WHA

SOVALDI (sofosbuvir)

SELF-ADMINISTRATION - ORAL 

Indications for Prior Authorization:
  • Chronic Hepatitis C Virus (HCV):
    • ADULT PATIENTS: Indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) infection as a component of a combination antiviral treatment regimen.
      • Genotype 1 or 4 infection without cirrhosis or with compensated cirrhosis for use in combination with pegylated interferon and ribavirin.
      • Genotype 2 or 3 infection without cirrhosis or with compensated cirrhosis for use in combination with ribavirin.
    • PEDIATRIC PATIENTS: Indicated for the treatment of chronic HCV genotype 2 or 3 infection in pediatric patients 3 years of age and older without cirrhosis or with compensated cirrhosis for use in combination with ribavirin.
All of the following must be met as a condition for coverage:

1. Request for chronic HCV, genotype 1 or 4, without decompensation, Sovaldi plus peginterferon plus ribavirin (12 weeks):

  • Dose does not exceed 400 mg once daily; 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 or 4

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

    • Patient does not have decompensated liver disease (i.e., Child-Pugh Class B or C)

    • Used in combination with peginterferon alfa and ribavirin; AND

  • Contraindication (e.g., safety concerns, not indicated for patient's age/weight), or intolerance to BOTH of the following:

    • Brand Epclusa (sofosbuvir/velpatasvir) or brand Harvoni (ledipasvir/sofosbuvir)

    • Mavyret (glecaprevir/pibrentasvir); AND

  • Patient has not experienced failure with a previous treatment regimen that includes Sovaldi

 

2. Request for chronic HCV, genotype 2, without decompensation, Sovaldi plus ribavirin (12 weeks):

  • Dose does not exceed 400 mg once daily; 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 2

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

    • Patient does not have decompensated liver disease (i.e., Child-Pugh Class B or C)

    • Used in combination with ribavirin; AND

  • Contraindication (e.g., safety concerns, not indicated for patient's age/weight), or intolerance to BOTH of the following:

    • Brand Epclusa (sofosbuvir/velpatasvir)

    • Mavyret (glecaprevir/pibrentasvir); AND

  • Patient has not experienced failure with a previous treatment regimen that includes Sovaldi

 

3. Request for chronic HCV, genotype 3, without decompensation, Sovaldi plus ribavirin (24 weeks):

  • Dose does not exceed 400 mg once daily; 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 3

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

    • Patient does not have decompensated liver disease (i.e., Child-Pugh Class B or C)

    • Used in combination with ribavirin; AND

  • Contraindication (e.g., safety concerns, not indicated for patient's age/weight), or intolerance to BOTH of the following:

    • Brand Epclusa (sofosbuvir/velpatasvir)

    • Mavyret (glecaprevir/pibrentasvir); AND

  • Patient has not experienced failure with a previous treatment regimen that includes Sovaldi

 

4. Request for chronic HCV - genotype 1, 2, 3, 4, 5, or 6 - without decompensation, treatment-experienced (prior failure of Vosevi) (16 weeks):

  • Dose does not exceed 400 mg once daily; 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 levels by quantitative assay in the last 6 months

    • Patient does not have decompensated liver disease (i.e., Child-Pugh Class B or C)

    • Contraindication (e.g., safety concerns, not indicated for patient's age/weight), or intolerance to Vosevi (sofosbuvir/velpatasvir/voxilaprevir); AND

  • Used in combination with Mavyret (glecaprevir/pibrentasvir) and ribavirin

 

Coverage Duration:

  • 12 weeks, 16 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

  • Warnings and precautions:

    • Bradycardia with amiodarone coadministration: amiodarone with Sovaldi in combination with another DAA is not recommended

    • Use with other drugs containing sofosbuvir is not recommended

  • Contraindication:

    • When used in combination with peginterferon alfa/ribavirin or ribavirin alone, all contraindications to peginterferon alfa and/or ribavirin also apply to Sovaldi combination therapy

  • Drug interactions

    • Coadministration of amiodarone with Sovaldi in combination with another DAA may result in serious symptomatic bradycardia

    • Drugs that are intestinal P-gp inducers (e.g., rifampin, St. John’s wort) may alter the concentrations of sofosbuvir

    • Consult the full prescribing information prior to and during treatment for potential drug interactions.

 
Policy Updates:

  • 02/15/2022 – Updated policy approved by P&T.

  • 9/12/2018 – 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. Sovaldi Prescribing Information. Gilead Sciences, Inc. Foster City, CA. March 2020.
  3. American Association for the Study of Liver Diseases and the Infectious Diseases Society of America. Recommendations for Testing, Managing, and Treating Hepatitis C. March 2021. http://www.hcvguidelines.org/full-report-view. Accessed May 13, 2021.

                                                        

Last review date: February 15, 2022