Precision oncology: The right treatment to the right patient at the right time (Guest blog)
Cancer care is on the verge of a paradigm shift with major benefits for patients, physicians and healthcare systems. However, precision oncology treatments are not yet the standard of care for patients in Europe.
A new position paper, published by the Cancer Drug Development Forum (CDDF), European Cancer Patient Coalition (ECPC) and the EFPIA Oncology Platform, identifies solutions to the regulatory and access barriers to precision therapies and genomic tests.
The paper follows a workshop attended by academics, payers, HTA bodies, patient advocacy groups, pharmaceutical manufacturers and molecular diagnostics companies. This broad group of stakeholders looked at how precision oncology can improve outcomes and make health systems more efficient, as well as the measures required to unlock the full potential of these advances in oncology care.
A radical new approach
First, let’s remind ourselves of the value precision therapies and biomarkers could deliver. The paper sets out the clear benefits that are on offer: better outcomes, fewer adverse events, and reduced costs. Not only could patients (and health systems) avoid unnecessary treatment, but there is also the considerable benefit of patients not wasting precious time receiving ineffective treatments.
This is achieved through a radical change in how we approach cancer treatment. Instead of treating cancer based on the location or origin of the tumour in the body, it has now become possible to develop treatments that specifically target molecular or genomic alterations in the tumour, sometimes even regardless of the location of the tumour itself.
As a result, the patient is much more likely to receive an effective treatment. For health systems, this brings greater certainty and improves the sustainability of healthcare.
All of this is made possible thanks to biomarkers. Their potential to predict clinical outcomes and define a personalised treatment strategy open the door to a new era of cancer care.
Barriers to uptake
When we speak to people outside the healthcare sector, this all makes perfect sense. But their inevitable question is: ‘If these technologies exist, why are they not the norm?’
The long answer is complex and multifaceted, but the short answer is simple: this approach is very innovative and our regulatory and reimbursement systems are built for another era.
The current approach to evaluating cancer therapies is in need of updating. It follows the traditional approach where therapies are selected based on tumour location rather than the specific nature of the patient’s cancer. New models are needed if we are to capitalise on the new wave of precision oncology treatment options, and incentivise the development of new ones.
The paper looks at other challenges too, including the need for new thinking on clinical trials; the need to embrace real-world data from electronic health records, genomic databases and digital tools; and low awareness of precision medicine among the public.
The way forward
It sets out several recommendations that would catalyse the uptake of personalised oncology. At the heart of this will be more ‘joined-up thinking’ from oncologists, pathologists and payers – with patient needs at the centre.
Access to high-quality real-world data and evidence will drive the future of oncology research and care. It should be at the heart of clinical decision-making and support regulatory, reimbursement and policy decisions. To maximise efficiency, data must be interoperable. Harmonised quality and content standards, and linked electronic health record systems, would be a major boost for all healthcare systems with particular benefits for oncology.
Therapies, companion diagnostics and digital tools should be co-developed. This would make R&D more efficient and shorten approval times. Here, the role of the European Medicines Agency (EMA) will be key. Just as research and approval of medicines and companion diagnostics should be linked, so too should reimbursement.
Finally, investing in next generation sequencing (NGS) would potentially offer significant benefits to health systems and patients.
We hope the paper can contribute to moving the conversation forward as we work together to transform cancer care.