CurrentUnitedHealthcarePolicy N/A

Harvoni (ledipasvir/sofosbuvir) prior authorization for Hepatitis C

This document governs prior authorization requests for Harvoni (ledipasvir/sofosbuvir) with or without ribavirin for treatment of chronic hepatitis C genotypes 1, 4, 5, and 6, detailing required clinical information, treatment durations, and prescriber attestations.

Policy Summary

PayerUnitedHealthcare

PolicyHarvoni (ledipasvir/sofosbuvir) prior authorization for Hepatitis C

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrior authorization must specify total length of therapy requested (8, 12, or 24 weeks) and whether Harvoni will be used with ribavirin.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3treatment duration options listed (weeks)

1,4,5,6HCV genotypes referenced

>=3minimum beneficiary age referenced

6HCV RNA lookback (months)

Coverage Criteria for Harvoni

Regimen-specific coverage criteria

Covered when ALL of the following are met for the selected duration/regimen:

Age and diagnosis: Beneficiary is 3 years or older with a diagnosis of chronic hepatitis C infection with confirmed genotype 1, 4, 5, or 6 (without cirrhosis or with compensated cirrhosis), or genotype 1 with decompensated cirrhosis when used in combination with ribavirin; or genotype 1 or 4 liver transplant recipients without cirrhosis or with compensated cirrhosis when used in combination with ribavirin.age >= 3 years

Refer to Clinical Information on the PA form for genotype- and cirrhosis-specific indications.

Documentation: Medical records documenting the diagnosis of chronic hepatitis C with genotype and subtype are attached to the prior authorization. Lab test results including a quantitative HCV RNA at baseline tested within the past 6 months (medical documentation and/or log10 value) are attached.HCV RNA within 6 months

Lab test results MUST be attached to the PA to be approved.

Policy Summary

PayerUnitedHealthcare

PolicyHarvoni (ledipasvir/sofosbuvir) prior authorization for Hepatitis C

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrior authorization must specify total length of therapy requested (8, 12, or 24 weeks) and whether Harvoni will be used with ribavirin.

SourceLink

On This Page

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Treatment selection and duration: The total length of therapy requested matches one of the form options and is appropriate for the beneficiary's genotype, prior treatment status, and cirrhosis/transplant status: 8 weeks for genotype 1 treatment-naive without cirrhosis with pre-treatment HCV RNA < 6 million IU/mL; 12 weeks for genotype 1, 4, 5, or 6 treatment-naive or treatment-experienced without cirrhosis or with compensated cirrhosis (Child-Pugh A); 24 weeks for treatment-experienced with compensated cirrhosis (Child-Pugh A); or Harvoni plus ribavirin for 12 weeks for genotype 1 treatment-naive or -experienced with decompensated cirrhosis (Child-Pugh B or C) or genotype 1 or 4 liver transplant recipients (without cirrhosis or with compensated cirrhosis).duration in {8,12,24} weeks

PA must specify total length of therapy being requested (8, 12, or 24 weeks) and whether Harvoni will be used with ribavirin.

Provider Submission Requirements

Prior Authorization

PA request must state treatment duration

Prior authorization requests must specify the total length of therapy being requested and whether Harvoni will be used in combination with ribavirin. Check ONE: 8 weeks, 12 weeks, or 24 weeks.

Total length of therapy requested: 8 weeks / 12 weeks / 24 weeks
Indicate if Harvoni will be used with ribavirin

Step Therapy

Step therapy

Step therapy requirements are not specified on this form. There are no explicit step-therapy prerequisites listed for Harvoni in the provided documentation; however, verify payer-specific formulary or utilization management guidance separately if applicable.

Documentation Required

Required clinical documentation

Attach medical records documenting diagnosis of chronic hepatitis C with genotype and subtype, and include a quantitative HCV RNA baseline tested within the past 6 months. Lab test results MUST be attached to the prior authorization request for approval.

Documented genotype and subtype
Quantitative HCV RNA baseline tested within past 6 months (include log10 value if available)
Medical records supporting diagnosis of chronic hepatitis C

Documentation Required

Administrative documentation

Include beneficiary identifying information and prescriber contact details. Prescriber signature is mandatory on the request.

Beneficiary name, ID number, date of birth, and gender
Prescribing provider NPI and provider fax
Requester contact name, phone, and extension
Prescriber signature and date (mandatory)

Denial Risk

Missing required labs

Failure to attach required laboratory results (genotype and quantitative HCV RNA) may prevent approval of the prior authorization request.

Missing genotype test results
Missing quantitative HCV RNA within required timeframe

Background

Harvoni (ledipasvir/sofosbuvir) is an oral fixed-dose combination direct-acting antiviral indicated for treatment of chronic hepatitis C virus (HCV) infection. The PA form frames regimen selection and duration around genotype, prior treatment history, and cirrhosis status: options include 8 weeks (Genotype 1, treatment-naive without cirrhosis with baseline HCV RNA < 6 million IU/mL), 12 weeks (Genotypes 1, 4, 5, or 6 for various treatment-naive or treatment-experienced scenarios and for patients with compensated cirrhosis), and 24 weeks (treatment-experienced with compensated cirrhosis). For certain decompensated or post-transplant indications, Harvoni plus ribavirin for 12 weeks is specified.

Definitions and Clinical Terms

Cirrhosis status — Compensated vs decompensated (Child‑Pugh distinctions)

Compensated cirrhosis definition in policyCompensated cirrhosis corresponds to Child‑Pugh A and is referenced to determine regimen and duration

Decompensated cirrhosis definition in policyDecompensated cirrhosis corresponds to Child‑Pugh B or C and affects regimen selection (Harvoni must be used with ribavirin for decompensated cases)

Treatment-duration linkageRegimen duration options (8, 12, or 24 weeks) are selected based on cirrhosis status and prior treatment experience

Transplant recipient noteGenotype 1 or 4 liver transplant recipients without cirrhosis or with compensated cirrhosis may require Harvoni + ribavirin per indications

Baseline quantitative HCV RNA — viral load measurement required at baseline within 6 months

DefinitionQuantitative HCV RNA = viral load measurement required at baseline

Timing requirementBaseline HCV RNA must have been tested within the past 6 months

Documentation to attachMedical documentation and/or log10 value of the baseline HCV RNA must be attached to the prior authorization

Role in coverage decisionPresence of a recent baseline HCV RNA is a required criterion for approval per the coverage criteria

OpenPayer

Harvoni (ledipasvir/sofosbuvir) prior authorization for Hepatitis C

Coverage Criteria for Harvoni

Testing and Coding Requirements

Provider Submission Requirements

Background

Definitions and Clinical Terms