Cigna Mavyret Prior Auth Coverage Update

Covered indications with criteria

Covered when specified criteria for the applicable indication and treatment history are met

Acute HCV (Genotypes 1–6): Approve for 8 weeks if A) Patient is ≥ 3 years of age; AND B) Patient meets ONE of: (i) patient does not have cirrhosis; OR (ii) patient 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, or HCV core antigen; OR (ii) signs/symptoms of acute hepatitis C per prescriber (eg, ALT >5× ULN and/or jaundice; nausea, fatigue, fever, myalgias); OR (iii) risk behavior for HCV within prior 6 months; AND E) Medication prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or liver transplant physician.

Based on chunk 12

Chronic HCV, Treatment-Naïve (Genotypes 1–6): Approve for 8 weeks if A) Patient is ≥ 3 years of age; AND B) Patient is HCV treatment-naïve for current chronic infection; AND C) Medication prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or liver transplant physician.

Based on chunk 13

Chronic HCV, Genotype 1, Treatment-Experienced: Approve for the duration noted if A) Patient is ≥ 3 years of age; AND B) Patient meets ONE of the following branches: (i) NS5A-experienced, NS3/4A-naïve: approve 16 weeks if a) patient does not have cirrhosis or has compensated cirrhosis (Child-Pugh A); AND b) prior null/partial response or relapse after an NS5A-inhibitor containing product (eg, daclatasvir, sofosbuvir/velpatasvir, ledipasvir/sofosbuvir); AND c) no prior treatment with specified NS3/4A inhibitor products (eg, simeprevir, boceprevir, telaprevir, ombitasvir/paritaprevir/ritonavir-containing regimens, voxilaprevir-containing products, elbasvir/grazoprevir); OR (ii) NS3/4A-experienced, NS5A-naïve: approve 12 weeks if a) patient does not have cirrhosis or has compensated cirrhosis (Child-Pugh A); AND b) patient has not previously been treated with listed NS5A-inhibitor products; AND c) prior null/partial response or relapse after an NS3/4A-containing product; OR (iii) prior interferon/pegylated interferon ± ribavirin ± sofosbuvir-experienced without cirrhosis: approve 8 weeks if a) no cirrhosis; AND b) prior null/partial response or relapse after those regimens; OR (iv) same prior regimens with compensated cirrhosis: approve 12 weeks. AND C) Medication prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician.

Derived from chunks 14-16

Chronic HCV, Genotype 2, 4, 5, 6, Treatment-Experienced: Approve for the duration noted if A) Patient is ≥ 3 years of age; AND B) Patient meets ONE of: (i) no cirrhosis AND prior null/partial response or relapse after interferon ± ribavirin, pegylated interferon ± ribavirin, or sofosbuvir-containing regimens → approve 8 weeks; OR (ii) compensated cirrhosis (Child-Pugh A) AND prior null/partial response or relapse after those regimens → approve 12 weeks; AND C) Medication prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician.

Based on chunk 17

Chronic HCV, Genotype 3, Treatment-Experienced: Approve for 16 weeks if A) Patient is ≥ 3 years of age; AND B) Patient does not have cirrhosis or has compensated cirrhosis (Child-Pugh A); AND C) Patient had a prior null response, prior partial response, or relapse after prior treatment with interferon ± ribavirin, pegylated interferon ± ribavirin, or sofosbuvir-containing regimens; AND D) Medication prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician.

From chunks 18 and 19

HCV Kidney or Liver Transplant Recipients: Approve for transplant recipients ≥ 3 years when A) Patient is ≥ 3 years of age; AND B) Patient is a kidney or liver transplant recipient with HCV; AND C) Patient meets ONE of the genotype-specific branches: (i) genotype 2, 4, 5, or 6 → approve 12 weeks; OR (ii) genotype 1 → approve per (a) or (b): a) NS5A-experienced, NS3/4A-naïve → approve 16 weeks if (1) prior null/partial response or relapse after an NS5A-containing product AND (2) no prior treatment with specified NS3/4A inhibitor products as listed; OR b) approve 12 weeks for all other genotype 1 patients; OR (iii) genotype 3 → approve 16 weeks if prior null/partial response or relapse after interferon ± ribavirin/sofosbuvir regimens, OR approve 12 weeks for other genotype 3 patients; AND D) Medication prescribed by or in consultation with a transplant-affiliated prescriber (gastroenterologist, hepatologist, infectious diseases physician, nephrologist, renal transplant physician, or liver transplant physician).

From chunks 18-19

Chronic Hepatitis C Virus (HCV), Genotype 3, Treatment-Experienced

Approve for 16 weeks if the patient meets ALL of the following (A, B, C, and D):

Chronic HCV genotype 3, treatment-experienced: A) Patient is ≥ 3 years of age; AND B) Patient does not have cirrhosis or has compensated cirrhosis (Child-Pugh A); AND C) Patient had a prior null response, prior partial response, or had relapse after prior treatment with one of the following regimens: interferon ± ribavirin, pegylated interferon ± ribavirin, Sovaldi (sofosbuvir) + ribavirin, or Sovaldi + pegylated interferon + ribavirin; AND D) Medication prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician.

Hepatitis C Virus (HCV) Kidney or Liver Transplant Recipient

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

HCV kidney or liver transplant recipient: A) Patient is ≥ 3 years of age; AND B) Patient is a kidney or liver transplant recipient with HCV; AND C) Patient meets ONE of the genotype-specific branches (i, ii, or iii): see children for genotype branches; AND D) Medication prescribed by or in consultation with a transplant-affiliated prescriber (gastroenterologist, hepatologist, infectious diseases physician, nephrologist, renal transplant physician, or liver transplant physician).

C.i genotype 2,4,5,6: Patient has genotype 2, 4, 5, or 6 HCV: Approve for 12 weeks.

C.ii genotype 1: Patient has genotype 1 HCV: Approve per (a) or (b): a) NS5A-experienced, NS3/4A-naïve: Approve for 16 weeks if BOTH (1) prior null/partial response or relapse after prior NS5A-containing products (eg, daclatasvir, sofosbuvir/velpatasvir, ledipasvir/sofosbuvir) AND (2) patient has not previously been treated with specified NS3/4A inhibitor or NS3/4A-containing products (eg, simeprevir, boceprevir, telaprevir, ombitasvir/paritaprevir/ritonavir-containing regimens, voxilaprevir-containing products, elbasvir/grazoprevir); OR b) Approve for 12 weeks for all other patients with genotype 1.

NS3/4A inhibitor product list specified in policy.

Chronic Hepatitis C Virus (HCV), Genotype Unknown/Undetermined

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

Chronic HCV genotype unknown/undetermined (other uses with supportive evidence): A) Patient is ≥ 18 years of age; AND B) Patient meets ONE of: (i) patient does not have cirrhosis; OR (ii) patient has compensated cirrhosis; AND C) Patient has not previously been treated for hepatitis C virus; 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) Medication prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician.

Recurrent Hepatitis C Virus (HCV) Post-Liver Transplantation

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

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

Continuation to Complete Therapy

Treatment completion policy

Patients already started on Mavyret: If a patient has been started on Mavyret, approve to complete the originally recommended course per the applicable indication (for example, if the course is 12 weeks and the patient received 3 weeks, approve the remaining 9 weeks).

Applies when initial therapy aligns with Recommended Authorization Criteria.

Coverage determinations are made according to the terms of the applicable benefit plan document and the specific clinical facts of each request. Reimbursement will be provided only when services are submitted in accordance with the criteria in this policy, including use of covered diagnosis and/or procedure codes. Claims submitted for services that are not accompanied by covered code(s) under this policy will be denied as not covered. Medical directors retain discretion to consider applicable laws, regulations, and collateral source materials when reviewing requests.

Use of Mavyret in patients with Child‑Pugh Class B or C liver disease (moderate or severe hepatic impairment) is contraindicated and not covered. Requests for Mavyret for members with moderate or severe hepatic impairment will be denied.

Combination use of Mavyret with any other direct‑acting antivirals (DAAs) is considered not medically necessary. Mavyret provides a complete antiviral regimen and concurrent DAA therapy is not supported by this policy.

Mavyret is not covered for pediatric patients aged 3 years. Safety and efficacy have not been established in children under 3 years; requests for patients younger than 3 years may be denied.

Claims for services billed with diagnoses or procedure codes that are not covered by this policy will be denied as not covered. Providers must use the most appropriate codes for the date of service and submit requests consistent with the applicable coverage criteria; failure to do so may result in denial of payment.

Mavyret is considered not medically necessary for any uses not specifically listed in the approval criteria. This includes use in patients with moderate or severe hepatic impairment (Child‑Pugh B or C), combination therapy with other DAAs, and in pediatric patients under 3 years of age. Requests outside the listed indications will be denied.

Provider Actions, Prior Authorization, and Prescribing Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for prescription benefit coverage of Mavyret. Approvals are granted when the applicable clinical criteria are met and will be provided for the duration specified in the policy.

Prior authorization required for all listed indications
Approvals granted for the duration(s) specified in the approval criteria (examples: 8, 12, 16 weeks depending on indication)

Prior Authorization

Specialist Prescribing / Consultation Required

Prescribing must be by or in consultation with a clinician who specializes in the condition being treated (due to required evaluation, diagnosis, and monitoring).

Acceptable prescribers/consultants: gastroenterologist, hepatologist, infectious diseases physician, liver transplant physician
For transplant recipients, prescriber should be affiliated with a transplant center (may include nephrologist or renal transplant physician as noted)

Documentation Required

Prior Treatment History Required for Certain Approvals

Some approvals require prior treatment history documentation (treatment‑naïve vs treatment‑experienced) or transplant status; ensure prior regimens and responses are documented when applicable.

Treatment‑naïve approvals require documentation the patient has not previously received HCV treatment
Treatment‑experienced approvals (e.g., genotype 3 or certain transplant scenarios) require documentation of prior regimens and prior response (null/partial/relapse) and specifics about prior NS5A or NS3/4A exposure when indicated

Denial Risk

Denial Triggers — Missing or Nonconforming Submissions

Denials will be issued for submissions that lack a covered diagnosis/procedure code, do not meet the clinical criteria, or are otherwise nonconforming to the policy requirements.

Claims submitted without covered diagnosis or procedure codes will be denied as not covered
Requests that do not meet the stated clinical criteria (age limits, cirrhosis status, prior treatment history, prescriber requirements) will be denied

Denial Risk

Contraindicated in Moderate/Severe Hepatic Impairment (Child‑Pugh B or C)

Mavyret is contraindicated and considered not medically necessary for patients with moderate or severe hepatic impairment (Child‑Pugh Class B or C).

Do not prescribe or request coverage for members with Child‑Pugh B or C hepatic impairment

Denial Risk

Minimum Age Exclusion

Minimum age limits apply. The safety and efficacy of Mavyret have not been established in pediatric patients younger than 3 years; such requests may be denied.

Requests for patients < 3 years of age are not covered

Prior Authorization

Ongoing Therapy — Complete Course Authorization

When a patient has already started Mavyret, approve the remaining duration necessary to complete the course listed in the criteria when the original indication is covered.

Example: If the course is 12 weeks and the patient has received 3 weeks, approve 9 weeks to complete therapy

Documentation Required

Provider Documentation Requirements

Because approvals depend on the benefit plan and clinical documentation, providers must follow the plan's submission requirements and include supporting clinical information to avoid delays or denials.

Include documentation of genotype, cirrhosis status (compensated vs decompensated), HCV RNA quantification, prior treatment regimens and responses, transplant status, and prescriber specialty/consultation notes as applicable

Definitions

PRS (Prior Regimen Experience)

Definition (PRS) — treatment-experiencedPRS = prior treatment experience with regimens containing interferon, pegylated interferon, ribavirin, and/or sofosbuvir (Sovaldi®) but no prior exposure to an HCV NS3/4A protease inhibitor or an NS5A inhibitor.

Implication for durationFor PRS patients (genotypes 1,2,4,5,6) durations: without cirrhosis = 8 weeks; with compensated cirrhosis (Child-Pugh A) = 12 weeks.

Context in dosing tablesPRS is the prior-treatment category used in Table 2 to assign treatment durations for treatment-experienced patients.

Compensated cirrhosis (Child-Pugh A) — definition

Child-Pugh A (compensated cirrhosis) — policy referenceCompensated cirrhosis is defined by Child-Pugh Class A and is the permitted cirrhosis status for treatment eligibility and duration decisions (e.g., some indications allow therapy in patients with compensated cirrhosis).

Role in indicationsMany approved durations (acute and chronic indications) explicitly allow patients with compensated cirrhosis (Child-Pugh A) to receive Mavyret per specified durations.

Distinction from decompensated diseaseChild-Pugh B or C (moderate or severe hepatic impairment) is contraindicated and considered not medically necessary.

Compensated cirrhosis (Child-Pugh A) — eligibility note

Eligibility note for Child-Pugh A patientsPatients with compensated cirrhosis (Child-Pugh A) are eligible for Mavyret under the policy when other criteria are met; some treatment durations differ for compensated cirrhosis (e.g., certain treatment-experienced indications).

Contrast with moderate/severe impairmentUse in patients with Child-Pugh Class B or C (moderate or severe hepatic impairment) is contraindicated and not covered.

Transplant and dosing contextTransplant recipients and treatment-experienced patients may receive adjusted durations when they have compensated cirrhosis (Child-Pugh A) as specified in the criteria sets.

NS5A-experienced

Definition — NS5A-experiencedNS5A-experienced = prior treatment with an NS5A-inhibitor containing product (examples listed: daclatasvir [Daklinza], sofosbuvir/velpatasvir, ledipasvir/sofosbuvir).

Impact on recommended durationNS5A-experienced, NS3/4A‑naïve genotype 1 transplant patients are recommended for 16 weeks when additional criteria (prior null/partial/relapse) are met.

Relation to prior NS3/4A exposurePolicy specifies different durations when patients have prior NS5A exposure versus prior NS3/4A protease inhibitor exposure or neither; NS5A experience alters recommended courses.

OpenPayer

Hepatitis C - Mavyret Prior Authorization Policy

Coverage Criteria for Mavyret (glecaprevir/pibrentasvir)

Coding

Provider Actions, Prior Authorization, and Prescribing Requirements

Definitions

Background