Clinical Policy: Elbasvir/Grazoprevir (Zepatier)
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Defines medical necessity criteria, prior authorization, and coverage rules for Zepatier (elbasvir/grazoprevir) for treatment of hepatitis C virus (HCV) infection for Delaware First Health (Medicaid); includes dosing by genotype, documentation requirements, step therapy preferences, and an appendix on managing missed therapy.
Added Appendix F for guidance on incomplete adherence and AASLD-IDSA recommended management of treatment interruptions.
For continued therapy criteria, added 'Prescribed regimen is consistent with an FDA or AASLD-IDSA recommended regimen' and revised minimum treatment duration from 60 days to 28 days and removed requirement for specific confirmed genotype.
Removed qualifier of 'chronic' from HCV criteria to align with AASLD-IDSA recommendation to treat both acute and chronic HCV.
Coverage Criteria for Elbasvir/Grazoprevir (Zepatier)
Initial Therapy — Hepatitis C Infection
Covered when ALL of the following are met:
Approval duration: up to a total of 16 weeks (approved duration should be consistent with a regimen in Section V Dosage and Administration).
Continued Therapy — Hepatitis C Infection
Covered when ALL of the following are met:
Approval duration: up to a total of 16 weeks (approved duration should be consistent with a regimen in Section V Dosage and Administration).
Other Diagnoses/Indications
Covered when ALL of the following are met:
Initial dosing by genotype and prior treatment
Dosing and duration recommendations by genotype and treatment history (per FDA labeling and AASLD-IDSA):
Based on FDA labeling and AASLD-IDSA guidance.
Based on FDA labeling and AASLD-IDSA guidance.
FDA labeling and AASLD-IDSA.
FDA labeling and AASLD-IDSA.
See product availability.
Incomplete adherence and treatment-interruption management
Management of incomplete adherence (AASLD-IDSA recommended actions):
Restart and obtain HCV RNA; extend treatment in select patients.
Stop and assess for SVR12; retreat if needed.
Coverage for uses of Zepatier (elbasvir/grazoprevir) that are not FDA-approved and not addressed in this policy is not authorized unless the provider supplies sufficient documentation demonstrating efficacy and safety. Such requests should be evaluated according to the plan's off‑label use policy (CP.PMN.53 for Medicaid) or applicable evidence of coverage documents; lacking that documentation, the use will be considered not authorized.
Zepatier is contraindicated in patients with moderate or severe hepatic impairment (Child‑Pugh B or C) due to substantially increased grazoprevir exposure and higher risk of ALT elevations. It is also contraindicated in patients with any history of hepatic decompensation for the same safety concerns. Providers must not prescribe Zepatier for members meeting these hepatic impairment criteria.
Policy includes plan- and state-specific notes regarding medical management techniques. In particular, certain medical management approaches (for example, quantity management beyond standard step therapy) may be restricted or disallowed in some states per local regulations (e.g., Nevada SB 439). Providers should follow the plan-specific step therapy and redirection rules and consult the policy appendices and state-specific guidance when questions arise.
Off‑label use of Zepatier is not authorized unless the request is supported by adequate documentation per the plan's off‑label policy. Requests for non‑FDA indications must reference CP.PMN.53 (Off‑label use policy for Medicaid) or present equivalent evidence of clinical efficacy and safety to be considered for coverage.
No explicit coverage guidance is provided for this inventory item in the policy document.
Product and Coding Information
| grazoprevir 100 mg / elbasvir 50 mg | Tablet: grazoprevir 100 mg with elbasvir 50 mg |
Prior Authorization, Documentation, and Provider Requirements
Prior authorization required; approvals up to 16 weeks
Prior authorization is required. Submit documentation showing the member meets all approval criteria; approvals should be consistent with a regimen in Section V and may be authorized for up to a total of 16 weeks. Dose must not exceed elbasvir/grazoprevir 50 mg/100 mg (one tablet) per day.
- Approval duration: up to a total of 16 weeks
- Dose limit: elbasvir/grazoprevir 50 mg/100 mg (1 tablet) per day
Specify genotype-specific regimen, duration, and supporting tests
Prior authorization requests must specify the genotype-directed regimen and duration per dosing guidance (e.g., one tablet PO QD grazoprevir 100 mg/elbasvir 50 mg for 8, 12, or 16 weeks as indicated) and include relevant baseline test results when indicated.
- Use genotype-specific durations (typical 8, 12, or 16 weeks depending on genotype, prior therapy, cirrhosis, and NS5A polymorphisms)
- Include NS5A polymorphism testing results when relevant (genotype 1a)
Preferred-product requirement: Mavyret or Epclusa AG first
Member must have trials of preferred alternatives first: Mavyret or sofosbuvir/velpatasvir (Epclusa authorized generic) should be used unless there are clinically significant adverse effects or contraindications per Appendix E.
- Coadministration with omeprazole ≤20 mg is not acceptable justification to avoid Epclusa
- Acceptable justifications and contraindications listed in Appendix E (e.g., ribavirin contraindication, amiodarone issues)
Step therapy, redirections, and plan/state-specific constraints
Policy includes step-therapy redirections and notes removal of the literal 'preferred' label for Epclusa AG; plan-specific step therapy or redirections and state restrictions (e.g., NV SB 439 limits certain medical management beyond step therapy) apply—follow plan addendums for exact prior-step requirements.
- Refer to plan-specific step therapy rules and state addenda for continuity/redirection requirements
- Medical management quantity restrictions may be limited in certain states (see SB 439 reference)
Required clinical documentation: chart notes, labs, genotype, NS5A results
Include complete clinical documentation with the prior authorization: chart notes and copies of lab results are required to confirm diagnosis, genotype, NS5A testing (when indicated), treatment status, cirrhosis/Child‑Pugh A confirmation, treatment start/stop dates, and HCV RNA results.
- Detectable HCV RNA by quantitative assay within last 6 months (chart notes and labs required)
- Document genotype confirmation and, for genotype 1a, NS5A polymorphism testing at positions 28, 30, 31, or 93
- Document treatment status (naïve vs experienced), cirrhosis status (Child‑Pugh A), and treatment start/stop dates
Document genotype and baseline NS5A polymorphisms and prior treatment history
Document genotype, presence or absence of baseline NS5A polymorphisms at amino acids 28, 30, 31, or 93 when relevant (genotype 1a), prior HCV treatment history, and any prior response; include these in the authorization to support regimen selection (e.g., addition of weight‑based ribavirin or extended duration).
- If genotype 1a with NS5A polymorphisms present, document results to justify 16‑week regimen with weight‑based ribavirin
- Include prior treatment history (treatment‑naïve vs pegIFN/RBV experienced) to determine recommended duration
Incomplete documentation may trigger denial
Lack of required documentation (e.g., missing chart notes, lab results, genotype/NS5A testing, treatment dates) may result in denial of the request because the policy requires evidence that all approval criteria are met.
- Ensure submission includes quantitative HCV RNA, genotype confirmation, NS5A test results (if indicated), and chart notes to avoid denial
Non‑adherence management: follow AASLD‑IDSA restart/retreatment guidance and document actions
If the member misses 8–20 consecutive DAA days, restart therapy immediately and obtain HCV RNA; if missed ≥21 consecutive days, stop DAA treatment and assess for SVR12—document missed days, restart/stop actions, HCV RNA results, and any retreatment decisions per AASLD‑IDSA guidance.
- For 8–20 missed days: restart DAA, obtain HCV RNA, complete planned course or extend per guidance
- For ≥21 missed days: stop treatment and assess SVR12; retreat if SVR12 not achieved
Background and Context
Zepatier is a fixed‑dose combination tablet containing grazoprevir 100 mg and elbasvir 50 mg indicated for treatment of HCV genotypes 1 and 4 in appropriate patients. The product is used according to FDA labeling and AASLD‑IDSA guidance, with baseline NS5A resistance testing recommended for genotype 1a because certain NS5A polymorphisms can reduce elbasvir efficacy. Clinicians should also be aware of the boxed warning for risk of HBV reactivation when treating HCV, and the drug is contraindicated in moderate or severe hepatic impairment (Child‑Pugh B or C) or in patients with prior hepatic decompensation.
Definitions and Key Terms
Revision History and Policy Changes
Continued therapy criteria updated to require that the prescribed regimen is consistent with an FDA or AASLD‑IDSA recommended regimen; minimum treatment duration for continued therapy revised from 60 days to 28 days and requirement for specifying confirmed genotype removed; references reviewed and updated.
Appendix F added to provide guidance on incomplete adherence and AASLD‑IDSA recommended management of treatment interruptions; references reviewed and updated and 'preferred' language removed for Epclusa authorized generic redirection.
Policy effective date set.
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