BERLIN, Dec 13 (APM) - The AMNOG procedure combining health technology assessment (HTA) and price negotiations in Germany has created "a growing gap with medical recommendations", pharma lobby vfa has said.
Vfa highlighted in a Monday press release that one in five new drugs - 29 out of 141 - launched on the German market since the AMNOG procedure was introduced in 2011 is no longer available.
These withdrawals mean that "patients and doctors lose therapy options", said Birgit Fischer, managing director of vfa. Furthermore, some of the withdrawn drugs were "preferred treatment options" according to medical guidelines.
"The gap between what doctors and medical societies recommend and what the AMNOG bodies consider useful is growing", Fischer said. This means that patients in Germany are "disadvantaged".
"In most cases, disagreements between the AMNOG bodies and the pharmaceutical companies are on how to assess data," in particular on formal criteria. This means that data provided by the company are not taken into account in the added benefit assessment.
In such cases, the company is "dragged down" in the pricing negotiations with umbrella payer group GKV-Spitzenverband that follow the added benefit assessment.
"For some companies, the only possible reaction is to withdraw the drug from the market".
This has frequently been the case for diabetes, cancer and neurological drugs, vfa said. The list of the 29 withdrawn drugs that vfa sent to APM includes nine for type 2 diabetes, three for cancer and four neurological drugs.
The recent withdrawals of Bayer's Stivarga (regorafenib) (APMMA 47463) and AstraZeneca's Tagrisso (osimertinib) (APMMA 50277) have been particularly criticised by oncologists' assocations.
vfa added that some of the withdrawals were not due to the AMNOG procedures but to rapid changes in therapy standards, citing "hepatitis C drugs". The list includes Janssen's Incivo (telaprevir) and Merck Sharp & Dohme's Victrelis (boceprevir).
The German Parliament is currently examining the drugs care reinforcement bill (AM-VSG), which will change some aspects of the AMNOG procedure as well as pricing criteria. On Wednesday, the health commission of the Bundestag is organising a hearing on the bill with around 40 organisations.
/hm/clg
TRY APM Market Access AND GET ACCESS TO THE FULL CONTENT
Interviews with KOLs/senior executives amongst the Regulators, Payers, Health, Medical & Pharmaceutical organisations
Events coverage with a unique focus on Market Access & sustainability of healthcare systems
6 European bureaus : Berlin, Brussels, London, Madrid, Milan & Paris
Ask for a Free trial and get access to the latest stories
Our coverage includes:
- Health Care
- Market Access
- HTA – policies & practices
- European medicine regulations
- Drug safety issues
- Pricing & Reimbursement
- International medicines agencies
If you are a Payer, Pharmaceutical or Consulting professional our premium data will keep you informed on the regulatory, pricing, market access and cost-effectiveness issues that impact all stakeholders.
REQUEST
an initial 10 day temporary access of APM Market Access.
