Prior Authorization Policy

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1 Prior Authorization Policy Ribavirin Rebetol (ribavirin capsule or oral solution) Copegus (ribavirin tablet), Moderiba (ribavirin tablet), Ribasphere (ribavirin tablet), Ribapak (ribavirin tablet), ribavirin (generic capsule and tablet) Pharmacy Benefit Commercial HMO / PPO / CDHP Setting Self-administered: Oral Medical Benefit Approval period Initial approval: 8 weeks Continued approval: up to 48 weeks CPT/HCPCS code J8499, J7699 Available through Paramount s specialty pharmacy network. Description of Medication Ribavirin is a synthetic nucleoside analog (purine analog) with antiviral activity. The mechanism by which the combination of ribavirin and an interferon product exerts its effects against the hepatitis C virus has not been fully established. 1-3, 12 FDA-APPROVED INDICATIONS Rebetol Rebetol is indicated in combination with interferon alfa-2b (pegylated and nonpegylated) for the treatment of Chronic Hepatitis C (CHC) in patients 3 years of age and older with compensated liver disease. Copegus Copegus is indicated in combination with Pegasys for the treatment of adults with CHC virus infection who have compensated liver disease and have not been previously treated with alpha interferon. Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A) and patients with HIV disease that is clinically stable (e.g., antiretroviral therapy not required or receiving stable antiretroviral therapy). Moderiba Moderiba is indicated for the treatment of chronic hepatitis C (CHC) virus infection in combination with peginterferon alfa- 2a in adults with compensated liver disease not previously treated with interferon alpha, and in CHC patients coinfected with HIV. Ribasphere Ribasphere is indicated in combination with peginterferon alfa-2a for the treatment of adults with CHC virus infection who have compensated liver disease and have not been previously treated with alpha interferon. Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A). Web document

2 Recommended authorization criteria For all patients with hepatitis C infection, ribavirin must be prescribed by, or in consultation with, a gastroenterologist, specializing in hepatology, an infectious disease physician, or a transplant physician. CRITERIA FOR APPROVAL 1. Does the patient have any of the following contraindications to ribavirin therapy? Hemoglobin <8.5 g/dl Hemoglobinopathy Poorly controlled or deteriorating cardiac disease Patient or the partner of the patient is pregnant Unwilling to use adequate contraception (self or partner) The patient is currently receiving or will be receiving Videx (didanosine) 2. Does the patient meet one of the following: Has a creatinine clearance (CrCl) 50 ml/min OR Has CrCl <50 ml/min and will use reduced dose of ribavirin and interferon with careful monitoring by a specialist 3. Prior to initiating therapy, did the patient have a diagnosis of chronic hepatitis C virus (HCV) infection as confirmed by detectable viral load in the serum? 4. Does the patient have genotype 2 or 3 infection? [If no, skip to question 6.] 5. Has the patient received 24 weeks of therapy as part of this treatment course? [ further questions.] 6. Is the patient being prescribed ribavirin as part of a three-drug treatment regimen that includes peginterferon alfa (e.g. Pegasys, PegIntron) and Victrelis? [If yes, skip to question 17.] 7. Is the patient being prescribed ribavirin as part of a three-drug regimen that includes peginterferon alfa (e.g. Pegasys, PegIntron) and Incivek? [If yes, skip to question 26.] 8. Is the patient being prescribed ribavirin as part of a two-drug treatment regimen that includes non-pegylated interferon alfa (e.g. Intron)? [If no, skip to question 10.] 9. Has the patient had a documented adverse reaction (ADR) or is the patient at higher risk for an ADR with pegylated interferon alfa (e.g. Pegasys, PegIntron)? [If yes, skip to question 16.] 10. Is the patient being prescribed ribavirin as part of a two-drug treatment regimen that includes pegylated interferon alfa (e.g. Pegasys, PegIntron)? [If no, skip to question 16.] 11. Is the patient Genotype 1 or Genotype 4? 12. Has the patient received 12 weeks of therapy as part of this treatment course? 13. Did the patient have undetectable HCV RNA at week 12 of treatment? [If yes, skip to question 16.] 14. Has the patient received 24 weeks of therapy as part of this treatment course? 15. Did the patient have undetectable HCV RNA after 24 weeks of treatment? 16. Has the patient received 48 weeks of therapy as part of this treatment course? [ further questions.] 17. Does the patient meet all of the following criteria for approval?

3 Has genotype 1 infection HCV RNA will be assessed at weeks 4, 8, 12, and 24 of treatment Has/will receive 4 weeks of PEG-IFN and ribavirin prior to starting Victrelis 18. Has the patient received 12 weeks of PEG-IFN and ribavirin and 8 weeks Victrelis? 19. Did the patient have HCV RNA 100 IU/mL at week 12 of treatment? 20. Has the patient received 24 weeks of PEG-IFN and ribavirin and 20 weeks Victrelis? 21. Did the patient have undetectable HCV RNA at week 24 of treatment? 22. Does the patient meet one of the following? Patient has cirrhosis OR Patient was poorly IFN responsive (<1.0-log 10 HCV-RNA decline in viral load) at week 4 of treatment 23. Is the request for retreatment of chronic HCV infection? [If no, skip to question 25.] 24. With prior therapy, did the patient have <2-log 10 drop in HCV-RNA after 12 weeks of treatment (i.e., null response)? 25. Did the patient have undetectable HCV RNA at week 8 of treatment? [ further questions.] 26. Does the patient meet both of the following? Has genotype 1 infection HCV RNA will be assessed at weeks 4, 12, and 24 of treatment 27. Has the patient received 4 weeks of ribavirin in combination with Incivek and PEG-IFN? 28. Did the patient have HCV RNA >1,000 IU/mL at week 4 of treatment? 29. Has the patient received 12 weeks of ribavirin in combination with Incivek and PEG-IFN? 30. Did the patient have HCV RNA >1,000 IU/mL at week 12 of treatment? 31. Is the patient treatment-naïve or prior relapser to HCV therapy? [If no, skip to question 34.] 32. Does the patient have cirrhosis? [If yes, skip to question 34.] 33. Did the patient have undetectable HCV RNA at weeks 4 and 12 of treatment? 34. Has the patient received 24 weeks of ribavirin in combination with Incivek and peginterferon alfa? 35. Did the patient have undetectable HCV RNA at week 24 of treatment? Special Populations - Retreatment Due to nresponse or Relapse Retreatment is considered for patients who did not achieve SVR with their prior course of therapy. 8 For nonresponders and relapsers to IFN monotherapy, higher SVR can be achieved with retreatment with IFN and ribavirin combination therapy. 8,10 The addition of protease inhibitor to PEG-IFN and ribavirin increases the rates of SVR and shortens the duration of treatment for genotype 1 nonresponders and relapsers. 12

4 Exclusions (Limitations) Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria or under the following circumstances. Criteria will be updated as new published data are available. Oral formulations 13 : Hypersensitivity to ribavirin or any component of the formulation; women who are pregnant or may become pregnant; males whose female partners are pregnant; patients with hemoglobinopathies (eg, thalassemia major, sickle cell anemia); patients with autoimmune hepatitis; concomitant use with didanosine. Ribasphere capsules and Rebetol capsules/solution 13 : Additional contraindications: Patients with a CrCl <50 ml/minute. Oral combination therapy with alfa interferons 13 : Autoimmune hepatitis, hepatic decompensation (Child-Pugh score >6; class B and C) in cirrhotic chronic hepatitis C monoinfected patients prior to treatment, hepatic decompensation (Child-Pugh score 6) in cirrhotic chronic hepatitis C patients coinfected with HIV prior to treatment. Also refer to individual monographs for Interferon Alfa-2b (Intron A), Peginterferon Alfa-2b, and Peginterferon Alfa-2a (Pegasys) for additional contraindication information. Indications lacking evidence to support medical necessity as defined below 14 : 1) The drug is not FDA approved for the indication prescribed; PLUS a. Standard medical reference compendia state that the drug is ineffective or unsafe for the off-label indication requested; OR b. The medical compendia is silent on the topic for the indication requested; AND i. One or more medical articles exist that conclude the drug is unsafe and/or ineffective; OR ii. iii. One or more medical articles concludes that safety and efficacy cannot be determined; OR Less than two articles in medical literature show safety and effectiveness for the indication prescribed *Major medical articles must meet uniform requirements for manuscripts to biomedical journals, be published in major peer-reviewed professional medical journals, be sound in methodology, sound statistically, and free from overt bias. Endorsed: 07/30/14 Approved: 08/12/14 Revised: Reviewed: Criteria adapted from CVS/Caremark Prior Authorization Policy MDC 558-A. Effective 04/2014 REFERENCES 1. Rebetol [package insert]. Kenilworth, NJ: Schering Corporation; October Copegus [package insert]. Nutley, NJ: Roche Laboratories Inc.; August Ribasphere [package insert]. Cranberry Township, PA: Three Rivers Pharmaceuticals, LLC.; February PegIntron [package insert]. Kenilworth, NJ: Schering-Plough Corporation; August Victrelis [package insert]. Whitehouse Station, NJ: Merck & Co., Inc.; February Incivek [package insert]. Cambridge, MA: Vertex Pharmaceuticals Inc.; April Dienstag JL, McHutchinson JG. American Gastroenterological Association Medical Position on the Management of Hepatitis C. Gastroenterology. 2006;130(1): Thompson A, Patel K, Tillman H, et al. Directly acting antivirals for the treatment of patients with hepatitis C infection: a clinical development update addressing key future challenges. J Hepatol. 2009;50(1): Ghany MG, Strader DB, Thomas DL, Seeff LB. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology. 2009;49(4): Ghany MG, Nelson DR, Strader DB, et al. An update on treatment of genotype 1 chronic hepatitis C virus infection: 2011 practice guideline by the American Association for the Study of Liver Diseases. Hepatology. 2011;54(4): Singal AG, Waljee AK, Shiffman M, et al. Meta-analysis: re-treatment of genotype 1 hepatitis C nonresponders and relapsers after failing interferon and ribavirin combination therapy. Aliment Pharmacol Ther. 2010;32: Moderiba [package insert]. rth Chicago, IL: AbbVie, Inc.; vember Lexicomp Online, Pediatric and Neonatal Lexi-Drugs Online, Hudson, Ohio: Lexi-Comp, Inc.; July 21, 2014

5 14. Ohio Revised Code Title [17] XVII Corporations Partnerships; Chapter 1751 Health Insuring Corporation law; Prescription Drugs accessed at on 07/22/14.

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