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requested Factor IX agentsBlue Cross Blue Shield of Texas

rare disease use when non-FDA labeled or alternative indication for BCBSNM or Ohio fully insured/HIM members

Initial criteria

  • For BCBSNM and Ohio Fully Insured or HIM members, requested agent approved when:
  • Patient has no FDA labeled contraindications
  • Requested indication is a rare disease AND ONE of: (1) patient has another FDA labeled indication and route, (2) patient has indication supported in compendia (DrugDex level 1, 2A, 2B; AHFS-DI supportive text; NCCN 1 or 2A; Clinical Pharmacology supportive; LexiDrugs evidence level A), OR (3) prescriber submits two peer-reviewed journal articles demonstrating safety and efficacy (not case studies)

Approval duration

12 months