Boehringer Ingelheim Receives Permanent J-Code (J1747) for SPEVIGO® (spesolimab-sbzo) Injection Effective April 1, 2023

RIDGEFIELD, Conn., April 6, 2023 /PRNewswire/ -- Boehringer Ingelheim announced today the U.S. Centers for Medicare & Medicaid Services (CMS) has issued a permanent J-code (J1747) for SPEVIGO (spesolimab-sbzo) Injection, indicated for the treatment of generalized pustular psoriasis (GPP) flares in adults. According to the Healthcare Common Procedure Coding System (HCPCS), the J-code for SPEVIGO becomes effective as of today, April 1, 2023.

"People living with GPP can experience unpredictable flares and are in need of timely access to novel treatment options," said Claudia Beqaj, Executive Director, Dermatology, Sales and Marketing, Boehringer Ingelheim. "We are pleased to receive the permanent J-code for SPEVIGO that aims to enhance and expand market access for those affected by this rare and potentially life-threatening neutrophilic skin disease."

J-codes are permanent, product-specific reimbursement codes used by commercial insurers and government payers to facilitate and streamline billing for Medicare Part B drugs, which cannot be self-administered.

The permanent J-code for SPEVIGO, J1747 (Injection, spesolimab-sbzo, 1 mg), has been published online in the CMS HCPCS Application Summaries and Coding Recommendations, Fourth Quarter, 2022 HCPCS Coding Cycle, here.

What is SPEVIGO? 
SPEVIGO is a prescription medicine used to treat generalized pustular psoriasis (GPP) flares in adults. It is not known if SPEVIGO is safe and effective in children.

Important Safety Information

Do not receive SPEVIGO if you have had a severe or life-threatening allergic reaction to spesolimab-sbzo or any of the ingredients in SPEVIGO.

What is the most important information I should know about SPEVIGO?

SPEVIGO may cause serious side effects, including:

• Infections. SPEVIGO may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with SPEVIGO and may treat you for TB before you begin treatment with SPEVIGO if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB after treatment with SPEVIGO. Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including:
• fever, chills or sweats
• muscle aches
• cough
• shortness of breath
• blood in your phlegm (mucus)
• burning when you urinate
• urinating more often than normal

• Allergic reactions and infusion-related reactions. Serious allergic reactions may happen during or after your infusion of SPEVIGO. If you have a serious allergic reaction, your healthcare provider will stop treatment with SPEVIGO. If you have an infusion-related reaction, your healthcare provider will stop your SPEVIGO infusion and treat your symptoms and may restart SPEVIGO at a slower infusion rate. Tell your healthcare provider or get emergency medical help right away if you get any of the following symptoms during or after your infusion of SPEVIGO:
• feeling faint, dizzy, or lightheaded
• swelling of your face, eyelids, lips, mouth, tongue, or throat
• trouble breathing or throat tightness
• fever
• mouth sores
• chest tightness
• hives or skin rash that is different than the rash from generalized pustular psoriasis (GPP)
• itching
• swollen lymph nodes

Before you receive SPEVIGO, tell your healthcare provider about all of your medical conditions, including if you:

• have an infection that does not go away or that keeps coming back.
• have TB or have been in close contact with someone with TB.
• have recently received or are scheduled to receive an immunization (vaccine). You should not receive live vaccines after treatment with SPEVIGO.
• are pregnant or plan to become pregnant. It is not known if SPEVIGO can harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if SPEVIGO passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with SPEVIGO.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the most common side effects of SPEVIGO:

• feeling tired or weak
• nausea and vomiting
• headache
• itching or itchy bumps
• a collection of blood under the skin at the infusion site or bruising
• urinary tract infection

These are not all of the possible side effects of SPEVIGO. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more information, please see Prescribing Information and Medication Guide.

CL-SPG-100001 09.01.2022

About generalized pustular psoriasis (GPP)
GPP is a rare, heterogenous and potentially life-threatening neutrophilic skin disease, which is clinically distinct from plaque psoriasis. GPP is caused by neutrophils (a type of white blood cell) accumulating in the skin, resulting in painful, sterile pustules all over the body. The clinical course varies, with some patients having a relapsing disease with recurrent flares, and others having a persistent disease with intermittent flares. While the severity of GPP flares can vary, if left untreated they can be life-threatening due to complications such as sepsis and multisystem organ failure. This chronic, systemic disease has a substantial quality of life impact for patients and increased healthcare burden. GPP has a varied prevalence across different geographical regions and more women are affected than men.

GPP flares can lead to hospitalization with serious complications, including heart failure, renal failure and sepsis, and the unpredictability and severity of these flares greatly affect a person's quality of life.

Boehringer Ingelheim Immunology: Pioneering Science, Inspired By Patients
Living with fibrotic and inflammatory diseases greatly impacts patients' lives emotionally and physically. These patients are our guides, partners, and inspiration as we redefine treatment paradigms. As a family-owned company, we can plan long-term. Our goal is to discover and develop first-of-their-kind therapies. With a deep understanding of molecular pathways, we are pioneering scientific breakthroughs that target, repair, and prevent many fibrotic and inflammatory diseases. By building on long-term external collaborations, we strive to bring treatment breakthroughs to patients in the shortest time. We won't rest until we can give people the chance to live the lives they want.

Boehringer Ingelheim
Boehringer Ingelheim is working on breakthrough therapies that improve the lives of humans and animals. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. Around 52,000 employees serve more than 130 markets in the three business areas, Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. Learn more at www.boehringer-ingelheim.com.

Media Contact
Taylor Pepe
Boehringer Ingelheim Pharmaceuticals, Inc.
Phone: +1 518.466.3621
Email: [email protected]
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