Prior authorization required; specified approval durations

Prior Authorization is required for benefit coverage of Vafseo. Approvals: initial therapy approved for 6 months when criteria are met; continuing therapy approved for 1 year when criteria are met.

• Initial therapy: 6 months when Initial Therapy criteria (i–vi) are satisfied.
• Continuing therapy: 1 year when Continuing Therapy criteria (i–vi) are satisfied.

Employer plans may require trial and failure/intolerance of one ESA

For certain employer plans, coverage may require that the patient has tried and, according to the prescriber, experienced inadequate efficacy or significant intolerance with one listed erythropoiesis-stimulating agent (epoetin alfa product, Aranesp, or Mircera).

• Examples listed: epoetin alfa products (Procrit, Epogen, Retacrit), Aranesp (darbepoetin alfa), Mircera (methoxy polyethylene glycol-epoetin beta).
• Employer-specific prior authorization rules may apply.

Prior authorization required; no additional PA process details in excerpt

The provided document excerpt states that prior authorization is required but does not list additional separate prior authorization procedures or forms in this excerpt.

• Policy statement: Prior Authorization is required and approvals are provided for the durations noted.
• No additional PA process details are present in the excerpted sections.

Employer-plan step requirement: trial of one ESA may be required

Some employer plans may require trial and inadequate response or significant intolerance to ONE erythropoiesis-stimulating agent (epoetin alfa product, Aranesp, or Mircera) as reported by the prescriber.

• Prescriber must document inadequate efficacy or significant intolerance to one listed ESA.
• Examples of ESAs are provided in the policy text.

No general step therapy requirements described in this excerpt

This portion of the policy does not describe any universal step therapy requirements for Vafseo; step therapy is only noted for certain employer plans.

• No broad step therapy program is specified in the main approval criteria.
• Employer-specific rules are separately noted.

Prescriber specialty required for prior authorization (nephrologist preferred)

Prior authorization requires that Vafseo be prescribed by or in consultation with a physician who specializes in the condition being treated; the policy specifies the medication should be prescribed by or in consultation with a nephrologist for the covered indications.

• Because of specialized skills required and monitoring, prescriber must be a specialist or consult with one (nephrologist preferred).
• Approval requires prescriber specialty as part of the PA criteria.

Document baseline hemoglobin and iron status before initiation

Provide baseline hemoglobin prior to initiation and documentation of iron status or current iron therapy, or a prescriber statement that the patient has adequate iron stores.

• Baseline hemoglobin requirement for initiation: < 11 g/dL.
• Document either current iron therapy or a prescriber statement of adequate iron stores.

References/revision history; no additional documentation requirements here

This section of the document contains references and revision history and does not add further specific provider documentation requirements beyond those already stated.

• References and revision history are included on the final page.
• No additional documentation steps are specified in these chunks.

Do not use Vafseo for non-dialysis CKD anemia — coverage will be denied

Use of Vafseo for anemia in chronic kidney disease patients who are NOT on dialysis is considered not medically necessary and will be denied.

• Policy explicitly states Vafseo is not indicated and safety has not been established for CKD patients not on dialysis.
• Coverage for non-dialysis CKD anemia is listed under 'Conditions Not Covered.'

Excluded conditions that will lead to denial

Do not prescribe Vafseo for anemia associated with cancer, active malignancy, anemia due to acute blood loss, or concomitant use with erythropoiesis-stimulating agents; these uses are listed as not medically necessary and will be denied.

• Concurrent use with ESAs is not recommended and listed as a condition not covered.
• Active malignancy and anemia due to acute blood loss are explicitly listed as excluded.

No additional explicit denial triggers listed in this excerpt

No explicit denial triggers (beyond the not medically necessary conditions and failure to meet coverage criteria) are stated in this part of the document.

• Denials are tied to conditions listed under 'Conditions Not Covered' or failure to meet the specified coverage criteria.
• No additional explicit denial triggers are provided in the excerpt.