CurrentCignaPolicy IP0157

Sovaldi Prior Authorization Policy

Defines Cigna's prior authorization, coverage criteria, and prescribing requirements for Sovaldi (sofosbuvir) for treatment of chronic hepatitis C in adults and pediatric patients aged ≥3 years; affects providers submitting pharmacy benefit requests under Cigna-administered plans.

Policy Summary

PayerCigna

PolicySovaldi Prior Authorization Policy

Policy CodePolicy IP0157

Change TypeMaterial operational updates

Effective DateJul 1, 2025

Next Review Date

Key ActionObtain prior authorization and ensure Sovaldi is prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or liver transplant physician.

SourceLink

POLICY UPDATE CHANGES

Removed criterion related to intolerance or contraindication to both Epclusa and Mavyret for chronic hepatitis C virus (HCV) Genotype 2 and 3.

Removed condition 'Life Expectancy Less Than 12 Months Due to Non-Liver Related Comorbidities' from Conditions Not Recommended for Approval.

For Employer Plans: note that use of preferred products is required before approval; refers to Hepatitis C Virus Direct-Acting Antivirals Preferred Specialty Management Policy (PSM025).

≥3minimum pediatric age for Sovaldi use covered

12 wksapproved duration for genotype 2 pediatric therapy

24 wksapproved duration for genotype 3 pediatric therapy

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Coverage Criteria for Sovaldi (sofosbuvir)

FDA-Approved Indication: Chronic HCV Genotype 2 (Pediatric)

Covered when ALL of the following are met for the specified genotype and duration

Genotype 2 pediatric (approve 12 weeks): A) Patient is >= 3 years and < 18 years; AND B) Patient does not have decompensated cirrhosis (Child-Pugh B or C); AND C) Medication will be prescribed in combination with ribavirin; AND D) Prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician.12 weeks

Coverage provided for patients without cirrhosis or with compensated (Child-Pugh A) cirrhosis.

FDA-Approved Indication: Chronic HCV Genotype 3 (Pediatric)

Covered when ALL of the following are met for the specified genotype and duration

Genotype 3 pediatric (approve 24 weeks): A) Patient is >= 3 years and < 18 years; AND B) Patient does not have decompensated cirrhosis (Child-Pugh B or C); AND C) Medication will be prescribed in combination with ribavirin; AND D) Prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician.24 weeks

Coverage provided for patients without cirrhosis or with compensated (Child-Pugh A) cirrhosis.

Treatment Completion

Other Uses with Supportive Evidence — treatment continuation

Continue/complete started therapy: Patient has been started on Sovaldi for an indication addressed by the policy; approve the remaining duration necessary to complete the originally intended course of therapy (for example, if a 12-week course was prescribed and 3 weeks have been completed, approve 9 weeks).remaining weeks to complete FDA-indicated course

Approve duration described in the applicable approval to complete the course of therapy.

Retreatment after Mavyret Failure

Other Uses with Supportive Evidence — selective retreatment scenarios

Retreatment with Mavyret + Sovaldi + ribavirin: In adults who experienced virologic failure to Mavyret, retreatment with Mavyret + Sovaldi + weight-based ribavirin for 12 or 16 weeks is a recommended regimen based on Phase IIIb data; Vosevi is also an FDA-approved recommended option for this scenario.12 or 16 weeks depending on genotype, cirrhosis status, and prior protease/NS5A exposure

Duration: 12 weeks for non-cirrhotic, protease/NS5A‑naïve patients with genotypes 1,2,4,5,6; 16 weeks for patients with genotype 3 and/or compensated cirrhosis and/or prior protease/NS5A experience.

Sovaldi (sofosbuvir) for any use not specifically approved in this policy is considered not medically necessary. Monotherapy with Sovaldi is not indicated; Sovaldi is intended to be used as a component of a combination antiviral regimen for hepatitis C virus (HCV) infection. This policy will be updated as new published data become available.

Use of Sovaldi for indications not addressed by the FDA‑Approved Indications or the Other Uses with Supportive Evidence sections of this policy is considered not medically necessary. The policy explicitly notes limited supportive scenarios described in the Other Uses section (for example, select retreatment regimens after Mavyret failure) and continues to exclude uses lacking established safety or efficacy, including pediatric patients < 3 years of age.

Coding and Age / Duration Details

Drugmixed

Sovaldi

sofosbuvir tablets and oral pellets (brand name)

inv-08: Pediatric age — minimum and maximum age boundaries for Sovaldi use

Pediatric age range>= 3 years and < 18 years

Coverage populationPediatric patients with chronic HCV genotype 2 or 3

Cirrhosis status requirementPatient does not have decompensated cirrhosis (Child-Pugh B or C); coverage provided for patients without cirrhosis or with compensated (Child-Pugh A) cirrhosis

Combination therapy requirementMedication must be prescribed in combination with ribavirin for pediatric genotypes 2 and 3

inv-09: Genotype 2 treatment duration — 12 weeks (with ribavirin)

Approved treatment duration (Genotype 2)12 weeks (Sovaldi in combination with ribavirin)

Provider Requirements and Prior Authorization

Prior Authorization

Prior authorization required for Sovaldi

Prior authorization is recommended for prescription benefit coverage of Sovaldi; approvals are provided for the duration noted in the policy and require specialist prescribing or consultation.

Step Therapy

Preferred products required for Employer Plans (PSM025)

For Employer Plans, use of preferred products is required before approval; refer to the Hepatitis C Virus Direct-Acting Antivirals Preferred Specialty Management Policy (PSM025) for additional preferred-product criteria and exceptions.

Documentation Required

Specialist prescriber or consultation required

Background

Sovaldi (sofosbuvir) is an NS5B polymerase inhibitor supplied as tablets and oral pellets and is used as part of combination antiviral regimens for chronic HCV. In current practice its role is primarily as a component of combination therapy rather than as a single agent; pediatric use is limited to specific genotype regimens (genotypes 2 and 3) in patients aged ≥ 3 years, typically administered with ribavirin for the durations specified in the FDA‑approved pediatric indications.

Definitions and Key Terms

inv-16: Sovaldi — sofosbuvir tablets and oral pellets; NS5B polymerase inhibitor used in combination antiviral regimens for HCV

Generic name and formulationsSofosbuvir — tablets and oral pellets

Drug classNS5B polymerase inhibitor (nucleotide analog)

Indication summaryUsed as a component of combination antiviral regimens for chronic HCV genotypes 1–4 in adults and genotypes 2–3 in pediatric patients ≥ 3 years (with ribavirin for pediatric use)

Therapeutic rolePart of combination DAA regimens; role diminished for many genotypes due to newer pangenotypic DAAs

inv-17: Child-Pugh A — policy specifies coverage provided for patients without cirrhosis or with compensated Child-Pugh A cirrhosis

Coverage for cirrhosis statusCoverage provided for patients without cirrhosis or with compensated (Child‑Pugh A) cirrhosis