Daklinza Sovaldi. Daklinza (daclatasvir) and Sovaldi (sofosbuvir) Description

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1 Federal Employee Program 1310 G Street, N.W. Washington, D.C Fax Subject: Daklinza Page: 1 of 8 Last Review Date: March 18, 2016 Daklinza Description Daklinza (daclatasvir) and (sofosbuvir) Background Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with hepatitis C virus (HCV) have no symptoms of the disease until liver damage becomes apparent, which may take several years. Some people with chronic HCV infection develop scarring and poor liver function (cirrhosis) over many years, which can lead to complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections or liver cancer (1). Daclatasvir in combination with sofosbuvir is the first all oral 12-week regimen specifically for the treatment of hepatitis C genotype 3. Clinical trial tested a 12-week, ribavirin-free regimen and resulted in sustained virologic response (SVR12) in 98% of treatment-naïve and 92% of treatment-experienced genotype 3 with non-cirrhotic patients. Approximately 10% of HCV patients in the U.S. have genotype 3 (1). Regulatory Status FDA-approved indications: Daklinza is a hepatitis C virus (HCV) NS5A inhibitor indicated for use with sofosbuvir, with or without ribavirin, for the treatment of chronic HCV genotype 1 or 3 infection (2).

2 Subject: Daklinza Page: 2 of 8 is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor indicated for the treatment of genotype 1, 2, 3, 4 chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen (3). Limitations of Use: Daklinza Sustained virologic response (SVR12) rates are reduced in genotype 3 patients with cirrhosis receiving Daklinza in combination with sofosbuvir for 12 weeks (2). Off-Label Uses: Daclatasvir with sofosbuvir for 12 weeks was approved by the FDA for the treatment of HCV genotype 3 infection in patients without and with cirrhosis. Although daclatasvir with sofosbuvir was not approved for the treatment of HCV genotype 2 infection, daclatasvir maintains adequate activity against HCV genotype 2 despite a 50% effective concentration (EC 50 ) that increases by several logs in the presence of the prevalent M31 polymorphism (4). Daklinza is contraindicated in combination with drugs that strongly induce CYP3A and may lead to lower exposure and loss of efficacy (2). Safety and effectiveness of Daklinza and in pediatric patients younger than 18 years of age have not been established (2, 3). Related policies Harvoni, Olysio,, Viekira Pak, Technivie, Zepatier Policy This policy statement applies to clinical review performed for pre-service (Prior Approval, Precertification, Advanced Benefit Determination, etc.) and/or post-service claims. Daklinza used in combination with may be considered medically necessary in patients 18 years of age or older with chronic Hepatitis C (required documented viral load (HCV RNA) at least 6 months prior to request for treatment) in patients with genotype 1 that have had inadequate response, intolerance, or contraindication to Harvoni therapy; in patients with genotype 2 that have had inadequate response, intolerance, or contraindication to and ribavirin therapy; in patients with genotype 3 that have inadequate response, intolerance, or contraindication to prior therapy with and ribavirin; in patients with genotype 4 with decompensated cirrhosis that have had inadequate response, intolerance, or contraindication to

3 Subject: Daklinza Page: 3 of 8 Harvoni therapy; used in combination with ; must be prescribed by a board-certified gastroenterologist, hepatologist, oncologist, or infectious disease specialist; absence of severe renal impairment (egfr less than 30 ml/min/1.73m 2 ) or end stage renal disease (ESRD) requiring hemodialysis; with no history of alcohol and/or substance abuse in the past 6 months; when combined with ribavirin then absence of significant or unstable cardiac disease, neither the patient nor the partner of the patient is pregnant, and if patient or their partner are of child bearing age, the patient has been or will be instructed to practice effective contraception during therapy and for 6 months after stopping ribavirin therapy. Daklinza used in combination with is considered investigational for patients that are under 18 years of age and for all other indications. Prior-Approval Requirements Age 18 years of age or older Diagnoses Patient must have the following: Chronic Hepatitis C (Required documented viral load (HCV RNA) at least 6 months prior to request for treatment.) AND ONE of the following: 1. Genotype 1: a. Inadequate response, intolerance, or contraindication to Harvoni therapy 2. Genotype 2: a. Inadequate response to prior therapy with and ribavirin 3. Genotype 3: a. Inadequate response to prior therapy with and ribavirin 4. Genotype 4 with decompensated cirrhosis a. Inadequate response to prior therapy with Harvoni therapy AND ALL of the following:

4 Subject: Daklinza Page: 4 of 8 1. Used in combination with 2. Must be prescribed by a board-certified gastroenterologist, hepatologist, oncologist, or infectious disease specialist 3. Absence of severe renal impairment (egfr less than 30 ml/min/1.73m 2 ) or end stage renal disease (ESRD) requiring hemodialysis 4. NO history of alcohol and/or substance abuse in the past 6 months AND ALL of the following if combined with ribavirin (RBV) therapy: 1. Absence of significant or unstable cardiac disease 2. Neither the patient nor the partner of the patient is pregnant 3. If patient or their partner are of child bearing age, the patient has been or will be instructed to practice effective contraception during therapy and for 6 months after stopping ribavirin therapy Prior Approval Renewal Requirements None Policy Guidelines Pre - PA Allowance None Prior - Approval Limits Duration Genotype 1 Treatment-Naïve with compensated cirrhosis or without cirrhosis: Daklinza 30mg 60mg Genotype 1 Treatment-experienced without cirrhosis: Daklinza 30mg 60mg Genotype 1 Treatment-Naïve with decompensated cirrhosis or post-transplant: Daklinza 30mg

5 Subject: Daklinza Page: 5 of 8 60mg 12 weeks Genotype 1 Treatment-experienced with decompensated cirrhosis and RBV intolerant/ineligible: Daklinza 30mg 60mg Genotype 1 Treatment-experienced with cirrhosis: Daklinza 30mg 60mg 24 weeks Genotype 2 Treatment-Naïve: Daklinza 30mg 60mg Genotype 2 Treatment- experienced: Daklinza 30mg 60mg 24 weeks Genotype 3 Treatment-Naïve without cirrhosis: Daklinza 30mg 60mg Genotype 3 Treatment-Naïve with cirrhosis and/or post-transplant : Daklinza 30mg 60mg 12 weeks

6 Subject: Daklinza Page: 6 of 8 Rationale Genotype 3 Treatment-experienced without cirrhosis previously treated with Peg-Interferon and : Daklinza 30mg 60mg Genotype 3 Treatment-experienced with cirrhosis previously treated with Peg- Interferon and : Daklinza 30mg 60mg 24 weeks Genotype 3 Treatment-experienced previously treated with and : Daklinza 30mg 60mg 24 weeks Genotype 4 with decompensated cirrhosis: Daklinza 30mg 60mg 12 weeks Genotype 4 with decompensated cirrhosis and RBV intolerant/ineligible: Daklinza 30mg 60mg Summary Daclatasvir in combination with sofosbuvir; is the first all oral 12-week regimen specifically for the treatment of hepatitis C genotype 3. Clinical trial tested a 12-week, ribavirin-free regimen and resulted in sustained virologic response (SVR12) in 98% of treatment-naïve and 92% of

7 Subject: Daklinza Page: 7 of 8 treatment-experienced genotype 3 with non-cirrhotic patients. Daklinza in combination with sofosbuvir with or without ribavirin can be used in the treatment of hepatitis C genotype1 and 2. Safety and effectiveness of Daklinza and in pediatric patients younger than 18 years of age have not been established (1-4). Prior authorization is required to ensure the safe, clinically appropriate and cost effective use of Daklinza when taken in combination with while maintaining optimal therapeutic outcomes. References 1. FDA News Release. FDA approves new treatment for chronic hepatitis C genotype 3 infections. July 24, Daklinza [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; February [package insert]. Foster City, CA: Gilead Sciences, Inc; August AASLD and IDSA: Recommendations for Testing, Managing, and Treating Hepatitis C; January Policy History Date August 2015 September 2015 December 2015 March 2016 Action New addition to PA Annual Review Annual review and reference update Addition of genotypes 1 and 3 with additional requirements to policy of inadequate response, intolerance, or contraindication to Harvoni for genotype 1 and and ribavirin with genotype 2; and quantity limits for both. Annual review Addition of genotype 4 with decompensated cirrhosis Removal of the requirement of no decompensated liver disease and not had a liver transplant -or- is treatment naïve post-transplant Policy change from Keywords

8 Subject: Daklinza Page: 8 of 8 This policy was approved by the FEP Pharmacy and Medical Policy Committee on March 18, 2016 and is effective on April 1, Deborah M. Smith, MD, MPH