies are mentioned. (Dellon, 2013)

References

1. Dellon ES, Gonsalves N, Hirano I, et al. ACG Clinical Guideline: Evidenced Based Approach to the Diagnosis and Management of Esophageal Eosinophilia and Eosinophilic Esophagitis (EoE). Am J Gastroenterol 2013; 108.679-692. 2. McEvoy GK, ed. AHFS 2017 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists, Inc; 2017. 3. Individual Drug Name Entries. Drug Facts and Comparisons. Facts & Comparisons® eAnswers [online]. Available from Wolters Kluwer Health, Inc. Accessed July, 2017. 4. U.S. Food and Drug Administration. Drugs@FDA. U.S. Department of Health & Human Services: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/. 5. U.S. Food and Drug Administration. FDA List of Authorized Generic Drugs: How Drugs are Developed and Approved: http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplica tions/abbreviatednewdrugapplicationandagenerics/ucm126389.htm 6. U.S Food and Drug Administration. Generic Drugs Questions and Answers: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/QuestionsAnswers/ucm100100.htm

“Cigna Companies” refers to operating subsidiaries of Cigna Corporation. All products and services are provided exclusively by or through such operating subsidiaries, including Cigna Health and Life Insurance Company, Connecticut General Life Insurance Company, Cigna Behavioral Health, Inc., Cigna Health Management, Inc., QualCare, Inc., and HMO or service company subsidiaries of Cigna Health Corporation. The Cigna name, logo, and other Cigna marks are owned by Cigna Intellectual Property, Inc. © 2021 Cigna.

Page 19 of 19 Coverage Policy Number: 1601