Medical Policy An independent licensee of the Blue Cross Blue Shield Association

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1 Hepatitis C Second Generation Antivirals (2015) Page 1 of 14 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: See also: Hepatitis C Second Generation Antivirals Through Preferred Oral Agent(s) (2015) (Harvoni [ledipasvir / sofosbuvir] and Viekira Pak [ombitasvir/ paritaprevir/ritonavir + dasabuvir) Hepatitis B / Oncology and Hepatitis C First Generation Agents medical policy Hepatitis C Sovaldi [sofosbuvir] (2015) medical policy Prime Therapeutics will review Prior Authorization requests Prior Authorization Form: Link to Drug List (Formulary): Professional Institutional Original Effective Date: October 1, 2014 Original Effective Date: October 1, 2014 Revision Date(s): October 1, 2014; October 24, 2014; February 24, 2015; September 1, 2015 Revision Date(s): October 1, 2014; October 24, 2014; February 24, 2015; September 1, 2015 Current Effective Date: September 1, 2015 Current Effective Date: September 1, 2015 State and Federal mandates and health plan member contract language, including specific provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. To verify a member's benefits, contact Blue Cross and Blue Shield of Kansas Customer Service. The BCBSKS Medical Policies contained herein are for informational purposes and apply only to members who have health insurance through BCBSKS or who are covered by a self-insured group plan administered by BCBSKS. Medical Policy for FEP members is subject to FEP medical policy which may differ from BCBSKS Medical Policy. The medical policies do not constitute medical advice or medical care. Treating health care providers are independent contractors and are neither employees nor agents of Blue Cross and Blue Shield of Kansas and are solely responsible for diagnosis, treatment and medical advice. If your patient is covered under a different Blue Cross and Blue Shield plan, please refer to the Medical Policies of that plan.

2 Hepatitis C Second Generation Antivirals (2015) Page 2 of 14 DESCRIPTION The intent of the Hepatitis C second generation antiviral Prior Authorization (PA) program is to appropriately select patients for therapy according to the Food and Drug Administration (FDA) approved product labeling and/or clinical guidelines and/or clinical studies. The PA process will evaluate the use of these agents when there is supporting clinical evidence for their use. Patients requesting Harvoni that are treatment naïve, noncirrhotic, are not HIV coinfected and have an initial viral load < 6 M IU/mL will be approved for 8 weeks assuming all other criteria are met. For the use of Sovaldi (sofosbuvir) see the Hepatis C Sovaldi [sofosbuvir] (2015) medical policy. For the use of Olysio in combination with peginterferon and ribavirin, see the Hepatitis B / Oncology and Hepatitis C First Generation Agents medical policy. For hepatocellular carcinoma patients, see the Hepatitis C Sovaldi [sofosbuvir] (2015) medical policy. Target Drugs Preferred Agents Harvoni (ledipasvir / sofosbuvir) Viekira Pak (ombitasvir / paritaprevir / ritonavir + dasabuvir) FDA Approved Indications and Dosage 6-16 Medication Indications Dose and Interval Harvoni (ledipasvir-sofosbuvir) Viekira Pak (paritaprevir / ritonavir / ombitasvir and dasabuvir) Treatment of chronic hepatitis C, genotype 1 infection With or without ribavirin in HCV genotype 1 patients including those with compensated cirrhosis. Limitation: Not recommended for use in patients with decompensated liver disease 1 tablet orally once daily containing 90 mg of ledipasvir and 400 mg of sofosbuvir for up to 24 weeks Two ombitasvir, paritaprevir, ritonavir 12.5/75/50 mg tablets once daily (in the morning) and one dasabuvir 250 mg tablet twice daily (morning and evening) for 12 to 24 weeks.

3 Hepatitis C Second Generation Antivirals (2015) Page 3 of 14 POLICY Prior Authorization Criteria for Approval A. Initial Evaluation - Harvoni or Viekira Pak (ombitasvir / paritaprevir / ritonavir + dasabuvir) will be approved when the following criteria are met: 1. The patient has a diagnosis of chronic hepatitis C, genotype 1 confirmed by serological markers 2. The prescriber has provided a baseline HCV RNA level 3. The agent is being prescribed by a specialist (i.e. gastroenterologist, hepatologist, or infectious disease) or in consultation with a specialist. If able, the prescriber will provide an SVR post treatment week These agents will not be used in combination with other protease inhibitors used to treat chronic hepatitis C (i.e. boceprevir, simeprevir, or telaprevir) 5. The patient does not have any FDA labeled contraindications to therapy with the requested agent Agent(s) Contraindication(s) Harvoni (ledipasvir/sofosbuvir) Viekira Pak (ombitasvir/paritaprevir/ ritonavir + dasabuvir) None Known hypersensitivity to ritonavir, severe hepatic impairment, co-administration with drugs that are highly dependent on CYP3A for clearance, strong inducers of CYP3A and CYP2C8, and strong inhibitors of CYP2C8. When co-administered with RBV: pregnancy, males whose female partners are pregnant, patients with hemoglobinopathies (e.g. thalassemia major or sickle-cell anemia) and in combination with didanosine. 6. The patient does not have hepatocellular carcinoma (see Sovaldi criteria for approval) 7. The patient is not co-infected with chronic hepatitis B 8. ONE of the following: a. The patient has a METAVIR score of 2 b. The patient has a Ishak score 3 c. The patient has a Fibroscan score of 7.65 kpa d. The patient has radiological imaging consistent with fibrosis and/or cirrhosis (e.g. portal hypertension, esophageal varices)

4 Hepatitis C Second Generation Antivirals (2015) Page 4 of 14 e. The patient has type 2 or 3 mixed cryoglobulinemia with end-organ manifestations (e.g. vasculitis) f. The patient has proteinuria, nephrotic syndrome, or membranoproliferative glomerulonephritis g. The patient is currently awaiting liver transplant h. The patient is post-liver transplant i. The patient is co-infected with HIV-1 9. If the request is for Viekira (ombitasvir/paritaprevir/ritonavir + dasabuvir) ALL of the following: a. The agent will be used in a combination antiviral treatment regimen supported by FDA approved labeling (see Table 2 below) b. The patient has not been previously treated with a regimen containing sofosbuvir, simeprevir, telaprevir, or boceprevir c. The patient s subtype has been identified and provided d. The patient does not have decompensated liver disease 10. If the request is for Harvoni, ALL of the following: a. The patient has not been previously treated with Viekira (ombitasvir / paritaprevir / ritonavir + dasabuvir) or Harvoni (ledipasvir / sofosbuvir) b. ONE of the following: i. The patient has NOT failed a previous sofosbuvir containing regimen ii. BOTH of the following: 1. The patient has failed a previous sofosbuvir containing regimen, not including Harvoni (ledipasvir/sofosbuvir) 2. The patient has advanced fibrosis (Metavir F3 or F4) 11. The dose is within the FDA labeled dose (90 mg of ledipasvir / 400 mg of sofosbuvir or 25 mg ombitasvir / 150 mg of paritaprevir / 100 mg ritonavir plus 250 mg twice daily of dasabuvir) Length of Approval: Up to 24 weeks as determined in Tables 1 and 2.

5 Hepatitis C Second Generation Antivirals (2015) Page 5 of 14 Table 1 Harvoni Treatment Duration Recommendations Genotype Patient Population Treatment Duration Treatment naïve without cirrhosis or without HIV infection and initial vial load < 6 M IU/mL 8 weeks* 1 Treatment naïve with or without cirrhosis 12 weeks* Treatment experienced** without cirrhosis 12 weeks Treatment experienced** with cirrhosis 24 weeks *8 weeks may be considered in treatment naïve patients without cirrhosis or without HIV infection, who have pre-treatment HCV RNA < 6 million IU/mL. For this patient population 8 weeks of therapy is required. **Treatment-experienced patients who have failed therapy with either peginterferon + ribavirin or an HCV protease inhibitor + peginterferon + ribavirin. Table 2 Viekira Treatment Duration Recommendations based on labeling Patient Population Treatment Duration Genotype 1a, no cirrhosis Viekira + RBV 12 weeks Genotype 1a, cirrhosis Viekira + RBV 24 weeks** Genotype 1b, no cirrhosis Viekira 12 weeks Genotype 1b, cirrhosis Viekira + RBV 12 weeks **Viekira with RBV for 12 weeks may be considered for some patients based on prior treatment history. The SVR12 rate difference between 24 and 12 weeks of treatment was +6% with differences varying by pretreatment history. ^HCV/HIV-1 coinfection, follow recommendations in table 2 above ^Liver transplant patients with normal hepatic function and mild fibrosis (Metavir 2), recommended duration with RBV is 24 weeks Non-Preferred Agent(s) will be approved when the ONE of the following additional criteria are met: 1. The patient is currently being treated with the non-preferred agent 2. The patient has an FDA labeled contraindication, documented intolerance, or hypersensitivity to the preferred agent(s) 3. The prescriber has submitted documentation in support of the use of the nonpreferred agent(s), for the intended diagnosis. RATIONALE Ledipasvir-sofosbuvir 1,2,3,8 Safety and efficacy of this combination ± ribavirin was evaluated in 3 open label studies which included treatment naïve, previous failures, cirrhotic and non-cirrhotic genotype 1 patients. The ION studies (1, 2, and 3) all had a primary efficacy endpoint of a sustained virologic response (SVR) at 12 weeks after the end of therapy. ION-1 was conducted in previously untreated patients including those with compensated cirrhosis. Up to 20% of patients could be cirrhotic (defined as a Metavir stage of F4). ION-2 was conducted in patients who had not had an SVR after treatment with peginterferon + ribavirin with or without a protease inhibitor. In this study 52% of patients had received a prior treatment regimen with a protease inhibitor. ION-3 was evaluated in treatment naïve patients without cirrhosis. All three of these trials showed efficacy

6 Hepatitis C Second Generation Antivirals (2015) Page 6 of 14 in these patient populations. SVR rates in these trials ranged from 93% to 100%. Guideline recommendations for patients that have failed a sofosbuvir containing regimen recommend that patients with advanced fibrosis receive ledipasvir/sofosbuvir plus ribavirin (see full guideline recommendation below) and patients without advanced fibrosis either enter a clinical trial or defer further therapy until such a time more evidence is available. 8 Ombitasvir/paritaprevir/ritonavir and dasabuvir 13,14,15 Safety and efficacy of this combination was evaluated in 4 pivotal trials including treatment naïve, previous failures, cirrhotics and non-cirrhotic genotype 1 patients. The studies (Sapphire I, Turquoise II, Pearl III and Pearl IV) all had a primary efficacy endpoint of a sustained virologic response (SVR) at 12 weeks after the end of therapy. Sapphire I was conducted in treatment naïve patients without cirrhosis. Turquoise-2 was conducted in treatment naïve and previously treated patients and included cirrhotic patients. Pearl III evaluated treatment naïve genotype 1b patients and Pearl IV evaluated treatment naïve genotype 1a patients. SVR rates in these trials ranged from 90% to 99%. Treatment guidelines recommend that patients that have failed a previous protease inhibitor containing regimen receive ledipasvir/sofosbuvir. Ombitasvir/paritaprevir/ritonavir + dasabuvir is not a recommended regimen in previous protease inhibitor failures due to risk of resistance. 8 The diagram below correlates METAVIR scores with fibrosis stages. METAVIR scores which describe liver damage are determined by liver biopsy. Liver biopsy is an invasive procedure and the current standard in viral hepatitis for staging the degree of injury and not for achieving a diagnosis. 11 Biopsy scoring systems for liver fibrosis including Metavir, Scheuer, Ishak and histological activity index give a number to a pattern of fibrosis. Fibroscan measures liver stiffness in kpa which correlates with increased fibrosis. Diagnosis of significant fibrosis (F>1) and cirrhosis measurements were 7.65 kpa and kpa, respectively. 11 Study data shows that Ishak fibrosis stages of 3 represent clinically progressive liver disease. Data from the HALT-C study showed that patients with Ishak fibrosis stage 2 had no clinical outcomes until nearly 5 years after randomization and closer to 6 years after the baseline biopsy. 12

7 Hepatitis C Second Generation Antivirals (2015) Page 7 of American Association for the Study of Liver Diseases (AASLD, 2015) guidelines recommend the following in treatment naïve patients (see guidelines for alternative regimen recommendations): 7 1. Genotype 1a 3 options with similar efficacy in general are recommended for treatmentnaïve patients with HCV genotype infection (listed alphabetically) Ledipasvir/sofosbuvir* for 12 weeks (Class I, Level A) Ombitasvir/paritaprevir/ritonavir + dasabuvir + RBV for 12 weeks (no cirrhosis) or 24 weeks (cirrhosis) [Class I, Level A] Sofosbuvir+simeprevir ± RBV for 12 weeks (no cirrhosis) or 24 weeks (cirrhosis without Q80K polymorphism) [Class I, Level A] 2. Genotype 1b 3 options with similar efficacy in general are recommended for treatment naïve patients with HCV genotype infection (listed alphabetically) Ledipasvir/sofosbuvir* for 12 weeks (Class I, Level A) Ombitasvir/paritaprevir/ritonavir + dasabuvir for 12 weeks. Addition of weight based RBV in patients with cirrhosis (Class I, Level A) Sofosbuvir+simeprevir ± for 12 weeks (no cirrhosis) or 24 weeks (cirrhosis without Q80K polymorphism) [Class I, Level A] 3. Genotype 2 sofosbuvir in combination with RBV for 12 weeks [Class I, Level A] (extending treatment to 16 weeks in patients with cirrhosis [Class IIb, Level C] 4. Genotype 3 - sofosbuvir in combination with RBV and PEG-IFN for 12 weeks (interferon eligible) [Class I, Level A] or sofosbuvir + RBV for 24 weeks (interferon ineligible) [Class I, Level A]

8 Hepatitis C Second Generation Antivirals (2015) Page 8 of Genotype 4-3 options with similar efficacy in general (listed in alphabetical order) Ledipasvir/sofosbuvir for 12 weeks [Class IIb, Level B] Ombitasvir/paritaprevir/ritonavir + dasabuvir + RBV for 12 weeks [Class I, Level B] Sofosbuvir + RBV for 24 weeks [Class IIa, Level B] 6. Genotype 5 ledipasvir/sofosbuvir for 12 weeks [Class IIa, Level B] 7. Genotype 6 ledipasvir/sofosbuvir for 12 weeks [Class IIa, Level B] *Post hoc analyses in treatment naïve, non-cirrhotic patients of the 2 RBV-free arms in the pivotal trial (ION-3) for ledipasvir/sofosbuvir assessed baseline predictors of relapse and identified lower relapse rates in patients receiving 8 weeks of ledipasvir/sofosbuvir who had baseline HCV RNA levels below 6 million IU/mL. AASLD guidelines recommend the following for previous failures of peg-interferon (PEG-IFN) and ribavirin (RBV): 8 1. Genotype 1a 3 options with similar efficacy in general (in alphabetical order) Ledipasvir/sofosbuvir for 12 weeks (no cirrhosis) [Class I, Level A] Ombitasvir/paritaprevir/ritonavir + dasabuvir + RBV for 12 weeks (no cirrhosis) [Class I, Level A] Sofosbuvir + simeprevir ± RBV for 12 weeks (no cirrhosis) [Class IIa, Level B] 2. Genotype 1b - 3 options with similar efficacy in general (in alphabetical order) Ledipasvir/sofosbuvir for 12 weeks (no cirrhosis) [Class I, Level A] Ombitasvir/paritaprevir/ritonavir + dasabuvir for 12 weeks (no cirrhosis) [Class I, Level A] Sofosbuvir + simeprevir ± RBV for 12 weeks (no cirrhosis) [Class IIa, Level B] 3. Genotype 1a or 1b with compensated cirrhosis Ledipasvir/sofosbuvir for 24 weeks [Class I, Level A] Ledipasvir/sofosbuvir + RBV for 12 weeks [Class I, Level B] Ombitasvir/paritaprevir/ritonavir + dasabuvir + RBV for 24 weeks (genotype 1a) and 12 weeks (genotype 1b) [Class I, Level A] Sofosbuvir + simeprevir ± RBV for 24 weeks (genotype Ia without Q80K polymorphism) [Class IIa, Level B], Sofosbuvir + simeprevir ± RBV for 24 weeks (genotype 1b) [Class IIa, level B] 4. Genotype 2 sofosbuvir + RBV for weeks [Class I, Level A] or sofosbuvir + PEG- IFN + RBV for 12 weeks (interferon eligible) [Class IIa, Level B] 5. Genotype 3 sofosbuvir + RBV + PEG-IFN for 12 weeks (interferon eligible) [Class I, Level A] or sofosbuvir + RBV for 24 weeks (interferon ineligible) [Class I, Level B] 6. Genotype 4 4 options with similar efficacy in general (alphabetical order) Ledipasvir/sofosbuvir for 12 weeks [Class IIa, Level B] Ombitasvir/paritaprevir/ritonavir + dasabuvir + RBV for 12 weeks [Class IIa, Level B] Sofosbuvir + PEG-IFN+ RBV for 12 weeks [Class IIa, Level B] Sofosbuvir + RBV for 24 weeks [Class IIa, Level B] 7. Genotype 5 ledipasvir/sofosbuvir for 12 weeks [Class IIa, Level C] or sofosbuvir + PEG- IFN + RBV for 12 weeks (interferon eligible) [Class IIa, Level C] 8. Genotype 6 ledipasvir/sofosbuvir for 12 weeks [Class IIa, Level C] or sofosbuvir + PEG- IFN + RBV for 12 weeks (interferon eligible) [Class IIa, Level C]

9 Hepatitis C Second Generation Antivirals (2015) Page 9 of 14 AASLD guidelines recommend the following for previous failures of a regimen containing a direct acting antiviral Genotype 1 after failure of sofosbuvir + RBV with or without PEG-IFN Ledipasvir/sofosbuvir + RBV for 12 weeks (no cirrhosis) [Class IIb, Level C] or for 24 weeks (cirrhosis) [Class IIa, Level C] 2. Genotype 1 after failure of an HCV NS3 protease inhibitor + PGN-IFN + either RBV or sofosbuvir (no prior treatment with an NS5A inhibitor (e.g. ledipasvir, ombitasvir)) Ledipasvir/sofosbuvir for 12 weeks (no cirrhosis) [Class I, Level A]* * Addition of RBV is recommended for those with prior failure of sofosbuvir + simeprevir [Class I, Level A] 3. Genotype 1 after failure of an HCV protease inhibitor + PEG-IFN + RBV - 2 options with similar efficacy in general Ledipasvir/sofosbuvir for 24 weeks (cirrhosis) [Class I, Level A]* Ledipasvir/sofosbuvir + RBV for 12 weeks (cirrhosis) [Class IIa Level B]^ * Addition of RBV is recommended for those with prior failure of sofosbuvir + simeprevir [Class I, Level A] ^ This regimen is NOT recommended for those with cirrhosis and prior failure of sofosbuvir + simeprevir [Class IIa, Level B] 4. Genotype 1 after failure of any HCV NS5A inhibitor (including ledipasvir/sofosbuvir or Ombitasvir/paritaprevir/ritonavir + dasabuvir + RBV) Deferral of treatment is recommended for patients with minimal liver disease [Class IIb, Level C] 5. Genotype 3 after failure of sofosbuvir + RBV Sofosbuvir + RBV + PEG-IFN for 12 weeks [Class IIa, Level C] AASLD guidelines recommend the following for special populations: 9 1. HIV/HCV coinfected patients should be treated and retreated the same as persons without HIV infection, after recognizing and managing drug interactions. The shortened treatment course with ledipasvir/sofosbuvir (i.e. 8 weeks) is not recommended for HIV/HCV co-infected patients. 2. Decompensated cirrhosis patients (including those with hepatocellular carcinoma, irrespective of candidacy for liver transplant), genotype 1 or 4 ledipasvir/sofosbuvir + RBV for 12 weeks (for RBV intolerance or anemia, recommend ledipasvir/sofosbuvir for 24 weeks) [Class IIb, Level C] 3. Decompensated cirrhosis, genotype 1 or 4 prior sofosbuvir failure, ledipasvir/sofsobuvir + RBV for 24 weeks (alternative regimen) [Class IIb, Level C] 4. Decompensated cirrhosis, genotype 2 or 3 (who may or may not be candidates for liver transplantation including those with hepatocellular carcinoma) Sofosbuvir + RBV for up to 48 weeks [Class IIb level B] 5. Post liver transplant, genotype 1 or 4 (irrespective of prior therapy, including compensated cirrhosis) ledipasvir/sofosbuvir + RBV for 12 weeks [Class I, Level B] 6. Post liver transplant genotypes 2 (irrespective of prior therapy, including compensated cirrhosis) sofsobuvir + RBV for 24 weeks [Class IIb, Level C] 7. Post liver transplant genotype 3 (irrespective of prior therapy, including compensated cirrhosis) sofosbuvir + RBV for 24 weeks [Class I, Level B] 8. Post liver transplant, genotypes 1 or 4 (irrespective of prior therapy, including decompensated cirrhosis) ledipasvir/sofosbuvir + RBV for 12 weeks [Class I, Level B]

10 Hepatitis C Second Generation Antivirals (2015) Page 10 of Post liver transplant, genotype 2 (irrespective of prior therapy, including decompensated cirrhosis) sofosbuvir + RBV for 24 weeks [Class IIb, Level C] 10. Post liver transplant, genotype 3 (irrespective of prior therapy, including decompensated cirrhosis) sofosbuvir + RBV for 24 weeks [Class I, Level B] AASLD guidelines on when and in whom to treat: 4 The goal of therapy is to reduce all-cause mortality and liver-related health adverse consequences, including end-stage liver disease and hepatocellular carcinoma, by the achievement of virologic cure as evidenced by an SVR. Evaluation of the degree of hepatic fibrosis using noninvasive testing or liver biopsy is recommended prior to starting treatment. Treatment is assigned the highest priority for those patients with advanced fibrosis (Metavir F3), those with compensated cirrhosis (Metavir F4), liver transplant recipients, and patients with severe extrahepatic hepatitis C. Based on available resources, treatment should be prioritized as necessary so that patients at high risk for liverrelated complications and severe extrahepatic hepatitis C complications are given high priority. Highest Priority for Treatment Owing to Highest Risk for Severe Complications o Advanced fibrosis (Metavir F3) or compensated cirrhosis (Metavir F4) Rating: Class I, Level A o Organ Transplant Rating: Class I, Level B o Type 2 or 3 essential mixed cryoglobulinemia with end-organ manifestations (eg. Vasculitis) Rating: Class I, Level B o Proteinuria, nephritic syndrome, or membranoproliferative glomerulonephritis Rating: Class IIa, Level B High Priority For Treatment Owing to High Risk for Complications o Fibrosis (Metavir F2) Rating: Class I, Level B o HIV-1 Co-infection Rating: Class I, Level B o HBV Co-infection Rating: Class IIa, Level C o Other coexistent liver disease (e.g., NASH) Rating: Class IIa, Level C o Debilitating fatigue Rating: Class IIa, Level B o Type 2 diabetes mellitus (insulin resistant) Rating: Class IIa, Level B o Porphyria cutanea tarda Rating: Class IIb, Level C

11 Hepatitis C Second Generation Antivirals (2015) Page 11 of 14 High HCV Transmission Risk rating on all is: Class IIa, Level C o Men who have sex with men (MSM) with high-risk sexual practices o Active injection drug users o Incarcerated persons o Persons on long-term hemodialysis o HCV infected women of child bearing potential wishing to get pregnant o HCV infected health care workers who perform exposure prone procedures AASLD guidelines on management of acute hepatitis C infection. 18 Hepatitis C infection is considered acute during the 6 month period following exposure. Patients diagnosed with acute HCV infection should be monitored regularly to determine if the infection has cleared or progressed into chronic HCV infection. If a decision is made to treat, AASLD guidelines recommend the same regimens recommended for treatment of chronic HCV. Treatment with antiviral therapy is not recommended for pre-exposure or post-exposure prophylaxis or for those in whom the acute infection clears spontaneously. Evidence ratings refer to the strength and level of evidence with regard to benefits of treatment in these patient populations. Evidence ratings of Class 1, Level A and B are supported by this criteria until such time evidence based treatment guidelines are updated to reflect appropriate use of these agents. REVISIONS Policy added to the bcbsks.com web site on October 2, Policy was effective on October 1, Policy published to the bcbsks.com web site on November 4, Policy was effective on October 24, 2014 In Title: Added Harvoni to read "(Harvoni [ledipasvir/sofosbuvir] " In Description section: Added Harvoni to Target Drugs Updated FDA Approved Indications and Dosage chart. In Policy section: In Item A added "Harvoni" to read " "Harvoni (ledipasvir/sofosbuvir and paritaprevir/ritonavir/ombitasvir + dasabuvir will be approved when the following criteria are met:" In Item A Length of Approval revised "6" to "24" and added "as determined in Table 1" to read, "Up to 214 weeks as determined in Table 1" In Item A added "Table 1 Harvoi Treatment Duration Recommendations" In Item B Length of approval added "for Sovaldi containing regimens" to read, "As determined in Table 3 below for Sovaldi containing regimens based on regimen and genotype" Coding section removed as codes are not used for pharmacy benefit. References updated Title changed to "Hepatitis C Second Generation Antivirals Through Preferred Oral Agent(s) (2015) (Harvoni [ledipasvir / sofosbuvir], and Viekira Pak [ombitasvir / paritaprevir / ritonavir + dasabuvir)" from " Hepatitis C Second Generation Antivirals Through Preferred Pegylated Interferon (2014) (Harvoni [ledipasvir/sofosbuvir], paritaprevir/ritonavir/ombitasvir + dasabuvir, and Sovaldi [sofosbuvir])" Related policy titles added under title.

12 Hepatitis C Second Generation Antivirals (2015) Page 12 of 14 Description section updated In Policy section: In Item A added "Initial Evaluation" and "or Viekira Pak" and removed "(ledipasvir/sofosbuvir and paritaprevir/ritonavir/ombitasvir + dasabuvir)" to read "Initial Evaluation - Harvoni or Viekira Pak will be approved when the following criteria are met:" In Item A 1 added "markers pretreatment HCV RNA level must be provided" and removed "(irrespective of subtype)" to read "The patient has a diagnosis of chronic hepatitis C, genotype 1 confirmed by serological markers pretreatment HCV RNA level must be provided " Removed old Item 2 "The patient has not been previously treated for chronic hepatitis C with another regimen containing any of the agents referenced above (individually or as part of any combination therapy)" In new Item 2 added "If able, the prescriber will provide an SVR post treatment week 12." In Item 4 added a Contraindications chart. Added Item 8 "If the request is for Viekira (ombitasvir/paritaprevir/ritonavir + dasabuvir) ALL of the following: a. The patient has not been previously treated with a regimen containing sofosbuvir, simeprevir, telaprevir, or boceprevir b. The patient s subtype has been identified and provided c. The patient does not have decompensated liver disease Added Item 9 If the request is for Harvoni, the following: a. The patient has not been previously treated with Viekira (ombitasvir/paritaprevir/ritonavir + dasabuvir) b. ONE of: i. The patient has NOT failed a previous sofosbuvir containing regimen ii. BOTH of the following: 1. The patient has failed a previous sofosbuvir containing regimen 2. The patient has advanced fibrosis (Metavir F3 or F4) In Item 10 move "25 mg ombitasavir" to another location within the statement. Updated Table 1 to indicated "Treatment naïve without cirrhosis and initial viral load < 6 M IU/mL" is "8 weeks" Added Table 2 reflecting "Viekira Treatment Duration Recommendations based on labeling" and "Length of Approval" Removed all criteria and Length of Approval for "Initial Evaluation Sovaldi (sofosbuvir ± Pegylated Interferon ± Olysio" "1. The patient is naïve to therapy with Sovaldi 2. The agent is being prescribed by a specialist or in consultation with a specialist (i.e. Gastroenterologist, Hepatologist, Infectious Disease) 3. The patient has a diagnosis of chronic hepatitis C infection confirmed by serological markers 4. Sofosbuvir will be used in a combination antiviral treatment regimen supported by FDA approved labeling or the AASLD guidelines (listed in Rationale below) a. If genotype 1, treatment naïve requesting the combination of simeprevir and sofosbuvir, the patient has BOTH of the following: i. a METAVIR score of 3 or 4 ii. Ineligible to receive peginterferon 5. The patient does NOT have any FDA labeled contraindications to sofosbuvir or the other agents used in the combination therapy 6. The patient will NOT be receiving Incivek (telaprevir) or Victrelis (boceprevir) concomitantly with sofosbuvir

13 Hepatitis C Second Generation Antivirals (2015) Page 13 of The patient is not coinfected with chronic hepatitis B 8. If the patient has hepatocellular carcinoma the following are met: a. The patient has either a single tumor 5 cm or less in diameter The patient has up to 3 tumors with each being 3 cm or less in diameter b. The patient has NO extrahepatic manifestations of cancer or evidence of vascular invasion of tumor 9. The dosing of sofosbuvir is within the FDA labeled dosage ( 400 mg daily) 10. If the treatment regimen includes simeprevir, the dosing of simeprevir is within the FDA labeled dosage (150 mg daily)" "Length of approval: As determined below in Table 3 for Sovaldi containing regimens based on regimen and genotype" Removed all criteria and Length of Approval for "Nonpreferred Agent(s) peginterferon (TRIPLE THERAPY)" "Nonpreferred Agent(s) peginterferon (TRIPLE THERAPY) will be approved when the criteria for the preferred peginterferon listed above are met ONE of the following additional criteria are is met: 1. The patient is currently being treated with the non-preferred agent 2. The patient has a history of a trial of the preferred peginterferon 3. The patient has an FDA labeled contraindication, documented intolerance, or hypersensitivity to the preferred agent(s) peginterferon 4. The prescriber has submitted documentation in support of the use of the nonpreferred agent(s) peginterferon, for the intended diagnosis" "Length of approval: Up to 48 weeks based on regimen" Removed related tables of "AASLD Supported Sovaldi Containing Antiviral Regimens", "IFN ineligible definitions", and "Approval Durations" Rationale section updated to include updates to 2014 AASLD guidelines. Reference updated Policy added to the bcbsks.com web site on and effective Description section updated In Policy section: In Item A added Viekira Pak genetic drug names "(ombitasvir / paritaprevir / ritonavir + dasabuvir)" In Item A 1 removed "-pretreatment HCV RNA level must be provided" to read, "The patient has a diagnosis of chronic hepatitis C, genotype 1 confirmed by serological markers" and made this a stand-alone Item A 2 "The prescriber has provided a baseline HCv RNA level" In Item A 8 d added "esophageal varices" to read "(e.g. portal hypertension, esophageal varices)" In Item 9 added "The agent will be used in a combination antiviral treatment regimen supported by FDA approved labeling (see Table 2 below) " In Item 10 added "ALL of" to read "If the request is for Harvoni, ALL of the following:" In Item 10 a added "or Harvoni (ledipasvir / sofosbuvir)" to read "The patient has not been previously treated with Viekira (ombitasvir / paritaprevir / ritonavir + dasabuvir) or Harvoni (ledipasvir / sofosbuvir)" In Item 10 b ii a added "not including Harvoni (ledipasvir / sofosbuvir" to read, "The patient has failed a previous sofosbuvir containing regimen, not including Harvoni (ledipasvir/sofosbuvir)" Updated the Harvoni Treatment Duration Recommendations table. Added: "Non-Preferred Agent(s) will be approved when the ONE of the following additional criteria are met: 1. The patient is currently being treated with the non-preferred agent 2. The patient has an FDA labeled contraindication, documented intolerance, or

14 Hepatitis C Second Generation Antivirals (2015) Page 14 of 14 hypersensitivity to the preferred agent(s) 3. The prescriber has submitted documentation in support of the use of the nonpreferred agent(s), for the intended diagnosis." Rationale section updated References updated REFERENCES 1. Afdal N, Zeuzem S, Kwo P et al. Ledipasvir and Sofosbuvir for Untreated HCV Genotype 1 Infection. New England Journal of Medicine 2014;370: Afdal N, Reddy KR, Nelson DR et al. Ledipasvir and Sofosbuvir for Previously Treated HCV Genotype 1 Infection. New England Journal of Medicine 2014;370: Kowdley K, Gordon S, Reddy KR et al. Ledipasvir and Sofosbuvir for 8 or 12 Weeks for Chronic HCV without Cirrhosis. New England Journal of Medicine 2014;370: AASLD Treatment Guidelines. When and In Whom to Initiate HCV Therapy. Available at: Accessed 7/2/ (paritaprevir/ritonavir/ombitasvir and dasabuvir) prescribing information. Abbvie. 6. Harvoni (ledipasvir-sofosbuvir prescribing information. Available at: Accessed 7/2/ AASLD Treatment Guidelines. Available at Accessed 7/2/ AASLD Treatment Guidelines. Available at: Accessed 7/2/ AASLD Treatment Guidelines. Available at: Accessed 7/2/ Photo - epgonline.org. Hepatology. Accessed: February Scott DR, Levy MT. Liver transient elastography (Fibroscan ): a place in the management algorithms of chronic viral hepatitis. Antiviral Therapy 2010;15:1-11 (doi: /IMP1474). 12. Everhart JE, Wright EC, Goodman ZD et al. Prognostic Value of Ishak Fribrosis Stage: Findings from the HALT-C Trial. Hepatology 2010 February:51(2): doi: /hep Feld JJ, Kowdley KV, Coakley E, et al. Treatment of HCV with ABT-450/r-Ombitasvir and Dasabuvir with Ribavirin. N Engl J Med 2014;370: Poordad F, Hezode C, Trinh R, et al. ABT-450/r-Ombitasvir and Dasabuvir with Ribavirin for Hepatitis C with Cirrhosis. N Engl J Med 2014;370: Ferenci P, Bernstein D, Lalezari J et al. ABT-450/r-Ombitasvir and Dasabuvir with or without Ribavirin for HCV. N Engl J Med 2014;370: Viekira Pak prescribing information. Abbvie, Inc. North Chicago, IL. March Osinusi A, Marti M, Kohli A et al. Sofosbuvir/ledipasvir in retreatment of HCV genotype-1 patients who previously failed sofosbuvir/ribavirin therapy. [Abstract 011.] 49th Annual Meeting of the European Association for the Study of the Liver (EASL). April 9-13, 2014a; London, United Kingdom 18. AASLD Treatment Guidelines, Management of Acute Hepatitis C Infection. Available at: Accessed 7/2/2015.

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