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Alhemo (concizumab-mtci) — Blue Cross Blue Shield of Montana

Hemophilia B with factor IX inhibitors

Initial criteria

  • Prescriber states the patient has been treated with the requested agent (samples not acceptable) within the past 90 days AND is at risk if therapy is changed OR ALL of the following below:
  • ONE of the following diagnoses:
  • A. Hemophilia A (factor VIII deficiency) with inhibitors AND ALL of the following: diagnosis of congenital factor VIII deficiency confirmed by blood coagulation testing AND inhibitor titer > 5 BU; requested agent used for primary prophylaxis (factor VIII <1%) OR secondary prophylaxis (≥2 spontaneous joint bleeds); prior prophylaxis therapy; ONE of: inadequate response to Immune Tolerance Induction (ITI) OR inhibitor ≥200 BU OR not a candidate for ITI
  • B. Hemophilia B (factor IX deficiency) with inhibitors AND ALL of the following: diagnosis confirmed by blood coagulation testing AND inhibitor titer > 5 BU; requested agent used for primary prophylaxis (factor IX <1%) OR secondary prophylaxis (≥2 spontaneous joint bleeds); prior prophylaxis therapy; ONE of: inadequate response to ITI OR inhibitor ≥200 BU OR not candidate for ITI
  • If patient has FDA-labeled indication: ONE of the following: age is within FDA labeling OR literature supports use for age
  • Agent used as prophylaxis to prevent or reduce bleeding episodes
  • Agent NOT used for treatment of breakthrough bleeding
  • Patient is NOT pregnant
  • Prescriber is a hemophilia specialist or has consulted with one
  • Agent NOT used in combination with clotting factor products, bypassing agents, or Emicizumab (for Hemophilia A with inhibitors) [factor products permissible for breakthrough bleeds]
  • No FDA-labeled contraindications
  • Requested dose within FDA labeling
  • Alternate approval pathway for BCBS MT Fully Insured or MT HIM members: patient age <18 years; no FDA-labeled contraindications; indication supported in TWO peer-reviewed publications as generally safe and effective; age bracket supported in TWO peer-reviewed publications
  • Alternate approval pathway for BCBS NM Fully Insured or NM HIM: no FDA-labeled contraindications; indication is rare disease; and EITHER another FDA-labeled indication for same route OR indication supported in compendia OR TWO peer-reviewed studies
  • Alternate approval pathway for Ohio Fully Insured or HIM Shop (SG): no contraindications; either another FDA-labeled indication, compendia-supported indication, or TWO peer-reviewed studies supporting efficacy and safety

Reauthorization criteria

  • Previously approved through plan’s prior authorization
  • ONE of: improvement or stabilization evidenced by reduced number of breakthrough bleeds OR continued support for use (medical records required)
  • Prescriber is hemophilia specialist or consulted with one
  • Agent NOT combined with prophylactic clotting factors (allowed for breakthrough bleeds)
  • Absence of unacceptable toxicity (e.g., thromboembolic events, hypersensitivity)
  • Plasma concentration of concizumab ≥200 ng/ml
  • No FDA-labeled contraindications

Approval duration

12 months