Following the launch of the second Lung Cancer Europe Report, the organisation’s president, Stefania Vallone, spoke to PEN about the disparities that remain in access to innovative lung cancer treatments.
Advances in surgical techniques and chemo-, radio- and immunotherapy, the advent of personalised medicine, and improvements in our understanding of the molecular drivers of cancer are shifting the landscape of lung cancer treatment and care and together contributing to improved outcomes for patients across the globe. But still too many people in Europe are without access to innovative treatments and diagnostics, and five-year survival rates remain low across the continent.
Lung Cancer Europe (LuCE) works on behalf of patients, their families and survivors to lobby for European policies that will lead to improvements in lung cancer prevention, early detection, treatment and care, and ultimately reduce lung cancer mortality.
To this end, the member-based platform is committed to promoting wider, more equitable access to high-quality care and the development of new and better treatments, reducing the stigma associated with the disease, and increasing the level of European funding allocated to lung cancer research.
Following the launch of the second Lung Cancer Europe Report in November, which highlights the persisting disparities among European lung cancer patients in terms of access to diagnostics, innovative drugs and healthcare services, the organisation’s president, Stefania Vallone, spoke to Pan European Networks about the progress that’s been made and the work still to be done.
Enormous strides forward have been made in the last decade in terms of new treatments for lung cancer – how far has this progress translated into tangible benefits for patients?
In recent decades research has delivered significant advancements in lung cancer and offered a new scenario of this disease. There is now more information about the way to fight against lung cancer, and new treatment options such as targeted therapies and immunotherapy are available in order to change the approach to this disease and bring new hope for patients. Diagnostic tools and therapies are more effective and safe nowadays, have extended durable remissions and prolonged the survival, and, something even more important, have offered a better quality of life to patients and families, who can now count on treatments with fewer or more manageable side effects.
What are the key barriers to faster access to treatment, diagnostics and care in Europe? How, and why, do these differ between (and within) individual countries?
Significant barriers in accessing the treatments still exist or are even increasing in some cases, in the form of high regulatory hurdles, so that five-year survival rates remain low in Europe. The main barriers to get faster access to treatment across Europe are:
1) High costs of innovations: the cost of drugs with recent market approval is the first cause of inequity in regard to access to treatments. The high cost of some of these treatments has produced differences in the ability of healthcare systems to reimburse all treatment options;
2) Differences in national economic strength; and
3) Regulatory barriers: delays in patient access vary across Europe and often depend on the country and the setting where the drugs are used.
While the EU has adopted a common procedure for granting market authorisation to cancer medicines, which is obligatory for oncology drugs, pricing and reimbursement decisions reside with national governments/agencies.
The current scenario results in a very complex and dynamic landscape, with many new drugs and studies ongoing and a huge diversity of national regulatory and reimbursement processes (and even regional, in some places).
Given the increasing financial pressures on healthcare systems across Europe, how can the high cost of some new treatments and innovations be effectively addressed?
In the most recent report launched by LuCE in the European Parliament, we have identified financial issues as the most important gaps in access to new treatments. We consider both this document and other activities developed by the organisation, such as a cycle of webinars focused on ‘patient advocacy and activism’, appropriate advocacy tool pillars for all our members active at national and local level to tackle the existing disparities.
In our call to action, we have identified several gaps and some possible solutions to reduce the disparities. Regarding the financial sustainability of healthcare systems, we propose among other things:
1) Improving transparency about the costs of research and development of new drugs;
2) Introducing new flexible payment procedures in pricing/reimbursement negotiations;
3) Setting a new approach in pricing based on an assessment of the added value and cost-effectiveness of drugs for patients;
4) Following the ESMO (European Society for Medical Oncology) Magnitude of Clinical Benefit Scale when deciding on reimbursement policies;
5) Ensuring transparent and regulated drug pricing and reimbursement; and
6) Getting more collaboration among nation states on price negotiations.
Moreover, considering the role of health technology assessments in patient access increasing, patients and patient organisations should be more involved in these processes since they are the ultimate beneficiary of the health technologies, and they should be engaged in the appraisal process, reimbursement and recommendation of health technologies. Payers will surely benefit from this because they would have patients aligned with the decisions taken.
How far are clinical trials a useful tool for expanding patient access to new treatments? Is the Clinical Trials Regulation fit for purpose in this regard?
Clinical trials are a great opportunity for lung cancer patients to receive cutting-edge treatments, and this can surely help to expand patient access to innovative treatments. Patients can also benefit from receiving drugs in the late stages that are not yet approved in their countries and they would not otherwise have access to.
It is therefore understandable that better access to clinical trials is a priority for many of them, but unfortunately it seems that the situation is unequal since clinical trials are usually run in a few specific countries, mostly in the western part of Europe; as such, not all European lung cancer patients have the same opportunities to get involved in a clinical trial.
As the last LuCE report highlighted, there are huge disparities to tackle in the clinical trials. We acknowledge the importance of the Clinical Trial Regulation (EU) No 536/2014 in providing consistent rules for conducting clinical trials throughout the EU, but it has to surpass various barriers – ethical, administrative, regulatory and logistical. The implementation of this regulation should provide Eastern European patients with better access to innovative treatments, but we will have to wait a little longer for that to happen. Due to delays, the regulation will now come into application in 2019 instead of October 2018, as previously scheduled.
While we are talking about clinical trials’ usefulness in expanding access to new treatment, we should also talk about the General Data Protection Regulation, which could become a major barrier to the rapid implementation of large multi-site clinical studies in Europe.
LuCE recently presented its report, ‘Disparities in diagnosis, care and treatment access’, at the European Parliament – what response have you received so far, and to what extent is unequal access to lung cancer innovations addressed in the EU health policy agenda?
I could answer this question with a quote from Alojz Peterle, president of the MEPs Against Cancer group and host of the event. He said: “It is strongly important to continue with such meetings in order to raise the public but primarily the political awareness on important issues such the access to new treatments.”
One conclusion drawn after the launch of the report was that multi-stakeholders addressing the disparities as major societies, including ESMO, share the will and the responsibility to lead the public policy debate on equitable access to anticancer therapies across borders.
More widely, how does Lung Cancer Europe work to support lung cancer patients, their families and survivors?
LuCE was launched in 2013 to represent the voice of lung cancer patients and their families at the European level. Since then the organisation has actively worked in order to provide a European platform for existing lung cancer patient advocacy groups and to support the establishment of national lung cancer patient groups in those parts of Europe where there weren’t any.
Our support to patients and caregivers takes the form of: the provision of adequate and up-to-date information on our website and social media, patient empowerment, and education programmes. Our last joint webinar, for instance, was organised in November with the European Patients’ Academy (EUPATI) and focused on how to address a public policy. Patient advocates were supplied with a developing advocacy kit as a basic start for their actions. This is not an isolated initiative as our prior webinar was focused on ‘advocating for access to treatments’.
During our annual meetings workshops and educational programmes are provided to advocates who attend the event in order to implement their knowledge in different areas (clinical and policy issues, for example) and motivate them to be more active in their own country.
Finally, our call to action is aimed at reducing disparities in terms of access to diagnostics and treatments, guidelines to set standards of care, the financial sustainability of healthcare systems, and patient involvement.
Lung Cancer Europe
This article will appear in issue four of Pan European Networks: Health, which will be published in February, 2018.