Differences in time to patient access to innovative cancer medicines in six European countries

Patients across Europe face inequity regarding access to anticancer medicines. While access is typically evaluated through reimbursement status or sales data, patients can receive first access through early access programs (EAPs) or off-label use. This study aims to assess the time to patient access at the hospital level, considering different indications and countries. (Pre-)registered access to six innovative medicines (Olaparib, Niraparib, Ipilimumab, Osimeritinib, Nivolumab and Ibritunib) was measured using a cross-sectional survey. First patient access to medicines and indications were collected using the hospital databases. Nineteen hospitals from Hungary, Italy, the Netherlands, Belgium, Switzerland and France participated. Analysis showed that some hospitals achieved patient access before national reimbursement, primarily through EAPs. The average time from EMA-approval to patient access for these medicines was 2.1 years (Range: −0.9-7.1 years). Hospitals in Italy and France had faster access compared to Hungary and Belgium. Variation was also found within countries, with specialized hospitals (x̄: −0.9 years; SD: 2.0) more likely to provide patient access prior to national reimbursement than general hospitals (x̄: 0.4 years; SD: 2.9). Contextual differences were observed, with EAPs or off-label use being more prevalent in Switzerland than Hungary. Recent EMA-approved indications and drug combinations reached patients at a later stage. Substantial variation in patient access time was observed between and within countries. Improving pricing and reimbursement timelines, fostering collaboration between national health authorities and market authorization holders, and implementing nationally harmonized, data-generating EAPs can enhance timely and equitable patient access to innovative cancer treatments in Europe.</p

Targeted combination therapies in oncology: Challenging regulatory frameworks designed for monotherapies in Europe

The pharmaceutical value chain, including clinical trials, pricing, access, and reimbursement, is designed for classical monotherapies. Although there has been a paradigm shift that increases the relevance of targeted combination therapies (TCTs), regulation and common practice have been slow to adapt. We explored access to 23 TCTs for advanced melanoma and lung cancer as reported by 19 specialists from 17 leading cancer institutions in nine European countries. We find heterogeneous patient access to TCTs between countries, differences in country-specific regulations, and differences in the clinical practice of melanoma and lung cancer. Regulation that is better tailored to the context of combinational therapies can increase equity in access across Europe and promote an evidence-based and authorized use of combinations.Health Research BoardEuropean Fair Pricing Network (EFPN

Improving Antarctic Bottom Water precursors in NEMO for climate applications

International audienceThe world's largest ice shelves are found in the Antarctic Weddell Sea and Ross Sea where complex interactions between the atmosphere, sea ice, ice shelves and ocean transform shelf waters into High Salinity Shelf Water (HSSW) and Ice Shelf Water (ISW), the parent waters of Antarctic Bottom Water (AABW). This process feeds the lower limb of the global overturning circulation as AABW, the world's densest and deepest water mass, spreads outwards from Antarctica. None of the coupled climate models contributing to CMIP6 directly simulated ocean-ice shelf interactions, thereby omitting a potentially critical piece of the climate puzzle. As a first step towards better representing these processes in a global ocean model, we run a 1∘ resolution Nucleus for European Modelling of the Ocean (NEMO; eORCA1) forced configuration to explicitly simulate circulation beneath the Filchner-Ronne Ice Shelf (FRIS), Larsen C Ice Shelf (LCIS) and Ross Ice Shelf (RIS). These locations are thought to supply the majority of the source waters for AABW, and so melt in all other cavities is provisionally prescribed. Results show that the grid resolution of 1∘ is sufficient to produce melt rate patterns and total melt fluxes of FRIS (117 ± 21 Gt yr-1), LCIS (36 ± 7 Gt yr-1) and RIS (112 ± 22 Gt yr-1) that agree well with both high-resolution models and satellite measurements. Most notably, allowing sub-ice shelf circulation reduces salinity biases (0.1 psu), produces the previously unresolved water mass ISW and re-organizes the shelf circulation to bring the regional model hydrography closer to observations. A change in AABW within the Weddell Sea and the Ross Sea towards colder, fresher values is identified, but the magnitude is limited by the absence of a realistic overflow. This study presents a NEMO configuration that can be used for climate applications with improved realism of the Antarctic continental shelf circulation and a better representation of the precursors of AABW