CurrentColorado Rocky Mountain Health PlansPolicy N/A

Mavyret (glecaprevir/pibrentasvir) prior authorization

Describes prior authorization requirements and coverage criteria for Mavyret (glecaprevir/pibrentasvir) for treatment of acute and chronic hepatitis C in members covered by the payer program.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyMavyret (glecaprevir/pibrentasvir) prior authorization

Policy CodePolicy N/A

Change TypeCriteria reorganizationadded acute HCV criteriaauthorization durations revised

Effective DateJan 1, 2026

Next Review DateJul 1, 2025

Key ActionSubmit prior authorization for Mavyret; approvals issued for 8 weeks (acute) or 12 months (chronic) when criteria are met.

SourceLink

POLICY UPDATE CHANGES

Authorization duration updated to 12 months for chronic hepatitis C treatment.

Criteria reorganized to address treatment-experienced patients and transplant recipients in one section and simplified pangenotypic treatment and cirrhosis status criteria.

Coverage criteria for acute HCV infection in treatment-naïve patients added with an 8-week authorization.

8 weeksauthorization duration for acute HCV treatment

12 monthsauthorization duration for chronic HCV treatment

3+ yrsminimum patient age for indication

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Coverage Criteria for Mavyret (glecaprevir/pibrentasvir)

inv-01: Acute HCV (treatment-naïve)

Covered when ALL of the following are met:

Acute HCV treatment — treatment-naïve: 1. Diagnosis of acute hepatitis C infection

Authorization issued for 8 weeks

No concurrent DAA therapy: 2. Patient is not receiving Mavyret in combination with another hepatitis C virus (HCV) direct acting antiviral agent (e.g., Epclusa, Harvoni, Sovaldi, Zepatier)

Concurrent DAA therapy excludes approval

inv-02: Chronic HCV (treatment-naïve)

Covered when ALL of the following are met:

Chronic HCV diagnosis: 1. Diagnosis of chronic hepatitis C infection

From coverage criteria section B

Treatment history: 2. Patient is treatment-naïve

Treatment-naïve requirement for chronic HCV approvals

No concurrent DAA therapy: 3. Patient is not receiving Mavyret in combination with another HCV direct acting antiviral agent (e.g., Epclusa, Harvoni, Sovaldi, Zepatier)

Concurrent DAA therapy excludes approval

Use of Mavyret in combination with another hepatitis C virus (HCV) direct-acting antiviral agent will exclude approval. Examples of other HCV DAAs include Epclusa (sofosbuvir/velpatasvir), Harvoni (ledipasvir/sofosbuvir), Sovaldi (sofosbuvir), and Zepatier (elbasvir/grazoprevir).

Coverage may be denied if medical necessity criteria are not met. The program may rely on automated review of prior claims and medication history, diagnosis codes (ICD-10), and/or claim logic to determine necessity and to approve or deny initial and reauthorization requests.

inv-11: Initial therapy — Initial therapy rules

Acute HCV initial: Diagnosis of acute hepatitis C infection; treatment-naïve; not used with other HCV direct-acting antivirals

Authorization issued for 8 weeks for acute infection

Chronic HCV initial: Diagnosis of chronic hepatitis C infection; treatment-naïve when specified; not used with other HCV direct-acting antivirals

Authorization issued for up to 12 months for chronic infection per program references

Operational approval pathways: UnitedHealthcare may approve initial therapy based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic

Automated approval processes may be used; supply limits may apply

Provider Actions, Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization/notification is required for Mavyret. Approvals for acute infection are generally issued for 8 weeks and for chronic infection for 12 months.

Prior authorization/notification required
Approval durations: acute infection — 8 weeks; chronic infection — 12 months

Denial Risk

Concurrent DAA Therapy Restriction

Mavyret will not be authorized if prescribed in combination with another HCV direct-acting antiviral (DAA). Examples include Epclusa (sofosbuvir/velpatasvir), Harvoni (ledipasvir/sofosbuvir), Sovaldi (sofosbuvir), and Zepatier (elbasvir/grazoprevir).

Do not co-prescribe Mavyret with another HCV DAA
Examples of prohibited concurrent DAAs: Epclusa, Harvoni, Sovaldi, Zepatier

Definitions and Clinical Classifications

Compensated cirrhosis — definition

DefinitionCirrhosis classified as Child-Pugh A (compensated cirrhosis)

Source contextPer prescribing information: indicated for patients without cirrhosis and with compensated cirrhosis (Child-Pugh A)

Applicable populationAdults and pediatric patients 3 years and older with acute or chronic HCV (GT 1–6)

Initial Therapy Coverage Rules

inv-11: Initial therapy — Initial therapy rules

Acute HCV initial: Diagnosis of acute hepatitis C infection; treatment-naïve; not used with other HCV direct-acting antivirals

Authorization issued for 8 weeks for acute infection

Chronic HCV initial: Diagnosis of chronic hepatitis C infection; treatment-naïve when specified; not used with other HCV direct-acting antivirals

Authorization issued for up to 12 months for chronic infection per program references

Operational approval pathways: UnitedHealthcare may approve initial therapy based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic

Automated approval processes may be used; supply limits may apply

Step	Requirement	Notes
1	Patient must be treatment-naïve	Applies to chronic HCV approvals where specified
	Patient is not receiving Mavyret in combination with another HCV direct-acting antiviral agent (e.g., Epclusa, Harvoni, Sovaldi, Zepatier)	Concurrent DAA therapy exclusion; will exclude approval

Reauthorization and Continuation Criteria

inv-12: Reauthorization

Reauthorization/continuation

Reauthorization logic: UnitedHealthcare may approve reauthorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic; supply limits may be in place

Automated approval and re-approval processes may be used

Background — Drug and Indication

Mavyret is a fixed-dose combination of glecaprevir (an HCV NS3/4A protease inhibitor) and pibrentasvir (an HCV NS5A inhibitor) indicated for the treatment of acute and chronic hepatitis C virus (HCV) infection in patients aged 3 years and older. The indication covers HCV genotypes 1–6 and includes use in patients without cirrhosis and those with compensated cirrhosis (Child-Pugh A), as well as certain treatment-experienced genotype 1 patients as described in the prescribing information.