Elbasvir/Grazoprevir (Zepatier) — Coverage Criteria
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Defines medical necessity criteria, prior authorization requirements, and dosing/administration guidance for Zepatier (elbasvir/grazoprevir) for members covered under Peach State Health Plan (Medicaid). Applies to providers requesting coverage for Zepatier.
Appendix F for guidance on incomplete adherence and AASLD-IDSA recommended management of treatment interruptions was added.
Removed qualifier of 'chronic' from HCV criteria to align with AASLD-IDSA recommendation to treat both acute and chronic HCV.
Dosing regimens presented per FDA labeling and AASLD-IDSA guidelines including genotype-specific regimens and recommendations for extension in select populations.
Coverage and Medical Necessity Criteria
inv-01: Initial Approval Criteria — Hepatitis C Infection
Covered when ALL of the following are met:
inv-02: Other diagnoses/indications
Covered when ONE of the following is met:
See Section III and Appendix E
inv-03: Treatment interruption management
Appendix F: AASLD-IDSA recommended management of treatment interruptions
source: Appendix F
source: Appendix F
inv-04: Genotype-specific dosing
Dosing and administration — genotype- and prior-treatment-specific regimens
FDA labeling and AASLD-IDSA referenced
AASLD-IDSA and FDA labeling referenced
FDA labeling and AASLD-IDSA referenced
FDA labeling and AASLD-IDSA referenced
Zepatier (elbasvir/grazoprevir) is contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh B or C) due to substantially increased grazoprevir exposure and risk of ALT elevations. It is also contraindicated with co-administration of agents that significantly increase grazoprevir concentrations such as inhibitors of OATP1B1/3, with strong CYP3A inducers, and with efavirenz. If Zepatier is given with ribavirin, the contraindications to ribavirin also apply. Additionally, clinicians should be aware of the boxed warning for HBV reactivation in patients co-infected with hepatitis B virus when initiating direct-acting antiviral therapy.
Requests for Zepatier for use after liver transplantation are excluded under this policy unless a specific regimen or labeling explicitly designates use in the post-liver transplant population. The policy language and approval pathways require that any post-transplant use be supported by regimen-specific recommendations in the product labeling or authoritative guidance before coverage will be authorized.
Zepatier will not be authorized when the member can appropriately receive a preferred alternative. Members must use Mavyret or sofosbuvir/velpatasvir (Epclusa authorized generic) unless there is documented inability to use those agents due to clinically significant adverse effects or contraindications. Appendix E lists acceptable and unacceptable justifications for inability to use preferred products and clarifies that common interactions (for example, with omeprazole ≤20 mg) are not considered acceptable justification to bypass preferred therapy.
The policy language was updated in the 3Q 2024 review to remove the qualifier 'chronic' from HCV criteria so that coverage aligns with current AASLD‑IDSA guidance; the policy now reflects that treatment is recommended for both acute and chronic HCV per the cited guidance.
Drug and Diagnostic Codes
| NDC | Product prescribing information reference (Zepatier PI) |
Prior Authorization, Documentation, and Provider Requirements
Prior authorization required for Zepatier
Prior authorization is required; Zepatier (elbasvir/grazoprevir) will be approved only when the member meets all initial approval criteria listed in the policy (see Initial Approval Criteria — Hepatitis C Infection). Approval duration must be consistent with a regimen in Section III (up to a total of 16 weeks).
- Approval only when all listed criteria are documented.
- Approved duration must align with Section III dosing regimens (up to 16 weeks).
Genotype- and regimen-specific prior authorization
Prior authorization requests must specify the patient's HCV genotype and the exact planned dosing regimen consistent with FDA labeling or AASLD‑IDSA guidance; include documentation of genotype and NS5A polymorphism status when required and the intended treatment duration.
- Document confirmed HCV genotype (1 or 4) and regimen consistent with Section III dosing.
- For genotype 1a, include NS5A resistance-associated polymorphism testing results when required.
Preferred alternatives required before Zepatier
The member must have used preferred alternatives (Mavyret or sofosbuvir/velpatasvir [Epclusa authorized generic]) unless clinically significant adverse effects are experienced or both are contraindicated; acceptable and unacceptable justifications are described in Appendix E.
- Coadministration with omeprazole up to 20 mg is not an acceptable justification for inability to use Epclusa.
- See Appendix B for dosing of preferred alternatives and Appendix E for acceptable/unacceptable rationale to bypass preferred agents.
Redirection to preferred agents and required justification
Prescribers may be redirected to preferred agents (e.g., Mavyret, Epclusa authorized generic); if bypassing a preferred agent, submit clinical justification per Appendix E (acceptable/unacceptable rationales) and reference the therapeutic alternatives table.
- Policy includes re-direction to preferred products and a Therapeutic Alternatives table (Appendix B).
- Appendix E lists acceptable and unacceptable clinical justifications for not using preferred agents.
Required documentation to support authorization
Submit office chart notes and laboratory results that demonstrate the member meets all approval criteria — specifically detectable HCV RNA within the last 6 months, confirmed genotype, NS5A testing when indicated, cirrhosis and treatment status, and HBV management as applicable.
- Include HCV RNA test results (within 6 months), genotype report, and NS5A resistance testing for genotype 1a when required.
- Provide documentation of cirrhosis status and treatment‑naïve or treatment‑experienced status.
Historical documentation expectations (HCV RNA and NS5A testing)
Historically the policy expects HCV RNA testing over time to confirm infection and documentation of NS5A resistance-associated polymorphisms (positions 28, 30, 31, or 93) when indicated; include product dosing per FDA labeling.
- Provide serial HCV RNA data used to confirm infection (previous policy language referenced HCV RNA levels over a six-month period).
- For genotype 1a, document baseline NS5A resistance-associated polymorphism testing results at amino acids 28, 30, 31, or 93.
Denial risk if documentation incomplete or criteria unmet
Requests may be denied if submitted documentation is missing or inconsistent with criteria — for example, no detectable HCV RNA within the last 6 months, incorrect or undocumented genotype, failure to meet age/weight thresholds, or missing required NS5A resistance testing for genotype 1a; contraindications (e.g., Child‑Pugh B/C or prohibited concomitant drugs) also risk denial.
- Detectable HCV RNA within the last 6 months is required.
- Confirmed genotype 1 or 4 must be documented; genotype not in these groups may be denied.
- Age ≥ 12 years or weight ≥ 30 kg must be met and documented.
- Missing NS5A resistance testing for genotype 1a when required may lead to denial.
- Presence of contraindications (Child‑Pugh B/C, prohibited concomitant agents) may lead to denial.
Exclusions and resistance testing requirements
Coverage excludes post‑liver transplant patients unless a regimen specifically designates use in that population; documentation of NS5A resistance-associated polymorphisms is required when indicated and absence of this documentation may result in denial.
- Post‑liver transplantation is excluded unless the chosen regimen specifically designates use for post‑transplant patients.
- For genotype 1a, document NS5A resistance testing (positions 28, 30, 31, or 93) as required by the criteria.
Drug and Clinical Background
Zepatier is a fixed‑dose oral combination of elbasvir (NS5A inhibitor) and grazoprevir (NS3/4A protease inhibitor) indicated for treatment of HCV genotypes 1 and 4. The product is formulated as a once‑daily tablet (grazoprevir 100 mg / elbasvir 50 mg) with genotype- and prior-treatment–specific regimens: for example, typical therapy for genotype 1b and most genotype 1a cases is one tablet PO QD for 12 weeks, while genotype 1a with baseline NS5A resistance may require extension to 16 weeks with addition of weight‑based ribavirin. Baseline NS5A resistance testing is recommended for genotype 1a because certain NS5A polymorphisms reduce elbasvir efficacy. Dosing and regimen selection should follow FDA labeling and AASLD‑IDSA recommendations and be documented in the prior authorization request.
Key Definitions and Clinical Terms
Policy Revision History
3Q 2024 annual review: removed the qualifier 'chronic' from HCV criteria to align with AASLD‑IDSA recommendation to treat both acute and chronic HCV; removed 'preferred' designation from Epclusa authorized generic redirection.
Added Appendix F providing AASLD‑IDSA–based guidance on incomplete adherence and recommended management of treatment interruptions.
Policy redirection and references updated (history entry noted in reviews and revisions).
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