CurrentCignaPolicy N/A

Hepatitis C - Epclusa Drug Quantity Management Policy - Per Days

Sets Cigna's quantity limits and medical-necessity exceptions for Epclusa (sofosbuvir/velpatasvir) tablets and pellet packets, and describes approval criteria for additional supply for patients (including those with decompensated cirrhosis and prior DAA treatment). Applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyHepatitis C - Epclusa Drug Quantity Management Policy - Per Days

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateAug 5, 2025

Key ActionRequest exceptions to the 84-per-365-day quantity limit only when the specified clinical criteria are documented to authorize higher quantities up to 168 or 336 units.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

84standard per 365 days

28per dispensing

168allowed in some decompensated cirrhosis cases

336pellet packets in specific retreatment

12standard duration (weeks)

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Coverage Criteria and Exceptions

Quantity limits and medical-necessity exceptions

Drug Quantity Limits are enforced; exceptions are covered as medically necessary only when the specific criteria below are met.

Standard Quantity Limit (default): Limit Epclusa supply to 84 tablets or 84 pellet packets per 365 days (28 per dispensing) for listed strengths/forms.84 per 365 days

This quantity corresponds to a 12-week course of therapy.

Exceptions for increased quantities

Exception A — 400 mg/100 mg or 200 mg/50 mg tablets for decompensated cirrhosis, ribavirin-ineligible (initial treatment): Approve 168 tablets per 365 days if ALL of the following: A. Patient is ≥ 18 years of age; AND B. Patient has not been previously treated with sofosbuvir/velpatasvir (Epclusa) or Vosevi; AND C. Patient has decompensated cirrhosis (Child-Pugh B or C); AND D. Patient is ribavirin-ineligible per prescriber.168 per 365 days
Moves age requirement inside criterion; applies to tablets.
Exception B — 400 mg/100 mg or 200 mg/50 mg tablets for prior sofosbuvir/velpatasvir or Vosevi treatment (retreatment): Approve 168 tablets per 365 days if ALL of the following: A. Patient has been previously treated with sofosbuvir/velpatasvir (Epclusa) or Vosevi; AND B. Patient has decompensated cirrhosis (Child-Pugh B or C); AND C. The medication will be prescribed in combination with ribavirin.168 per 365 days
Retreatment scenario requiring ribavirin combination.
Exception C — 150 mg/37.5 mg pellet packets for retreatment in decompensated cirrhosis: Approve 168 pellet packets per 365 days if ALL of the following: A. Patient has been previously treated with sofosbuvir/velpatasvir (Epclusa) or Vosevi; AND B. Patient has decompensated cirrhosis (Child-Pugh B or C); AND C. The medication will be prescribed in combination with ribavirin.168 pellet packets per 365 days
Exception D — 200 mg/50 mg pellet packets for retreatment in decompensated cirrhosis: Approve 336 pellet packets per 365 days if ALL of the following: A. Patient has been previously treated with sofosbuvir/velpatasvir (Epclusa) or Vosevi; AND B. Patient has decompensated cirrhosis (Child-Pugh B or C); AND C. The medication will be prescribed in combination with ribavirin.336 pellet packets per 365 days
Higher quantity reflects dosing/packet usage for patients requiring two packets/day or longer duration.
Quantity to complete therapy: For any approved indication above, approve the quantity requested up to the specified exception limit to complete a course of therapy (e.g., if 21 units already received toward a 24-week course, approve remaining units up to the limit).
Allows partial-course completion within the specified maximums.

Point-of-service rule: If the Drug Quantity Management rule is not met at point of service, coverage will be determined by the criteria above; any exception not meeting these criteria is considered not medically necessary and may be denied.

All approvals are provided for the duration noted in the criteria.

Any exceptions to the quantity limits that do not meet the specific criteria listed in this policy are considered not medically necessary.

Requests that exceed the drug quantity limits and that do not satisfy the stated exception criteria will be denied as not medically necessary.

Product Coding and Quantities

Covered NDC/product formsNDCCovered

NDC	Drug product billing via NDCs for Epclusa tablets and pellet packets (various strengths/forms)

Maximum quantity per 365 days — standard and exception quantities

Standard maximum (per 365 days)84 tablets or 84 pellet packets (28 per dispensing) — sufficient for a 12‑week course

Exception — 168 tablets per 365 daysApprove 168 tablets (400 mg/100 mg or 200 mg/50 mg tablets) for patients with decompensated cirrhosis when criteria met (see exceptions) — allows extended or ribavirin‑related regimens

Exception — 168 pellet packets per 365 daysApprove 168 pellet packets (150 mg/37.5 mg) for specified retreatment in decompensated cirrhosis when criteria met

Exception — 336 pellet packets per 365 daysApprove 336 pellet packets (200 mg/50 mg) for specified retreatment in decompensated cirrhosis when criteria met

Quantity to complete therapyFor any approved indication, authorize the remaining quantity requested up to the applicable exception limit to complete a course of therapy (example provided in criteria)

Provider Actions, Prior Authorization, and Denial Risk

Documentation Required

Documentation and submission requirements

Review applicable benefit plan terms. Prior authorization/Drug Quantity Management exceptions require submission of clinical documentation supporting medical necessity, including but not limited to: diagnosis (HCV genotype), Child-Pugh score or documentation of decompensated cirrhosis, prior HCV treatment history (including dates, regimens, response — e.g., null/partial/relapser), weight (for pellet vs tablet dosing), and prescriber plan for combination therapy when required (ribavirin eligibility or justification for ribavirin use). Include prior authorization forms, relevant laboratory results (HCV RNA), and any specialty pharmacy dispensing information. Incomplete documentation may delay review or result in denial.

Include HCV genotype and treatment history (dates, regimens, outcomes).
Provide Child-Pugh classification or clinical notes confirming decompensated cirrhosis.
Supply weight for pediatric/low-weight dosing and pellet vs tablet justification.
Document ribavirin eligibility or rationale for ribavirin use when requesting extended quantities.

Note

Key Definitions

Decompensated cirrhosis (Child-Pugh B or C) — definition and dosing note regarding ribavirin

DefinitionDecompensated cirrhosis = advanced hepatic impairment classified as Child‑Pugh B or C

Ribavirin coadministration requirementIn patients with decompensated cirrhosis, sofosbuvir/velpatasvir is administered with weight‑based ribavirin per dosing guidance (adult dosing: one 400 mg/100 mg tablet QD)

Ribavirin‑ineligible exception noteAn exception exists to approve 168 tablets when patient is ribavirin‑ineligible and meets other decompensated cirrhosis criteria (initial treatment)

Retreatment dosing noteFor patients previously treated with sofosbuvir/velpatasvir or Vosevi and who have decompensated cirrhosis, additional supply approvals (168 or 336 packets/tablets) require that the medication be prescribed in combination with ribavirin

Background

Epclusa (sofosbuvir/velpatasvir) is a fixed‑dose combination antiviral indicated for chronic hepatitis C virus (HCV) infection (genotypes 1–6) in appropriate patients. The FDA‑approved standard duration of therapy is 12 weeks; patients with decompensated cirrhosis (Child‑Pugh B or C) are managed with sofosbuvir/velpatasvir in combination with weight‑based ribavirin and may require extended or modified treatment per guideline recommendations. This policy sets quantity limits for Epclusa tablets and pellet packets and defines clinical exceptions that, when met, authorize increased quantities for completion of therapy.