Spevigo (spesolimab-sbzo) subcutaneous solution — Blue Cross Blue Shield of Illinois
any other FDA labeled indication
Initial criteria
- BOTH of the following:
- • 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 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 OR 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 a specialist
- ONE of the following regarding tuberculosis (TB): the patient does NOT have active or latent TB OR the patient has latent TB and has begun or completed therapy for latent TB prior to initiating therapy
- ONE of the following regarding concomitant use: 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 such combination AND BOTH of the following: the prescribing information for the requested agent does NOT limit combination use AND there is support for combination therapy (e.g., clinical trials, guidelines)
- The patient does NOT have any FDA labeled contraindications to the requested agent
- Ohio-specific criteria: The member resides in Ohio AND the plan is Fully Insured or HIM Shop (SG) AND BOTH of the following are met: (1) no FDA labeled contraindications AND (2) ONE of the following: another FDA labeled indication for the requested agent and route OR an indication supported in compendia OR submission of two peer-reviewed journal articles supporting the proposed use (excluding case studies)
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 a specialist
- ONE of the following regarding concomitant use: 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 such combination AND BOTH of the following: the prescribing information for the requested agent does NOT limit combination use AND there is support for combination therapy (e.g., clinical trials, guidelines)
- The patient does NOT have any FDA labeled contraindications to the requested agent
Approval duration
12 months