Mavyret (glecaprevir/pibrentasvir) Letter of Medical Necessity
Mavyret (glecaprevir/pibrentasvir) prior authorization is highly state-Medicaid- and payer-specific, with sobriety, fibrosis-stage, and specialist requirements driving denials. A complete Letter of Medical Necessity citing AASLD/IDSA universal-treatment guidance is the standard appeal.
FDA-Approved Indications
- ● chronic hepatitis C virus (HCV) infection (genotypes 1-6) in treatment-naive and treatment-experienced adults and pediatric patients ≥3 years
Why Mavyret Prior Authorization Gets Denied
The most common denial reasons across major payers:
- 1. HCV genotype not documented
- 2. HCV RNA viral load not on file
- 3. Fibrosis stage (METAVIR, FIB-4, transient elastography) not documented
- 4. Prior treatment history not specified for treatment-experienced patients
- 5. Specialist (hepatology, GI, ID) prescriber requirement not met
- 6. Sobriety or active substance-use restrictions (state Medicaid)
What to Include in a Mavyret Letter of Medical Necessity
Document confirmed HCV diagnosis with genotype/subtype, current HCV RNA viral load, fibrosis stage by elastography or FIB-4, prior treatment history, comorbidities (HIV co-infection, decompensated liver disease excluded), prescriber specialty, and citation of AASLD/IDSA guidance recommending universal treatment regardless of fibrosis stage or substance-use status.
Key clinical evidence to cite:
- ✓ ENDURANCE-1 through ENDURANCE-5, EXPEDITION-1, EXPEDITION-4, EXPEDITION-8 trials
- ✓ SVR12 rates ≥98% across genotypes
- ✓ Shortened 8-week regimen for treatment-naive patients without cirrhosis
Relevant guidelines:
- 📖 AASLD/IDSA HCV Treatment Guidance
- 📖 EASL HCV Guidelines
Mavyret Prior Authorization Criteria
Standard criteria across major US payers for Mavyret. Specific criteria vary by plan — RxCheckUp tailors each LMN to your patient's exact payer policy.
Typical step therapy requirements:
- → Prior treatment history not specified for treatment-experienced patients
Required documentation:
- ✓ ICD-10 diagnosis code with specificity
- ✓ Prior therapy history with dates, doses, and discontinuation reasons
- ✓ Specialist evaluation (where applicable)
- ✓ Baseline disease activity or biomarker results
- ✓ Clinical rationale citing FDA labeling or guidelines
Approval details:
Initial approval: typically 6 months. Renewal: 12 months with documented clinical response.
Payers Covering Mavyret
RxCheckUp tailors each LMN to the specific payer's medical policy and step therapy requirements:
Mavyret Prior Authorization FAQ
Why was my Mavyret prior authorization denied?
The most common denial reasons for Mavyret are: HCV genotype not documented; HCV RNA viral load not on file; Fibrosis stage (METAVIR, FIB-4, transient elastography) not documented; Prior treatment history not specified for treatment-experienced patients; Specialist (hepatology, GI, ID) prescriber requirement not met; Sobriety or active substance-use restrictions (state Medicaid).
What should a Mavyret Letter of Medical Necessity include?
Document confirmed HCV diagnosis with genotype/subtype, current HCV RNA viral load, fibrosis stage by elastography or FIB-4, prior treatment history, comorbidities (HIV co-infection, decompensated liver disease excluded), prescriber specialty, and citation of AASLD/IDSA guidance recommending universal treatment regardless of fibrosis stage or substance-use status.
Which payers cover Mavyret?
Mavyret is covered by major US payers including UnitedHealthcare, Aetna, Cigna, BCBS, Medicare Part D, State Medicaid, though formulary tier and prior authorization criteria vary.