Spesolimab-sbzo Receives a New, Permanent J-code

A permanent J-code (J1747) has been released for the spesolimab-sbzo injection (Spevigo) to treat generalized pustular psoriasis (GPP) flares in adults. The J-code is effective as of this month and can be used by commercial insurers and government payers to streamline billing for Medicare Part B drugs.¹

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Spesolimab-sbzo was given the green light by the US Food and Drug Administration on September 1, 2022. Boehringer Ingelheim Pharmaceuticals, Inc. submitted the request to make the 2022 fourth quarter deadline for a J-code to establish a new Healthcare Common Procedure Coding System (HCPCS) Level II code to identify spesolimab-sbzoas a humanized antagonistic monoclonal immunoglobulin G1 antibody blocking human IL36R signaling. “Binding of spesolimab to IL36R prevents the subsequent activation of IL36R by cognate ligands (IL36 α, β and γ) and downstream activation of pro-inflammatory and pro-fibrotic pathways,” the company explained.

Before this month, there was no HCPCS Level II code assigned for the drug, and using a Not-Otherwise-Classified (NOC) HCPCS code prevented concise tracking of utilization, which resulted in under-payment or incorrect billing.

Mark Lebwohl, MD has been practicing dermatology since 1983 and currently serves as the dean for clinical therapeutics at the Icahn School of Medicine at Mount Sinai and professor and chairman emeritus of the Kimberly and Eric J. Waldman Department of Dermatology. He is well versed in GPP treatment and shared the impact of the new J-code.

“Spesolimab is a life-saving treatment for a potentially deadly disease,” said Lebwohl. “Everything that can be done to enable access for these very sick patients is a step forward.”

The US Centers for Medicare & Medicaid Services has published its document of new J-codes now available as of this month in a 2022 HCPCS report.

The future of spesolimab is bright. Earlier this year, researchers met primary and secondary endpoints in the EFFISAYIL 2 (NCT04399837) trial² showing significant prevention of GPP flares in adolescents and adults for up to 48 weeks. The positive study results from EFFISAYIL 2 build on data from the previous EFFISAYIL 1 trial (NCT03782792), which demonstrated rapid pustular and skin clearance in patients with GPP flares sustained over 12 weeks.

For more information on GPP and the efficacy of spesolimab, visit our Case-Based Partner Perspectives series featuring Mark Lebwohl.

References

1. Boehringer Ingelheim Receives Permanent J-Code (J1747) for SPEVIGO® (spesolimab-sbzo) Injection Effective April 1, 2023. Boehringer Ingelheim. Published April 1, 2023. Accessed April 6, 2023. https://www.boehringer-ingelheim.com/us/press-release/boehringer-ingelheim-receives-permanent-j-code-spevigo-spesolimab-sbzo-injection.

2. A study to test whether BI 655130 (spesolimab) prevents flare-ups in patients with generalized pustular psoriasis. ClinicalTrials.gov identifier: NCT04399837. Updated December 30, 2022. Accessed April 6, 2023. https://clinicaltrials.gov/ct2/show/NCT04399837?term=EFFISAYIL+2&draw=2&rank=1