Precision Oncology: Better Treatment For Cancer Patients Needs Better Legislation
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We have achieved unprecedented scientific breakthroughs in the fight against cancer. But whether larger groups of patients will benefit from new precision medicines any time soon depends on developments in our healthcare systems.
Over the past 30 years, scientists have learnt more about the complexity of cancer and come to realize that no two cancers are alike. As a result, new approaches to treatment have been developed. In place of the conventional approach of chemotherapy followed by second line treatment, with all the associated side effects, today new-generation precision medicine has opened a much brighter chapter for some cancer patients.
Although the traditional approaches – surgery, radiation and chemotherapy, will remain important pillars in treating cancer, some of these newer innovations have the potential to further improve treatment outcomes, lessening the burden for millions of cancer patients, their loved ones and society. Cancer affects millions of people worldwide. Ensuring that these medical advances are available to a wide population is essential.
Genomic testing and precision medicines
The conventional approach to cancer treatment is to target and destroy specific tumour cells, often based on their location in human organs or tissue. Today, thanks to major advances in academic and commercial research, we understand that cancer is a disease of the genome. For some of the known oncogenic drivers, new approaches are developed targeting precisely those oncogenic drivers, which are the result of genomic alterations in tumor cells. Genomic testing is at the heart of these new developments.1 This allows clinicians to deploy tailor-made treatments with pin-point accuracy. It promises not only higher efficacy and better care for patients with fewer side effects, but also better allocation of already stretched healthcare resources.
Good reason to be optimistic, one could argue. But before larger groups of cancer patients can even get the chance of enjoying improved treatment, better quality of life and potentially cure, significant obstacles must be overcome. These challenges are not of a scientific nature. They will not be resolved by research teams in high-tech laboratories but must be addressed through concerted efforts by policymakers on a national and international level.
Medical innovation has outpaced practices in our healthcare systems. Awareness, policies and infrastructures have not kept up with the remarkable scientific progress and are failing so far to make new medicines and treatments available to larger groups of patients.
Access to new precision medicines varies from country to country. Only in the US, UK and Germany do patients have access to more than 40 of the 55 cancer medicines made available by the pharma industries between 2012 and 2016.2 Across the board, the bodies responsible for the assessment of newly approved cancer drugs apply very different methods in the value-assessment process. As a result, access to new tested and licensed medicines is restricted.3 Genomic tests are often simply not part of clinical practice and in turn not reimbursed or even available to patients.4 Cancer patients themselves very often lack awareness of treatments that today are at least theoretically available to them.5
A way forward
The regulatory agencies in the EU, Brazil, Taiwan, Canada and the United States have shown signs of willingness to accept novel trial designs and efficiently evaluate precision cancer and even tumour-agnostic medicines. This is a welcome development and should be expanded.
Now, policymakers must rethink HTA legislation. Decisions on value assessments should be based on transparent, scientifically sound and predictable frameworks. HTA bodies should take into account the value of precision oncology and develop innovative methodologies that can adapt to available evidence from novel trial designs – such as basket trials, for example – and also accept smaller data sets. Interim and early access programmes can allow for the early provision of innovative medicines while additional value assessment and pricing negotiations are being conducted. Uncertainties that exist at the time of assessment can be overcome if the assessment body requires the development of additional technologies or processes for data collection and review, such as real-world evidence concepts. The same flexibility should exist where there is a lack of comparators.
The advantages of genomic testing should be recognized and should become part of routine clinical practice. This requires robust infrastructures and funds to be made available for health centres to carry out such tests.
Innovative cancer diagnostics and treatments can dramatically lessen the burden of cancer. But for these achievements to improve the lives of millions of cancer patients now and in the future, health systems need to reform and catch up with medical progress.
1 Aronson SJ, Rehm HL. Building the foundation for genomics in precision medicine. Nature. 2015; 526(7573): 336-342. 2 IQVIA. Global Oncology Trends 2018. Innovation, Expansion and Disruption, May 2018.
2 Akehurst RL, Abadie E, Renaudin N, et al. Variation in health technology assessment and reimbursement processes in Europe. Value Health. 2017;20:67-76.
3 IQVIA. Global Oncology Trends 2018. Innovation, Expansion and Disruption, May 2018.
4 Charles River Associates. The benefits of personalised medicine to patients, society and healthcare systems: final report. Prepared for: European Biopharmaceutical Enterprises (EBE) and the European Federation of Pharmaceutical Industries and Associations (EFPIA), July 2018. https://www.efpia.eu/media/362040/cra-ebe-efpia-benefits-of-pm-final-report-6-july-2018.pdf. Accessed April 25, 2019.
5 European Cancer Patient Coalition. “Cracking the Cancer Code: Personalised Medicine Awareness Month 2018.” http://www.ecpc.org/PMAM_Campaign_Toolkit.pdf. Accessed April 18, 2019.