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Drug and Biologic Coverage Policy

Effective Date ...... 6/1/2021 Next Review Date ...... 6/1/2022 Coverage Policy Number ...... 1201

Quantity Limitations

Table of Contents Related Coverage Resources

Overview ...... 1 Coverage Policy Statement ...... 1 Product-specific Quantity Limitations / Exceptions .... 2 General Background ...... 21 References ...... 22

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 Coverage Policy addresses Quantity Limitation requirements and exceptions, in accordance to generally accepted drug and biologic dose, frequency, supply, and duration of therapy medical practice standards supported by FDA product information (Label), standard medical reference compendia, or evidence-based literature.

Coverage Policy Statement

Drugs and Biologics are considered medically necessary to exceed generally accepted quantity limitations, in accordance with benefit plan specifications, when BOTH of the following criteria have been met: • Dosage, frequency, site of administration, and duration of therapy is supported by the FDA product information (Label)

• Dosage, frequency, site of administration, and duration of therapy should be reasonable, clinically appropriate, and supported by evidence-based literature and adjusted based upon severity, alternative available treatments, and previous response to therapy as applicable

Page 1 of 22 Drug and Biologic Coverage Policy: 1201

Supportive evidence examples include, but are not limited: FDA product information (Label), Standard medical reference compendia [for example, American Hospital Formulary Service-Drug Information (AHFS-DI)]. Product- specific exceptions are noted in table below.

Any other exception is considered not medically necessary.

Product-specific Quantity Limitations / Exceptions

Therapeutic Drug Quantity Limitation / Exception Category Allergen Immunotherapy Agents Grastek (Timothy • 1 tablet per day Grass Pollen Allergen Extract)*

Odactra House Dust Mite (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract*

Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy, and 6 Kentucky Blue Grass Mixed Pollens Allergen Extract)*

Ragwitek (Short Ragweed Pollen Allergen Extract)* Allergy-Antihistamine Agents Desloratadine • 2.5mg, 5mg orally disintegrating tablet: 1 ODT per day • 5mg tablet: 1 tablet per day Anticoagulation Agents Betrixaban (Bevyxxa) • 42 capsules per 42 days Dabigatran (Pradaxa) • 75mg, 110mg, 150mg: 2 capsules per day Dalteparin (Fragmin) • 2 syringes per day • 0.25 multi-dose vial (95,000 units/3.8 ml) per day or 7 vials per 30 days Edoxaban (Savaysa) • 15mg, 30mg 60mg: 1 tablet per day Enoxaparin • 2 syringes per day (Lovenox) • 1 multi-dose vial (300mg/3ml) per day Fondaparinux • 1 syringe per day (Arixtra) Rivaroxaban • 2.5mg, 15mg: 2 tablets per day (Xarelto) • 10mg, 20mg: 1 tablet per day • Starter Pack: 51 tablets (1 pack) per 180 days Anticonvulsants Agents Eslicarbazepine • 200mg, 400mg: 1 tablet per day (Aptiom) • 600mg, 800mg: 2 tablets per day

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Therapeutic Drug Quantity Limitation / Exception Category Lacosamide (Vimpat) • 50mg, 100mg, 150mg, 200mg: 2 tablets per day • 10mg/mL solution = 400mg (40mL) per day Oxcarbazepine • 150mg, 300mg: 3 tablets per day (Oxtellar XR) • 600mg: 4 tablets per day Perampanel • 2mg: 6 tablets per day (Fycompa) • 4mg, 6mg, 8mg, 10mg, 12mg: 1 tablet per day Ezogabine (Potiga) • 6 tablets per day Pregabalin (Lyrica) • 25mg: 24 capsules per day • 50mg: 12 capsules per day • 75mg: 8 capsules per day • 100mg: 6 capsules per day • 150mg: 4 capsules per day • 200mg: 3 capsules per day • 225mg, 300mg: 2 capsules per day • 20mg/mL solution: 600mg (30mL) per day Rufinamide (Banzel) • 200 mg: 480 tablets per 30 days • 400 mg: 240 tablets per 30 days • 40 mg/mL: 2400 mL per 30 days Tiagabine (Gabitril) • 12 mg: 8 tablets per day • 16 mg: 6 tablets per day Vigabatrin (Sabril) • 500 mg tablet: 6 tablets per day • 500 mg powder packets: 6 packets per day Antiemetic Therapy Agents Aprepitant (Emend) • up to 4 treatment cycles (one 125 mg capsule and two 80 mg capsule capsules) per 28 days OR one 40 mg capsule per 28 days Aprepitant (Emend) • 12 packets per 28 days (3 packets per week) suspension Dolasetron • 5 tablets per 30 days (Anzemet) Granisetron • 4 patches per 30 days (Sancuso) transdermal Ondansetron • 24 oral films per 30 days (Zuplenz) Palonosetron/netupit • 4 capsules per 28 days ant (Akynseo) capsule Rolapitant (Varubi) • 4 tablets (2 doses) per 28 days tablet Antimalarial Therapy Agents Tafenoquine • 2 tablets for a single course of therapy (Krintafel) Antimigraine Agents Amerge, Axert, Refer to Antimigraine: Serotonin-1 Receptor Agonist Agents section Frova, Relpax, for more detailed information. Rizatripan (Maxalt), Sumatriptan (Imitrex, Quantity limitations are based upon FDA product dosing Onzetra Xsail, recommendations regarding treatment for a maximum number of Sumavel Dose Pro, headaches per 30 day period. Zembrace), Zolmitriptan (Zomig)

Page 3 of 22 Drug and Biologic Coverage Policy: 1201

Therapeutic Drug Quantity Limitation / Exception Category (all forms), sumatriptan and naproxen sodium (Treximet) Dihydroergotamine • 8 nasal units per 30 days (Migranal) nasal Dihydroergotamine • 10 ampules per 30 days (DHE) injection Ergotamine/ • 40 tablets per 28 days (Cafergot) Lasmidtan (Reyvow) • 8 tablets (1 pack) per 30 days Rimegepant orally • 16 tablets (2 packs) per 30 days disintegrating tablets (Nurtec ODT) Antiparkinson Agents • 1 tablet per day (30 tablets per 30 days) extended-release (Osmolex ER) Antipsychotics Agents Injection • 2 injections per 30 days (Abilify Maintena) • 2 syringes per 30 days Injection (Aristada) Asenapine (Saphris) • 2.5mg, 5mg, 10mg: 2 sublingual tablets per day Cariprazine (Vraylar) • 1.5mg, 3mg, 4.5mg, 6mg: 1 capsule per day • Starter Pack: 1 pack (7 capsules) per 180 days Iloperidone (Fanapt) For Employer Group Benefit Plans: • 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg: 4 tablets per day • Titration pack: 4 packs (32 tablets) per 365 days

For Individual & Family Benefit Plans: • 1 mg: 24 tablets per day • 2 mg: 12 tablets per day • 4 mg: 6 tablets per day • 6 mg: 4 tablets per day • 8 mg, 10 mg, 12 mg: 2 tablets per day • Titration pack: 1 pack (8 tablets) every 180 days (Latuda) • 20mg, 40mg, 60mg, 120mg: 1 tablet per day • 80mg: 2 tablets per day injection • 210 mg and 300 mg: 4 kits per 28 days kit (Zyprexa • 405mg: 2 kits per 28 days Relprevv) Paliperidone Injection • 39 mg, 78 mg and 117 mg: 2 syringes per 28 days (Invega Sustenna) • 156 mg and 234 mg: 1 syringe per 28 days Paliperidone Injection • 2 syringes per 90 days (Invega Trinza) Risperidone Injection • 4 syringes per 28 days (Risperdal Consta) Risperidone Injection • 1 kit (90 mg or 120 mg) per 28 days (Perseris) Anti-infective Agents Acyclovir (Sitavig) • 2 buccal tablets per prescription

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Therapeutic Drug Quantity Limitation / Exception Category Acyclovir topical • 5 grams per 30 days cream (Zovirax) Acyclovir topical • 15 grams per 30 days ointment (Zovirax) Acyclovir/hydrocortis • 5 grams per 30 days one topical cream 5%-1% cream (Xerese) Artemether/lumefantri • 24 tablets per 30 days ne (Coartem) Baloxavir (Xofluza) • 2 tablets per 30 days (4 Rx per year) Fidaxomicin (Dificid) • 28 tablets per 28 days (Onmel) • 84 tablets per 84 days (1 Rx per 9 months) Ledipasvir/sofosbuvir • 45 mg/200 mg: 1 tablet per day (Harvoni) Lefamulin (Xenleta) • 10 tablets per 30 days oral tablet Oseltamivir (Tamiflu) • 45mg and 75mg: 10 capsules per 30 days • 30mg: 20 capsules per 30 days • 180mls per 30 days (4 Rx per year) Penciclovir topical • 5 grams per 30 days cream (Denavir) Sofosbuvir (Sovaldi) • 200 mg: 1 tablet per day Rifamycin (Aemcolo) • 12 tablets per 3 days Rifaximin (Xifaxan) • 550 mg: 42 tabs per 14 days, 126 tabs per 365 days (Quantity Limit does not apply for Hepatic Encephalopathy) Zanamavir (Relenza) One inhaler per prescription (4 Rx per year) Alzheimer’s Disease Agents Galantamine • 8mg, 16mg, 24mg: 1 capsule per day extended-release (ER) Memantine • Titration pack: 4 packs (112 tablets) per 365 days (Namenda XR) Memantine/Donepezil • 7 mg-10 mg, 14 mg-10 mg, 21 mg-10 mg, 28 mg-10 mg: 2 (Namzaric) capsules per day • Titration pack: 4 packs (112 tablets) per 365 days Amyloidosis Transthyretin-Cardiomyopathy (ATTR-CM) Agents Tafamidis • 1 capsule per day (Vyndamax)

Tafamidis meglumine • 4 capsules per day (Vyndaqel)

Anaphylaxis Agents Epinephrine • 4 pens per prescription per 30 days (Adrenaclick, AUVI- Q, Epipen, Epipen Jr., Symjepi)

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Therapeutic Drug Quantity Limitation / Exception Category Anxiety/Depression/Bipolar Disorder Agents HCL • 75 mg: 6 tablets per day • 100 mg: 4 tablets per day Bupropion (Aplenzin • 100 mg: 4 tablets per day ER, Wellbutrin SR) • 150 mg: 2 tablets per day • 174 mg: 3 tablets per day • 200 mg: 2 tablets per day • 348 mg and 522 mg: 1 tablet per day Bupropion • 150 mg: 3 tablets per day (Budeprion XL, • 300 mg: 1 tablet per day Forfivo) • 450 mg: 1 tablet per day Citalopram (Celexa) • 10mg/5mL oral solution: 30 mL per day • 10 mg: 6 tablets per day • 20 gm: 3 tablets per day • 40 mg: 1 tablet per day Desvenlafaxine • 25 mg: 16 tablets per day (Khedezla, Pristiq • 50 mg: 8 tablets per day ER) • 100 mg: 4 tablets per day Duloxetine • 20 mg: 6 capsules per day (Cymbalta) • 30 mg: 4 capsules per day • 40 mg: 3 capsules per day • 60 mg: 2 capsules per day Duloxetine (Drizalma) • 20 mg, 30 mg and 40 mg: 1 capsule per day • 60 mg: 2 capsules per day Escitalopram • 5mg/5mL, 10mg/10mL oral solution: 20 mL per day (Lexapro) • 5 mg: 4 tablets per day • 10 mg: 2 tablets per day • 20 mg: 1 tablet per day Fluoxetine (Prozac) • 20mg/5mL oral solution: 20 mL per day • 10 mg: 8 capsules or tablets per day • 20 mg: 4 capsules or tablets per day • 40 mg: 2 capsules per day • 60 mg: 1 tablet per day • 90 mg: 1 capsule per week Fluvoxamine maleate • 25 mg: 12 tablets per day • 50 mg: 6 tablets per day • 100 mg: 3 tablets per day Fluvoxamine maleate • 100 mg: 3 capsules per day ER • 150 mg: 2 capsules per day Isocarboxazid • 12 tablets per day (Marplan) Levomilnacipran • 20 mg: 6 capsules per day (Fetzima ER, Fetzima • 40 mg: 3 capsules per day titration pak) • 80 mg: 1 capsule per day • 120 mg: 1 capsule per day • 20-40 mg titration pak: 1 pak per 6 months HCL • 10mg/5mL oral suspension: 30 mL per day (Paxil) • 10 mg: 6 tablets per day • 20 mg: 3 tablets per day • 30 mg: 2 tablets per day

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Therapeutic Drug Quantity Limitation / Exception Category • 40 mg: 1 tablet per day Paroxetine HCL ER • 12.5 mg: 6 tablets per day (Paxil CR) • 25 mg: 3 tablets per day • 37.5 mg: 2 tablets per day Paroxetine mesylate • 10 mg: 6 tablets per day (Pexeva) • 20 mg: 3 tablets per day • 30 mg: 2 tablets per day • 40 mg: 1 tablet per day Selegiline (Emsam) • 6 mg: 60 patches per 30 days transdermal patch • 9 mg and 12 mg: 30 patches per 30 days Sertraline (Zoloft) • 20mg/mL oral concentrate: 10 mL per day • 25 mg: 8 tablets per day • 50 mg: 4 tablets per day • 100 mg: 2 tablets per day Venlafaxine (Effexor) • 25 mg: 15 tablets per day • 37.5 mg: 10 tablets per day • 50 mg: 7 tablets per day • 75 mg: 5 tablets per day • 100 mg: 3 tablets per day Venlafaxine ER • 37.5 mg: 8 tablets or capsules per day (Effexor XR) • hyp75 mg: 4 tablets or capsules per day • 150 mg: 2 tablets or capsules per day • 225 mg: 1 tablet per day • 10mg, 20mg, 40mg: 1 tablet per day hydrochloride • Starter Pack: 30 tablets per 180 days (Viibryd) • 5mg, 10mg, 20mg: 1 tablet per day (Trintellix) Attention Deficit Hyperactivity Disorder (ADHD) Agents /dextro • 5 mg,10 mg, 15 mg, 20, 25mg, 30mg: 1 capsule per day amphetamine (Adderall XR) Amphetamine/dextro • 12.5 mg, 25 mg, 37.5 mg, 50 mg: 1 capsule per day amphetamine (Mydayis) Amphetamine • 1.25 mg/mL: 15 mL / day (450 mL / 30 days) (Adzenys ER) Amphetamine • 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, 18.8 mg: 1 tablet (Adzenys XR ODT) per day Amphetamine • 2.5 mg/mL: 8mL / day (240 mL / 30 days) (Dyanavel XR) Dexmethylphenidate • 5mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, 40 mg: 1 (Focalin XR) capsule per day Dextroamphetamine • 5 mg, 10 mg: 1 capsule per day (Dexedrine Spansule) • 15 mg: 3 capsules per day Lisdexamphetamine • 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg 70 mg: 1 capsule (Vyvanse) per day • 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg: 1 chewable tablet per day CD • 10 mg, 20 mg, 40 mg, 50 mg, 60 mg: 1 capsule per day

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Therapeutic Drug Quantity Limitation / Exception Category Methylphenidate ER • 25 mg, 35 mg, 45 mg, 55 mg, 70 mg and 85 mg: 1 capsule per (Adhansia XR) day Methylphenidate ER • 18 mg, 27 mg, 54 mg: 1 tablet per day (Concerta) • 36 mg: 2 tablets per day Methylphenidate • 8.6 mg, 17.3 mg: 1 tablet per day (Cotempla XR ODT) • 25.9 mg: 2 tablets per day Methylphenidate • 10mg/9hr, 15mg/9hr, 20mg/9hr, 30mg/9hr: 1 patch per day (Daytrana) transdermal system Methylphenidate ER • 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg: 1 capsule (Aptensio XR) per day Methylphenidate ER • 20 mg, 40 mg, 60 mg, 80 mg, 100 mg: 1 capsule per day (Jornay PM) Methylphenidate ER • 10 mg: 2 tablets per day (Metadate) • 20 mg: 3 tablets per day Methylphenidate ER • 72 mg: 1 tablet per day (Relexxii) Methylphenidate • 20 mg, 40 mg: 1 tablet per day (Quillichew ER) • 30 mg: 2 tablets per day Methylphenidate • 25 mg/5 mL:12 mL / day (360 mL / 30days) (Quillivant XR) Methylphenidate • 10 mg, 20 mg, 40 mg: 1 capsule per day (Ritalin LA) • 30 mg: 2 capsules per day Benign Prostatic Hypertrophy Agents Silodosin (Rapaflo) • 4mg, 8mg: 1 capsule per day Blood Pressure/Heart Agents Aliskiren (Tekturna) • 150mg, 300mg: 1 tablet per day Amlodipine (Katerzia) • 10 mL (10 mg) per day Azilsartan medoxomil • 40mg, 80mg: 1 tablet per day (Edarbi) Azilsartan • 40/12.5mg, 40/25mg: 1 tablet per day medoxomil/chlorthalid one (Edarbyclor) Captopril/Hydrochloro • 25-15 mg and 50-15 mg: 90 tablets per 30 days thiazide • 25-25 mg and 50-25 mg: 60 tablets per 30 days Dofetilide (Tikosyn) • 125 mcg* and 250 mcg: 120 capsules per 30 days • 500 mcg: 60 capsules per 30 days * Individual & Family Benefit Plans cover up to 8 capsules of 125 mcg per day. Isosorbide/Hydralazin • 180 tablets per 30 days e (Bidil) Nisoldipine ER • 8.5mg, 17mg, 20mg, 25.5mg, 30mg, 34mg, 40mg: 1 tablet per day Nebivolol (Bystolic) • 2.5mg, 5mg, 10mg: 1 tablet per day • 20mg: 2 tablets per day (Ranexa) • 4 tablets per day Bone Modifier Agents – Bisphophonate Alendronate 40mg • 2 tablets per day tablet Bone Modifief Agents - Other

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Therapeutic Drug Quantity Limitation / Exception Category Abaloparatide • 1 multi-dose pen per 30 days (Tymlos) *Note: lifetime maximum of 24 monthly doses of treatment [(including previous use of Forteo (teriparatide)]

Romosozumab • Two (105 mg/1.17 mL) syringes per 30 days (Evenity) Teriparatide (Forteo) • 1 multi-dose pen per 28 days

*Note: lifetime maximum of 24 monthly doses of treatment [(including previous use of Tymlos (abaloparatide)] Cancer Agents Nilutamide • 4 tablets per day (Nilandron) Pemigatinib • 14 tablets per 21-days (Pemazyre) Toremifene • 2 tablets per day (Fareston) Cholesterol Lowering Agents – HMG-CoA Reductase Inhibitors (statins) Pitavastatin (Livalo) • 1 mg, 2 mg, 4 mg: 1 tablet per day Simvastatin (Zocor) • 80 mg: 1 tablet per day Continuous Glucose Monitoring System Sensors Freestyle Libre 10- • Three sensors every 30 days day system* Freestyle Libre 14- • Two sensors every 28 days day system* Dexcom G6* • Three sensors every 30 days Cystic Fibrosis Antibiotic Agents Aztreonam • Limit to 3 mL per day, a maximum 28 days therapy per 56 days (Cayston®) Tobramycin • Limit to 8 mL per day, a maximum 28 days therapy per 56 days Inhalation Solution (Bethkis®) Tobramycin • Limit to 10 mL per day, a maximum 28 days therapy per 56 Inhalation Solution days (KitabisTM Pak, TOBI®) Tobramycin • Limit to 8 each per day, a maximum 28 days therapy per 56 Inhalation Powder days (TOBI® Podhaler™) Cystic Fibrosis Non-antibiotic Agents Elexacaftor/tezacaftor • 100-75-50 mg; 150 mg: 3 tablets per day /ivacaftor (Trikafta) Ivacaftor (Kalydeco) • 25 mg, 50mg, 75 mg granules: 2 packets per day • 150 mg tablets: 2 tablets per day Lumacaftor/ivacaftor • 100 mg/125 mg, 150 mg/188 mg granules: 2 packets per day (Orkambi) • 100 mg/125 mg, 200 mg/125 mg tablets: 4 tablets per day Ivacaftor/tezacaftor • 100 mg/ 150 mg tablets: 2 tablets per day (Symdeko) Diabetes Care Agents DPP-4 Inhibitors (and combinations)

Page 9 of 22 Drug and Biologic Coverage Policy: 1201

Therapeutic Drug Quantity Limitation / Exception Category Alogliptin (Nesina • 1 tablet per day authorized generic) / Nesina Alogliptin/metformin • 2 tablets per day (Kazano authorized generic) Alogliptin/pioglitazone • 1 tablet per day (Oseni authorized generic) Linagliptin (Tradjenta) • 1 tablet per day Linagliptin/metformin • 2 tablets per day (Jentadueto) Linagliptin/metformin • 2.5-1,000 mg: 2 tablets per day (Jentadueto XR) • 5-1,000 mg: 1 tablet per day Saxagliptin (Onglyza) • 1 tablet per day Saxagliptin/metformin • 2.5-1,000 mg: 2 tablets per day (Kombiglyze XR) • 5-500 mg, 5-1,000 mg: 1 tablet per day Sitagliptin (Januvia) • 1 tablet per day Sitagliptin/metformin • 2 tablets per day (Janumet) Sitagliptin/metformin • 50-1,000 mg: 2 tablets per day (Janumet XR) • 50-500 mg, 100-1,000 mg: 1 tablet per day GLP-1 Receptor Agonist dulaglutide (Trulicity) • 4 pens or pre-filled syringes per 28 days • 5 mcg pen pack: 2 boxes per 30 days exenatide (Byetta) • 10 mcg pen pack: 1 box per 30 days exenatide (Bydureon) • 4 single-dose trays or pens per 28 days liraglutide (Victoza) • 3 pens per 30 days • Starter Pack: 1 box per 28 days lixisenatide (Adlyxin) • Maintenance Pack: 1 box per 28 days semaglutide • 2 pens per 28 days (Ozempic) injectable semaglutide • 1 tablet per day (Rybelsus) oral SGLT2 Inhibitors (and combinations) Canagliflozin • 1 tablet per day (Invokana) Canagliflozin/ • 2 tablets per day metformin (Invokamet / Invokamet XR) Dapagliflozin • 1 tablet per day (Farxiga) Dapagliflozin/ • 5-500 mg, 10-500 mg, 10-1,000 mg: 1 tablet per day metformin (Xigduo • 5-1,000 mg, 2.5-1,000 mg: 2 tablets per day XR) Dapagliflozin/ • 1 tablet per day saxagliptin (Qtern) Empagliflozin • 1 tablet per day (Jardiance) Empagliflozin/ • 1 tablet per day linagliptin (Glyxambi)

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Therapeutic Drug Quantity Limitation / Exception Category Empagliflozin/ • 1 tablet per day linagliptin /metformin ER (Trijardy XR) Empagliflozin/ • 2 tablets per day metformin (Synjardy) Empagliflozin/ • 25-1,000 mg: 1 tablet per day metformin (Synjardy • 5-1,000 mg, 10-1,000 mg, 12.5-1,000 mg: 2 tablets per day XR) Ertugliflozin • 1 tablet per day (Steglatro) Ertugliflozin/ • 2 tablets per day metformin (Segluromet) Ertugliflozin/sitagliptin • 1 tablet per day (Steglujan) Diabets Care Agents - Insulin Rapid-acting Aspart (Novolog, • 1.5 mL (150 units) per day Novolog Flexpen) Aspart niacinamide • 1.5 mL (150 units) per day (Fiasp, Fiasp Flexpen, Fiasp Penfill) Glulisine (Apidra, • 1.5 mL (150 units) per day Apidra Solostar) Lispro (Admelog, • 1.5 mL (150 units) per day Admelog Solostar) Lispro (Humalog, • 1.5 mL (150 units) per day Humalog Kwikpen U- 100) Lispro (Humalog • 1.0 mL (200 units) per day Kwikpen U-200) Short-acting Regular (Humulin R, • 1.5 mL (150 units) per day Novolin R) Regular (Afrezza) • 4 unit: 36 cartridges per day • 4 unit/8 unit/12 unit: 6 cartridges per day • 8 unit: 18 cartridges per day • 12 unit: 12 cartridges per day • 90-4 unit / 90-8 unit: 12 cartridges per day • 90-8 unit / 90-12 unit: 12 cartridges per day Regular (Humulin R- • 1 mL (500 units) per day 500 vial / Kwikpen) NPH (Humulin N, • 1.5 mL (150 units) per day Intermediate- Humulin Kwikpen, acting Novolin N, Relion, Novolin N) Long-acting Degludec (Tresiba, • 1.5 mL (150 units) per day Tresiba Flextouch U- 100) Degludec (Tresiba • 0.9 mL (180 units) per day Flextouch U-200) Detemir (Levemir, • 1.5 mL (150 units) per day Levemir Flextouch)

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Therapeutic Drug Quantity Limitation / Exception Category Glargine (Basaglar • 1.5 mL (150 units) per day Kwikpen, Lantus, Lantus Solostar) Glargine (Toujeo Max • 0.6 mL (180 units) per day Solostar, Toujeo Solostar: U-300) Mixed Aspart • 2 mL (200 units) per day protamine/aspart (Novolog Mix 70-30, Novolog Mix 70-30 Flexpen) Lispro • 2 mL (200 units) per day protamine/lispro (Humalog 50-50 vial/Kwikpen, Humalog 75-25 vial/Kwikpen) NPH/regular • 2 mL (200 units) per day (Humulin 70-30 vial/Kwikpen, Novolin 70-30 vial/Flexpen, Novolin Relion 70-30 vial/Flexpen) Endocrine Agents • 16 tablets per 28 days Agents Alprostadil • 6 injections per 30 days (Caverject) Alprostadil (Edex) • 6 injections per 30 days Alprostadil (Muse) • 6 pellets per 30 days (Stendra) • 8 tablets per 30 days (Viagra) • 8 tablets per 30 days (Cialis) • 5 mg, 10 mg, 20 mg: 8 tablets per 30 days • 2.5 mg, 5 mg: 30 tablets per 30 days Vardenafil (Levitra, • 8 tablets per 30 days Staxyn) Eye Condition Agents Bimatoprost • 10 mls per 30 days ophthalmic solution Cysteamine • 120 mls per 30 days ophthalmic solution (Cystaran) Tafluprost ophthalmic • 60 single-use vials per 30 days solution (Zioptan) Glucose-Elevating Drugs Glucagon (Baqsimi) • 2 devices per 30 days Glucagon (Glucagen, • 2 autoinjectors or syringes per prescription per 30 days Glucagon Emergency Kit) Glucagon (Glucagen • 2 autoinjectors per 30 days Hypokit) Glucagon (Gvoke) • 2 pens or syringes per 30 days

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Therapeutic Drug Quantity Limitation / Exception Category Pramlintide acetate • 60 mcg pen: 0.2 mL per day (Symlin pen) • 120 mcg pen: 0.36 mL per day Headache Combination Agents Butalbital-caffeine- • Maximum daily dose – 6 capsules/tablets APAP (Esgic) tablet Butalbital-caffeine- APAP (Fioricet) cap Butalbital-caffeine- APAP (Zebutal) cap Butalbital-caffeine- aspirin (Fiorinal) capsule Hormonal Agents transdermal • 16 patches per 28 days patch (Alora) Estradiol transdermal • 8 patches per 28 days patch (Menostar) Estradiol transdermal • 16 patches per 28 days patch (Minivelle) Estradiol vaginal • Starter pack (4 mcg, 10 mcg): 36 tablets per 28 days insert (Imvexxy) • Maintenance pack (4 mcg, 10 mcg): 16 tablets per 28 days Estradiol vaginal ring • 2 rings per 90 days (Estring) Estradiol vaginal • 36 vaginal tablets per 28 days tablet (Vagifem) Hyperuricemia Treatment Agents Febuxostat (Uloric) • 40mg, 80mg: 1 tablet per day Hypoactive Sexual Disorder Agents • 8 injections per 30 days (4 per carton = 2 cartons) (Vyleesi) Immunomodulator Agents Abatacept (Orencia) • 4 Clickjects or pre-filled syringes per 28 days Adalimumab (Humira, • 2 pens or pre-filled syringes per 28 days Humira CF) • Starter Kit: 1 kit per 365 days

* Note: For a documented diagnosis of Rheumatoid Arthritis, Crohn’s Disease, or Hidradenitis Suppurativa additional quantities up to 4 pens or pre-filled syringes per 28 days may be approved

* Note: Induction for Plaque Psoriasis, Uveitis, Crohn’s Disease, Ulcerative Colitis, Hidradenitis Suppurativa: Quantity limit to FDA recommended dose Anakinra (Kineret) • 28 pre-filled syringes per 28 days (Otezla) • 2 tablets per day • Starter Pack: 1 pack per 365 days Baricitinib (Olumiant) • 1 tablet per day Brodalumab (Siliq) • 2 syringes per 28 days

• * Note: Induction for Plaque Psoriasis: Quantity limit to FDA recommended dose Certolizumab pegol • 2 vials or pre-filled syringes per 28 days (Cimzia) • Starter Kit: 1 kit per 365 days

Page 13 of 22 Drug and Biologic Coverage Policy: 1201

Therapeutic Drug Quantity Limitation / Exception Category

* Note: For a documented diagnosis of Plaque Psoriasis additional quantities up to 4 syringes per 28 days may be approved

* Note: Induction for Crohn’s Disease, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis: Quantity limit to FDA recommended dose Etanercept (Enbrel) • 25mg: 8 vials or pre-filled syringes per 28 days • 50mg: 4 Sureclicks, mini cartridges, or pre-filled syringes per 28 days

* Note: Induction for Plaque Psorasis: Quantity limit to FDA recommended dose Golimumab (Simponi) • 50mg: 1 pen or pre-filled syringe per 28 days • 100mg: 1 pen or pre-filled syringe per 28 days

* Note: Induction for Ulcerative Colitis: Quantity limit to FDA recommended dose Guselkumab • 1 pre-filled syringe per 56 days (Tremfya) * Note: Induction for Plaque Psoriasis: Quantity limit to FDA recommended dose Ixekizumab (Taltz) • 1 auto-injector per 28 days

* Note: Induction for Plaque Psoriasis, Psoriatic Arthritis: Quantity limit to FDA recommended dose Risankizumab-rzaa • 1 kit per 84 days = 2 syringes (Skyrizi) * Note: Induction for Plaque Psoriasis: Quantity limit to FDA recommended dose Sarilumab (Kevzara) • 2 pens or pre-filled syringes per 28 days Secukinumab • Carton of two 150 mg/mL (300 mg dose) per 28 days (Cosentyx) • Carton of one 150mg/ml (150mg dose) per 28 days

* Note: Induction for Ankylosing Spondylitis, Plaque Psoriasis, Psoriatic Arthritis: Quantity limit to FDA recommended dose Tildrakizumab-asmn • 1 pre-filled syringe per 84 days (Ilumya) * Note: Induction for Plaque Psoriasis: Quantity limit to FDA recommended dose Tocilizumab • 4 pens or pre-filled syringes per 28 days (Actemra) Tofacitinib (Xeljanz, • 5mg, 10mg: 2 tablets per day Xeljanz XR) • 11mg XR: 1 tablet per day Upadacitinib (Rinvoq) • 1 tablet per day Ustekinumab • 1 pre-filled syringe per 84 days (Stelara) * Note: For a documented diagnosis of Crohn’s Disease or Ulcerative Colitis, additional quantities up to 1 pre-filled syringe per 56 days may be approved

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Therapeutic Drug Quantity Limitation / Exception Category * Note: Induction for Plaque Psoriasis, Psoriatic Arthritis: Quantity limit to FDA recommended dose Lambert-Eaton myasthenic syndrome (LEMS) Agents Amifampridine • 10 mg: 8 tablets per day (Firdapse) Miscellaneous Agents Dextromethorphan/ • 4 capsules per day Quinidine (Nuedexta) Pyridostigmine • 30 mg: 20 tablets per day Narcotic Withdrawal Therapy Agents Lofexidine • 192 tablets per 30 days (Lucemyra) Nasal Steroid Agents Mometasone nasal • 4 inhalers per 30 days spray (Nasonex) Non-Steroidal Anti-inflammatory Drugs (NSAIDs) Agents Celecoxib (Celebrex) • 50 mg, 100 mg, 200mg: 2 capsules per day • 400 mg: 1 capsule per day Diclofenac epolamine • 2 patches per day (Flector) Diclofenac sodium • 10 tubes (1000 grams) per 30 days (Voltaren) gel Ketorolac all forms • 20 tablets per 30 days (1 Rx per 30 days) and Sprix • For Sprix Nasal: 5 bottles per Rx (1 Rx per 30 days) • Injection (intramuscular or intravenous): 120 mg per day for 5 days (per 30 days) Naproxen/esomepraz • 2 tablets per day ole (Vimovo) Nutritional/Dietary Agents Ferric Citrate • 360 tablets per 30 days (Auryxia) Opiate Antagonist Agents Naloxone (Evzio) • 0.8 mL (2 auto-injectors) per 30 days injection Naloxone (Narcan) • 2 units per 30 days nasal spray Naltrexone tablet • 180 tablets per 30 days Opioid Antitussive and Antihistamine Combination Agents Codeine • 2 tablets per day phosphate/chlorpheni ramine maleate extended-release tablet (Tuxarin ER) Overactive Bladder / Urinary Tract Antispasmodic Agents Fesoterodine • 4mg, 8mg: 1 tablet per day fumarate (Toviaz ER) Mirabegron • 25mg, 50mg: 1 tablet per day extended-release (Myrbetriq) Solifenacin succinate • 5mg, 10mg: 1 tablet per day (Vesicare) Pain Control Agents

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Therapeutic Drug Quantity Limitation / Exception Category Buprenorphine • 4 patches per 28 days (Butrans) patch Buprenorphine • 2 films per day (Belbuca) buccal film Butorphanol nasal • 6 nasal units per 30 days spray Lidocaine 5 % • 145 grams of ointment per 30 days ointment Tramadol (Ultram) • 8 tablets per day tablet Tramadol ER • 1 capsule per day (Conzip) capsule Tramadol ER tablet • 100mg, 200mg, 300mg: 1 tablet per day Tramadol HCL ER • 1 capsule per day 150mg capsule Tramadol/Acetamino • 8 tablets per day phen (Ultracet) tablet Potassium Channel Blocker Agents Amifampridine • 8 tablets per day (Firdapse) Proton Pump Inhibitor Agents Dexlansoprazole • 30 mg: 2 capsules per day (Dexilant) • 60 mg: 1 capsule per day Esomeprazole • 2.5 mg: 16 packets per day magnesium (Nexium) • 5 mg: 8 packets per day • 10 mg: 4 packets per day • 20 mg: 2 capsules or packets per day • 40 mg: 1 capsule or packet per day

* Note: For a documented diagnosis of Zollinger-Ellison syndrome additional quantities for doses between 80 mg and 240 mg per day may be approved. * Note: For a documented diagnosis of Helicobacter pylori, additional quantities for doses up to 80 mg per day up to 14 days may be approved. Esomeprazole • 24.65 mg: 2 capsules per day strontium • 49.3 mg: 1 capsule per day

* Note: For a documented diagnosis of Zollinger-Ellison syndrome additional quantities for doses between 89.2 mg and 267.6 mg (equivalent to 240 mg of esomeprazole magnesium) per day may be approved. * Note: The FDA recommended dose per day for treatment of Helicobacter pylori does not exceed the quantity limits above. Lansoprazole • 15 mg: 2 capsules or solutabs per day (Prevacid, • 30 mg: 1 capsule or solutab per day Heartburn Relief 24 Hour) * Note: For a documented diagnosis of Zollinger-Ellison syndrome additional quantities for doses between 60 mg and 180 mg per day may be approved.

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Therapeutic Drug Quantity Limitation / Exception Category * Note: For a documented diagnosis of Helicobacter pylori, additional quantities for doses up to 90 mg per day up to 14 days may be approved. Omeprazole • 2.5 mg: 16 packets per day magnesium (Prilosec) • 10 mg: 4 capsules or packets per day • 20 mg: 2 capsules per day • 40 mg: 1 capsule per day

* Note: For a documented diagnosis of Zollinger-Ellison syndrome, additional quantities for doses between 60 mg and 360 mg per day may be approved.

* Note: For a documented diagnosis of Helicobacter pylori, additional quantities for doses up to 80 mg per day up to 14 days may be approved. Omeprazole/sodium • 20 mg-1100 mg: 2 capsules per day bicarbonate (Omeppi, • 20 mg-1680 mg: 2 packets per day Zegerid) • 40 mg-1100 mg: 1 capsule per day • 40 mg-1680 mg: 1 packet per day Pantoprazole • 20 mg: 2 tablets per day (Protonix) • 40 mg: 1 tablet or packet per day

* Note: For a documented diagnosis of Zollinger-Ellison syndrome, additional quantities for doses between 80 mg and 240 mg per day may be approved.

* Note: For a documented diagnosis of Helicobacter pylori, additional quantities for doses up to 160 mg per day up to 14 days may be approved. Rabeprazole • 5 mg: 4 sprinkle caps per day (Aciphex) • 10 mg: 2 sprinkle caps per day • 20 mg: 1 tablet per day

* Note: For a documented diagnosis of Zollinger-Ellison syndrome, additional quantities for doses between 60 mg and 120 mg per day may be approved.

* Note: For a documented diagnosis of Helicobacter pylori, additional quantities for doses up to 80 mg per day up to 14 days may be approved. Respiratory Agents Long-Acting Beta-Agonists Formoterol nebulizer 120 ampules (240 mls) per 30 days solution (Perforomist) Other Cromolyn nebulizer Cromolyn nebulizer solution solution (Daliresp) Roflumilast (Daliresp) Short-Acting Beta-Agonist (inhaled) ProAir HFA Quantity limit: (albuterol sulfate)

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Therapeutic Drug Quantity Limitation / Exception Category Proventil HFA • 1 inhaler per 30 days (albuterol sulfate) • 1 inhaler equals: Ventolin HFA o ProAir HFA = 8.5 grams (albuterol sulfate) o Proventil HFA = 6.7 grams ProAir Respiclick o Ventolin HFA = 18 grams ProAir Digihaler o ProAir Respiclick = 1 gram ProAir Digihaler = 0.65 grams Xopenex HFA o Xopenex HFA = 15 grams (levalbuterol) o

1. For patients with Asthma/Reactive Airway Disease, or Chronic Obstructive Pulmonary Disease (COPD), AND the prescriber attests that the patient needs an additional inhaler per 30 days, approve a one-time override of one inhaler based on the quantities as noted above. Sleep Disorder/Sedative Agents Doxepin (Silenor) • 3mg, 6mg: 1 tablet per day Ramelteon • 30 capsules per 30 days (Rozerem) Solriamfetol (Sunosi) • 75 mg, 150 mg: 1 tablet per day Suvorexant • 5mg, 10mg, 15mg, 20mg: 1 tablet per day (Belsomra) Skin Condition Agents Becaplermin gel • 30 grams per 30 days (Regranex) Calcitriol (Vectical) • 800 grams per 30 days ointment Collagenase ointment • 60 grams per 30 days (Santyl) Doxepin (Prudoxin, • 5% cream: 90 grams per 30 days Zonalon) Imiquimod topical • 3.75% cream: 112 grams per 30 days cream (Zyclara) • 2.5% pump: 30 grams per 30 days Tardive dyskinesia Valbenazine • 1 titration pack per year (Ingrezza) Topical Corticosteroid (rectal) Agents Budesonide (Uceris) • Tablet: 1 tablet per day; 56 tablets per 180 days • Foam: 2 kits per 56 days; 2 RXs per year (1 RX per every 6 months) Agents Androderm 1 patch per day Androgel • Gel packets: 2 packets per day • Gel metered-dose pump: 2 bottles per 30 days Axiron Solution metered-dose pump: 2 bottles per 30 days Fortesta Gel metered-dose pump: 2 bottles per 30 days Natesto 3 metered-dose pumps per 30 days Striant 2 buccal systems per day Testim 2 packets per day Vogelxo • 50 mg/5 gram gel: 2 packets per day • 50 mg/5 gram gel packets: 60 packets per 30 days • 12.5 mg/1.25 gram pump: 2 bottles per 30 days Xyosted 4 autoinjecters per 28 days

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Therapeutic Drug Quantity Limitation / Exception Category Women’s Health Agents Paroxetine (Brisdelle 1 tablet per day (30 tablets per 30 days) 7.5mg)

Antimigraine: Serotonin-1 Receptor Agonist Agents

Drug Maximum Headaches Dose How Supplied Quantity Dose per 24 per 30 Allowed per hours days** month or Prescription Amerge (naratriptan) 5 mg 4 1 mg One pack of One pack or 9 nine tablets tablets 2.5 mg One pack of One pack or 9 nine tablets tablets Axert (almotriptan) 25 mg 4 6.25 mg One pack of 6 Two packs or 12 tablets tablets 12.5 mg One pack of 12 One pack or 12 tablets tablets Frova (frovatriptan) 7.5 mg 4 2.5 mg One pack of 9 Two packs or 18 tablets tablets Relpax (eletriptan) 80 mg 3 20 mg One pack of 6 One pack of 6 tablets tablets 40 mg One pack of 6 One pack of 6 tablets or tablets One carton with two packs of 6 tablets Maxalt 30 mg 4 5 mg Brand: Cartons 12 tablets of 18 tablets Maxalt-MLT 10 mg 12 tablets

Rizatriptan Generic: Varies by manufacturer 5 mg MLT Brand: Cartons 12 tablets with 6 packages 10 mg MLT 12 tablets of 3 tablets (18 tablets total)

Generic: Varies by manufacturer Imitrex tablets 200 mg 4 25 mg Brand: One One pack or 9 pack of 9 tablets Sumatriptan tablets

50 mg Generic: Varies One pack or 9 by manufacturer tablets

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Drug Maximum Headaches Dose How Supplied Quantity Dose per 24 per 30 Allowed per hours days** month or Prescription 100 mg One pack or 9 tablets Imitrex nasal 40mg 4 5 mg One box of six Two boxes or 12 sprays Sumatriptan nasal sprays 20 mg One box of six Two boxes or 12 sprays sprays Sumatriptan/ Imitrex 12 mg Not 4 mg/0.5 mL Two prefilled Four pen kits/refills available syringe/cartridge or 8 StatDose injection syringes/cartridges kit/refills 6 mg/0.5 mL Two prefilled Four pen kits/refills syringe/cartridge or 8 syringes/cartridges Sumatriptan/ Imitrex 12 mg Not 6 mg/0.5 mL One case of two Four cases or 8 available pens pens autoinjector with prefilled syringe Sumatriptan/ Imitrex 12 mg Not 6 mg/0.5 mL One case of two Four cases or 8 available syringes syringes prefilled syringe Sumatriptan/ Imitrex 12 mg Not 6 mg/0.5 mL Brand: 6 mg Two cartons or 10 available single-dose vials vials vials in carton of five vials Sumavel Dose Pro 12 mg Not 4 mg/0.5 mL Six prefilled Two boxes or 12 available single-dose single-dose units (sumatriptan) units 6 mg/0.5 mL Six prefilled Two boxes or 12 single-dose single-dose units units Onzetra Xsail 44 mg 4 11 mg / Eight pouches One kit or eight nosepiece containing two pouches (sumatriptan) nosepieces Tosymra (sumatriptan) 10 mg Not 10 mg One carton of Two cartons or 12 available six single-dose sprays units Treximet 9 tablets 2 10 mg One pack of Two packs or 18 (90 mg sumatriptan nine tablets tablets Sumatriptan/Naproxen sumatriptan / 60 mg (10 mg sumatriptan/ 60 / 540 mg naproxen mg naproxen sodium) naproxen sodium per sodium) tablet Treximet 2 tablets 5 85 mg One pack of Two packs or 18 (170 mg sumatriptan/ nine tablets tablets Sumatriptan/Naproxen sumatriptan/ 500 mg (85 mg sumatriptan/ 1,000 mg naproxen 500 mg naproxen naproxen sodium per sodium) sodium) tablet

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Drug Maximum Headaches Dose How Supplied Quantity Dose per 24 per 30 Allowed per hours days** month or Prescription Zecuity (sumatriptan) 2 Not 86 mg One carton of One carton or 4 iontophoretic available sumatriptan four iontophoretic systems that delivers iontophoretic systems 6.5 mg of systems sumatriptan (one iontophoretic system) Zembrace 12 mg 4 3 mg One carton of Four cartons or 16 four auto- auto-injectors (sumatriptan) injectors Zolmitriptan 10 mg 3 2.5 mg One pack of six One pack or six tablets tablets Zomig

Zomig ZMT 5 mg One pack of Two packs or six three tablets tablets

Zomig Nasal Spray 10 mg 4 2.5 mg One pack of six Two packs or 12 sprays sprays (zolmitriptan) 5 mg One pack of six Two packs or 12 sprays sprays

** The safety of treating an average of more than this number of migraine attacks in a 30-day period has not been established

General Background

Commercial medical plans (employer group and individual and family plans) may be subject to quantity limitations associated with the quantity submitted where the quantity limitations are set in accordance to the published FDA recommended dosing of a product, published clinical compendia, and in accord with CMS (Center for Medicare Medicaid) published allowances. Claims in excess of these standards can be considered medically necessary as long as not contraindicated by the FDA and supported with published clinical information in drug compendia or peer-reviewed studies showing both safety and efficacy at the proposed dose or quantity of use for a specific indication.

The Institute of Medicine (IOM) estimates that at least 1.5 million preventable adverse drug events occur within the healthcare system each year. The costs of these preventable adverse drug events have been estimated to exceed $4 billion annually.

Certain preventable adverse drug events relate to improper medication use. The Food and Drug Administration (FDA) launched the Safe Use Initiative to avoid improper medication use. Improper medication use increases the risk of harm from medication, often resulting in hundreds of thousands of injuries or deaths each year. Many of these injuries and adverse events could have been prevented with currently available knowledge. Frequency limitations are placed on pharmaceutical products to assure appropriate dosing and safe medication use as published in the FDA Product Information or “Label”.

Standard Medical Reference Compendia Standard medical reference compendia utilized to establish frequency limitations include, but not limited to: American Hospital Formulary Service-Drug Information (AHFS), Truven Health Analytics Micromedex Drugpoints, and Wolters Kluwer Facts & Comparisons eAnswers.

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References

1. McEvoy GK, ed. AHFS 2020 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists, Inc; 2020. 2. National Research Council. Preventing Medication Errors: Quality Chasm Series. Washington, DC: The National Academies Press, 2007. 3. U.S. Department of Health and Human Services Food and Drug Administration (FDA). FDA Safe Use Initiative. Nov 4, 2009. Accessed 6/14/2020. Available at http://www.fda.gov/downloads/Drugs/DrugSafety/UCM188961.pdf 4. U.S. Food and Drug Administration. Drugs@FDA. U.S. Department of Health & Human Services: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/.

“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.

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