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Hemlibra (emicizumab-kxwh) — Blue Cross Blue Shield of Montana

hemophilia A with or without inhibitors

Initial criteria

  • ONE of the following: (A) The requested agent is eligible for continuation of therapy AND the prescriber states the patient has been treated with the requested agent within the past 90 days (starting on samples is not approvable) AND is at risk if therapy is changed OR (B) The patient has a diagnosis of hemophilia A with or without inhibitors OR (C) The patient has another FDA labeled or compendia supported indication for the requested agent and route of administration
  • The requested agent will be used as prophylaxis to prevent or reduce the frequency of bleeding episodes
  • The prescriber is a specialist in the area of the patient’s diagnosis (e.g., prescriber working in a hemophilia treatment center, hematologist with hemophilia experience) OR the prescriber has consulted with a specialist in the area of the patient’s diagnosis
  • The patient will NOT be using the requested agent in combination with any of the following while on maintenance dosing: (A) Prophylaxis with a Factor VIIa product (e.g., NovoSeven RT) OR (B) Prophylaxis with a Factor VIII product (e.g., Advate, Adynovate, Eloctate, Nuwiq, Recombinate, Xyntha) OR (C) Prophylaxis with a bypassing agent (e.g., Feiba, NovoSeven) OR (D) Immune tolerance therapy
  • If the patient is receiving Feiba for breakthrough bleeds, BOTH of the following: (A) The patient will be monitored for thrombotic microangiopathy and thromboembolism AND (B) The prescriber has counseled the patient on the maximum Feiba dosage (no more than 100 u/kg/24 hours)
  • The patient does NOT have any FDA labeled contraindications to the requested agent
  • The requested quantity (dose) is within the FDA labeled dosing based on the patient’s weight and dosing interval
  • For members residing in Ohio with Fully Insured or HIM Shop plans: the patient does NOT have any FDA labeled contraindications AND ONE of the following applies: (1) the patient has another FDA labeled indication and route of administration OR (2) the patient has a compendia supported indication OR (3) the prescriber has submitted two peer-reviewed journal articles supporting proposed use (randomized, double blind, placebo controlled clinical trials)

Reauthorization criteria

  • The patient has been previously approved for the requested agent through the plan’s prior authorization process
  • ONE of the following: (A) The patient has had improvements or stabilization with the requested agent as indicated by the number of breakthrough bleeds as reported in the treatment log and/or chart notes OR (B) There is support for the continued use of the requested agent (medical record required)
  • If the patient is receiving Feiba for breakthrough bleeds, the patient will be monitored for thrombotic microangiopathy and thromboembolism
  • The prescriber is a specialist in the area of the patient’s diagnosis or has consulted with a specialist
  • The patient will NOT be using the requested agent in combination with: (A) Prophylaxis with a Factor VIIa product OR (B) Prophylaxis with a Factor VIII product OR (C) Prophylaxis with a bypassing agent OR (D) Immune tolerance therapy
  • The patient does NOT have any FDA labeled contraindications to the requested agent
  • The requested quantity (dose) is within the FDA labeled dosing based on the patient’s weight and dosing interval

Approval duration

induction 3 months; maintenance 12 months