CurrentCignaPolicy N/A

POLICY: Hepatitis C - Sovaldi Prior Authorization Policy

Defines Cigna's prior authorization coverage criteria for Sovaldi (sofosbuvir tablets and oral pellets) for FDA-approved pediatric genotype 2 and 3 indications and certain other supportive situations, lists non-covered uses, prescriber requirements, and treatment durations.

Policy Summary

PayerCigna

PolicyPOLICY: Hepatitis C - Sovaldi Prior Authorization Policy

Policy CodePolicy N/A

Change TypeAnnual revisions; selected revision (removed a condition)

Effective Date

Next Review Date

Key ActionPrior Authorization is recommended; document patient age, cirrhosis status (Child-Pugh), combination with ribavirin for covered pediatric genotype 2 or 3 indications, and prior initiation if requesting completion of therapy.

SourceLink

POLICY UPDATE CHANGES

Annual Revision, Summary of Changes = No criteria changes.

Selected Revision removed condition 'Life Expectancy Less Than 12 Months Due To Non-Liver Related Comorbidities' from Conditions Not Covered.

2Covered Pediatric Genotypes

3Not Covered Conditions Listed

1Required Prescriber Specialty

Coverage Summary & Scope

Scope: This policy defines Cigna prior authorization coverage criteria for Sovaldi (sofosbuvir tablets and oral pellets) for FDA‑approved pediatric genotype 2 and 3 indications and certain supportive situations (for example, completing a course of therapy that was previously started). It lists uses considered not medically necessary (including combination use with DAAs other than ribavirin, Sovaldi monotherapy, and pediatric patients < 3 years), specifies prescriber requirements (prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or liver transplant physician), and defines authorized treatment durations for covered pediatric indications (12 weeks for genotype 2 and 24 weeks for genotype 3 when given with ribavirin).

Policy status: CURRENT. Last review date: 2026-01-14.

Threshold and Quick Facts

Pediatric age threshold≥ 3 years and < 18 years

Covered pediatric genotypesGenotype 2 and Genotype 3

Treatment duration (Genotype 2)Sovaldi + ribavirin for 12 weeks

Treatment duration (Genotype 3)Sovaldi + ribavirin for 24 weeks

Required prescriber specialtyPrescribed by or in consultation with gastroenterologist, hepatologist, infectious diseases physician, or liver transplant physician

Not covered conditions (examples)Combination with DAAs other than ribavirin; monotherapy; pediatric < 3 years

Quick statsCovered Pediatric Genotypes: 2; Not Covered Conditions Listed: 3; Required Prescriber Specialty: 1

Initial Therapy Criteria (Pediatric FDA Indications)

FDA-Approved Indications - Genotype 2 (Pediatric)

Approve for 12 weeks if ALL of the following are met:

ALL of the following

Patient is ≥ 3 years of age and < 18 years of age
Patient does not have decompensated cirrhosis (Child-Pugh B or C)
Coverage provided for patients without cirrhosis or with compensated (Child-Pugh A) cirrhosis
Medication will be prescribed in combination with ribavirin
Medication is prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician

FDA-Approved Indications - Genotype 3 (Pediatric)

Approve for 24 weeks if ALL of the following are met:

ALL of the following

Patient is ≥ 3 years of age and < 18 years of age
Patient does not have decompensated cirrhosis (Child-Pugh B or C)
Coverage provided for patients without cirrhosis or with compensated (Child-Pugh A) cirrhosis
Medication will be prescribed in combination with ribavirin
Medication is prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician

Continuation / Completion of Therapy

Other Uses with Supportive Evidence

Approve when ALL of the following are met:

ALL of the following

Patient has been started on Sovaldi
Approved for the duration necessary to complete a course of therapy corresponding to an approval in the Recommended Authorization Criteria (e.g., remaining weeks to complete 12- or 24-week course)

Not Medically Necessary / Exclusions

Conditions Not Covered (Not Medically Necessary)

Sovaldi is considered not medically necessary for ANY other use(s) including, but not limited to:

ANY of the following

HCV (any genotype): combination use with direct-acting antivirals (DAAs) other than ribavirin (e.g., Sovaldi + other DAAs) is not covered
Specifically notes combination with DAAs other than ribavirin in adults and references alternative regimens (e.g., Vosevi) and study data
Monotherapy with Sovaldi
Sovaldi is indicated as a component of a combination antiviral treatment regimen for HCV
Pediatric patients age < 3 years
Safety and efficacy not established in pediatric patients < 3 years of age

Provider Actions & Documentation Requirements

Prior Authorization

Prior authorization required

Prior authorization is recommended for prescription benefit coverage of Sovaldi. Approvals are provided for the specified durations per indication and require the medication to be prescribed by or in consultation with a specialist: gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician.

Prescription benefit

Documentation Required

Prescribing and combination therapy documentation

Document the patient’s age and cirrhosis status using Child‑Pugh classification. For covered pediatric genotype 2 or 3 indications, document that Sovaldi will be given in combination with ribavirin. If requesting approval to complete a previously started course, document that therapy was already initiated and provide the prior therapy start information/remaining duration.

Patient age (≥3 and <18 years for pediatric approvals)
Cirrhosis status (Child‑Pugh classification; exclude Child‑Pugh B or C for pediatric approvals)
Combination therapy: Sovaldi + ribavirin for covered pediatric genotype 2 or 3 indications
If requesting completion: date therapy was started / remaining weeks to complete course

Clinical Evidence & References

Evidence:

Prescribing information: Sovaldi tablets and oral pellets [prescribing information], Gilead; December 2024.

Guidelines: American Association for the Study of Liver Diseases and the Infectious Diseases Society of America (AASLD/IDSA) HCV guidance, updated December 19, 2023.

Background

Background: Sovaldi (sofosbuvir) is an NS5B polymerase inhibitor indicated as a component of combination antiviral regimens for certain HCV infections, including chronic HCV genotype 2 or 3 in pediatric patients ≥ 3 years of age without cirrhosis or with compensated cirrhosis when combined with ribavirin. The place in therapy for Sovaldi has greatly lessened due to availability of newer pangenotypic DAAs with greater efficacy; regimens combining Sovaldi with peginterferon or with ribavirin alone are generally no longer favored in guidelines except for selected pediatric uses. This policy therefore restricts Sovaldi primarily to pediatric genotype 2 and 3 treatment in combination with ribavirin and to completing previously started courses of therapy.

Definitions:

• Compensated cirrhosis: Child‑Pugh A (policy notes coverage for patients without cirrhosis or with compensated (Child‑Pugh A) cirrhosis).

• Decompensated cirrhosis: Child‑Pugh B or C (policy excludes these patients for pediatric approvals).

Revision History

01/24/2024Annual Revision

Annual revision — No criteria changes.

02/28/2024Selected Revision

Selected revision removed the condition 'Life Expectancy Less Than 12 Months Due to Non-Liver Related Comorbidities' from Conditions Not Covered.

01/29/2025Annual Revision

Annual revision — No criteria changes; Sovaldi tablets (generic) were added to the product header for completeness (already included).

01/14/2026Annual RevisionLatest

Annual revision — No criteria changes; generic sofosbuvir tablets were removed from the product header (not available).

Policy Summary

PayerCigna

PolicyPOLICY: Hepatitis C - Sovaldi Prior Authorization Policy

Policy CodePolicy N/A

Change TypeAnnual revisions; selected revision (removed a condition)

Effective Date

Next Review Date

SourceLink

On This Page

OpenPayer

POLICY: Hepatitis C - Sovaldi Prior Authorization Policy

Coverage Summary & Scope

Initial Therapy Criteria (Pediatric FDA Indications)

Continuation / Completion of Therapy

Not Medically Necessary / Exclusions

Provider Actions & Documentation Requirements

Applicable Codes

Clinical Evidence & References

Background

Revision History