WHA

VOSEVI (sofosbuvir/velpatasvir/voxilaprevir)

SELF-ADMINISTRATION - ORAL

Diagnosis considered for coverage:
  • Chronic Hepatitis C Virus (HCV) - Indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have:
    • Genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor.
    • Genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor. (Additional benefit of Vosevi over Epclusa [sofosbuvir/velpatasvir] was not shown in adults with genotype 1b, 2, 4, 5, or 6 infection previously treated with sofosbuvir without an NS5A inhibitor.)
Coverage Criteria:

1. Request for chronic HCV; genotype 1, 2, 3, 4, 5, or 6; treatment-experienced to NS5A-based regimen; without decompensated cirrhosis (12 weeks):

  • Dose does not exceed one tablet (400 mg of sofosbuvir, 100 mg of velpatasvir, and 100 mg of voxilaprevir) taken orally once daily for 12 weeks; AND

  • Prescribed by or in consultation with a hepatologist, gastroenterologist, or infectious disease (ID) specialist; AND

  • Medical records (e.g., chart notes, laboratory values) document all of the following:

    • HCV genotype 1, 2, 3, 4, 5, or 6

    • Detectable serum HCV RNA level by quantitative assay in the last 6 months

    • Patient does not have decompensated cirrhosis (i.e., does not have Child-Pugh class B or class C)

    • Patient is treatment-experienced with an NS5A-based regimen (see additional information for examples); AND

  • Patient is not receiving Vosevi in combination with another HCV direct-acting antiviral agent (e.g., inhibitors of the NS3/4A protease, the NS5A protein, or the NS5B polymerase)

 

2. Request for chronic HCV; genotype 1a or 3; treatment-experienced to sofosbuvir-based regimen without an NS5A-inhibitor; without decompensated cirrhosis (12 weeks):

  • Dose does not exceed one tablet (400 mg of sofosbuvir, 100 mg of velpatasvir, and 100 mg of voxilaprevir) taken orally once daily for 12 weeks; AND

  • Prescribed by or in consultation with a hepatologist, gastroenterologist, or infectious disease (ID) specialist; AND

  • Medical records (e.g., chart notes, laboratory values) document all of the following:

    • HCV genotype 1a or 3

    • Detectable serum HCV RNA level by quantitative assay in the last 6 months

    • Patient does not have decompensated cirrhosis (i.e., does not have Child-Pugh class B or class C);

    • Patient is treatment-experienced with an NS5A-based regimen (see additional information for examples); AND

  • Patient is not receiving Vosevi in combination with another HCV direct-acting antiviral agent (e.g., inhibitors of the NS3/4A protease, the NS5A protein, or the NS5B polymerase).

 

3. Request for chronic HCV; genotype 1, 2, 3, 4, 5, or 6; treatment-experienced to Vosevi; without decompensated cirrhosis (24 weeks):

  • Dose does not exceed one tablet (400 mg of sofosbuvir, 100 mg of velpatasvir, and 100 mg of voxilaprevir) taken orally once daily for 12 weeks; AND

  • Prescribed by or in consultation with a hepatologist, gastroenterologist, or infectious disease (ID) specialist; AND

  • Medical records (e.g., chart notes, laboratory values) document all of the following:

    • HCV genotype 1, 2, 3, 4, 5, or 6

    • Detectable serum HCV RNA level by quantitative assay in the last 6 months

    • Patient does not have decompensated cirrhosis (i.e., does not have Child-Pugh class B or class C);

    • Patient failed treatment with Vosevi (sofosbuvir/velpatasvir/voxilaprevir);

    • Used in combination with ribavirin; AND

  • Patient is not receiving Vosevi in combination with another HCV direct-acting antiviral agent (e.g., inhibitors of the NS3/4A protease, the NS5A protein, or the NS5B polymerase).

 

Coverage Duration:

  • 12 weeks or 24 weeks as determined to be medically necessary (see above).

Authorization is not covered for the following:

  • The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

  • Child-Pugh (CP) score calculation = sum of points from 5 categories:

    • Encephalopathy: None = 1 point; Grade 1 and 2 = 2 points; Grade 3 and 4 = 3 points

    • Ascites:  None = 1 point; slight = 2 points; moderate = 3 points

    • Bilirubin: under 2 mg/ml = 1 point; 2 to 3 mg/ml = 2 points; over 3 mg/ml = 3 points

    • Albumin: greater than 3.5mg/ml = 1 point; 2.8 to 3.5mg/ml = 2 points; less than 2.8mg/ml = 3 points

    • Prothrombin Time* (sec prolonged): less than 4 sec = 1 point; 4 to 6 sec = 2 points; over 6 sec = 3 points

  • Severity of cirrhosis classification using Child-Pugh (CP) calculation:

    • Child-Pugh A: 5 to 6 points - good hepatic function

    • Child-Pugh B: 7 to 9 points - moderately impaired hepatic function

    • Child-Pugh C: 10 to 15 points - advanced hepatic dysfunction

  • Examples of NS5A protein inhibitors include:

    • daclatasvir (Daklinza)

    • elbasvir (component of Zepatier)

    • ledipasvir (component of Harvoni)

    • ombitasvir (component of Viekira Pak)

    • pibrentasvir (component of Mavyret)

    • velpatasvir (component of Epclusa, component of Vosevi).

  • Examples of NS3/4A protease inhibitors include:

    • glecaprevir (component of Mavyret)

    • grazoprevir (component of Zepatier)

    • paritaprevir (component of Viekira Pak)

    • simeprevir (Olysio)

    • voxilaprevir (component of Vosevi)

  • Examples of NS5B polymerase inhibitors include:

    • sofosbuvir (Sovaldi, component of Harvoni, component of Epclusa, component of Vosevi)

    • dasabuvir (component of Technivie)

 

Policy Updates:
  • 02/15/2022 – Updated policy approved by P&T.
  • 09/04/2018 - Last reviewed 
References:
  1. Tsoris A, Marlar CA. Use of the Child Pugh Score in Liver Disease. [Updated 2021 Mar 22]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2021 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK542308/
  2. Vosevi Prescribing Information. Gilead Sciences, Inc. Foster City, CA. November 2019.
  3. American Association for the Study of Liver Diseases and the Infectious Diseases Society of America. Recommendations for Testing, Managing, and Treating Hepatitis C. September 2021. http://www.hcvguidelines.org/full-report-view. Accessed January 02, 2022.

 

Last review date: February 15, 2022