CurrentNeighborhood Health Plan of Rhode IslandPolicy 2141-A

Sovaldi (sofosbuvir) — coverage criteria

Defines coverage criteria and authorization durations for Sovaldi (sofosbuvir) for treatment of chronic hepatitis C virus (HCV) across genotypes, including pediatric use and special situations; applies to Neighborhood Health Plan of Rhode Island members as governed by this payer's SGM.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySovaldi (sofosbuvir) — coverage criteria

Policy CodePolicy 2141-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization; approval durations vary by genotype, prior treatment status, age, interferon eligibility, and combination regimens.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Genotypes 1-4FDA-approved adult indications

≥3 yrs (2,3)Approved pediatric use

12–48 weeksAuthorization durations

5920-A, 6284-ARelated Qsets

Sovaldi Coverage Criteria

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Coverage criteria by indication

Covered when ALL of the following apply as specified per genotype/regimen:

Base approvals: Requested use is an FDA-approved indication or compendial use for Sovaldi; prescriber is experienced in HCV management or consults with such a provider; member has no exclusions to the prescribed therapy.

FDA-approved indications include adults with genotype 1–4 and pediatric patients ≥3 years with genotypes 2 or 3 (see FDA-approved Indications).

Genotype 1 adults: Authorization of up to 12 weeks total for treatment‑naïve adults; up to 24 weeks total may be granted for adults with documented interferon (IFN) ineligibility.12 or 24 weeks

Interferon ineligibility defined in Appendix.

Genotype 4 adults: Authorization of up to 12 weeks total for treatment‑naïve adults.12 weeks

Genotype 2: Authorization of up to 12 weeks total for members ≥3 years who are treatment‑naïve or who failed prior PEG‑IFN±RBV.12 weeks

Applies to pediatric and adult members as specified.

Genotype 3: Authorization of up to 24 weeks total for members ≥3 years who are treatment‑naïve or who failed prior PEG‑IFN±RBV.24 weeks

Hepatocellular carcinoma awaiting transplant: Authorization of up to 48 weeks total or until liver transplantation (whichever occurs first) for adult members with genotype 1–4 infection and hepatocellular carcinoma awaiting transplant.48 weeks

Combination with Mavyret: When Sovaldi is prescribed in combination with Mavyret (with ribavirin), authorization of up to 24 weeks total may be granted when the member meets the Mavyret SGM criteria for approval and durations.24 weeks

Refer to Mavyret SGM for specific criteria and durations.

Coinfection with HIV: Authorization may be granted for HCV/HIV coinfected members when the criteria for the requested regimen above are met.

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

Prior Authorization & Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Sovaldi. Approval durations vary by genotype, prior treatment status, age, interferon eligibility, and special indications. All other indications beyond the listed FDA‑approved and compendial uses are considered experimental/investigational and are not medically necessary.

Genotype 1, treatment‑naïve: up to 12 weeks total for adults
Genotype 1, interferon‑ineligible: up to 24 weeks total for adults (see Appendix)
Genotype 2: up to 12 weeks total for members ≥3 years who are treatment‑naïve or failed prior PEG‑IFN ± RBV
Genotype 3: up to 24 weeks total for members ≥3 years who are treatment‑naïve or failed prior PEG‑IFN ± RBV
Genotype 4, treatment‑naïve: up to 12 weeks total for adults
Genotype 5 or 6: refer to Mavyret SGM (compendial use)
Hepatocellular carcinoma awaiting liver transplant (genotypes 1–4): authorization up to 48 weeks or until transplant, whichever occurs first
HCV/HIV coinfection: may be authorized when regimen criteria are met
When prescribed with Mavyret (with ribavirin): member must meet Mavyret SGM criteria; authorization up to 24 weeks total as applicable

Documentation Required

Documentation May Be Requested

Provider documentation may be requested to support authorization decisions or regulatory reporting. Furnish requested records promptly to avoid delays.

Treatment status (treatment‑naïve or retreatment)
For initial treatment: confirmation of member readiness to start therapy
For retreatment: reason for retreatment (e.g., prior treatment failure, reinfection), confirmation of readiness, and ability to adhere to proposed treatment plan
Hepatitis B virus screening results
Metavir/Fibrosis score
Any additional clinical information supporting interferon ineligibility (if applicable)

Denial Risk

Provider Actions & Other Indications

Some elements of this policy may not be enforced for certain plans due to regulatory requirements. Continuation of therapy requests (including new members requesting continuation) must meet all requirements in the coverage criteria. Remember: any indication not listed as an FDA‑approved or compendial use is considered experimental/investigational and is not medically necessary.

Continuation of therapy: all members must meet coverage criteria for continuation
Regulatory exceptions: certain plan rules may be waived when required by law or contract

Key Definitions

IFN ineligibility — definition listing criteria for interferon ineligibility.

DefinitionInterferon (IFN) ineligibility is defined as one or more of the following clinical findings or conditions.

Intolerance to IFNDocumented intolerance to interferon therapy.

Autoimmune diseaseAutoimmune hepatitis or other autoimmune disorders that contraindicate IFN use.

HypersensitivityHypersensitivity to pegylated interferon (PEG-IFN) or any of its components.

Psychiatric contraindicationMajor uncontrolled depressive illness.

Hematologic thresholdsBaseline neutrophil count < 1,500 cells/mcL; baseline platelet count < 90,000 cells/mcL; baseline hemoglobin < 10 g/dL.

Cardiac historyHistory of pre-existing cardiac disease.

OpenPayer

Sovaldi (sofosbuvir) — coverage criteria

Sovaldi Coverage Criteria

Drug Coding

Prior Authorization & Provider Requirements

Key Definitions

Background