(No) Opt-Out for Bosutinib

20.12.2013 10:25

According to Dr. Tobias Eichhorn, Managing Director of Pfizer Pharma GmbH and Head of the Oncology Department in Germany, Pfizer saw "no prospect of an agreement and a reimbursement amount that adequately reflects the benefit of Bosulif for the treatment of a very small patient group after the first negotiation meeting with the National Association of Statutory Health Insurance Funds." Based on this reasoning, the pharmaceutical company exercised its opt-out option for "Bosulif" (active ingredient bosutinib) on November 15th, a decision which was revised on December 16th.

After the first (of a possible four) negotiation meeting, during which, according to the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband), no initial offers regarding the reimbursement amount had even been exchanged, Pfizer exercised its opt-out option for bosutinib. Just under four weeks later – on December 16 – Pfizer and the National Association reached an agreement on a reimbursement price, just as surprisingly as the market withdrawal had occurred. "The National Association of Statutory Health Insurance Funds considered the decision premature and is now pleased to have found a patient-friendly and balanced solution with Pfizer following this decision," both parties stated in a joint declaration. This price negotiation coincided with a second price negotiation – for "Xalkori" (active ingredient: crizotinib) – between Pfizer and the National Association, which also took place on December 16, 2013 – and was successful on the first attempt. For Crizotinib, the G-BA had also identified an indication of considerable additional benefit, while Bosutinib had only been granted a proven, but in terms of extent not quantifiable (and also limited to five years) additional benefit.