Influence of market access conditions on utilization of innovative drugs in Europe: The cases of trastuzumab and cetuximab.

Abstract

1601 Background: Market access conditions of innovative drugs are expected to affect their utilization. Prices of recently launched monoclonal antibodies are high and their accessibility differs across Europe. In Italy most products are associated to risk-sharing schemes while in France they are approved with no restrictions. Funding process varies: these products are funded on top of diagnostic-related group (DRG) costs in France, but not in the United Kingdom and Germany. Trastuzumab (TRZ) was recommended by payers for early- and late-stage breast cancer (BC) in Europe, with differences in the process and timelines of recommendations. Cetuximab (CTX) for metastatic colorectal cancer (mCRC) was not recommended in the United Kingdom (until June 2009), but accepted under a price volume agreement scheme with prior authorization in Italy, and without restriction in France and Germany. Methods: We reviewed how such differences might affect usage of TRZ and CTX in France, Germany, Italy, and the United Kingdom. Data on drug utilization from June 2006 to July 2009 were extracted from the Synovate Oncology Monitor, an ongoing database tracking prescribing of anticancer therapies. Sample sizes varied between countries and cancer types, from 1,700 to 6,200 patients. Results: Utilization rates from July 2008 to Jun 2009 are shown below (Table). Differences across countries were larger for TRZ than CTX. Utilization of TRZ increased over time in early stage BC (irrespective of HER2 screening) but there was no clear trend in late stage. Utilization of CTX was stable in France, increased in Germany, and decreased in Italy. Dosages and patient profiles were comparable across countries. Conclusions: Funding on top of DRG does not appear to increase drug uptake. Health technology assessment conclusions influence utilization strongly. Even when access is granted, the existence of administrative constraint may reduce first-line utilization to the benefit of second-line. This should be considered when decisions are made about access to innovative medicine. France Germany Italy United Kingdom Trastuzumab—BC Early stage 10% 12% 16% 9% Late stage, 1st-line 19% 16% 12% 14% Late stage, 2nd-line 10% 22% 34% 16% Cetuximab—mCRC 1st-line 7% 13% 3% 0% 2nd-line 17% 16% 19% 2% No significant financial relationships to disclose.