CurrentCentenePolicy HIM.PA.SP2

Sofosbuvir (Sovaldi) (PDF)

Defines Centene medical necessity criteria, prior authorization requirements, dosing, and continuity/continuation rules for sofosbuvir (Sovaldi) across HIM lines of business (exclusions for CA Exchange). Includes required prescriber qualifications, genotype and age restrictions, step therapy redirection to sofosbuvir-velpatasvir (Epclusa) authorized generic, and dosing regimens for adults and pediatrics.

Policy Summary

PayerCentene

PolicySofosbuvir (Sovaldi) (PDF)

Policy CodePolicy HIM.PA.SP2

Change TypeMultiple revisions (2022-2025)

Effective DateAug 1, 2016

Next Review Date

Key ActionProvider must submit chart notes, lab results or other clinical information supporting that member meets all approval criteria (including HCV RNA, genotype, cirrhosis status, treatment status).

SourceLink

POLICY UPDATE CHANGES

Member must use sofosbuvir-velpatasvir (Epclusa authorized generic) unless contraindicated; coadministration with omeprazole up to 20 mg is not acceptable justification to bypass Epclusa.

Prescriber exception for HIM Georgia added and IL HIM step therapy bypass added per IL HB 5395.

Continuation minimum treatment duration changed from 60 days to 28 days and requirement for specific confirmed genotype removed for continued therapy.

Removed qualifier 'chronic' from HCV criteria aligning with AASLD-IDSA recommending treatment of acute and chronic HCV.

Eliminated adherence program participation requirement.

6Adult genotypes covered

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Pediatric genotypes (age ≥3)

400 mg/dayMax daily dose

24 weeksMax approval duration

Coverage Summary

Policy stance: covered_with_criteria for Sofosbuvir (Sovaldi) per HIM.PA.SP2 (status CURRENT), with effective date 2016-08-01 and last review 2025-08-25. Scope: defines Centene medical necessity criteria, prior authorization requirements, dosing, continuity/continuation rules, prescriber qualifications, genotype and age restrictions, step therapy redirection to the preferred pan‑genotypic agent, and dosing regimens across HIM lines of business (exclusions for California Exchange).

Preferred agent redirect: requests for Sovaldi should be redirected to the preferred pan‑genotypic agent sofosbuvir‑velpatasvir (Epclusa authorized generic) unless contraindicated or clinically significant adverse effects occur; coadministration with omeprazole up to 20 mg is not acceptable justification to bypass Epclusa.

Safety note: a boxed warning for HBV reactivation applies to Sovaldi and all direct‑acting antivirals; patients should be monitored for HBV reactivation and hepatitis flare during treatment and post‑treatment follow‑up, with treatment of HBV infection as clinically indicated.

HCV RNA testing recencyDetectable serum HCV RNA by quantitative assay within the last 6 months

Minimum treatment exposure for continuationAt least 28 days of Sovaldi treatment for continuation option

Maximum daily doseDose must not exceed 400 mg per day

Life expectancy requirementLife expectancy ≥ 12 months with HCV treatment

Adult genotypes coveredGenotypes 1, 2, 3, 4, 5, or 6 (age ≥ 18 years)

Pediatric genotypes coveredGenotypes 2 or 3 for pediatrics age ≥ 3 years (use with RBV)

Maximum approval durationApproval duration: up to a total of 24 weeks (consistent with regimen in Dosage and Administration)

Initial Therapy Criteria - Hepatitis C Infection

Initial Approval Criteria - Hepatitis C Infection

Covered when ALL of the following are met:

ALL of the following

Diagnosis of HCV infection as evidenced by detectable serum HCV RNA levels by quantitative assay in the last 6 months
Prescriber requirement: Prescribed by or in consultation with a gastroenterologist, hepatologist, infectious disease specialist, or provider who has expertise in treating HCV based on a certified training program
Prescriber requirement does not apply to HIM Georgia
Confirmed HCV genotype
- Adult genotypes: For adults (age ≥ 18 years): Genotypes 1, 2, 3, 4, 5, or 6

Initial Therapy Criteria - Other Diagnoses/Indications

Initial Approval Criteria - Other diagnoses/indications

Covered when ALL of the following are met:

ALL of the following

Preferred agent requirement (other indications): Member must use sofosbuvir-velpatasvir (Epclusa authorized generic), if applicable for the requested indication, unless contraindicated or clinically significant adverse effects are experienced
Coadministration with omeprazole up to 20 mg is NOT acceptable justification for inability to use Epclusa
Redirects
- Formulary label change redirect: If this drug has recently (within the last 6 months) undergone a label change that is not yet reflected in this policy, redirect per formulary/no coverage or non-formulary policy (HIM.PA.33 or HIM.PA.103)

Continuation Therapy Criteria

Continuation/Continued Therapy - Hepatitis C Infection

Covered when ALL of the following are met:

Continuation criteria - HCV

Continuation eligibility
- Prior Centene benefit or prior approval: Currently receiving medication via Centene benefit or member has previously met initial approval criteria
- Continuity of care: Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations
  Refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B
- Minimum treatment exposure:

Not Authorized / Exclusions

Not Authorized Indications

Coverage is NOT authorized for:

Not authorized indications: Non-FDA approved indications that are not addressed in this policy unless there is sufficient documentation of efficacy and safety according to the off label use policy HIM.PA.154 or evidence of coverage documents

Provider Actions and Requirements

Documentation Required

Submit supporting documentation

Submit chart notes, laboratory results, or other clinical information that demonstrate the member meets all approval criteria. Required documents include recent HCV RNA quantitative results, confirmed HCV genotype, documentation of cirrhosis status (none, compensated, or decompensated), and documentation of treatment status (treatment-naïve or treatment-experienced).

Chart notes
HCV RNA quantitative result (detectable within last 6 months)
Confirmed HCV genotype
Cirrhosis status documentation
Treatment status documentation (naïve or experienced)

Prior Authorization

Prescriber qualification and consultation

Prescriptions must be from or in consultation with a gastroenterologist, hepatologist, infectious disease specialist, or a provider with certified HCV training per Appendix F. Note: the prescriber requirement is waived for HIM Georgia.

Applicable Codes and Product Availability

Product availability (NDC not listed)mixed

Tablet strengths	400 mg, 200 mg
Oral pellets strengths	200 mg, 150 mg

Clinical Evidence & Guidelines

Key evidence sources cited in the policy: Sovaldi Prescribing Information, December 2024 and the AASLD‑IDSA HCV guidance (updated December 19, 2023).

Safety and monitoring: the policy references the boxed warning for HBV reactivation associated with direct‑acting antivirals and states that patients should be monitored for HBV reactivation and hepatitis flare during HCV treatment and post‑treatment follow‑up.

Treatment-experiencedFrom clinical trials, refers to previous treatment with NS3/4A protease inhibitor and/or peginterferon/RBV unless otherwise stated.

Child-Pugh ClassScore-based classification: A = 5-6, B = 7-9, C = 10-15 (points criteria listed in Appendix E).

Background

Background: Sofosbuvir (Sovaldi) is an HCV nucleotide analog NS5B polymerase inhibitor.

Policy direction: when applicable for the requested indication, the policy redirects use to the preferred pan‑genotypic agent sofosbuvir‑velpatasvir (Epclusa authorized generic); coadministration with omeprazole up to 20 mg is not considered acceptable medical justification to bypass Epclusa.

Safety: HBV reactivation is a boxed warning for Sovaldi and all direct‑acting antivirals; patients should be monitored for HBV reactivation and hepatitis flare during HCV treatment and post‑treatment follow‑up, and treated for HBV as clinically indicated.

Scope note: the policy defines Centene medical necessity criteria, prior authorization, dosing, continuity/continuation rules and prescriber qualifications across HIM lines of business and includes an exclusion for California Commercial Exchange plans per the scope summary.

Revision History

2016-08-01initial_effective_date

Policy effective date established (Clinical Policy: Sofosbuvir (Sovaldi) effective 08.01.16).

3Q2023annual_review

3Q2023 annual review: eliminated adherence program participation requirement; added asterisk to Epclusa redirection for Florida requests; applied Epclusa authorized generic redirection to all requests per SDC; removed redirection to Vosevi.

3Q2024annual_review

Policy Summary

PayerCentene

PolicySofosbuvir (Sovaldi) (PDF)

Policy CodePolicy HIM.PA.SP2

Change TypeMultiple revisions (2022-2025)

Effective DateAug 1, 2016

Next Review Date

SourceLink

On This Page

Pediatric genotypes: For pediatrics (age ≥ 3 years): Genotypes 2 or 3

Documentation of treatment status of the member (treatment-naïve or treatment-experienced)

Documentation of cirrhosis status of the member (no cirrhosis, compensated cirrhosis, or decompensated cirrhosis)

Preferred agent requirement: Member must use sofosbuvir-velpatasvir (Epclusa authorized generic), unless contraindicated or clinically significant adverse effects are experienced

Coadministration with omeprazole up to 20 mg is NOT acceptable justification for inability to use Epclusa; Illinois HIM requests: step therapy requirements do not apply as of 1/1/2026 per IL HB 5395

Pediatric RBV: For pediatric patients (age ≥ 3 years) with genotype 2 or 3: Use is in combination with ribavirin (RBV)

Life expectancy ≥ 12 months with HCV treatment

Regimen alignment: Prescribed regimen is consistent with an FDA or AASLD-IDSA recommended regimen

Refer to Section V Dosage and Administration

Dose limit: Dose does not exceed 400 mg per day≤ 400 mg/day

Off-label redirect: If the requested use is not listed under section III and the above does not apply, refer to off-label use policy HIM.PA.154

Documentation supports that member is currently receiving Sovaldi for HCV infection and has recently completed at least 28 days of treatment with Sovaldi

Response: Member is responding positively to therapy

Regimen alignment: Prescribed regimen is consistent with an FDA or AASLD-IDSA recommended regimen

See Section V Dosage and Administration

Dose limit: Dose does not exceed 400 mg per day≤ 400 mg/day

Continuation/Continued Therapy - Other diagnoses/indications

Covered when ONE of the following applies:

Continuation - other indications

Label change redirect: If drug recently had a label change, redirect per HIM.PA.33 or HIM.PA.103 as applicable
Off-label redirect: If requested use not listed under section III and above does not apply, refer to off-label use policy HIM.PA.154

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Acceptable HCV training programs listed in Appendix F
Prescriber requirement does not apply to HIM Georgia

Step Therapy

Preferred agent requirement

Member must use sofosbuvir-velpatasvir (Epclusa authorized generic) unless contraindicated or clinically significant adverse effects occur. Coadministration with omeprazole up to 20 mg is not an acceptable justification to bypass Epclusa.

Preferred agent: sofosbuvir-velpatasvir (Epclusa authorized generic)
Omeprazole ≤20 mg is not acceptable justification to bypass Epclusa

Documentation Required

Continuation documentation

For continuation requests, provide documentation that the member is responding positively to therapy and meets continuity criteria. Continuity options include current receipt of medication via the Centene benefit, prior approval meeting initial criteria, enrollment in a program/state with continuity regulations, or documentation of having completed at least 28 days of Sovaldi therapy.

Evidence of positive response to therapy
Proof of prior approval or ≥28 days of Sovaldi treatment
Prescribed regimen consistent with FDA or AASLD-IDSA recommendations

Billing Rule

Dose limit enforcement

Dose must not exceed 400 mg per day. Approval durations should align with Dosage & Administration regimens (approved duration up to a total of 24 weeks as applicable to the regimen).

Maximum daily dose: ≤ 400 mg/day
Approval duration consistent with Dosage & Administration (up to 24 weeks)

3Q2024 annual review: removed qualifier 'chronic' from HCV criteria to align with AASLD-IDSA (clarification); added prescriber exception for HIM Georgia; added 'if applicable for the requested indication' to Epclusa authorized generic redirection in other diagnoses/indications; added Appendix G guidance on incomplete adherence and treatment interruptions.

2024added

2022–2024 updates: omeprazole coadministration (up to 20 mg) added as unacceptable medical justification for inability to use Epclusa; Epclusa authorized generic redirection applied to all requests (clarified for Florida then applied universally).

3Q2025material_revisionLatest

3Q2025 annual review (Date 07.15.25 / P&T 08.25): added step therapy bypass for Illinois HIM per IL HB 5395; in continued therapy criteria added requirement that prescribed regimen is consistent with FDA or AASLD-IDSA recommendations; revised continuation minimum treatment duration option from 60 days to 28 days and removed requirement for specific confirmed genotype for continued therapy.

2025material_revisionLatest

2025 changes include prescriber exception for HIM Georgia and IL HIM step therapy bypass added per IL HB 5395 (policy-level redirection and access changes).