Critical voices for benefit assessment of AMNOG-procedure – Will AMNOG be revised in 2018?
About the author
Prof. Matthias P. Schönermark, M.D., Ph.D.
Founder and Managing Director
Founder and Managing Director
Fon: +49 511 64 68 14 – 0
Fax: +49 511 64 68 14 18
Fax: +49 511 64 68 14 18
According to the GKV-Spitzenverband (the umbrella organization of the German payers), the AMNOG-procedure saved EUR 2.85 billion between 2012 and 2016. Nevertheless, for social health insurances the cost of drugs has steadily increased. A comparison of the first three quarters of 2016 und 2017 displays a further increase of 2.48%. Due to this, different entities demand a revision of the existing system.
Therefore, the GKV-Spitzenverband demands that the benefit assessment from the G-BA decision, which is differentiated according to patient groups, has to be reflected with the same differentiation in the reimbursement level. Prof. Josef Hecken, chairman of the Federal Joint Comittee (Gemeinsamer Bundesausschuss, G-BA), requests for a downgraded benefit assessment if there are no indications about the quality of life: “Oncology products are still being rated above average. Only every fifth of the 88 assessed cancer drugs did not show an added benefit. However: Most of these therapies only prolonged the life of the patients by three to six months in average.”
The pharmaceutical association (vfa) emphasizes the improved treatment possibilities of admissions in 2017. The assortment of medicine has been enlarged by 31 drugs with a new active substance. Furthermore, new dosage forms and combinations expanded the treatment possibilities, e.g. for small children. In particular, the vfa criticized the early benefit assessment of the AMNOG-procedure and describes it as “a process that is as complex as it is complicated, and in several places it is questionable from a methodological standpoint”. With respect to the high cost pressure the question arises, whether or not the legislature will include the points of criticism and revise the procedure in 2018?
For all questions regarding market access in Germany and AMNOG-procedure you can receive competent support by SKC Beratungsgesellschaft.
BY Prof. Matthias P. Schönermark, M.D., Ph.D., Founder and Managing Director, SKC Beratungsgesellschaft mbH
Sources
Pharmazeutische Zeitung: G-BA will schärfere Regeln für Krebsmedikamente (German only)
vfa: Bilanz 2017 - Fortschritte durch neue Arzneimittel (German only)
vfa: Early benefit assessment: Reviews and negotiations – Problems and conflicts
GKV Spitzenverband: Arneimittel (German only)
GKV Spitzenverband: Fokus: AMNOG-Verhandlungen (German only)