ModifiedCentenePolicy CP PHAR.677

Vadadustat (Vafseo)

Defines Centene coverage and prior authorization criteria for Vafseo (vadadustat) to treat anemia due to chronic kidney disease in adults receiving dialysis, across Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerCentene

PolicyVadadustat (Vafseo) clinical coverage criteria

Policy CodePolicy CP PHAR.677

Change TypeMaterial updates to continuation duration, step therapy and coding

Effective DateJun 1, 2024

Next Review DateMay 25, 2025

Key ActionSubmit prior authorization with documentation showing dialysis duration, specialist involvement, iron labs, hemoglobin levels and prior ESA trial results.

SourceLink

POLICY UPDATE CHANGES

Added requirement that Vafseo is not prescribed concurrently with Jesduvroq.

HCPCS code JO901 was added and C93991 was removed.

Adults on dialysis ≥3 moRequired patient population

Medicaid/HIM 12 moAuthorization length

Max 600 mg/dayDosing ceiling

JO901HCPCS code added

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Coverage Criteria for Vafseo (vadadustat)

inv-01: Initial Therapy

Covered when ALL of the following are met:

Initial Approval for Vafseo: 1) Diagnosis of anemia due to chronic kidney disease; 2) Age ≥ 18 years; 3) Member has received dialysis for ≥ 3 months; 4) Prescribed by or in consultation with a hematologist or nephrologist; 5) Adequate iron stores: current (within the last 3 months) serum ferritin ≥ 100 mcg/L or serum transferrin saturation (TSAT) ≥ 20%; 6) Pretreatment hemoglobin level meets the policy-specified threshold (pretreatment hemoglobin as documented in the medical record); 7) Step therapy: failure of Retacrit (epoetin alfa-epbx) unless contraindicated, clinically significant adverse effects, or unavailable, AND failure of Epogen (epoetin alfa) unless contraindicated or clinically significant adverse effects are experienced (state-level exceptions apply, e.g., Illinois HIM after 1/1/2026).

inv-02: Continuation Therapy

Covered when ALL of the following are met:

Continuation Therapy for Vafseo: 1) Member is currently receiving Vafseo via the Centene benefit or previously met initial approval criteria (continuity-of-care exceptions per state addendums may apply); 2) Member is responding positively to therapy as documented in the medical record; 3) Current hemoglobin < 11 g/dL; 4) Adequate iron stores: current (within the last 3 months) serum ferritin ≥ 100 mcg/L or serum transferrin saturation (TSAT) ≥ 20%; 5) Vafseo is not prescribed concurrently with Jesduvroq.

Vafseo (vadadustat) is not indicated for the treatment of anemia due to chronic kidney disease in patients who are not on dialysis. It is not an appropriate substitute for red blood cell transfusion when immediate correction of anemia is required. Use of Vafseo for other non-FDA–approved indications is not covered under this policy unless the use is supported by sufficient documentation of efficacy and safety and meets the applicable off‑label use policy criteria.

Concurrent prescribing of Vafseo with Jesduvroq is expressly prohibited. Requests that document concurrent use of these agents will be subject to denial in accordance with the policy’s concurrent therapy restriction.

Use of Vafseo for indications not approved by the FDA (including anemia due to CKD in patients not on dialysis and other non‑FDA indications) requires documentation that meets the health plan’s off‑label use policies (for example, CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, or CP.PMN.53 for Medicaid) before authorization will be granted.

Coding, Lab Thresholds, and Drug Alternatives

Therapeutic alternatives / referenced ESAsmixed

Retacrit	epoetin alfa-epbx (therapeutic alternative)
Epogen	epoetin alfa (therapeutic alternative)

HCPCS referenced/updatedHCPCS

JO901	Vadadustat, oral, 1 mg (HCPCS)
C93991	Previously referenced code removed from policy

inv-08: Serum ferritin requirement

Requirement>= 100 mcg/L (current within last 3 months)

ContextAdequate iron stores required for initial and continuation approval

DocumentationSerum ferritin result must be current within the last 3 months and submitted with request

inv-09: Transferrin saturation (TSAT) requirement

Requirement>= 20% TSAT (current within last 3 months)

ContextTransferrin saturation may be used alternatively to serum ferritin to demonstrate adequate iron stores

Prior Authorization, Step Therapy, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Vafseo. Approval is contingent on meeting the applicable initial or continuation criteria and involvement of a hematologist or nephrologist where specified. Providers must submit supporting documentation (office notes, lab results, dialysis history, specialist consultation) demonstrating that all approval criteria are met.

Prior authorization required — approval contingent on meeting initial or continuation criteria and specialist involvement where specified
Document required: office notes, labs (including iron studies within 3 months), dialysis duration, diagnosis, and specialist involvement

Step Therapy

Step Therapy Requirements

Step therapy is required for most members with anemia of chronic kidney disease. Members must demonstrate failure of Retacrit (epoetin alfa-epbx) unless there is a documented contraindication, clinically significant adverse effects, or Retacrit is unavailable due to shortage. If the member is unable to use Retacrit, failure of Epogen is required unless contraindicated or clinically significant adverse effects are documented. For Illinois HIM requests, step therapy requirements do not apply as of 1/1/2026 per IL HB 5395. Redirection steps (trial of Retacrit, then Epogen if unable to use Retacrit) must be documented when applicable.

Clinical Background

Vadadustat (Vafseo) is an oral hypoxia‑inducible factor prolyl hydroxylase (HIF‑PH) inhibitor indicated for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least 3 months. The drug is available in oral tablet strengths and carries boxed warnings for increased risk of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access.

Definitions and Drug Details

inv-24: Vafseo (vadadustat)

DefinitionVafseo (vadadustat) is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor indicated for anemia due to CKD in adults who have been receiving dialysis for at least three months

IndicationTreatment of anemia due to chronic kidney disease in adults on dialysis >= 3 months

SafetyBoxed warnings include increased risk of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access

inv-25: ESA definition

DefinitionESA = erythropoiesis-stimulating agent

ExamplesRetacrit (epoetin alfa-epbx) and Epogen (epoetin alfa)

Policy Summary

PayerCentene

PolicyVadadustat (Vafseo) clinical coverage criteria

Policy CodePolicy CP PHAR.677

Change TypeMaterial updates to continuation duration, step therapy and coding

Effective DateJun 1, 2024

Next Review DateMay 25, 2025

Key ActionSubmit prior authorization with documentation showing dialysis duration, specialist involvement, iron labs, hemoglobin levels and prior ESA trial results.

SourceLink

On This Page

DocumentationTSAT result must be current within the last 3 months and provided with the authorization request

inv-10: Age requirement

Requirement>= 18 years

ContextPolicy applies to adult members only for initial approval

SourceAge criterion listed in initial approval criteria

inv-11: Dialysis duration requirement

RequirementReceiving dialysis for >= 3 months

ContextFDA indication and policy require dialysis duration of at least three months

DocumentationEvidence of dialysis duration should be included in supporting documentation

inv-12: Pretreatment hemoglobin

RequirementPretreatment hemoglobin level per policy-specified threshold

ContextPretreatment hemoglobin is required as part of initial approval criteria (policy text includes specific threshold)

DocumentationSubmit pretreatment hemoglobin lab value with authorization request

inv-13: Continuation therapy hemoglobin threshold

RequirementCurrent hemoglobin < 11 g/dL

ContextRequired for continuation/renewal approval to demonstrate ongoing response and need

DocumentationProvide most recent hemoglobin lab result when requesting continuation

inv-14: Continuation approval duration

Duration12 months for Medicaid/HIM (updated from 6 months)

CommercialApproval remains 6 months or to member's renewal period per policy

Change noteContinuation approval duration extended to 12 months for Medicaid/HIM as part of 2Q 2025 annual review

Initial therapy: failure of Retacrit required unless contraindicated, adverse effects, or shortage
If unable to use Retacrit: failure of Epogen required unless contraindicated or adverse effects
Illinois HIM: step therapy bypass effective 1/1/2026 per IL HB 5395

Documentation Required

Required Supporting Documentation / Insufficient Documentation

Requests lacking required documentation may be denied. Ensure documentation includes diagnosis of anemia of CKD, member age, duration of dialysis (if applicable, ≥3 months), pretreatment hemoglobin, current iron studies (serum ferritin ≥100 mcg/L or TSAT ≥20% within 3 months), and specialist involvement (prescribed by or in consultation with hematologist or nephrologist). Also document the specific redirection/step therapy trials (dates, doses, reason for discontinuation or contraindication) and, if applicable, any oncology exceptions per Appendix D.

Required supporting documentation: office notes, labs (hemoglobin, ferritin, TSAT), dialysis records, specialist consult notes
Insufficient documentation (missing diagnosis, dialysis duration, iron labs, or step therapy trial documentation) may result in denial

Billing Rule

Coding and Redirection Documentation

Coding and program-specific step therapy updates are in effect. Reference the most up-to-date HCPCS/claim coding guidance and the policy appendices for state-specific redirection or oncology exceptions. Document any redirection steps taken (e.g., Retacrit trial followed by Epogen if applicable) in the clinical record submitted with the prior authorization request.

Refer to up-to-date HCPCS coding guidance (e.g., J0901 vadadustat HCPCS entries) and policy appendices for state-specific modifications
Document redirection steps and any prior authorization requirements for Retacrit or Epogen

Denial Risk

Concurrent Therapy Restriction

Concurrent therapy restriction: Vafseo must not be prescribed concurrently with Jesduvroq. Concurrent prescribing may trigger denial of the request.

Vafseo concurrent with Jesduvroq is disallowed and may lead to denial

Preferred therapeutic alternatives and step therapy options referenced in policy

inv-26: Vafseo product details

FormulationOral tablets

Available strengths150 mg, 300 mg, and 450 mg tablet strengths referenced in policy appendices

Dosing ceilingMaximum dose noted in policy materials is 600 mg/day