Sporanox and Onmel (Itraconazole)

Home , Microsporidiosis, Sporotrichosis, Tinea manuum

Sporanox/Onmel (itraconazole) Policy Number: C4734-A

CRITERIA EFFECTIVE DATES: ORIGINAL EFFECTIVE DATE LAST REVIEWED DATE NEXT REVIEW DATE 05/2013 12/2018 12/2019 J CODE TYPE OF CRITERIA LAST P&T APPROVAL NA RxPA Q1

PRODUCTS AFFECTED: Sporanox (itraconazole), Onmel (itraconazole)

DRUG CLASS: Triazoles

ROUTE OF ADMINISTRATION: Oral

PLACE OF SERVICE: Retail Pharmacy

AVAILABLE DOSAGE FORMS: itraconazole 100mg capsules, Sporanox 100mg capsules, itraconazole 10mg/ml solution, Sporanox 10mg/ml solution, Onmel 200mg tablet

FDA-APPROVED USES: Sporanox (itraconazole) capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: Blastomycosis, pulmonary and extrapulmonary, Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy. Sporanox (itraconazole) capsules are also indicated for the treatment of the following fungal infections in non-immunocompromise patients: Onychomycosis of the toenail, with or without fingernail involvement, due to dermatophytes (tinea unguium), and Onychomycosis of the fingernail due to dermatophytes (tinea unguium).

COMPENDIAL APPROVED OFF-LABELED USES: Coccidioidomycosis, Cryptococcosis, Microsporidiosis, Penicilliosis, Pityriasis versicolor/Tinea versicolor, Sporotrichosis,Tinea corporis/Tinea cruris, Tinea manuum/Tinea pedis

COVERAGE CRITERIA: INITIAL AUTHORIZATION

DIAGNOSIS: Blastomycosis, pulmonary and extrapulmonary, Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy, Onychomycosis of the toenail, with or without fingernail involvement, due to dermatophytes (tinea unguium), and Onychomycosis of the fingernail due to dermatophytes (tinea unguium). Coccidioidomycosis, Cryptococcosis, Microsporidiosis, Penicilliosis, Pityriasis versicolor/Tinea versicolor, Sporotrichosis,Tinea corporis/Tinea cruris, Tinea manuum/Tinea pedis

REQUIRED MEDICAL INFORMATION: A. ONYCHOMYCOSIS TINEA:

Molina Healthcare, Inc. confidential and proprietary © 2018 This document contains confidential and proprietary information of Molina Healthcare and cannot be reproduced, distributed or printed without written permission from Molina Healthcare. This page contains prescription brand name drugs that are trademarks or registered trademarks of pharmaceutical manufacturers that are not affiliated with Molina Healthcare. Page 1 of 3 1. Member has the diagnosis of onychomycosis due to tinea that has been confirmed by a fungal diagnostic test. AND 2. The member does not have any of the following: A) Evidence of ventricular dysfunction, such as congestive heart failure (CHF), or B) Current use of certain drugs metabolized by cytochrome P450 3A4 (CYP3A4) AND 3. Documentation of trial/failure or contraindication to terbainafine

B. PITYRIASIS VERSICOLOR OR TINEA VERSICOLOR 1. Member has a documented diagnosis of Pityriasis versicolor or Tinea versicolor. AND 2. Documentation of trial/failure or contraindication to fluconazole

C. ALL OTHER INDICATIONS 1. (a) Member has a documented diagnosis of ANY of the following: Blastomycosis, Histoplasmosis, Aspergillosis, Coccidioidomycosis, Cryptococcosis, Sporotrichosis, Penicilliosis, Microsporidiosis. OR (b) Member has one of the following diagnoses: Tinea corporis, Tinea cruris, Tinea manuum, Tinea pedis. AND (b) Member experienced an inadequate treatment response, adverse event, intolerance, or contraindication to Lamisil (terbinafine) tablets

DURATION OF APPROVAL: Initial authorization: 3 months, one time authorization

QUANTITY: None

PRESCRIBER REQUIREMENTS: None

AGE RESTRICTIONS: 18 years of age and older

GENDER: Male and female

CONTINUATION OF THERAPY: NA

CONTRAINDICATIONS/EXCLUSIONS/DISCONTINUATION: Hypersensitivity to itraconazole or any component of the formulation; concurrent administration with avanafil, cisapride, disopyramide, dofetilide, dronedarone, eplerenone, ergot derivatives, felodipine, irinotecan, isavuconazole, ivabradine, lomitapide, lovastatin, lurasidone, methadone, midazolam (oral), naloxegol, nisoldipine, pimozide, quinidine, ranolazine, simvastatin, ticagrelor, or triazolam; concurrent administration with colchicine, fesoterodine, or solifenacin in patients with varying degrees of renal or hepatic impairment; coadministration with eliglustat in patients who are poor or intermediate metabolizers of CYP2D6 and in patients taking strong or moderate CYP2D6 inhibitors; treatment of onychomycosis (or other non-life-threatening indications) in patients with evidence of ventricular dysfunction, such as congestive heart failure (CHF) or a history of CHF; treatment of onychomycosis in women who are pregnant or contemplating pregnancy

OTHER SPECIAL CONSIDERATIONS: None

BACKGROUND: None

APPENDIX: None

REFERENCES:

1. Sporanox capsule [package insert]. Raritan, NJ: Janssen Pharmaceuticals, Inc.; April 2015. 2. AHFS DI (Adult and Pediatric) [database online]. Hudson, OH: Lexi-Comp, Inc.; http://online.lexi.com/lco/action/index/dataset/complete_ashp [available with subscription]. Accessed May 2016. 3. Micromedex Solutions [database online]. Greenwood Village, CO: Truven Health Analytics Inc. Updated periodically. www.micromedexsolutions.com [available with subscription]. Accessed May 2016. 4. American Academy of Dermatology. http://www.aad.org. Accessed May 2016. 5. Gris-Peg [package insert]. Farmingdale, NY: Pedinol Pharmacal Inc.; October 2010. 6. WalshT, Anaissie E, Denning D, et al. Treatment of Aspergillosis: Clinical Practice Guidelines of the Infectious Diseases Society of America. Clinical Infectious Diseases. 2008;46:327–60. 7. Wheat L, Freifeld A, Kleiman M, et al. Clinical Practice Guidelines for the Management of Patients with Histoplasmosis: 2007 Update by the Infectious Diseases Society of America. Clinical Infectious Diseases. 2007;45:807–25. 8. Chapman S, Dismukes W, Proia L, et al. Clinical Practice Guidelines for the Management of Blastomycosis: 2008 Update by the Infectious Diseases Society of America. Clinical Infectious Diseases. 2008;46:1801–12. 9. Perfect J, Dismukes W, Dromer F, et al. Clinical Practice Guidelines for the Management of Cryptococcal Disease: 2010 Update by the Infectious Diseases Society of America. Clinical Infectious Diseases. 2010;50:291–322. 10. Kaplan J, Benson C, Holmes K, et al. Guidelines for Prevention and Treatment of Opportunistic Infections in HIVinfected Adults and Adolescents: Recommendations from CDC, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. MMWR Recomm Rep. 2009;58:1-207.