Cigna hepatitis C DAA policy update Coverage

Coverage Criteria for Hepatitis C Direct-Acting Antivirals

General approach — Preferred first, exceptions per product

Non-preferred DAA products are considered medically necessary only when the specified exception criteria for each product are met.

Preferred product requirement

Preferred products by genotype: Genotype 1: generic sofosbuvir/velpatasvir or generic ledipasvir/sofosbuvir. Genotype 2: generic sofosbuvir/velpatasvir. Genotype 3: generic sofosbuvir/velpatasvir. Genotype 4: generic sofosbuvir/velpatasvir or generic ledipasvir/sofosbuvir. Genotype 5/6: generic sofosbuvir/velpatasvir or generic ledipasvir/sofosbuvir.
chunk 7

Epclusa exception criteria

Epclusa (brand 400/100 mg and other formulations) may be approved only under defined circumstances.

Epclusa 400/100 mg (brand only): Approve for the duration specified in the standard Hepatitis C - Epclusa PA Policy if the patient has met the Hepatitis C - Epclusa PA Policy criteria AND the Preferred Product (sofosbuvir/velpatasvir) is not available on the market per a verifiable source (e.g., FDA Drug Shortage database or ASHP Drug Shortage list).

chunk 8

Epclusa 200/50 mg tablets or oral pellets (pediatric): Approve for the duration specified in the standard Hepatitis C - Epclusa PA Policy if the patient has met the Hepatitis C - Epclusa PA Policy criteria AND one of: (1) Pediatric patient ≥17 kg and <30 kg with genotype 1–6 and no cirrhosis or compensated cirrhosis (Child-Pugh A); (2) Pediatric patient ≥17 kg and <30 kg with decompensated cirrhosis (Child-Pugh B or C); OR (3) Adult ≥18 years when indicated per the standard Hepatitis C - Epclusa PA Policy. Note: brand-only 200/50 mg tablets or pellets are not approved for adults; requests for the preferred generic may be reviewed under the standard Epclusa PA Policy.

chunk 9

Harvoni exception criteria

Harvoni brand and pediatric formulations have specific exception rules.

Harvoni 90/400 mg (brand only): Approve for the duration specified in the standard Hepatitis C - Harvoni PA Policy if the patient has met the Hepatitis C - Harvoni PA Policy criteria AND the Preferred Product (ledipasvir/sofosbuvir) is not available on the market per a verifiable source (e.g., FDA Drug Shortage database or ASHP Drug Shortage list).

chunk 9

Harvoni 45/200 mg tablets or oral pellets (pediatric): Approve for pediatric patients (≥3 to <12 years) with genotype 1, 4, 5, or 6, or recurrent post-liver transplant genotype 1 or 4 when the patient has met the standard Hepatitis C - Harvoni PA Policy criteria. Brand-only 45/200 mg tablets or pellets are not approved for patients ≥12 years; requests for the preferred generic may be reviewed under the Harvoni PA Policy.

chunk 10

Mavyret exception criteria

Mavyret approvals depend on genotype, prior treatment history, and specific clinical scenarios; many new-start adult indications require prior therapy or documented failure of specified agents.

Mavyret — acute HCV (genotypes 1–6): Approve for the duration specified in the Hepatitis C - Mavyret PA Policy for PSM if the patient has met the Hepatitis C - Mavyret PA for PSM Policy criteria.

chunk 11

Mavyret — Genotype 1 adult new start: If treatment-naïve: Mavyret is not approved; a request for preferred generics may be reviewed under their PA criteria. If not treatment-naïve: approve for the duration specified in the Hepatitis C - Mavyret PA Policy if BOTH (i) patient meets the Hepatitis C - Mavyret PA Policy criteria AND (ii) patient meets ONE of: (a) prior treatment with pegylated interferon/ribavirin, Incivek, Olysio, or Victrelis AND completed a course of Epclusa (brand or generic), Harvoni (brand or generic), or Zepatier with documentation of lack of SVR (virus undetectable 12 weeks following therapy) [documentation required]; OR (b) prior treatment with Daklinza, Epclusa, Harvoni, or Zepatier; OR (c) prior Sovaldi + ribavirin ± pegylated interferon/interferon or Sovaldi + Olysio. Documentation of prior therapy and SVR status required when applicable.

chunks 11-13

Mavyret — Genotype 2 or 3 adult new start:

Vosevi and Zepatier exception criteria

Vosevi and Zepatier approvals tied to standard PA criteria and prior treatment history.

Vosevi — new start (genotypes 1–6): Approve for the duration specified in the standard Hepatitis C - Vosevi PA Policy criteria if the patient has met the standard Hepatitis C - Vosevi PA Policy criteria.

chunk 18

Zepatier — new start (genotype 1 or 4): If treatment-naïve: Zepatier is not approved; requests for preferred generics may be reviewed under their PA criteria. Approve per the standard Hepatitis C - Zepatier PA Policy if BOTH (i) the patient meets the standard Zepatier PA Policy criteria AND (ii) the patient completed a course of Epclusa (brand or generic), Harvoni (brand or generic), or Mavyret and did not achieve a sustained viral response (SVR; virus undetectable 12 weeks following therapy) [documentation required]. If the patient meets the PA criteria but lacks documented prior failure, consider preferred products under their PA policies.

chunk 18

Vosevi exception criteria

Approve non-preferred products only when referenced standard Hepatitis C PA policy criteria are met or specified exception conditions apply.

Vosevi: genotypes unknown and chronic genotypes 1–6: Approve for the duration specified in the Hepatitis C - Mavyret PA Policy criteria if the patient has met the Hepatitis C - Mavyret PA Policy criteria; for genotype 1–6 new starts, approve per the Hepatitis C - Vosevi PA Policy if standard Vosevi criteria are met; refer to standard Vosevi PA criteria for continuing therapy.

chunk 18

Zepatier exception criteria

Zepatier is non-preferred for genotype 1 or 4 chronic HCV new starts with distinct rules:

Zepatier new start and prior therapy conditions: A) If patient is treatment-naïve: Zepatier is not approved; requests for preferred products (generic sofosbuvir/velpatasvir or generic ledipasvir/sofosbuvir) may be reviewed under their PA criteria. B) Approve per Zepatier PA if BOTH (i) patient meets the standard Zepatier PA Policy criteria AND (ii) patient completed a course of Epclusa (brand or generic), Harvoni (brand or generic), or Mavyret and did not achieve SVR (virus undetectable 12 weeks following completion of therapy) [documentation required]. C) If patient meets B(i) but not B(ii): consider preferred products per their PA policies.

chunk 18

Continuation Therapy

Continuing therapy rules

Continuing therapy for Vosevi and Zepatier: Requests for patients continuing therapy with Vosevi or Zepatier should be referred to the respective standard Hepatitis C PA policy criteria for continuation approvals.

chunk 18

Certain brand pediatric formulations are limited by age. Epclusa 200/50 mg tablets and oral pellets are approved only for pediatric patients weighing ≥17 kg and <30 kg for genotypes 1–6 (no cirrhosis, compensated cirrhosis, or decompensated cirrhosis per the Epclusa PA criteria). Epclusa 200/50 mg brand formulations are not approved for adults (≥18 years); requests should be reviewed using the preferred generic sofosbuvir/velpatasvir under the standard Hepatitis C – Epclusa PA Policy. Similarly, Harvoni 45/200 mg tablets and oral pellets are approved only for pediatric patients ≥3 to <12 years for specified genotypes and post-transplant indications and are not approved for patients ≥12 years (preferred generic ledipasvir/sofosbuvir should be considered for older patients).

For new treatment starts with genotype 1 or 4 chronic HCV, Zepatier (grazoprevir/elbasvir) is not approved for treatment‑naïve patients. A request for Zepatier for a new start may be considered only if the patient meets the standard Hepatitis C – Zepatier PA Policy criteria and has completed a full course of therapy with one of Epclusa, Harvoni, or Mavyret and has documentation of failure to achieve a sustained viral response (SVR; virus undetectable 12 weeks following therapy). If the patient is treatment‑naïve, preferred generics such as sofosbuvir/velpatasvir or ledipasvir/sofosbuvir should be reviewed per their PA criteria.

Requests for non-preferred direct-acting antivirals are reviewed under exception criteria. If a request for a non-preferred product does not meet the specific exception conditions listed for that product (for example, prior-treatment requirements, documented lack of SVR where required, or verified unavailability of the preferred product), the request is considered not medically necessary and will not be approved.

Specifically for Zepatier new starts in genotype 1 or 4: if the patient is treatment‑naïve, coverage for Zepatier is denied under these criteria; approval is allowed only when the patient both meets the standard Hepatitis C – Zepatier PA Policy criteria and has completed prior therapy with Epclusa, Harvoni, or Mavyret with documentation showing the patient did not achieve an SVR (documentation required). When those conditions are not met, consider the preferred generic products per their respective PA policies.

Initial Therapy Preferences and Rules

Initial therapy preferences

Preferred products by genotype should be used for initial therapy; non-preferred products have specific exception-based initial use.

Preferred initial therapy by genotype: Genotype 1: generic sofosbuvir/velpatasvir or generic ledipasvir/sofosbuvir. Genotype 2: generic sofosbuvir/velpatasvir. Genotype 3: generic sofosbuvir/velpatasvir. Genotype 4: generic sofosbuvir/velpatasvir or generic ledipasvir/sofosbuvir. Genotype 5/6: generic sofosbuvir/velpatasvir or generic ledipasvir/sofosbuvir.

chunk 7

Initial therapy rules — new start rules for non-preferred products

New start rules for non-preferred products

New start: Vosevi, Zepatier, Mavyret: Vosevi: Approve per referenced Vosevi PA criteria for genotypes 1–6 when standard Vosevi criteria are met. Zepatier: Not approved for treatment-naïve genotype 1 or 4; may be approved only if standard Zepatier PA criteria are met AND the patient completed a course of Epclusa, Harvoni, or Mavyret without achieving SVR (documentation required). Mavyret: See Hepatitis C - Mavyret PA Policy for PSM for genotype- and prior-treatment–specific criteria and approved indications (including acute HCV and select pediatric/renal/transplant indications).

Continuation Therapy Rules

Continuation therapy — follow standard product PA policy

Continuing therapy rules follow the respective standard product PA policy.

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

chunk 18

Continuation therapy — rules for patients already on non-preferred products

For patients already on therapy with non-preferred products:

Continuation for patients on non-preferred products: Refer to the standard Hepatitis C - Vosevi PA Policy or Hepatitis C - Zepatier PA Policy criteria for continuing therapy approvals; documentation of prior authorization and treatment response may be required.

chunk 18

Continuation Therapy (duplicate contextual rule)

Step Therapy Requirements

Step	Requirement	Notes
1
Trial of a Preferred Product is required prior to approval of many non-preferred products
Per the Preferred Specialty Management program, patients must meet the respective standard Hepatitis C Prior Authorization Policy criteria and be directed to try one Preferred Product; non-preferred requests are reviewed under exception criteria when preferred products were not effective or unavailable

Step	Requirement	Notes
1
Prior use of preferred products or documentation of prior therapy failure may be required before approving certain non-preferred products
For example, Zepatier is not approved for treatment‑naïve genotype 1 or 4 new starts; approval requires meeting Zepatier PA criteria and documented completion of Epclusa, Harvoni, or Mavyret without achieving sustained viral response (SVR) where specified

Provider Actions, Prior Authorization and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization Required — all Hepatitis C medications (Preferred and Non-Preferred) require prior authorization. Requests for non-preferred products will be reviewed against the standard Hepatitis C prior authorization criteria and the non-preferred product exception criteria. If the patient meets the standard Hepatitis C PA criteria but has not tried a Preferred Product, the request may be reviewed for a Preferred Product using the respective Hepatitis C PA criteria.

All approvals follow the duration specified in the respective standard Hepatitis C Coverage/PA policy.
Refer to the specific Hepatitis C product PA policy (e.g., Mavyret, Vosevi, Zepatier) for duration and product-specific criteria.

Documentation Required

Documentation Required for Non-Preferred Product Requests

Documentation is required when requesting a non-preferred product. Acceptable documentation may include chart notes, prescription claims records, prescription receipts, and other relevant information. All documentation must include patient-specific identifying information.

Background

All‑oral direct-acting antivirals (DAAs) are the standard of care for treating chronic hepatitis C across genotypes. Preferred initial agents by genotype are the generic combinations sofosbuvir/velpatasvir and ledipasvir/sofosbuvir, and the Preferred Product list should be tried before non-preferred alternatives per the Preferred Specialty Management program. Mavyret (glecaprevir/pibrentasvir) is additionally indicated for acute HCV (genotypes 1–6) and has specific exception pathways for pediatric, renal impairment, transplant, and certain previously treated adult populations; other non-preferred agents (Vosevi, Zepatier, Epclusa brand, Harvoni brand) are only approved when their product‑specific exception criteria and the referenced standard Hepatitis C PA policy criteria are met.

Definitions

Sustained viral response (SVR) definition

DefinitionSustained viral response (SVR) = undetectable hepatitis C virus 12 weeks following completion of therapy.

Purpose in policyUsed as documentation of treatment failure when approvals for non-preferred products require prior completion of therapy without achieving SVR.

Documentation timingMeasured at 12 weeks after finishing the course of HCV therapy (SVR12).

Clinical significanceSVR12 is the standard endpoint indicating virologic cure in HCV treatment assessments referenced by the policy.

SVR: virus undetectable 12 weeks following therapy (alternate reference)

Alternate phrasingSVR: virus undetectable 12 weeks following therapy (also cited as documentation required for exception approvals).

Coding and Billing Notes

Billing Rule

Coding mismatch may cause denial

Use covered codes and the applicable Coverage Policy coding guidance; claims submitted without covered codes under the policy will be denied as not covered.

Ensure coding aligns with the Coverage Policy's 'Coding Information' and use current, appropriate codes at time of submission.

OpenPayer

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

Coverage Criteria for Hepatitis C Direct-Acting Antivirals

Initial Therapy Preferences and Rules

Continuation Therapy Rules

Step Therapy Requirements

Provider Actions, Prior Authorization and Documentation

Background

Definitions

Coding and Billing Notes