BPI: AMNOG – does the learning system learn?
10.06.2015 12:51
According to the Federal Association of the Pharmaceutical Industry (BPI), the supply of innovative medicines in Germany has deteriorated after the introduction of early benefit assessment. In a report by health economist Prof. Dr. Dieter Cassel and Prof. Dr. Volker Ulrich, who was commissioned by the BPI, was able to determine that even medicines that have received a positive assessment from the Federal Joint Committee do not reach patients to the extent that would be necessary based on the current state of knowledge.
In particular, doctors' uncertainty as to whether they are allowed to prescribe these effective and better medicines would slow down progress in therapy. “We urgently need clarification here so that doctors know that a drug whose reimbursement amount has been negotiated is cost-effective and that they are not threatened with recourse. It must be ensured that therapeutic improvements actually reach patients!” explained Dr. Martin Zentgraf, Chairman of the BPI.
What is also highly problematic, according to the experts' investigations, is that after 70 completed procedures, 13 of these evaluated drugs are no longer available on the German market. This would significantly limit the variety of treatments and the doctor's options. In addition, the verdict “no additional benefit proven” is not the same as the claim that there is no additional benefit. In the vast majority of cases, data are available that were not accepted as proof of additional benefit for formal methodological reasons. There is a reason why this number is so high
In the opinion of the experts and the association, based on the practice of AMNOG: Rigid criteria are applied to avoid products being evaluated too positively. However, the risk that products are wrongly assessed too negatively and are subsequently no longer available for therapy is ignored.
In the BPI's opinion, there is still an urgent need for improvement in the area of governance. The omnipresence and de facto omnipotence of the National Association of Statutory Health Insurance Funds in the process must be ended. In addition, the price anchor of a generic appropriate comparative therapy should not be viewed as dogma. “You cannot measure the remuneration for a new development based on the price of a drug that has taken a long time to recoup its development costs. This medicine was also new and had its price. Anyone who proceeds in this way accepts market exits and withdrawals and impairs therapeutic progress,” says Zentgraf.