CurrentmhnPolicy CP.PHAR.281

Clinical Policy: Sofosbuvir (Sovaldi)

Pharmacy clinical policy defining medical necessity criteria, dosing, prior authorization documentation, and coverage limitations for sofosbuvir (Sovaldi) for treatment of hepatitis C virus (HCV) across Medicaid lines of business (Centene-affiliated plans).

Policy Summary

Payermhn

PolicyClinical Policy: Sofosbuvir (Sovaldi)

Policy CodePolicy CP.PHAR.281

Change TypeAnnual revisions (2022-2025)

Effective DateSep 1, 2016

Next Review Date

Key ActionProvider must submit chart notes and lab results supporting diagnosis (HCV RNA), genotype, treatment status, and cirrhosis status to meet approval criteria.

POLICY UPDATE CHANGES

Continued therapy criteria: added 'Prescribed regimen is consistent with an FDA or AASLD-IDSA recommended regimen'; changed minimum treatment duration for continued therapy from 60 days to 28 days and removed requirement for specific confirmed genotype.

3Q 2024 annual review: removed qualifier 'chronic' from HCV criteria; removed 'preferred' wording from Epclusa redirection; added Appendix F for adherence/interruptions guidance.

3Q 2023 annual review: removed prescriber specialty requirement; added previous Mavyret experience to initial approval scenarios; eliminated adherence program participation requirement.

Added statement that coadministration with omeprazole up to 20 mg is not acceptable justification to avoid Epclusa.

Added disclaimer that medical management techniques beyond step therapy are not allowed for members in Nevada per SB 439.

6Adult Genotypes Covered

2Pediatric Genotypes Covered (age ≥3)

400 mg/day

Coverage Summary

Coverage stance: Covered with criteria for sofosbuvir (Sovaldi) for the treatment of hepatitis C virus (HCV) per Clinical Policy CP.PHAR.281, effective date 09.16 with policy metadata referencing Reference Number CP.PHAR.281 and Last Review Date 08.25 (P&T Approval 08.25.25 reflected in revision history). The policy aligns coverage with FDA labeling and AASLD-IDSA guidance, and when applicable redirects to sofosbuvir/velpatasvir (Epclusa authorized generic) or Mavyret as preferred alternatives unless clinically significant adverse effects or contraindications exist. Approval is subject to the policy's specified medical necessity criteria, dosing limits (maximum 400 mg/day), documentation requirements, and authorization duration (up to 24 weeks).

I. Initial Therapy Criteria — Hepatitis C Infection

I. 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
Chart note documentation and copies of lab results are required
Confirmed HCV genotype
- genotype by age
  - Adults (age ≥ 18 years): Genotypes 1, 2, 3, 4, 5, or 6
  - Pediatrics (age ≥ 3 years): Genotypes 2 or 3
Treatment status: Documentation of treatment status of the member (treatment-naïve or treatment-experienced)
Cirrhosis status: Documentation of cirrhosis status of the member (no cirrhosis, compensated cirrhosis, or decompensated cirrhosis)
Preferred agent/redirection requirements
- If not failed Mavyret/Vosevi: If member has not experienced treatment failure with Mavyret or Vosevi: Member must use sofosbuvir/velpatasvir (Epclusa authorized generic) or Mavyret, unless clinically significant adverse effects are experienced or both are contraindicated
  See Appendix B for dosing; Appendix E lists acceptable medical justification
- If treatment-experienced with Mavyret/Vosevi: If treatment-experienced with Mavyret or Vosevi: Member must use Sovaldi in combination with Mavyret and RBV, unless any individual agent is contraindicated or clinically significant adverse effects are experienced
  Refer to Section V dosing for combination regimen
Pediatric RBV requirement: For pediatric patients (age ≥ 3 years) with genotype 2 or 3: use is in combination with RBV
Per FDA pediatric indication
Life expectancy ≥ 12 months with HCV treatment
Regimen consistency: Prescribed regimen is consistent with an FDA or AASLD-IDSA recommended regimen
See Section V Dosage and Administration and AASLD-IDSA guidance
Dose limit: Dose does not exceed 400 mg per day≤ 400 mg/day
Approval duration up to a total of 24 weeks consistent with dosing section
Documentation required: Provider must submit chart note documentation and copies of lab results

I. Initial Therapy Criteria — Other diagnoses/indications

I. Initial Approval Criteria - Other diagnoses/indications

Covered when ALL of the following are met:

ALL of the following

Preferred agent redirection: Member must use sofosbuvir/velpatasvir (Epclusa authorized generic) or Mavyret, if applicable for the requested indication, unless clinically significant adverse effects are experienced or both are contraindicated
Coadministration with omeprazole up to 20 mg is not considered acceptable justification for inability to use Epclusa
If recent label change or off-label use
- Recent label change: If this drug has recently (within the last 6 months) undergone a label change that is not yet reflected in this policy: refer to CP.PMN.255 (no coverage criteria) or CP.PMN.16 (non-formulary) as applicable for Medicaid

II. Continued Therapy — Hepatitis C Infection

II. Continued Therapy - Hepatitis C Infection

Continued coverage when ALL of the following are met:

ALL of the following

Member status for continuation
- Currently receiving via Centene or prior met initial: Currently receiving medication via Centene benefit or member has previously met initial approval criteria
- Continuity of care regulations: Member is currently receiving medication and is enrolled in a state/product with continuity of care regulations (refer to state addendums CC.PHARM.03A and CC.PHARM.03B)
- Minimum treatment exposure: Documentation supports that member is currently receiving Sovaldi for HCV infection and has recently completed at least 28 days of treatment with Sovaldi

II. Continued Therapy — Other diagnoses/indications

II. Continued Therapy - Other diagnoses/indications

For other indications (meet 1 or 2):

Other indications continued therapy branch

Recent label change: If this drug has recently (within the last 6 months) undergone a label change that is not yet reflected in this policy: refer to CP.PMN.255 (no coverage criteria) or CP.PMN.16 (non-formulary) as applicable for Medicaid
Off-label use: If the requested use is NOT listed in section III and the above does not apply: refer to off-label use policy CP.PMN.53 for Medicaid

III. Diagnoses / Indications NOT authorized

III. Diagnoses/Indications NOT authorized

Not authorized indications: Non-FDA approved indications not addressed in this policy are not covered unless there is sufficient documentation of efficacy and safety per off-label use policy CP.PMN.53 or evidence of coverage documents

Refer to CP.PMN.53

Applicable Codes

Product availability (drug strengths/forms)NDC|mixed

Tablet 400 mg	Sovaldi tablet 400 mg
Tablet 200 mg	Sovaldi tablet 200 mg
Oral pellets 200 mg	Sovaldi oral pellets 200 mg
Oral pellets 150 mg	Sovaldi oral pellets 150 mg

Provider Actions

Prior Authorization

Prior authorization required

Coverage requires prior authorization. Documentation submitted for prior authorization must verify the prescribed regimen is consistent with FDA labeling or AASLD‑IDSA recommended regimens. Approval durations may be granted consistent with dosing guidance, up to a total of 24 weeks.

Documentation Required

Submit clinical documentation

Submit clinical documentation to support approval: chart notes and copies of laboratory results demonstrating detectable serum HCV RNA (quantitative assay within the last 6 months), confirmed HCV genotype (as applicable by age), treatment status (treatment‑naïve or treatment‑experienced), and cirrhosis status (no cirrhosis, compensated, or decompensated).

Clinical Evidence & References

Primary references: Sovaldi Prescribing Information (December 2024) and American Association for the Study of Liver Diseases / Infectious Diseases Society of America (AASLD‑IDSA) HCV guidance (last updated December 19, 2023). This policy states it aligns with and references FDA-approved labeling and AASLD‑IDSA recommendations for HCV treatment.

Background

Background: Sofosbuvir (Sovaldi) is an NS5B nucleotide analog polymerase inhibitor indicated for treatment of HCV per FDA labeling. The policy explicitly aligns coverage and regimen requirements with FDA labeling and AASLD‑IDSA guidance, and includes preferred redirection to sofosbuvir/velpatasvir (Epclusa authorized generic) or Mavyret when applicable, with defined exceptions and acceptable medical justification criteria. Product availability includes tablets (400 mg, 200 mg) and oral pellets (200 mg, 150 mg). The policy scope covers pharmacy clinical policy criteria, prior authorization, dosing, and coverage limitations for sofosbuvir (Sovaldi) across Medicaid/Centene-affiliated lines of business.

Revision History

08.25.25revisedLatest

3Q 2025 annual review: Continued therapy criteria — added requirement that prescribed regimen is consistent with an FDA or AASLD‑IDSA recommended regimen; changed minimum treatment duration for continued therapy from 60 days to 28 days and removed requirement for specific confirmed genotype.

08.24revised

3Q 2024 annual review: removed qualifier 'chronic' from HCV criteria; removed the word 'preferred' from Epclusa authorized generic redirection; added Appendix F for guidance on incomplete adherence and AASLD‑IDSA recommended management of treatment interruptions; references reviewed and updated.

08.23