CurrentCignaPolicy N/A

Hepatitis C - Zepatier Prior Authorization Policy

Cigna's prior authorization policy governing coverage and medical necessity criteria for Zepatier (grazoprevir/elbasvir) for treatment of chronic hepatitis C genotypes 1 and 4, applicable to covered members and prescribers under Cigna-administered benefit plans.

Policy Summary

PayerCigna

PolicyHepatitis C - Zepatier Prior Authorization Policy

Policy CodePolicy N/A

Change TypeMinor editorial (no material clinical changes)

Effective DateN/A

Next Review DateFeb 12, 2025

Key ActionObtain prior authorization and document prescriber specialty and NS5A test results when applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Genotypes 1 & 4HCV genotypes addressed

Age ≥12 / ≥30 kgMinimum eligibility

12 or 16 wksTreatment durations

Contraindicated: Child‑Pugh B/CHepatic impairment

Prior auth requiredAuthorization

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Coverage and Medical Necessity Criteria

FDA-Approved Indication: HCV Genotype 1a

Approve for the duration noted if the patient meets ALL of the following (A, B, and C):

Genotype 1a approval

A) Age or weight
- i. Patient is ≥ 12 years of age.
- ii. Patient weighs ≥ 30 kg.
B) Treatment history and duration
- Approve for 12 weeks
  - a) Patient meets BOTH of the following: (1) Patient is treatment-naïve, OR patient has previously been treated with pegylated interferon + ribavirin only; AND (2) Patient does NOT have a baseline NS5A polymorphism at one (or more) of the amino acid positions: 28, 30, 31, or 93.
  - b) Patient meets BOTH of the following: (1) Patient has previously been treated with pegylated interferon + ribavirin and an HCV protease inhibitor; AND (2) The medication will be prescribed in combination with ribavirin.
- Approve for 16 weeks
  - a) Patient meets ONE of the following: (1) Patient is treatment-naïve; OR (2) Patient has previously been treated with pegylated interferon + ribavirin only.
  - b) Patient has a baseline NS5A polymorphism at one (or more) of the amino acid positions: 28, 30, 31, or 93.
  - c) The medication will be prescribed in combination with ribavirin.
C) Prescriber specialty: The medication is prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician.

FDA-Approved Indication: HCV Genotype 1b

Approve for 12 weeks if the patient meets ALL of the following (A, B, and C):

Genotype 1b approval

A) Age or weight
- i. Patient is ≥ 12 years of age.
- ii. Patient weighs ≥ 30 kg.
B) Treatment history
- Option i: Patient meets ONE of the following: a) Patient is treatment-naïve; OR b) Patient has previously been treated with pegylated interferon + ribavirin only.
- Option ii

FDA-Approved Indication: HCV Genotype 4

Approve for the duration noted if the patient meets ALL of the following (A, B, and C):

Genotype 4 approval

A) Age or weight
- i. Patient is ≥ 12 years of age.
- ii. Patient weighs ≥ 30 kg.
B) Treatment history and duration
- Treatment-naïve: Patient is treatment-naïve: Approve for 12 weeks.
- Previously treated with pegylated interferon + ribavirin

Other Uses with Supportive Evidence: Continuing Therapy

Patients currently receiving Zepatier

Continuation to complete course: Approve to complete a course of therapy for the duration remaining (e.g., if total course is 12 weeks and patient has received 3 weeks, approve 9 weeks), provided the original indication met the Recommended Authorization Criteria.

Use of Zepatier in patients with Child-Pugh Class B or C (moderate or severe hepatic impairment) is contraindicated and not covered. Zepatier is contraindicated in decompensated cirrhosis and use in these patients will be denied.

Combination therapy of Zepatier with any other direct-acting antivirals (DAAs) (excluding ribavirin) is considered unproven and not covered. Zepatier provides a complete antiviral regimen for genotypes 1 and 4; coadministration with other DAAs is not an accepted use under this policy.

Zepatier is not covered for pediatric patients who are under 12 years of age or who weigh < 30 kg. The safety and efficacy of Zepatier have not been established in these younger/smaller pediatric populations.

Retreatment with Zepatier in patients who have previously received Zepatier is not recommended and not covered. This includes prior null responders, prior partial responders, prior relapsers, and patients who did not complete a prior course of therapy.

Any use of Zepatier outside the FDA-approved indications or the specific uses listed in the Recommended Authorization Criteria is considered experimental, investigational, or unproven and therefore not medically necessary/not covered under this policy.

Provider Requirements and Authorization Details

Prior Authorization

Prior Authorization Required

Prior authorization is required for Zepatier. Approvals are provided for the treatment durations specified in the FDA‑Approved Indications (12 or 16 weeks) and to complete an ongoing course when the member is currently receiving therapy.

Approval durations: 12 weeks or 16 weeks as outlined in the FDA‑Approved Indications.
Prior authorization required to initiate or continue therapy.

Documentation Required

Prescriber Specialty / Consultation

Zepatier must be prescribed by or in consultation with a physician who specializes in the condition being treated. Approvals require the prescriber to be a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician, or documentation of consultation with one of these specialists.

Prescriber specialty required: gastroenterologist, hepatologist, infectious diseases physician, or liver transplant physician.
Document specialist consultation when the prescribing clinician is not one of the specialties listed.

Documentation Required

Baseline NS5A Testing (Genotype 1a)

For patients with HCV genotype 1a, baseline NS5A resistance‑associated substitution (RAS) testing at amino acid positions 28, 30, 31, and 93 is required to determine appropriate treatment duration and regimen. If a baseline NS5A polymorphism is present, a different regimen should be considered and longer duration with ribavirin may be required per dosing guidance.

Required baseline NS5A testing positions: 28, 30, 31, 93.
Presence of NS5A polymorphism impacts regimen choice and may necessitate combination with ribavirin and/or 16‑week duration.

Denial Risk

No Other DAA Combinations / Retreatment Restriction

Zepatier is not to be used in combination with any other direct‑acting antivirals (DAAs) except ribavirin. Retreatment with Zepatier in patients who have previously received Zepatier is not recommended and is considered not covered.

Combination with other DAAs (other than ribavirin) is considered experimental/unproven and is not covered.
Retreatment exclusion: prior recipients of Zepatier (including prior null/partial responders, relapsers, or those who discontinued due to adverse reaction) are not candidates for retreatment with Zepatier.

Key Terms and Abbreviations

inv-18: NS5A polymorphism / resistance-associated substitution

DefinitionBaseline amino acid substitutions at NS5A positions 28, 30, 31, or 93 that affect treatment response and are recommended to be tested in genotype 1a patients prior to initiating Zepatier.

PurposeTesting is recommended to guide treatment duration because presence of NS5A polymorphisms in genotype 1a is associated with lower sustained virologic response at 12 weeks when treated with Zepatier.

Affected positionsAmino acid positions 28, 30, 31, and 93 (NS5A).

Implication for regimenIf baseline NS5A polymorphism is present for genotype 1a, Zepatier should be prescribed with ribavirin and treatment duration is extended to 16 weeks.

When not applicableNS5A testing is not applicable (NA) for genotype 1b and genotype 4 per dosing table notes.

inv-19: TN / PR / PI / TE

TNTreatment‑naïve.

PRPegylated interferon + ribavirin.

PIProtease inhibitor.

TETreatment‑experienced.

Background and Drug Information

Zepatier is an oral fixed-dose combination tablet of grazoprevir (a protease inhibitor) and elbasvir (an NS5A inhibitor). It is indicated, with or without ribavirin, for treatment of chronic hepatitis C virus (HCV) genotypes 1 and 4 in patients who are ≥ 12 years of age or weigh ≥ 30 kg. Zepatier is contraindicated in patients with Child-Pugh Class B or C liver disease (decompensated cirrhosis).

Policy Summary

PayerCigna

PolicyHepatitis C - Zepatier Prior Authorization Policy

Policy CodePolicy N/A

Change TypeMinor editorial (no material clinical changes)

Effective DateN/A

Next Review DateFeb 12, 2025

Key ActionObtain prior authorization and document prescriber specialty and NS5A test results when applicable.

SourceLink

On This Page

a) Patient has previously been treated with pegylated interferon + ribavirin + an HCV protease inhibitor.

b) The medication will be prescribed in combination with ribavirin.

C) Prescriber specialty: The medication is prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician.

a) Patient has previously been treated with pegylated interferon + ribavirin.

b) The medication will be prescribed in combination with ribavirin.

Approve for 16 weeks if both (a) and (b) are met.

C) Prescriber specialty: The medication is prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician.