CurrentColorado Rocky Mountain Health PlansPolicy N/A

Vafseo (vadadustat) prior authorization

Defines prior authorization and reauthorization criteria for Vafseo (vadadustat) for treatment of anemia due to chronic kidney disease in adults on dialysis, applicable to Colorado Rocky Mountain Health Plans members.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyVafseo (vadadustat) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateDec 1, 2025

Next Review DateSep 1, 2025

Key ActionObtain prior authorization: initial approval requires diagnosis of anemia due to CKD and documentation that the patient has been receiving dialysis for at least three months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥3 morequired dialysis duration

12 moauthorization length

9/2024,9/2025P&T dates

12/1/2025effective

Coverage Criteria for Vafseo (vadadustat)

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Initial Therapy

Covered when ALL of the following are met:

Initial Authorization

Diagnosis of anemia due to chronic kidney disease (CKD)
Dialysis duration: Patient has been receiving dialysis for at least three months>= 3 months

Initial Authorization

Initial authorization required prior to initiating therapy.

Initial Authorization: Diagnosis of anemia due to chronic kidney disease (CKD) AND patient has been receiving dialysis for at least three months

Authorization will be issued for 12 months

Provider Actions, Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required. Initial approval requires documentation of a diagnosis of anemia due to chronic kidney disease (CKD) and documentation that the patient has been receiving dialysis for at least three months. Authorization will be issued for 12 months.

Diagnosis: anemia due to CKD
Dialysis: receiving dialysis >= 3 months
Initial authorization duration: 12 months

Denial Risk

Initial Authorization — Denial Triggers

Initial authorization will be denied if documentation does not include a diagnosis of anemia due to CKD or if documentation shows the patient has not been receiving dialysis for at least three months.

Denial triggers: absence of documented diagnosis of anemia due to CKD
Denial triggers: documentation that the patient has not been receiving dialysis for at least three months

Documentation Required

Reauthorization & Required Documentation

For reauthorization, provide documentation demonstrating a positive clinical response to Vafseo therapy. Reauthorizations are issued for 12 months.

Required documentation for reauthorization: evidence of positive clinical response to Vafseo
Reauthorization duration: 12 months

Note

Automated Approval / Reapproval Processes

Automated approval and reapproval processes may be used based on prior claim/medication history, diagnosis codes (ICD-10), and claim logic; program-specific rules determine use of automation and may allow approval without additional documentation when criteria in claims history are met.

Automated approvals: may rely on prior claims, medication history, and ICD-10 diagnosis codes
Use of automation varies by program/therapeutic class

Definitions

inv-12: Anemia due to CKD — Labeled indication; coverage limited to adults on dialysis for ≥3 months

Labeled indicationAnemia due to chronic kidney disease in adults who have been receiving dialysis for at least three months

Coverage scopeCoverage limited to adults on dialysis for ≥3 months

Authorization durationAuthorization will be issued for 12 months on initial approval

Limitations of useNot indicated as a substitute for transfusion or for CKD patients not on dialysis; not shown to improve quality of life or fatigue

Background

Vafseo (vadadustat) is a hypoxia-inducible factor prolyl hydroxylase inhibitor indicated for the treatment of anemia due to chronic kidney disease. Coverage and use are limited by the labeled restrictions above, including the lack of evidence for improvement in quality of life measures and the exclusion of non-dialysis CKD patients or those needing immediate transfusion.