CMS Recognizes Innovation of GAMIFANT® (emapalumab-lzsg) with New Technology Add-on Payment to Support Hospital Access

GAMIFANT met CMS criteria for newness, cost and substantial clinical improvement, enabling additional Medicare reimbursement for eligible hospitals beginning October 1, 2026

Waltham, MA -- Sobi today announced that the Centers for Medicare & Medicaid Services (CMS) has granted New Technology Add-on Payment (NTAP) status for GAMIFANT® (emapalumab-lzsg) under the Medicare Hospital Inpatient Prospective Payment System, effective October 1, 2026.

The decision recognizes GAMIFANT as a qualifying technology that meets CMS criteria for newness, cost and substantial clinical improvement, while providing eligible hospitals with additional Medicare reimbursement when treating appropriate patients with GAMIFANT. Together, these elements underscore the innovation GAMIFANT brings to the treatment of hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) in known or suspected Still's disease and help support access to treatment in the hospital setting.

"Innovation has the greatest impact when it reaches the patients who need it," said Duane H Barnes, President, Sobi North America. "CMS's decision recognizes the clinical advancement represented by GAMIFANT while helping address an important consideration for hospitals seeking to make innovative therapies available to patients. This milestone reflects both the innovation behind GAMIFANT and our commitment to helping patients with rare and serious diseases access the care they need."

Recognizing Innovation in a Rare and Serious Disease

NTAP is designed to support the introduction of new medical technologies into the inpatient hospital setting. To qualify through the traditional NTAP pathway, technologies must satisfy CMS requirements related to newness and cost and demonstrate substantial clinical improvement over existing services or technologies.

CMS's substantial clinical improvement standard considers, among other factors, whether a new technology offers a treatment option for a patient population that is unresponsive to or ineligible for currently available treatments, or whether use of the technology significantly improves clinical outcomes compared with available treatments.

GAMIFANT's qualification for NTAP reflects CMS's assessment of the therapy against these criteria and represents an important recognition of the innovation it brings for patients with HLH/MAS in known or suspected Still's disease.

Helping Support Hospital Access

Bringing a new therapy into the inpatient setting requires hospitals to consider both its clinical value and the costs associated with providing treatment. Because those costs may not yet be fully reflected in existing Medicare payment rates, NTAP provides additional reimbursement to eligible hospitals during the early years following the introduction of a qualifying technology.

For GAMIFANT, the additional payment can help reduce potential reimbursement barriers as hospitals provide treatment to eligible Medicare patients—helping translate therapeutic innovation into access for the people who may benefit from it.

Indication and Important Safety Information

What is GAMIFANT?

Gamifant (emapalumab-lzsg) is a prescription medicine used for the treatment of hemophagocytic lymphohistiocytosis (HLH) in adults and children (newborn and older) with:

• primary HLH whose disease has come back or progressed, or other medicines have not worked well enough or cannot be tolerated.
• HLH/macrophage activation syndrome (MAS) in Still’s disease, including systemic Juvenile Idiopathic Arthritis (sJIA), when glucocorticoids have not worked well enough or cannot be tolerated, or with MAS that has come back.

IMPORTANT SAFETY INFORMATION

Gamifant can cause serious side effects including:

• Infections. GAMIFANT affects your immune system and may lower the ability of your immune system to fight infections. Gamifant may increase your risk of serious infections that can lead to death. These infections include tuberculosis (TB), histoplasmosis, herpes zoster infection (shingles), and other infections caused by viruses, fungi, or bacteria that can spread throughout the body. Infections are common in people treated with Gamifant. Your healthcare provider will:
  • Test you for TB before you start Gamifant
  • Treat you with a medicine for TB if you are at risk for TB or if you have a known positive TB test

Before starting Gamifant, tell your doctor if you:

• had TB in the past, or if you or a member of your family have been in recent close contact with someone with TB
• have ever had a positive TB skin test (PPD)
• currently have or have had a history of infections, including histoplasmosis or herpes zoster (shingles)
• are being treated for an active infection
• have symptoms of an infection, such as fever, sweat and chills, cough, breathing problems, blood in mucus (phlegm), or warm, red, or painful skin or sores on your body

After starting Gamifant, tell your healthcare provider if:

• New symptoms of an infection appear
• Symptoms of an infection that you already had when starting Gamifant worsen. Your healthcare provider will monitor you closely for signs and symptoms of infections during treatment with Gamifant

Your healthcare provider may give you medicine to help prevent certain infections before you receive Gamifant and will monitor you closely for signs and symptoms of infections during treatment with Gamifant.

Infusion Reactions. These are common, can also be severe, and can happen during or shortly after treatment with Gamifant. Your healthcare provider may temporarily stop your infusion and treat your symptoms before continuing your infusion if you have severe infusion reactions. Tell your healthcare provider right away if you get any of the following symptoms:

• skin redness
• itching
• fever
• rash
• excessive sweating
• headache
• bone pain
• chills
• chest pain
• shortness of breath
• nausea or vomiting
• lightheadedness or dizziness
• tingling, burning, or numbness
• cold hands, arms, legs, or feet

Before starting Gamifant, tell your doctor about all of your medical conditions including if you:

• have an infection
• have received or are scheduled to receive an immunization (vaccine). You should not receive live or live attenuated vaccines while taking Gamifant and for at least 4 weeks after your last dose of Gamifant
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

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

The most common side effects of Gamifant in people with primary HLH include infections, high blood pressure (hypertension), and fever.

The most common side effects of Gamifant in people with HLH/MAS in Still’s disease include viral infection and rash.

These are not all the possible side effects of Gamifant. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.