Cigna Mavyret Prior Auth Coverage Update

Coverage criteria for Mavyret (glecaprevir/pibrentasvir)

inv-01: Acute HCV (FDA‑approved) — Approve for 8 weeks if ALL required conditions are met

Approve for 8 weeks if ALL of the following are met:

Acute HCV (FDA‑approved): A) Patient is ≥ 3 years of age; AND B) Patient does ONE of: i) does not have cirrhosis; OR ii) has compensated cirrhosis; AND C) Patient has quantifiable HCV RNA; AND D) Patient meets ONE or more of: i) conversion from negative to positive anti‑HCV antibody, HCV RNA, and/or HCV core antigen; OR ii) signs or symptoms of acute HCV (e.g., ALT > 5× ULN and/or jaundice; nausea, fatigue, fever, myalgias) as assessed by the prescriber; OR iii) risk behavior for HCV within the prior 6 months per prescriber assessment; AND E) Medication is prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or liver transplant physician.

Treatment duration = 8 weeks.

inv-02: Chronic HCV Genotype‑specific approvals (FDA‑approved) — Approvals vary by genotype, prior treatment status, and cirrhosis

Approval durations depend on genotype, prior treatment status, and cirrhosis; prescriber must be a gastroenterologist, hepatologist, infectious diseases physician, or liver transplant physician.

Genotype 1: A) Patient is ≥ 3 years of age; AND B) The medication is prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or liver transplant physician; AND C) ONE of: i) Approve 12 weeks if patient is treatment‑naïve OR previously treated with pegylated interferon/ribavirin, Incivek (telaprevir), Olysio (simeprevir), or Victrelis (boceprevir); OR ii) Approve 16 weeks if previously treated with Daklinza (daclatasvir), sofosbuvir/velpatasvir, ledipasvir/sofosbuvir, Zepatier (elbasvir/grazoprevir), Sovaldi (sofosbuvir) + ribavirin (+/- pegylated interferon), or Sovaldi + Olysio.

Genotype 2: A) Patient is ≥ 3 years of age; AND B) The medication is prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or liver transplant physician; AND C) Approve for 12 weeks.

Genotype 3: A) Patient is ≥ 3 years of age; AND B) The medication is prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or liver transplant physician; AND C) ONE of: i) Approve 12 weeks if treatment‑naïve; OR ii) Approve 16 weeks if previously treated with Sovaldi (sofosbuvir) + ribavirin (+/- interferon) or previously treated with pegylated interferon/ribavirin.

Genotype 4: A) Patient is ≥ 3 years of age; AND B) The medication is prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or liver transplant physician; AND C) Approve for 12 weeks.

Genotype 5 or 6: A) Patient is ≥ 3 years of age; AND B) The medication is prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or liver transplant physician; AND C) Approve for 12 weeks.

inv-03: Renal impairment (eGFR <30 mL/min or ESRD) and Kidney Transplant — Approve duration based on genotype and prior treatment; specialist prescriber required

Approve duration based on genotype and prior treatment status with required specialist prescriber (includes nephrologist or kidney transplant physician for renal/transplant indications).

Genotype 1 with renal impairment: A) Patient is ≥ 3 years of age; AND B) The medication is prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, nephrologist, kidney transplant physician, or liver transplant physician; AND C) ONE of: i) Approve 12 weeks if treatment‑naïve or previously treated with pegylated interferon/ribavirin, Incivek, Olysio, or Victrelis; OR ii) Approve 16 weeks if previously treated with Daklinza, sofosbuvir/velpatasvir, ledipasvir/sofosbuvir, Zepatier, Sovaldi + ribavirin (+/- interferon), or Sovaldi + Olysio.

Genotype 4 with renal impairment: A) Patient is ≥ 3 years of age; AND B) The medication is prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, nephrologist, kidney transplant physician, or liver transplant physician; AND C) Approve for 12 weeks.

Genotype 2,5,6 or genotype 3 with renal impairment: A) Patient is ≥ 3 years of age; AND B) The medication is prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, nephrologist, kidney transplant physician, or liver transplant physician; AND C) ONE of: i) If genotype 2, 5, or 6 — Approve 12 weeks; OR ii) If genotype 3 and treatment‑naïve — Approve 12 weeks; OR iii) If genotype 3 and previously treated — Approve 16 weeks.

inv-04: Kidney Transplant recipients — Approve duration based on genotype and prior treatment

Approve duration based on genotype and prior treatment for kidney transplant recipients; prescriber must be affiliated with a transplant center.

Genotype 1 kidney transplant: A) Patient is ≥ 3 years of age; AND B) Patient is a kidney transplant recipient; AND C) ONE of: i) treatment‑naïve — Approve 12 weeks; OR ii) previously treated for HCV — Approve 16 weeks; AND D) Medication prescribed by or in consultation with a prescriber affiliated with a transplant center (gastroenterologist, hepatologist, infectious diseases physician, nephrologist, renal transplant physician, or liver transplant physician).

Genotype 2,3,5,6 kidney transplant: A) Patient is ≥ 3 years of age; AND B) Patient is a kidney transplant recipient; AND C) ONE of: i) genotype 2, 5, or 6 — Approve 12 weeks; OR ii) genotype 3 and treatment‑naïve — Approve 12 weeks; OR iii) genotype 3 and previously treated — Approve 16 weeks; AND D) Medication prescribed by or in consultation with a prescriber affiliated with a transplant center (gastroenterologist, hepatologist, infectious diseases physician, nephrologist, renal transplant physician, or liver transplant physician).

inv-05: HCV Genotype 1 — Kidney Transplant — Approve for the duration noted if ALL specified conditions (A–D) are met

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

Kidney transplant genotype 1 approval: A) Patient is ≥ 3 years of age; AND B) Patient is a kidney transplant recipient; AND C) ONE of: i) treatment‑naïve — approve for 12 weeks; OR ii) previously treated for HCV — approve for 16 weeks; AND D) Medication prescribed by or in consultation with one of the following prescribers who is affiliated with a transplant center: gastroenterologist, hepatologist, infectious diseases physician, nephrologist, renal transplant physician, or liver transplant physician.

inv-06: HCV Genotype 2,3,5,6 — Kidney Transplant — Approve for the duration noted if ALL specified conditions (A–D) are met

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

Kidney transplant genotypes 2/3/5/6 approval: A) Patient is ≥ 3 years of age; AND B) Patient is a kidney transplant recipient; AND C) ONE of: i) genotype 2, 5, or 6 — approve for 12 weeks; OR ii) genotype 3 and treatment‑naïve — approve for 12 weeks; OR iii) genotype 3 and previously treated for HCV — approve for 16 weeks; AND D) Medication prescribed by or in consultation with one of the following prescribers who is affiliated with a transplant center: gastroenterologist, hepatologist, infectious diseases physician, nephrologist, renal transplant physician, or liver transplant physician.

inv-07: HCV Genotype 4 — Kidney Transplant — Approve for 12 weeks if ALL specified conditions (A–C) are met

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

Kidney transplant genotype 4 approval: A) Patient is ≥ 3 years of age; AND B) Patient is a kidney transplant recipient; AND C) The medication is prescribed by or in consultation with one of the following prescribers who is affiliated with a transplant center: gastroenterologist, hepatologist, infectious diseases physician, nephrologist, renal transplant physician, or liver transplant physician.

inv-08: HCV Genotype 1–6 — Liver Transplant — Approve for the duration noted if ALL specified conditions (A–D) are met

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

Liver transplant genotypes 1–6 approval: A) Patient is ≥ 3 years of age; AND B) Patient is a liver transplant recipient; AND C) ONE of: i) genotype 2, 4, 5, or 6 — Approve for 12 weeks; OR ii) genotype 1 or 3 and treatment‑naïve — Approve for 12 weeks; OR iii) genotype 1 or 3 and previously treated for HCV — Approve for 16 weeks; AND D) Medication prescribed by or in consultation with one of the following prescribers who is affiliated with a transplant center: a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician.

inv-09: Chronic HCV — Genotype Unknown/Undetermined — Approve for 8 weeks if ALL specified conditions (A–H) are met

Approve for 8 weeks if the patient meets ALL of the following (A–H):

Chronic HCV genotype unknown approval: A) Patient is ≥ 18 years of age; AND B) Patient meets ONE of: i) does not have cirrhosis; OR ii) has compensated cirrhosis; AND C) Patient has not previously been treated for HCV; AND D) Patient does not have hepatitis B virus; AND E) Patient is not pregnant; AND F) Patient does not have hepatocellular carcinoma; AND G) Patient has not had a liver transplantation; AND H) The medication will be prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician.

inv-10: Recurrent HCV Post-Liver Transplant — Approve for 12 weeks if ALL specified conditions (A–C) are met

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

Recurrent HCV post-liver transplant approval: A) Patient is ≥ 3 years of age; AND B) Patient has recurrent HCV after a liver transplantation; AND C) The medication is prescribed by or in consultation with one of the following prescribers who is affiliated with a transplant center: gastroenterologist, hepatologist, infectious diseases physician, or liver transplant physician.

inv-11: Patients Already Started on Mavyret — Continuation/transition rule (single top-level node)

Patients already started on Mavyret: Approve the remaining duration needed to complete the indicated course (e.g., if total indicated is 12 weeks and patient received 3 weeks, approve for 9 additional weeks).

Prescribing Mavyret outside the specific indications and criteria listed in this policy, or without meeting the stated clinical requirements, will not meet coverage. Prior authorization is required for Mavyret; approvals are provided only for the durations noted in the criteria and require that the medication be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., gastroenterologist, hepatologist, infectious diseases physician, or transplant specialist as applicable).

The following uses are explicitly excluded and may be denied as not medically necessary: use in patients with Child‑Pugh Class B or C hepatic impairment (moderate or severe hepatic impairment); use in combination with any other direct‑acting antiviral (DAA); and use in pediatric patients < 3 years of age. These situations are listed as conditions not covered in this policy.

Mavyret is considered not medically necessary for any other uses not listed in this policy. This explicitly includes patients with moderate or severe hepatic impairment (Child‑Pugh Class B or C), combination therapy with other DAAs, and pediatric patients under 3 years of age.

Provider actions, prior authorization, and documentation requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required. Prior authorization is required for coverage of Mavyret. All approvals are provided for the duration specified in the indications below. Requests that do not meet the documented criteria will not be approved.

Approvals are provided for the duration noted in each FDA‑approved indication or transplant/renal scenario.
If a patient has already started Mavyret, approve remaining weeks needed to complete the prescribed course (e.g., patient started and received 3 of 12 weeks → approve 9 weeks).

Documentation Required

Prescriber specialty / Consultation Requirement

Prescriber specialty / consultation requirement. Because of the specialized evaluation and monitoring required, Mavyret must be prescribed by — or in consultation with — an appropriate specialist.

For routine (non‑transplant) indications: prescription must be written by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or liver transplant physician.

Background: drug description and indications

Mavyret is a fixed‑dose direct‑acting antiviral combination of glecaprevir (an NS3/4A protease inhibitor) and pibrentasvir (an NS5A inhibitor). It is indicated for treatment of acute and chronic hepatitis C virus (HCV) infection across genotypes 1–6 in eligible patients (including many patients with compensated cirrhosis and certain renal‑ or transplant‑related populations). Use and approved treatment duration depend on factors such as HCV genotype, prior treatment history, presence of cirrhosis, renal impairment or transplant status, and patient age; prior authorization is required and approvals are issued for the specific durations noted in the coverage criteria.

Key definitions used in criteria

inv-24: Treatment‑experienced — Definition for patients previously treated for current HCV infection

DefinitionPatients who previously received treatment for the current HCV infection, including prior regimens containing interferon, pegylated interferon, ribavirin, and/or sofosbuvir (Sovaldi) or other specified regimens.

IncludesPrior exposure to older protease regimens (e.g., Olysio + Sovaldi, Victrelis, Incivek) and regimens referenced as 'PRS' in prescribing information.

Impact on durationTreatment-experienced status modifies recommended duration (e.g., 12–16 weeks depending on genotype and prior regimen).

Reference age criterionApplies to patients meeting the policy age requirements (typically ≥ 3 years unless noted otherwise).

inv-25: Compensated cirrhosis — Child‑Pugh A cirrhosis (not decompensated); referenced in indications/durations

Policy revision history

2025-06-25selected_revisionLatest

Added acute HCV indication: Mavyret approved for 8 weeks for acute HCV (genotypes 1–6) when criteria are met.

2025-04-02annual_revision

Annual revision recorded (no criteria changes noted in HISTORY entry for this date).

2024-04-03annual_revision

Chronic HCV, genotype unknown/undetermined criterion modified to allow patients without cirrhosis OR with compensated cirrhosis.

OpenPayer

Mavyret (glecaprevir/pibrentasvir) prior authorization

Coverage criteria for Mavyret (glecaprevir/pibrentasvir)

Provider actions, prior authorization, and documentation requirements

Background: drug description and indications

Key definitions used in criteria

Policy revision history