Elbasvir/grazoprevir (Zepatier) coverage
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Defines medical necessity, prior authorization, and continuation criteria for Zepatier (elbasvir/grazoprevir) for treatment of chronic hepatitis C virus (HCV) infections for Delaware First Health Medicaid members.
Added Appendix F for guidance on incomplete adherence and AASLD‑IDSA recommended management of treatment interruptions.
Removed qualifier of 'chronic' from HCV criteria to align with AASLD‑IDSA recommendation to treat both acute and chronic HCV.
For continued therapy criteria, minimum treatment duration option was revised from 60 days to 28 days and requirement for specific confirmed genotype was removed.
Coverage Criteria for Zepatier (elbasvir/grazoprevir)
inv-01: Initial Therapy — Hepatitis C Infection — Covered when ALL of the following are met
Covered when ALL of the following are met:
Approval duration: up to a total of 16 weeks; approved duration should align with Section V Dosage and Administration.
inv-02: Continued Therapy — Hepatitis C Infection — Covered when ALL of the following are met
Covered when ALL of the following are met:
Approval duration: up to a total of 16 weeks; minimum treatment duration for continued therapy revised to ≥28 days.
inv-03: Other Indications — single top-level node
Applies to requests for other diagnoses/indications.
inv-04: Initial Therapy (genotype-directed) — genotype- and prior-treatment-dependent dosing/regimen criteria
Dosing and regimen coverage is genotype- and prior-treatment-dependent; covered when regimens align with FDA labeling and AASLD-IDSA guidance.
For treatment‑naïve or pegIFN/RBV‑experienced patients with or without compensated cirrhosis and without baseline NS5A polymorphisms.
Per FDA labeling and AASLD‑IDSA guidance.
For treatment‑naïve or pegIFN/RBV‑experienced patients with or without compensated cirrhosis.
Per FDA‑approved labeling.
inv-05: Treatment Interruptions — Management per AASLD-IDSA recommended approach (Appendix F)
Management of treatment interruptions (AASLD‑IDSA recommended):
Requests for uses of Zepatier that are not FDA‑approved and are not specifically addressed in this clinical policy will not be authorized unless the prescriber provides sufficient supporting documentation of efficacy and safety consistent with the off‑label use policy (see CP.PMN.53 for Medicaid) or there is an applicable evidence of coverage document. Such requests should be evaluated following the off‑label and non‑formulary procedures referenced in the policy.
For Delaware First Health Medicaid members, state Medicaid coverage provisions take precedence when they conflict with this clinical policy. Providers must follow the applicable state Medicaid manual and any state‑specific coverage rules; failure to adhere to state Medicaid requirements may result in denial of coverage.
Zepatier is contraindicated in patients with moderate or severe hepatic impairment (Child‑Pugh B or C) and in any patient with a history of hepatic decompensation due to the substantially increased grazoprevir exposure and risk of ALT elevations and hepatic decompensation. These contraindications are listed in Appendix C and should be confirmed prior to prescribing or authorizing therapy.
No additional explicit 'not medically necessary' conditions beyond those already stated in the policy text were identified in the referenced sections. Review Appendix C for contraindications and other sections of the policy for the full list of NMN definitions and criteria.
Initial Therapy Authorization Requirements
inv-26: Initial Therapy — Authorization criteria for Zepatier for HCV infection
Initial authorization criteria for Zepatier for HCV infection (must meet ALL):
Approval duration: up to a total of 16 weeks; prior authorization should reflect genotype‑directed regimen and planned duration per guidance.
inv-27: Initial Therapy Dosing — genotype- and prior-treatment-based dosing per FDA/AASLD-IDSA
Dosing regimens and duration depend on genotype and prior treatment history; follow FDA labeling and AASLD‑IDSA guidance:
Applicable to treatment‑naïve and pegIFN/RBV‑experienced patients with or without compensated cirrhosis when no baseline NS5A RAS present.
Per FDA labeling; applicable to treatment‑naïve or pegIFN/RBV‑experienced patients with or without compensated cirrhosis.
Per FDA labeling and AASLD‑IDSA.
Per FDA labeling.
Continued Therapy / Reauthorization Criteria
inv-28: Continued Therapy — Coverage criteria for continued Zepatier therapy
Criteria for continued coverage of Zepatier for HCV infection (must meet ALL):
Approval duration: up to a total of 16 weeks; minimum exposure requirement for continuation is ≥28 days.
inv-29: Continuation Therapy — Continued therapy authorization when regimen consistent with guidance and minimum exposure criteria
Continued therapy authorization when regimen is consistent with guidance and minimum exposure met:
Specific genotype confirmation requirement removed for continuation.
Provider Requirements and Documentation
Submit evidence that member meets all initial criteria
Prior authorization will only be approved when the request includes evidence that the member meets all initial approval criteria, including a quantitative HCV RNA detectable within the last 6 months, age ≥12 years or weight ≥30 kg, confirmed HCV genotype 1 or 4, NS5A resistance testing for genotype 1a when applicable, documentation of treatment status, Child‑Pugh A if cirrhosis, attempted preferred alternatives or documented contraindication, and a prescribed regimen consistent with FDA or AASLD‑IDSA guidance.
- Detectable serum HCV RNA by quantitative assay in the last 6 months
- Age ≥ 12 years or weight ≥ 30 kg
- Confirmed HCV genotype 1 or 4
- NS5A polymorphism testing for genotype 1a (positions 28, 30, 31, or 93)
- Documentation of treatment‑naïve or treatment‑experienced status
- If cirrhosis, confirm Child‑Pugh A status
- Member has tried Mavyret or sofosbuvir/velpatasvir (Epclusa authorized generic) unless contraindicated or intolerant
- Prescribed regimen consistent with FDA or AASLD‑IDSA recommendations
- Dose does not exceed elbasvir/grazoprevir 50 mg/100 mg per day
Authorize regimens and durations per genotype (FDA/AASLD‑IDSA)
Prior authorization and continuation requests must specify genotype‑directed regimens and durations consistent with FDA labeling and AASLD‑IDSA guidance; continuation assessments may consider a minimum of 28 days of completed therapy for continuation criteria.
- Dosing and regimen must align with FDA labeling and AASLD‑IDSA (genotype‑specific tables)
- Minimum exposure for continuation: at least 28 days of therapy (revised from 60 days)
Document trial or contraindication to preferred therapies (Mavyret or Epclusa)
Provider must document that the member has tried preferred alternatives—Mavyret (glecaprevir/pibrentasvir) or sofosbuvir/velpatasvir (Epclusa authorized generic)—and that these agents are ineffective or contraindicated before Zepatier is approved, unless clinically significant adverse effects or contraindications to both are present.
- Epclusa coadministration with omeprazole up to 20 mg is not acceptable justification for inability to use Epclusa
- Appendix B lists Mavyret and Epclusa as preferred therapeutic alternatives
Follow redirections and therapeutic alternatives in Appendix B
The policy includes redirections to other therapies and therapeutic alternatives in Appendix B; follow the policy’s Appendix B and Appendix E guidance when applying step‑therapy or preferred‑agent logic.
- Refer to Appendix B for therapeutic alternatives and Appendix E for acceptable/unacceptable rationale to bypass preferred agents
Submit office notes and lab results to support approval
Include supporting clinical documentation with the prior authorization request: office chart notes, laboratory results (including quantitative HCV RNA), and any other clinical information that demonstrates the member meets all approval criteria.
- Chart note documentation and copies of lab results are required
- Provide recent quantitative HCV RNA and documentation of attempted preferred therapies or contraindications
Document genotype and baseline NS5A polymorphism testing when applicable
When relevant, prescribers must document HCV genotype and the presence or absence of baseline NS5A polymorphisms at amino acid positions 28, 30, 31, or 93 (for genotype 1a), plus cirrhosis status, prior treatment history, planned treatment duration, and use of ribavirin if indicated.
- Document baseline NS5A resistance‑associated polymorphisms for genotype 1a (positions 28, 30, 31, 93)
- Document cirrhosis status (Child‑Pugh), prior treatment history (treatment‑naïve vs experienced), planned duration, and RBV use if required
Non‑FDA indications require off‑label documentation or will be denied
Requests for indications that are not FDA‑approved and are not addressed by this policy will be denied unless sufficient evidence of efficacy and safety is provided per the off‑label use policy (CP.PMN.53) or applicable evidence of coverage documents.
- Non‑FDA approved indications not addressed in this policy require documentation per off‑label policy CP.PMN.53
- Lack of sufficient off‑label documentation will result in denial
Follow state Medicaid provisions when they conflict with this policy
For Medicaid members, state Medicaid coverage provisions supersede this clinical policy when there is a conflict; providers must follow the state Medicaid manual requirements to avoid denial.
- When state Medicaid provisions conflict with this policy, the state provisions take precedence
- Refer to the state Medicaid manual for specific coverage provisions
Drug and Laboratory Coding
| NDC | Product NDC referenced via prescribing information (Zepatier PI) |
Step Therapy and Therapeutic Alternatives
| Step | Requirement | Failure criteria / acceptable justification | Coverage |
|---|---|---|---|
| 1 | Member must trial preferred alternatives prior to Zepatier: Mavyret (glecaprevir/pibrentasvir) or sofosbuvir/velpatasvir (Epclusa authorized generic). | Documented clinically significant adverse effects to both preferred agents or documented contraindication(s) to both (see Appendix E). Note: coadministration with omeprazole ≤20 mg is NOT acceptable justification for inability to use Epclusa. | Covered with criteria |
| Redirection / Appendix | Description | Where to find specific sequences |
|---|---|---|
| Appendix B — Therapeutic Alternatives | Lists preferred alternatives and dosing information (e.g., Epclusa one tablet daily; Mavyret three tablets daily) and is used for redirection to other therapies when clinically appropriate. | See Appendix B in the policy for drug-specific dosing and any formulary status notes; specific step sequences or additional redirections may be specified elsewhere in the full policy or appendices. |
Quantity Limits and Product Information
Background and Drug Information
Zepatier is a fixed‑dose oral direct‑acting antiviral composed of an NS5A inhibitor, elbasvir, combined with an NS3/4A protease inhibitor, grazoprevir (tablet strength grazoprevir 100 mg/elbasvir 50 mg). The product is indicated for treatment of HCV genotypes specified in the labeling, and carries important safety considerations including contraindications in moderate‑to‑severe hepatic impairment and a boxed warning for risk of hepatitis B virus reactivation.
Definitions and Preferred Alternatives
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