CurrentNeighborhood Health Plan of Rhode IslandPolicy 2141-A

Sofosbuvir (Sovaldi) — Authorization Criteria for Chronic Hepatitis C

Covers authorization criteria and limits for Sovaldi (sofosbuvir) for treatment of chronic hepatitis C virus (HCV) infection across indicated genotypes and special populations for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySofosbuvir (Sovaldi) — Authorization Criteria for Chronic Hepatitis C

Policy CodePolicy 2141-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and document genotype, treatment history, interferon eligibility, and required supporting clinical data.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1-4 (+peds 2,3)FDA-indicated HCV genotypes listed

up to 12–48 wksAuthorization durations

>=3 yrsPediatric threshold

HCV-experiencedPrescriber requirement

Coverage Criteria for Sofosbuvir (Sovaldi)

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Medical necessity criteria

Covered when ALL of the following apply as specified per indication

General coverage: Requested use is an FDA-approved indication or listed compendial use for sofosbuvir and the member has no exclusions to the prescribed therapy.

See product indications and compendial uses.

Indication-specific durations

Genotype 1, treatment‑naive adults: Authorization up to 12 weeks total may be granted for adult members who are treatment‑naive.
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Genotype 4, treatment‑naive adults: Authorization up to 12 weeks total may be granted for adult members who are treatment‑naive.
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Genotype 1, IFN‑ineligible adults: Authorization up to 24 weeks total may be granted for adult members with documented interferon (IFN) ineligibility.
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Genotype 2 (>=3 years): Authorization up to 12 weeks total may be granted for members 3 years of age or older who are treatment‑naive or who failed prior PEG‑IFN (with or without RBV).
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Genotype 3 (>=3 years): Authorization up to 24 weeks total may be granted for members 3 years of age or older who are treatment‑naive or who failed prior PEG‑IFN (with or without RBV).
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Hepatocellular carcinoma awaiting liver transplant: Authorization up to 48 weeks total or until liver transplantation, whichever occurs first, may be granted for adult members with genotype 1–4 infection and hepatocellular carcinoma awaiting transplant.
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Combination with Mavyret (with RBV): Authorization up to 24 weeks total may be granted for members 3 years of age or older when Sovaldi is prescribed in combination with Mavyret (with ribavirin) and the member meets the Mavyret criteria for approval.
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HCV/HIV coinfection: Authorization may be granted for members coinfected with HCV and HIV when the criteria for the requested regimen above are met.

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Prescriber requirement: Medication must be prescribed by or in consultation with a provider experienced in management of HCV.

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Continuation of therapy: All members (including new members) requesting authorization for continuation of therapy must meet all requirements in the coverage criteria.

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Authorization, Documentation, and Prescriber Requirements

Prior Authorization

Prior Authorization Required — Time-limited Approvals

Prior authorization is required for Sovaldi (sofosbuvir). Approvals are time-limited and durations vary by genotype, treatment status, and special indications (see policy coverage criteria).

Authorization durations vary by genotype and treatment status (e.g., up to 12 or 24 weeks as specified per genotype; up to 48 weeks for members with hepatocellular carcinoma awaiting liver transplantation).

Prior Authorization

Combination Therapy with Mavyret — Follow Mavyret SGM

Requests to use Sovaldi in combination with Mavyret (plus ribavirin) are subject to special approval requirements. Authorization of up to 24 weeks total may be granted for members ≥3 years meeting the regimen criteria. The Mavyret supplemental guidance (SGM) criteria and approval durations must be met and referenced when submitting the request.

When prescribing Sovaldi + Mavyret (with RBV), include documentation that the patient meets the Mavyret SGM criteria and indicate the requested regimen and duration.

Documentation Required

Supporting Documentation That May Be Requested

Payers may request supporting documentation to verify medical necessity and regulatory compliance. Provide clear clinical evidence to support the requested regimen to avoid delays or denials.

Treatment status (treatment‑naive vs retreatment) and rationale for retreatment (e.g., prior treatment failure or reinfection).
Confirmation of member readiness and ability to adhere to the proposed treatment plan.
Relevant laboratory and staging data as applicable (e.g., Metavir/fibrosis score, hepatitis B screening results).
For continuation requests, documentation that the member meets all coverage criteria for continuation of therapy.

Denial Risk

Non‑Covered Indications — Denial Risk

Indications other than FDA‑approved and listed compendial uses (for example, genotypes or clinical situations not specified in the coverage criteria) are considered experimental/investigational and are not covered. Requests for non‑covered indications are at high risk for denial.

Compendial use noted: HCV genotype 5 or 6 infection (refer to Mavyret SGM for guidance).
All other unlisted indications will generally be denied as not medically necessary.

Definitions

Interferon (IFN) ineligibility — defined list

Intolerance to interferon (IFN)Member exhibits intolerance to IFN therapy (e.g., prior severe adverse reaction preventing its use).

Autoimmune hepatitis or other autoimmune disordersPresence of autoimmune hepatitis or other autoimmune disorders that contraindicate IFN use.

Hypersensitivity to PEG-IFN or componentsDocumented hypersensitivity or allergic reaction to pegylated interferon (PEG-IFN) or any of its formulation components.

Baseline neutrophils <1,500 cells/mcLBaseline absolute neutrophil count less than 1,500 cells per microliter.

Baseline platelets <90,000 cells/mcLBaseline platelet count less than 90,000 cells per microliter.

Baseline hemoglobin <10 g/dLBaseline hemoglobin level below 10 grams per deciliter.

Major uncontrolled depressive illness or pre-existing cardiac diseaseMajor uncontrolled depressive illness or a history of pre-existing cardiac disease that precludes IFN therapy.

OpenPayer

Sofosbuvir (Sovaldi) — Authorization Criteria for Chronic Hepatitis C

Coverage Criteria for Sofosbuvir (Sovaldi)

Authorization, Documentation, and Prescriber Requirements

Background on Sofosbuvir (Sovaldi)

Definitions