Yolande Lievens and Denis Lacombe, Co-Chairs of the Health Systems and Treatment Optimisation Network, highlighted the Network’s aims of optimising cancer treatment for the benefit of the patient, and cancer care delivery for the benefit of the healthcare system.
Optimising cancer care for patients means achieving the best clinical outcome with minimal toxicity, and lowering the burden of the disease, while optimising cancer care delivery relies on the inclusion of other disciplines beyond oncology. This throws up a number of challenges around identifying, measuring and accessing innovation and the integration of multidisciplinary treatment strategies.
The clinically relevant question is how to use innovations, particularly when there is a lack of supportive data. Lacombe believes the answer lies in re-engineering the innovation process via a reserve continuum approach. Too many treatment pathways are drug-centric and a better approach would be to start with the needs of the healthcare system and work retrospectively.
This would naturally raise research questions over the head-to-head performance of treatments and how to combine and optimise biomarkers. Another unaddressed pragmatic research gap is how to decommission treatments.
Above all, the patient should be at the centre of cancer care. The Network supports accelerated access to innovation but attention needs to be paid to how the process is controlled. Key to that is the proposed Resolution, voted on at the end of the session.
Row 1 - Yolande Lievens (European Cancer Organisation’s Health Systems and Treatment Optimisation Network); Lydie Meheus (Anticancer Fund); Bengt Jönsson (Stockholm School of Economics). Row 2 - Denis Lacombe (European Cancer Organisation’s Health Systems and Treatment Optimisation Network); Jan Geissler (EU Cancer Mission Board; European Cancer Organisation’s Patient Advisory Committee); Benjamin Besse (Institut Gustave Roussy). Row 3 - Bartosz Arłukowicz MEP (European Parliament’s Special Committee for Beating Cancer).
The first speaker was Benjamin Besse, Head of the Medical Oncology Department, at Institut Gustave Roussy. He said, twenty years ago, the treatment paradigm for non-small cell lung cancer (NSCLC) consisted of computed tomography staging, biopsy to confirm the tumour pathology, then systemic treatment. The only option was platinum chemotherapy, and median survival was around eight months.
Now, the treatment landscape has changed entirely, with chemotherapy just one of several treatment options, the selection of which depends on the phenotype and genetic profile of the cancer. Targeted immunotherapy can offer survival of up to 60 months, or 18 months with chemotherapy plus immunotherapy, but the workflow now consists of imaging, biopsy, molecular profiling and then treatment. European Society for Medical Oncology guidelines stipulate that five biomarkers need to be tested to adequately profile a tumour, but recent data suggests 25% of NSCLC patients are not tested for epidermal growth factor receptor mutations in Europe and only 18% in the USA have a full molecular profile.
Besse said that the solution could lie in initiatives such as the SPECTA trial, in which patients treated at 166 centres across Europe will have a broad molecular profile offered for free, and then guided to routine treatment in clinical trials. However, the trial is limited by the lack of Europe-wide grants.
Another issue is how Europe can reduce the cost of immunotherapy. Besse will run a trial to determine whether the immunotherapy pembrolizumab can be given every six weeks rather than the three weeks stipulated in the indication.
While this kind of therapy de-escalation approach, if validated, could save €1 billion every year in France alone, it is not possible to conduct the trial across Europe due to variations in the way drug treatment is paid for in trials.
Fatima Cardoso, MD, Director Breast Unit at the Champalimaud Clinical Center, Lisbon, Portugal, commented that the price of drugs should be linked to their benefit, even if that means different prices for each indication. To those ends, the European Society for Medical Oncology Magnitude of Clinical Benefit Scale could be used to classify the benefits of new treatments, and some regulators are already using it to prioritise access.
Another issue is the outdated reimbursement rules in Europe slowing the implementation of high quality care. Cardoso said radiotherapy is still paid by session in many countries, which reduces the incentive for hypofractionation regimens, while some pay for treatments only if in-hospital facilities are used, which favours intravenous over oral treatments.
Besse’s response was that more publicly funded research is needed, as the data that is relevant to those questions is of low value to industry. He noted there is no direct relationship between the dose of a drug and its benefit, suggesting a per-patient price would be more appropriate.
Next, Bengt Jönsson, Professor Emeritus of Health Economics, Stockholm School of Economics, said, while cancer care has improved and there has been an explosion in the number of treatments, the increasing cost of care has created tensions around the need for economic choices.
The data suggests that, while the direct costs have doubled over the past two decades, they have remained stable as a percentage of overall healthcare expenditure, and indirect costs have reduced. Nevertheless, more and tougher choices will be needed on how to use healthcare resources, as the range of innovations and technologies is increasing faster than the resources to pay for them.
This will require data on total cancer spending and how this is allocated, and evidence on the effectiveness and value of treatment, which is not readily provided by regulatory trials. Moreover, clinical and translational research should address the needs of patients and society to make informed choices on the value of different options.
Bartosz Arłukowicz MEP, Chair of the European Parliament’s Special Committee on Beating Cancer, said the Committee has goals around common basic healthcare standards, reducing inequalities and supporting the early and rapid diagnosis of patients.
He said the common purchase of the most important medicines is needed to avoid shortages, alongside a greater focus on rare and paediatric cancers. Personalised medicine should be more widely available, and common standards and protocols for drugs are needed, including the sequencing, combination and duration of drugs.
Importantly, the EU already has the tools to support a lot of these aims, but what is required is common datasets.
In the panel discussion, Jan Geissler, CML Advocates Network and European Cancer Organisation’s Patient Advisory Committee member, said the key issue is access to optimal treatment, as only the treatment that is accessible is the one that works.
Only academia is interested in over-treatment and de-escalation, and such data is not routinely collected and reported. There is also not enough real-world data on drug performance, nor enough focus on patient-related outcomes. Industry and academic data needs to be pooled to identify signals and evolve cancer care. Geissler believes data protection is also not often implemented in the interests of patients.
Lydie Meheus, Managing Director of the Anticancer Fund, echoed many by saying that Europe should invest in independent international research to fill gaps that are outside the scope of the industry but that can benefit patients.
There needs to be greater support for combination trials, alongside regulatory reforms to better serve patients and society. Market approval should be conditional if the data is immature and quality of life data is lacking, to offer an incentive to optimise treatment, and identifying novel indications for pre-existing therapies should be made easier.