CurrentUnitedHealthcarePolicy N/A

Mavyret (glecaprevir/pibrentasvir) prior authorization form

Prior authorization form and clinical criteria for outpatient coverage of Mavyret for treatment of chronic hepatitis C virus (HCV) for UnitedHealthcare beneficiaries; applies to prescribers requesting pharmacy benefit coverage.

Policy Summary

PayerUnitedHealthcare

PolicyMavyret (glecaprevir/pibrentasvir) prior authorization form

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete the prior authorization form and attach medical records including baseline quantitative HCV RNA (within 6 months) and prescriber signature.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12+minimum beneficiary age or weight criteria (12 years or ≥45 kg)

84default quantity per 30 days field on form

8,12,16treatment duration options (weeks)

1-6HCV genotypes supported by form

Coverage Criteria — Mavyret (glecaprevir/pibrentasvir)

Standard approval criteria

Covered when ALL of the following are met (as documented on the PA form):

Age/Weight and Diagnosis: Beneficiary is 12 years of age or older or weighs at least 45 kg with a diagnosis of chronic hepatitis C (CHC) genotype 1-6 (documentation of genotype waived if treatment-naive)age >=12 or weight >=45 kg

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Baseline viral load: Documented quantitative HCV RNA at baseline tested within the past 6 months (medical documentation required; lab test results MUST be attached to the PA to be approved)HCV RNA tested within past 6 months

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Cirrhosis status:

Policy Summary

PayerUnitedHealthcare

PolicyMavyret (glecaprevir/pibrentasvir) prior authorization form

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete the prior authorization form and attach medical records including baseline quantitative HCV RNA (within 6 months) and prescriber signature.

SourceLink

On This Page

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Diagnostic and Eligibility Coding / Baseline Data

Baseline quantitative HCV RNA — tested within the past 6 months

RequirementDocumented quantitative HCV RNA at baseline tested within the past 6 months (medical documentation required)

What to submitBaseline HCV RNA value (IU/ml) and/or log10 value as recorded on lab report

Consequence of missingLab test results MUST be attached to the prior authorization for approval

Age/weight eligibility — 12 years of age or older or weighing at least 45 kg

Age requirementBeneficiary is 12 years of age or older

Weight requirementOr weighing at least 45 kg

Combined eligibilityPatient must meet either the age or weight threshold and have a diagnosis of chronic hepatitis C (genotype 1-6)

Provider Actions / Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required — completion of beneficiary, prescriber, drug, and clinical information sections including age/weight eligibility, genotype, HCV RNA, and treatment duration selection. The PA form must be fully completed to be processed.

Complete beneficiary demographics, prescriber information, drug name, strength, quantity, and selected total length of therapy (8, 12, or 16 weeks).
Age/weight eligibility: beneficiary must be ≥12 years or ≥45 kg with chronic hepatitis C genotype 1–6.

Prior Authorization

Treatment History Assessment

Form requires documentation of treatment history to support selection of therapy duration (treatment‑naïve vs treatment‑experienced). Indicate whether patient is treatment‑naïve or treatment‑experienced on the form.

Selection of 8, 12, or 16 weeks must match documented genotype, cirrhosis status, transplant status, and prior antiviral exposure.
If treatment‑experienced, specify prior regimen(s) (e.g., prior NS3/4A PI exposure or prior NS5A inhibitor exposure) to justify duration.

Documentation Required

Required Diagnostic Documentation

Medical records documenting chronic hepatitis C diagnosis, including genotype/subtype, and baseline quantitative HCV RNA (tested within the past 6 months) are required and must be attached to the PA.

Genotype and subtype documentation must be submitted unless the patient is treatment‑naïve (genotype documentation waived for treatment‑naïve patients).
Baseline quantitative HCV RNA (IU/mL and/or log10) must be provided and tested within the past 6 months.
Medical records supporting cirrhosis status (including Child‑Pugh classification when applicable) and transplant status must be attached.

Denial Risk

Missing Required Labs — Approval Will Be Denied

Lab test results MUST be attached to the prior authorization; absence of required laboratory documentation will prevent approval.

Attach baseline quantitative HCV RNA results (within 6 months).
Attach genotype/subtype results unless treatment‑naïve and genotype documentation is waived.
Attach documentation of cirrhosis/Child‑Pugh score and prior treatment records when applicable.

Documentation Required

Prescriber Attestation and Signature Required

Prescriber signature is mandatory on the PA form; unsigned forms will not be accepted. By signing, the prescriber attests that the information is accurate and complete.

Prescriber must sign and date the form in the signature field.
Unsigned or missing signature may result in denial or return for completion.

Background — Policy and Drug Context

This prior authorization form pertains to outpatient pharmacy coverage of Mavyret (glecaprevir/pibrentasvir) for treatment of chronic hepatitis C (CHC). The form captures the total length of therapy selection (options: 8, 12, or 16 weeks), beneficiary eligibility (must be 12 years of age or older or weigh at least 45 kg with CHC genotype 1–6; genotype documentation is waived if treatment‑naïve), cirrhosis status including Child‑Pugh class (Child‑Pugh A supports the 8‑week option), whether medical records and lab results are submitted (lab test results MUST be attached), baseline quantitative HCV RNA tested within the past 6 months, assessment of expected clinical benefit, FDA‑labeled contraindications to Mavyret, and concurrent use with interacting agents (atazanavir or rifampin).

Definitions and Hepatic Impairment

Compensated cirrhosis — Child-Pugh A classification used to determine eligibility for 8-week treatment option.

DefinitionCirrhosis classified as Child-Pugh A (compensated cirrhosis)

Implication for treatment durationChild-Pugh A supports eligibility for the 8-week treatment option (all genotypes without cirrhosis or with compensated cirrhosis)

DocumentationForm requests cirrhosis status and Child-Pugh classification to be provided

Moderate to severe hepatic impairment — Child-Pugh B or C; form asks whether beneficiary has moderate to severe hepatic impairment.

DefinitionModerate to severe hepatic impairment is defined as Child-Pugh class B or C

Form fieldThe form asks whether the beneficiary has moderate to severe hepatic impairment (Child-Pugh B or C) with Yes/No checkboxes

Prescriber actionProvide Child-Pugh classification on the PA form and sign the attestation

Initial Therapy — Duration Selection and Criteria

Initial therapy duration selection

Prescriber must select one total therapy duration on the form; approval follows the selection aligned with genotype, cirrhosis status, and prior treatment history.

Duration options: 8 weeks for all genotypes: without cirrhosis or with compensated cirrhosis (Child-Pugh A); 12 weeks for treatment-naïve liver or kidney transplant recipients, or for certain treatment-experienced Genotype 1 patients previously treated with an NS3/4A PI and not previously treated with an NS5A inhibitor; 16 weeks for Genotype 1 recipients previously treated with an NS5A inhibitor without prior NS3/4A protease inhibitor exposure, or for recipients with Genotype 3 previously treated with a regimen containing PRS38|12|16 weeks

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Step Therapy / Prior Treatment Capture

Prior treatment history	Implication for therapy duration
Treatment-naïve	Prescriber may select shorter durations when appropriate (e.g., 8 weeks for patients without cirrhosis or with compensated cirrhosis); documentation of genotype may be waived for treatment‑naïve patients.
Treatment‑experienced	Prescriber selects duration based on prior regimen and genotype (examples include 12 weeks for certain treatment‑experienced Genotype 1 patients previously treated with an NS3/4A protease inhibitor but not an NS5A inhibitor; 16 weeks for Genotype 1 patients previously treated with an NS5A inhibitor without prior NS3/4A PI exposure, and for certain Genotype 3 prior regimens).
No explicit mandated step failures on form	Form captures prior treatment history to inform duration selection but does not require failure of specific prior agents as a condition of approval.

OpenPayer