Centene Mavyret Coverage Update: Prior Auth

Coverage Criteria for Mavyret (glecaprevir/pibrentasvir)

Initial therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial therapy general requirements: 1) Diagnosis of HCV infection evidenced by detectable serum HCV RNA by quantitative assay within the last 6 months; 2) Prescribed by or in consultation with a gastroenterologist, hepatologist, infectious disease specialist, or provider with certified HCV training (prescriber requirement exceptions noted); 3) Age ≥ 3 years; 4) Member is treatment-naive or has compensated cirrhosis (eligible for simplified regimen) per criteria; 5) Member is not treatment-experienced with BOTH an NS3/4A protease inhibitor AND an NSSA inhibitor (e.g., Technivie, Viekira, Zepatier); 6) If cirrhosis is present, confirmation of Child-Pugh A status; 7) Member must use sofosbuvir-velpatasvir (Epclusa authorized generic) unless contraindicated or clinically significant adverse effects are experienced (step therapy exceptions for certain states apply); 8) Prescribed regimen is consistent with FDA labeling or AASLD-IDSA recommended regimen; 9) Life expectancy ≥ 12 months with HCV treatment; 10) Dose does not exceed the age/weight-based maximums in Section V (adult dose: glecaprevir 300 mg/pibrentasvir 120 mg [3 tablets] per day; pediatric weight bands and doses as specified).

Prescriber and step therapy exceptions for certain states (e.g., Illinois HIM) and required documentation are noted in the policy.

Continuation therapy — Covered continuation when ALL of the following are met

Covered continuation when ALL of the following are met

Continuation therapy requirements: 1) Member is currently receiving Mavyret via Centene benefit, or continuity of care provisions apply, or member previously met initial approval criteria; 2) Documentation member has completed at least 28 days (≥28 days) of Mavyret therapy; 3) Documentation that member is responding positively to therapy; 4) Member is not treatment-experienced with both an NS3/4A protease inhibitor AND an NSSA inhibitor (e.g., Technivie, Viekira, Zepatier); 5) Prescribed regimen remains consistent with FDA labeling or AASLD-IDSA recommendations; 6) Dose remains within pediatric/adult weight-based limits; Approved duration up to a total of 16 weeks as clinically indicated.duration<=16 weeks

Continuation requires evidence of response and prior initiation via Centene benefit or applicable continuity of care provisions.

Other indications / off-label consideration — For other diagnoses/indications

For other diagnoses/indications

Other indications pathway: 1) If the requested use reflects a recent FDA label change within the last 6 months that is not yet in this policy, follow the referenced internal policies for updated coverage decisions; or 2) If the requested diagnosis, age, or dosing regimen is not specifically listed in the policy and the medication is on-formulary, follow the no-coverage criteria policy for the applicable line of business; or 3) If the requested use is not listed and the drug is off-formulary, refer to the applicable off-label or non-formulary policies (HIM.PA.154, HIM.PA.103) for coverage determination.

Step therapy requirement to attempt sofosbuvir-velpatasvir (Epclusa authorized generic) applies when relevant unless contraindicated; state-specific exceptions (e.g., Illinois) are noted.

Covered regimens and durations — Covered when regimens and durations align with FDA labeling or AASLD‑IDSA recommended regimens for the indicated genotype and treatment history

Covered when regimens and durations align with FDA labeling or AASLD‑IDSA recommended regimens for the indicated genotype and treatment history.

Treatment-naive adults without cirrhosis: Mavyret three tablets PO once daily for 8 weeks is the recommended regimen for treatment-naive adults without cirrhosis across genotypes 1–6.duration=8 weeks

Genotyping may be bypassed when using a pangenotypic regimen per guidance.

Treatment-naive adults with compensated cirrhosis: Mavyret three tablets PO once daily for 8 weeks is a recommended option; Epclusa 12 weeks is an alternative in selected situations.duration=8–12 weeks

Genotype testing may be recommended if not using a pangenotypic approach.

Treatment-experienced (IFN/RBV and/or sofosbuvir) genotypes 1,2,4,5,6:

Treatment interruption management — Management of missed doses and interruptions per AASLD‑IDSA guidance (restart/extension/stop rules)

Management of missed doses and interruptions per AASLD‑IDSA guidance (applies to patients receiving Mavyret or Epclusa unless otherwise noted).

Interruption <7 days (any time): If a patient misses <7 consecutive days of DAA therapy, restart the DAA immediately and complete the originally planned treatment duration (e.g., 8 or 12 weeks).missed <7 days

Applies to treatment-naive patients without decompensated cirrhosis receiving Mavyret or Epclusa.

Interruption >7 days during first 28 days: If missed >7 days during the first 28 days (guidance notes >8 days threshold), restart DAA immediately and obtain HCV RNA as soon as possible. If HCV RNA is negative, complete the originally planned course; consider extending therapy an additional 4 weeks for patients with genotype 3 and/or cirrhosis. If HCV RNA is positive or not obtained, extend therapy by an additional 4 weeks or stop and retreat per AASLD‑IDSA retreatment guidance as indicated.missed >7 days within first 28 days

Recommendation source: Appendix G.

Requests for members who are treatment‑experienced with BOTH an NS3/4A protease inhibitor and an NSSA inhibitor are not authorized. Examples of such combination therapies listed in the policy include Technivie, Viekira, and Zepatier. These cases are subject to denial under the policy's exclusions for prior DAA exposure and should not be approved without a documented, policy‑supported justification.

The policy historically includes formulary redirection and step‑therapy language that channels requests to preferred alternatives (for example, Epclusa or previously Vosevi) and documents specific unacceptable rationales for bypassing those alternatives. The policy clarifies that certain reasons, such as coadministration with omeprazole up to 20 mg, are not acceptable medical justifications for inability to use the preferred agent and notes that redirection and state‑specific exceptions have been updated over time.

Use of Mavyret for indications that are not FDA‑approved and not specifically listed in this policy is not authorized unless there is sufficient supporting documentation of efficacy and safety per the applicable off‑label use policy (for example, HIM.PA.154 for marketplace requests) or other evidence of coverage documents. Providers must follow the off‑label review process and submit the required clinical evidence to support such requests.

The policy specifies that use of non‑recommended regimens or regimens that do not follow labeled dosing, approved durations, or AASLD‑IDSA guideline recommendations may be considered not medically necessary. Requests that propose departures from FDA labeling or guideline‑recommended dosing/duration should include clinical justification consistent with the appendices; absent such justification, coverage may be denied or redirected to a preferred regimen.

Coding, Codes and Product Details

Codes referenced in policymixed

NDC/HCPCS/CPT not specified

No specific procedure, diagnosis, or billing codes are listed in this portion of the policy.

Product formulations and strengthsNDC | mixed

glecaprevir 300 mg / pibrentasvir 120 mg	Mavyret tablet dosing (3 tablets daily for adults/weight ≥45 kg)
glecaprevir 100 mg / pibrentasvir 40 mg	Tablet formulation strength
glecaprevir 50 mg / pibrentasvir 20 mg	Oral pellet formulation strength

HCV RNA testing recency

RequirementDetectable serum HCV RNA by quantitative assay within the last 6 months is required to document active HCV infection for PA consideration.

PurposeEstablishes current viremia to support initiation or continuation of DAA therapy.

Accepted evidenceLaboratory report showing quantitative HCV RNA (viral load) within past 6 months; office chart note referencing such result is acceptable if source documentation available.

Pediatric weight/age dosing thresholds

Adult dosing thresholdAge ≥12 years OR body weight ≥45 kg = adult dose (glecaprevir 300 mg / pibrentasvir 120 mg = 3 tablets daily).

Peds 3 to <12 years — ≤20 kg

Prior Authorization, Documentation, and Step Therapy Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Prior authorization is required and approval is contingent on meeting all medical necessity criteria in this policy. Requests must document a current diagnosis of Hepatitis C virus (HCV) infection with detectable serum HCV RNA by quantitative assay within the last 6 months, prescriber specialty (unless exempt per state exceptions), age criteria, cirrhosis status, prior HCV treatment history, and that the prescribed regimen is consistent with FDA or AASLD‑IDSA recommendations.

Provider must submit supporting documentation: office chart notes, quantitative HCV RNA lab results, genotype testing when required, prior treatment records, and documentation of cirrhosis status (e.g., Child‑Pugh A confirmation if cirrhosis present).
Medical necessity requires meeting ALL applicable criteria (diagnosis, prescriber specialty or consultation, age ≥ 3 years for Mavyret, treatment‑naive/experienced status as applicable, genotype scenarios, not treatment‑experienced with BOTH NS3/4A protease inhibitors AND NSSA inhibitors).
Step therapy/redirection: Member must use sofosbuvir‑velpatasvir (Epclusa authorized generic) when applicable for the requested indication unless contraindicated or clinically significant adverse effects occur; Epclusa inability justifications are limited (e.g., coadministration with omeprazole ≤20 mg is NOT acceptable). State‑specific exceptions apply (e.g., Illinois HIM bypass as of 1/1/2026 per IL HB 5395; Nevada restrictions on medical management beyond step therapy).
For continued therapy/continuity of care: document current receipt of medication, at least 28 days of Mavyret treatment for continuation requests, and clinical response to therapy. Genotype documentation may be bypassed for treatment‑naive members eligible for AASLD‑IDSA simplified regimen (compensated cirrhosis or no cirrhosis).

Background on Medication and Indications

Mavyret is a fixed‑dose oral combination of glecaprevir (an NS3/4A protease inhibitor) and pibrentasvir (an NSSA inhibitor). It is indicated for the treatment of acute or chronic hepatitis C virus infection across genotypes 1–6 in adults and pediatric patients aged 3 years and older, including patients with compensated cirrhosis (Child‑Pugh A). The policy notes the boxed warning for risk of hepatitis B virus reactivation and recommends appropriate monitoring for HBV during and after HCV therapy.

Definitions and Key Terms

Direct-acting antiviral (DAA) class

DefinitionDirect-acting antivirals (DAAs) are a class of HCV medications that target viral proteins (including NS3/4A protease inhibitors and NSSA inhibitors) to inhibit hepatitis C virus replication.

Examples in policyGlecaprevir (NS3/4A protease inhibitor) and pibrentasvir (NSSA inhibitor) are the DAA components of Mavyret.

Clinical noteDAAs carry a boxed warning for HBV reactivation; patients should be monitored for HBV reactivation during and after HCV treatment.

Child‑Pugh class (hepatic impairment)

DefinitionChild-Pugh class is a scoring system for hepatic impairment determined by points assigned for bilirubin, albumin, INR, ascites, and encephalopathy.

Score rangesClass A = 5–6 points (compensated); Class B = 7–9 points; Class C = 10–15 points (severe hepatic impairment).

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Glecaprevir/Pibrentasvir (Mavyret) coverage criteria

Coverage Criteria for Mavyret (glecaprevir/pibrentasvir)

Coding, Codes and Product Details

Prior Authorization, Documentation, and Step Therapy Requirements

Background on Medication and Indications

Definitions and Key Terms