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

other FDA labeled indications

Initial criteria

  • The patient has a diagnosis of generalized pustular psoriasis (GPP) AND ALL of the following: the patient has moderate to severe GPP AND the patient has a history of 2 or more flares AND the patient is NOT currently experiencing an acute flare OR the patient has another FDA labeled indication for the requested agent
  • If the patient has an FDA labeled indication, then ONE of the following: the patient’s age is within FDA labeling for the requested indication for the requested agent OR there is support for using the requested agent for the patient’s age
  • If the patient has a diagnosis of GPP, the patient weighs ≥ 40 kg
  • The prescriber is a specialist in the area of the patient’s diagnosis (e.g., dermatologist), or has consulted with a specialist in the area
  • ONE of the following regarding tuberculosis: the patient does NOT have active or latent TB OR the patient has latent TB and has begun or completed therapy prior to initiating therapy with the requested agent
  • ONE of the following: 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 the patient will be using in combination AND BOTH of the following: the prescribing information does NOT limit such use AND there is support for combination therapy (copy of clinical support required)
  • The patient does NOT have any FDA labeled contraindications to the requested agent
  • Alternate approval when ALL of the following apply: the member resides in Ohio AND the plan is Fully Insured or HIM Shop (SG) AND BOTH of the following: the patient does NOT have any FDA labeled contraindications AND ONE of the following: the patient has another FDA labeled indication and route OR an indication supported in compendia OR two peer-reviewed journal articles supporting safe and effective use

Reauthorization criteria

  • The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
  • The patient has had clinical benefit with the requested agent
  • The prescriber is a specialist in the area of the patient’s diagnosis, or has consulted with a specialist
  • ONE of the following regarding combination therapy: the patient will NOT be using the requested agent in combination with another immunomodulatory agent OR if used in combination BOTH of the following: prescribing information does NOT limit use AND there is support for combination therapy
  • The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months