*Maximum units allowed for duration of approval
Commercial Utilization Management Policy
Version Date: May 2024
Restricted Product(s):
- spesolimab-sbzo (Spevigo®) intravenous infusion and subcutaneous injection for administration by a healthcare professional
FDA Approved Use:
- For treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg
Criteria for Medical Necessity:
The restricted product(s) may be considered medically necessary when the following criteria are met:
- The patient is 12 years of age or older; AND
- The patient has a diagnosis of generalized pustular psoriasis (GPP); AND
- If the request is for the intravenous infusion, the patient is experiencing a moderate to severe flare of GP); AND
- The patient has NOT received treatment with 2 or more infusions of the requested agent for the current flare; AND
- If the request is for the subcutaneous injection, the patient is NOT experiencing a moderate to severe flare of GPP; 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
- The patient does NOT have any FDA labeled contraindications to the requested agent; AND
- The patient has been tested for latent tuberculosis (TB) when required by the prescribing information for the requested agent AND if positive the patient has begun therapy for latent TB; AND
- The requested quantity (dose) is within FDA labeled dosing for the requested indication; AND9.
- The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below)
Duration of Approval: IV: 30 days (1 month) SC:365 days (1 year)
| Medication | Indication | Dosing | HCPCS | Maximum Units* |
|---|---|---|---|---|
| spesolimab-sbzo (Spevigo®) | Generalized pustular psoriasis flares in patients ≥ 12 years old | SC: No flare: Loading dose of 600 mg followed by 300 mg 4 weeks later and every 4 weeks thereafter | J1747 | IV:1800 SC: 4200 |
| intravenous (IV) infusion, subcutaneous (SC) injection | SC after IV for Flare: After 4 weeks of IV treatment, 300mg(SC) every 4 weeks for maintenance | |||
| IV: Administer IV as a single 900 mg dose. If flare symptoms persist, may administer an additional 900 mg dose IV one week after initial dose. |
References:
All information referenced is from FDA package insert unless otherwise noted below.
Policy Implementation/Update Information:
Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q1 annually.
May 2024: Criteria change: Added expanded indication for Spevigo to patients 12 years of age and older per FDA approval update and dosing table updates.
April 2023: Coding update: Added HCPCS code J1747 to dosing reference table effective 4/1/2023; deleted C9399, J3490, and J3590 termed 3/31/2023.
April 2023: Original medical policy criteria issued. Policy notification given 12/30/2022 for effective date 4/1/2023.
Blue Cross and Blue Shield of North Carolina does not discriminate on the basis of race, color, national origin, sex, age or disability in its health programs and activities. Learn more about our non-discrimination policy and no-cost services available to you.
Information in other languages: Español 中文 Tiếng Việt 한국어 Français العَرَبِيَّة Hmoob ру́сский Tagalog ગુજરાતી ភាសាខ្មែរ Deutsch हिन्दी ລາວ 日本語
© 2025 Blue Cross and Blue Shield of North Carolina. ®, SM Marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans. All other marks and names are property of their respective owners. Blue Cross and Blue Shield of North Carolina is an independent licensee of the Blue Cross and Blue Shield Association.