ModifiedCignaPolicy N/A

Hepatitis C Virus Direct-Acting Antivirals Preferred Specialty Management Policy for National Preferred Formulary and Basic Formulary

Defines Cigna's Preferred Specialty Management program for direct-acting antivirals (DAAs) for hepatitis C virus (HCV), listing preferred and non-preferred products by genotype and exception criteria that apply to patients and prescribers under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyHepatitis C Virus Direct-Acting Antivirals Preferred Specialty Management Policy for National Preferred Formulary and Basic Formulary

Policy CodePolicy N/A

Change TypeMaterial revision — added and revised Mavyret genotype unknown/undetermined criteriaapproval condition added

Effective DateN/A

Next Review DateN/A

Key ActionObtain and document prior authorization per the referenced product-specific PA policies and supply required documentation (prior therapy and SVR evidence) for non-preferred exceptions.

SourceLink

POLICY UPDATE CHANGES

Criteria for Mavyret for genotype unknown/undetermined were modified to add 'No Cirrhosis' as a distinct indication and new criteria were created for compensated cirrhosis.

A new condition of coverage was added for Mavyret for chronic HCV with genotype unknown/undetermined offering review for Epclusa (brand only).

A condition of approval was added stating Mavyret is approved for the duration specified in the Hepatitis C - Mavyret PA for PSM Policy if the patient meets that policy's criteria.

9DAA products

1–6Genotypes addressed

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

Non-Preferred Product Exception Criteria

Non-preferred products are covered as medically necessary only when the listed exception criteria are met; otherwise considered not medically necessary.

General: Patient must meet the respective standard Hepatitis C Prior Authorization Policy criteria for the requested product; documentation required for non-preferred exceptions.

All approvals provided for the duration documented in the respective standard Hepatitis C PA Policy

Epclusa (brand only): Approve if patient meets standard Hepatitis C - Epclusa PA Policy criteria.

Sofosbuvir/velpatasvir (generic only) is not approved; offer brand Epclusa review.

Harvoni (brand only): Approve if patient meets standard Hepatitis C - Harvoni PA Policy criteria.

Ledipasvir/sofosbuvir (generic only) is not approved; offer brand Harvoni review.

Mavyret - genotype-specific rules: Mavyret approvals require meeting the Hepatitis C - Mavyret PA for PSM Policy criteria AND, for many new-start indications, documented prior-treatment history as specified (see genotype-specific branches).

Multiple genotype- and age-specific branches define acceptable prior therapies and required documentation of failure (SVR documentation required where specified).

Sovaldi is not approved for most new pediatric starts for some genotypes; continuing therapy follows the standard Sovaldi PA Policy criteria.

For pediatric genotype 2 or 3 new starts offer Epclusa (brand) review per Epclusa PA.

Genotype 1 with renal impairment: If treatment‑naïve, Mavyret is not approved; offer review for Zepatier. Mavyret may be approved only if patient meets Mavyret PA for PSM criteria AND meets defined prior‑treatment conditions (including required documentation of prior therapy failure).eGFR < 30 mL/min or ESRD

See genotype‑ and renal‑specific criteria for acceptable prior regimens and documentation requirements.

Initial Therapy and Prior-Treatment Failure Pathways

Covered when the specified product-specific PA policy criteria are met and additional listed conditions are satisfied

General requirement for Mavyret approvals: Patient has met the Hepatitis C - Mavyret PA for PSM Policy criteria.

Applies as first-level requirement for many approvals.

Genotype-specific prior-treatment failure pathways (example Genotype 1)

Scenario: prior pegylated interferon/ribavirin then completed Epclusa/Harvoni/Zepatier without SVR: Patient previously treated with pegylated interferon/ribavirin AND has completed a course of Epclusa (brand or generic), Harvoni (brand or generic), or Zepatier with documentation that the patient did not achieve SVR (virus undetectable 12 weeks following completion of therapy) [documentation required]
Documentation of lack of SVR required
Scenario: prior Sovaldi‑based or other listed regimens: Patient previously treated with Sovaldi + ribavirin ± pegylated interferon/interferon OR Sovaldi + Olysio OR other listed regimens (Daklinza, Incivek, Olysio, Victrelis) as specified in genotype branches

Renal impairment, Pediatric, and Genotype-specific rules

Specific rules for renal impairment, transplant, pediatric, and recurrent disease

Genotype 1 or 4 with renal impairment (adult) - New Start: If treatment‑naïve, Mavyret is not approved; offer review for Zepatier using the standard Zepatier PA criteria OR if prior‑treatment criteria are met (per Mavyret PA for PSM Policy and documented prior therapy failure), approve per Mavyret duration.eGFR < 30 mL/min or ESRD

Contains two branches: treatment‑naïve routing to Zepatier or approve after documented prior‑treatment failure.

Pediatric genotype 1 or 4 with renal impairment (age ≥3 and <18) - New Start: Approve for the duration specified in the Hepatitis C - Mavyret PA for PSM Policy if the patient has met that policy's criteria.age ≥3 and <18

Direct approval when Mavyret PA criteria met.

Genotype 2,3,5,6 with renal impairment - New Start:

Transplant-related approvals

Liver transplant and recurrent HCV pathways

Post-liver transplant genotype 2 or 3 recurrent HCV - New Start: Approve per Hepatitis C - Mavyret PA for PSM Policy if Mavyret PA criteria met.

Applies specifically to genotype 2 or 3 recurrent disease after liver transplant.

Post-liver transplant genotype 1,4,5,6 recurrent HCV - New Start (adult): Approve per Mavyret PA for PSM if patient meets Mavyret PA criteria AND has completed Harvoni with documentation of no SVR; if the patient meets the Mavyret PA criteria but lacks Harvoni‑failure documentation, offer review for Harvoni (brand only) under Harvoni PA.

Documentation of Harvoni treatment and failure required for this approval pathway.

Liver transplant recipient any genotype - New Start: Approve per Mavyret PA for PSM Policy if Mavyret PA criteria met.

Applies to liver transplant recipients across genotypes when Mavyret PA criteria are satisfied.

Genotype Unknown/Undetermined

Genotype unknown/undetermined pathways

Unknown/undetermined genotype without cirrhosis: Mavyret is not approved; offer review for Epclusa (brand only) using Epclusa PA Policy criteria.

This 'No Cirrhosis' condition was added in the Early Annual Revision and is a required routing for these patients.

Unknown/undetermined genotype with compensated cirrhosis: Approve per duration specified in the Hepatitis C - Mavyret PA for PSM Policy if the patient has met the Mavyret PA criteria.compensated cirrhosis

Compensated‑cirrhosis pathway was created as part of annual revisions and allows Mavyret approval when Mavyret PA criteria are met.

Sofosbuvir/velpatasvir and ledipasvir/sofosbuvir are not approved when presented as generic-only products. In these situations, the policy directs clinicians to request review for the corresponding brand alternative (Epclusa for sofosbuvir/velpatasvir; Harvoni for ledipasvir/sofosbuvir) under the standard Hepatitis C PA criteria.

For adult patients with Genotype 1 or 4 who have renal impairment defined as eGFR < 30 mL/min or End-Stage Renal Disease (ESRD), Mavyret is not approved for treatment-naïve starts; these patients should be offered review for Zepatier per the standard Zepatier PA Policy. Approval of Mavyret in renal-impaired patients is limited to situations that meet the Hepatitis C - Mavyret PA for PSM Policy criteria and any specified prior-treatment history branches in the Mavyret policy.

Non-preferred products are covered only when they meet the listed non-preferred product exception criteria; any use of a non-preferred product that does not satisfy those exception criteria is considered not medically necessary.

For Chronic HCV with Genotype Unknown/Undetermined and no cirrhosis, Mavyret is not approved. The policy directs clinicians to request review for Epclusa (brand only) using the standard Hepatitis C - Epclusa PA Policy criteria.

Coding and Clinical Thresholds

NDC Codes (Not listed in source) - Manufacturer NDCs vary by package and are not specified in the source. Recommend using current payer pharmacy system or manufacturer prescribing information to obtain NDCs for claims submission.NDC

See payer pharmacy system

NDCs not provided in source; verify in formulary/NDC database or manufacturer PI.

Relevant Drug Codes (HCPCS/NDC guidance)mixed

Mavyret (glecaprevir/pibrentasvir)	See AbbVie prescribing information for dosing; NDCs vary by package (source citation 6).
Zepatier (elbasvir/grazoprevir)	See Merck prescribing information for dosing; NDCs vary by package (source citation 3).
Epclusa (sofosbuvir/velpatasvir)	See Gilead prescribing information for dosing; NDCs vary by package (source citation 4).
Harvoni (ledipasvir/sofosbuvir)	See Gilead prescribing information for dosing; NDCs vary by package (source citation 1).
Sovaldi (sofosbuvir)	See Gilead prescribing information for dosing; NDCs vary by package (source citation 2).
Vosevi (sofosbuvir/velpatasvir/voxilaprevir)	See Gilead prescribing information for dosing; NDCs vary by package (source citation 5).

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required — All Hepatitis C DAA requests (preferred and non-preferred) must meet the applicable standard Hepatitis C prior authorization policy criteria. If the member meets the standard Hepatitis C PA criteria but has not trialed a Preferred Product, review will be offered for a Preferred Product under the respective standard Hepatitis C PA policy. Approvals are provided for the duration specified in the referenced standard Hepatitis C PA policy.

Prior Authorization

Product‑Specific Prior Authorization Required

Product‑specific prior authorization is required for non‑preferred agents. Approvals for non‑preferred products (for example, Mavyret, Vosevi, Zepatier, Epclusa [when non‑preferred formulation], Harvoni [when non‑preferred formulation]) are contingent on meeting the referenced product‑specific PA criteria (e.g., Hepatitis C - Mavyret PA for PSM Policy, Hepatitis C - Zepatier PA Policy, Hepatitis C - Vosevi PA Policy, Hepatitis C - Epclusa PA Policy, Hepatitis C - Harvoni PA Policy). If the criteria in the product‑specific PA are met, approve for the duration specified in that product’s PA policy.

Background

All-oral direct-acting antivirals (DAAs) represent the standard of care for HCV across genotypes. Mavyret is one of the DAAs included in this program and is specifically addressed across multiple genotype, renal, pediatric, transplant, and prior-treatment scenarios. Where approved, Mavyret authorizations follow the duration and requirements specified in the Hepatitis C - Mavyret PA for PSM Policy and may require documentation of prior therapies and lack of sustained virologic response (SVR) depending on the genotype and clinical context.

Definitions

Definition of Sustained Viral Response (SVR)

DefinitionSustained viral response (SVR): virus undetectable 12 weeks following completion of therapy

Documentation requirementDocumentation that the patient did not achieve SVR is required when prior‑treatment failure is used as an exception criterion

Context of useSVR is used as evidence of treatment failure in prior‑therapy pathways for approval of non‑preferred products such as Mavyret

SVR (redundant listing) — sustained viral response definition

SVR definition (redundant)Sustained viral response (SVR): virus undetectable 12 weeks following completion of therapy

Role in prior‑therapy scenariosRequired as documentation when prior completed therapy (e.g., Zepatier, Epclusa, Harvoni) failed to achieve SVR