EPCLUSA (sofosbuvir/velpatasvir)

SELF-ADMINISTRATION - ORAL 

Indications for Prior Authorization:
  • Chronic Hepatitis C Virus (HCV) - Indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infections without cirrhosis or with compensated cirrhosis, and with decompensated cirrhosis for use in combination with ribavirin. 

All of the following must be met as a condition for coverage:
 

1. Request for Chronic HCV (without decompensation) – genotype 1, 2, 3, 4, 5, or 6 (12 weeks):

  • Dose does not exceed one tablet/pellet (400 mg of sofosbuvir, 100 mg of velpatasvir) 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)

    • Epclusa (sofosbuvir/velpatasvir) is being used as monotherapy; AND

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

  • For Epclusa ABA (generic Epclusa) only: Contraindication (e.g., safety concerns, not indicated for patient's age/weight), or intolerance to brand Epclusa (sofosbuvir/velpatasvir)
     

2. Request for Chronic HCV – genotype 1, 2, 3, 4, 5, or 6 – decompensated liver disease – Epclusa plus ribavirin (12 weeks):

  • Dose does not exceed one tablet/pellet (400 mg of sofosbuvir, 100 mg of velpatasvir) 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 has decompensated liver disease (i.e., Child-Pugh Class B or C)

    • Epclusa (sofosbuvir/velpatasvir) is used in combination with ribavirin; AND

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

  • For Epclusa ABA (generic Epclusa) only:  Contraindication (e.g., safety concerns, not indicated for patient's age/weight), or intolerance to brand Epclusa (sofosbuvir/velpatasvir)
     

3. Request for Chronic HCV – genotype 1, 2, 3, 4, 5, or 6 – decompensated liver disease, ribavirin intolerant/ineligible OR prior sofosbuvir or NS5A-based treatment failure (24 weeks):

  • Dose does not exceed one tablet/pellet (400 mg of sofosbuvir, 100 mg of velpatasvir) 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 has decompensated liver disease (i.e., Child-Pugh Class B or C); AND

  • One of the following:
    • Patient is ribavirin intolerant or ineligible

    • Both of the following:

      • Prior failure (defined as viral relapse, breakthrough while on therapy, or non-responder therapy) to Sovaldi or NS5A-based therapy

      • Epclusa (sofosbuvir/velpatasvir) is used in combination with ribavirin; AND

  • Patient is not receiving Epclusa in combination with another HCV direct-acting antiviral agent (e.g., inhibitors of the NS3/4A protease, the NS5A protein, or the NS5B polymerase)
  • For Epclusa ABA (generic Epclusa) only:  Contraindication (e.g., safety concerns, not indicated for patient's age/weight), or intolerance to brand Epclusa (sofosbuvir/velpatasvir)
     
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:
  • Resistance testing: NS5A RAS testing is recommended for genotype 3-infected, treatment naïve patients with cirrhosis and treatment-experienced patients (w/o cirrhosis) being considered for 12 weeks of Epclusa

  • Dose does not exceed:

    • Adult and pediatric members with body weight greater than or equal to 30 kg: sofosbuvir/velpatasvir 400 mg/100 mg (1 tablet) per day

    • Pediatric members 3 years of age and older with bodyweight less than 17 kg: sofosbuvir/velpatasvir 150 mg/37.5 mg per day

    • Pediatric members 3 years of age and older with body weight 17 kg to less than 30 kg: sofosbuvir/velpatasvir 200 mg/50 mg per day.

  • 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 drug classes:

    • 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).

    • NS3/4A protease inhibitors include:

      • glecaprevir (component of Mavyret)

      • grazoprevir (component of Zepatier)

      • paritaprevir (component of Viekira Pak)

      • simeprevir (Olysio)

      • voxilaprevir (component of Vosevi)

    • NS5B polymerase inhibitors include:

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

      • dasabuvir (component of Technivie)

  • Warnings and precautions:

    • Risk of Hepatitis B Virus Reactivation: test all patients for evidence of current or prior HBV infection before initiation of HCV treatment.  Monitor HCV/HBV coinfected patients for HBV reactivation and hepatitis flare during HCV treatment and post-treatment follow-up.

    • Bradycardia with amiodarone coadministration: coadministration of amiodarone with Epclusa is not recommended.  In patients without alternative, viable treatment options, cardiac monitoring is recommended

  • Contraindication:

    • If Epclusa is administered with ribavirin, the contraindications to ribavirin also apply to this combination regimen.  Refer to the ribavirin prescribing information for a list of contraindications for ribavirin

  • Drug interactions

    • P-gp inducers and/or moderate to strong CYP inducers (e.g., rifampin, St. John’s wort, carbamazepine): use of Epclusa with P-gp inducers and/or moderate to strong CYP inducers is not recommended

    • Consult the full prescribing information prior to use for potential drug interactions

    • Frequent monitoring of relevant laboratory parameters (INR or blood glucose) and dose adjustments of certain concomitant medications may be necessary

Policy Updates:
  • 02/15/2022 – Updated policy approved by P&T.
  • 08/20/2018 – 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. Epclusa Prescribing Information. Gilead Science, Inc. Foster City, CA. June 2021.
  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