Background: Oncology combination medicines increasingly represent the best treatment option for many patients, delivering significant benefits over monotherapies. However, there are challenges to ensuring patients have access to these medicines. Here, we investigate these challenges and propose potential solutions to ensure sustainable access to oncology combinations in the future.

Methods: This study is based on an analysis of the availability and access delays for combination products across Europe, Australia and Canada from 2015 to 2020. The current debate and national approaches were investigated with 18 cross-stakeholder interviews, to validate the analysis of the challenges and investigate the viability of potential policy solutions.

Results: On average, 70.2% of all oncology medicines receive positive recommendation, compared to only 59.9% of branded combinations; a discrepancy of over 10%. This is particularly pronounced in certain countries, including Australia and UK. Combination therapies also require an average 99 days extra between regulatory approval to reimbursement decision. All combinations face novel pricing and reimbursement challenges, but these can appear insurmountable for specific types of combinations. It is particularly challenging when constituents are owned by different manufacturers. Problems are exacerbated by lifecycle considerations and the presence of existing indications for each constituent.

Conclusions: Given the value of combination therapies, it is important to ensure patients have timely access to these vital treatments. Without appropriate policy solutions there may be further delays or restrictions. The challenges of combinations are clearly mitigated by: confidential rebates by combination, combination-based tracking of the usage, and value-based assessment of the combination, as an aggregated intervention. We show these are required but additional mechanisms will be needed. In some cases, voluntarily “competition-law-proof” negotiations between manufacturers or the establishment of a method for value attribution can be a way for accelerating access.