CurrentCignaPolicy N/A

Sofosbuvir/velpatasvir (Epclusa) prior authorization

Defines Cigna's prior authorization requirements and coverage criteria for Epclusa (sofosbuvir/velpatasvir) tablets and oral pellets, including FDA-approved indications and selected other uses with supportive evidence for members of Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicySofosbuvir/velpatasvir (Epclusa) prior authorization

Policy CodePolicy N/A

Change TypeAdded coverage condition

Effective DateN/A

Next Review DateApr 3, 2024

Key ActionSubmit prior authorization with specialist documentation and required clinical information to support approval.

SourceLink

POLICY UPDATE CHANGES

A new condition of coverage for Chronic Hepatitis C Virus (HCV), Genotype Unknown/Undetermined was added to 'Other Uses with Supportive Evidence'.

≥3minimum age for most approvals

12 weeksstandard FDA-approved treatment duration

24 weeksduration for certain decompensated or retreatment scenarios

1–6covered HCV genotypes

Specialist

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Sofosbuvir/Velpatasvir (Epclusa)

Initial Therapy: Genotype 1-6, No Cirrhosis or Compensated Cirrhosis

Covered when ALL of the following are met (FDA-Approved Indication: No Cirrhosis or Compensated Cirrhosis)

FDA-Approved: No Cirrhosis or Compensated Cirrhosis: Approve for 12 weeks if A) patient is ≥ 3 years of age; AND B) patient meets ONE of the following: i) patient does not have cirrhosis; OR ii) patient has compensated cirrhosis (Child-Pugh A); AND C) patient has not been previously treated with sofosbuvir/velpatasvir; AND D) the medication is prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician.12 weeks

Adult Decompensated Cirrhosis (Child-Pugh B or C)

Covered when ALL of the following are met (FDA-Approved Indication: Adult Decompensated Cirrhosis)

FDA-Approved: Adult Decompensated Cirrhosis: Approve for the duration below if A) patient is ≥ 18 years of age; AND B) patient has decompensated cirrhosis (Child-Pugh B or C); AND C) patient meets ONE of the following: i) patient is ribavirin-eligible per prescriber — approve for 12 weeks in combination with ribavirin; OR ii) patient is ribavirin-ineligible per prescriber — approve for 24 weeks; AND D) the medication is prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician.12 or 24 weeks

Duration depends on ribavirin eligibility determined by prescriber.

Pediatric Decompensated Cirrhosis

Covered when ALL of the following are met (FDA-Approved Indication: Pediatric Decompensated Cirrhosis)

Pediatric Decompensated Cirrhosis: Approve for 12 weeks if A) patient is ≥ 3 years of age and < 18 years of age; AND B) patient has decompensated cirrhosis (Child-Pugh B or C); AND C) the medication will be prescribed in combination with ribavirin; AND D) the medication is prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician.12 weeks

Pediatric use limited to ≥3 years of age.

Other Uses: Genotype Unknown/Undetermined

Covered when ALL of the following are met (Other Uses with Supportive Evidence: Genotype Unknown/Undetermined)

Genotype Unknown/Undetermined (Adults): Approve for 12 weeks if A) patient is ≥ 18 years of age; AND B) patient does not have cirrhosis; AND C) patient has not previously been treated for hepatitis C virus; AND D) patient does not have hepatitis B virus; AND E) patient is not pregnant; AND F) patient does not have hepatocellular carcinoma; AND G) patient has not had a liver transplantation; AND H) the medication will be prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician.12 weeks

New condition of coverage added per history.

Retreatment: Prior Non-Responders/Relapsers (Decompensated Cirrhosis)

Covered when ALL of the following are met (Retreatment / Prior Null Responder/Relapser to Epclusa or Vosevi with Decompensated Cirrhosis)

Retreatment in Decompensated Cirrhosis: Approve for 24 weeks if A) patient is ≥ 3 years of age; AND B) patient has decompensated cirrhosis (Child-Pugh B or C); AND C) patient meets ONE of the following: i) patient has been previously treated with sofosbuvir/velpatasvir; OR ii) patient has previously been treated with Vosevi; AND D) the medication will be prescribed in combination with ribavirin; AND E) the medication is prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician.24 weeks

Applies to prior null responders, partial responders, and relapsers.

Continuation Therapy

Covered when ALL of the following are met (Patients Already Started on Therapy)

Continuation to Complete a Course: Approve the remaining duration necessary to complete the course if the patient has been started on sofosbuvir/velpatasvir for an indication addressed in this policy (e.g., if the full course is 12 weeks and the patient has received 3 weeks, approve the remaining 9 weeks).Remaining weeks to complete course

Use of sofosbuvir/velpatasvir in combination with any other direct-acting antivirals (DAAs), excluding ribavirin, is considered experimental, investigational, or unproven and is not covered. The policy specifies that sofosbuvir/velpatasvir provides a complete antiviral regimen and is not recommended to be used with other products containing sofosbuvir.

Pediatric patients younger than 3 years of age: the safety and efficacy of sofosbuvir/velpatasvir have not been established in this age group. Use in patients < 3 years is considered experimental, investigational, or unproven and is not covered.

Any use of sofosbuvir/velpatasvir that is not included in the FDA-approved indications or in the policy's listed 'Other Uses with Supportive Evidence' is considered experimental, investigational, or unproven and is not medically necessary. The policy lists examples (not exhaustive) and will be updated as new published data become available.

Drug and Age Coding Information

Covered NDC/Drug ProductsNDCCovered

NDC (varies)

Epclusa (sofosbuvir/velpatasvir) tablets and oral pellets; authorized generic sofosbuvir/velpatasvir

Age thresholds

Minimum age (most indications)≥ 3 years of age

Adults for genotype unknown/other adult-only uses≥ 18 years of age

Pediatric decompensated cirrhosis≥ 3 and < 18 years of age (approve for 12 weeks in combination with ribavirin)

Adult decompensated cirrhosis≥ 18 years of age (approve 12 weeks with ribavirin or 24 weeks if ribavirin-ineligible)

Provider Requirements and Actions

Prior Authorization

Prior Authorization Required — Prior authorization is required for sofosbuvir/velpatasvir

Prior authorization is required for sofosbuvir/velpatasvir. Approvals are provided for the specified treatment duration and require that the medication be prescribed by or in consultation with a physician who specializes in the condition being treated (gastroenterologist, hepatologist, infectious diseases physician, or liver transplant physician).

Approvals are provided for the duration noted in the authorization criteria.
Prior authorization applies to both FDA‑approved indications and other uses with supportive evidence listed in the policy.
Prescriber specialty documentation is required.

Note

Guideline Context (not a requirement) — Notes alternative pangenotypic regimen (Mavyret) as an 8-week option for certain treatment-naïve adults without cirrhosis

The AASLD/IDSA HCV guidance (Dec 19, 2023) supports simplified, pangenotypic treatment approaches in certain populations. For treatment‑naïve adults without cirrhosis, recommended regimens include Mavyret (glecaprevir/pibrentasvir) for 8 weeks or sofosbuvir/velpatasvir for 12 weeks. Genotyping is not required for all patients when a pangenotypic regimen is used, but remains recommended in patients with cirrhosis and/or prior treatment failure. These guideline points are provided for clinical context and are not authorization requirements.

Background

Sofosbuvir/velpatasvir is a fixed‑dose combination antiviral for hepatitis C virus (HCV) that combines a nucleotide analog NS5B polymerase inhibitor (sofosbuvir) with an NS5A inhibitor (velpatasvir). It is indicated for treatment of chronic HCV genotypes 1–6 in patients aged 3 years and older.

Definitions

Child-Pugh B or C — Decompensated cirrhosis

DefinitionDecompensated cirrhosis is identified as Child-Pugh class B or C.

Therapy context (adults)For adults with Child-Pugh B or C, sofosbuvir/velpatasvir is administered with weight-based ribavirin; duration is 12 weeks with ribavirin or 24 weeks if ribavirin-ineligible.

Therapy context (pediatrics)Pediatric patients (≥3 and <18 years) with Child-Pugh B or C are approved for 12 weeks when therapy is prescribed in combination with ribavirin.