Grössmann, N. and Wild, C. and Mayer, J. (2016): Drugs in Oncology: an overview of benefit and refund practices in Europe. Rapid Assessment 008.
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Austria belongs to those countries, which adopt new cancer drugs not only early and fast, but also use them widely. In 2009, the LBI-HTA launched the programme "Horizon Scanning in Oncology" (HSO) in order to enable evidence based decisions on the use of cancer drugs and estimations on implications for the health care budget in Austria. Since then numerous (n=59) early assessments of new cancer drugs were published. This review provides an overview of all cancer drugs approved by the European Medicines Agency (EMA) between 2009 and 2015 and the state of knowledge on patient-benefit at the time of approval, and analyses which policies for high-prized cancer drugs are applied in other (European) countries.
At the time of approval by EMA, for 26 (23%) of 73 cancer drugs between 2009 and 2015 no information about the two endpoints overall survival (OS) and progression free survival (PFS) was available. For 37 (45%) of cancer drugs, OS was increased up to 3 months, and for 14 (13%) up to 5.8 months in relation to the comparator. The benefit assessments in various countries (Germany, England, Norway, Belgium, Netherlands, Canada) differ in the point in time they were carried out (before/ after approval), in methods used (only clinical benefit assessment or additional cost-effectiveness analysis), the publication of results (degree of transparency) and the binding character of recommendations (from purely informational to binding). In a comparison of national benefit assessments of cancer drugs, 14 drugs in 15 indications, including also some drugs that are in the Austrian MEL-catalogue, have been assessed consistently negative (not recommended). 16 drugs in 22 indications have been assessed consistently positive (recommended).
Assessments with (binding) recommendations, health economical evaluations, "Managed-Entry Agreements" and "Value-based pricing" are approaches to identify cancer drugs with the highest benefit whilst incurring acceptable costs, through transparent and traceable methods.
|Item Type:||Rapid Assessment LBI-HTA|
|Keywords:||Oncology, cancer, drugs, Benefit Assessment, reimbursement, value-based pricing, Managed-Entry Agreements|
|Subjects:||WA Public health > WA 525-590 Health administration and organisation|
WB Practice of medicine > WB 300-962 Therapeutics
W Health professions > W 74-80 Medical economics. Health care costs
WB Practice of medicine > WB 102 Evidence-based medicine
W Health professions > W 84 Health services. Quality of health care
QZ Pathology > QZ 200-380 Neoplasms.Cysts
QV Pharmacology, toxicology, pharmacy > QV 60-370 Pharmacology
|Series Name:||Rapid Assessment 008|
|Deposited on:||08 Jul 2016 13:30|
|Last Modified:||14 Jul 2016 23:39|
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