CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Harvoni 2134 A 2677 A Sgm P2022

Defines clinical authorization criteria for Harvoni (ledipasvir/sofosbuvir) for treatment of chronic hepatitis C virus (HCV) in patients aged >=3 years across genotypes 1, 4, 5, and 6, including special populations (decompensated cirrhosis, post-transplant, kidney transplant, HCV/HIV coinfection) and ribavirin ineligibility considerations.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyHarvoni 2134 A 2677 A Sgm P2022

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrior authorization is required; authorization durations vary by genotype, cirrhosis status, treatment history, transplant status, and RBV eligibility (examples: 8, 12, 24 weeks as specified in criteria).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes to policy

4HCV genotypes addressed

3Min age (yrs)

8-24 weeksDurations

Coverage summary

Defines clinical authorization criteria for Harvoni (ledipasvir/sofosbuvir) for treatment of chronic hepatitis C virus (HCV) in patients aged >= 3 years with genotypes 1, 4, 5, and 6. Coverage is covered_with_criteria, requiring that all approval criteria in the policy are met and the member has no exclusions to the prescribed therapy.

Key thresholds and statistics

Minimum age (years)3

Pre-treatment HCV RNA threshold6,000,000 IU/mL (used to distinguish 8 vs 12 week duration)

Baseline hemoglobin (anemia) cutoff< 10 g/dL

Authorized treatment durations8-24 weeks

HCV genotypes addressed1, 4, 5, 6 (policy covers these; stats field highlights 4)

Initial therapy (authorization criteria)

General Indications and Prescriber Requirement

Covered when ALL of the following are met:

ALL of the following

Indication is an FDA-approved indication or compendial use listed in policy (HCV genotype 1, 4, 5, or 6 infection for adults and pediatric patients >= 3 years).
Age: Member age is 3 years or older.>= 3 years
Prescriber: Medication is prescribed by or in consultation with a prescriber specializing in infectious disease, gastroenterology, hepatology, or transplant.
Exclusions: Member has no exclusions to the prescribed therapy.

ref": "b1_0",

title": "General Indications and Prescriber Requirement"

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A. Hepatitis C virus infection, without ribavirin (by genotype and clinical scenario)

Authorization may be granted when ALL of the following genotype-specific criteria are met:

Genotype 1, 4, 5, 6 (summary branches)

Genotype 1 (treatment-naïve or prior treatment considerations)
- Treatment-naïve with compensated cirrhosis: Authorization up to 12 weeks total may be granted for treatment-naïve members with compensated cirrhosis.12 weeks
- Treatment-naïve without cirrhosis with specific factors: Authorization up to 12 weeks total may be granted for treatment-naïve members without cirrhosis who have HIV co-infection, are <18 years of age, or have pre-treatment HCV RNA >= 6,000,000 IU/mL.12 weeks
  Pre-treatment HCV RNA threshold: 6,000,000 IU/mL

B. Hepatitis C virus infection, with ribavirin (decompensated cirrhosis / post-transplant scenarios)

Authorization may be granted when criteria below are met for members requiring ribavirin in combination with Harvoni:

RBV-required scenarios

Decompensated cirrhosis (CTP class B or C): Authorization up to 12 weeks may be granted for members with HCV genotype 1, 4, 5 or 6 infection. Authorization up to 24 weeks may be granted for members who failed prior treatment with a sofosbuvir-based regimen (examples: sofosbuvir + RBV; sofosbuvir + PEG-IFN + RBV; sofosbuvir + simeprevir ± RBV).12-24 weeks
Examples of sofosbuvir-based regimen failure provided
Recurrent HCV infection post liver transplantation (with decompensation or treatment history distinctions): Authorization up to 12 weeks total may be granted for treatment-naïve members with recurrent HCV genotype 1, 4, 5 or 6 infection post liver transplantation and decompensated cirrhosis. Authorization up to 24 weeks total may be granted for treatment-experienced members with recurrent infection and decompensated cirrhosis. Authorization up to 12 weeks total may be granted for treatment-naïve members with HCV genotype 1 or 4 infection post liver transplantation without cirrhosis or with compensated cirrhosis. Authorization 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 failed prior treatment with PEG-IFN ± RBV ± an HCV protease inhibitor.

Continuation of therapy

Covered when ALL initial authorization criteria continue to be met:

Continuation requirement: All members (including new members) requesting continuation must meet all initial authorization criteria.

Ribavirin ineligibility & definitions

RBV Ineligibility Appendix

RBV ineligibility is defined as ONE or more of:

RBV ineligibility items

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

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

Treatment-naïve refers to a member with no prior HCV antiviral treatment (as referenced in the policy where relevant).

Provider actions & prior authorization

Prior Authorization

Authorization required with regimen-specific duration

Prior authorization is required. Authorization durations vary based on genotype, cirrhosis status, prior treatment history, transplant status, and ribavirin (RBV) eligibility. Examples of authorized durations in the policy include 8 weeks (treatment‑naïve, genotype 1 without cirrhosis and pre‑treatment HCV RNA < 6,000,000 IU/mL), 12 weeks (many treatment‑naïve or certain treatment‑experienced scenarios, post‑transplant recipients, compensated cirrhosis, or HIV coinfection), and 24 weeks (compensated cirrhosis with prior PEG‑IFN treatment failure or decompensated cirrhosis/other specified treatment‑experienced scenarios or RBV ineligibility).

Documentation Required

Supportive documentation may be requested

Supportive documentation may be requested to meet regulatory requirements. Items that may be requested include confirmation of treatment status (treatment‑naïve vs retreatment), confirmation of member readiness and ability to adhere to the proposed treatment plan, reason for retreatment (when applicable), hepatitis B screening results, and the Metavir/Fibrosis score.

Treatment status (naïve vs retreatment)
Confirmation of member readiness/adherence
Reason for retreatment (if applicable)
Hepatitis B screening results
Metavir/Fibrosis score

Documentation Required

Prescriber specialty requirement

Medication must be prescribed by, or in consultation with, a prescriber specializing in infectious disease, gastroenterology, hepatology, or transplant.

Applicable codes

Reference numbersmixed

2134-A	Reference number
2677-A	Reference number

Clinical evidence & guidelines

Primary reference: Harvoni [package insert], Gilead Sciences; March 2020.

Guideline: AASLD/IDSA/IAS-USA HCV recommendations (hcvguidelines.org), last changes Oct 5, 2021.

Background

Harvoni (ledipasvir/sofosbuvir) is FDA-indicated for adults and pediatric patients 3 years of age and older with chronic HCV genotype 1, 4, 5, or 6 infection, including without cirrhosis or with compensated cirrhosis; certain genotype 1 and 4 indications and decompensated cirrhosis indications require combination with ribavirin. Regimen durations and ribavirin use are determined by genotype, cirrhosis status, prior treatment history, transplant status, and RBV eligibility: examples include 8 weeks for selected genotype 1, noncirrhotic, treatment-naïve patients with pre-treatment HCV RNA < 6,000,000 IU/mL; 12 weeks for most treatment-naïve or treatment-experienced compensated cirrhosis or post-transplant scenarios; and up to 24 weeks for certain prior treatment failures or decompensated cirrhosis or retreatment after sofosbuvir-based regimen failure. Prescriber specialty and other supportive documentation requirements apply.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyHarvoni 2134 A 2677 A Sgm P2022

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

SourceLink

On This Page

Treatment-naïve without cirrhosis, HIV-uninfected, low viral load: Authorization up to 8 weeks total may be granted for treatment-naïve members without cirrhosis who are HIV-uninfected and have pre-treatment HCV RNA < 6,000,000 IU/mL.8 weeks

Pre-treatment HCV RNA threshold: 6,000,000 IU/mL

Prior PEG-IFN ± RBV ± protease inhibitor, no cirrhosis: Authorization up to 12 weeks total may be granted for members without cirrhosis who failed prior treatment with PEG-IFN ± RBV ± an HCV protease inhibitor.12 weeks

Prior PEG-IFN ± RBV ± protease inhibitor, compensated cirrhosis: Authorization up to 24 weeks total may be granted for members with compensated cirrhosis who failed prior treatment with PEG-IFN ± RBV ± an HCV protease inhibitor.24 weeks

Genotype 4 or 5: Authorization up to 12 weeks total may be granted for members without cirrhosis or with compensated cirrhosis who are treatment-naïve or who failed prior treatment with PEG-IFN ± RBV ± an HCV protease inhibitor.12 weeks

Genotype 6

Genotype 6 sub-criteria
- Treatment-naïve without 6e subtype: Member is treatment-naïve and does not have genotype 6e subtype.
- Prior PEG-IFN ± RBV ± protease inhibitor failure: Member failed prior treatment with PEG-IFN ± RBV ± an HCV protease inhibitor.

Decompensated cirrhosis (CTP class B or C): For members with HCV genotype 1, 4, 5, or 6 and documented anemia (baseline Hgb < 10 g/dL) or RBV ineligibility: Authorization up to 24 weeks total may be granted.24 weeks

Baseline hemoglobin threshold: < 10 g/dL; RBV ineligibility per Appendix

Recurrent HCV infection post liver transplantation: For members without cirrhosis or with compensated cirrhosis and recurrent HCV genotype 1, 4, 5, or 6 infection post liver transplantation: Authorization up to 12 weeks total may be granted.12 weeks

Kidney transplant recipients: For members without cirrhosis or with compensated cirrhosis who have HCV genotype 1, 4, 5, or 6 infection and are treatment-naïve or have not failed prior treatment with a direct-acting antiviral: Authorization up to 12 weeks total may be granted.12 weeks

Genotype 1 (treatment-naïve or prior treatment considerations) - duplicate: (See primary Genotype 1 branch above.)

Includes examples and distinctions by treatment history

Examples of sofosbuvir-based regimen failure: Examples include: sofosbuvir + RBV; sofosbuvir + PEG-IFN + RBV; sofosbuvir + simeprevir with or without RBV.