Glecaprevir/Pibrentasvir (Mavyret) — Clinical Coverage Criteria
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Clinical coverage policy governing use of the hepatitis C direct-acting antiviral combination glecaprevir/pibrentasvir (Mavyret) for members (including pediatric) under Delaware First Health Medicaid.
No material clinical or coverage changes in this revision.
Coverage Criteria for Glecaprevir/Pibrentasvir (Mavyret)
Initial Therapy
Covered when ALL of the following are met
Continuation Therapy
Covered when ALL of the following are met
AASLD-IDSA recommended management of treatment interruptions
Covered guidance for managing DAA treatment interruptions (AASLD‑IDSA recommendations)
applies to treatment‑naïve patients without decompensated cirrhosis receiving Mavyret or Epclusa
applies to treatment‑naïve patients without decompensated cirrhosis receiving Mavyret or Epclusa
Dosage and Administration guidance
Dosing regimens and recommended durations (high-level, as presented in the appendix table)
treatment‑naïve definition provided
specific pediatric dosing and duration referenced
See appendix table and AASLD‑IDSA for specifics
Coverage is not authorized for non‑FDA approved indications that are not specifically addressed in this policy unless the request is supported by sufficient documentation of efficacy and safety per the plan's off‑label use policy (CP.PMN.53 for Medicaid) or applicable evidence‑of‑coverage documents. Additionally, coverage is not authorized for hepatitis C virus (HCV) infection in members who are treatment‑experienced with both an NS3/4A protease inhibitor and an NS5A inhibitor (for example, prior exposure to combination regimens such as Technivie, Viekira, or Zepatier).
The AASLD‑IDSA interruption management recommendations summarized in Appendix F do not apply to certain populations. Specifically, these guidance rules are intended for treatment‑naive patients with HCV who do not have decompensated cirrhosis (i.e., without cirrhosis or with compensated cirrhosis) and who are receiving either Mavyret or Epclusa. The recommendations do not apply to patients with prior DAA treatment, patients receiving other DAA regimens, post‑transplant patients, or those with decompensated cirrhosis—these patients should be managed in consultation with an expert.
Initial Therapy Criteria and Dosing
Initial Therapy
Covered when ALL of the following are met
Initial therapy — dosing guidance
Dosing guidance by genotype, prior treatment status, age and weight
From appendix dosing table; treatment‑naïve defined as no prior treatment for current infection
From appendix dosing table
See appendix and AASLD‑IDSA for specifics
Criteria for Continued Therapy
Continued Therapy
Covered when ALL of the following are met
Continued therapy — policy edits
Policy-level edits affecting continued therapy
Documented in policy revision history
Provider Actions, Prior Authorization, and Documentation
Prior authorization required — submit documentation meeting all criteria
Prior authorization requires submission of clinical documentation demonstrating that the member meets all approval criteria, including evidence of detectable serum HCV RNA by quantitative assay within the last 6 months, age ≥ 3 years, documentation of genotype/cirrhosis/treatment history as applicable, life expectancy ≥ 12 months, and that the prescribed regimen and dosing are consistent with FDA or AASLD‑IDSA recommendations.
- Detectable serum HCV RNA within the last 6 months
- Age ≥ 3 years
- Genotype, cirrhosis status (Child‑Pugh A if cirrhosis), and prior treatment history as applicable
- Regimen and dosing consistent with FDA or AASLD‑IDSA recommendations
- Life expectancy ≥ 12 months
Prior authorization summary — policy-level edits recorded
Policy-level notes record administrative edits: addition of a genotype documentation bypass for treatment‑naïve members eligible for the simplified regimen, removal of prescriber specialty and adherence program participation requirements, and inclusion of prior Mavyret exposure scenarios; explicit PA submission codes or stepwise PA form details are not listed in these review notes.
- Bypass for genotype documentation when member is treatment‑naïve and eligible for simplified regimen
- Removal of prescriber specialty requirement
- Elimination of adherence program participation requirement
- Added prior Mavyret experience to initial approval scenarios
Step therapy note — Nevada protections
The policy references step therapy and other medical management techniques, but specifies that for members in Nevada, medical management (including quantity management) beyond step therapy is not allowed.
- Step therapy and quantity management are referenced in the policy
- Nevada members are protected from medical management beyond step therapy
State-specific limitation — Nevada (SB 439)
Per review notes the policy includes a Nevada‑specific disclaimer (SB 439): medical management techniques, including quantity management beyond step therapy, are not allowed for members in Nevada.
- SB 439 prohibition: no medical management beyond step therapy for Nevada members
Required documentation — submit clinical records and labs
Provider must submit supporting documentation such as office/chart notes, laboratory results, or other clinical information showing the diagnosis of HCV and that the member meets all approval criteria.
- Office chart notes and clinical records
- Laboratory results demonstrating detectable HCV RNA within 6 months
- Documentation of genotype, cirrhosis status, prior treatment history, and life expectancy as applicable
Required documentation highlights — genotype bypass and regimen concordance
Revisions highlight that genotype documentation may be bypassed when the member is treatment‑naïve and eligible for the AASLD‑IDSA simplified regimen; policy also emphasizes that prescribed regimens should align with FDA or AASLD‑IDSA recommended regimens for continued therapy.
- Genotype documentation bypass for treatment‑naïve members eligible for simplified regimen
- Prescribed regimen must be consistent with FDA or AASLD‑IDSA recommendations (noted for continued therapy)
Denial triggers — non‑FDA indications and excluded prior‑treatment scenarios
Requests for non‑FDA approved indications that are not addressed in this policy will be denied unless sufficient documentation of efficacy and safety is provided in accordance with off‑label use policies; coverage is also not authorized for members treatment‑experienced with both an NS3/4A protease inhibitor AND an NS5A inhibitor.
- Non‑FDA indications not addressed in policy require off‑label use documentation per CP.PMN.53 for Medicaid
- HCV in members treatment‑experienced with both NS3/4A protease inhibitor and NS5A inhibitor is excluded
Historical edits — removed prescriber specialty and adherence program
Historical edits removed prescriber specialty and adherence program participation requirements and added a genotype documentation bypass and prior Mavyret experience scenarios; these are noted as revisions rather than new provider submission requirements.
- Removed prescriber specialty requirement
- Eliminated adherence program participation requirement
- Added genotype documentation bypass for eligible treatment‑naïve members
- Added prior Mavyret experience to initial approval scenarios
Step Therapy and Medical Management
| Step | Requirement / Notes |
|---|---|
| 1 | |
| Policy references step therapy and medical management (including quantity management); for members in Nevada, medical management techniques beyond step therapy (including quantity management) are not allowed per SB 439. |
| Aspect | Detail |
|---|---|
| Sequencing described | |
| No explicit step therapy sequencing or step‑failure requirements are described in the policy chunks provided; the document instead notes restrictions on medical management beyond step therapy for Nevada members per SB 439. |
Quantity Limits and Formulations
Background and Drug Information
Mavyret (glecaprevir/pibrentasvir) is a fixed‑dose, oral direct‑acting antiviral combination used to treat acute and chronic hepatitis C virus (HCV) infection. Appendix F of this policy incorporates AASLD‑IDSA guidance on managing incomplete adherence and treatment interruptions for patients receiving Mavyret (applicable to treatment‑naive patients without decompensated cirrhosis). The guidance notes that brief interruptions (<7 days) are unlikely to affect SVR12, and provides specific actions based on timing of missed therapy (during the first 28 days versus after ≥28 days), including when to restart therapy immediately, when to obtain HCV RNA testing, when to extend treatment (e.g., by 4 weeks for genotype 3 and/or cirrhosis), and when to stop treatment and consider retreatment per AASLD‑IDSA recommendations.
Key Definitions
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