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Spevigo (spesolimab-sbzo) — Blue Cross Blue Shield of New Mexico

other FDA labeled indications

Initial criteria

  • Diagnosis: ONE of the following: (1) The patient has 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.
  • If the patient has an FDA labeled indication, ONE of the following: (a) The patient’s age is within FDA labeling for the requested indication OR (b) There is support for using the requested agent for the patient’s age.
  • If the patient has a diagnosis of GPP, then 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 such a specialist.
  • 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.
  • Concomitant therapy: 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 be using combination therapy AND BOTH of the following: (1) The prescribing information for the requested agent does NOT limit such use AND (2) There is support for use of combination therapy (e.g., clinical trials, guidelines).
  • The patient does NOT have any FDA labeled contraindications to the requested agent.
  • Length of Approval: 12 months.
  • Alternate OH-specific criteria: (1) Member resides in Ohio AND (2) Plan is Fully Insured or HIM Shop (SG) AND BOTH of the following: (a) The patient has no FDA labeled contraindications AND (b) ONE of the following: patient has another FDA labeled indication and route of administration OR indication supported in compendia OR two peer-reviewed studies supporting the proposed 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 (e.g., dermatologist) OR has consulted with such a specialist.
  • Concomitant therapy: 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 be using combination therapy AND BOTH of the following: (1) The prescribing information for the requested agent does NOT limit such use AND (2) There is support for use of combination therapy (e.g., clinical trials, guidelines).
  • The patient does NOT have any FDA labeled contraindications to the requested agent.
  • Length of Approval: 12 months.

Approval duration

12 months