Cigna Drug and Biologic Coverage Policy

Transcription

1 Cigna and Biologic Coverage Policy Subject Quantity Limitations Table of Contents Coverage Policy... 1 General Background... 6 Coding/Billing Information References Effective Date...2/15/2018 Next Review Date...5/15/2018 Coverage Policy Number Related Coverage Resources 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. Coverage Policy Cigna covers drugs in excess of the Quantity Limit requirements, in accordance with benefit plan specifications, as medically necessary when both of the following criteria have been met: Dosage, frequency, site of administration, and duration of therapy is not contraindicated or otherwise not recommended in 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. Specific Quantity Limitations: Therapeutic Quantity Limitation Acne Isotretinoin oral capsules (Absorica, Amnesteem, Claravis, Myorisan, Sotret, Zenatane) Limit to 5 months of therapy with a minimum of 2 months before a second course (When a lower initial starting dose is used for titration, additional quantities may be approved to achieve a maximum cumulative dose of up to 150mg/kg ) Allergy/Nasal Sprays Mometasone nasal spray (Nasonex) 4 inhalers per 30 days Page 1 of 11

2 Quantity Limitation Alzheimer s Disease Memantine (Namenda XR) Titration pack: 4 packs (112 ) per 365 days Memantine/Donepezil (Namzaric) 7 mg-10 mg, 14 mg-10 mg, 21 mg-10 mg, 28 mg-10 mg: 2 capsules per day Titration pack: 4 packs (112 ) per 365 days Anaphylaxis Epinephrine (Adrenaclick, AUVI-Q, Epipen, 4 pens per prescription per 30 days Epipen Jr.) Anti-coagulation Betrixaban (Bevyxxa) 42 capsules per 60 days 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 Enoxaparin (Lovenox) 2 syringes per day 1 multi-dose vial (300mg/3ml) per day Fondaparinux (Arixtra) 1 syringe per day Anti-infective Acyclovir (Sitavig) 2 buccal per prescription Acyclovir topical cream (Zovirax) 10 grams per 30 days Artemether/lumefantrine (Coartem) 24 per 30 days Oseltamivir (Tamiflu) 45mg and 75mg: 10 capsules per 30 days 30mg: 20 capsules per 30 days 180mls per 30 days (4 Rx per year) Zanamavir (Relenza) One inhaler per prescription (4 Rx per year) Itraconazole (Onmel) 84 per 84 days (1 Rx per 9 months) Anti-inflammatory Ketorolac all forms and Sprix 20 per 30 days (1 Rx per 30 days) 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) Anti-migraine Anti-nausea Amerge, Axert, Frova, Relpax, Rizatripan (Maxalt), Sumatriptan (Alsuma. Imitrex, Onzetra Xsail, Sumavel Dose Pro, Treximet, Zembrace), Zolmitriptan (Zomig) (all forms) Refer to Appendix: Table of Anti-Migraine Serotonin-1 Receptor Agonists quantity limitations are based upon FDA product dosing recommendations regarding treatment for a maximum number of headaches per 30 day period. Dihydroergotamine (Migranal) nasal 8 nasal units per 30 days Dihydroergotamine (DHE) injection 10 ampules per 30 days Aprepitant (Emend) Up to 4 treatment cycles per 28 days: a THREE day supply consisting of ONE 125mg tablet and TWO 80 mg per treatment cycle 40 mg: one capsule per 28 days For Emend suspension: 3 packets per week, up to 12 packets per 28 days Dolasetron (Anzemet) 5 per 30 days Page 2 of 11

3 Quantity Limitation Granisetron (Sancuso) Patch 4 patches per 30 days Ondansetron (Zuplenz) 24 oral films per 30 days Netupitant and palonosetron (Akynzeo) 4 capsules per 28 days Rolapitant (Varubi) 4 (2 doses) per 28 days Anxiety/Depression/Bipolar Disorder Desvenlafaxine (Pristiq ER) 25 mg and 100 mg: 2 per day Isocarboxazid (Marplan) 12 per day Asthma/COPD/Respiratory Cromolyn nebulizer solution 240 ampules (480 mls) per 30 days Formoterol nebulizer solution (Perforomist) 120 ampules (240 mls) per 30 days Roflumilast (Daliresp) 2 per day Blood Pressure/Heart Medications Ranolazine (Ranexa) 4 per day Cancer Nilutamide (Nilandron) 4 per day Toremifene (Fareston) 2 per day Diabetes Care Albiglutide (Tanzeum) 4 pens per 28 days Dulaglutide (Trulicity) 4 pens or pre-filled syringes per 28 days Exenatide (Bydureon, Bydureon BCise) 4 single-dose trays, pens or auto-injectors per 28 days Glucagon (Glucagen, Glucagon Emergency 2 pens per prescription per 30 days Kit) Linagliptin (Tradjenta) 2 per day Linagliptin/Metformin (Jentadueto) 4 per day Liraglutide (Victoza) 3 pens per 30 days Endocrine Cabergoline 16 per 28 days Erectile Dysfunction Alprostadil (Caverject) 6 injections per 30 days Alprostadil (Edex) 6 injections per 30 days Alprostadil (Muse) 6 pellets per 30 days Eye Conditions Bimatoprost ophthalmic solution 10 mls per 30 days Cysteamine ophthalmic solution (Cystaran) 120 mls per 30 days Tafluprost ophthalmic solution (Zioptan) 60 single-use vials per 30 days Headache Combinations Butalbital-caffeine-APAP (Esgic) tablet Butalbital-caffeine-APAP (Fioricet) cap Butalbital-caffeine-APAP (Zebutal) cap Maximum daily dose 6 capsules/ Hormonal Agents Estradiol transdermal patch (Alora) 16 patches per 28 days Estradiol transdermal patch (Menostar) 8 patches per 28 days Estradiol transdermal patch (Minivelle) 16 patches per 28 days Estradiol vaginal ring (Estring) 2 rings per 90 days Estradiol vaginal tablet (Vagifem) 36 vaginal per 28 days Miscellaneous Dextromethorphan/Quinidine (Nuedexta) 4 capsules per day Non-Steroidal Anti-inflammatory s (NSAIDs) Celecoxib (Celebrex) 50 mg, 100 mg, 200mg: 2 capsules per day 400 mg: 1 capsule per day Page 3 of 11

4 Quantity Limitation Diclofenac epolamine (Flector) 2 patches per day Naproxen/esomeprazole (Vimovo) 2 per day Osteoporosis Products Alendronate 40mg tablet 2 per day Pain Control Lidocaine 5 % ointment 145 grams of ointment per 30 days Schizophrenia/Anti-Psychotics Aripiprazole Injection (Abilify Maintena) 2 injections per 30 days Aripiprazole Lauroxil Injection (Aristada) 2 syringes per 30 days Iloperidone (Fanapt) 1 mg, 2 mg, 4 mg, 6 mg, 8mg, 10 mg: 4 per day Titration pack: 4 packs (32 ) per 365 days Olanzapine injection kit (Zyprxa Relprevv) 210 mg and 300 mg: 4 kits per 28 days 405mg: 2 kits per 28 days Paliperidone Injection (Invega Trinza) 2 syringes per 90 days Risperidone Injection (Risperdal Consta) 4 syringes per 28 days Seizure Disorders Ezogabine (Potiga) 6 per day Tiagabine (Gabitril) 12 mg: 8 per day 16 mg: 6 per day Skin Conditions Becaplermin gel (Regranex) 30 grams per 30 days Collagenase ointment (Santyl) 60 grams per 30 days Imiquimod topical cream (Zyclara) 3.75% cream: 112 grams per 30 days 2.5% pump: 30 grams per 30 days Penciclovir topical cream (Denavir) 10 grams per 30 days Testosterone 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 Striant 2 buccal systems per day Testim 2 packets per day Natesto 3 metered-dose pumps per 30 days Women s Health Paroxetine (Brisdelle 7.5mg) 1 tablet per day (30 per 30 days) Anti-Migraine Serotonin-1 Receptor Agonists Maximum Dose per 24 hours Headaches per 30 days** Dose How Supplied Quantity Allowed per month or Prescription Amerge 5 mg 4 1 mg One pack of nine One pack or mg One pack of nine One pack or 9 Axert 25 mg mg One pack of 6 Two packs or 12 Page 4 of 11

5 Maximum Dose per 24 hours Headaches per 30 days** Dose How Supplied Quantity Allowed per month or Prescription 12.5 mg One pack of 12 One pack or 12 Frova 7.5 mg mg One pack of 9 Two packs or 18 Relpax 80 mg 3 20 mg One pack of 6 One pack of 6 Rizatriptan, Maxalt, Maxalt-MLT 40 mg One pack of 6 or One carton with two packs of 6 One pack of 6 30 mg 4 5 mg Brand: Cartons of mg 12 Generic: Varies by manufacturer 5 mg MLT Brand: Cartons with mg MLT packages of 3 (18 total) 12 Generic: Varies by manufacturer Alsuma 12 mg Not available 6 mg Two prefilled Four pen kits or 8 syringe/cartridge syringes/cartridges Sumatriptan, 200 mg 4 25 mg Brand: One pack of 9 One pack or 9 Imitrex 50 mg One pack or mg Generic: Varies by One pack or 9 manufacturer Sumatriptan, Imitrex nasal Sumatriptan/ Imitrex StatDose injection kit/refills Sumatriptan/ Imitrex autoinjector with prefilled syringe Sumatriptan/ Imitrex prefilled syringe Sumatriptan/ Imitrex vials 40mg 4 5 mg One box of six sprays Two boxes or 12 sprays 20 mg One box of six sprays Two boxes or 12 sprays 12 mg Not available 4 mg/0.5 ml Two prefilled Four pen kits/refills or 8 syringe/cartridge syringes/cartridges 6 mg/0.5 ml Two prefilled Four pen kits/refills or 8 syringe/cartridge syringes/cartridges 12 mg Not available 6 mg/0.5 ml One case of two pens Four cases or 8 pens 12 mg Not available 6 mg/0.5 ml One case of two syringes 12 mg Not available 6 mg/0.5 ml Brand: 6 mg singledose vials in carton of five vials 12 mg Not available 4 mg/0.5 ml Six prefilled singledose units Four cases or 8 syringes Two cartons or 10 vials Two boxes or 12 singledose units Page 5 of 11

6 Sumavel Dose Pro Maximum Dose per 24 hours Headaches per 30 days** Onzetra Xsail 44 mg 4 11 mg / nosepiece Treximet (10 mg sumatriptan/ 60 mg sodium) Treximet (85 mg sumatriptan/ 500 mg sodium) 9 (90 mg sumatriptan / 540 mg sodium) 2 (170 mg sumatriptan/ 1,000 mg sodium) Dose How Supplied Quantity Allowed per month or Prescription 6 mg/0.5 ml Six prefilled singledose units 2 10 mg sumatriptan / 60 mg sodium per tablet 5 85 mg sumatriptan/ 500 mg sodium per tablet Eight pouches containing two nosepieces One pack of nine One pack of nine Two boxes or 12 singledose units One kit or eight pouches Two packs or 18 Two packs or 18 Zembrace 12 mg 4 3 mg One carton of four Four cartons or 16 autoinjectors auto-injectors Zolmitriptan, 10 mg mg One pack of six One pack or six Zomig, Zomig ZMT Zomig, Nasal Spray 5 mg One pack of three Two packs or six 10 mg mg One pack of six sprays Two packs or 12 sprays 5 mg One pack of six sprays Two packs or 12 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 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 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. Quantity Limitations are placed on pharmaceutical products to assure appropriate dosing and safe medication use as published in the FDA Product Information or Label. Employers that have selected Cigna Health Care benefit plans may choose Quantity Limitations as a part of the pharmacy benefit program. The rationale for each drug or therapy group of Quantity Limitations is defined in the table below. Therapeutic Acne Isotretinoin oral capsules (Absorica, Rationale Limits to FDA recommended dose/duration of therapy based upon The American Academy of Page 6 of 11

7 Amnesteem, Claravis, Myorisan, Sotret, Zenatane) Allergy/Nasal Sprays Mometasone nasal spray (Nasonex) Alzheimer s Disease Memantine (Namenda XR) Memantine/ Donepezil (Namzaric) Anaphylaxis Epinephrine (Adrenaclick, AUVI- Q, Epipen, Epipen Jr.) Anti-coagulation Betrixaban (Bevyxxa) Dalteparin (Fragmin) Anti-infective Enoxaparin (Lovenox) Fondaparinux (Arixtra) Acyclovir (Sitavig) Acyclovir topical cream (Zovirax) Artemether/ lumefantrine (Coartem) Oseltamivir (Tamiflu) Zanamavir (Relenza) Itraconazole (Onmel) Anti-inflammatory Ketorolac all forms and Sprix Anti-migraine Rationale Dermatology Association (AAD) supports initiation of isotretinoin at 0.5 mg/kg/day when appropriate, subsequently increasing to a full dose of 1 mg/kg/day after the first month as tolerated, with a goal cumulative dose between 120 and 150 mg/kg. The AAD also noted that a cumulative dose of 220mg/kg may result in lower relapse rates, but remains investigational. (Zaenglein, 2016) Limits to FDA recommended dosing consist of emergency treatment of life-threatening allergic reactions (anaphylaxis) and for people who are at increased risk for these reactions. Use is for immediate self-administration as emergency supportive therapy only. Seek immediate emergency medical treatment after use. Limits to FDA recommended dose of therapy based upon efficacy and safety studies. Limits to FDA recommended dose of therapy based upon efficacy and safety studies. Twice daily dosing is indicated for the prophylaxis of ischemic complications in unstable angina and non- Q-wave myocardial infarction. Limits to FDA recommended weight-based dosing for the treatment of deep vein thrombosis (DVT) with or without pulmonary embolism (PE). Limits to FDA recommended dose of therapy based upon efficacy and safety studies. Limits to FDA recommended dosing of a single dose with an additional dose in case of loss of tablet as per labeled instructions. Limits to FDA recommended dosing associated with approved indication of treatment of susceptible malarial infections Limits to FDA recommended influenza treatment use. Authorization may be provided for community prophylaxis use. Limits to FDA recommended influenza treatment use. Authorization may be provided for community prophylaxis use. Limits to FDA recommended dosing for onychomycosis where the optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for outgrowth of healthy nail. Authorization may be provided for non-onychomycosis uses where indicated. Limits to FDA recommended dose / duration of therapy based upon Page 7 of 11

8 Anti-nausea Amerge, Axert, Frova, Relpax, Rizatripan (Maxalt), Sumatriptan (Alsuma. Imitrex, Onzetra Xsail, Sumavel Dose Pro, Treximet, Zembrace), Zolmitriptan (Zomig) (all forms) Dihydroergotamine (DHE, Migranal) all forms Aprepitant (Emend) Dolasetron (Anzemet) Granisetron (Sancuso) patch Ondansetron (Zuplenz) Netupitant and palonosetron (Akynzeo) Rolapitant (Varubi) Anxiety/Depression/Bipolar Disorder Desvenlafaxine (Pristiq ER) Isocarboxazid (Marplan) Asthma/COPD/Respiratory Cromolyn nebulizer solution Formoterol nebulizer solution (Perforomist) Roflumilast (Daliresp) Blood Pressure/Heart Medications Ranolazine (Ranexa) Cancer Nilutamide (Nilandron) Toremifene (Fareston) Diabetes Care Albiglutide (Tanzeum) Dulaglutide (Trulicity) Rationale Limits to FDA recommended dose / duration of therapy based upon Limits to FDA recommended dose / duration of therapy based upon Use is for prevention of nausea and vomiting. Limits to FDA recommended dose of therapy based upon efficacy and safety studies. Limits to FDA recommended dose of therapy based upon efficacy and safety studies. Limits to FDA recommended dose of therapy. Limit provides dosing for weekly chemotherapy. Page 8 of 11

9 Endocrine Exanetide (Bydureon, Bydureon BCise) Glucagon (Glucagen, Glucagon Emergency Kit) Linagliptin (Tradjenta) Linagliptin/Metformin (Jentadueto) Liraglutide (Victoza) Cabergoline Erectile Dysfunction Alprostadil (Caverject, Edex, Muse) Eye Conditions Bimatoprost ophthalmic solution Cysteamine ophthalmic solution (Cystaran) Tafluprost ophthalmic solution (Zioptan) Headache Combinations Butalbital/acetamino phen/ caffeine (Esgic) tablet Butalbital/acetamino phen/ caffeine (Fioricet, Zebutal) capsule Hormonal Agents Estradiol transdermal patch (Alora, Menostar, Minivelle) Estradiol vaginal ring (Estring) Estradiol vaginal tablet (Vagifem) Miscellaneous Rationale Limits to FDA recommended use consist of treatment of insulin coma or insulin reaction resulting from severe hypoglycemia (low blood sugar). Give intramuscular injection only if the patient is unconscious, unable to eat sugar or a sugar-sweetened product, is having a seizure, or repeated administration of sugar or a sugar-sweetened product does not improve the patient s condition. Limits to FDA recommended dose / duration of therapy based upon Coverage may be excluded under certain benefit plans. Please review benefit plan for details of specific coverage. Limits to FDA recommended dose of therapy are based on efficacy and safety studies and recommend the lowest possible effective dose be employed when medication is used. Limits to FDA recommended dose of therapy based on efficacy and safety studies. Extended and repeated use of this product is not recommended because of potential for physical dependence. Limits to FDA recommended dose of therapy based on efficacy and safety studies. Extended and repeated use of this product is not recommended because of potential for physical dependence. Dextromethorphan/ Quinidine (Nuedexta) Non-Steroidal Anti-inflammatory s (NSAIDs) Page 9 of 11

10 Celecoxib (Celebrex) Diclofenac epolamine (Flector) Naproxen/ esomeprazole (Vimovo) Osteoporosis Products Alendronate 40mg tablet Pain Control Lidocaine 5% ointment Schizophrenia/Anti-Psychotics Aripiprazole Injection (Abilify Maintena) Aripiprazole Lauroxil Injection (Aristada) Iloperidone (Fanapt) Olanzapine injection kit (Zyprxa Relprevv) Paliperidone Injection (Invega Trinza) Risperidone Injection (Risperdal Consta) Seizure Disorders Ezogabine (Potiga) Tiagabine (Gabitril) Skin Conditions Becaplermin gel (Regranex) Collagenase ointment (Santyl) Imiquimod topical Testosterone cream (Zyclara) Penciclovir topical cream (Denavir) Androderm, Androgel, Axiron, Fortesta, Striant, Testim, Natesto Women s Health Paroxetine (Brisdelle 7.5mg) Rationale Limits to FDA recommended daily maximum dose (17-20 grams of ointment or 850 mg to 1,000 mg of lidocaine USP base per day) for short-term use (per the FDA approved indication: Production of anesthesia of accessible mucous membranes of the oropharynx. It is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites). The product label includes a warning that excessive dosage, or short intervals between doses, can result in high plasma levels and serious adverse effects. Limits to FDA recommended daily dose for treatment of moderate to severe vasomotor symptoms associated with menopause. Page 10 of 11

11 Coding/Billing Information Note: Quantity Limitations is typically covered under pharmacy benefit plans. Certain prescription drugs require an authorization for coverage to ensure that appropriate treatment regimens are followed. Medical drug coding and diagnosis codes, however, are generally not required for pharmacy claims submissions, therefore, this section is not in use. References 1. Individual Name Entries. Facts and Comparisons. Facts & Comparisons eanswers [online]. 2012, Available from Wolters Kluwer Health, Inc. Accessed April, McEvoy GK, ed. AHFS 2017 Information. Bethesda, MD: American Society of Health- Systems Pharmacists, Inc; National Research Council. Preventing Medication Errors: Quality Chasm Series. Washington, DC: The National Academies Press, U.S. Department of Health and Human Services Food and Administration (FDA). FDA Safe Use Initiative. Nov 4, Accessed 4/18/2017. Available at 5. U.S. Food and Administration. U.S. Department of Health & Human Services: 6. Zaenglein AL, Pathy AL, Schlosser BJ, Alikhan A, Baldwin HE, Berson DS, et al. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol Feb See more at: 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 Cigna. Page 11 of 11