Cigna Drug and Biologic Coverage Policy

Transcription

1 Cigna Drug and Biologic Coverage Policy Subject Voriconazole Effective Date... 3/15/2018 Next Review Date... 3/15/2019 Coverage Policy Number Table of Contents Coverage Policy... 1 General Background... 2 Coding/Billing Information... 4 References... 4 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 voriconazole (Vfend ) as medically necessary for ANY of the following indications: Aspergillosis in EITHER of the following conditions: o Prophylaxis post transplantation o Treatment of invasive infection Empiric therapy of presumed fungal infections in a febrile neutropenic individual or as prophylaxis antifungal therapy for an individual at high risk for neutropenia (for example, allogeneic hematopoietic stem cell transplant (HSCT) recipients or those undergoing intensive remission-induction or salvageinduction chemotherapy for acute leukemia) Treatment of EITHER of the following when there is documented failure or contraindication per FDA label, intolerance to, or not a candidate for fluconazole: o Invasive or severe candida infections (for example, abdomen, bladder wall, candidemia, esophageal, kidney, oropharyngeal, skin) o Treatment of meningoencephalitis or pulmonary disease caused by cryptococcosis Treatment of fungal infection caused by Scedosporium apiospermum and Fusarium spp. Treatment of CNS blastomycosis Treatment of coccidioidomycosis AND documented failure or contraindication per FDA label, intolerance to or not a candidate for fluconazole or itraconazole. Treatment of histoplasmosis AND documented failure or contraindication per FDA label, intolerance to, or not a candidate for itraconazole HIV-infected adults and adolescents with EITHER of the following: Page 1 of 5

2 o o Treatment of or chronic suppressive therapy for coccidioidomycosis AND documented failure or contraindication per FDA label, intolerance to, or not a candidate for fluconazole and itraconazole Treatment of mild Penicillium marneffei infection AND documented failure or inadequate response, contraindication per FDA label, intolerance to, or not a candidate for itraconazole Cigna does not cover the use of voriconazole (Vfend) for any other indication because it is considered experimental, investigational or unproven. When coverage is available and medically necessary, the dosage, frequency, duration of therapy, and site of care should be reasonable, clinically appropriate, and supported by evidence-based literature and adjusted based upon severity, alternative available treatments, and previous response to voriconazole (Vfend). Note: Receipt of sample product does not satisfy any criteria requirements for coverage FDA Approved Indications Vfend is indicated for use in patients 12 years of age and older in the treatment of the following fungal infections: Invasive aspergillosis Candidemia in non-neutropenic patients and the following candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall, and wounds Esophageal candidiasis Serious fungal infections caused by Scedosporium apiospermum (asexual form of Pseudallescheria boydii) and Fusarium spp. Including Fusarium solani, in patients intolerant of, or refractory to, other therapy FDA Recommended Dosing Vfend tablets or oral suspension should be taken at least one hour before or after a meal. Vfend IV for injection requires reconstitution to 10 mg/ml and subsequent dilution to 5 mg/ml or less prior to administration as an infusion, at a maximum rate of 3 mg/kg per hour over 1 to 2 hours. Drug Availability Powder for Solution for Injection Vfend IV for injection is supplied in a single use vial equivalent to 200 mg Vfend and 3200 mg sulfobutyl ether beta-cyclodextrin sodium (SBECD). A generic formulation of voriconazole powder for injection is also available. Tablets Vfend is available in 50 mg and 200 mg tablets in bottles of 30. Generic formulations of voriconazole tablets are available. Powder for Oral Suspension Reconstitution of Vfend powder for oral suspension provides a usable volume of 70 ml (40 mg voriconazole/ml). Generic formulations of voriconazole for oral suspension are available. General Background Pharmacology Voriconazole is a broad-spectrum triazole antifungal which inhibits fungal cytochrome P450 mediated 14 alphalanosterol demethylation and disrupts the synthesis of ergosterol, resulting in abnormal fungal cell membrane. Guidelines Infectious Diseases Society of America (IDSA) Aspergillosis Early initiation of antifungal therapy in patients with strongly suspected invasive aspergillosis is warranted while a diagnostic evaluation is conducted. Because of better survival and improved responses of initial therapy with Page 2 of 5

3 voriconazole, primary therapy with deoxycholate amphotericin B (D-AMB) is not recommended. For primary treatment of invasive pulmonary aspergillosis, IV or oral voriconazole is recommended for most patients. Oral therapy can be maximized by using a dose of 4 mg/kg rounded up to convenient tablet sizes. For seriously ill patients, the parenteral formulation is recommended (2016). Blastomycosis While blastomycosis is typically localized in the lungs, some patients will develop extrapulmonary infection (cutaneous, osteoarticular, genitourinary, or CNS disease). Voriconazole is only listed as a treatment option for CNS blastomycosis. The recommendation for CNS blastomycosis is to give amphotericin B as a lipid formulation for 4 6 weeks, followed by an oral azole (either fluconazole 800mg per day; itraconazole 200mg 2 or 3 times per day; or voriconazole mg twice per day) for at least 12 months and until resolution of CSF abnormalities (2008). Candidiasis For esophageal candidiasis, fluconazole is the treatment of choice for esophageal candidiasis. For fluconazolerefractory disease, itraconazole, posaconazole or voriconazole may be administered. Ketoconazole and itraconazole capsules are less effective than fluconazole because of variable absorption. Voriconazole is as effective as fluconazole and has also useful in treating mucosal candidiasis refractory to fluconazole. For oropharyngeal candidiasis, fluconazole is the treatment of choice. For fluconazole refractory disease, itraconazole or posaconazole may be administered. Voriconazole may be considered as third-line therapy when treatment with other agents has failed. For candidemia in the non-neutropenic setting, intravenous voriconazole is effective for candidemia, but offers little advantage over intravenous fluconazole as initial therapy. Voriconazole is recommended as step-down oral therapy for selected cases of candidemia due to Candida krusei. In neutropenic individuals, intravenous voriconazole can be used in situations in which additional mold coverage is desired. Voriconazole can also be used as step-down therapy during neutropenia in clinically stable patients who have had documented bloodstream clearance and isolates that are susceptible to voriconazole (2016). Cryptococcosis Voriconazole is a treatment option for relapsed cryptococcal meningoencephalitis and for pulmonary cryptococcal disease in nonimmunosuppressed individuals. Recommendations for relapsed cryptococcal meningoencephalitis state that after induction therapy and in vitro susceptibility testing, oral salvage therapy with either fluconazole ( mg per day), voriconazole ( mg twice per day), or posaconazole (200mg orally 4 times per day or 400mg twice per day) for weeks can be considered. For pulmonary cryptococcosis in nonimmunosuppressed patients, oral itraconazole (200 mg twice per day), oral voriconazole (200 mg twice per day), and oral posaconazole (400 mg twice per day) are acceptable alternatives if fluconazole is unavailable or contraindicated (2010). Coccidioidomycosis Fluconazole and itraconazole are considered first line therapies, while voriconazole is reserved for treatment failures. More severe disease (for example, severe osseous infections) requires intravenous amphotericin B with subsequent transition to long term azole therapy (2016). Histoplasmosis Voriconazole has been used in a limited number of individuals with various forms of histoplasmosis and is considered a second-line alternative to itraconazole (2007). Neutropenia Antifungal therapy is appropriate in neutropenic patients who have persistent unexplained fever, despite receipt of 4 7 days of broad-spectrum antibacterial therapy. The choice of antifungal agent is based on likely fungal pathogens (e.g., if patient was on antifungal prophylaxis), toxicities, and cost. Amphotericin B has been the standard empirical antifungal agent used for decades with recent trials evaluating potential alternatives. A randomized trial in patients with neutropenia and persistent fever did not demonstrate that voriconazole was non-inferior to liposomal amphotericin B as empiric antifungal therapy. However the authors noted that Page 3 of 5

4 voriconazole was superior to amphotericin B in reducing documented breakthrough fungal infections, infusionrelated toxicity, and nephrotoxicity and was similar in individual elements of the composite score (Walsh 2002). Patients who are a high risk of invasive candidal infection (e.g. allogeneic hematopoietic stem cell transplant recipients or patients receiving intense remission-induction or salvage-induction chemotherapy for acute leukemia) should receive prophylactic treatment. Suitable options include fluconazole, itraconazole, voriconazole, posaconazole, micafungin and caspofungin. (2011) Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America (2013, 2016, 2017) Coccidioidomycosis For HIV-infected adults and adolescents with coccidioidomycosis, voriconazole is an alternative for patients who failed to respond to fluconazole and itraconazole for the treatment of mild infections (such as focal pneumonia). It is also an alternative to fluconazole for the treatment of meningeal infections. Primary prophylaxis in individuals with low CD4 cell counts, living in areas where Coccidioides is prevalent, is not recommended. (2016) Esophageal Candidiasis Voriconazole is an alternative therapy for HIV-infected adults and adolescents with esophageal candidiasis. Fluconazole is the preferred therapy. In pediatric patients, voriconazole is an alternative for fluconazolerefractory esophageal disease. (2017) Histoplasmosis Voriconazole is listed as an alternative therapy for HIV-infected adults and adolescents with less severe disseminated histoplasmosis who are intolerant to the preferred therapy, itraconazole and are only moderately ill. (2013) Coding/Billing Information Note: Vfend 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. Clinical Practice Guidelines for the Management of Blastomycosis: 2008 Update by the Infectious Diseases Society of America. Clinical Infectious Diseases 2008; 46: Clinical Practice Guidelines for the Management of Candidiasis: Update by the Infectious Diseases Society of America (IDSA). Clinical Infectious Diseases 2009; 48: Clinical Practice Guideline for the Management of Candidiasis: 2016 Update by the Infectious Diseases Society of America. Clinical Infectious Diseases 2016; 62(4): e Clinical Practice Guidelines for the Management of Cryptococcal Disease: 2010 Update by the Infectious Diseases Society of America. Clinical Infectious Diseases 2010; 50: Clinical Practice Guideline for the Use of Antimicrobial Agents in Neutropenic Patients with Cancer: 2010 Update by the Infectious Diseases Society of America. Clinical Infectious Diseases 2011; 52 (4):e56 e Clinical Practice Guidelines for the Management of Patients with Histoplasmosis: 2007 Update by the Infectious Diseases Society of America. Clinical Infectious Diseases 2007; 45: Kontoyiannis DP. A clinical perspective for the management of invasive fungal infections: focus on IDSA guidelines. Infectious Diseases Society of America. Pharmacotherapy 2001; 21: 175S-187S. Page 4 of 5

5 8. McEvoy GK, ed. AHFS 2016 Drug Information. Bethesda, MD: American Society of Health-System Pharmacists, Inc; Panel on Opportunistic Infections in HIV-Exposed and HIV-Infected Children. Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Exposed and HIV-Infected Children. Department of Health and Human Services. Available at oi_guidelines_pediatrics.pdf. 10. Panel on Opportunistic Infections in HIV-Infected Adults and Adolescents. Guidelines for the prevention and treatment of opportunistic infections in HIV-infected adults and adolescents: recommendations from the Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. Available at Treatment of Aspergillosis: Clinical Practice Guidelines of the Infectious Diseases Society of America (IDSA) (2008). Clinical Infectious Disease. (2008) 46 (3): Treatment of Aspergillosis: Clinical Practice Guidelines of the Infectious Diseases Society of America (IDSA) (2008). Clinical Infectious Disease. (2016) 63: Vfend (voriconazole) Prescribing Information. Pfizer, Inc., New York, NY: July Walsh TJ, Pappas P, Winston DJ, et al. Voriconazole compared with liposomal amphotericin B for empirical antifungal therapy in patients with neutropenia and persistent fever. N Engl J Med 2002; 346: 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 5 of 5