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concizumab-mtci — Blue Cross Blue Shield of Texas

Hemophilia B (factor IX deficiency) with factor IX inhibitors

Initial criteria

  • Prescriber states the patient has been treated with the requested agent (not samples) within the past 90 days and is at risk if therapy is changed OR all of the following:
  • ONE of the following:
  • A. Diagnosis of Hemophilia A (factor VIII deficiency) with factor VIII inhibitors AND all of the following (medical records required): BOTH of the following: (A) Diagnosis of congenital factor VIII deficiency confirmed by blood coagulation testing AND (B) Inhibitors to factor VIII have a current or historical titer > 5 Bethesda units; AND the requested agent used for primary prophylaxis in patients with severe factor VIII deficiency (<1%) OR secondary prophylaxis in patients with ≥2 spontaneous bleeding episodes into joints; AND patient has had previous prophylaxis therapy; AND ONE of: (A) tried and inadequate response to Immune Tolerance Induction (ITI) OR (B) inhibitor level ≥ 200 BU OR (C) not a candidate for ITI.
  • B. Diagnosis of Hemophilia B (factor IX deficiency) with factor IX inhibitors AND all of the following (medical records required): BOTH of the following: (A) Diagnosis of congenital factor IX deficiency confirmed by blood coagulation testing AND (B) Inhibitors to factor IX have a current or historical titer > 5 Bethesda units; AND the requested agent used for primary prophylaxis in patients with severe factor IX deficiency (<1%) OR secondary prophylaxis in patients with ≥2 spontaneous bleeding episodes into joints; AND patient has had previous prophylaxis therapy; AND ONE of: (A) tried and inadequate response to ITI OR (B) inhibitor level ≥ 200 BU OR (C) not a candidate for ITI.
  • If patient has an FDA labeled indication, ONE of: (A) Patient’s age within FDA labeling OR (B) Support exists for using the agent for patient’s age for the indication.
  • Requested agent will be used as prophylaxis, not for breakthrough bleeding.
  • Patient is NOT pregnant.
  • Prescriber is a specialist in hemophilia or has consulted a specialist.
  • Requested agent will NOT be used in combination with clotting factor products (factor VIII or IX concentrates), hemophilia bypassing agents (factor VIIa or anti-inhibitor coagulant complex), or Emicizumab for hemophilia A with inhibitors (factor products may be used for breakthrough bleeds).
  • Patient does NOT have any FDA labeled contraindications.
  • Requested dose is within FDA labeled dosing.
  • Length of Approval: BCBSIL, BCBSMT, BCBSTX: 12 months; BCBSNM: 3 months; others: 8 weeks.
  • Exceptions:
  • 1. BCBS MT Fully Insured or MT HIM member: patient age < 18 years, no FDA contraindications, indication supported in two major peer-reviewed journal articles as generally safe and effective, and age bracket supported similarly in two articles (no case studies).
  • 2. BCBS NM Fully Insured or NM HIM member: no FDA contraindications, requested indication is rare disease, and one of: another FDA labeled indication for same route, or supported in compendia, or supported by two major peer-reviewed articles (no case studies).
  • 3. Ohio members (Fully Insured or HIM Shop): reside in Ohio, no FDA contraindications, and one of: another FDA indication, compendia-supported indication, or two peer-reviewed journal articles supporting proposed use (no case studies).
  • Non-oncology compendia accepted: DrugDex level 1, 2A, 2B, AHFS-DI (supportive). Oncology compendia accepted: NCCN 1 or 2A, AHFS-DI, DrugDex 1, 2A, 2B, Clinical Pharmacology (supportive), Lexi-Drugs evidence level A.

Reauthorization criteria

  • Patient previously approved for the requested agent through plan’s prior authorization process.
  • ONE of the following: (A) Patient has had improvement or stabilization as indicated by number of breakthrough bleeding episodes (medical records required) OR (B) Support exists for continued use (medical records required).
  • Prescriber is a specialist in hemophilia or has consulted such a specialist.
  • Requested agent will NOT be used in combination with clotting factor products used as prophylaxis (factor VIII or IX may be used for breakthrough bleeds).
  • Absence of unacceptable toxicity (e.g., thromboembolic events, hypersensitivity).
  • Plasma concentration of concizumab ≥ 200 ng/ml.
  • Patient does NOT have any FDA labeled contraindications.
  • Length of Approval: 12 months.

Approval duration

12 months