1319MO - Actual patient access to innovative medicines in six European countries

Background

As patient access to therapeutic innovations is critical in oncology, our study aims to assess the availability and time to access to innovative cancer drugs and their indications for the EU market.

Methods

To obtain actual patient access beyond sales data, hospital pharmacists were invited to participate in a survey and interview regarding the timing, context and first patient access to six cancer medicines and their indications in their hospital. The selected medicines (Olaparib, Niraparib, Ipilimumab, Osimeritinib, Nivolumab, and Ibritunib) are recently registered, high-priced, and clinically relevant (ESMO-Magnitude of Clinical Benefit Scale>3).

Results

22 hospitals (five university- and seven comprehensive cancer centers) from Hungary, Italy, the Netherlands, Belgium, Switzerland, and France participated in this study. In every country, all medicines were available in at least one of the hospitals. A total overview per drug, hospital and country was produced. Niraparib was least available (in only six of the 18 hospitals that treated ovarian cancer) and Nivolumab was most available (in 17 of the 18 hospitals that treated at least one of its indications). High variation in patient access was observed between medicines with shortest time to access for Nivolumab (Mean: 266 days; SD: 473), and the longest time for Ipilimumab (Mean:1012 days; SD: 848). In Hungary, selected medicines were mostly available after a national reimbursement decision (Mean: 1338 days; SD: 830). In Switzerland, they were often earlier available through early access schemes or off-label use (Mean: 512 days; SD: 525). Heterogeneity was also observed within hospitals per countries. For example in the Netherlands, first access to Olaparib was reported in one hospital in early access scheme 164 days after EMA approval, while it became in another hospital available in reimbursed context 2212 days after EMA approval.

Conclusions

Due to divergent marketing strategies, cancer center priorities and reimbursement processes, there are very large differences in patient access to new cancer drugs between and within EU countries. Reducing complexity and harmonizing processes of early access schemes and off-label use could ensure more timely and equitable access to innovative cancer drugs across EU.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The Netherlands Cancer Institute.

Funding

European Fair Pricing Network.

Disclosure

V. Retel: Financial Interests, Institutional, Research Grant, The authors declare that they have nothing to disclose for the work under consideration.: Intuitive , Agendia . W. van Harten: Financial Interests, Institutional, Research Grant, The authors declare that they have nothing to disclose for the work under consideration.: Novartis, Intuitive Surgical , Agendia. All other authors have declared no conflicts of interest.