Applicable X X X X X X X Pegylated Interferon Agents for Hepatitis C Override(s) Prior Authorization Quantity Limit Initial for Monotherapy or Combination with Ribavirin based on Genotype, Status, or Co-Infection Status: Additional Based on documented HCV-RNA results at a-d : in Combination with ribavirin and Olysio or Sovaldi: Based on Genotype, status, Cirrhosis status, Transplant status, Peginterferon Eligibility status, or Q80K polymorphism status Medications Pegasys (peg-interferon alfa-2a) PEG Intron (peg-interferon alfa-2b) Quantity Limit 4 vials or 1 kit per 28 days Genotype (GT) and Status GT 1,2,3,4,5,6; treatment-naïve (TN) GT 1, 4, 5, 6; TN GT 2, 3; TN Regimen HCV RNA Results at treatment week 12* Additional 34-38 weeks 34 weeks 48-52 weeks 48 weeks 10 weeks 24 weeks PAGE 1 of 7 04/03/2017 WEB-PEC-0569-17
Applicable X X X X X X X Genotype (GT) and Status GT 1,2,3,4,5,6; dual** treatmentexperienced (TE) GT 1,2,3,4,5,6; HCV-HIV 2 Regimen HCV RNA Results at treatment week 12* Additional 34 weeks 34 weeks *Per label and clinical trials, lack of an early virologic response or detectable HCV RNA at 12-24 weeks is correlated with an unlikely achievement of SVR and discontinuation of therapy should be considered. **Per label, dual treatment-experienced refers to a prior trial of interferon-alfa and ribavirin. 48 weeks 48 weeks NOTES: a Early Virologic Null Responder (EVNR) : Individual has not achieved at least a 2 log 10 drop or loss of HCV RNA from baseline. b Early Virologic Responder (EVR) : Individual has achieved at least a 2 log 10 drop or loss of HCV RNA from baseline. c Detected : Individual has a detectable HCV RNA level. d Undetected : Individual has an undetectable HCV RNA level. e Per FDA-approved labels and AASLD/IDSA 2016 treatment guidance, pegylated interferons may be used in combination with ribavirin ± Sovaldi or Olysio in individuals co-infected with HIV-1. in Combination with ribavirin and Olysio or Sovaldi: Based on Genotype, status, Cirrhosis status or Q80K Polymorphism status Genotype (HCV mono-infected or HCV/HIV-1 co-infected e ) Genotype 1a (treatment-naïve or dual treatment-experienced^, with compensated cirrhosis or without cirrhosis, without Q80K polymorphism) Genotype 1b (treatment-naïve or dual treatment-experienced^, with compensated cirrhosis or without cirrhosis) Regimens Olysio Olysio of PAGE 2 of 7 04/03/2017
Applicable X X X X X X X Genotype (HCV mono-infected or HCV/HIV-1 co-infected e ) Genotype 1 (with compensated cirrhosis or without cirrhosis) Genotype 4 (treatment-naïve or dual treatment-experienced^, with compensated cirrhosis or without cirrhosis) Genotype 4 (treatment-naïve or dual treatment-experienced, with compensated cirrhosis or without cirrhosis) Regimens Sovaldi Olysio Sovaldi of ^Per Olysio label, treatment-experienced includes prior dual therapy (peginterferon and ribavirin) relapsers (HCV RNA not detected at the end of prior based therapy and detected during follow-up), prior partial responders (prior on-treatment 2 log 10 IU/mL reduction in HCV RNA from baseline at Week 12 and HCV RNA detected at end of prior dual therapy) or prior null responders (prior on-treatment < 2 log 10 reduction in HCV RNA from baseline at Week 12 during prior dual therapy). APPROVAL CRITERIA Requests for a pegylated interferon agent (Pegasys, PegIntron) may be approved if the following criteria are met: I. A copy of the baseline quantitative hepatitis C virus (HCV) RNA test result is provided to document baseline level of viremia; AND II. One of the following: A. Documentation is provided for a diagnosis of chronic hepatitis C (CHC) infection, which includes genotype 2 and a positive HCV RNA test result for at least 6 months following positive baseline positive HCV RNA result or reactive HCV antibody test (AASLD/IDSA 2016, CDC 2013); OR B. Individual is unable to delay treatment for 6 months owing to concurrent factors [such as but not limited to, advanced liver disease (Metavir fibrosis stage of F3 or F4 2 ), post-liver transplant recipients, co-infection with human immunodeficiency virus (HIV) or hepatitis B virus (HBV), coexistent liver diseases (such as nonalcoholic steatohepatitis), chronic HCV infection-associated extrahepatic manifestations (such as membranoproliferative glomerulonephritis, glomerular disease, cryoglobulinemia syndrome)] (AASLD/IDSA 2016); AND C. Documentation is provided for a diagnosis of chronic CHC infection, which includes genotype e (AASLD/IDSA 2016), a reactive HCV antibody (CDC 2013), and a subsequent positive HCV RNA result (CDC 2013); AND PAGE 3 of 7 04/03/2017
Applicable X X X X X X X III. Individual does not have a short life expectancy (less than 12 months owing to non-liver related comorbid conditions) that cannot be remediated by treating HCV, by transplantation or other directed therapy (AASLD/IDSA 2016); AND IV. Individual has compensated liver disease 3 (with or without cirrhosis); AND V. Individual is using with one of the following antiviral treatment regimens: A. As monotherapy in treatment-naïve individuals with contraindications or significant intolerance to HCV antiviral agents/regimens and Genotypes 1, 2, 3, 4, 5, or 6; OR B. Individual is using in combination with ribavirin and is treatment-naïve or dual (interferon-alfa and ribavirin) treatment-experienced with Genotypes 1, 2, 3, 4, 5, or 6; OR C. Individual is using in combination with Olysio (simeprevir) and ribavirin for one of the following: 1. Individuals with Genotype 1a or 1b with compensated 3 cirrhosis or without cirrhosis; AND 2. Individual is treatment-naïve or dual (peginterferon and ribavirin) treatment-experienced; AND 3. Individual has been screened and is negative for the NS3Q80K polymorphism associated with HCV Genotype 1a subtype; AND 4. Individual is currently on and completing a course of therapy with the requested regimen; OR 5. Individual has had a prior trial (medication samples/coupons/discount cards are excluded from consideration as a trial) and inadequate response to Harvoni OR Zepatier; OR 6. Individuals with Genotype 4 with compensated 3 cirrhosis or without cirrhosis; AND 7. Individual is treatment-naïve or dual (peginterferon and ribavirin) treatment-experienced; AND 8. Individual is currently on and completing a course of therapy with the requested regimen; OR 9. Individual has had a prior trial (medication samples/coupons/discount cards are excluded from consideration as a trial) and inadequate response to Harvoni OR Zepatier; OR D. Individual is using in combination with Sovaldi (sofosbuvir) and ribavirin for one of the following: 1. Individuals with compensated 3 cirrhosis or without cirrhosis, Genotype 1; OR 2. Individual is treatment-naïve with compensated 1 cirrhosis or without cirrhosis, Genotype 4; AND 3. Individual is currently on and completing a course of therapy with the requested regimen; OR PAGE 4 of 7 04/03/2017
Applicable X X X X X X X 4. Individual has had a prior trial (medication samples/coupons/discount cards are excluded from consideration as a trial) and inadequate response to Harvoni OR Zepatier. Pegylated interferon agents (Pegasys, PegIntron) for hepatitis C may not be approved for the following: I. Individual has a diagnosis of autoimmune hepatitis; OR II. Individual has hepatic decompensation (Child-Pugh Class B or C) prior or during treatment; OR III. Use of Pegasys (peginterferon alfa-2a) in neonates or infants; OR IV. Solid organ transplant recipients; OR V. Individual is using in combination with a regimen containing paritaprevir or Zepatier (elbasvir/grazoprevir); OR VI. Individual is using in combination with Harvoni (ledipasvir/sofosbuvir) or dasabuvir; OR VII. Individual is using in combination with a NS5A inhibitor [such as but not limited to, Harvoni (ledipasvir/sofosbuvir), a regimen containing ombitasvir, Daklinza (daclatasvir), Epclusa (sofosbuvir/velpatasvir), or Zepatier (elbasvir/grazoprevir)]; OR VIII. Individual is requesting for re-treatment as monotherapy or in combination with ribavirin and has received previous treatment for HCV with peginterferon alfa-a or alfa-b and ribavirin; OR IX. Individual is requesting peginterferon for re-treatment as monotherapy, in combination with ribavirin, in combination with Olysio (simeprevir), or in combination with Sovaldi (sofosbuvir) and has received previous treatment for HCV with one of the following: A. A peginterferon-based triple therapy regimen, which includes ribavirin and an oral direct-acting antiviral [Incivek (telaprevir), Victrelis (boceprevir), Olysio (simeprevir), or Sovaldi (sofosbuvir)]; OR B. A therapy regimen containing a NS5A inhibitor [such as but not limited to, Harvoni (ledipasvir/sofosbuvir), Daklinza (daclatasvir), ombitasvir, Epclusa (sofosbuvir/velpatasvir), or Zepatier (elbasvir/grazoprevir)]; OR C. A therapy regimen containing paritaprevir or dasabuvir. NOTES: 1. Pegylated interferons () have black box warnings for risk of serious disorders and ribavirin-associated effects. may cause or aggravate fatal or lifethreatening neuropsychiatric, autoimmune, ischemic, or infectious disorders. Periodic clinical and laboratory monitoring should occur with discontinuation of therapy for persistently severe or worsening signs or symptoms of a serious disorder. Ribavirin may cause birth defects and/or prenatal death. Pregnancy should be avoided in female individuals or female partners of male individuals receiving treatment with and ribavirin. Ribavirin can cause hemolytic anemia and result in worsening of cardiac disease. PAGE 5 of 7 04/03/2017
Applicable X X X X X X X 2. Per FDA-approved labels and AASLD/IDSA 2016 treatment guidance, pegylated interferons may be used in combination with ribavirin ± Sovaldi or Olysio in individuals co-infected with HIV-1. 3. Compensated Liver Disease: According to the American Association for the Study of Liver Diseases (AASLD 2009, 2016), the specific criteria for compensated liver disease include all of the following: a total bilirubin; serum albumin; prothrombin time/inr; presence of ascites; and presence of hepatic encephalopathy. However, these criteria do not establish a comprehensive definition of compensated liver disease. In fact, the AASLD guidance refers to compensated liver disease as Class A based on the Child Pugh-Turcotte (CPT) classification scoring system. Child Pugh Classification (AASLD/IDSA 2016) Parameters Points Assigned 1 point 2 points 3 points Bilirubin (µmol/l) <34 34-50 >50 Serum Albumin (g/l) >35 28-35 <28 Prothrombin time/inr <1.7 1.71-2.30 >2.30 Ascites None Mild Moderate to Severe Hepatic Grade I-II (or suppressed Grade III-IV (or None Encephalopathy with medication) refractory) Child Pugh Score Interpretation (AASLD/IDSA 2009, 2016) Class A 5-6 points Well compensated liver disease Class B 7-9 points Significant functional compromise (moderate hepatic impairment) Class C 10-15 points Uncompensated liver disease (severe hepatic impairment) 4. Metavir Scoring Systems for Fibrosis Staging (AASLD 2009): Stage (F) 0 No fibrosis 1 Periportal fibrotic expansion 2 Periportal septae 1 (septum) 3 Porto-central septae 4 Cirrhosis State name State Specific Mandates Date effective Mandate details (including specific bill if applicable) PAGE 6 of 7 04/03/2017
Applicable X X X X X X X Key References: Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.: 2016. URL: http://www.clinicalpharmacology.com. Updated periodically. DailyMed. Package inserts. U.S. National Library of Medicine, National Institutes of Health website. http://dailymed.nlm.nih.gov/dailymed/about.cfm. DrugPoints System (electronic version). Truven Health Analytics, Greenwood Village, CO. Updated periodically. Lexi-Comp ONLINE with AHFS, Hudson, Ohio: Lexi-Comp, Inc.; 2016; Updated periodically. PAGE 7 of 7 04/03/2017