EPCLUSA (sofosbuvir/velpatasvir)
SELF-ADMINISTRATION - ORAL
Indications for Prior Authorization:
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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):
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Dose does not exceed one tablet/pellet (400 mg of sofosbuvir, 100 mg of velpatasvir) once daily; AND
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Prescribed by or in consultation with a hepatologist, gastroenterologist, or infectious disease (ID) specialist; AND
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Medical records (e.g., chart notes, laboratory values) document ALL of the following:
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- HCV genotype 1, 2, 3, 4, 5, or 6
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Detectable serum HCV RNA levels by quantitative assay in the last 6 months
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Patient does not have decompensated liver disease (i.e., Child-Pugh Class B or C)
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Epclusa (sofosbuvir/velpatasvir) is being used as monotherapy; AND
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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):
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Dose does not exceed one tablet/pellet (400 mg of sofosbuvir, 100 mg of velpatasvir) once daily; AND
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Prescribed by or in consultation with a hepatologist, gastroenterologist, or infectious disease (ID) specialist; AND
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Medical records (e.g., chart notes, laboratory values) document ALL of the following:
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HCV genotype 1, 2, 3, 4, 5, or 6
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Detectable serum HCV RNA levels by quantitative assay in the last 6 months
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Patient has decompensated liver disease (i.e., Child-Pugh Class B or C)
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Epclusa (sofosbuvir/velpatasvir) is used in combination with ribavirin; AND
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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)
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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):
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Dose does not exceed one tablet/pellet (400 mg of sofosbuvir, 100 mg of velpatasvir) once daily; AND
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Prescribed by or in consultation with a hepatologist, gastroenterologist, or infectious disease (ID) specialist; AND
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Medical records (e.g., chart notes, laboratory values) document ALL of the following:
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HCV genotype 1 ,2 ,3, 4, 5 or 6
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Detectable serum HCV RNA levels by quantitative assay in the last 6 months
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Patient has decompensated liver disease (i.e., Child-Pugh Class B or C); AND
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- One of the following:
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Patient is ribavirin intolerant or ineligible
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Both of the following:
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Prior failure (defined as viral relapse, breakthrough while on therapy, or non-responder therapy) to Sovaldi or NS5A-based therapy
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Epclusa (sofosbuvir/velpatasvir) is used in combination with ribavirin; AND
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- 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:
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12 weeks or 24 weeks as determined to be medically necessary (see above).
Authorization is not covered for the following:
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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:
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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
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Dose does not exceed:
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Adult and pediatric members with body weight greater than or equal to 30 kg: sofosbuvir/velpatasvir 400 mg/100 mg (1 tablet) per day
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Pediatric members 3 years of age and older with bodyweight less than 17 kg: sofosbuvir/velpatasvir 150 mg/37.5 mg per day
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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.
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Child-Pugh (CP) score calculation = sum of points from 5 categories:
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Encephalopathy: None = 1 point; Grade 1 and 2 = 2 points; Grade 3 and 4 = 3 points
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Ascites: None = 1 point; slight = 2 points; moderate = 3 points
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Bilirubin: under 2 mg/ml = 1 point; 2 to 3 mg/ml = 2 points; over 3 mg/ml = 3 points
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Albumin: greater than 3.5mg/ml = 1 point; 2.8 to 3.5mg/ml = 2 points; less than 2.8mg/ml = 3 points
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Prothrombin Time* (sec prolonged): less than 4 sec = 1 point; 4 to 6 sec = 2 points; over 6 sec = 3 points
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Severity of cirrhosis classification using Child-Pugh (CP) calculation:
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Child-Pugh A: 5 to 6 points - good hepatic function
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Child-Pugh B: 7 to 9 points - moderately impaired hepatic function
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Child-Pugh C: 10 to 15 points - advanced hepatic dysfunction
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Examples of drug classes:
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NS5A protein inhibitors include:
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daclatasvir (Daklinza)
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elbasvir (component of Zepatier)
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ledipasvir (component of Harvoni)
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ombitasvir (component of Viekira Pak)
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pibrentasvir (component of Mavyret)
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velpatasvir (component of Epclusa, component of Vosevi).
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NS3/4A protease inhibitors include:
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glecaprevir (component of Mavyret)
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grazoprevir (component of Zepatier)
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paritaprevir (component of Viekira Pak)
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simeprevir (Olysio)
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voxilaprevir (component of Vosevi)
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NS5B polymerase inhibitors include:
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sofosbuvir (Sovaldi, component of Harvoni, component of Epclusa, component of Vosevi)
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dasabuvir (component of Technivie)
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Warnings and precautions:
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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.
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Bradycardia with amiodarone coadministration: coadministration of amiodarone with Epclusa is not recommended. In patients without alternative, viable treatment options, cardiac monitoring is recommended
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Contraindication:
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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
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Drug interactions
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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
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Consult the full prescribing information prior to use for potential drug interactions
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Frequent monitoring of relevant laboratory parameters (INR or blood glucose) and dose adjustments of certain concomitant medications may be necessary
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Policy Updates:
- 02/15/2022 – Updated policy approved by P&T.
- 08/20/2018 – Last reviewed
References:
- 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/
- Epclusa Prescribing Information. Gilead Science, Inc. Foster City, CA. June 2021.
- 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