Mavyret (glecaprevir/pibrentasvir) coverage and prior authorization criteria
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Defines Amerigroup prior authorization, quantity limits, approval durations, clinical eligibility and exclusion criteria for Mavyret (glecaprevir/pibrentasvir) for treatment of chronic hepatitis C in covered members.
No material clinical or coverage changes in this revision.
Mavyret (glecaprevir/pibrentasvir) Coverage Criteria
Coverage Criteria for Mavyret
Requests for Mavyret may be approved when ALL inclusion criteria are met and none of the exclusion criteria apply.
ALL of the following
ALL of the following
- Individual is 12 years of age or older or weighing at least 45 kg.
ALL of the following
- Documentation of chronic hepatitis C (CHC) infection with genotype and a positive HCV RNA result.
ALL of the following
- Not short life expectancy (less than 12 months) due to non-liver related comorbid conditions that cannot be remediated by treating HCV, by transplantation or other directed therapy.
ALL of the following
- Individuals who abuse alcohol or intravenous drugs must be enrolled in a substance abuse program.
ALL of the following
- Individual has compensated liver disease (Child‑Pugh Class A), with or without cirrhosis (decompensated cirrhosis is excluded).
ALL of the following
ONE of
- Treatment‑naïve individuals (with compensated cirrhosis or without cirrhosis) for Genotypes 1, 2, 3, 4, 5, or 6 (Mavyret monotherapy).
- Treatment‑experienced individuals with a prior HCV NS5A inhibitor regimen (without prior NS3/4A protease inhibitor exposure), with compensated cirrhosis or without cirrhosis, for Genotype 1.
- Treatment‑experienced individuals with a prior HCV NS3/4A protease inhibitor regimen (without prior NS5A inhibitor exposure), with compensated cirrhosis or without cirrhosis, for Genotype 1.
- Individuals who are dual peginterferon/ribavirin (P/R) treatment‑experienced without prior treatment with an NS3/4A protease inhibitor, sofosbuvir‑based regimen, or NS5A inhibitor, with compensated cirrhosis or without cirrhosis, for Genotypes 1, 2, 3, 4, 5, or 6.
- Treatment‑experienced individuals after a sofosbuvir‑containing regimen without an NS5A inhibitor, with compensated cirrhosis or without cirrhosis, for Genotypes 1 or 2.
- Post‑liver transplant recipients (with or without compensated cirrhosis) for Genotypes 1–6.
- Post‑kidney transplant recipients (with or without compensated cirrhosis) for Genotypes 1–6.
ALL of the following
- May be used in individuals co‑infected with HIV‑1 per label and AASLD/IDSA guidance.
None of the following exclusion criteria may be present:
ALL of the following
- Individual has decompensated cirrhosis (excluded).
ALL of the following
- Requesting concurrent therapy with contraindicated or not recommended agents (examples include but are not limited to ritonavir‑containing antiretroviral regimens, efavirenz, etravirine, nevirapine, darunavir/cobicistat, atazanavir, carbamazepine, St John’s wort, ethinyl estradiol‑containing medications, atorvastatin, lovastatin, simvastatin, rifampin).
ALL of the following
- Using Mavyret in combination with a regimen containing a non‑nucleoside NS5B polymerase inhibitor (e.g., dasabuvir) or nucleotide NS5B polymerase inhibitor (e.g., sofosbuvir).
- Using Mavyret in combination with another NS5A inhibitor.
- Using Mavyret in combination with another NS3/4A protease inhibitor.
ALL of the following
- Requesting the regimen for re‑treatment when the individual previously failed to achieve a sustained virologic response (SVR; HCV RNA > lower limit 25 IU/mL) or relapsed after achieving SVR following prior treatment with elbasvir/grazoprevir, ombitasvir/paritaprevir/ritonavir and dasabuvir, ombitasvir/paritaprevir/ritonavir, or sofosbuvir/velpatasvir/voxilaprevir.
Quantity, Billing, and Approval Durations
| Quantity limit specified as 3 tablets per day |
Prior Authorization, Documentation, and Denial Risks
Prior authorization required; quantity limited to 3 tablets/day
Prior authorization is required for Mavyret (glecaprevir/pibrentasvir). Quantity is limited to 3 tablets per day. Approval duration is assigned based on genotype, prior treatment history, cirrhosis status, and transplant status and will vary accordingly.
- Quantity limit: 3 tablets per day
- Prior authorization required; approval duration determined by clinical factors (genotype, treatment history, cirrhosis, transplant)
Approval duration rules (8 / 12 / 16 weeks)
Approval durations are determined by genotype, treatment history, cirrhosis (compensated) and transplant status: commonly 8 weeks for treatment‑naïve without cirrhosis, 12 weeks for compensated cirrhosis or post‑transplant recipients, and up to 16 weeks for certain treatment‑experienced genotype‑1 scenarios.
- Genotypes 1–6, treatment‑naïve without cirrhosis: 8 weeks (chunk 2)
- Treatment‑naïve with compensated cirrhosis: 12 weeks (chunk 2)
- Genotype 1, treatment‑experienced with prior NS5A inhibitor (without prior NS3/4A PI): 16 weeks (chunk 2)
- Genotype 1, treatment‑experienced with prior NS3/4A PI or sofosbuvir (without prior NS5A): 12 weeks (chunk 2)
- Post‑liver or post‑kidney transplant (treatment‑naïve or experienced), with or without compensated cirrhosis: 12 weeks (chunk 4)
- Various dual P/R or sofosbuvir‑experienced scenarios have specific 8–16 week assignments per genotype and history (chunks 3–4)
Denial risk: decompensated liver disease, contraindicated concomitant meds, and certain re‑treatment failures
Denials are likely if the member has decompensated cirrhosis, if Mavyret is prescribed concurrently with contraindicated or not‑recommended agents, or if requesting re‑treatment after failure of certain prior regimens listed in the policy.
- Decompensated cirrhosis is excluded (policy will not approve) (chunk 8)
- Contraindicated concomitant medications include ritonavir‑containing regimens, efavirenz, etravirine, nevirapine, darunavir/cobicistat, atazanavir, carbamazepine, St. John's wort, ethinyl‑estradiol products, atorvastatin, lovastatin, simvastatin, and rifampin (chunk 8)
- Not approved for use in combination with other NS5A or NS3/4A inhibitors or NS5B polymerase inhibitors (e.g., dasabuvir, sofosbuvir) (chunk 8)
- Re‑treatment requests after failure or relapse following certain prior regimens (elbasvir/grazoprevir; ombitasvir/paritaprevir/ritonavir ± dasabuvir; sofosbuvir/velpatasvir/voxilaprevir) may not be approved (chunk 8)
Required documentation: diagnosis, genotype/HCV RNA, compensated liver disease, age/weight, treatment history
Provide documentation of age or weight, a confirmed CHC diagnosis with genotype and positive HCV RNA, evidence of compensated liver disease, and prior treatment history as applicable; active alcohol/IV drug abuse requires enrollment in a substance abuse program.
- Age ≥12 years or weight ≥45 kg (chunk 5)
- Documented chronic hepatitis C infection with genotype and a positive HCV RNA result (chunk 5)
- Evidence of compensated liver disease (Child‑Pugh Class A) and absence of decompensated cirrhosis (chunks 5 and 10)
- Prior antiviral treatment history and regimen details to determine appropriate approval duration (chunks 6–7)
- If individual abuses alcohol or IV drugs, documentation of enrollment in a substance abuse program is required (chunk 5)
Clinical Definitions and Prior Exposure Terms
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