Actual developments in European regulatory and health technology assessment of new cancer drugs: what does this mean for oncology in Europe?


Annals of oncology

The incidence of cancer has been estimated at 11 million cases per year with a global prevalence of 25 million cases, and the World Health Organisation (WHO) has predicted that within the next decade these figures could increase up to 50%, reaching 15 million new cases per year by 2020. In Europe, there were an estimated 3.2 million new cases of cancer and 1.7 million deaths from cancer in 2008. As such, there is a current and growing requirement for more emphasis on cancer prevention, research, therapy in general and better targeted anticancer drugs. Rapid licencing and market availability of innovative, more effective oncology drugs are also a necessity.

Inevitably, health care policy makers have to balance between the infinite level of healthcare demands and their finite healthcare resources. This means that oncology drugs have to be assessed not only on their clinical merit, but also on their cost-effectiveness in comparison with currently available alternative therapies. Currently, this system involves input from two different bodies which increases not only the workload associated with drug development, but also the costs. Most EU member states have delegated these so called relative efficacy, relative effectiveness and cost-effectiveness assessments to dedicated health technology assessment (HTA) agencies. Despite commonalities in scope of the assessments conducted by regulatory agencies and HTA bodies, the applied evidentiary and analytical standards, extrapolations from the underlying clinical evidence base as well as scientific value judgements for the same drug differ substantially between the regulatory and HTA agencies.