CurrentCignaPolicy N/A

Hepatitis C - Epclusa Prior Authorization Policy

Defines Cigna's prior authorization requirements, coverage criteria, and restrictions for sofosbuvir/velpatasvir (Epclusa and authorized generic) for treatment of chronic hepatitis C in pediatric and adult patients.

Policy Summary

PayerCigna

PolicyHepatitis C - Epclusa Prior Authorization Policy

Policy CodePolicy N/A

Change TypeEarly Annual Revision — added coverage for genotype unknown/undetermined

Effective DateN/A

Next Review DateApr 3, 2024

Key ActionObtain prior authorization and document prescriber specialty, age, cirrhosis status, treatment history, pregnancy/HBV status, and ribavirin eligibility.

SourceLink

POLICY UPDATE CHANGES

A new condition of coverage was added for Chronic Hepatitis C Virus (HCV), Genotype Unknown/Undetermined allowing approval for 12 weeks when specified criteria are met.

12 wksFDA-approved treatment duration for most indications

24 wksDuration for certain decompensated scenarios

≥3 yrsMinimum pediatric age

PangenotypicGenotype coverage

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.

Prescriber requirement

Coverage Criteria for Sofosbuvir/Velpatasvir (Epclusa)

COVERAGE CRITERIA

Covered when ALL of the following are met (criteria grouped by indication):

1. Chronic HCV genotype 1-6, no cirrhosis or compensated cirrhosis (Child-Pugh A) - 12 weeks

A: Patient is >= 3 years of age>=3 years
B
- i: Patient does not have cirrhosis
- ii: Patient has compensated cirrhosis (Child-Pugh A)
C: Patient has not been previously treated with sofosbuvir/velpatasvir
D: Prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or liver transplant physician

2. Chronic HCV genotype 1-6, decompensated cirrhosis (Child-Pugh B or C) - Adult

A: Patient is >= 18 years of age>=18 years
B: Patient has decompensated cirrhosis (Child-Pugh B or C)
C
- i: Patient is ribavirin-eligible per prescriber — Approve for 12 weeks if prescribed in combination with ribavirin
- ii: Patient is ribavirin-ineligible per prescriber — Approve for 24 weeks

3. Chronic HCV genotype 1-6, decompensated cirrhosis - Pediatric

A: Patient is >= 3 years and < 18 years of age3-17 years
B: Patient has decompensated cirrhosis (Child-Pugh B or C)
C: Medication will be prescribed in combination with ribavirin
D: Prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician

4. Genotype Unknown/Undetermined - Other uses with supportive evidence

A: Patient is >= 18 years of age>=18 years
B: Patient does not have cirrhosis
C: Patient has not previously been treated for hepatitis C virus
D: Patient does not have hepatitis B virus
E: Patient is not pregnant

5. Decompensated cirrhosis prior null/partial/relapser to sofosbuvir/velpatasvir or Vosevi

A: Patient is >= 3 years of age>=3 years
B: Patient has decompensated cirrhosis (Child-Pugh B or C)
C
- i: Previously treated with sofosbuvir/velpatasvir
- ii: Previously treated with Vosevi

6. Patients already started on therapy: Approve remaining duration to complete course if initial initiation meets one of the approved indications

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. Sofosbuvir/velpatasvir is intended as a complete antiviral regimen and should not be co-administered with other products that contain sofosbuvir. Additionally, use in pediatric patients aged <3 years is not covered because safety and efficacy have not been established in that age group.

Provider Actions, Authorization, and Denial Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required for sofosbuvir/velpatasvir (Epclusa and authorized generic). Approvals are provided for the duration specified in the policy criteria. Ensure prior authorization is obtained before initiating therapy to avoid claim denials or delays.

Prior authorization applies to Epclusa® (sofosbuvir/velpatasvir tablets and oral pellets) and the authorized generic.
Approvals are granted for the durations noted under FDA-approved indications and Other Uses with Supportive Evidence (e.g., 12 or 24 weeks as specified).

Note

Guideline Context (No Explicit Step Therapy)

The AASLD/IDSA guideline context: genotyping is not required for all patients when a pangenotypic regimen is used, and simplified treatment algorithms exist for treatment-naïve adults without cirrhosis. However, genotyping and NS5A resistance testing may still be recommended in specific circumstances (for example, patients with cirrhosis, prior treatment failure, or genotype 3 with cirrhosis). This guidance is contextual and does not replace the policy's explicit coverage criteria.

Genotyping may be omitted for treatment‑naïve adults without cirrhosis when using a pangenotypic regimen per AASLD/IDSA guidance.

Background

Sofosbuvir/velpatasvir is a fixed‑dose pangenotypic combination antiviral that pairs sofosbuvir, an HCV nucleotide analog NS5B polymerase inhibitor, with velpatasvir, an HCV NS5A inhibitor. It is indicated for chronic hepatitis C virus infection across genotypes 1–6 in eligible patients, with an FDA‑approved treatment duration of 12 weeks for most indications and special dosing/combination considerations (for example, addition of weight‑based ribavirin or extended duration) in patients with decompensated cirrhosis or other specific retreatment scenarios. Prior authorization is required for coverage and prescriptions must be written by or in consultation with an appropriate specialist.

Definitions and Special Populations

inv-08: Decompensated cirrhosis — Child-Pugh class B or C; dosing/combination notes (often with ribavirin).

DefinitionDecompensated cirrhosis is defined as Child-Pugh class B or C liver disease.

Adult dosing/combinationIn patients with decompensated cirrhosis (Child-Pugh B or C), sofosbuvir/velpatasvir is administered with weight-based ribavirin per FDA‑approved labeling.

Treatment durationsApprove for 12 weeks when prescribed with ribavirin; if ribavirin-ineligible per prescriber, approve for 24 weeks in adults.

Pediatric noteFor pediatric patients (≥ 3 and < 18 years) with decompensated cirrhosis, therapy is approved for 12 weeks when prescribed in combination with ribavirin.

Prior treatment/retry scenariosPatients with prior null/partial/relapser to sofosbuvir/velpatasvir or Vosevi with decompensated cirrhosis may be approved for 24 weeks in combination with ribavirin.

Policy Summary

PayerCigna

PolicyHepatitis C - Epclusa Prior Authorization Policy

Policy CodePolicy N/A

Change TypeEarly Annual Revision — added coverage for genotype unknown/undetermined

Effective DateN/A

Next Review DateApr 3, 2024

Key ActionObtain prior authorization and document prescriber specialty, age, cirrhosis status, treatment history, pregnancy/HBV status, and ribavirin eligibility.

SourceLink

On This Page

D: Prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician

F: Patient does not have hepatocellular carcinoma

G: Patient has not had a liver transplantation

H: Prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician

D: Medication will be prescribed in combination with ribavirin

E: Prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician

Patients with cirrhosis, prior unsuccessful treatment, or suspected genotype 3 may require genotyping or baseline NS5A resistance testing per guideline recommendations.

The guideline context informs clinical decision-making but does not change the documented prior authorization and coverage requirements in this policy.

Documentation Required

Required Prescriber Specialty and Documentation; Non‑Covered Uses Trigger Denial

Because of the specialized skills required for evaluation, diagnosis, and monitoring of patients treated with sofosbuvir/velpatasvir, the medication must be prescribed by or in consultation with an appropriate specialist. Required supporting clinical documentation must be provided with the authorization request.

Required prescriber specialty: gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician (prescription or documented consultation).
Supporting documentation to include with the prior authorization request: relevant diagnosis and genotype or rationale if genotype unknown, cirrhosis status (including Child‑Pugh class where applicable), prior HCV treatment history, pregnancy and hepatitis B status, transplant history, and treatment plan (including ribavirin use if applicable).
Use for non‑covered indications (including combinations with other DAAs except ribavirin, or pediatric patients <3 years) will be denied as experimental/investigational.

inv-09: Simplified treatment — AASLD/IDSA simplified treatment note for certain treatment-naïve adults without cirrhosis.

DefinitionSimplified treatment refers to AASLD/IDSA guidance allowing certain treatment-naïve adults without cirrhosis to be treated without pre-treatment HCV genotyping when a pangenotypic regimen is used.

Eligibility criteriaTreatment‑naïve adults without cirrhosis are eligible if they do NOT have hepatitis B (HBsAg positive), are not pregnant, do not have hepatocellular carcinoma, and have not had liver transplantation.

Recommended regimen and durationPer AASLD/IDSA simplified algorithm, sofosbuvir/velpatasvir for 12 weeks is an accepted regimen for eligible treatment‑naïve adults without cirrhosis.

Genotyping note for compensated cirrhosisTreatment‑naïve adults with compensated cirrhosis may also be eligible for simplified treatment but recommendations are genotype specific (genotype 3 requires baseline NS5A RAS testing).