ModifiedCignaPolicy PSM026

Hepatitis C Virus Direct-Acting Antivirals Preferred Specialty Management Policy for Individual and Family Plans

Defines preferred and non-preferred direct-acting antivirals (DAAs) for chronic hepatitis C and establishes a Preferred Specialty Management program requiring patients to meet standard Hepatitis C prior authorization criteria and generally try a preferred product before non-preferred agents are approved.

Policy Summary

PayerCigna

PolicyHepatitis C Virus Direct-Acting Antivirals Preferred Specialty Management Policy for Individual and Family Plans

Policy CodePolicy PSM026

Change TypeNew policy

Effective DateJul 1, 2025

Next Review Date

Key ActionSubmit prior authorization and required documentation demonstrating prior preferred-product use or clinical exception criteria to request non-preferred DAAs.

SourceLink

POLICY UPDATE CHANGES

New policy created with exception and prior authorization criteria for non-preferred Hepatitis C direct-acting antivirals.

7HCV DAA products listed

1-6HCV genotypes addressed

By genotypePreferred vs Non-Preferred

07/01/2025Effective date

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Coverage Criteria for Non-Preferred Hepatitis C DAAs

inv-01: Non-Preferred Product Exception Criteria (by agent and genotype)

Non-preferred products are considered medically necessary only when ALL applicable exception criteria below are met for the specified genotype and patient scenario.

Non-Preferred Exception Overview

Mavyret - General rule
- Mavyret Genotype 1 Adults (New Start): A) If treatment-naïve: Mavyret is not approved (request for Preferred Products may be reviewed using respective Hepatitis C PA Policy); OR B) Approve if: i) patient meets Hepatitis C - Mavyret PA Policy criteria AND ii) patient meets ONE of: a) previously treated with pegylated interferon/ribavirin, Incivek, Olysio, or Victrelis AND has completed a course of Epclusa, Harvoni, or Zepatier with documentation of lack of sustained viral response (SVR) [documentation required]; OR b) previously treated with Daklinza, Epclusa, Harvoni, or Zepatier; OR c) previously treated with Sovaldi + ribavirin ± pegylated interferon/interferon or Sovaldi + Olysio. Documentation of prior therapy and SVR status is required.
  Applies similarly to pediatric and other genotype branches

Mavyret - Other genotypes and scenarios: For genotypes 2–6 (adult and pediatric branches): A) If treatment‑naïve: Mavyret is not approved and Preferred Products may be reviewed; OR B) Approve when patient meets Hepatitis C - Mavyret PA Policy criteria AND meets specified prior-treatment conditions (e.g., prior pegylated interferon/ribavirin with documented lack of SVR after Epclusa/Harvoni, prior Sovaldi-containing regimens, or other listed prior regimens).

Includes genotype‑specific prior‑therapy options and required documentation

Mavyret - Renal impairment / Transplant: Approve Mavyret for patients with eGFR <30 mL/min or ESRD, kidney transplant recipients, certain post‑liver transplant recurrent HCV, and liver transplant recipients when Hepatitis C - Mavyret PA Policy criteria are met.

See Mavyret PA Policy for durations and details

Mavyret - Unknown genotype: Mavyret is not approved for chronic HCV with unknown/undetermined genotype and no cirrhosis; may be approved for compensated cirrhosis if Hepatitis C - Mavyret PA Policy criteria are met.

Documentation and PA criteria required

Vosevi specific: Approve Vosevi for genotypes 1–6 new starts when the patient has met the standard Hepatitis C - Vosevi PA Policy criteria. Continuing therapy with Vosevi follows the standard Vosevi PA Policy criteria.

See Hepatitis C - Vosevi PA Policy for durations and exact criteria

Zepatier new start: For genotype 1 or 4 new starts: A) If treatment‑naïve: Zepatier is not approved (Preferred Products may be reviewed under respective PA policies). B) Approve only if: i) patient meets Hepatitis C - Zepatier PA Policy criteria AND ii) patient completed a course of Epclusa, Harvoni, or Mavyret and has documentation of lack of sustained viral response (SVR; virus undetectable 12 weeks following therapy) [documentation required]; OR C) patient meets other standard Zepatier PA criteria. Continuing therapy with Zepatier follows the standard Zepatier PA Policy criteria.

Documentation of prior therapy and SVR status is required for prior‑therapy exceptions

inv-02: Preferred product selection

Preferred and non-preferred products are designated by genotype; Preferred products are encouraged and patients are directed to try a Preferred Product prior to non-preferred agents.

Preferred products by genotype: Preferred agents are listed by genotype: Genotype 1: Epclusa, Harvoni, sofosbuvir/velpatasvir (generic), ledipasvir/sofosbuvir (generic). Genotype 2: Epclusa, sofosbuvir/velpatasvir (generic). Genotype 3: Epclusa, sofosbuvir/velpatasvir (generic). Genotype 4: Epclusa, Harvoni, sofosbuvir/velpatasvir (generic), ledipasvir/sofosbuvir (generic). Genotype 5 or 6: Epclusa, Harvoni, sofosbuvir/velpatasvir (generic), ledipasvir/sofosbuvir (generic). Providers should select Preferred agents first; exceptions are managed via Non‑Preferred Product Exception Criteria.

See policy Preferred/Non‑Preferred lists for full details

inv-03: Special scenarios

Special scenarios are addressed in exception criteria for specific agents.

Mavyret - renal impairment and transplant: Mavyret may be approved for patients with eGFR <30 mL/min or end‑stage renal disease (ESRD), kidney transplant recipients, and certain post‑liver transplant recurrent HCV when Hepatitis C - Mavyret PA Policy criteria are met.

Refer to Mavyret PA Policy for treatment duration and detailed criteria

Post‑transplant and pediatric indications: Mavyret may be approved for liver transplant recipients and recurrent HCV post‑liver transplant (adult and pediatric as specified) when Hepatitis C - Mavyret PA Policy criteria are met.

See chunks 16–18 for genotype‑specific transplant branches

Vosevi and Zepatier continuing therapy: Approvals for continuing therapy with Vosevi or Zepatier should refer to the respective standard PA Policy criteria; Zepatier new starts are not approved for treatment‑naïve patients unless documented prior therapy failure per criteria.

See Vosevi and Zepatier PA Policies for continuation rules

inv-04: Non-preferred product exception criteria

Non-preferred product exception criteria — approvals are allowed only when specified criteria are met or when the member meets referenced preferred-product PA policy criteria.

Mavyret specific: Approvals for multiple genotypes and post‑transplant scenarios are allowed when the member meets Hepatitis C - Mavyret PA Policy criteria; Mavyret is not approved for chronic HCV with unknown/undetermined genotype without cirrhosis but may be approved for compensated cirrhosis if Mavyret PA Policy criteria are met.

Refer to Hepatitis C - Mavyret PA Policy for durations and exact criteria.

Vosevi specific: Approve Vosevi for genotypes 1–6 chronic HCV new starts when the patient has met the Hepatitis C - Vosevi PA Policy criteria; continuation follows the standard Vosevi PA Policy.

Refer to Hepatitis C - Vosevi PA Policy for durations and exact criteria.

Zepatier new start: For genotype 1 or 4 new starts: Zepatier is not approved for treatment‑naïve patients. Approve only if the patient meets Hepatitis C - Zepatier PA Policy criteria AND either (a) patient completed therapy with Epclusa, Harvoni, or Mavyret and did not achieve SVR (documentation required), or (b) meets other standard Zepatier PA Policy criteria.

This policy does not address Sovaldi. For coverage criteria and prior authorization requirements related to sofosbuvir (Sovaldi), refer to the separate Hepatitis C - Sovaldi Prior Authorization Policy.

For Mavyret: Mavyret is not approved for chronic HCV when the genotype is unknown/undetermined and there is no cirrhosis; such requests should be directed to preferred agents (for example, Epclusa or sofosbuvir/velpatasvir) and reviewed under their PA policies. Mavyret may be approved for compensated cirrhosis, transplant, pediatric, and other scenarios when the Hepatitis C - Mavyret PA Policy criteria are met.

For Zepatier: Zepatier is listed as a non-preferred agent for certain genotypes and has specific restrictions for new starts. In particular, for genotype 1 or 4 new starts, Zepatier is not approved for treatment‑naïve patients; approvals for new starts require meeting the standard Hepatitis C - Zepatier PA Policy criteria and documented prior therapy failure with a preferred DAA (e.g., Epclusa, Harvoni, or Mavyret) with lack of sustained viral response (SVR) where applicable.

Any use of a non-preferred product that does not meet the specified non-preferred product exception criteria in this policy is considered not medically necessary and is not eligible for coverage under this policy.

Requests that do not meet the listed non-preferred exception criteria or the referenced preferred-product PA policy criteria may be denied as not medically necessary. Examples include Zepatier requests for treatment‑naïve patients and Mavyret requests for unknown genotype without cirrhosis when the exception criteria are not satisfied.

What Providers Must Do

Prior Authorization

Prior Authorization Required

All medications (preferred and non-preferred) require meeting the respective standard Hepatitis C Prior Authorization Policy criteria. Prior authorization is required before dispensing; approvals are provided for the duration specified in the referenced Hepatitis C PA policies.

Applies to both Preferred and Non-Preferred Products
See respective Hepatitis C PA Policy for covered diagnosis/procedure codes

Prior Authorization

Non-Preferred Product Prior Authorization

Non-preferred Hepatitis C products (for example: Mavyret, Vosevi, Zepatier when listed as non-preferred) require prior authorization. Approval is contingent on meeting the non-preferred product exception criteria in this policy or the referenced standard Hepatitis C PA Policy.

Non-preferred list by genotype located in Preferred and Non-Preferred Products section
Approval follows exception criteria in this document or referenced PA policies

Step Therapy

Try Preferred Product First

The program directs that patients try one Preferred Product prior to approval of a non-preferred product unless an exception criterion is met.

If the patient meets standard Hepatitis C PA criteria but has not tried a Preferred Product, requests may be reviewed for Preferred Products per the respective PA policy
Preferred products include Epclusa, Harvoni, and authorized generics listed by genotype

Documentation Required

Documentation Required for Non‑Preferred Exceptions

When requesting a non-preferred product, documentation is required. Documentation may include, but is not limited to, chart notes, prescription claims records, prescription receipts, and/or other supporting information.

Provide chart notes or prescription claim/receipt showing prior therapies and dates
Include relevant lab results and clinical notes supporting medical necessity

Documentation Required

SVR Failure Documentation / Zepatier Step Requirement

For requests for Zepatier after prior therapy, provide documentation that the patient completed a course of Epclusa (brand or generic), Harvoni (brand or generic), or Mavyret and did not achieve a sustained virologic response (SVR; virus undetectable 12 weeks following completion of therapy). Without documentation of SVR failure, Zepatier requests for treatment‑naïve patients are not approved.

Document completion of prior designated preferred therapy and post-treatment HCV RNA showing detectable virus at 12 weeks post-therapy (no SVR)
If patient is treatment‑naïve, Zepatier is not approved — consider Preferred Products instead

Billing Rule

Coding‑Based Denials

Claims submitted without covered diagnosis or procedure codes specified in the applicable Coverage Policy will be denied as not covered. Providers must use the most appropriate and current codes as of the submission date.

Verify covered ICD-10 and procedure codes per the applicable Hepatitis C Coverage Policy before billing
Claims lacking covered codes will be denied

Initial Therapy: Preferred Product Selection and Rules

inv-21: Initial therapy guidance

For initial therapy, Preferred products listed per genotype should be used.

Initial therapy selection: Preferred products by genotype (see Preferred product lists) should be used for new starts. Requests for non‑preferred agents for initial therapy are generally not approved unless specific exception criteria are met (e.g., prior treatment failure, specific prior regimens, renal impairment, transplant status).

See Non‑Preferred Product Exception Criteria for allowed exceptions

inv-22: Initial therapy rules

Initial therapy approvals for non-preferred agents are limited and require meeting exception rules or prior failure of preferred agents.

Zepatier initial: Zepatier is not approved for treatment‑naïve patients. To approve Zepatier for a new start, the patient must meet the Hepatitis C - Zepatier PA Policy criteria AND have completed a course of Epclusa, Harvoni, or Mavyret with documentation of lack of sustained viral response (SVR) [documentation required]; otherwise Preferred Products should be considered via their PA policies.

Continuation Therapy

inv-23: Continuation therapy rules

Continuation therapy approvals defer to the respective product PA policies.

Continuing therapy with Mavyret/Vosevi/Zepatier: Patients continuing prior therapy with Mavyret, Vosevi, or Zepatier should be referred to the respective Hepatitis C DAA PA Policy criteria for continuation approvals.

See respective product PA Policies for continuation durations and criteria

inv-24: Continuation therapy references

Continuation approvals follow the established PA policy for the specific product.

Mavyret continuation: Patient continuing therapy with Mavyret: refer to Hepatitis C - Mavyret PA Policy criteria for continuation.

Vosevi continuation: Patient continuing therapy with Vosevi: refer to Hepatitis C - Vosevi PA Policy criteria for continuation.

Zepatier continuation: Patient continuing therapy with Zepatier: refer to Hepatitis C - Zepatier PA Policy criteria for continuation.

Step Therapy Requirements

Step requirement	Details
Try a Preferred Product first
Program directs patient to try one Preferred Product prior to use of a Non‑Preferred DAA; requests for Non‑Preferred products will be reviewed using the Non‑Preferred Product Exception Criteria and all therapies (Preferred and Non‑Preferred) must meet the respective standard Hepatitis C Prior Authorization Policy criteria.

Coverage label	Zepatier new-start requirement
Zepatier step requirement
For new starts, Zepatier is not approved for treatment‑naïve patients. Approve only if the patient meets the standard Hepatitis C - Zepatier PA Policy criteria AND has completed a course of therapy with ONE of Epclusa, Harvoni, or Mavyret and documentation shows the patient did not achieve a sustained viral response (SVR; virus undetectable 12 weeks following therapy) [documentation required]. If the patient meets PA criteria but not prior‑therapy failure, consideration will be given to Preferred Products per their PA policies.

Coverage label

Zepatier new-start requirement

Zepatier step requirement

For new starts, Zepatier is not approved for treatment‑naïve patients. Approve only if the patient meets the standard Hepatitis C - Zepatier PA Policy criteria AND has completed a course of therapy with ONE of Epclusa, Harvoni, or Mavyret and documentation shows the patient did not achieve a sustained viral response (SVR; virus undetectable 12 weeks following therapy) [documentation required]. If the patient meets PA criteria but not prior‑therapy failure, consideration will be given to Preferred Products per their PA policies.

Background and Context

Background: The standard of care for chronic hepatitis C across genotypes is all-oral therapy with direct-acting antivirals (DAAs). Multiple DAAs exist with genotype-specific indications; preferred product lists by genotype are provided in this policy (e.g., Epclusa, Harvoni, sofosbuvir/velpatasvir, ledipasvir/sofosbuvir), while other agents (Mavyret, Vosevi, Zepatier) are designated non-preferred for certain genotypes and are subject to exception criteria for approval.

Key Definitions

Sustained viral response (SVR)

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

Use in policyUsed as documentation of treatment failure when absent (i.e., lack of SVR indicates failed prior therapy).

TimingAssessment performed 12 weeks after finishing the antiviral regimen.

SVR — virus undetectable 12 weeks following therapy

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

Documentation requirementWhen required for approval (e.g., Zepatier after prior therapy), documentation that the patient did not achieve SVR is required.

Policy implicationLack of SVR after a completed course of a preferred DAA may satisfy exception criteria for some non-preferred products.

Policy Revision History

2025-07-01policy_createdLatest

New Preferred Specialty Management policy (PSM026) established defining preferred vs non-preferred Hepatitis C DAAs and exception/prior-authorization criteria; effective date set for 07/01/2025.