Feedback on Europe's Beating Cancer Plan
The European Commission kicked off the consultation of Europe's Beating Cancer Plan on the 4th of February 2020. The plan itself is expected to be published in November 2020. We gave our feedback.
The Anticancer Fund supports the objective of increasing survival rates and improving quality of life of cancer patients by providing access to the best possible treatments for all. However, studies have shown that the current European system for clinical research, approval and market access of new cancer medicines is failing to achieve this goal. To ensure that the best treatment reaches the patient, Europe’s Beating Cancer Plan should address the following:
Look for added therapeutic value
First, the current regulatory system is focused on approval of a single medical product based on safety and efficacy, NOT on added therapeutic value. The ongoing discussion about suitable endpoints for drug approvals should aim at clinical relevance for patients, and in that context surrogate endpoints could only be accepted to allow fast access if there is a high unmet need and should always be linked to conditional approval and post-authorisation effectiveness data collection. To provide the best possible treatment to patients, we recommend strengthened European cooperation in HTA (and preferably joint clinical assessments), earlier dialogue between EMA and HTA organisations, and the requirement for registration studies with robust and meaningful clinical endpoints.
Ideally, registration trials should be designed by independent trialists in a patient-centred and efficient way, enabling reliable and timely access to evidence based treatment options. Nowadays companies understandably design their registration trials to maximise their chances of success and financial return. For rare cancers (including paediatric cancers), platform trials managed by collaborative groups could be the preferred format since they will allow direct and efficient comparison of different treatment options. Europe should explore innovative trial designs and could set up a clinical trials transformation initiative (www.CTTI-clinicaltrials.org) in dialogue with the US. Continuous proper registration of cancer treatment outcomes should be enforced by European legislation as these data will be crucial for cost-effectiveness calculations.
Non-commercial research should be incentivised
Second, The Anticancer Fund recognises the need for companies to create value for their shareholders and therefore to develop treatments with high return on investment. However, this should be compensated by non-commercial health stakeholders identifying societal health priorities and investing in areas where there is little or no financial interest, such as drug repurposing and rare cancers including paediatric cancers. A symbiotic relationship between commercial stakeholders and public authorities, foundations, academia, patients and healthcare professionals as non-commercial stakeholders needs to be incentivised.
Synergies with the pharmaceutical agenda are necessary
Third, Europe’s Beating Cancer Plan must be developed synergistically with the EU pharmaceutical strategy. The pace at which science is revealing the underlying biology of cancer and how this information is used to develop innovative therapies is unprecedented. As a result, combination treatments are becoming commonplace but the approval system and the price setting framework are not fit for purpose as they are designed to approve one medicine for one indication - something which today applies very rarely in the oncology field.
Health claims should be monitored
Fourth, Europe must make efforts to ensure a transparent system is in place for provision of information to patients about “the best treatments”. In contrast to FDA, EMA is not policing unproven health claims because this is the legal responsibility of Member States. Unproven health claims and the marketing and selling of cancer treatments over the internet is increasing and is happening across borders. Health fraud scams should be monitored at the European level and actions towards companies and website operators taken in coordination with Member States. Monitoring could be undertaken by the European Cancer Knowledge Centre already suggested in the plan as a possible instrument for connecting data and scientific evidence.