Sanofi Launches Warranty Program for Cablivi

Sanofi has introduced a warranty program for Cablivi, its treatment for the rare blood-clotting disorder acquired thrombotic thrombocytopenic purpura (aTTP) in adults.

Cablivi is used together with a plasma exchange procedure and immunosuppressive therapy to treat aTTP in adults. It is a small protein that is meant to prevent dangerous blood clots from forming during an aTTP episode.

Under the program, first reported on by STAT,  the cost of Cablivi will be refunded in the hospital setting for up to six inpatient doses for patients who fail to reach initial clinical response to Cablivi or up to 12 inpatient doses for patients who exacerbate while on Cablivi treatment. Additional eligibility requirements, terms, and conditions apply. The estimated average cost for treating a typical aTTP episode with Cablivi is $270,000, according to Optum Rx.

The decision follows Pfizer’s use of warranty programs for two of its drugs. BioMarin, has also said it plans to introduce a warranty program for its hemophilia gene therapy once it is approved in the United States. It reflects the need for drug companies to mitigate the risk for patients and payers with new high-priced therapies that provide uncertain benefits to individual patients. 

aTTP is a rare, life-threatening, autoimmune disorder. Despite the current standard-of-care treatment, consisting of daily plasma exchange and immunosuppression, episodes of aTTP are still associated with a mortality rate of up to 20 percent, with most deaths occurring within 30 days of diagnosis. The European Commission approved Cablivi in August 2018.

Cablivi is Sanofi’s first nanobody-based medicine to receive approval and the first newly approved product that will be part of Sanofi Genzyme’s Rare Blood Disorders franchise. Ablynx, which Sanofi acquired in 2018, developed Cablivi. It targets von Willebrand factor, a protein in the blood involved in hemostasis. It is designed to inhibit the interaction between vWF and platelets.

Author: Rare Daily Staff