CurrentNeighborhood Health Plan of Rhode IslandPolicy 2134-A

Harvoni (ledipasvir-sofosbuvir) coverage criteria

Defines coverage and prior authorization criteria for Harvoni (ledipasvir-sofosbuvir) for treatment of chronic hepatitis C virus (HCV) across genotypes 1, 4, 5, and 6 in adults and pediatric patients 3 years and older, including special populations (decompensated cirrhosis, post-liver transplant, kidney/liver transplant recipients, and HCV/HIV coinfection).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyHarvoni (ledipasvir-sofosbuvir) coverage criteria

Policy CodePolicy 2134-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization per the coverage criteria and ensure the member meets genotype-, cirrhosis-, prior treatment-, and age-specific requirements; provide required documentation (treatment status, readiness, fibrosis score, Hepatitis B screening).

POLICY UPDATE CHANGES

No material changes — has_material_change = false.

4Covered genotypes

>=3Min age (yrs)

8-24Durations (weeks)

2134-APolicy ref

Coverage Summary

Harvoni (ledipasvir-sofosbuvir) is covered for the treatment of chronic hepatitis C virus (HCV) infection in adults and pediatric patients 3 years of age and older for genotypes 1, 4, 5, and 6 in the FDA‑approved clinical scenarios specified in this policy (including without cirrhosis or with compensated cirrhosis, select post‑liver transplant uses, and genotype‑specific indications). Prescriptions must be by or in consultation with a provider experienced in management of HCV infection.

Special populations addressed by this policy include members with decompensated cirrhosis (CTP class B or C) (for whom extended durations and the use of ribavirin or documented RBV ineligibility are specifically detailed), post‑liver transplant recipients (recurrent HCV), kidney transplant recipients, and members with HCV/HIV coinfection when the regimen‑specific coverage criteria are met. All other indications not listed as covered are considered experimental/investigational and not medically necessary.

Initial Therapy Criteria

General eligibility

Covered when ALL of the following are met:

ALL of the following

Member is 3 years of age or older
Prescribed by or in consultation with a provider experienced in management of HCV infection
Indication is one of the FDA-approved or compendial covered indications listed in this policy (genotype and clinical scenario specific)
Member has no exclusions to the prescribed therapy

Genotype 4 or 5

Authorization durations for treatment-naive or prior PEG-IFN ± RBV ± protease inhibitor failure:

Authorization of up to 12 weeks total may be granted for members without cirrhosis or with compensated cirrhosis who are treatment-naive or who failed prior treatment with PEG-IFN with or without RBV with or without an HCV protease inhibitor

Genotype 6

Authorization durations and subtype exclusion:

ALL of the following

Authorization of up to 12 weeks total may be granted for members without cirrhosis or with compensated cirrhosis when EITHER of the following criteria is met:
ANY of the following
- Member is treatment-naive and does not have genotype 6e subtype
- Member has failed prior treatment with PEG-IFN with or without RBV with or without an HCV protease inhibitor

Decompensated cirrhosis (CTP class B or C)

Authorization may vary based on genotype, documented anemia or RBV ineligibility, and prior therapy:

ANY of the following

Authorization of up to 24 weeks total may be granted for members with HCV genotype 1, 4, 5, or 6 infection who have decompensated cirrhosis and documented anemia (baseline hemoglobin below 10 g/dL) or RBV ineligibility (see Appendix)Hgb < 10 g/dL
RBV ineligibility reasons are defined in Appendix
Authorization of up to 24 weeks total may be granted for members with HCV genotype 1, 4, 5, or 6 infection and decompensated cirrhosis who failed prior treatment with a sofosbuvir-based regimen (e.g., sofosbuvir and RBV, sofosbuvir plus PEG-IFN and RBV, sofosbuvir plus simeprevir with or without RBV)
Authorization of up to 12 weeks total may be granted for members with HCV genotype 1, 4, 5, or 6 infection and decompensated cirrhosis (alternative shorter duration when criteria met)

Recurrent HCV infection post liver transplantation

Authorization durations based on treatment-naive vs experienced and cirrhosis status:

ANY of the following

Authorization of up to 12 weeks total may be granted for members with recurrent HCV genotype 1, 4, 5, or 6 infection post liver transplantation without cirrhosis or with compensated cirrhosis
Authorization of up to 12 weeks total may be granted for treatment-naive members with recurrent HCV genotype 1, 4, 5, or 6 infection post liver transplantation and decompensated cirrhosis
Authorization of up to 24 weeks total may be granted for treatment-experienced members with recurrent HCV genotype 1, 4, 5, or 6 infection post liver transplantation and decompensated cirrhosis
Authorization of up to 12 weeks total may be granted for members with HCV genotype 1 or 4 infection post liver transplantation without cirrhosis or with compensated cirrhosis who are treatment-naive or have failed prior PEG-IFN ± RBV ± protease inhibitor

Kidney transplant recipients

Duration for transplant recipients without cirrhosis or with compensated cirrhosis:

Authorization of up to 12 weeks total may be granted for members with HCV genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis who are treatment-naive or who have not failed prior treatment with a direct-acting antiviral

HCV and HIV coinfection

Coverage when HCV regimen criteria are met:

Authorization may be granted for members with HCV and HIV coinfection when the criteria for approval of the requested ledipasvir-sofosbuvir regimen in the coverage criteria above are met

Continuation of Therapy

Continuation of therapy

Requirements for continuation (including new members):

ALL of the following

Member must be 3 years of age or older
All members requesting continuation must meet all requirements in the coverage criteria
Documentation (may be requested): Documentation that may be requested: treatment status (treatment-naive or retreatment); for initial treatment: confirmation of member readiness; for retreatment: reason for retreatment, confirmation of readiness, and ability to adhere to proposed plan; Metavir/Fibrosis score; Hepatitis B virus screening results
Some elements may be requested for regulatory requirements and may not be used to decide individual requests; some elements may not be enforced for certain plans

Provider Actions

Prior Authorization

Prior authorization required

Authorization durations and approval must be obtained per the coverage criteria; prescriptions must be by or in consultation with a provider experienced in the management of hepatitis C virus infection. The member must meet the genotype-, cirrhosis-, prior treatment-, and age-specific criteria outlined in the policy to qualify for coverage and a prior authorization.

Documentation Required

Documentation to support request

Provide documentation to support the request, which may include treatment status (treatment‑naive or retreatment); for initial treatment, confirmation of member readiness; for retreatment, reason for retreatment plus confirmation of readiness and ability to adhere to the proposed treatment plan; Metavir/fibrosis score; and Hepatitis B virus screening results. Some elements may be requested for regulatory reasons and may not be enforced for certain plans.

Prior Authorization

RBV ineligibility documentation

If requesting extended duration in the setting of decompensated cirrhosis based on ribavirin (RBV) ineligibility, document one or more reasons for RBV ineligibility. The policy defines RBV ineligibility as any of the specific conditions listed below.

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

Policy: 2134-A	Internal policy reference number
Qsets: 5920-A,6284-A	Related query sets

OpenPayer

Harvoni (ledipasvir-sofosbuvir) coverage criteria

Coverage Summary

Initial Therapy Criteria

Continuation of Therapy

Provider Actions

Applicable Codes

Clinical Evidence & References

Definitions

Revision History