Cigna Drug and Biologic Coverage Policy

Transcription

1 Cigna Drug and Biologic Coverage Policy Subject Controlled Substance Analgesic and Narcotic Antagonist Quantity Limitations Table of Contents Coverage Policy... 1 General Background... 6 Coding/Billing Information References Effective Date 1/1/2018 Next Review Date...5/15/2018 Coverage Policy Number Related Coverage Resources Transmucosal Fentanyl - (1018) Opioid Therapy - (1704) 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 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 For opioid therapy only, attestation that opioids will be prescribed in accordance with current clinical practice guidelines AND that an assessment of risks, harms, and goals consistent with an opioid agreement (or similar agreement) has been undertaken. Specific s: LONG-ACTING OPIOIDS FENTANYL Page 1 of 10

2 LONG-ACTING OPIOIDS Fentanyl (Duragesic) Patch HYDROCODONE Hydrocodone (Hysingla ER)Tablet Hydrocodone (Zohydro ER)Capsule 15 patches per 30 days 1 tablet per day 10 mg, 15 mg, 20 mg, 30 mg, 40 mg: 2 capsules per day 50 mg: 4 capsules per day HYDROMORPHONE Hydromorphone (Exalgo) Tablet 8mg: 1 tablet per day 12mg, 32mg: 2 tablets per day 16 mg: 4 tablets per day MORPHINE SULFATE Morphine sulfate (Arymo ER) Tablet 3 tablets per day Morphine sulfate (Avinza) Capsule 3 capsules per day Morphine sulfate (Kadian) Capsule 3 capsules per day Morphine sulfate (Morphabond ER) Tablet 2 tablets per day Morphine sulfate (MS Contin) Tablet 4 tablets per day MORPHINE-NALTREXONE Morphine-Naltrexone (Embeda) Capsule 3 capsules per day OXYCODONE Oxycodone (Oxycontin)Tablet 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg: 2 tablets per day 80 mg: 4 tablets per day Oxycodone (Xtampza ER) Capsule 9mg, 13.5mg,18mg: 2 capsules per day 27mg: 4 capsules per day 36mg: 8 capsules per day OXYMORPHONE Oxymorphone (Opana ER) Tablet 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg: 2 tablets per day 40 mg: 4 tablets per day SHORT-ACTING OPIOIDS CODEINE SULFATE Codeine Sulfate Liquid 960 ml per 30 days Codeine SulfateTablet CODEINE-ACETAMINOPHEN Codeine-Acetaminophen Liquid 960 ml per 30 days Codeine-Acetaminophen Tablet CODEINE-CARISOPRODOL-ASPIRIN Codeine-Carisoprodol-Aspirin Tablet DIHYDROCODEINE COMBINATIONS Dihydrocodeine-Caffeine-Acetaminophen (Trezix) Capsule 180 capsules per 30 days Dihydrocodeine-Caffeine-Acetaminophen Tablet Dihydrocodeine-Caffeine-Aspirin (Synalgos-DC) Capsule 180 capsules per 30 days FENTANYL Fentanyl (Abstral) Sublingual Tablet 100mcg: 128 tablets per 30 days 200mcg, 300mcg, 400mcg, 600mcg, 800mcg: 96 tablets per 30 days Fentanyl (Actiq) Lozenge 90 lozenges per 30 days Page 2 of 10

3 SHORT-ACTING OPIOIDS Fentanyl (Fentora) Buccal Tablet 100mcg: 112 tablets per 30 days 200mcg, 400mcg, 600mcg, 800mcg: 84 tablets per 30 days Fentanyl (Lazanda) Nasal Spray 100mcg: 15 bottles (120 sprays) per 30 days 300mcg, 400mcg: 10 bottles (80 sprays) per 30 days Fentanyl (Onsolis) Film 90 films per 30 days Fentanyl (Subsys) Sublingual Spray 100mcg: 120 sprays per 30 days 200mcg, 400mcg, 600mcg, 800mcg, 1200mcg, 1600mcg: 90 sprays per 30 days HYDROCODONE-ACETAMINOPHEN Hydrocodone-Acetaminophen (Lortab,Zamicet) Liquid 960 ml per 30 days mg, mg, 5-163mg, 5-217mg, 5-334mg, mg, mg, mg, mg Hydrocodone-Acetaminophen (Lorcet HD) Capsule 180 capsules per 30 days Hydrocodone-Acetaminophen (Norco, Vicodin ES, Vicodin HP, Xodol) Tablet mg, 5-400mg, 5-500mg, mg, mg, mg, mg, mg, mg, mg, ,10-400mg, mg, mg, mg, mg Hydrocodone-Acetaminophen (Norco, Verdocet, Xodol) 270 tablets per 30 days mg, 5-300mg, 5-325mg HYDROCODONE-IBUPROFEN Hydrocodone-Ibuprofen (Reprexain, Vicoprofen, Xylon) Tablet Maximum daily dose 5 tablets mg, 5-200mg, mg, mg HYDROMORPHONE Hydromorphone Liquid 480 ml per 30 days Hydromorphone Suppository 120 suppositories per 30 days Hydromorphone Tablet 2mg, 4mg: 8mg: 90 tablets per 30 days LEVORPHANOL Levorphanol 120 tablets per 30 days MEPERIDINE Meperidine Liquid 960 ml per 30 days Meperidine Tablet METHADONE Methadone Liquid 1800 ml per 30 days Methadose Oral Concentrate 360 ml per 30 days Methadone Tablet 5mg, 10mg: 360 tablets per 30 days 40mg: 90 tablets per 30 days MORPHINE SULFATE Morphine Sulfate Liquid 10mg/5ml, 20mg/5ml: 960 ml per 30 days 100mg/5ml: 480 ml per 30 days Morphine Sulfate Oral Concentrate 480 ml per 30 days Morphine Sulfate Suppository 5mg, 10mg, 20mg: 120 Suppositories per 30 days 30mg: 84 Suppositories per 30 days Morphine Sulfate IR Tablet 15mg: 30mg: 90 tablets per 30 days OPIUM Opium Tincture 960 ml per 30 days Page 3 of 10

4 SHORT-ACTING OPIOIDS OPIUM-BELLADONNA Opium-Belladonna Suppository 120 Suppositories per 30 days OXYCODONE Oxycodone HCL Liquid 5mg/5ml: 960 ml per 30 days 100mg/5ml: 480 ml per 30 days Oxycodone HCL Oral Concentrate 480 ml per 30 days Oxycodone HCL IR Capsule 180 capsules per 30 days Oxycodone HCL IR (Oxecta, Roxicodone) Tablet 5mg, 7.5mg, 10mg: 15mg, 20mg: 120 tablets per 30 days 30mg: 90 tablets per 30 days OXYCODONE-ACETAMINOPHEN Oxycodone-Acetaminophen (Roxicet) Liquid 960 ml per 30 days Oxycodone-Acetaminophen (Magnacet, Percocet, Primlev, 270 tablets per 30 days Xolox) Tablet mg, 5-300mg, 5-325mg 5-300mg, 5-400mg, 5-500mg, mg, mg, mg, mg, mg, mg, mg, mg, mg OXYCODONE-ASPIRIN Oxycodone-Aspirin (Percodan)Tablet OXYCODONE-IBUPROFEN Oxycodone-Ibuprofen Tablet Maximum daily dose 5 tablets OXYMORPHONE Oxymorphone (Numorphan) Suppository 120 suppositories per 30 days Oxymorphone HCL Tablet 5mg: 10mg: 90 tablets per 30 days COUGH COMBINATIONS Cotabflu MG Tablet Allfen CD MG Tablet Maxifed CD MG Tablet Maxiflu CD MG Tablet Maxiflu CDX MG Tablet Phenflu CD MG Tablet Phenflu CDX MG Tablet Tussigon MG Tablet Tussicaps ER 5-4 MG Capsule Tussicaps ER 10-8 MG Capsule Allfen CDX MG/5mL Liquid Codeine-Promethazine MG/5mL Hydrocodone-Chlorpheniramine ER Liquid Hydrocodone-Homatropine Liquid Hydromet MG/5mL Liquid J-COF DHC MG/5mL Liquid J -MAX DHC MG/5mL Liquid KG-Tussin MG/5mL Liquid 180 capsules per 30 days 240 ml per 30 days Page 4 of 10

5 COUGH COMBINATIONS Promethazine VC with Codeine Liquid Rezira 5-60 MG/5mL Liquid Tussionex ER Suspension Vituz 5-4 MG/5mL Liquid Hycofenix MG/5mL Liquid Obredon MG/5mL Liquid Tuzistra XR MG/5mL Liquid Zutripro MG/5mL Liquid DETOXIFICATION AGENTS Naloxone (Evzio) injection Naloxone (Narcan) nasal spray Naltrexone tablet 0.8 ml (2 auto-injectors) per 30 days 2 units per 30 days HEADACHE COMBINATIONS Butalbital-caffeine-aspirin (Fiorinal) capsule Codeine-butalbital-caffeine-APAP tablet Codeine-butalbital-caffeine-APAP capsule Codeine-butalbital-caffeine-aspirin capsule PAIN CONTROL Maximum daily dose 6 capsules/tablets Buprenorphine (Butrans) patch Buprenorphine (Belbuca) buccal film Butorphanol nasal spray Pentazocine-acetaminophen tablet Pentazocine-naloxone tablet Tapentadol (Nucynta) tablet Tapentadol (Nucynta ER) extended-release tablet Tramadol (Ultram) tablet Tramadol ER (Conzip) capsule Tramadol ER (Ultram ER) tablet Tramadol HCL ER 150mg capsule Tramadol/Acetaminophen (Ultracet) tablet 4 patches per 28 days 60 films per 30 days 6 nasal units per 30 days 6 tablets per day 2 tablets per day 8 tablets per day 1 capsule per day 1 tablet per day 1 capsule per day 8 tablets per day PARENTERAL SHORT-ACTING OPIOIDS Note: Injectable opioid medications are specifically excluded under most benefit plans. Please refer to the applicable benefit plan document to determine benefit availability and the terms and conditions of coverage. Page 5 of 10

6 PARENTERAL SHORT-ACTING OPIOIDS When coverage is available for injectable opioid therapy, the quantity limitation is 1 ml per 30 days. 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 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. s 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 s as a part of the pharmacy benefit program. The rationale for each drug or therapy group of s is defined in the table below. Therapeutic Drug Category Long Acting Opioids Fentanyl (Duragesic) patch Hydrocodone (Zohydro ER) Hydromorphone (Exalgo) Morphine sulfate (Arymo ER, Avinza, Kadian, Morphabond ER, MS Contin) Morphine sulfate/naltrexone (Embeda) extended-release tablet Oxycodone (OxyContin) Rationale review of doses exceeding what was studied in clinical trials). review of doses exceeding what was studied in clinical trials). review of doses exceeding either the usual dosing schedule or a more frequent than recommended schedule [to allow for patient variability in dosing requirements]). review of doses exceeding either the usual dosing schedule or a more frequent than recommended schedule [to allow for patient variability in dosing requirements]). Page 6 of 10

7 Therapeutic Category Drug Oxycodone (Xtampza ER) Short Acting Opioids Codeine sulfate Acetaminophen/codeine (Tylenol with Codeine) Carisoprodol/aspirin/codeine (Soma Compound with Codeine) Dihydrocodeine/ acetaminophen/caffeine (Trezix) Dihydrocodeine/aspirin/ caffeine (Synalgos-DS) Fentanyl (Abstral, Actiq, Fentora, Lazanda, Onsolis, Subsys) transmucosal Hydrocodone/acetaminophen (Lortab, Norco, Vicodin, Vicodin ES, Vicodin HP, Xodol) Hydrocodone/ibuprofen (Reprexain, Vicoprofen, Xylon) Hydromorphone (Dilaudid) Levorphanol Methadone Rationale maximum recommended daily dose is 288 mg per day (eight 36 mg capsules, equivalent to 320 mg oxycodone HCl per day) maximum recommended daily dose is 360mg) maximum recommended daily dose is 360mg of codeine and 4000mg of acetaminophen for individuals 12 years and older. For individuals 3 to 12 years of age: Acetaminophen 75mg/kg per 24 hours, not to exceed 4000 maximum recommended daily dose is 8 tablets). maximum recommended daily dose is 10 capsules or tablets). maximum recommended daily dose for Abstral, Actiq, Lazanda, Onsolis, and Subsys is 4 doses; the FDA does not provide a maximum recommended dose for Fentora). maximum recommended daily dose of acetaminophen from all drug products should not exceed 4,000 maximum recommended daily dose is 5 tablets). Page 7 of 10

8 Therapeutic Category Drug Morphine sulfate Opium tincture Belladonna/opium suppository Oxycodone (Oxecta, Roxicodone) Oxycodone/acetaminophen (Magnacet, Percocet, Primlev, Roxicet, Xolox) Oxycodone/aspirin (Percodan) Oxymorphone (Numorphan) Cough Combinations Promethazine with codeine oral solution Hydrocodone/ pseudoephedrine (Rezira) oral solution Hydrocodone/ chlorpheniramine (Vituz) oral solution Hydrocodone/ pseudoephedrine/guaifenesin (Hycofenix) solution Hydrocodone/guaifenesin (Obredon) oral solution Hydrocodone/ chlorpheniramine (Tussionex) ER oral suspension Codeine/chlorpheniramine (Tuzistra XR) ER suspension Hydrocodone/ chlorpheniramine/ pseudoephedrine (Zutripro) oral solution Rationale maximum recommended daily dose is 4 doses). maximum recommended daily dose of acetaminophen from all drug products should not exceed 4,000 maximum recommended daily dose is 12 tablets). maximum recommended daily dose is 30 milliliters). maximum recommended daily dose is 20 milliliters). maximum recommended daily dose is 20 milliliters). maximum recommended daily dose is 40 milliliters). maximum recommended daily dose is 60 milliliters). maximum recommended daily dose is 10 milliliters). maximum recommended daily dose is 20 milliliters). maximum recommended daily dose is 20 milliliters). Page 8 of 10

9 Therapeutic Drug Category Detoxification Agents Naloxone (Evzio) injection Naloxone (Narcan) nasal spray Naltrexone tablet Headache Combinations Butalbital/acetaminophen/ caffeine/codeine (Fioricet with Codeine) capsule Butalbital/aspirin/caffeine (Fiorinal) capsule Pain Control Buprenorphine (Butrans) patch Buprenorphine (Bulbuca) buccal film Butorphanol nasal spray Pentazocine/acetaminophen tablet Pentazocine/naloxone tablet Tapentadol (Nucynta) tablet Tapentadol (Nucynta ER) extended-release tablet Tramadol (Ultram) tablet Tramadol (Conzip) extendedrelease capsule Rationale maximum recommended daily dose is 6 capsules). maximum recommended daily dose is 6 capsules). maximum recommended dose is (1) 20mcg/hour patch every 7 days). maximum recommended dose is 900 micrograms every 12 hours). maximum recommended daily dose is 6 tablets). maximum recommended daily dose is 12 tablets). maximum recommended daily dose is 600 maximum recommended daily dose is 500 maximum recommended daily dose is 400 Page 9 of 10

10 Therapeutic Category Drug Tramadol (Ultram ER) extended-release tablet Tramadol/ acetaminophen (Ultracet) tablet Rationale maximum recommended daily dose is 300 maximum recommended daily dose is 300 maximum recommended daily dose is 8 tablets). Coding/Billing Information Note: s 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. McEvoy GK, ed. AHFS 2017 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists, Inc; Individual Drug Name Entries. Drug Facts and Comparisons. Facts & Comparisons eanswers [online]. 2012, Available from Wolters Kluwer Health, Inc. Accessed April, 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 Drug Administration (FDA). FDA Safe Use Initiative. Nov 4, Accessed 4/18/2017. Available at 5. U.S. Food and Drug Administration. Drugs@FDA. U.S. Department of Health & Human Services: 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 10 of 10