Clinical Policy: Glecaprevir/Pibrentasvir (Mavyret)
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Clinical coverage policy governing medical necessity criteria, approval duration, and prescribing limitations for Mavyret (glecaprevir/pibrentasvir) for treatment of hepatitis C virus (HCV) in Delaware First Health members (Medicaid line of business). Applies to prescribers requesting prior authorization.
Added Appendix F for guidance on incomplete adherence and AASLD‑IDSA recommended management of treatment interruptions.
Removed qualifier of 'chronic' from HCV criteria as AASLD‑IDSA recommends treatment of both acute and chronic HCV.
For continued therapy criteria, revised minimum treatment duration option from 40 days to 28 days and removed requirement for specific confirmed genotype.
Coverage Criteria for Mavyret (glecaprevir/pibrentasvir)
Initial Therapy
Covered when ALL of the following are met:
Continuation Therapy
Continued therapy covered when ALL of the following are met:
AASLD‑IDSA management of DAA treatment interruptions
Management recommendations for incomplete adherence and interruptions (treatment‑naïve, no or compensated cirrhosis):
Applies to Mavyret or Epclusa in treatment‑naïve patients without decompensated cirrhosis.
Applies to Mavyret or Epclusa in treatment‑naïve patients without decompensated cirrhosis.
Dosage and Administration (selected)
Dosing and treatment‑duration guidance (selected excerpts):
See full Dosage and Administration tables for all genotypes and pediatric weight bands.
Refer to full prescribing information and AASLD‑IDSA guidance for complete regimen tables and retreatment recommendations.
Coverage is not authorized for members who are treatment‑experienced with both an NS3/4A protease inhibitor and an NS5A inhibitor. Examples of such combination therapies include Technivie, Viekira, and Zepatier. This exclusion applies to initial and continued therapy determinations and will result in denial of coverage when documentation confirms prior exposure to agents from both classes.
For authorization purposes, confirm treatment history with chart notes and lab documentation as required by the policy; members with prior exposure to both classes should not be approved for Mavyret per this policy's criteria.
Appendix F guidance on management of incomplete adherence and treatment interruptions applies only to treatment‑naïve patients without cirrhosis or with compensated cirrhosis who are receiving Mavyret or Epclusa. The appendix explicitly excludes patients with prior DAA treatment, patients receiving other DAA regimens, post‑transplant patients, and those with decompensated cirrhosis — these groups should be managed in consultation with an expert.
Providers should therefore not apply Appendix F timing‑based recommendations to excluded populations and must seek specialist input or follow alternative guidance when managing interruptions in those groups.
Non‑FDA‑approved indications that are not specifically addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety in accordance with the off‑label use policy CP.PMN.53 (Medicaid) or other applicable evidence‑of‑coverage documents. Requests for off‑label use must include supporting clinical evidence consistent with CP.PMN.53 to be considered for authorization.
If an interruption occurs and subsequent HCV RNA testing is positive or not obtained when indicated by the timing rules in Appendix F, the policy directs stopping the interrupted DAA course and retreating per the AASLD‑IDSA Retreatment Section rather than continuing the prior regimen. These actions follow the Appendix F timing framework for missed doses (first 28 days vs. ≥28 days) and the associated HCV RNA testing recommendations.
Providers must obtain and document HCV RNA testing as specified by Appendix F; failure to obtain testing or to stop and retreat per AASLD‑IDSA when HCV RNA is positive (or not obtained where required) may render continuation of therapy not medically appropriate and necessitate retreatment.
Provider Actions, Prior Authorization, and Documentation
Prior authorization criteria — required evidence
Prior authorization requires evidence that the member has a diagnosis of HCV infection with detectable serum HCV RNA by quantitative assay within the last 6 months, is age ≥ 3 years, meets the specified treatment‑naïve or treatment‑experienced genotype/previous‑therapy criteria, has Child‑Pugh A if cirrhotic, is not treatment‑experienced with BOTH an NS3/4A protease inhibitor AND an NS5A inhibitor, has life expectancy ≥ 12 months, is prescribed a regimen consistent with FDA or AASLD‑IDSA recommendations, and dosed within the age/weight maximums in the policy.
- Detectable serum HCV RNA by quantitative assay within the last 6 months is required.
- Age ≥ 3 years is required.
- Chart note documentation and copies of lab results are required for genotype and treatment history.
- Prescribed regimen must be consistent with FDA or AASLD‑IDSA recommended regimens and dosing must not exceed listed age/weight‑based maxima.
Prior authorization and documentation headline — recent policy changes
The policy was revised to remove the qualifier of 'chronic' (aligning with AASLD‑IDSA to include acute HCV) and to eliminate certain prior requirements such as prescriber specialty; it also allows bypassing genotype documentation for some treatment‑naïve patients with compensated or no cirrhosis while otherwise maintaining the clinical prior authorization criteria.
- Removed qualifier of 'chronic' from HCV criteria (policy now includes acute HCV).
- Prescriber specialty requirement was removed.
- Bypass for genotype documentation applied in specified treatment‑naïve, compensated/no cirrhosis scenarios per policy alignment with AASLD‑IDSA.
State-specific management note — Nevada
For members in Nevada, the policy specifies that medical management techniques beyond step therapy—including quantity management—are not allowed; standard prior authorization criteria otherwise apply.
- Nevada members: medical management techniques beyond step therapy (including quantity management) are not permitted per SB 439.
Step therapy notes — policy edits (no explicit sequence)
The policy documents step‑therapy–related edits (e.g., removal of prescriber specialty) but does not prescribe a specific step‑therapy sequence in the prior authorization text.
- Policy notes removals and additions to prior criteria; no explicit step‑therapy sequence is detailed in the cited sections.
Required documentation — submit supporting clinical records
Providers must submit supporting documentation (office chart notes, laboratory results, or other clinical information) showing the member meets all approval criteria, including genotype confirmation and prior treatment history when applicable.
- Chart note documentation and copies of lab results are required for genotype and treatment history.
- Submit office chart notes, lab results, or other clinical information demonstrating criteria are met.
Required documentation following interruptions — HCV RNA and treatment history
If treatment is interrupted, obtain and document HCV RNA testing as specified by the AASLD‑IDSA guidance (obtain HCV RNA as soon as possible when advised) and document genotype and prior treatment history when relevant to post‑interruption management.
- After missed doses ≥8 days (depending on timing), restart and obtain HCV RNA ASAP; management depends on HCV RNA result (negative = complete or extend; positive or not obtained = extend or stop/retreat as specified).
- Document genotype and prior treatment history if relevant to decisions about extension, stopping, or retreatment.
Excluded prior DAA exposure — dual NS3/4A + NS5A history
Coverage is not authorized for members who are treatment‑experienced with both an NS3/4A protease inhibitor AND an NS5A inhibitor (e.g., Technivie, Viekira, Zepatier).
- Members with prior exposure to both classes (NS3/4A PI and NS5A inhibitor) are excluded from coverage.
Risks related to treatment interruptions — clinical and coverage consequences
Failure to follow the AASLD‑IDSA recommended management after treatment interruptions (for example, not obtaining HCV RNA when advised or not stopping and retreating after ≥21 consecutive missed days) may result in increased risk of resistance, treatment failure, and may lead to denial of continued therapy or requirement for retreatment per guidance.
- If HCV RNA is positive or not obtained in certain interruption scenarios, stopping treatment and retreatment per AASLD‑IDSA is recommended; not following this may jeopardize continued coverage.
- Missed ≥21 days: stop DAA and assess for SVR12; if SVR12 not achieved, retreat per AASLD‑IDSA.
Definitions and Clinical Terms
Background
Mavyret is a fixed‑dose combination of the NS3/4A protease inhibitor glecaprevir and the NS5A inhibitor pibrentasvir. It is approved for treatment of acute or chronic hepatitis C virus infection across genotypes 1–6 in patients age ≥ 3 years, including those with compensated cirrhosis (Child‑Pugh A).
The policy references AASLD‑IDSA guidance endorsing simplified pangenotypic regimens (for example, 8‑week courses for many treatment‑naïve patients without cirrhosis) and includes Appendix F with specific management recommendations for treatment interruptions in eligible patients receiving Mavyret.
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