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Spevigo (spesolimab-sbzo) — Blue Cross Blue Shield of Montana

other FDA labeled indication

Initial criteria

  • 1. BOTH of the following: A. ONE of the following: 1. The patient has a diagnosis of generalized pustular psoriasis (GPP) AND ALL of the following: A. The patient has moderate to severe GPP AND B. The patient has a history of 2 or more flares AND C. The patient is NOT currently experiencing an acute flare OR 2. The patient has another FDA labeled indication for the requested agent AND B. If the patient has an FDA labeled indication, then ONE of the following: 1. The patient’s age is within FDA labeling for the requested indication OR 2. There is support for using the requested agent for the patient’s age
  • 2. If the patient has a diagnosis of GPP, the patient weighs ≥ 40 kg
  • 3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., dermatologist), or has consulted with a specialist
  • 4. ONE of the following: A. The patient does NOT have active or latent tuberculosis (TB) OR B. The patient has latent TB and has begun or completed therapy for latent TB prior to initiating therapy
  • 5. ONE of the following: A. The patient will NOT be using the requested agent in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) OR B. The patient will use in combination AND BOTH of the following apply: 1. Prescribing information does NOT limit use with another immunomodulatory agent AND 2. There is clinical support for combination therapy (clinical trials, studies, or guidelines)
  • 6. The patient does NOT have any FDA labeled contraindications to the requested agent
  • Alternative approval (Ohio members): 1. Member resides in Ohio AND plan is Fully Insured or HIM Shop (SG) AND BOTH of the following: A. The patient does NOT have any FDA labeled contraindications B. ONE of the following: 1. Patient has another FDA labeled indication for the requested agent and route OR 2. Patient has another indication supported in compendia for the requested agent and route OR 3. Prescriber submits two peer-reviewed professional medical journal articles supporting the proposed use as generally safe and effective

Reauthorization criteria

  • 1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
  • 2. The patient has had clinical benefit with the requested agent
  • 3. The prescriber is a specialist in the area of diagnosis (e.g., dermatologist), or has consulted with a specialist
  • 4. ONE of the following: A. The patient will NOT be using the requested agent in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) OR B. The patient will use in combination AND BOTH: 1. Prescribing information does NOT limit use with another immunomodulatory agent AND 2. There is support for combination therapy (clinical trials, guidelines)
  • 5. The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months