Abstract 1348P
Background
Over the past 20 years, there have been significant advances in cancer treatment with the introduction of targeted therapies, which are often used in combination. These treatments are important for many patients due to prolonged survival compared to existing standard of care. However, patient access to combinations has proved difficult, especially when: the constituents are produced by different manufacturers and the constituents are used in multiple indications. Challenges include difficulties in attributing the value of the constituents in the combination and where value and price is not a simple sum of the parts as well as structural limitations of the access process (such as, legal framework and considerations around manufacturers jointly participating in price negotiations). This makes price and access discussions complex, delaying access to treatment and prevents treatment optimisation and ultimately, dis-incentivises progress in developing oncology medicines.
Methods
This study evaluates the challenges and potential solutions to improve patient access to oncology combination therapies in Belgium, England, France, Germany, Ireland, Italy, Poland, Portugal, Slovenia, Spain, Sweden, and Switzerland. Research methods include a targeted literature review, interviews with pharmaceutical national industry associations and roundtable discussions with policymakers, payers, patients and clinicians.
Results
While there are specific country nuances to consider across different health system archetypes, our research identified common challenges, specifically within the value assessment and pricing negotiation processes, and the general lack of enablers that support access. Table: 1348P
| Theme | Key issues from the literature |
| Value assessment | Current value assessment cannot attribute value within the combination |
| Some clinically effective combination therapies would not be cost-effective even if the second constituent is priced at zero | |
| Pricing negotiation | The limited commercial incentives for the manufacturer of the initial entrant may prevent engagement in price negotiations |
| Price may not be jointly negotiated between manufacturers due to competition law | |
| Additional barriers to access | Lack of data infrastructure for innovative pricing models prevent effective reimbursement negotiations |
| Lack of adequate payment options may lead to access restrictions |
Conclusions
This study finds that there is potential to improve patient access to combinations in Europe. There are important lessons from ongoing debates about potential solutions for future implementation.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Charles River Associates.
Funding
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has funded the research to inform this study. However, the views expressed in this publication are not necessarily the views of EFPIA.
Disclosure
All authors have declared no conflicts of interest.