Market FL & FL FL FHK* MMA LTC Applicable X NA NA Market Applicability/Effective Date GA KS KY LA MD NJ NV X X X X NA X X NY TN TX WA NA NA NA NA Medication Quantity Limit Sovaldi (sofosbuvir) one tablet per day OVERRIDE(S) Prior authorization of benefits APPROVAL DURATION Based on genotype or hepatocellular carcinoma status: Status type (HCV Mono-infected or HCV/HIV-1 Co-infected) Genotype 1 CHC Genotype 1 CHC ineligible for an interferon-based regimen Genotype 2 CHC Genotype 3 CHC Genotype 3 CHC (treatment naïve or nonresponder**) Genotype 4 CHC Genotype 4 CHC (treatment nonresponder**) Genotype 5 or 6 CHC (treatment naïve or prior relapser) Hepatocellular Carcinoma awaiting liver transplant Associated Treatment Regimens Total Approval Duration for Sovaldi Sovaldi + IFN + RBV Sovaldi + Olysio ± RBV (regardless of IFN eligibility) Sovaldi + RBV Sovaldi + Olysio ± RBV Sovaldi + IFN + RBV Sovaldi + RBV Sovaldi + RBV Sovaldi + IFN + RBV 12 weeks 24 weeks 12 weeks 12 weeks^ 24 weeks 12 weeks Sovaldi + IFN + RBV Sovaldi + RBV 12 weeks 24 weeks Sovaldi + IFN + RBV 12 weeks Sovaldi + RBV Up to 48 weeks* ^ In individuals who are treatment non-responders with concurrent cirrhosis, therapy duration with Sovaldi + RBV may be extended up to four additional weeks for a total of 16 weeks (AASLD/IDSA 2014) ** Treatment non-responder refers to partial or no response to previous dual therapy with interferon and ribavirin. * Therapy duration is recommended for up to 48 weeks or until the time of liver transplantation, whichever occurs first. APPROVAL CRITERIA This policy does not apply to health plans or member categories that do not have pharmacy benefits, nor does it apply to Medicare. Note that market specific restrictions or transition-of-care benefit limitations may apply. PEC-ALL-1266-14-Sovladi PAGE 1 of 5 Requests for Sovaldi (sofosbuvir) may be approved if the following criteria are met: I. II. III. IV. Individual is 18 years of age or older; AND Documentation is provided for a diagnosis of chronic hepatitis C (CHC) infection1; AND Individual has compensated liver disease2; AND Individual is using with one of the following antiviral treatment regimens: a. In combination with peg interferon and ribavirin for one of the following: 1. Individuals with hepatitis C virus (HCV) Genotype 1; OR 2. Individual has had a partial or nonresponse to interferon and ribavirin with HCV Genotype 2 (AASLD/IDSA 2014); OR 3. Individual is treatment naïve or has had a partial or nonresponse to interferon and ribavirin with HCV Genotype 3 (AASLD/IDSA 2014); OR 4. Individuals with HCV Genotype 4; OR 5. Individual is treatment naïve or a prior treatment relapser with HCV Genotype 5 or 6 (AASLD/IDSA 2014); OR b. In combination with ribavirin alone for one of the following: 1. Individual is treatment naïve or a prior treatment relapser with HCV Genotype 1 and is ineligible for an interferon-based regimen, as defined by the presence of one of the following: i. Intolerance to interferon (AASLD/IDSA 2014); OR ii. Autoimmune disorders (AASLD/IDSA 2014), including autoimmune hepatitis; OR iii. Child-Pugh score greater than six (Class B or C) before or during interferon treatment; OR iv. Known hypersensitivity to interferon products; OR v. History of depression, or clinical features consistent with depression (AASLD/IDSA 2014); OR vi. Baseline neutrophil count below 1500/µL, baseline platelet count below 90,000/µL or baseline hemoglobin below 10 g/dL (AASLD/IDSA 2014); OR vii. History of preexisting cardiac disease (AASLD/IDSA 2014); OR 2. Individuals with HCV Genotype 2; OR 3. Individuals with HCV Genotype 3; OR 4. Individual has had a partial or nonresponse to interferon and ribavirin with HCV Genotype 4 (AASLD/IDSA 2014); OR 5. Individuals with CHC and concurrent hepatocellular carcinoma meeting Milan criteria3 (awaiting liver transplantation); OR This policy does not apply to health plans or member categories that do not have pharmacy benefits, nor does it apply to Medicare. Note that market specific restrictions or transition-of-care benefit limitations may apply. PEC-ALL-1266-14-Sovladi PAGE 2 of 5 [date] c. In combination with Olysio (simeprevir) with or without ribavirin for the following (AASLD/IDSA 2014): 1. Individual has an advanced fibrosis staging score of greater than or equal to F34,5; AND 2. Individual is treatment naïve with HCV Genotype 1 and ineligible for an interferonbased regimen, as defined in the above criteria; OR 3. Individuals with HCV Genotype 1, regardless of interferon eligibility; AND 4. Individual has had a partial or nonresponse to interferon and ribavirin Sovaldi (sofosbuvir) may not be approved for the following: I. II. Individual has severe renal impairment (CrCl less than 30 mL/min), end stage renal disease, or requires dialysis (AASLD/IDSA 2014); OR Individual has received previous treatment for hepatitis C virus (HCV) with triple therapy, which consists of the following: a. A pegylated interferon; AND b. Ribavirin; AND c. A serine protease inhibitor [such as but not limited to, Incivek (telaprevir), Victrelis (boceprevir), Olysio (simeprevir)]; OR d. A polymerase inhibitor [such as but not limited to, Sovaldi (sofosbuvir)]. Notes: 1 Sovaldi (sofosbuvir) may be used in individuals co-infected with human immunodeficiency virus (HIV)-1. Child-Pugh Score,also known as Child-Turcotte-Pugh (CTP) score: a scoring system for severity of liver disease and likelihood of survival based on the presence of: degenerative disease of the brain (encephalopathy), the escape or accumulation of fluid in the abdominal cavity (ascites), laboratory measures of various substances in the blood (see table below), and the presence of other co-existing diseases. After calculating the CTP score using a table similar to the one below, classify individuals into one of three categories:  Childs A (5-6 points): 10 year survival 80-90%  Childs B (7-9 points): five year survival 60-80%  Childs C (10-15 points): two year survival less than 50% Child Pugh classification Variable One Point Two Points Three Points This policy does not apply to health plans or member categories that do not have pharmacy benefits, nor does it apply to Medicare. Note that market specific restrictions or transition-of-care benefit limitations may apply. PEC-ALL-1266-14-Sovladi PAGE 3 of 5 [date] Encephalopathy Ascites Albumin (mg/dL) None None Greater than 3.5 Prothombin time (International Less than 4 Normalized ratio) prolonged Bilirubin (mg/dL) Primary biliary cirrhosis 1-4 Cirrhosis/primary Primary sclerosing cholangitis All other diseases Less than 2 Moderate Mild 2.8-3.5 Severe Moderate Less than 2.8 4-6 Greater than 6 4-10 Greater 10 1-3 Greater than 3 than 2 Compensated liver disease: Child-Pugh score less than or equal to six (class A) in cirrhotic individuals before or during treatment Decompensated liver disease: Child-Pugh score greater than six (class B or class C) in cirrhotic individuals before or during treatment 3 Milan criteria: A solitary tumor less than or equal to 5 cm or up to three nodules less than or equal to 3 cm each with no extrahepatic manifestations or evidence of vascular invasion of tumor 4 According to the American Association for the Study of Liver Diseases/Infectious Diseases Society of America (AASLD/IDSA 2014), it may be advisable, in many instances, to delay treatment for some individuals with documented early fibrosis stage (F 0-2). In these instances, waiting for future highly effective, pangenotypic, direct-acting antiviral agent combinations in interferon-free regimens may be prudent. 5 Scoring Systems for fibrosis staging (AASLD 2009): Stage (F) 0 1 IASL* Batts-Ludwig Metavir Ishak No fibrosis Mild fibrosis No fibrosis Fibrosis portal expansion No fibrosis Periportal fibrotic expansion No fibrosis Fibrosis expansion of some portal areas with or without short fibrous septa 2 Moderate fibrosis Rare bridges or septae Periportal septae 1 (septum) Fibrous expansion of most portal areas with or without short fibrous septa 3 Severe fibrosis Numerous bridges or septae Porto-central septae Fibrous expansion of most portal areas with occasional portal to portal bridging 4 Cirrhosis Cirrhosis Cirrhosis Fibrous expansion of most portal areas with marked bridging (portal to portal and portal to central) This policy does not apply to health plans or member categories that do not have pharmacy benefits, nor does it apply to Medicare. Note that market specific restrictions or transition-of-care benefit limitations may apply. PEC-ALL-1266-14-Sovladi PAGE 4 of 5 [date] 5 Marked bridging (portal to portal and portal to central) with occasional nodules (incomplete cirrhosis) 6 Cirrhosis *IASL = The International Association for the Study of Liver . This policy does not apply to health plans or member categories that do not have pharmacy benefits, nor does it apply to Medicare. Note that market specific restrictions or transition-of-care benefit limitations may apply. PEC-ALL-1266-14-Sovladi PAGE 5 of 5 [date]