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

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 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, ONE of the following: • The patient’s age is within FDA labeling for the requested indication • OR There is support for use for patient’s age
• - If diagnosis is GPP, patient weight ≥ 40 kg
• - Prescriber is a specialist in the area of the patient’s diagnosis (e.g., dermatologist) or has consulted with one
• - ONE of the following infection requirements: • Patient does NOT have active or latent TB • OR Patient with latent TB has begun or completed therapy for latent TB prior to initiation
• - ONE of the following concomitant therapy requirements: • Patient will NOT use in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) • OR If used with another immunomodulatory agent, BOTH: – Prescribing information does NOT limit such use – There is support for combination therapy (copy of support required: clinical trials, phase III studies, or guidelines)
• - Patient does NOT have any FDA labeled contraindications to the requested agent
• - For members residing in Ohio with Fully Insured or HIM Shop (SG) plan: additional criteria apply: • No FDA labeled contraindications • AND ONE of the following: – Patient has another FDA labeled indication and route of administration – OR Patient has a compendia-supported indication (non-oncology: DrugDex 1, 2A, 2B; AHFS-DI supportive narrative; oncology: NCCN 1 or 2A, AHFS-DI supportive narrative, DrugDex 1–2B, Clinical Pharmacology supportive narrative, LexiDrugs level A) – OR Prescriber submitted TWO peer-reviewed journal articles (JAMA, NEJM, Lancet) supporting proposed use as safe and effective

Reauthorization criteria

• - Patient previously approved through plan Prior Authorization process
• - Patient has had clinical benefit with the requested agent
• - Prescriber is a specialist or has consulted with a specialist in the area of patient’s diagnosis
• - ONE of the following concomitant therapy requirements: • Patient will NOT be using in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) • OR If used in combination, BOTH: – Prescribing information does NOT limit such use – There is support for combination therapy
• - Patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months