BJMO - volume 17, issue 6, october 2023
M. Piccart MD, PhD, J. Vansteenkiste MD, PhD, H. Prenen MD, PhD, F. Duhoux MD, PhD, A. Janssens MD, PhD, M. Delforge MD, PhD, A. Awada MD, PhD, P. Neven MD, PhD, A. Sibille MD, B. Neyns MD, PhD
The oncological treatment landscape is evolving at a very rapid pace with a continuous stream of novel treatment options. To fully leverage these therapeutic advances in clinical practice it is important to facilitate a rapid access to innovative anticancer drugs for patients. Specifically for Belgium, the delay from EMA approval to reimbursement for anticancer drugs is very long, with an average of almost 600 days, and a substantial proportion of innovative drugs never make it to the patient. The stringent focus of the Belgian Commission for Reimbursement of Medicines (CRM) on overall survival (OS) data in reimbursement decisions is believed to be an important contributor to this situation. However, the ever-increasing pace at which new anticancer therapies are being developed in combination with an earlier detection of cancer will make it increasingly difficult to present mature OS data at the time of regulatory approval in the years to come. As such, there is an urgent need for a debate with the regulators to consider more readily available endpoints in their reimbursement assessments. In fact, when a strong treatment effect is seen on an intermediate endpoint such as disease-free or progression-free survival, a benefit in OS is quite likely. As such, our reimbursement system needs to be adapted to better align with the scientific progress in oncology. In this, a temporary reimbursement decision based on intermediate endpoints could give Belgian patients earlier access to promising lifesaving medicines. In this, we as oncologists, including specialists in haematology, respiratory oncology, and gastrointestinal cancer, strongly encourage the CRM to use the grading provided by the ESMO magnitude of clinical benefit scale to evaluate the clinical added value of future cancer treatments. This will not only facilitate a faster patient access to innovative therapies, but will also help policy-makers in advancing ‘accountability for reasonableness’ in their resource allocation deliberations.
(BELG J MED ONCOL 2023;17(6):211–5)
Read moreBJMO - volume 12, issue 2, march 2018
J. Raskin , B.I. Hiddinga MD, A. Janssens MD, PhD, P. Pauwels MD, PhD, J.P. Van Meerbeeck MD, PhD
Targeted therapies have transformed the management of non–small-cell lung cancer and placed an increased emphasis on stratifying patients on the basis of the presence of oncogenic drivers. The best characterised molecular driver to date is epidermal growth factor receptor. Selective oral inhibitors of epidermal growth factor receptor that are superior to chemotherapy have become available in clinical practice. Unfortunately progression develops after a median of ten to twelve months. This article provides a framework for understanding clinically relevant resistance mechanisms to epidermal growth factor receptor-tyrosine kinase inhibitors and strategies to delay or overcome resistance, both those clinically available and those in development.
(BELG J MED ONCOL 2018;12(2):68–74)
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