CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Sovaldi (sofosbuvir) coverage for Hepatitis C

Defines medical necessity criteria, prescriber requirements, and approval durations for Sovaldi (sofosbuvir) in the treatment of chronic hepatitis C virus (HCV) infection for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySovaldi (sofosbuvir) coverage for Hepatitis C

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization; approvals granted for specified durations based on genotype, regimen, age, and treatment history.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 weeksTypical max authorization

24 weeksSome regimens / genotype 3

48 weeksHCC awaiting transplant

Specialty requiredPrescriber requirement

Coverage Criteria for Sovaldi (sofosbuvir)

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Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Requirement and Duration

Prior authorization is required for the requested regimen. Approvals are granted for specified durations depending on genotype, regimen, age, treatment history, and related factors. Refer to the policy criteria for regimen-specific approval durations (e.g., up to 12, 24, or 48 weeks as applicable).

Documentation Required

Interferon Ineligibility Pathway

IFN ineligibility is defined by clinical criteria. Members meeting one or more of the following may be considered interferon (IFN) ineligible and therefore eligible for certain regimens that require IFN ineligibility documentation.

Intolerance to interferon (IFN)
Autoimmune hepatitis or other autoimmune disorders
Hypersensitivity to peginterferon alfa (PEG-IFN) or any of its components
Major uncontrolled depressive illness
Baseline neutrophil count < 1,500/mcL
Baseline platelet count < 90,000/mcL
Baseline hemoglobin < 10 g/dL
History of pre-existing cardiac disease

Documentation Required

Supporting Documentation That May Be Requested

Supporting documentation may be requested to verify clinical indications, treatment history, and eligibility criteria. Provide documentation promptly to avoid delays in authorization.

Treatment status (treatment-naïve or retreatment) and prior HCV therapy details
For initial treatment: confirmation of member readiness to start therapy
For retreatment: reason for retreatment (e.g., prior treatment failure, reinfection), confirmation of member readiness, and plan for adherence
Hepatitis B screening results
Metavir or fibrosis score (liver staging)
Laboratory values supporting IFN ineligibility when claimed (e.g., CBC showing neutrophil, platelet, or hemoglobin levels; documentation of intolerance, hypersensitivity, autoimmune disease, psychiatric history, or cardiac disease)

Denial Risk

Non-covered Indications

Requests for indications or uses not listed in the policy are considered not covered / not medically necessary unless otherwise approved in writing by the plan.

Laboratory Thresholds and Related Coding Details

inv-04: Neutrophil count — IFN safety threshold

Neutrophil count thresholdBaseline neutrophil count < 1,500/mcL

Clinical roleOne of the laboratory criteria used to define interferon (IFN) ineligibility for treatment selection

Actionable implicationIf baseline ANC is < 1,500/mcL, patient meets an IFN ineligibility criterion and may qualify for IFN-sparing regimens per policy

inv-05: Platelet count — IFN safety threshold

Platelet count thresholdBaseline platelet count < 90,000/mcL

Clinical roleListed laboratory criterion contributing to interferon (IFN) ineligibility

Actionable implicationIf baseline platelets are < 90,000/mcL, patient meets an IFN ineligibility criterion and may be eligible for IFN‑free regimens per policy

inv-06: Hemoglobin — IFN safety threshold

Hemoglobin thresholdBaseline hemoglobin < 10 g/dL

Clinical roleIncluded as a laboratory criterion defining interferon (IFN) ineligibility

Actionable implicationBaseline hemoglobin < 10 g/dL constitutes IFN ineligibility and supports selection of IFN‑sparing treatment options per policy

Definitions

inv-12: IFN ineligibility definition — One or more listed clinical criteria define interferon ineligibility

DefinitionInterferon (IFN) ineligibility is defined as one or more of the listed clinical criteria

Clinical criteria — non‑laboratoryIntolerance to IFN; autoimmune hepatitis and other autoimmune disorders; hypersensitivity to PEG‑IFN or its components; major uncontrolled depressive illness; history of pre‑existing cardiac disease

Clinical criteria — laboratory thresholdsBaseline neutrophil count < 1,500/mcL; baseline platelet count < 90,000/mcL; baseline hemoglobin < 10 g/dL

Background on Sovaldi (sofosbuvir)

Sovaldi (sofosbuvir) is an oral antiviral used as a component of combination regimens to treat chronic hepatitis C virus (HCV) infection across multiple genotypes. This policy references compendial uses for certain genotypes (for example, genotype 5 or 6 via the Mavyret SGM) and clarifies that uses outside the FDA-approved indications and specified compendial references are considered experimental/investigational.