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Oncology drugs under AMNOG: part one

Segmentation and comparator choice - lessons for cancer drug market access in Germany

Oncology drugs under AMNOGThe AMNOG early benefit assessment process in Germany is now over three years old and as tweaks are made to regulations and manufacturers gain more familiarity with the process we look at what can be learned from its oncology drug benefit assessments. 

Drugs coming to the German market no longer have free pricing. Instead, they are reimbursed at the manufacturer's price only during the first year on the market, while the Federal Joint Committee (G-BA) assesses the new product or indication for a benefit relative to comparator/s selected by the G-BA. Usually the G-BA also seeks the advice of expert Health Technology Assessment (HTA) body IQWiG (the Institute for Quality and Efficiency in Healthcare), to determine the level of added benefit of a drug relative to comparators. This benefit can be at one of four positive levels - major, considerable, minor or unquantifiable added benefit - or there can be a finding of no benefit or of increased harm.

The G-BA also rules on the strength of evidence of the added benefit. If any positive level of added benefit is found, for any patient subpopulation, the drug can go forward to the next step of price negotiation with the payers, the federal association of sickness funds (GKV). If 'no benefit' is found for all patient groups across all comparators, the drug should be priced at the level of other available options - often cheap generics. This is not an acceptable option for manufacturers of novel, expensive cancer therapies, meaning that for oncology manufacturers, gaining a positive benefit level against the right comparator in the right population is critical to market success. 

Click here to read the whole article on Kantar's PMHub profile

Part two will be up next month

Article by
Christine Henry

oncology market access – EU consultant, Kantar Health

7th May 2014

Article by
Christine Henry

oncology market access – EU consultant, Kantar Health

7th May 2014

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