CurrentCignaPolicy N/A

Zepatier (grazoprevir/elbasvir) drug quantity limits per days

Defines Cigna's drug quantity management limits and medical necessity criteria for Zepatier (grazoprevir/elbasvir) supply per 365 days for members receiving treatment for chronic hepatitis C genotypes 1a and 4.

Policy Summary

PayerCigna

PolicyZepatier (grazoprevir/elbasvir) drug quantity limits per days

Policy CodePolicy N/A

Change TypeRevised prior-treatment requirement

Effective DateN/A

Next Review DateJul 8, 2024

Key ActionRequest up to 112 tablets per 365 days only when genotype, NS5A polymorphism and prior-treatment criteria are met and therapy will include ribavirin.

SourceLink

POLICY UPDATE CHANGES

Criteria for genotype 1a patients previously treated with pegylated interferon + ribavirin were modified to 'treated with pegylated interferon + ribavirin only'.

84Standard 12-week max (per 365 days)

112Approved when criteria met (per 365 days)

28Tablets per dispensing

1 QDDosing frequency

Coverage and Medical Necessity Criteria

Approved Quantity Exceptions (112 tablets per 365 days)

Zepatier is covered as medically necessary when the Drug Quantity Management criteria below are met. Any other exception is considered not medically necessary.

Approved scenarios for 112 tablets per 365 days

Criteria Set 1: Genotype 1a: Patient has Genotype 1a chronic HCV; A) baseline NS5A polymorphism at one or more positions 28, 30, 31, or 93; AND B) patient meets one of: i) treatment-naïve OR ii) previously treated with pegylated interferon + ribavirin only; AND C) medication will be prescribed in combination with ribavirin.
Criteria Set 2: Genotype 4: Patient has Genotype 4 chronic HCV; AND A) previously treated with pegylated interferon and ribavirin; AND B) medication will be prescribed in combination with ribavirin.
Course completion rule: If the patient has been started on Zepatier for an indication or condition addressed as an approval above, approve the remaining tablets necessary to complete the described course (example: if the patient has received 3 weeks [21 tablets], approve 91 tablets to complete 16 weeks of treatment).

Policy Summary

PayerCigna

PolicyZepatier (grazoprevir/elbasvir) drug quantity limits per days

Policy CodePolicy N/A

Change TypeRevised prior-treatment requirement

Effective DateN/A

Next Review DateJul 8, 2024

Key ActionRequest up to 112 tablets per 365 days only when genotype, NS5A polymorphism and prior-treatment criteria are met and therapy will include ribavirin.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Standard Quantity

Standard quantity allowance

Standard coverage: Up to 84 tablets per 365 days (28 tablets per dispensing) is considered sufficient to treat a standard 12-week course and is covered when requested quantities are within this limit.

Zepatier is covered as medically necessary only when the Drug Quantity Management criteria in this policy are met. Any quantity request or exception that does not meet these stated criteria is considered not medically necessary and may be denied.

The standard Drug Quantity Management allowance for Zepatier is 84 tablets per 365 days (sufficient for a 12‑week course; dispensed as 28 tablets per dispensing). Requests that exceed this standard quantity are considered not medically necessary unless they meet the authorized exception rules. Approvals for up to 112 tablets per 365 days are permitted only when the specific genotype-, resistance-, and prior‑treatment criteria are satisfied (see criteria for Genotype 1a and Genotype 4) or when approval is needed to complete an already‑started 16‑week course.

What Providers Must Do

Denial Risk

Quantity limits and exceptions

Zepatier has a Drug Quantity Management rule limiting standard coverage to 84 tablets per 365 days (28 tablets per dispensing). This quantity is sufficient for a 12‑week course. If the quantity management rule is not met at point of service, coverage will be determined by the criteria below and a coverage determination (including denial) may result.

Standard allowance: 84 tablets per 365 days (28 tablets per dispensing)
If Drug Quantity Management rule not met, coverage determination per policy criteria — may result in denial

Step Therapy

Step therapy

Step therapy is not required for Zepatier under this policy. No step therapy requirements are specified.

Documentation Required

Required clinical documentation

Prescribers must supply supporting clinical documentation with prior authorization or coverage requests. Documentation should include genotype and NS5A resistance-associated substitution (RAS) testing results when applicable, treatment history (including prior pegylated interferon + ribavirin exposure), and the planned regimen (e.g., whether ribavirin will be co‑administered).

Baseline NS5A polymorphism test results (positions 28, 30, 31, or 93) when requesting 112 tablets for genotype 1a
Documentation of prior treatment history (treatment‑naïve or pegylated interferon + ribavirin exposure)
Prescription showing Zepatier will be given in combination with ribavirin when required by criteria

Denial Risk

Denial risk for exceeding quantity limits

There is an increased risk of denial if requests exceed the Drug Quantity Management limits and do not meet the specific exception criteria. Prior authorization should clearly reference the applicable criteria (e.g., genotype 1a with NS5A polymorphism plus ribavirin) to support approval of 112 tablets per 365 days.

Requests exceeding 84 tablets per 365 days require meeting criteria for 112‑tablet exception
For genotype 1a, exception requires baseline NS5A polymorphism at 28, 30, 31, or 93; appropriate treatment history; and co‑prescription with ribavirin
For genotype 4, exception requires prior pegylated interferon + ribavirin exposure and co‑prescription with ribavirin

Drug Quantity Management Limits

Standard quantity (84 tablets per 365 days)

Standard maximum quantity per 365 days84 tablets (28 tablets per dispensing) — sufficient for a standard 12‑week course

Strength and formulationZepatier (grazoprevir/elbasvir) 50/100 mg tablets

Covered sitesRetail and home delivery

Coverage stanceCovered with criteria when within quantity limits; requests exceeding 84 tablets require exception criteria

Exception quantity (112 tablets per 365 days)

Exception maximum quantity per 365 days112 tablets — approved for extended 16‑week therapy when specified criteria are met

When allowedApproved at retail or home delivery if patient meets genotype, resistance, and ribavirin co‑prescription criteria (see clinical criteria)

Course‑completion ruleIf treatment already started under an approved indication, remaining tablets necessary to complete the 16‑week course will be approved (example: 21 tablets already received → approve 91 tablets)

Relation to standard limitRequests exceeding the standard 84 tablets per 365 days are not medically necessary unless one of the 112‑tablet exception scenarios or course‑completion applies

Key Definitions

NS5A resistance‑associated polymorphisms (positions 28, 30, 31, 93)

DefinitionNS5A resistance‑associated polymorphisms are amino acid substitutions at positions 28, 30, 31, or 93 in the HCV NS5A protein that can affect response to NS5A‑containing regimens

Clinical roleIn genotype 1a patients, presence of a baseline NS5A polymorphism at one or more of positions 28, 30, 31, or 93 guides extension of Zepatier therapy to 16 weeks and addition of ribavirin

Testing recommendationTesting for NS5A resistance‑associated polymorphisms is recommended prior to initiating Zepatier in genotype 1a infection to guide treatment duration

Positions specifiedAmino acid positions: 28, 30, 31, 93

Drug Background and Indications

Zepatier is an oral fixed‑dose combination tablet containing grazoprevir (a protease inhibitor) and elbasvir (an NS5A inhibitor). It is indicated for the treatment of chronic hepatitis C virus infection in patients with genotype 1 or 4 (approved for adults and pediatric patients ≥12 years or ≥30 kg). The recommended dosing is one tablet once daily, with a typical treatment duration of 12 weeks; certain genotype, resistance, or prior‑treatment scenarios may require extension to 16 weeks and addition of ribavirin.