CurrentUnitedHealthcarePolicy N/A

Sovaldi (sofosbuvir) prior authorization for hepatitis C - Coverage Criteria

Defines UnitedHealthcare prior authorization and coverage criteria for Sovaldi (sofosbuvir) for treatment of chronic hepatitis C across specified genotypes, including combination regimens and durations; applies to UnitedHealthcare pharmacy benefit populations subject to state mandates.

Policy Summary

PayerUnitedHealthcare

PolicySovaldi (sofosbuvir) prior authorization for hepatitis C - Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateAug 1, 2025

Next Review DateAug 1, 2025

Key ActionObtain prior authorization and document genotype, combination regimen, peginterferon eligibility, absence of prior Sovaldi failure, and transplant candidacy when applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Genotypes 1-4HCV genotypes addressed

≥3 yrsMinimum pediatric age

12–48 wksAuthorization durations

2025-08-01Policy effective

Coverage Criteria

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Initial Therapy Criteria

Covered when ALL of the following sets apply depending on genotype and clinical situation:

Genotype 1 or 4 with peginterferon alfa: Diagnosis of chronic hepatitis C genotype 1 or 4 infection AND used in combination with ribavirin AND (used in combination with peginterferon alfa OR [patient is ineligible for peginterferon alfa AND patient has genotype 1 infection]).

Authorization issued for 12 weeks for genotypes 1 and 4 in combination with peginterferon alfa and ribavirin.

Genotype 1 when ineligible for peginterferon alfa: Diagnosis of chronic hepatitis C genotype 1 infection AND used in combination with ribavirin AND patient is ineligible for peginterferon alfa.

Authorization issued for 24 weeks when used with ribavirin and patient is ineligible for peginterferon alfa.

Genotype 2: Diagnosis of chronic hepatitis C genotype 2 infection AND used in combination with ribavirin.

Authorization issued for 12 weeks for genotype 2 in combination with ribavirin.

Genotype 3: Diagnosis of chronic hepatitis C genotype 3 infection AND used in combination with ribavirin.

Authorization duration for genotype 3 in combination with ribavirin is specified in policy but duration text is incomplete in source document.

Hepatocellular carcinoma or decompensated liver disease awaiting transplant: Diagnosis of chronic hepatitis C genotype 1, 2, 3, or 4 infection AND (diagnosis of hepatocellular carcinoma OR patient has decompensated liver disease [Child-Pugh Class B or C]) AND patient is an active candidate on the waiting list for a liver transplant AND used in combination with ribavirin.

Authorization will be issued for 48 weeks in this scenario.

General requirement across criteria: Patient has not experienced failure with a previous treatment regimen that includes Sovaldi.

Requests for Sovaldi in patients with decompensated liver disease (Child-Pugh Class B or C) are generally excluded from coverage unless the patient is an active candidate on the liver transplant waiting list. In that transplant-waiting scenario, Sovaldi may be authorized when used in combination with ribavirin and documentation confirms the patient is an active transplant candidate and has decompensated disease (Child-Pugh B or C).

Use of Sovaldi in patients who have experienced failure with a previous treatment regimen that included Sovaldi is not consistent with the approval criteria and is a basis for denial. Authorization requires documentation that the patient has not previously failed a Sovaldi-containing regimen; exceptions are limited to the specific transplant-waiting scenario described in policy where other criteria are met.

Initial Therapy Requirements

Initial therapy requirements

Initial approval is regimen- and genotype-specific and requires documentation as specified below.

Regimen and genotype documentation: Documentation must support chronic hepatitis C diagnosis with specified genotype and the exact combination regimen (e.g., Sovaldi used with ribavirin with or without peginterferon alfa as required by genotype).

Prior authorization required; approval contingent on meeting genotype- and regimen-specific criteria.

Peginterferon eligibility status: For regimens that allow either peginterferon alfa or an interferon-ineligible pathway, documentation must specify whether the patient is eligible or ineligible for peginterferon alfa therapy.

If ineligible and genotype 1, authorization duration differs (see Initial Therapy Criteria).

Combination therapy requirements: When policy specifies use in combination with ribavirin and/or peginterferon alfa, the request must document that Sovaldi will be used with the required agents for the specified duration.

Requests missing documentation of required combination regimen risk denial.

Prior Sovaldi exposure: Patient has not experienced failure with a previous treatment regimen that includes Sovaldi.

Use in patients with prior Sovaldi treatment failure is not consistent with approval criteria and may be denied.

Transplant and decompensation documentation: If patient has hepatocellular carcinoma or decompensated liver disease and is awaiting liver transplantation, documentation must show active status on the transplant waiting list and decompensated status (Child-Pugh Class B or C) where applicable.

Authorization in this scenario is issued for 48 weeks.

Programmatic rules: Be aware UnitedHealthcare may use prior claim/medication history, diagnosis codes, and automated approval logic to approve initial requests and may apply supply limits or step therapy.

Use of automated processes and supply limits varies by program; medical necessity review may apply.

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required — approval contingent on genotype- and regimen-specific criteria, including required combination therapy and approved duration by genotype and clinical scenario.

Affected genotypes: 1, 2, 3, 4
Combination requirements: e.g., Sovaldi (sofosbuvir) must be used with ribavirin; some indications require peginterferon alfa or documentation of ineligibility for peginterferon
Authorization durations: genotype- and regimen-specific (examples: genotypes 1 & 4 with peginterferon + ribavirin = 12 weeks; genotype 1 with ribavirin only when peginterferon-ineligible = 24 weeks; genotype 2 with ribavirin = 12 weeks; genotype 3 with ribavirin = per regimen; advanced disease or transplant-waitlist scenarios = up to 48 weeks)

Documentation Required

Documentation must support chronic hepatitis C diagnosis with specified genotype, prior treatment history, clinical status (e.g., decompensated liver disease, hepatocellular carcinoma, transplant candidacy), and evidence when peginterferon is not used that the patient is ineligible for peginterferon therapy.

Required details: genotype, prior antiviral treatment history (including whether prior Sovaldi-containing regimens failed), Child-Pugh class if applicable, transplant wait-list status, and concomitant medications/regimens

Denial Risk

Denial Risk — Missing or Inconsistent Information

Requests may be denied if diagnosis, genotype, prior treatment history, or required combination regimen documentation is missing, inconsistent, or shows prior failure on the requested therapy.

Examples of denial risks: missing genotype specification, absence of documentation that required companion drugs will be used, evidence of prior failure with the same agent/regimen, or conflicting clinical information

Step Therapy

Supply Limits, Step Therapy, and Medical Necessity

Supply limits, step therapy, and medical necessity review may apply. UnitedHealthcare may also approve initial or reauthorization decisions based on prior claim/medication history, diagnosis codes, and claim logic per program-specific automated processes.

Policies that may apply: quantity/supply limits, step therapy requirements, medical necessity reviews
Operational note: automated approval/re-approval may use claims history and ICD-10 diagnosis codes

Step Therapy & Quantity Limits

Policy element	Details
Supply limits
Supply limits may be applied as part of medical necessity review; automated approvals and reauthorizations may rely on prior claim/medication history and claim logic.
Step therapy enforcement
Step therapy may be enforced; UnitedHealthcare may require trials of preferred therapies or other program-specific steps prior to approval and may use prior claim/medication history and diagnosis codes to evaluate step requirements.
Automated approvals using claims/diagnosis
UnitedHealthcare may approve initial and reauthorization requests solely on previous claim/medication history, diagnosis codes (ICD-10) and claim logic; use of automated approval/re-approval processes varies by program/therapeutic class.

Definitions

Decompensated liver disease (Child-Pugh B or C)

DefinitionDecompensated liver disease refers to liver disease classified as Child-Pugh Class B or C.

General policy positionPatients with decompensated liver disease (Child-Pugh B or C) are generally excluded from coverage unless specific transplant-related criteria are met.

Transplant exception (most actionable)Coverage may be approved for patients with Child-Pugh B or C disease only if the patient is an active candidate on the waiting list for a liver transplant and treatment is used in combination with ribavirin (authorization issued for 48 weeks in this scenario).

Documentation requirementDocumentation must support Child-Pugh Class designation and active status on the liver transplant waiting list when requesting exception-based coverage for decompensated patients.

Combination therapy requirementWhen covered under the transplant exception, sofosbuvir must be used in combination with ribavirin as specified by the criteria.

OpenPayer