non-preferred Factor IX agents included in this program — Blue Cross Blue Shield of Texas

Initial criteria

• ALL preferred agents are expected to be ineffective OR cause significant barrier to adherence OR worsen comorbid condition OR decrease ability to perform daily activities OR cause adverse reaction or harm [chart notes required] OR ALL preferred agents are not in best interest of patient based on medical necessity [chart notes required] OR patient has tried another prescription drug in same pharmacologic class or with same mechanism as all preferred agents discontinued due to lack of efficacy or adverse event [chart notes required]
• IF patient has FDA labeled indication THEN ONE of: (A) age is within FDA labeling, OR (B) there is support for use at patient’s age
• Prescriber is specialist in area of diagnosis (e.g., hemophilia treatment center, hematologist) OR has consulted specialist
• Patient has no FDA labeled contraindications to requested agent
• Prescriber provides actual prescribed dose with ALL of: patient’s weight; severity of factor deficiency (severe <1%, moderate ≥1–≤5%, mild >5–40% factor activity); inhibitor status; intended use/regimen (prophylaxis, on-demand, peri-operative)
• ONE of: (A) patient will not use requested agent in combination with another Factor IX agent included in this program OR (B) support for use of more than one Factor IX agent (medical records required)

Reauthorization criteria

• Previously approved through plan’s prior authorization (or requires initial evaluation for new or emergency only approvals)
• Prescriber is specialist in area of diagnosis or has consulted specialist
• Patient has no FDA labeled contraindications to requested agent
• Prescriber provides prescribed dose with weight, severity of deficiency, inhibitor status, intended use/regimen
• ONE of: (A) prescriber has verified patient does not have >5 on-demand doses on hand OR (B) support exists for >5 doses on hand
• ONE of: (A) patient will not use requested agent with another Factor IX agent OR (B) support for use of more than one (medical records required)

Approval duration

12 months (BCBSIL/BCBSMT/BCBSTX); BCBSNM: 3 months for perioperative/on-demand, 12 months (≥3 months) prophylaxis; others: 1-time or 2 weeks-3 months per indication