Prior Authorization Required

Prior authorization is required. Approval durations vary by line of business: Commercial — 6 months or to member's renewal period, whichever is longer; Medicaid/HIM — 6 months (note: continuation approval duration for Medicaid/HIM was extended to 12 months per 2Q 2025 annual review — see Coding Implications/history). Prior authorization may also be required for comparator products (Retacrit, Epogen) when used per step therapy.

• Commercial approval: 6 months or to member's renewal period, whichever is longer
• Medicaid/HIM approval: 6 months (continuation duration extended to 12 months in 2Q 2025 update)
• Prior authorization may be required for Retacrit and Epogen

Required Documentation

Providers must submit supporting clinical documentation with the prior authorization request. Acceptable documentation includes office chart notes, pertinent lab results (e.g., hemoglobin, serum ferritin, transferrin saturation within the timeframe specified), and consult notes when applicable. Lack of required documentation may result in denial.

• Chart notes reflecting diagnosis and treatment rationale
• Current labs within last 3 months: serum ferritin and transferrin saturation, and hemoglobin values
• Consultation notes if prescribed in consultation with hematologist or nephrologist

Denial Risk / Triggers

Denials may be issued if required criteria or documentation are not met. Common denial triggers include: missing or outdated laboratory values, failure to demonstrate prior failure of required step-therapy agents when applicable, requests for concurrent use with contraindicated therapies, or requests for non‑covered indications.

• Missing chart notes or labs (e.g., ferritin/TSAT not within last 3 months)
• Failure to document trial/failure of Retacrit (or Epogen when applicable) unless contraindicated or unavailable
• Concurrent prescribing of Vafseo with Jesduvroq is prohibited and may trigger denial
• Requests for non‑FDA approved indications without appropriate off‑label documentation per off‑label policies

Step-Therapy and Redirection Requirements

Step therapy requires redirection to preferred agents unless exceptions apply. Per policy updates, providers must document failure, contraindication, clinically significant adverse effects, or unavailability of Retacrit before approval of Vafseo. If the member is unable to use Retacrit, redirection to Epogen is required (and prior authorization for Epogen may be needed). State-specific exceptions apply — for Illinois HIM requests, step therapy redirection requirements do not apply as of 1/1/2026 per IL HB 5395. Additionally, certain states have oncology redirection prohibitions (see Appendix D).

• Must document failure of Retacrit unless contraindicated, adverse effects, or shortage/unavailable
• If unable to use Retacrit, provider must document and redirect to Epogen prior to Vafseo (prior auth for Epogen may be required)
• IL HIM: step therapy bypass effective 1/1/2026 per IL HB 5395
• Refer to Appendix D for states and circumstances where redirection/step therapy is prohibited