BJH - volume 14, 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 HEMATOL 2023;14(6):245–9)
Read moreBJH - volume 10, issue 4, june 2019
A. Awada MD, PhD, J-F. Baurain MD, PhD, P. Clement MD, PhD, P. Hainaut MD, PhD, S. Holbrechts MD, PhD, K. Jochmans MD, PhD, V. Mathieux MD, PhD, J. Mebis MD, PhD, M. Strijbos MD, PhD, C. Vulsteke MD, PhD, T. Vanassche MD, PhD, P. Verhamme MD, PhD
Cancer patients are at an increased risk of venous thromboembolism (VTE). The current standard initial treatment of an acute episode of VTE in cancer patients consists of the administration of three to six months of subcutaneous low molecular weight heparin (LMWH) at a dose adjusted to the body weight. The efficacy and safety profile of LMWHs are well established, but a drawback of these agents is that they require daily subcutaneous administration. In addition, they are mainly cleared through the kidneys, and their use in patients with severe renal insufficiency may require dose reduction or monitoring of the anti-Xa activity. To address the issues with LMWH, several direct oral anticoagulants (DOAC) have been developed for the treatment of VTE. In contrast to LMWHs and vitamin K antagonist, DOACs directly interfere with thrombin or activated factor X (FXa). DOACs have now become standard treatment options in the general management of VTE, but until recently, there were no results of clinical trials specifically assessing the role of DOACs in the treatment of cancer-associated thrombosis. Recently, the Hokusai VTE cancer study and preliminary data from the Select-D trial demonstrated that DOACs are non-inferior to LMWH in preventing recurrent VTE. However, both studies also show that this comes at the cost of an increased rate of both major and clinically-relevant non-major bleeding. Especially in the subgroup of patients with gastrointestinal cancer, the benefit in VTE recurrence with the DOAC seems to be outbalanced by a significantly increased bleeding risk. Based on the available results, DOACs might represent an interesting alternative for LMWH in certain subgroups of patients, but with an important list of exceptions. It seems reasonable not to use DOACs in patients with a high bleeding risk, and especially in patients with gastrointestinal cancer, DOACs should not be the first-line choice. In summary, while LMWHs are currently the standard of care in the acute management of cancer-associated thrombosis, the advent of DOACs is welcomed for patients at a low bleeding risk who are in need of long-term anticoagulation.
(BELG J HEMATOL 2019;10(4):169–76)
Read moreBJH - volume 7, issue 6, december 2016
A. Awada MD, PhD, J-F. Baurain MD, PhD, P. Clement MD, PhD, P. Hainaut MD, PhD, S. Holbrechts MD, PhD, J-M. Hougardy , K. Jochmans MD, PhD, V. Mathieux MD, PhD, J. Mebis MD, PhD, M. Strijbos MD, PhD, C. Vulsteke MD, PhD, P. Verhamme MD, PhD
Venous thrombosis is a common complication in cancer patients and thromboembolism is the second most common cause of death. Several practice guidelines provide recommendations for the management of cancer-associated thrombosis. However, these guidelines do not sufficiently cover commonly encountered clinical challenges. With this expert panel, consisting of medical oncologists, haematologists, internists and thrombosis specialists, we aimed to develop a practical Belgian guidance for adequate prevention and treatment of cancer-associated thrombosis that covered several challenging situations encountered in daily clinic. This paper discusses the following topics: type and treatment duration of anticoagulant therapy, recurrent VTE despite anticoagulation, anticoagulation in case of renal impairment, liver disease and thrombocytopenia, the role of anti-Xa monitoring, central venous catheter-associated thrombosis, the position of direct oral anticoagulants and thromboprophylaxis, both in ambulatory and hospitalised patients. For an overview of the recommendations formulated by the expert panel, we refer to the key messages for clinical practice in this article.
(BELG J HEMATOL 2016;7(6):217–23)
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