CurrentCignaPolicy PSM025

Hepatitis C Virus Direct-Acting Antivirals Preferred Specialty Management Policy for Employer Plans

Defines preferred vs non-preferred direct-acting antiviral (DAA) products by HCV genotype for employer plans administered by Cigna, requires meeting respective standard Hepatitis C Prior Authorization (PA) Policy criteria for all medications, and specifies exception criteria for non-preferred products including documentation requirements and substitution rules when preferred products are unavailable.

Policy Summary

PayerCigna

PolicyHepatitis C Virus Direct-Acting Antivirals Preferred Specialty Management Policy for Employer Plans

Policy CodePolicy PSM025

Change TypeNew policy; Mavyret acute indication added; generic availability criteria clarified

Effective Date02/01/2026

Next Review Date

Key ActionAll medications require meeting the respective standard Hepatitis C Prior Authorization Policy criteria; provide required documentation for non-preferred exceptions and verify preferred brand market availability via a verifiable source when approving generics.

POLICY UPDATE CHANGES

New policy created.

Mavyret acute HCV indication added.

Market availability language for generics updated to require verifiable source.

8Antiviral products listed

21Exception clinical scenarios enumerated

PSM025Policy number

Coverage Summary

Scope: This policy defines preferred versus non-preferred direct-acting antiviral (DAA) products for Hepatitis C virus (HCV) by genotype for employer plans administered by Cigna and requires that all requests meet the respective standard Hepatitis C Prior Authorization (PA) Policy criteria. It directs patients to try one Preferred Product prior to use of a non-preferred product unless applicable exception criteria are met.

High-level stance: For each HCV genotype the policy identifies Preferred Products (examples include Epclusa (brand), Harvoni (brand), Vosevi, Zepatier for selected genotypes) and lists specific Non-Preferred Products (examples include Mavyret and certain generics) that are subject to exception criteria. All medications require PA and approvals are provided for the duration documented in the respective standard Hepatitis C PA Policy. Non-preferred products may be granted via defined exception pathways that typically require documentation (for example, prior failure to achieve SVR or verifiable market unavailability of the preferred brand).

General Policy Statement

Covered when ALL of the following are met:

Patient must meet the respective standard Hepatitis C Prior Authorization (PA) Policy criteria for the requested medication.
Patient must try one Preferred Product prior to non-preferred product unless exception criteria are met.
Approvals are provided for the duration documented in the respective standard Hepatitis C Prior Authorization Policy.

Administrative Note: Documentation is required for use of a non-preferred product as noted in the criteria; documentation may include chart notes, prescription claims records, prescription receipts, and must include patient-identifying information.

Preferred vs Non‑Preferred by Genotype

Preferred vs Non-Preferred by Genotype (Coverage preference)

Preferred Products by Genotype

Genotype 1 Preferred
- Epclusa (brand)
- Harvoni (brand)
- Vosevi
- Zepatier
Genotype 2 Preferred

Non‑Preferred Product Exception Criteria

Non-Preferred Product Exception Criteria (by product)

Non-preferred products are considered medically necessary ONLY when the listed exception criteria specific to each non-preferred product are met. Any other exception is not medically necessary.

Product-specific exception branches

Epclusa (brand) - Exception: Approve for the duration specified in the standard Hepatitis C - Epclusa PA Policy if the patient has met the standard Hepatitis C - Epclusa PA Policy criteria.
sofosbuvir/velpatasvir (generic only) - Exception: Approve for the duration specified in the standard Hepatitis C - Epclusa PA Policy if the patient has met the standard Hepatitis C - Epclusa PA Policy criteria AND the Preferred Product, Epclusa (brand), is not available on the market per a verifiable source (for example, FDA Drug Shortage database or ASHP Drug Shortage List).
Harvoni (brand) - Exception:

Applicable Products / Codes

Products listedmixed

	Epclusa (sofosbuvir/velpatasvir) - brand and authorized generic tablets and oral pellets
	sofosbuvir/velpatasvir - authorized generic to Epclusa (Asegua Therapeutics)
	Harvoni (ledipasvir/sofosbuvir) - brand and authorized generic tablets and oral pellets
	ledipasvir/sofosbuvir - authorized generic to Harvoni (Asegua Therapeutics)
	Mavyret (glecaprevir/pibrentasvir) - tablets and oral pellets
	Sovaldi (sofosbuvir) - tablets and oral pellets
	Vosevi (sofosbuvir/velpatasvir/voxilaprevir) - tablets
	Zepatier (grazoprevir/elbasvir) - tablets

Provider Actions

Prior Authorization

Prior authorization required

All medications (preferred and non-preferred) require meeting the respective standard Hepatitis C Prior Authorization (PA) Policy criteria. Approvals are provided for the duration documented in the respective standard Hepatitis C PA Policy.

Prior Authorization

Market availability substitution rule

Generic sofosbuvir/velpatasvir or generic ledipasvir/sofosbuvir may be approved only when the corresponding preferred brand (Epclusa or Harvoni, respectively) is not available on the market per a verifiable source such as the FDA Drug Shortage database or the ASHP Drug Shortage List.

Clinical Evidence and Indications

Brief Evidence

Epclusa indication age≥ 3 years for genotypes 1–6; decompensated cirrhosis in combination with ribavirin

Mavyret indication≥ 3 years for acute or chronic HCV genotypes 1–6; additional kidney and liver transplant and renal impairment dosing/indications per prescribing information

Background: All-oral direct-acting antivirals (DAAs) are the standard of care for all HCV genotypes. Product-specific labeling included in the policy notes age and genotype indications: for example, Epclusa is indicated for genotypes 1–6 in patients ≥ 3 years (with decompensated cirrhosis only in combination with ribavirin); Harvoni is indicated in patients ≥ 3 years for genotypes 1, 4, 5, and 6 (with additional transplant/decompensated cirrhosis indications per prescribing information); Mavyret is indicated for acute and chronic HCV genotypes 1–6 in patients ≥ 3 years and includes additional transplant and renal dosing/indications per its labeling; Sovaldi, Vosevi, and Zepatier have the genotype and age indications summarized in the prescribing information referenced by the policy.

Program implementation: This document implements a Preferred Specialty Management program that encourages use of Preferred Products, requires meeting the respective standard Hepatitis C PA criteria for all medications, and establishes exception pathways for non-preferred products. Exceptions include product-specific clinical branches (for example, Mavyret and generics) that require documentation such as prior treatment completion with lack of sustained viral response (SVR) or verification that a preferred brand is unavailable on the market per a verifiable source (e.g., FDA Drug Shortage database or ASHP Drug Shortage List).

Definitions

SVR (Sustained Viral Response) definitionVirus undetectable 12 weeks following completion of therapy

Preferred Product definitionAn agent designated as preferred in this policy for a given HCV genotype; the patient is directed to try one Preferred Product prior to non-preferred products unless exception criteria are met

Revision History

2025-07-01policy_created

New policy created; initial effective/creation noted.

2025-11-01material_revision

Mavyret acute HCV indication added (Mavyret approved for acute HCV genotypes 1-6); listed as selected revision dated 11/01/2025 and reflected in exception criteria.

2026-02-01material_clarificationLatest

Market availability language for generics (sofosbuvir/velpatasvir generic and ledipasvir/sofosbuvir generic) clarified to require that the Preferred Product (Epclusa or Harvoni brand) is not available on the market per a verifiable source (e.g., FDA Drug Shortage database or ASHP Drug Shortage List); effective date equals policy effective date.

Policy Summary

PayerCigna

PolicyHepatitis C Virus Direct-Acting Antivirals Preferred Specialty Management Policy for Employer Plans

Policy CodePolicy PSM025

Change TypeNew policy; Mavyret acute indication added; generic availability criteria clarified

Effective Date02/01/2026

Next Review Date

On This Page

Genotype 3 Preferred

Epclusa (brand)
Vosevi

Genotype 4 Preferred

Epclusa (brand)
Harvoni (brand)
Vosevi
Zepatier

Genotype 5 or 6 Preferred

Epclusa (brand)
Harvoni (brand)
Vosevi

Non-Preferred Examples by Genotype: Genotype 1 non-preferred: Mavyret; sofosbuvir/velpatasvir (generic); ledipasvir/sofosbuvir (generic). Genotype 2 non-preferred: Mavyret; Sovaldi; sofosbuvir/velpatasvir (generic). Genotype 3 non-preferred: Mavyret; Sovaldi; sofosbuvir/velpatasvir (generic). Genotype 4 non-preferred: Mavyret; sofosbuvir/velpatasvir (generic); ledipasvir/sofosbuvir (generic). Genotype 5 or 6 non-preferred: Mavyret; sofosbuvir/velpatasvir (generic); ledipasvir/sofosbuvir (generic).

Approve for the duration specified in the standard Hepatitis C - Harvoni PA Policy if the patient has met the standard Hepatitis C - Harvoni PA Policy criteria.

ledipasvir/sofosbuvir (generic only) - Exception: Approve for the duration specified in the standard Hepatitis C - Harvoni PA Policy if the patient has met the standard Hepatitis C - Harvoni PA Policy criteria AND the Preferred Product, Harvoni (brand), is not available on the market per a verifiable source (for example, FDA Drug Shortage database or ASHP Drug Shortage List).

Sovaldi - Exception: Genotype 2 or 3 chronic HCV, pediatric patient (≥ 3 and < 18 years) - New start: Sovaldi is not approved; request for Epclusa (brand only) may be reviewed using Epclusa PA criteria. Patient continuing therapy with Sovaldi: refer to the standard Hepatitis C - Sovaldi PA Policy criteria.

Mavyret - Exception (many genotype- and population-specific branches): Comprehensive Mavyret exception criteria by genotype and patient population; includes acute HCV approval if Mavyret PA criteria met; and numerous genotype-specific new start branches requiring either (A) treatment-naïve disallowance with referral to Preferred Products, or (B) approval only if Mavyret PA criteria met AND specified prior-treatment conditions (e.g., prior therapies listed) with documentation of failure to achieve SVR when required. Also includes renal impairment, transplant, genotype unknown, compensated cirrhosis, and continuation rules as detailed in policy.

Documentation of prior therapy completion and failure to achieve SVR (virus undetectable 12 weeks post-therapy) is required in specified branches.

Vosevi - Exception: Genotype 1-6 chronic HCV: Approve for the duration specified in the standard Hepatitis C - Vosevi PA Policy criteria if patient has met that PA criteria. Patient continuing therapy with Vosevi: refer to the standard Hepatitis C - Vosevi PA Policy criteria.

Zepatier - Exception: Genotype 1 or 4 chronic HCV - New start: Approve for the duration specified in the standard Hepatitis C - Zepatier PA Policy criteria if patient has met that PA criteria. Patient continuing therapy with Zepatier: refer to the standard Hepatitis C - Zepatier PA Policy criteria.

Administrative: Any approval for non-preferred products follows the documentation and duration rules in the respective standard Hepatitis C PA Policy; market-availability exceptions for generic sofosbuvir/velpatasvir and generic ledipasvir/sofosbuvir require verifiable source evidence (e.g., FDA Drug Shortage database or ASHP Drug Shortage List).

Documentation Required

Documentation for non-preferred exceptions

Documentation is required for use of a non-preferred product where noted in the criteria. Examples include chart notes, prescription claims records, and prescription receipts. All documentation must include patient-specific identifying information.

Chart notes
Prescription claims records
Prescription receipts
Other supporting information

Documentation Required

SVR failure documentation required

For many Mavyret exception pathways, approval requires documentation that the patient completed the prior therapy and did not achieve a sustained viral response (SVR). SVR is defined as virus undetectable 12 weeks following completion of therapy.

Completed prior course of the specified therapy
Documentation that SVR was not achieved (virus undetectable 12 weeks post-therapy)