Epclusa – Enhanced & Essential Formularies

Restricted Product(s)

Restriction applies to brand and generic formulations

• Epclusa® (Velpatasvir/sofosbuvir)

FDA Approved Use

• Treatment of adult and pediatric patients 3 years and older or weighing at least 17 kg with chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection: 
  • without cirrhosis or with compensated cirrhosis 
  • with decompensated cirrhosis for use in combination with ribavirin 

Criteria for Approval of Restricted Product(s)

1. The patient has a diagnosis of chronic hepatitis C virus (HCV) with either of the following: 
   1. Patient has confirmed genotypes 1,2,3,4,5, or 6 without cirrhosis or with compensated cirrhosis (medical record documentation required); OR 
   2. Patient had confirmed genotypes 1,2,3,4,5, or 6 with decompensated cirrhosis and meets ONE of the following (medical record documentation required); 
      1. Patient will use generic velpatasvir/sofosbuvir with ribavirin; OR 
      2. The patient has a documented clinical ineligibility to co-administer ribavirin; OR 
   3. Genotype is unknown and patient is treatment-naïve without cirrhosis and ALL of the following apply; (medical record documentation required); 
      1. Hepatitis B surface antigen (HBsAg) negative 
      2. NOT currently pregnant 
      3. No known or suspected hepatocellular carcinoma 
      4. No prior liver transplantation; OR 
   4. Genotype is unknown and patient is treatment-naïve with compensated cirrhosis (Child-Pugh A) and ALL of the following apply (medical record documentation required); 
      1. Patient has NOT had current or prior episode of decompensated cirrhosis, defined as Child-Turcotte-Pugh (CTP) score greater than or equal to 7 (ascites, hepatic encephalopathy, total bilirubin greater than 2.0 mg/dL, albumin less than or equal to 3.5 g/dL, or INR greater than or equal to 1.7) 
      2. Does NOT have end-stage renal disease (i.e., eGFR less than 30 mL/min/m^2) 
      3. Hepatitis B surface antigen (HBsAg) negative 
      4. NOT currently pregnant 
      5. No known or suspected hepatocellular carcinoma 
      6. No prior liver transplantation; AND
2. HCV screening, fibrosis score, Child-Pugh score, and HCV RNA at baseline (within the last 6 months) have been completed (medical record documentation required); AND 
3. The patient has NOT attempted a previous course of therapy with a NS5A or NS5B inhibitor containing regimen (i.e., generic ledipasvir/sofosbuvir, Harvoni or Sovaldi); AND 
4. The patient is being managed by or in consultation with a specialist in the area of the patient’s diagnosis (e.g., Gastroenterologist, Hepatologist, or Infectious Disease provider); AND 
5. The requested medication will not be used in combination with other protease inhibitors used to treat chronic hepatitis C infection; AND 
6. If the requested medication is brand Epclusa 400-100 mg tablet: 
   1. The patient has a known contraindication to an inactive ingredient in generic velpatasvir/sofosbuvir 400-100mg tablet (medical record documentation required); AND 
7. If the requested medication is for brand Epclusa 200-50 mg tablet; 
   1. The patient’s body weight is between 17 and 29 kg; AND 
   2. The patient will be taking one tablet daily of the 200-50 mg dose; AND 
8. If the requested medication is Epclusa pellet pack: 
   1. The patient is between 3-11 years of age; AND 
   2. The provider attests that the patient is unable to take solid dosage forms; AND 
   3. The patient is not taking any other medication in a solid dosage form; AND 
9. The prescribed dosing does not exceed FDA labeling; AND 
10. For products that require Medical Necessity PA, refer to the Medical Necessity PA UM Criteria.

References

All information referenced is from FDA package insert unless otherwise noted below.

American Association for the Study of Liver Diseases and Infectious Disease Society of America. Recommendations for Testing, Managing, and Treating Hepatitis C. When and in Whom to Initiate HCV Therapy. 2016

Bhattacharya D, Aronsohn A, Price J, Lo Re III V. Hepatitis C Guidance 2023 Update: AASLD-IDSA Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection. Clinical Infectious Diseases. 2023 May 25:ciad319.

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q2 annually.

August 2024: Criteria change: Policy updated to align with AASLD guidelines for Simplified HCV Treatment for treatment-naive adults without cirrhosis. Added criteria to address patients with unknown genotype.
September 2023: Criteria change: Criteria review and formatting changes. Removed several medications from policy which are no longer available.
November 2021: Criteria update: Added new to market Epclusa pellets to policy and expanded indication to 3 years of age and older.
November 2020: Criteria update: Added new strength of 200-50mg to the policy.
October 2020: Criteria update: Clarified duration of approval for members with decompensated cirrhosis and ribavirin ineligible.
April 2020: Criteria change: Requests for patients who have decompensated cirrhosis and are ribavirin ineligible may be approved for 24 weeks of therapy. Duration of therapy chart updated.
March 2020: Criteria update: Added expanded indication to include pediatric patients 6 years and older or weighing at least 17kg.
Jan 2019: Added generic Velpatasvir/sofosbuvir (Epclusa) to the criteria; contraindication added to generic Velpatasvir/sofosbuvir (Epclusa®)
June 2017: Annual FDA label review; formatting update; no change to criteria
July 2016: Original utilization management criteria issued