Clinical Policy: Nabilone (Cesamet), Dronabinol (Marinol, Syndros)
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Clinical Policy: Nabilone (Cesamet), Dronabinol (Marinol, Syndros) Reference Number: CP.CPA.242 Effective Date: 11.16.16 Last Review Date: 11.17 Revision Log Line of Business: Medicaid See Important Reminder at the end of this policy for important regulatory and legal information. Description The following are synthetic cannabinoids requiring prior authorization: dronabinol (Marinol®, Syndros®), nabilone (Cesamet™) FDA approved indication Marinol Cesamet Syndros Controlled Substance Schedule Category CIII CII CII Treatment of nausea and vomiting associated with X X X cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments Treatment of Anorexia associated with weight loss X X in patients with acquired immune deficiency syndrome (AIDS) Policy/Criteria Provider must submit documentation (which may include office chart notes and lab results) supporting that member has met all approval criteria It is the policy of health plans affiliated with Centene Corporation® that Cesamet, Marinol, and Syndros are medically necessary when the following criteria are met: I. Initial Approval Criteria A. Nausea and Vomiting Associated with Cancer Chemotherapy (must meet all): 1. Diagnosis of nausea and vomiting associated with cancer chemotherapy; 2. Patient has received highly or moderately emetogenic chemotherapy; 3. Failure of a trial of a 5-HT3 serotonin antagonist (e.g. ondansetron), in combination with Emend® and dexamethasone unless contraindicated or clinically significant adverse effects are experienced; 4. Failure of TWO of the following unless contraindicated or clinically significant adverse effects are experienced: metoclopramide, prochlorperazine, lorazepam; 5. Dose does not exceed 15 mg/m2 per dose (6 doses per day) (Marinol), 6 mg/day (Cesamet), 12.6 mg/m2 per dose (6 doses per day) (Syndros). Approval duration: Length of benefit B. Anorexia (Marinol and Syndros requests only) (must meet all): 1. Diagnosis of anorexia with weight loss in patients with AIDS or cancer; Page 1 of 9 CLINICAL POLICY Nabilone, Dronabinol 2. Prescribed for appetite stimulation; 3. Request is for Marinol or Syndros; 4. Failure of a trial of megestrol at maximally indicated doses unless contraindicated or clinically significant adverse effects are experienced; 5. Dose does not exceed 20 mg/day (Marinol), 16.8 mg/day (Syndros). Approval duration: Length of benefit C. Other diagnoses/indications 1. Refer to CP.PMN.53 if diagnosis is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) II. Continued Therapy A. All indications in Section I (must meet all): 1. Currently receiving medication via a health plan affiliated with Centene Corporation or member has previously met initial approval criteria; 2. Member is responding positively to therapy; 3. If request is for a dose increase, new dose does not exceed the FDA approved maximum recommended dose for the relevant indication. Approval duration: Length of benefit B. Other diagnoses/indications (must meet 1 or 2): 1. Currently receiving medication via a health plan affiliated with Centene Corporation and documentation supports positive response to therapy. Approval duration: Duration of request or 12 months (whichever is less); or 2. Refer to CP. PMN.53 if diagnosis is NOT specifically listed under section (Diagnoses/Indications for which coverage is NOT authorized) III. Diagnoses/Indications for which coverage is NOT authorized: A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policy – CP. PMN.53 or evidence of coverage documents IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key AIDS: acquired immune deficiency syndrome Appendix B: General Information Cesamet may be administered for 48 hours after the last dose of each cycle of chemotherapy. Cesamet is not intended for use on an as-needed basis. Because of its potential to alter the mental state, Cesamet is intended for use under circumstances that permit close supervision of the patient by a responsible individual particularly during initial use of Cesamet and during dose adjustments. Marinol capsules contain cannabinoid and sesame oil and should never be used by patients allergic to these substances. Page 2 of 9 CLINICAL POLICY Nabilone, Dronabinol The following table is the National Comprehensive Cancer Network’s classification for emetogenic potential of significant chemotherapy and other agents. Agents Frequency of Emesis AC combination defined as either doxorubicin or epirubicin High Emetic Risk with cyclophosphamide, carmustine > 250 mg/m2, cisplatin, >90% cyclophosphamide > 1,500 mg/m2, dacarbazine, doxorubicin ≥ 60 mg/m² epirubicin >90 mg/m², ifosamide > 2 g/m² per dose, mechlorethamine, streptozocin aldesleukin > 12-15 million IU/m2, amifostine > 300 mg/m2, Moderate Emetic Risk 30- arsenic trioxide, azacitidine, bendamustine, busulfan, 90% carboplatin, carmustine ≤ 250 mg/m2, clofarabine, cyclophosphamide ≤ 1500 mg/m2, cytarabine > 200 mg/m2, dactinomycin, daunorubicin, doxorubicin <60 mg/ m², epirubicin ≤ 90 mg/m², idarubicin, ifosfamide <2 g/m² per dose, interferon alfa ≥10 million IU/m2, irinotecan, melphalan, methotrexate (MTX) ≥250 mg/m2, oxaliplatin, temozolomide ado-trastuzumab emtansine, amifostine ≤ 300 mg/m2, Low Emetic Risk aldesleukin ≤ 12 million IU/m2, belinostatm, blinatumomab, 10-30% brentuximab vedotin, cabazitaxol, carfilzomib, cytarabine (low dose) 100 - 200 mg/m2, docetaxel, doxorubicin (liposomal), eribulin, etoposide, 5-fluorouracil, floxuridine, gemcitabine, interferon alfa > 5 <10 million IU/m2, ixabepilone, MTX > 50 mg/m2 < 250 mg/m2, mitomcyin, mitoxantrone, omacetaxine, paclitaxel, paclitaxel-albumin, pemetrexed, pentostatin, pralatrexate, romidepsin,thiotepa, topotecan, ziv-aflibercept alemtuzumab, asparaginase, bevacizumab, bleomycin, Minimal Emetic Risk bortezomib, cetuximab, 2-chlorodeoxyadenosine (cladribine), <10% cytarabine < 100 mg/m2, decitabine, denileukin diftitox, dexrazoxane, fludarabine, interferon alfa ≤ 5 million IU/m2, ipilimumab, MTX ≤ 50 mg/m2, nelarabine, nivolumab, obinutuzumab, ofatumumab, panitumumab, pegaspargase,peginterferon, pembrolizumab, pertuzumab, rituximab, temsirolimus, trastuzumab, valrubicin, vinblastine, vincristine, vincristine (liposomal), vinorelbine altretamine, busulfan (≥ 4 mg/d), crizotinib, cyclophosphamide Emetogenic potential of oral (≥100 mg/m2/d), estramustine, etoposide, lomustin (single antineoplastic agents: day), mitotane, procarbazine, temozolomide (> 75 mg/m2/d), Moderate to High vismodegib Afatinib, axitinib, bexarotene,bosutinib, busulfan (< 4 mg/d), Emetogenic potential or oral cabozantinib, capecitabine, chlorambucil, cyclophosphamide antineoplastic agents: (< 100 mg/m2/d), dasatinib,dabrafenib, erlotinib, everolimus, Minimal to low fludarabine, gefitinib, hydroxyurea, imatinib, lapatinib, lenalidomide, melphalan, mercaptopurine, methotrexate, nilotinib, pazopanib, pomalidomide, ponatinib, regorafenib, ruxolitinib, sorafenib, sunitinib, temozolomide (≤ 75 mg/m2/d), Page 3 of 9 CLINICAL POLICY Nabilone, Dronabinol thalidomide, thioguanine, topotecan, trametinib, tretinoin, vandetanib, vemurafenib, vorinostat Appendix C: Therapeutic Alternatives Drug Dosing Regimen Dose Limit/Maximum Dose 5-HT3 Antagonists Moderately emetogenic chemotherapy As specified by length Ondansetron (MEC): of chemotherapy (Zofran®)* 12 years or older: 8 mg PO beginning 30 minutes before chemotherapy; repeat dose 8 hours after initial dose, then 8 mg PO BID for 1 to 2 days after chemotherapy completed Adults: 0.15 mg/kg IV for 3 doses up to a maximum of 16 mg per dose. The first dose is infused over 15 minutes beginning 30 minutes before the start of chemotherapy. Subsequent doses may be repeated twice, administered 4 and 8 hours after the first dose. Highly emetogenic chemotherapy (HEC): Adults: 24 mg PO (given as three 8 mg tablets) 30 minutes prior to start of single day chemotherapy Adults: 0.15 mg/kg IV for 3 doses up to a maximum of 16 mg per dose. The first dose is infused over 15 minutes beginning 30 minutes before the start of chemotherapy. Subsequent doses may be repeated twice, administered 4 and 8 hours after the first dose. 5-HT3 Antagonists Moderately emetogenic chemotherapy: As specified by length Anzemet® of chemotherapy (dolasetron)* Adults: 100 mg PO within 1 hour prior to chemotherapy 5-HT3 Antagonists Moderately and highly emetogenic As specified by length Granisetron* chemotherapy: of chemotherapy 2 mg PO QD 1 hour prior to chemotherapy OR 1 mg BID 1 hour prior to chemotherapy and then 12 hours later 5-HT3 Antagonists MEC and HEC: As specified by length of chemotherapy Page 4 of 9 CLINICAL POLICY Nabilone, Dronabinol Drug Dosing Regimen Dose Limit/Maximum Dose Sancuso® Adults: Apply a single patch to the upper (granisetron)* outer arm from 24 to 48 hours before chemotherapy. Remove the patch a minimum of 24 hours after completion of chemotherapy. The patch can be worn for up to 7 days depending on the duration of chemotherapy regimen. 5-HT3 Antagonists Highly or Moderately emetogenic As specified by length Aloxi® chemotherapy: of chemotherapy (palonosetron)* 0.25 mg IV infused over 30 seconds beginning 30 minutes prior to chemotherapy NK1 Receptor Moderately and highly emetogenic 1 x 125 mg and 2 x 80 Antagonist chemotherapy: mg capsules per cycle Emend® (aprepitant)* 125 mg PO 1 hour prior to chemotherapy and 80 mg on days