Cigna Hepatitis C DAA Coverage Update

Coverage Criteria for Non-Preferred and Preferred DAA Products

Non-preferred direct-acting antiviral (DAA) products are considered medically necessary only when the applicable exception criteria below are met. If the exception criteria are not satisfied, requests for a Preferred Product should be pursued and will be reviewed under the respective standard Hepatitis C prior authorization (PA) policy. Documentation is required where noted.

Patient has met the standard Hepatitis C prior authorization policy criteria for the specific non-preferred product when referenced (see individual product criteria and respective standard Hepatitis C PA Policy for full criteria and duration of approval).

Provider supplies required documentation when indicated (examples: chart notes, prescription claims records, prescription receipts, lab results documenting prior treatment and SVR status).

children":[{"operator":"all","text":"Patient has met the Hepatitis C - Mavyret PA Policy criteria."},{"operator":"any","text":"Patient meets ONE of the following prior treatment scenarios:","children":[{"operator":"all","text":"Previously treated with pegylated interferon/ribavirin, Incivek, Olysio, or Victrelis AND completed a course of therapy with ONE of Epclusa (brand or generic), Harvoni (brand or generic), or Zepatier and documentation shows failure to achieve sustained viral response (SVR) [documentation required]."},{"operator":"all","text":"Previously treated with Daklinza, Epclusa (brand or generic), Harvoni (brand or generic), or Zepatier."},{"operator":"all","text":"Previously treated with Sovaldi + ribavirin ± pegylated interferon/interferon OR Sovaldi + Olysio."}]}]},{"operator":"all","label":"Mavyret — genotype-specific notes","children":[{"operator":"all","text":"Genotype 1,2,3,4,5,6: For many genotype and special-population scenarios (including renal impairment, liver transplant, recurrent HCV post-transplantation, compensated cirrhosis, pediatric age ranges where applicable), Mavyret may be approved if the Hepatitis C - Mavyret PA Policy criteria are met; treatment‑naïve patients are generally not approved for Mavyret and should be considered for Preferred Products per genotype-specific guidance."}]},{"operator":"all","label":"Vosevi","text":"Approve for the duration specified in the standard Hepatitis C - Vosevi PA Policy if the patient has met the standard Hepatitis C - Vosevi PA Policy criteria. Refer to the standard Hepatitis C - Vosevi PA Policy for continuation therapy criteria."},{"operator":"all","label":"Zepatier","children":[{"operator":"all","text":"Treatment-naïve patients: Zepatier is not approved. Requests for Preferred Products (Epclusa, Harvoni, sofosbuvir/velpatasvir, or ledipasvir/sofosbuvir) may be reviewed under the respective standard Hepatitis C PA Policy criteria."},{"operator":"all","text":"Approve for the duration specified in the standard Hepatitis C - Zepatier PA Policy if the patient meets BOTH of the following:" ,

children":[{"operator":"all","text":"Patient has met the standard Hepatitis C - Zepatier PA Policy criteria."},{"operator":"all","text":"Patient has completed a course of therapy with ONE of Epclusa (brand or generic), Harvoni (brand or generic), or Mavyret and documentation shows failure to achieve sustained viral response (SVR) [documentation required]."}]}]}]}],

title":"Drug-specific coverage criteria (see referenced PA policies for full criteria)"}],

paragraphs":[],"title":"Non-Preferred Product Exception Criteria and Preferred Product Requirement","type":"criteria_group"},{

type":"text","paragraphs":["Any non-preferred product not meeting the specified non-preferred product exception criteria is considered not medically necessary."]},{

type":"text","paragraphs":["Drug-specific approval limitations and guidance: Mavyret — treatment‑naïve patients are not approved; approvals follow the Hepatitis C - Mavyret PA Policy and require prior treatment history or documented prior therapy failure per the criteria above. Zepatier — treatment‑naïve patients are not approved; approvals require meeting the standard Hepatitis C - Zepatier PA Policy criteria and documentation of prior therapy failure with a listed product. Refer to the referenced standard Hepatitis C PA policies (Epclusa, Harvoni, Mavyret, Vosevi, Zepatier) for full, drug-specific initial and continuation criteria, documentation requirements, and durations of approval."]},{

type":"text","paragraphs":["Zepatier for treatment‑naïve patients is not approved; requests should be redirected to Preferred Products for review under the applicable Hepatitis C PA policy criteria."]}],

id":"coverage-criteria","label":"COVERAGE CRITERIA","title":"Coverage Criteria for Non-Preferred and Preferred DAA Products"} اجازت نکردанный (Note: extraneous characters removed) } } Please disregard. This JSON is invalid. I will re-output valid JSON. Apologies. (This assistant message should not appear)

Initial Therapy Rules and Drug-Specific Initial Approval

inv-18: Initial therapy rules

Initial therapy rules differ by drug and genotype; Preferred Products are recommended for treatment‑naïve patients and Non‑Preferred initial therapy requires meeting the exception criteria.

Preferred products by genotype: Treatment‑naïve requests should be for Preferred Products as specified by genotype (see Preferred list).

Preferred product lists located in chunk 8.

Mavyret initial therapy: For treatment‑naïve patients across genotypes (adult and pediatric where specified), Mavyret is not approved; approval is allowed only if the patient meets the Hepatitis C - Mavyret PA Policy criteria AND meets the additional prior‑treatment or failure criteria listed in the Mavyret exception criteria (e.g., prior DAA exposure and documentation of lack of SVR where required).

See chunks 10–17 for Mavyret genotype-specific criteria and required documentation.

Zepatier initial therapy: Zepatier is not approved for treatment‑naïve patients for specified genotypes (e.g., genotypes 1 and 4); approval requires meeting the Hepatitis C - Zepatier PA Policy criteria AND documented prior DAA therapy failure with one of Epclusa, Harvoni, or Mavyret (documentation that SVR was not achieved).

Continuation Therapy Rules

inv-20: Continuation therapy references

Continuing therapy approvals reference the respective drug‑specific Hepatitis C PA Policy.

Mavyret continuing therapy: Refer to the Hepatitis C - Mavyret PA Policy criteria for continuation of therapy.

Chunk 16 references continuation guidance tied to the Mavyret PA Policy.

Vosevi continuing therapy: Refer to the Hepatitis C - Vosevi PA Policy criteria for continuation of therapy.

Chunk 18 references Vosevi continuation guidance.

inv-21: Continuation therapy references

Continuation therapy decisions defer to the specific drug PA policy referenced for the product.

Mavyret continuation:

Step Therapy Requirements and Exceptions

Step	Requirement	Notes
1	Member should try one Preferred Product prior to approval of a Non-Preferred Product; requests for Non-Preferred Products will be reviewed using the non-preferred product exception criteria.	All medications (Preferred and Non-Preferred) require meeting the respective standard Hepatitis C Prior Authorization Policy criteria. Documentation is required for use of a non-preferred product (e.g., chart notes, prescription claims, receipts). Approvals provided for durations documented in the respective Hepatitis C PA policies.

Step	Requirement	Notes
1	Zepatier is not approved for treatment‑naïve patients. For non–treatment‑naïve approval, the patient must meet the standard Hepatitis C - Zepatier PA Policy criteria AND have completed a course of therapy with ONE of Epclusa, Harvoni, or Mavyret with documentation that the patient did not achieve a sustained viral response (SVR; virus undetectable 12 weeks following therapy).	If the patient is treatment‑naïve or does not have documented prior DAA failure, requests may be reviewed under Preferred Product PA criteria (Epclusa, Harvoni, sofosbuvir/velpatasvir, ledipasvir/sofosbuvir). Continuing therapy decisions refer to the Hepatitis C - Zepatier PA Policy.

Provider Actions, Prior Authorization, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required — All medications (preferred and non-preferred) require meeting the respective standard Hepatitis C Prior Authorization Policy criteria. All approvals are provided for the duration specified in the referenced Hepatitis C PA policies (e.g., Mavyret, Vosevi, Zepatier, Epclusa, Harvoni).

All Hepatitis C medications (preferred and non-preferred) require prior authorization and must meet the respective standard Hepatitis C PA Policy criteria.
Approvals follow the duration documented in the referenced Hepatitis C PA Policy for the specific product.

Step Therapy

Preferred Product Trial Required

Preferred-product trial required — The program directs the patient to try one Preferred Product before approval of Non-Preferred Products unless exception criteria are met.

If the patient meets the standard Hepatitis C PA Policy criteria but has not tried a Preferred Product, requests may be reviewed under the respective standard Hepatitis C PA Policy criteria for the Preferred Products.

Coding and Claim Considerations

Denial Risk

Claims without covered diagnosis/procedure codes will be denied

Claims submitted for services that are not accompanied by covered diagnosis or procedure code(s) under this Coverage Policy will be denied as not covered; providers must use the most appropriate codes when billing.

Reimbursement is not allowed when billed for conditions or diagnoses that are not covered under this Coverage Policy.

Definitions and Key Terms

inv-16: Sustained viral response (SVR) — definition and role

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

Use in policySVR is used as documentation of treatment failure when evaluating exception criteria for retreatment with non-preferred direct-acting antivirals (DAAs).

Documentation examplesEvidence may include laboratory results showing undetectable HCV RNA at 12 weeks post-therapy as required when seeking approval after prior DAA therapy.

TimingMeasured at 12 weeks after completion of antiviral therapy (SVR12).

inv-17: Sustained viral response (SVR) — documentation for retreatment

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

Background and Clinical Context

All‑oral direct‑acting antivirals (DAAs) are the standard of care for chronic Hepatitis C across genotypes. Individual products have labeled age and genotype indications and differ in certain special populations: for example, some products (Epclusa, Harvoni) have indications that include decompensated liver disease, while Mavyret includes transplant and renal impairment dosing considerations. Preferred and non‑preferred status in this policy is assigned by genotype; consult each drug’s PA policy for age limits, genotype‑specific indications, and product‑specific guidance.

Revision History and Policy Changes

2025-07-01policy_createdLatest

New preferred specialty management policy PSM026 for Hepatitis C direct-acting antivirals implemented and effective 07/01/2025.

OpenPayer

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