CurrentCentenePolicy HIMPA.SP

Sofosbuvir/Velpatasvir (Epclusa)

Clinical coverage policy defining medical necessity, eligibility, dosing, approval duration, continuation criteria, contraindications, appendices, and required documentation for sofosbuvir/velpatasvir (Epclusa) for treatment of HCV across Centene HIM line(s) of business.

Policy Summary

PayerCentene

PolicySofosbuvir/Velpatasvir (Epclusa)

Policy CodePolicy HIMPA.SP

Change TypeRevisions to continued and initial criteria (3Q 2023-2025)

Effective DateAug 16, 2008

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that member has met all approval criteria.

POLICY UPDATE CHANGES

3Q 2025 annual review: for continued therapy criteria, added 'Prescribed regimen is consistent with an FDA or AASLD-IDSA recommended regimen' and revised minimum treatment duration from 60 days to 28 days.

3Q 2024 annual review: revised policy to include generic sofosbuvir/velpatasvir, removed 'chronic' qualifier, added prescriber exception for HIM Georgia, and added Appendix G guidance on treatment interruptions.

3Q 2023 annual review: added bypass for genotype documentation for treatment-naive noncirrhotic patients eligible for simplified AASLD-IDSA regimen and eliminated adherence program participation criterion.

08.30.22: Added criterion for NSSA RAS test for specific genotype 3 scenarios per AASLD recommendation and template changes to other sections.

1-6Covered HCV Genotypes

3 yrsMinimum pediatric age

24 wksMaximum approval duration

28 daysMinimum treatment exposure for continuation

Coverage Summary

Scope: This policy defines medical necessity, eligibility, dosing, approval duration, continuation criteria, contraindications, appendices, and required documentation for sofosbuvir/velpatasvir (Epclusa) across Centene HIM lines of business and is covered_with_criteria for Hepatitis C virus (HCV) genotypes 1-6 (policy stats and scope summary).

Coverage stance and subject: Epclusa (sofosbuvir/velpatasvir) is the preferred pangenotypic direct-acting antiviral (DAA) and is covered with criteria for treatment of HCV genotypes 1-6 in adults and pediatric patients aged ≥ 3 years (FDA-approved indication and policy alignment with guidance).

Indications and pediatric age: Indicated for treatment of adults and pediatric patients 3 years of age and older with HCV genotype 1–6 (without cirrhosis or with compensated cirrhosis; with decompensated cirrhosis use in combination with ribavirin per labeling). Pediatric formulations and oral pellets/tablets are available (see dosing Table in Section V / product availability).

Boxed warnings and contraindications: The policy includes a boxed warning for HBV reactivation in patients coinfected with HBV and notes that Epclusa + ribavirin (RBV) regimens are contraindicated in patients for whom RBV is contraindicated (Appendix C).

Alignment with FDA and AASLD‑IDSA guidance: Policy dosing, treatment duration, and simplified regimen provisions align with FDA labeling and AASLD‑IDSA HCV guidance (including simplified 12‑week Epclusa regimen for noncirrhotic, treatment‑naive adults and genotype‑driven recommendations for special scenarios such as genotype 3 RAS Y93H).

Thresholds and quick facts

Covered HCV GenotypesGenotypes 1-6

Minimum pediatric age3 years

Maximum approval durationUp to 24 weeks

Minimum treatment exposure for continuation≥ 28 days

Life expectancy threshold≥ 12 months with HCV treatment

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

Initial Therapy — Hepatitis C Infection (must meet all)

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 monthsHCV RNA within 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
Age criteria: Pediatric members 3 years of age and older

Continuation Therapy / Reauthorization — Hepatitis C Infection (must meet all)

ALL of the following

Member is currently receiving Epclusa (sofosbuvir/velpatasvir) and documentation supports the member has recently completed at least 28 days of treatment with Epclusa≥ 28 days
Surface the 28-day minimum threshold
Prescribed regimen is consistent with an FDA-approved or AASLD-IDSA recommended regimen
Refer to Section V: Dosage and Administration for regimen specifics
Member is responding positively to therapy as evidenced by clinical notes or laboratory data (e.g., declining or undetectable HCV RNA)
Continuity-of-care / alternative paths

Other diagnoses/indications and off-label use

Covered when ALL of the following are met:

ALL of the following

Authorized generic requirement: Member must use sofosbuvir-velpatasvir (Epclusa authorized generic), unless contraindicated or clinically significant adverse effects are experienced
Recent label changes / formulary/off-label pathway: If the drug has recently (within the last 6 months) undergone a label change not reflected in this policy (e.g., newly approved indication, age expansion, new dosing regimen), follow the relevant formulary/no-coverage or non-formulary/off-label policies: HIM.PA.33 or HIM.PA.103 as appropriate; OR if the requested use is not listed under Diagnoses/Indications for which coverage is NOT authorized AND recent label change criterion does not apply, refer to the off-label use policy HIM.PA.154

Not authorized indications (must meet none)

Coverage is NOT authorized for:

Authorization length

Approval duration

Authorization length:

Approval duration: Initial and continued therapy: up to a total of 24 weeksup to 24 weeks total

Approved duration should be consistent with a regimen in Section V Dosage and Administration

Applicable Codes / Product Forms

NDC / Product forms referencedNDC|mixed

Tablet 400 mg/100 mg	Sofosbuvir 400 mg / Velpatasvir 100 mg tablet (one tablet PO QD)
Tablet 200 mg/50 mg	Sofosbuvir 200 mg / Velpatasvir 50 mg tablet
Pellet 200 mg/50 mg	Oral pellets: sofosbuvir 200 mg with velpatasvir 50 mg
Pellet 150 mg/37.5 mg	Oral pellets: sofosbuvir 150 mg with velpatasvir 37.5 mg
Tablet 150 mg/37.5 mg	Pediatric formulation sofosbuvir 150 mg / velpatasvir 37.5 mg

Provider Actions & Requirements

Documentation Required

Continuation evidence

For reauthorization requests, include documentation that the member has completed at least 28 days of therapy and is responding positively to treatment; ensure the prescribed regimen remains consistent with an FDA or AASLD‑IDSA recommended regimen and dosing does not exceed weight/age limits. Continuity of care exceptions apply for members currently receiving medication via Centene or enrolled in state/product continuity programs.

Evidence of ≥ 28 days of Epclusa treatment
Documentation of positive response to therapy (e.g., clinical assessment, HCV RNA)
Prescribed regimen consistent with FDA or AASLD‑IDSA recommendations
Dose within specified weight/age limits
If continuity of care applies, document current Centene benefit receipt or state‑specific continuity status

Clinical Evidence & Definitions

Primary evidence references cited in this policy are the Epclusa Prescribing Information (April 2022) and the AASLD‑IDSA HCV guidance (last updated December 19, 2023). These sources are listed in the policy references and were used to inform dosing, indications, and special recommendations.

Policy alignment: The clinical policy explicitly references and aligns with FDA labeling (Epclusa PI) and AASLD‑IDSA guidance for recommended regimens, dosing by genotype and cirrhosis status, and management of special scenarios (e.g., genotype 3 with Y93H).

Safety notices cited from the policy: the policy includes the boxed warning for HBV reactivation during DAA therapy and restates that combination regimens including ribavirin are contraindicated in patients for whom RBV is contraindicated, consistent with the prescribing information and guidance.

Definitions:

• RAS: Resistance-associated substitution — substitution in the HCV genome associated with reduced susceptibility to an antiviral.

• SVR12: Sustained virologic response at 12 weeks — undetectable HCV RNA 12 weeks after completion of therapy; DAA: Direct-acting antiviral — class of agents targeting HCV nonstructural proteins.

Background

Background: Epclusa (sofosbuvir/velpatasvir) is a pangenotypic DAA indicated for treatment of HCV genotypes 1–6 in adults and pediatric patients aged ≥ 3 years (FDA‑approved indication).

Formulations and dosing: Pediatric formulations and oral pellets are available (oral pellets and tablet strengths listed in product availability); exact weight‑based dosing and weight bands are provided in the Section V dosing table and the policy dosing text (examples: adult/pediatric ≥ 30 kg = sofosbuvir/velpatasvir 400 mg/100 mg PO QD; pediatric weight bands for 17–<30 kg and <17 kg are specified in the dosing table).

Policy alignment: The clinical policy and its criteria (including simplified regimen eligibility, genotype/RAS testing recommendations for genotype 3 scenarios, use of an authorized generic, and required documentation) are aligned with FDA labeling and AASLD‑IDSA guidance and reference the AASLD‑IDSA recommendations for simplified regimens and management of interruptions.

Revision History

2025-08-25policy revisionLatest

2024-08-24policy revision

3Q 2024 annual review: revised policy to include generic sofosbuvir/velpatasvir, removed 'chronic' qualifier from HCV criteria, added prescriber exception for HIM Georgia, and added Appendix G guidance on treatment interruptions.

2023-09-21policy revision

Policy Summary

PayerCentene

PolicySofosbuvir/Velpatasvir (Epclusa)

Policy CodePolicy HIMPA.SP

Change TypeRevisions to continued and initial criteria (3Q 2023-2025)

Effective DateAug 16, 2008

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that member has met all approval criteria.

On This Page

Genotype / treatment-naive bypass

Treatment-naive no cirrhosis bypass: Member is treatment-naive and does not have cirrhosis (eligible for simplified AASLD-IDSA regimen) — bypasses genotype documentation
Genotype documented: Confirmed HCV genotype is 1, 2, 3, 4, 5, or 6

Genotype 3 special scenario

Genotype 3 scenario A: If genotype 3: Member is treatment-naive and has cirrhosis
Genotype 3 scenario B: If genotype 3: Member has had previous HCV treatment and has no cirrhosis
RAS testing: If genotype 3 in specified scenarios: laboratory testing for presence or absence of NSSA RAS Y93H for velpatasvir is required

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

Documentation requirements: Documentation of the treatment status of the member (treatment-naive or treatment-experienced) and documentation of cirrhosis status (no cirrhosis, compensated cirrhosis, or decompensated cirrhosis)

Life expectancy ≥ 12 months with HCV treatment>= 12 months

Regimen consistency: Prescribed regimen is consistent with an FDA or AASLD-IDSA recommended regimen (see Section V Dosage and Administration)

Dosing limits: Dose does not exceed specified dosing per weight/age — adult and pediatric members ≥ 30 kg: sofosbuvir/velpatasvir 400 mg/100 mg daily; pediatric 3 years and older with body weight ≥ 17 kg to < 30 kg: sofosbuvir/velpatasvir 200 mg/50 mg daily; pediatric 3 years and older with body weight ≥ 17 kg: sofosbuvir/velpatasvir 150 mg/37.5 mg dailySee Section V dosing table

See Section V Dosage and Administration for exact weight bands

Member is currently receiving medication via the Centene benefit or previously met initial approval criteria
Member is enrolled in a state/product with continuity of care regulations and meets that state's continuity criteria

Dosing limits

Adult and pediatric members with body weight \u2265 30 kg: sofosbuvir/velpatasvir 400 mg/100 mg (1 tablet) per day
Pediatric members 3 years of age and older with body weight \u2265 17 kg to < 30 kg: sofosbuvir/velpatasvir 200 mg/50 mg per day
Pediatric members 3 years of age and older with body weight \u2265 17 kg: sofosbuvir/velpatasvir 150 mg/37.5 mg per day
Dose must not exceed the age/weight-based maximums listed

Documentation Required

Continuation evidence

Providers must submit documentation for reauthorization. Evidence should include that the member has completed 628 days of Epclusa therapy and is responding positively to treatment. Continuity-of-care exceptions (members currently receiving therapy or covered under state continuity rules) are acceptable when documented. Additional required items are listed below.

Prescriber specialty requirement: Medication must be prescribed by or in consultation with a gastroenterologist, hepatologist, infectious disease specialist, or a provider with certified HCV treatment training (unless state-specific exceptions apply; e.g., HIM Georgia exception).
Genotype and RAS testing: Provide documentation of HCV genotype; for genotype 3 patients meeting specified scenarios, provide RAS testing for velpatasvir-associated Y93H when indicated.
Use authorized generic when required: Member must use sofosbuvir-velpatasvir (Epclusa authorized generic) unless contraindicated or there are clinically significant adverse effects; document justification if generic cannot be used.

Not authorized indications: Non‑FDA approved indications which are not addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety according to the off‑label use policy HIM.PA.154 or evidence of coverage documentsmust meet none (no non‑FDA indications)

Per April SDC, Epclusa authorized generic redirection to all requests applied; 3Q 2023 annual review added bypass for genotype documentation for treatment‑naive noncirrhotic patients eligible for simplified AASLD‑IDSA regimen and eliminated adherence program participation criterion.

2022-08-30policy revision

08.30.22: Added criterion for NSSA RAS (Y93H) testing for specific genotype 3 scenarios per AASLD recommendation and applied template changes to other sections.