This is a medical prior authorization/step-edit form for eculizumab products used to treat PNH and must be completed and signed by the prescribing physician and faxed to the payer. Prescribers must meet qualification requirements: medication must be prescribed by or in consultation with a hematologist or nephrologist, and for Soliris® the prescriber must be enrolled in the Soliris® REMS program (requests may require prior authorization).
Laboratory confirmation is required: a diagnosis of PNH must be confirmed by flow cytometry demonstrating at least ≥ 10% PNH clones, and the flow cytometry pathology report must show at least 2 different GPI protein deficiencies in 2 different cell lines (e.g., CD55, CD59 across granulocytes, monocytes, erythrocytes). Providers must submit flow cytometry reports, recent LDH and hemoglobin values, and transfusion history as documentation.
Indications eligible for therapy require that the member have ONE of the listed criteria: transfusion dependence (defined as a transfusion within the last 12 months with either hemoglobin ≤ 7 g/dL or symptomatic anemia with hemoglobin ≤ 9 g/dL), elevated LDH (≥ 1.5× upper limit of normal with clinical symptoms), presence of a thrombotic event (e.g., DVT, PE), organ damage secondary to chronic hemolysis, or pregnancy when benefits outweigh fetal risk. For Bkemv® and Soliris® requests, documentation of inadequate response, intolerance, or contraindication to Ultomiris™ (ravulizumab) is required.
Vaccination and infection requirements: Members must NOT have a systemic infection. For Soliris®, individuals should receive a meningococcal vaccine at least two weeks prior to initiation and be revaccinated per guidelines; alternatively, documentation that risks of delaying eculizumab outweigh meningococcal infection risk may be provided. Therapy will NOT be approved for unresolved meningococcal disease or untreated systemic bacterial/significant infections.
Documentation and billing guidance: submit all required documentation (signed prior authorization, flow cytometry, labs, chart notes) and indicate administration site or specialty pharmacy with NPI/DEA. Maximum quantity limit is 4 vials every 14 days; one 300 mg vial (30 mL) = 150 billable units (1 billable unit per 2 mg). Claims may be denied if medication is prescribed concurrently with another FDA-approved PNH product.