Spevigo (spesolimab-sbzo) subcutaneous injection — Medical Mutual

Initial criteria

• ONE of the following: - 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; AND
• 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; AND
• The prescriber is a specialist in the area of the patient’s diagnosis (e.g., dermatologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis; AND
• ONE of the following: - The patient does NOT have active or latent tuberculosis (TB); OR - The patient has latent tuberculosis (TB) and the patient has begun or completed therapy for latent TB prior to initiating with the requested agent; AND
• 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 the requested agent in combination with another immunomodulatory agent AND BOTH of the following: ▪ The prescribing information for the requested agent does NOT limit the use with another immunomodulatory agent; AND ▪ There is support for the use of combination therapy (copy of support required, i.e., clinical trials, phase III studies, guidelines); AND
• The patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

• The patient has been previously approved for the requested agent through the plan’s Prior Authorization process [Note: patients not previously approved for the requested agent will require initial evaluation review]; AND
• The patient has had clinical benefit with the requested agent; AND
• The prescriber is a specialist in the area of the patient’s diagnosis (e.g., dermatologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis; AND
• 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 the requested agent in combination with another immunomodulatory agent AND BOTH of the following: ▪ The prescribing information for the requested agent does NOT limit the use with another immunomodulatory agent; AND ▪ There is support for the use of combination therapy (copy of support required, i.e., clinical trials, phase III studies, guidelines); AND
• The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months