Prior Authorization Guideline Guideline: MPD PHC - Marinol Therapeutic Class: Anti-Emetic Agents Therapeutic Sub-Class: Cannabinoid Client: 2007 MPD PHC Approval Date: 10/3/2006 Revision Date: 12/5/2006 **THIS GUIDELINE IS USED TO DETERMINE PART B VS PART D COVERAGE** I. BENEFIT COVERAGE A. Background Section 4557 of the Balanced Budget Act of amends §1861(s)(2) by extending the coverage of oral anti-emetic drugs under the following conditions:1 • • • • Coverage is provided only for oral drugs approved by the FDA for use as antiemetics; The oral anti-emetic(s) must either be administered by the treating physician or in accordance with a written order from the physician as part of a cancer chemotherapy regimen; Oral anti-emetic drug(s) administered with a particular chemotherapy treatment must be initiated within 2 hours of the administration of the chemotherapeutic agent and may be continued for a period not to exceed 48 hours from that time; and The oral anti-emetic drug(s) provided must be used as a full therapeutic replacement for the intravenous anti-emetic drugs that would have otherwise been administered at the time of the chemotherapy treatment B. Formulary Status Table 1. Formulary status Non-Formulary Products Formulary Products Tier 4 Marinol® (dronabinol)* * Subject to Prior Authorization II. INDICATIONS A. FDA Approved Indications2 1. Anorexia in Patients with AIDS Marinol is indicated for the treatment of anorexia associated with weight loss in patients with AIDS 2. Nausea and Vomiting Marinol is indicated for the treatment of nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. III. GUIDELINE A. Part B 1. Marinol will be covered under Part B based on both of the following criteria:1 a. Oral anti-emetic drug administered with chemotherapy treatment that is initiated within 2 hours of the administration of chemotherapy and continued for a period not to exceed 48 hours from that time -ANDb. Oral anti-emetic drug is used as a full therapeutic replacement for IV anti-emetic drugs that would have been administered at the time of the chemotherapy treatment B. Part D – Nausea and Vomiting Associated with Cancer Chemotherapy 1. Marinol will be covered under Part D based on the following criteria: a. All of the following: (1) Patient does not meet criteria for Part B above -AND(2) History of failure or contraindication to a 5HT-3 Receptor Antagonist (e.g., Anzemet, Kytril or Zofran)2,a -AND(3) History of failure or contraindication to one agent from at least one of the following drug classes:2,a i. Antihistamines (Prochlorperazine, Promethazine) ii. Corticosteroids (Dexamethasone) iii. Prokinetic Agents (Metoclopramide) iv. Antipsychotic Agents (Haloperidol) - OR b. As continuation of therapy for treatment covered under Part B Authorization will be issued for length of therapy. C. Part D – Anorexia in Patients with AIDS 1. Marinol will be covered under Part D based on all of the following criteria: a. Diagnosis of anorexia with weight loss in patients with AIDS.2 IV. CONTRAINDICATIONS AND WARNINGS A. Contraindications 1. Hypersensitivity Marinol is contraindicated in any patient who has a known sensitivity to Marinol or any of its ingredients. It contains cannabinoid and sesame oil and should never be used by patients allergic to these substances. B. Warnings 1. Hazardous Activities Patients receiving treatment with Marinol should be specifically warned not to drive, operate machinery, or engage in any hazardous activity until it is established that they are able to tolerate the drug and to perform such tasks safely. V. DOSING Appetite Stimulation: 2.5 mg twice daily before lunch and dinner. For patients unable to tolerate this 5 mg/day dosage, the dosage can be reduced to 2.5 mg/day, administered as a single dose in the evening or at bedtime. If clinically indicated, the dosage may be gradually increased to a maximum of 20 mg/day , administered in divided oral doses. Caution should be exercised in escalating the dosage because of the increased frequency of dose-related adverse experiences at higher dosages. Antiemetic: 5 mg/m2, given 1 to 3 hours prior to the administration of chemotherapy, then every 2 to 4 hours after chemotherapy is given, for a total of 4 to 6 doses/day. Should the 5 mg/m2 dose prove to be ineffective, and in the absence of significant side effects, the dose may be escalated by 2.5 mg/m2 increments to a maximum of 15 mg/m2 per dose. Caution should be exercised in dose escalation, however, as the incidence of disturbing psychiatric symptoms increases significantly at maximum dose. VI. AVAILABILITY Marinol: 2.5 mg, 5 mg, and 10 mg capsules Marinol is a Schedule III (CIII) controlled substance. VII. BACKGROUND A. Description Dronabinol is an orally active cannabinoid which, like other cannabinoids, has complex effects on the central nervous system (CNS), including central sympathomimetic activity. Cannabinoid receptors have been discovered in neural tissues. These receptors may play a role in mediating the effects of dronabinol and other cannabinoids. B. Clinical Studies 1. Anorexia in Patients with AIDS Dronabinol was shown to increase appetite in patients with AIDS-related anorexia in a multicenter, double-blind, randomized controlled trial (n=221).3 Patients randomized to receive dronabinol 2.5 mg twice daily reported significantly improved appetite, as measured by visual analog scale, compared to those receiving placebo (p=0.05 for all patients, p=0.015 for evaluable patients. Mean increase in appetite from baseline to end point was 37% and 17% in the dronabinol and placebo groups, respectively (p=0.05). In a long-term (12 months), open label evaluation of dronabinol 2.5 mg once or twice daily, patients treated with dronabinol maintained improvements in hunger (measured by VAS) compared to baseline.4 A head-to-head trial between dronabinol and megestrol acetate (n=469) showed that a greater percentage of megestrol acetate-treated patients reported appetite improvement compared to those receiving dronabinol (75% vs. 49%, p=0.001).5 More patients receiving megestrol acetate reported weight gain than those receiving dronabinol (11% vs. 3%, p=0.02). Combination treatment did not result in significant improvements compared to megestrol acetate alone. 2. Nausea and Vomiting The use of dronabinol for chemotherapy induced nausea and vomiting was evaluated in a randomized controlled trial comparing the combination of dronabinol and prochlorperazine with either agent along (n=62).6 The use of combination therapy was associated with significantly shorter duration of nausea or vomiting compared to either agent alone (p<0.001 vs. either single agent). Differences in the number of patients who experienced nausea or vomiting were not significant, but consistently favored groups receiving dronabinol. Patients receiving dronabinol were more likely to experience side effects than those receiving prochlorperazine alone (p<0.01). Neuropsychiatric side effects occurred in 62% of patients in the dronabinol group vs. 29% in the prochlorperazine group. C. National Guidelines 1. National Comprehensive Cancer Network (2006)7 Breakthrough emesis presents a difficult situation, because refractory ongoing nausea and vomiting is often challenging to reverse. Generally, it is much easier to prevent nausea and vomiting than to treat it. The general principle of breakthrough treatment is to give an additional agent from a different drug class. Multiple concurrent agents, perhaps in alternating schedules or by alternating routes, may be necessary. Dopamine antagonists, metoclopramide, butyrophenones (e.g., haloperidol), corticosteroids, and agents such as lorazepam may be required. Routine around-the-clock administration of antiemetics should be strongly considered, rather than PRN (as required) dosing. Adequate hydration or fluid repletion should be ensured, and any possible electrolyte abnormalities should be assessed and corrected. VIII. REFERENCES 1. Centers for Medicaid & Medicare Services. Medicare Intermediary Manual Part 3 - Claims Process (Transmittal 1848). Available at: http://www.cms.hhs.gov/transmittals/downloads/R1848A3.pdf Accessed September 22, 2006. 2. Marinol® Prescribing Information. Solvay Pharmaceuticals, Inc., July 2006. 3. Beal JE, Olson R, Laubenstein L, et al. Dronabinol as a treatment for anorexia associated with weight loss in patients with AIDS. J Pain Symptom Manage. 1995;10:89-97. 4. Beal JE, Olson R, Lefkowitz L, et al. Long-term efficacy and safety of dronabinol for acquired immunodeficiency syndrome-associated anorexia. J Pain Symptom Manage. 1997;14:7-14. 5. Jatoi A, Windschitl HE, Loprinzi CL, et al. Dronabinol versus megestrol acetate versus combination therapy for cancer-associated anorexia: a North Central Cancer Treatment Group study. J Clin Oncol. 200220:567-573. 6. Lane M, Vogel CL, Ferguson J, et al. Dronabinol and prochlorperazine in combination for treatment of cancer chemotherapy-induced nausea and vomiting. J Pain Symptom Manage. 1991;6:352-359. 7. National Comprehensive Cancer Network. Practice Guidelines in Oncology – v.2.2006. Antiemesis. Available at: http://www.nccn.org/professionals/physician_gls/PDF/antiemesis.pdf. Accessed September 22, 2006. X. ENDNOTES a. Marinol is indicated for the treatment of nausea and vomiting associated with cancer chemotherapy only in patients who have failed to respond adequately to conventional antiemetic treatments. This Prior Authorization Guideline represents the recommendation of Prescription Solutions’ Pharmacy and Therapeutics (P&T) Committee. It is based upon the P&T Committee’s review of the available evidence as of the date of drafting or revision of this Prior Authorization Guideline. It is subject to updating from time to time, based upon changes in scientific knowledge and information. This Prior Authorization Guideline is intended as a resource for making coverage decisions for Health Plan members, but it does not replace an individualized case-by-case review and medical necessity determination for each Health Plan member. Copyright © 2006 by Prescription Solutions. All rights reserved. This Prior Authorization Guideline is intended for use by Prescription Solutions and Health Plan employees and applicable contracted providers and practitioners only. The information contained in this Prior Authorization Guideline is confidential and proprietary to Prescription Solutions and shall not be used, reproduced, or transferred in whole or in part without Prescription Solutions’ prior written consent.
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