CurrentmhnPolicy CP.PHAR.677

Vadadustat (Vafseo) clinical coverage for anemia due to chronic kidney disease (CKD)

Defines medical necessity criteria, prior authorization expectations, dosing limits, and coding implications for Vafseo (vadadustat) for treatment of anemia in adults with dialysis-dependent CKD; applies to Commercial, HIM, and Medicaid lines of business affiliated with Centene.

Policy Summary

Payermhn

PolicyVadadustat (Vafseo) clinical coverage for anemia due to chronic kidney disease (CKD)

Policy CodePolicy CP.PHAR.677

Change TypeAnnual reviewcoding and step therapy updates

Effective DateJun 1, 2024

Next Review Date

Key ActionProvider must submit documentation (office notes, labs) showing current hemoglobin and iron indices and complete prior authorization; requests will be denied if Vafseo is prescribed concurrently with Jesduvroq.

SourceLink

POLICY UPDATE CHANGES

Requirement that Vafseo is not prescribed concurrently with Jesduvroq was added.

Continuation of therapy approval duration extended from 6 to 12 months for Medicaid/HIM.

Step therapy modified to require redirection to both Retacrit and Epogen (if member unable to use Retacrit); IL HIM step therapy bypass added per IL HB 5395.

HCPCS code J0901 (Vadadustat, oral, 1 mg) was added and C9399 removed from coding list.

Adults on dialysis ≥3 monthsPopulation eligible for FDA indication

8–11 g/dLRequired pretreatment Hb range for initial approval

Ferritin ≥100 mcg/L or TSAT ≥20%

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Medical Necessity Criteria for Vafseo (vadadustat)

I. Initial Approval Criteria 6 Anemia due to Chronic Kidney Disease

Vafseo is medically necessary when ALL of the following are met:

I.B. Initial Approval 6 Other diagnoses/indications

For non-CKD or other indications (initial), must meet ALL of the following:

ALL of the following

ANY of the following
- Step therapy route (a.i and a.ii)
  - Failure of Retacrit unless contraindicated, clinically significant adverse effects are experienced, or Retacrit is unavailable due to shortage
    Prior authorization may be required for Retacrit
  - If unable to use Retacrit, failure of Epogen unless contraindicated or clinically significant adverse effects are experienced
    Prior authorization may be required for Epogen
- Request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix D)
ANY of the following
- If drug label recently changed within last 6 months not reflected in policy, follow formulary/no-coverage or non-formulary policies referenced
- If requested use is not listed under section III and 2a does not apply, refer to off-label use policy referenced

II. Continued Therapy 6 Anemia due to CKD

Vafseo continuation is medically necessary when ALL of the following are met:

II.B Continued Therapy 6 Other diagnoses/indications

For non-CKD or other indications (continued therapy), must meet ALL of the following:

ALL of the following

ANY of the following
- Step therapy route (a.i and a.ii)
  - Failure of Retacrit unless contraindicated, clinically significant adverse effects are experienced, or Retacrit is unavailable due to shortage
    Prior authorization may be required for Retacrit
  - If unable to use Retacrit, failure of Epogen unless contraindicated or clinically significant adverse effects are experienced
    Prior authorization may be required for Epogen
- Request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix D)

III. Diagnoses/Indications Not Authorized

Coverage is NOT authorized for:

ALL of the following

Non-FDA approved indications not addressed in this policy unless there is sufficient documentation of efficacy and safety according to the off-label use policies referenced

Relevant Billing Codes

HCPCS codes (informational)HCPCS

J0901

Vadadustat, oral, 1 mg (for ESRD on dialysis)

What Providers Must Do / Watch For

Prior Authorization

Prior authorization and documentation required

Provider must submit documentation (such as office chart notes, lab results, or other clinical information) that supports the member meets all approval criteria. Prior authorization may be required for Retacrit and Epogen when used as redirection agents. Include HCPCS code J0901 for vadadustat when applicable.

Affected HCPCS code: J0901 (Vadadustat, oral, 1 mg)

Documentation Required

Iron indices and hemoglobin documentation

Provide current (within the last 3 months) serum ferritin level or transferrin saturation (TSAT) and current hemoglobin values to support both initial and continued therapy criteria.

Clinical and Safety Context

Vafseo (vadadustat) is a hypoxia‑inducible factor prolyl hydroxylase (HIF‑PH) inhibitor indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months (not indicated for patients with CKD‑related anemia who are not on dialysis).

Vafseo is not a substitute for urgent red blood cell transfusion in patients who require immediate correction of anemia. Providers must document appropriate clinical information (including specialist involvement and laboratory data) to support use.

The product carries boxed warnings for an increased risk of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access; contraindications include known hypersensitivity to vadadustat or uncontrolled hypertension. Prescribing should reflect these safety risks and consider alternative therapies when appropriate.

Defined Terms

CKDChronic kidney disease

ESAErythropoiesis-stimulating agent

HIMHealth Insurance Marketplace (line of business)

Policy Changes and Version Notes

2025-03-11step_therapy_revision

Per March SDC, step therapy modified to require redirection to both Retacrit and Epogen (if member unable to use Retacrit) and added a step therapy bypass for Illinois HIM per IL HB 5395.

2025-03-11concurrency_exclusion_added

Requirement added that Vafseo not be prescribed concurrently with Jesduvroq.

2025-03-11approval_duration_extension

Continuation of therapy approval duration for Medicaid/HIM extended from 6 months to 12 months.

Vadadustat (Vafseo) clinical coverage for anemia due to chronic kidney disease (CKD)

Medical Necessity Criteria for Vafseo (vadadustat)

Relevant Billing Codes

What Providers Must Do / Watch For

Clinical and Safety Context

Policies to Read With This One

Defined Terms

Policy Changes and Version Notes