Sanofi US News

Cambridge, MA– October 9, 2019 – The Centers for Medicare & Medicaid Services (CMS) recently published its 2020 final Inpatient Prospective Payment System (IPPS) rule, awarding Cablivi (caplacizumab-yhdp) the New Technology Add-on Payment (NTAP) status.

Cablivi was approved by the U.S. Food and Drug Administration (FDA) in February 2019 for the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP) in combination with plasma exchange (PEX) and immunosuppressive therapy. Under the NTAP program, acute care hospitals reimbursed under IPPS may receive a payment of up to $32,215 per qualifying case.  NTAP status for Cablivi began on October 1, 2019 and will be in effect for a minimum of two years, not to exceed three years.

CMS approves NTAP for products when it determines the product provides a substantial clinical improvement over existing therapies; when the product is new and not substantially similar to another technology; and when the product would not be adequately reimbursed.

“We are pleased with the decision from CMS to grant NTAP status to Cablivi,” says Bill Sibold, Executive Vice President and Head of Sanofi Genzyme, Sanofi. “Cablivi is the first FDA approved treatment in combination with PEX and immunosuppressive therapy specifically for aTTP, a rare, life-threatening, autoimmune blood disorder. We believe having NTAP status in place will help expand access to Medicare patients to help in treating this serious and often debilitating disease.” 

Cablivi is an antibody fragment which inhibits the microthrombi formation and targets von Willebrand factor (vWF), a protein in the blood involved in hemostasis.  Cablivi is Sanofi’s first Nanobody^®-based medicine to receive approval in the U.S. Nanobodies^® are a novel class of proprietary therapeutic proteins based on single-domain antibody fragments that contain the unique structural and functional properties of naturally-occurring heavy chain only antibodies.

About aTTP

aTTP is a rare, life-threatening, autoimmune blood disorder.  aTTP is considered an urgent, medical emergency.  For some patients, resuscitative measures might be required and the immediate outcome might not be predictable.   In most cases, patients are treated in intensive care units during the first few days following their aTTP episodes. It is estimated that 8 to 20% of patients die from aTTP episodes with PEX and immunosuppression alone, with median time to death of 9 days from diagnosis.  In the U.S., aTTP affects fewer than 2,000 adults each year.

INDICATION AND IMPORTANT SAFETY INFORMATION 

What is CABLIVI?
CABLIVI (caplacizumab-yhdp) is a prescription medicine used for the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.

Who should not take CABLIVI?
Do not take CABLIVI if you’ve had an allergic reaction to caplacizumab-yhdp or to any of the ingredients in CABLIVI. 

What should I tell my healthcare team before starting CABLIVI? 
Tell your doctor if you have a medical condition including if you have a bleeding disorder.  Tell your doctor about any medicines you take.
Talk to your doctor before scheduling any surgery, medical or dental procedure.

What are the possible side effects of CABLIVI?
CABLIVI can cause severe bleeding. In clinical studies, severe bleeding adverse reactions of nosebleed, bleeding from the gums, bleeding in the stomach or intestines, and bleeding from the uterus were each reported in 1% of subjects. Contact your doctor immediately if excessive bleeding or bruising occur.

You may have a higher risk of bleeding if you have a bleeding disorder (i.e. hemophilia) or if you take other medicines that increase your risk of bleeding such as anti-coagulants.  

CABLIVI should be stopped for 7 days before surgery or any medical or dental procedure. Talk to your doctor before you stop taking CABLIVI.

The most common side effects include nosebleed, headache and bleeding gums.
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of CABLIVI. Call your doctor for medical advice about side effects. 

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