CurrentNeighborhood Health Plan of Rhode IslandPolicy 2134-A

Harvoni Treatment Criteria

Defines covered indications, clinical authorization durations, prescriber requirements, continuation rules, age limits, and RBV ineligibility criteria for Harvoni (ledipasvir-sofosbuvir) across genotypes 1,4,5,6 and specific clinical scenarios (decompensated cirrhosis, post-transplant, kidney transplant, HIV coinfection).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyHarvoni Treatment Criteria

Policy CodePolicy 2134-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionProviders must request prior authorization and will be approved for durations consistent with genotype, cirrhosis status, prior treatment history, transplant status, and RBV eligibility (e.g., 8, 12, 24 weeks as specified).

POLICY UPDATE CHANGES

No material clinical or coverage changes to policy 2134-A in this brief.

4Covered genotypes explicitly listed

3Possible treatment durations (weeks)

3Minimum age (years)

Coverage Summary & Indications

Policy header: Policy number 2134-A; payer: CVS Caremark. Harvoni (ledipasvir-sofosbuvir) is indicated for treatment of chronic hepatitis C virus (HCV) in adults and pediatric patients 3 years of age and older for genotypes 1, 4, 5, and 6, including settings without cirrhosis, with compensated cirrhosis, and selected decompensated cirrhosis and transplant scenarios. Coverage is aligned with FDA-approved indications and recognized compendial uses, and authorization durations are based on genotype, cirrhosis status, prior treatment history, transplant status, and ribavirin (RBV) eligibility. Scenarios specifically addressed include decompensated cirrhosis (CTP class B or C), post-liver transplant/recurrent HCV, kidney transplant recipients, and HIV coinfection, with duration pathways of 8, 12, or 24 weeks depending on clinical criteria.

Ribavirin (RBV) Ineligibility (Appendix)

RBV ineligibility is defined as one or more of the following:

Intolerance to RBV
Pregnancy: Pregnant female or male whose female partner is pregnant
Hemoglobinopathy
Didanosine coadministration: Coadministration with didanosine
Cardiac disease: History of significant or unstable cardiac disease

RBV ineligibility is defined as one or more of the following: intolerance to ribavirin; a pregnant female or a male whose female partner is pregnant; hemoglobinopathy; coadministration with didanosine; or history of significant or unstable cardiac disease.

Decompensated cirrhosis is defined as Child Turcotte Pugh (CTP) class B or C.

Operational thresholds used in policy decisions include: Pre-treatment HCV RNA threshold of 6 million IU/mL (used to determine 8-week versus 12-week duration in treatment‑naïve, noncirrhotic genotype 1 patients); Baseline hemoglobin threshold of < 10 g/dL (documented anemia relevant to RBV eligibility and consideration of extended, up to 24-week, regimens in decompensated cirrhosis); and the minimum age for treatment of ≥ 3 years.

Provider Requirements & Documentation

Prior Authorization

Prior authorization required with genotype- and scenario-specific duration limits

Prior authorization is required. Approval durations are genotype- and scenario-specific and depend on genotype, cirrhosis status (none, compensated, decompensated), prior treatment history, transplant status, and ribavirin (RBV) eligibility or documented anemia. Example authorized durations include 8 weeks, 12 weeks, and 24 weeks as specified by the clinical scenario.

8 weeks (e.g., genotype 1 without cirrhosis, treatment‑naïve, HCV RNA < 6 million IU/mL and no HIV coinfection) — chunk 5
12 weeks (multiple indications: treatment‑naïve with compensated cirrhosis; many post‑transplant, genotype 4/5/6 pathways) — chunks 5, 6, 9
24 weeks (e.g., compensated cirrhosis after prior PEG‑IFN failure in some genotype 1 cases; decompensated cirrhosis with RBV ineligibility or prior sofosbuvir‑based regimen failure) — chunks 5, 8, 12

Documentation Required

Clinical documentation and provider expertise

Prescribers must be experienced in management of hepatitis C or consult with such a provider. Clinical documentation may be requested for regulatory purposes, including treatment status, confirmation of readiness (for initial treatment or retreatment), reason for retreatment, hepatitis B screening results, and Metavir/fibrosis score.

Evidence of prescriber expertise or consultation with an HCV‑experienced provider — chunk 4
Treatment status (treatment‑naïve vs retreatment) — chunk 16
Confirmation of member readiness and ability to adhere to treatment plan (initial treatment and retreatment) — chunk 16
Reason for retreatment (e.g., prior treatment failure, reinfection) — chunk 16
Hepatitis B virus screening results — chunk 16
Metavir/Fibrosis score — chunk 16

Background

Harvoni (ledipasvir-sofosbuvir) is indicated for chronic HCV infection in adults and pediatric patients aged 3 years and older for genotypes 1, 4, 5, and 6, including patients without cirrhosis and those with compensated cirrhosis, and in specific decompensated cirrhosis and transplant contexts where used with ribavirin as specified. The policy aligns coverage with FDA-approved indications and compendial uses and requires prescription by or consultation with a provider experienced in HCV management.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyHarvoni Treatment Criteria

Policy CodePolicy 2134-A

Change TypeNo material changes

Effective Date

Next Review Date

On This Page

OpenPayer

Harvoni Treatment Criteria

Coverage Summary & Indications

Continuation of Therapy

Exclusions / Not Medically Necessary

Ribavirin (RBV) Ineligibility (Appendix)

Provider Requirements & Documentation

Applicable Codes

Clinical Evidence & References

Background

Revision History