CurrentPeach State Health PlanPolicy CP.PHAR.281

Clinical Policy: Sofosbuvir (Sovaldi)

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Defines medical necessity, prior authorization, and coverage criteria for sofosbuvir (Sovaldi) for treatment of hepatitis C virus (HCV) for Peach State Health Plan Medicaid members.

Policy Summary

PayerPeach State Health Plan

PolicyClinical Policy: Sofosbuvir (Sovaldi)

Policy CodePolicy CP.PHAR.281

Change TypeNo material changes

Effective DateSep 16, 2016

Next Review DateAug 25, 2025

Key ActionProvider must submit documentation (chart notes, labs) showing detectable HCV RNA within 6 months, genotype, treatment and cirrhosis status for prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

24 weeksmaximum approval duration

≥3 yrsminimum pediatric age

400 mg/daymax daily dose

Genotypes 1-6covered adult genotypes

Black Box

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CurrentPeach State Health PlanPolicy CP.PHAR.281

Clinical Policy: Sofosbuvir (Sovaldi)

Customize your policy alerts

Sign up for Peach State Health Plan Policy CP.PHAR.281 alerts

Get alerted when Policy CP.PHAR.281 changes without checking for updates manually.

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Defines medical necessity, prior authorization, and coverage criteria for sofosbuvir (Sovaldi) for treatment of hepatitis C virus (HCV) for Peach State Health Plan Medicaid members.

Policy Summary

PayerPeach State Health Plan

PolicyClinical Policy: Sofosbuvir (Sovaldi)

Policy CodePolicy CP.PHAR.281

Change TypeNo material changes

Effective DateSep 16, 2016

Next Review DateAug 25, 2025

Key ActionProvider must submit documentation (chart notes, labs) showing detectable HCV RNA within 6 months, genotype, treatment and cirrhosis status for prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

24 weeksmaximum approval duration

≥3 yrsminimum pediatric age

400 mg/daymax daily dose

Genotypes 1-6covered adult genotypes

Black Box

HBV reactivation risk

Coverage Criteria for Sofosbuvir (Sovaldi)

inv-01: Initial Therapy — Hepatitis C Infection

Covered when ALL of the following are met:

Initial therapy criteria: 1. Diagnosis of HCV infection as evidenced by detectable serum HCV RNA by quantitative assay within the last 6 months; 2. Confirmed HCV genotype: adults (≥18 years) — genotypes 1, 2, 3, 4, 5, or 6; pediatrics (≥3 years) — genotypes 2 or 3; 3. Documentation of treatment status (treatment‑naïve or treatment‑experienced); 4. Documentation of cirrhosis status (no cirrhosis, compensated cirrhosis, or decompensated cirrhosis); 5. Must meet one of the following: a) 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 occur or both are contraindicated (note: coadministration with omeprazole up to 20 mg is NOT acceptable justification to avoid Epclusa); b) If treatment‑experienced with Mavyret or Vosevi: member must use Sovaldi in combination with Mavyret and weight‑based ribavirin unless an individual agent is contraindicated or clinically significant adverse effects occur; 6. For pediatric patients (≥3 years) with genotype 2 or 3: Sovaldi must be used in combination with ribavirin per pediatric weight‑based dosing; 7. Life expectancy ≥ 12 months with HCV treatment; 8. Prescribed regimen is consistent with an FDA or AASLD‑IDSA recommended regimen (see Dosage and Administration); 9. Dose does not exceed 400 mg per day.

Approved duration: up to a total of 24 weeks consistent with dosing section.

inv-02: Continuation Therapy — Hepatitis C Infection

Covered when ALL of the following are met:

Continued therapy criteria: 1. Member meets one of the following: a) currently receiving medication via Centene benefit or previously met initial approval criteria; b) currently receiving medication and enrolled in a state/product with continuity of care regulations; c) documentation supports member has completed ≥28 days of Sovaldi treatment; 2. Member is responding positively to therapy; 3. Prescribed regimen is consistent with an FDA or AASLD‑IDSA recommended regimen; 4. Dose does not exceed 400 mg per day.

Approval duration: up to a total of 24 weeks consistent with dosing section.

inv-03: Other Indications

Covered when ALL of the following are met:

Other diagnoses/indications: 1. Member must use sofosbuvir/velpatasvir (Epclusa authorized generic) or Mavyret for the requested indication if applicable unless clinically significant adverse effects occur or both are contraindicated (coadministration with omeprazole up to 20 mg is NOT acceptable justification to avoid Epclusa); 2. If the drug underwent a label change within the last 6 months not yet reflected in this policy, follow applicable formulary/no‑coverage/non‑formulary policies (CP.PMN.255 or CP.PMN.16 as applicable); 3. If the requested use is not listed under coverage exclusions and criterion 2 does not apply, refer to the off‑label use policy CP.PMN.53 for consideration.

Approval duration: up to a total of 24 weeks.

inv-04: Treatment interruption management

AASLD-IDSA recommended management of missed DAA doses (applies to treatment‑naive patients without decompensated cirrhosis receiving Mavyret or Epclusa; other populations require expert consultation).

Interruptions during the first 28 days: If missed ≤7 days: restart DAA therapy immediately and complete originally planned duration (e.g., 8 or 12 weeks). If missed ≥8 days: restart DAA therapy immediately and obtain HCV RNA as soon as possible; if HCV RNA is negative, complete originally planned course (consider extending an additional 4 weeks for genotype 3 and/or cirrhosis); if HCV RNA is positive or not obtained, extend DAA treatment by an additional 4 weeks.<=7 days vs >=8 days

Applies to interruptions during the first 28 days.

Interruptions after ≥28 days of therapy: If missed ≤7 days: restart DAA therapy immediately and complete originally planned duration. If missed 8–20 consecutive days: restart DAA therapy immediately and obtain HCV RNA; if HCV RNA is negative, complete originally planned course (consider +4 weeks for genotype 3 and/or cirrhosis); if HCV RNA is positive or not obtained, stop treatment and retreat per AASLD‑IDSA retreatment recommendations. If missed ≥21 consecutive days: stop DAA treatment and assess for SVR12; if SVR12 not achieved, retreat per AASLD‑IDSA retreatment recommendations.<=7 days, 8-20 days, >=21 days

inv-05: Dosing and indications

Sovaldi dosing by genotype, prior treatment, cirrhosis status, and age/weight.

Adult genotype 1 or 4 (with pegIFN): Sovaldi 400 mg + pegylated interferon (pegIFN) + weight‑based ribavirin for 12 weeks for treatment‑naïve patients without cirrhosis or with compensated cirrhosis (FDA‑approved).Sovaldi 400 mg

Reference: FDA‑approved dosing in Dosage and Administration.

Genotype 2: Sovaldi 400 mg + weight‑based ribavirin for 12 weeks for treatment‑naïve and treatment‑experienced patients without cirrhosis or with compensated cirrhosis (FDA‑approved).Sovaldi 400 mg

Reference: FDA‑approved dosing in Dosage and Administration.

Genotype 3: Sovaldi 400 mg + weight‑based ribavirin for 24 weeks for treatment‑naïve and treatment‑experienced patients without cirrhosis or with compensated cirrhosis (FDA‑approved).

Non‑FDA approved indications that are not specifically addressed by this policy are not authorized for coverage unless the provider supplies sufficient documentation of efficacy and safety consistent with the plan's off‑label use policy CP.PMN.53 (Medicaid) or other applicable evidence‑of‑coverage documentation.

Use of Mavyret (glecaprevir/pibrentasvir) is not recommended in members with moderate or severe hepatic impairment (Child‑Pugh B or C) or in those with any history of prior hepatic decompensation because postmarketing cases of hepatic decompensation or failure have been reported. This circumstance is listed in Appendix E as an acceptable medical justification for inability to use Mavyret when considering alternative regimens.

Requests to use Sovaldi for indications that are non‑FDA approved and not supported by the plan's off‑label use policy (CP.PMN.53) or supporting evidence may be considered not medically necessary and may be denied.

Appendix E explicitly lists coadministration with omeprazole up to 20 mg as an unacceptable medical justification for not using Epclusa (sofosbuvir/velpatasvir). Per the Epclusa prescribing information, if coadministration is deemed necessary, Epclusa should be given with food and taken 4 hours before omeprazole 20 mg; omeprazole use alone does not justify bypassing Epclusa.

Initial Therapy Criteria and Authorization

inv-24: Initial therapy — Initial therapy criteria for Sovaldi in HCV infection.

Initial therapy criteria for Sovaldi in HCV infection.

Initial therapy nodes (Sovaldi): Refer to policy Initial Approval Criteria A (Hepatitis C Infection): detectable HCV RNA within last 6 months; genotype confirmation (adults 1–6; pediatrics ≥3 years: 2 or 3); documentation of treatment and cirrhosis status; preferred product requirement (use Epclusa authorized generic or Mavyret unless unacceptable/contraindicated) or, if prior Mavyret/Vosevi failure, use Sovaldi in combination with Mavyret and ribavirin; pediatric combination with ribavirin for ages ≥3 years where applicable; life expectancy ≥12 months; regimen consistent with FDA or AASLD‑IDSA; dose ≤400 mg/day.

Approved duration up to total of 24 weeks consistent with dosing section.

inv-25: Initial therapy authorization — Initial approval considerations reference preferred agents and acceptable/unacceptable justifications for bypass.

Initial approval considerations and redirection to preferred agents; acceptable and unacceptable justifications for bypass are defined in Appendix E.

Initial approval scenarios and authorization considerations:

Criteria for Continued Therapy

inv-26: Continued therapy — Criteria for continued therapy for Sovaldi for HCV infection.

Criteria for continued therapy for Sovaldi for HCV infection.

Continuation nodes (Sovaldi): 1. Member meets one of: currently receiving medication via Centene benefit or previously met initial criteria; enrolled in a state/product with continuity of care regulations; or has completed ≥28 days of Sovaldi treatment; 2. Member is responding positively to therapy; 3. Prescribed regimen is consistent with an FDA or AASLD‑IDSA recommended regimen; 4. Dose does not exceed 400 mg per day.

Approval duration up to a total of 24 weeks consistent with dosing section.

inv-27: Continued therapy — Planned continued therapy criteria (not fully present in this excerpt).

Planned continued therapy criteria (2025 update referenced) — regimen consistency with FDA or AASLD‑IDSA recommended regimens is required.

Planned continued therapy (2025 update): For continued therapy, prescribed regimen must be consistent with an FDA or AASLD‑IDSA recommended regimen; treatment duration options and other details are revised in the planned 3Q 2025 update (refer to full policy at that time).

Step Therapy / Product Redirection

Step	Requirement
1	Member must use sofosbuvir/velpatasvir (Epclusa authorized generic) or Mavyret as the preferred product for applicable HCV indications unless the member has clinically significant adverse effects to both agents or both are contraindicated. Coadministration with omeprazole up to 20 mg is not an acceptable justification to bypass Epclusa.

Step	Redirection / Documentation requirement
1	Prescribers should redirect to Epclusa or Mavyret when appropriate per Appendix B and Appendix E. If Sovaldi is requested instead of preferred agents, the provider must document an acceptable medical justification per Appendix E (for example, moderate or severe hepatic impairment or prior hepatic decompensation making Mavyret not recommended). Unacceptable reasons (e.g., omeprazole ≤20 mg coadministration) must not be used to justify Sovaldi use.

Step

Redirection / Documentation requirement

Prescribers should redirect to Epclusa or Mavyret when appropriate per Appendix B and Appendix E. If Sovaldi is requested instead of preferred agents, the provider must document an acceptable medical justification per Appendix E (for example, moderate or severe hepatic impairment or prior hepatic decompensation making Mavyret not recommended). Unacceptable reasons (e.g., omeprazole ≤20 mg coadministration) must not be used to justify Sovaldi use.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Obtain prior authorization with required HCV clinical data

Prior authorization is required. Submit office chart notes, lab results, or other clinical information demonstrating detectable serum HCV RNA by quantitative assay within the last 6 months, confirmed HCV genotype, treatment status (treatment‑naïve or treatment‑experienced), cirrhosis status (no, compensated, or decompensated), that the prescribed regimen is consistent with FDA or AASLD‑IDSA recommended regimens, and that the total sofosbuvir dose will not exceed 400 mg/day.

Chart note documentation and copies of lab results are required.
Regimen must be consistent with an FDA or AASLD‑IDSA recommended regimen (see Dosage and Administration).
Dose must not exceed 400 mg per day.

Prior Authorization

Document regimen/dose consistency with FDA or AASLD‑IDSA

Prior authorization requests must document that the prescribed regimen and dosing align with FDA labeling or AASLD‑IDSA recommendations; when requesting Sovaldi instead of preferred agents, include justification per Appendix E (acceptable/unacceptable justifications) and cite the supporting appendix evidence.

Coding Elements and Definitions

Child-Pugh Score components

Bilirubin1 = <2 mg/dL (<34 µmol/L); 2 = 2–3 mg/dL (34–50 µmol/L); 3 = >3 mg/dL (>50 µmol/L)

Albumin1 = >3.5 g/dL (>35 g/L); 2 = 2.8–3.5 g/dL (28–35 g/L); 3 = <2.8 g/dL (<28 g/L)

INR1 = <1.7; 2 = 1.7–2.2; 3 = >2.2

Ascites1 = None; 2 = Mild / medically controlled; 3 = Moderate–severe / poorly controlled

Encephalopathy1 = None; 2 = Mild / medically controlled; 3 = Moderate–severe / poorly controlled

Treatment interruption thresholds

<= 7 days

Background on Sofosbuvir (Sovaldi)

Sofosbuvir (Sovaldi) is a nucleotide analog NS5B polymerase inhibitor indicated for use in combination regimens to treat chronic hepatitis C virus (HCV) infection. Treatment selection is genotype‑ and cirrhosis‑dependent and should follow FDA labeling or AASLD‑IDSA recommended regimens. The policy notes the boxed warning for HBV reactivation with direct‑acting antivirals and directs monitoring for HBV reactivation during and after HCV treatment.

Appendices, Operational Notes, and Appendices References

Operationally, Appendix E is the cross‑reference for acceptable and unacceptable justifications when redirecting to preferred agents. It documents that omeprazole up to 20 mg is not an acceptable reason to avoid Epclusa and that moderate/severe hepatic impairment or prior hepatic decompensation are acceptable reasons to avoid Mavyret. Refer to Appendix E when documenting the clinical rationale for bypassing preferred products.

Policy Summary

PayerPeach State Health Plan

PolicyClinical Policy: Sofosbuvir (Sovaldi)

Policy CodePolicy CP.PHAR.281

Change TypeNo material changes

Effective DateSep 16, 2016

Next Review DateAug 25, 2025

Key ActionProvider must submit documentation (chart notes, labs) showing detectable HCV RNA within 6 months, genotype, treatment and cirrhosis status for prior authorization.

SourceLink

On This Page

Applies after ≥28 days of therapy.

Reference: FDA‑approved dosing in Dosage and Administration.

Prior SOF/VEL/VOX or GLE/PIB failure: AASLD‑IDSA guideline‑supported (off‑label) regimen: Sovaldi 400 mg + Mavyret (glecaprevir/pibrentasvir) 300/120 mg + weight‑based ribavirin for 16–24 weeks (policy notes 16 weeks in one place and 24 weeks elsewhere; follow AASLD‑IDSA guidance for final regimen/duration).Sovaldi 400 mg

AASLD‑IDSA supported off‑label regimen.

Pediatric dosing (≥3 years) — Genotype 2: For genotype 2 without cirrhosis or with compensated cirrhosis: ≥35 kg — Sovaldi 400 mg + weight‑based ribavirin for 12 weeks; 17 to <35 kg — Sovaldi 200 mg + weight‑based ribavirin for 12 weeks; <17 kg — Sovaldi 150 mg + weight‑based ribavirin for 12 weeks (FDA‑approved).weight bands

Reference: Pediatric dosing in Dosage and Administration.

Pediatric dosing (≥3 years) — Genotype 3: For genotype 3 without cirrhosis or with compensated cirrhosis: ≥35 kg — Sovaldi 400 mg + weight‑based ribavirin for 24 weeks; 17 to <35 kg — Sovaldi 200 mg + weight‑based ribavirin for 24 weeks; <17 kg — Sovaldi 150 mg + weight‑based ribavirin for 24 weeks (FDA‑approved).weight bands

Reference: Pediatric dosing in Dosage and Administration.

1. Member must use Epclusa (sofosbuvir/velpatasvir authorized generic) or Mavyret first for applicable indications unless clinically significant adverse effects occur or both agents are contraindicated; 2. Acceptable medical justification for inability to use Mavyret includes moderate or severe hepatic impairment (Child‑Pugh B or C) or prior hepatic decompensation, and certain drug‑drug interactions (see Appendix E); 3. Unacceptable justification to avoid Epclusa includes coadministration with omeprazole up to 20 mg; 4. Previous Mavyret experience or prior failure with preferred agents is included among initial approval scenarios allowing Sovaldi use per AASLD recommendations; 5. Prior authorization requires documentation that the prescribed regimen and dosing align with FDA labeling or AASLD‑IDSA recommended regimens and justification per Appendix E when bypassing preferred agents.

See Appendix E for full list of acceptable/unacceptable justifications and Appendix B for therapeutic alternatives.

consistent with FDA or AASLD‑IDSA regimen

Details to be confirmed in 3Q 2025 policy update.

If bypassing preferred agents, submit acceptable medical justification per Appendix E.
Prescribed regimen should match FDA or AASLD‑IDSA recommended dosing in Dosage and Administration.

Step Therapy

Redirect to preferred products (Epclusa or Mavyret)

Use sofosbuvir/velpatasvir (Epclusa authorized generic) or Mavyret as the preferred products for applicable indications; Sovaldi is only authorized when preferred agents are contraindicated, cause clinically significant adverse effects, or other Appendix E–approved justification is provided.

Coadministration with omeprazole up to 20 mg is not an acceptable reason to avoid Epclusa.
Appendix B lists Epclusa and Mavyret as therapeutic alternatives/preferred options.

Step Therapy

Step therapy: document justification to bypass preferred agents

Redirect members to preferred agents (Epclusa or Mavyret) for applicable indications; if requesting Sovaldi, provide an acceptable justification per Appendix E or documented prior Mavyret/Vosevi treatment failure as applicable.

Appendix E lists acceptable justifications for inability to use Mavyret (e.g., Child‑Pugh B/C or prior hepatic decompensation).
Policy added previous Mavyret experience to initial approval scenarios per AASLD recommendations.

Documentation Required

Provide chart notes and lab results proving HCV RNA and clinical status

Submit required clinical documentation with the prior authorization: office chart notes and lab results supporting detectable serum HCV RNA within the last 6 months, genotype confirmation, treatment‑naïve or treatment‑experienced status, and cirrhosis status.

Include copies of quantitative HCV RNA results dated within the last 6 months.
Provide documentation of treatment history and cirrhosis classification (no, compensated, decompensated).

Documentation Required

Document genotype, prior treatment, cirrhosis and pediatric weight bands

Document genotype, prior treatment history, cirrhosis status, and member weight for dosing; for pediatric patients, provide weight band information to determine the appropriate pediatric Sovaldi dose and ribavirin use.

Pediatric weight bands required: ≥35 kg, 17 to <35 kg, and <17 kg with corresponding Sovaldi doses and RBV durations.
Specify whether member is treatment‑naïve or treatment‑experienced.

Denial Risk

Non‑covered/off‑label indications require off‑label documentation

Requests for non‑FDA approved indications not addressed in this policy may be denied unless sufficient evidence of efficacy and safety is provided per the off‑label use policy (CP.PMN.53); include off‑label documentation if the requested indication is outside this policy.

Refer to off‑label use policy CP.PMN.53 for Medicaid when requested use is not listed in this policy.
If the drug label changed within the last 6 months and the policy does not reflect it, follow the referenced formulary/non‑formulary policies instead.

Denial Risk

Risk of denial: missing HBV monitoring or insufficient justification to bypass preferred agents

Failure to monitor for HBV reactivation in patients coinfected with HBV during and after HCV treatment is a serious risk; ensure HBV monitoring and document rationale for any deviation. Also, lack of appropriate justification for bypassing preferred agents (e.g., omeprazole use is not acceptable to avoid Epclusa) may result in denial.

HBV reactivation is a Black Box Warning for all DAA agents; monitor for reactivation and treat HBV as clinically indicated.
Coadministration with omeprazole up to 20 mg is explicitly not an acceptable justification to avoid Epclusa.

Restart DAA therapy immediately and complete originally planned duration (8 or 12 weeks).

8–20 daysRestart DAA immediately and obtain HCV RNA; if RNA negative, complete original course (consider +4 weeks for genotype 3 and/or cirrhosis); if RNA positive or not obtained, stop and retreat per AASLD‑IDSA.

>= 21 daysStop DAA treatment and assess for SVR12; if SVR12 not achieved, retreat per AASLD‑IDSA recommendations.

HBV reactivation

Boxed warningRisk of hepatitis B virus (HBV) reactivation in patients coinfected with HCV and HBV; patients should be monitored during and after HCV treatment.

MonitoringMonitor for HBV reactivation in patients with current or prior HBV infection during and after DAA therapy.

Contraindication noteHBV coinfection is called out in the boxed warning and informs contraindication considerations when using combination regimens including peginterferon/RBV.

SVR12

DefinitionSustained virologic response at 12 weeks (SVR12).

Clinical relevanceUsed as the primary virologic endpoint to indicate virologic cure after completing HCV therapy.

Assessment timingEvaluated 12 weeks after completion of DAA treatment to determine treatment success.

Child-Pugh score

PurposeScoring system for hepatic function using five components (bilirubin, albumin, INR, ascites, encephalopathy) with 1–3 points per component to classify hepatic impairment.

ComponentsBilirubin, Albumin, INR, Ascites, Encephalopathy — each scored 1, 2, or 3 based on defined ranges/clinical status.

UseUsed to categorize hepatic impairment (Child‑Pugh A, B, C) to guide therapy selection and contraindications for DAAs and alternatives.