2 May 2016 -  The IQWIG in Germany has found ibrutinib has an additional clinical benefit for certain patients with Mantle cell lymphoma and that it offers no additional benefit for patients with chronic lymphocytic leukaemia or Waldenström macroglobulinaemia.

Ibrutinib is a drug for the treatment of rare diseases. It has been approved for the treatment of adults with chronic lymphocytic leukaemia (CLL) or with relapsed or refractory mantle cell lymphoma (MCL) since 2014, and since 2015 also for the treatment of adults with Waldenström macroglobulinaemia. Regarding the treatment of patients with CLL or MCL, the Federal Joint Committee (G-BA) already conducted a benefit assessment and made a decision in 2015.

On request of the G-BA, its sponsor has submitted a new dossier because the turnover of the drug in the statutory health insurance exceeded 50 million euros in the preceding 12 months. The German IQWiG therefore examined in an early benefit assessment whether the drug offers an additional benefit for patients with these diseases in comparison with the respective appropriate comparator therapies.

According to the findings, there is no hint of an additional clinical benefit in CLL and Waldenström macroglobulinaemia. In relapsed or refractory mantle cell lymphoma, there is an indication of major additional benefit for patients for whom temsirolimus is the individually optimized treatment option. An additional benefit is not proven for patients for whom temsirolimus is no or only a secondary option.

For more details, go to: https://www.iqwig.de/en/press/press-releases/press-releases/ibrutinib-indication-of-added-benefit-in-one-of-three-therapeutic-indications.7318.html