See Important Reminder at the end of this policy for important regulatory and legal information.

Transcription

1 Clinical Policy: (Onmel, Sporanox) Reference Number: CP.CPA.134 Effective Date: Last Review Date: Line of Business: Medicaid Medi-Cal Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description (Onmel, Sporanox ) is an azole antifungal. FDA approved indication Sporanox capsule is indicated: For the treatment of the following fungal infections in immunocompromised and nonimmunocompromised patients: o Blastomycosis, pulmonary and extrapulmonary o Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, nonmeningeal histoplasmosis o Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy For the treatment of the following fungal infections in non-immunocompromised patients: o Onychomycosis of the toenail, with or without fingernail involvement, due to dermatophytes (tinea unguium) o Onychomycosis of the fingernail due to dermatophytes (tinea unguium) Onmel tablet is indicated: For the treatment of onychomycosis of the toenail caused by Trichophyton rubrum or T. Mentagrophytes Sporanox oral solution is indicated: Treatment of oropharyngeal and esophageal candidiasis 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 (Onmel, Sporanox) is medically necessary when the following criteria are met: I. Initial Approval Criteria A. Tinea Versicolor (must meet all): 1. Diagnosis of tinea versicolor; 2. Failure to one of the following, unless contraindicated or clinically significant adverse effects are experienced: oral fluconazole, topical or oral ketoconazole; 3. Dose does not exceed 200 mg/day. Page 1 of 8

2 Approval duration: 7 days B. Tinea Capitis (must meet all): 1. Diagnosis of tinea capitis; 2. Failure of a 4-8 week trial of terbinafine, unless contraindicated or clinically significant adverse effects are experienced; 3. Dose does not exceed: solution 3 mg/kg/day; capsules 5 mg/kg/day. Approval duration: 12 weeks C. Tinea Pedis, Tinea Corporis, Tinea Cruris (must meet all): 1. Diagnosis of one of the following: tinea pedis, tinea corporis, tinea cruris; 2. Failure to a minimum of two 2-week trials of TWO prescription strength topical antifungal agents, unless contraindicated or clinically significant adverse effects are experienced; 3. Dose does not exceed 200 mg/day. Approval duration: Tinea pedis - 15 days; Tinea corporis, Tinea cruris- 7 days D. Onychomycosis (Tinea Unguium) (must meet all): 1. Diagnosis of onychomycosis (tinea unguium); 2. For Onmel requests, failure to capsules, unless contraindicated or clinically significant adverse effects are experienced; 3. Dose does not exceed: Sporanox 800 mg/day; Onmel 200 mg/day. Approval duration: Sporanox Pulsepak 3 months (toenails), 2 months (fingernails); Onmel 12 weeks ( Note: Authorization for onychomycosis is limited to one course of therapy per year). E. Various Indications (must meet all): 1. Diagnosis of one of the following (a f): a. Blastomycosis (pulmonary or extrapulmonary); b. Histoplasmosis (including chronic cavitary pulmonary disease and disseminated, nonmeningeal disease); c. Aspergillosis (pulmonary or extrapulmonary); d. Coccidioidomycosis (primary pulmonary with increased risk for complications or dissemination or persistent symptoms of fatigue, malaise, or fever lasting beyond 3 weeks); e. Sporotrichosis (cutaneous, lymphonodular); f. Oropharyngeal and esophageal candidiasis; 2. Dose does not exceed 400 mg/day. Approval duration: Blastomycosis, Histoplasmosis, Aspergillosis, Coccidioidomycosis, Sporotrichosis: 12 months Oropharyngeal candidiasis: 4 weeks Esophageal candidiasis: 6 weeks F. Other diagnoses/indications Page 2 of 8

3 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 Centene benefit or member has previously met initial approval criteria; 2. Member is responding positively to therapy; 3. Dose does not exceed the FDA approved maximum recommended dose for the relevant indication. Approval duration: Refer to initial approval duration (Section I) B. Other diagnoses/indications (must meet 1 or 2): 1. Currently receiving medication via Centene benefit 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 III (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 B. More than one course of therapy per year for onychomycosis. Sporanox remains in the nail plate areas for 9 months. Full therapeutic effect is expected upon new nail growth. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key Appendix B: General Information Cardiac dysrrhythmias have occurred in patients using pimozide, triazolam, dofetilide, nisoldipine, oral midazolam, levacetylmethadol (levomethadyl), or quinidine with Sporanox. Sporanox may increase plasma concentrations of these CYP3A4 substrates, and lead to serious cardiovascular events, including QT prolongation, torsades de pointes, ventricular tachycardia, cardiac arrest, and/or sudden death. Concomitant use of these agents and Sporanox is contraindicated. Due to the increased risk of skeletal muscle toxicity, including rhabdomyolysis, HMG CoA-reductase inhibitors are contraindicated with Sporanox. Increased plasma concentrations of atorvastatin, cerivastatin, lovastatin, and simvastatin have been observed in patients concurrently using Sporanox in clinical studies. Ergot alkaloids metabolized by CYP3A4 such as dihydroergotamine, ergometrine (ergonovine), ergotamine and methylergometrine (methylergonovine) are contraindicated with Sporanox. Sporanox may increase plasma concentrations of ergot alkaloids and lead to ergotism, potentially leading to cerebral ischemia and/or ischemia of the extremities. Page 3 of 8

4 Sporanox is not FDA-approved, but has an A-II recommendation for the treatment of Sporotrichosis per Infectious Disease Society of America (IDSA). For cutaneous and lymphocutaneous sporotrichosis infections, response rates of 90% 100% were noted with therapy, compared with a 63% 71% response rate associated with fluconazole therapy. Appendix C: Therapeutic Alternatives Drug Dosing Regimen Dose/Limit/ Maximum Dose Econazole 1% cream Tinea corporis or cruris: Apply QD x 2 weeks Tinea pedis: Apply QD x 4 weeks Exelderm (sulconazole) Tinea corporis or cruris: Apply QD-BID x 1% cream, solution 3 weeks Tinea pedis: Apply BID x 4 weeks Ketoconazole 2% cream Tinea corporis or cruris: Apply QD x 2 weeks Ciclopirox (Loprox ) 0.77% gel Naftin (naftifine) 1%, 2% cream, gel Oxistat (oxiconazole nitrate) 1% cream, lotion Ketoconazole (Nizoral ) shampoo, cream Tinea pedis: Apply QD x 6 weeks Tinea corporis or cruris: Apply BID x 4 weeks Tinea pedis: Apply BID x 4 weeks Tinea corporis or cruris: Cream Apply QD, Gel Apply BID x 2-4 weeks Tinea pedis: Cream Apply QD, Gel Apply BID) x 4-6 weeks Tinea corporis or cruris: Apply QD-BID x 2 weeks Tinea pedis: Apply QD-BID x 4 weeks Apply shampoo topically QD for 5 minutes and rinse Apply cream topically QD for 2 weeks Fluconazole (Diflucan ) mg PO weekly x 2-4 weeks tablets Therapeutic alternatives are listed as Brand name (generic) when the drug is available by brand name only and generic (Brand name ) when the drug is available by both brand and generic Varies V. Dosage and Administration Drug Name Indication Dosing Regimen Maximum Dose (Onmel) Onychomycosis of Toenails due to Trichophyton rubrum or T. mentagrophytes 200 mg PO QD for 12 weeks 200 mg/day Onychomycosis Toenails: 400 mg/day Page 4 of 8

5 Pulse: 400 mg PO BID x 1 week/month x 3 months Continuous: 200 mg PO QD x 3 months Nonmeningeal Blastomycosis; Histoplasmosis Fingernails: Pulse: 200 mg PO BID x 1 week/month x 2 months 200 mg PO QD BID 400 mg/day Aspergillosis 200 mg PO QD BID 400 mg/day Oropharyngeal candidiasis Esophageal candidiasis Tinea capitis 200 mg (20 ml) PO daily or if unresponsive/refractory to fluconazole tablets, 100 mg (10 ml) PO BID mg (10-20 ml) daily Solution: 3 mg/kg/day PO Capsules: 5 mg/kg/day PO 400 mg/day 400 mg/day 400 mg/day Tinea pedis 200 mg PO QD x 15 days 400 mg/day Tinea cruris, corporis 200 mg PO QD x 1 week 400 mg/day Tinea versicolor 200 mg PO QD x 7 days 400 mg/day Sporotrichosis (cutaneous, lymphocutaneous) 200 mg PO QD or 200 mg PO BID for patients not responding; continue for 2 to 4 weeks after all lesions have healed 400 mg/day VI. Product Availability Drug (Onmel) Availability Capsules: 100 mg Pulsepak: contains 28 of the 100 mg capsules Oral solution: 10 mg/ml Tablets: 200 mg VII. References 1. Sporanox Prescribing information. Titusville, NJ: Janssen Pharmaceuticals, Inc.; April Available at: Page 5 of 8

6 df. Accessed January 5, Sporanox Solution Prescribing information. Titusville, NJ: Janssen Pharmaceuticals, Inc.; April Available at: df. Accessed January 5, Onme Prescribing information. Research Triangle Park, NC: Stiefel Laboratories, Inc.; April Available at: Accessed January 5, Gilbert D, Sande M, Moellering R, et al. Sanford Guide to Antimicrobial Therapy. 37th ed. Hyde Park, VT: Antimicrobial Therapy, Inc; Micromedex Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed January 11, Stevens DA, Kan VL, Judson MA, et al. IDSA Treatment Guidelines for Diseases Caused by Apergillus. Clinical Infectious Diseases. 2008;46: Kauffman CA, Bustamante B, Chapman SW, et al: Clinical practice guidelines for the management of sporotrichosis: 2007 update by the Infectious Diseases Society of America. Clin Infect Dis 2007;45: American Hospital Formulary Drug Information. Available at: Accessed January 5, Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; Available at: Micromedex Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed January 5, 2017 Reviews, Revisions, and Approvals Date P&T Approval Date Converted to new template. Minor changes to verbiage and grammar. References updated Important Reminder This clinical policy has been developed by appropriately experienced and licensed health care professionals based on a review and consideration of currently available generally accepted standards of medical practice; peer-reviewed medical literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and other available clinical information. The Health Plan makes no representations and accepts no liability with respect to the content of any external information used or relied upon in developing this clinical policy. This clinical policy is consistent with standards of medical practice current at the time that this clinical policy was approved. Health Plan means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan s affiliates, as applicable. Page 6 of 8

7 The purpose of this clinical policy is to provide a guide to medical necessity, which is a component of the guidelines used to assist in making coverage decisions and administering benefits. It does not constitute a contract or guarantee regarding payment or results. Coverage decisions and the administration of benefits are subject to all terms, conditions, exclusions and limitations of the coverage documents (e.g., evidence of coverage, certificate of coverage, policy, contract of insurance, etc.), as well as to state and federal requirements and applicable Health Plan-level administrative policies and procedures. This clinical policy is effective as of the date determined by the Health Plan. The date of posting may not be the effective date of this clinical policy. This clinical policy may be subject to applicable legal and regulatory requirements relating to provider notification. If there is a discrepancy between the effective date of this clinical policy and any applicable legal or regulatory requirement, the requirements of law and regulation shall govern. The Health Plan retains the right to change, amend or withdraw this clinical policy, and additional clinical policies may be developed and adopted as needed, at any time. This clinical policy does not constitute medical advice, medical treatment or medical care. It is not intended to dictate to providers how to practice medicine. Providers are expected to exercise professional medical judgment in providing the most appropriate care, and are solely responsible for the medical advice and treatment of members. This clinical policy is not intended to recommend treatment for members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. Providers referred to in this clinical policy are independent contractors who exercise independent judgment and over whom the Health Plan has no control or right of control. Providers are not agents or employees of the Health Plan. This clinical policy is the property of the Health Plan. Unauthorized copying, use, and distribution of this clinical policy or any information contained herein are strictly prohibited. Providers, members and their representatives are bound to the terms and conditions expressed herein through the terms of their contracts. Where no such contract exists, providers, members and their representatives agree to be bound by such terms and conditions by providing services to members and/or submitting claims for payment for such services. Note: For Medicaid members, when state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence. Please refer to the state Medicaid manual for any coverage provisions pertaining to this clinical policy Centene Corporation. All rights reserved. All materials are exclusively owned by Centene Corporation and are protected by United States copyright law and international copyright law. No part of this publication may be reproduced, copied, modified, distributed, displayed, stored in a retrieval system, transmitted in any form or by any means, or otherwise published without the prior written permission of Centene Corporation. You may not alter or remove any trademark, copyright or other notice contained herein. Centene and Centene Corporation are registered trademarks exclusively owned by Centene Corporation. Page 7 of 8

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