Zepatier (elbasvir/grazoprevir) — Coverage Criteria
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Defines prior authorization, quantity limits, approval durations, and clinical criteria for coverage of Zepatier (elbasvir/grazoprevir) for members with hepatitis C; applies to Amerigroup pharmacy benefits (excludes Medicare and plans without pharmacy benefits).
No material clinical or coverage changes in this revision.
Coverage Criteria for Zepatier (elbasvir/grazoprevir)
Initial therapy — Covered when ALL of the following are met
Covered when ALL of the following are met:
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Zepatier will not be approved for individuals with decompensated cirrhosis. Requests that propose concurrent use of Zepatier with agents that are contraindicated or not recommended are also excluded. Examples of such interacting agents include strong CYP3A4 inducers (for example, efavirenz, phenytoin, phenobarbital, carbamazepine, St. John's Wort, rifampin, rifabutin, rifapentine) and potent OATP1B1/1B3 inhibitors, as well as certain antiretroviral/cobicistat-containing regimens, oral ketoconazole, and other listed interacting regimens. Concurrent regimens that include other NS3/4A protease inhibitors or other NS5A inhibitors are likewise not appropriate with Zepatier.
Zepatier is not approved 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 a prior completed regimen that included a NS5B polymerase inhibitor (other than sofosbuvir) or an NS5A inhibitor, unless specific re-treatment criteria described elsewhere in the policy are met.
Coding and Approval Durations
| NDC (not listed) | Zepatier (elbasvir/grazoprevir) — quantity limit 1 tablet/day |
Provider Requirements, Prior Authorization, and Denial Risks
Prior authorization required; QL 1 tablet/day; approval duration per genotype/cirrhosis/prior tx
Prior authorization is required for Zepatier; the policy enforces a quantity limit of 1 tablet per day. Approval duration is determined by the individual’s HCV genotype, cirrhosis status, prior treatment experience, and NS5A resistant-associated polymorphism (RAS) results as specified in the approval duration tables.
- Quantity limit: 1 tablet/day.
- Approval duration varies by genotype, cirrhosis status, prior treatment experience, and NS5A RAS result.
Step/coverage conditioned on prior trial of preferred DAAs
Use of Zepatier for many genotypes/prior-exposure combinations requires a prior trial and inadequate response to an authorized generic Epclusa (sofosbuvir/velpatasvir) OR Mavyret, unless the member is currently completing Zepatier, has documented hypersensitivity to the preferred agents, or is concurrently using a non-substitutable contraindicated agent.
- Medication samples, coupons, and discount cards are excluded from consideration as a prior trial.
- Exceptions to prior trial requirement: currently completing Zepatier; documented severe hypersensitivity to Epclusa or Mavyret not shared with Zepatier; concurrent non-substitutable contraindicated therapy.
Documentation: CHC diagnosis, genotype, positive HCV RNA, baseline NS5A RAS when required
Provide documentation of chronic hepatitis C diagnosis including genotype and a positive HCV RNA result; if genotype 1a is present, include a baseline NS5A resistant-associated polymorphism test result. Also document enrollment in a substance abuse program when the individual abuses alcohol or intravenous drugs.
- Diagnosis documentation must include genotype and positive HCV RNA (AASLD/IDSA 2017, CDC 2013).
- Baseline NS5A RAS result is required for genotype 1a.
- Evidence of prior trials or prior treatment response where applicable (medication samples/coupons/discount cards excluded).
Denial risks: decompensated cirrhosis or contraindicated concurrent agents
Denial may be issued if the individual has decompensated cirrhosis or requests concurrent therapy with listed contraindicated or not recommended agents (for example, strong CYP3A4 inducers, strong OATP1B1/1B3 inhibitors, or other specified interacting regimens).
- Examples of contraindicated agents include strong CYP3A4 inducers such as efavirenz, phenytoin, phenobarbital, carbamazepine, St John's Wort, rifampin, rifabutin, and rifapentine.
- Denial may also apply if Zepatier is requested in combination with another NS3/4A protease inhibitor, another NS5A inhibitor, or an NS5B polymerase inhibitor other than sofosbuvir.
- Re-treatment requests after failure to achieve SVR or relapse following prior NS5A/NS5B/NS3 regimens are not approved unless re-treatment criteria are met.
Background
Zepatier (elbasvir/grazoprevir) is a direct-acting antiviral indicated for treatment of chronic hepatitis C. Treatment regimen and duration depend on HCV genotype, prior treatment history, presence of baseline NS5A resistance-associated polymorphisms (notably for genotype 1a), and cirrhosis status; certain genotype- and prior-exposure–specific combinations may require coadministration with ribavirin or sofosbuvir per the approval-duration guidance. DAAs including Zepatier carry risks that require appropriate baseline testing and monitoring prior to and during therapy.
Definitions
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