Hepatitis C Antiviral Prior Authorization Criteria
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Criteria and documentation requirements for prior authorization of hepatitis C antiviral agents for Select Health members, including preferred agents and treatment-specific testing and prescriber requirements.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial therapy — required ALL conditions
Covered when ALL of the following are met
All items must be met for initial approval.
Preferred agent requirement (coverage preference)
Coverage preference
Documented medical reason required to justify use of a non‑preferred agent.
Approval duration
Initial approval rule
Subsequent continuation or follow‑up approvals are guided by treatment summary, lab results, and guideline recommendations.
Do not use Mavyret (glecaprevir/pibrentasvir) when Mavyret has previously failed treatment or when the prior regimen included an NS3/4 protease inhibitor (for example, Olysio, Incivek, or Victrelis). An alternate regimen may be considered only if the member previously failed a regimen that included an NS3/4 protease inhibitor plus pegylated interferon and ribavirin (Peg/Ribavirin).
Coding, Dosing & Thresholds
Provider Actions & Documentation Requirements
Prior authorization required; approvals issued as 28-day supply
Prior authorization is required for listed hepatitis C agents; all initial approvals are issued as a 28-day supply and will be consistent with product labeling or current guidelines.
- All approvals are for a 28 days' supply.
- Approvals are subject to change as guidelines are updated and must align with labeling or current guidance.
Preferred agents required unless documented medical reason
Use Mavyret (glecaprevir/pibrentasvir), sofosbuvir/velpatasvir (generic Epclusa), or ledipasvir/sofosbuvir (generic Harvoni) as preferred agents; a documented medical reason (e.g., intolerance, hypersensitivity, contraindication) is required to justify use of a non‑preferred agent.
- Preferred agents: MAVYRET; SOFOSBUVIR/VELPATASVIR (generic Epclusa); LEDIPASVIR/SOFOSBUVIR (generic Harvoni).
- Documented medical reason (intolerance, hypersensitivity, contraindication, etc.) required to use non‑preferred agents.
Attest and submit required HBV/HIV testing, labs, and supporting documentation
Provider must attest and supply documentation of hepatitis B status and management, HIV screening/treatment status, addressed drug interactions, substance use counseling/referral if applicable, and commitment to lab monitoring including submission of SVR12; required pre‑treatment labs (copies) including genotype and AASLD‑recommended RAS testing when indicated must be provided.
- Provide either a complete hepatitis B immunization series or hepatitis B screening (sAb, sAg, cAb).
- If HBsAg positive, include quantitative HBV DNA results and an HBV treatment plan if HBV DNA is detectable.
- Document HIV Ag/Ab screening and, if positive, HIV treatment status or rationale for not treating.
- Attest that all potential drug interactions have been addressed.
- If active or history of substance abuse, document counseling and offer of referral for substance use disorder treatment.
- Submit required pre‑treatment labs (copies), including genotype when indicated and AASLD‑recommended RAS testing when indicated, and commit to SVR12 testing submission.
Ensure eligibility criteria met for initial approval or risk denial
Initial requests must meet all listed eligibility requirements: prescribed by an appropriate specialist, member age ≥3 years, appropriate FDA‑approved/AASLD indication/dose/duration, life expectancy >12 months (nonliver causes), and required documentation/testing; failure to meet these may result in denial.
- Prescriber must be a specialist in hepatology, gastroenterology, infectious disease, HIV, or liver transplant.
- Member must be 3 years of age or older.
- Request must be for an appropriate FDA‑approved/AASLD guideline indication at an approved dose and duration.
- Provider must attest the member does not have limited life expectancy (<12 months) due to nonliver comorbid conditions.
- Provider must have documented required testing and attestations (see documentation requirements).
Definitions & Special Populations
Background
This policy aligns with AASLD-recommended direct-acting antiviral (DAA) treatment approaches and emphasizes use of preferred pan-genotypic or guideline-recommended regimens. Mavyret, generic Epclusa (sofosbuvir/velpatasvir), and generic Harvoni (ledipasvir/sofosbuvir) are the preferred agents and should be selected when appropriate; non-preferred agents require documentation of a medical reason for use. Providers should follow AASLD guidance for genotype-directed dosing, duration, and special-population considerations (pediatrics, renal impairment, decompensated cirrhosis, post-transplant) and document the recommended pre-treatment testing and monitoring (including HBV and HIV screening and commitment to report SVR12).
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