Authors' objectives: Currently nearly 400,000 people in the Netherlands are being treated with anticoagulants of a type Vitamin K antagonists (VKAs). Although VKAs are very effective in treating and preventing thrombosis and embolisms, there are some important disadvantages to taking these 'blood thinners' on a daily basis. The primary objection is that treatment with VKAs requires intensive supervision and monitoring. VKAs also interact with a large number of foods and other medications. This means that people who use VKAs have to pay attention to what they eat and drink, and it is important to be aware of whether any other kind of medication they are prescribed can be taken with VKAs. There is now an alternative: a new generation of anticoagulants with certain important advantages is in the process of being placed on the market. However, the introduction of these new oral anticoagulants (NOACs) brings with it a number of questions, as a result of which the Minister of Health, Welfare and Sport has asked the Health Council for advice. The Health Council has set up a committee in preparation for issuing this advice. In its advice, the Committee is formulating answers to the following questions: How does the safety and effectiveness of the NOACs compare to that of the VKAs? Are the NOACs cost-effective? What will the consequences be for the Thrombosis Services? The Minister has also asked the Committee to examine experiences in monitoring the anticoagulant treatment in other countries.

Authors' recommendations: The Committee has concluded that after more than fifty years of reliance on VKAs, the new medications offer the possibility of significantly simplifying anticoagulant treatment for both patients and health care providers. NOACs are a potentially promising new option in anticoagulant treatment for the registered medical grounds. The Committee is therefore of the opinion that these medications should be part of doctors' arsenal of treatments, and should be made available to patients. For the time being use should be restricted to patients who have undergone an elective knee or hip replacement in order to prevent deep vein thrombosis, patients with atrial fibrillation, and patients with VTE. According to the results of the clinical studies carried out so far, frequent monitoring of the treatment will no longer be necessary. As a result, this treatment will be just as "ordinary" as other forms of drug treatment. However, doubts remain as to the safety of NOACs in everyday practice. It is also uncertain as to whether the health benefits offered by the medications and the cost-effectiveness of the medications in the context of anticoagulant treatment in the Netherlands are sufficient to justify the extra costs. Therefore the Committee feels that introduction of the NOACs must be accompanied by more detailed research into their safety, effectiveness and cost-effectiveness. The goal of this research should be to remove the remaining uncertainties and definitively establish the added value of the new medications. In the opinion of the Committee, the manufacturers of the medications could participate in financing this research. The Committee offers proposals for the design and organisation of the research. In addition, the professional groups must adjust their guidelines in order to guarantee safe use of the new medications and promote compliance with treatment. They also need to indicate how the disappearance of the management function of the Thrombosis Services will be compensated for.

Project Status: Completed

URL for project: http://www.gr.nl/en/publications/healthcare/new-anticoagulants-well-dosed-introduction

Year Published: 2012

URL for published report: http://www.gr.nl/sites/default/files/201707ENewAnticoagulants.pdf

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Netherlands

Organisation Name: Health Council of the Netherlands Gezondheidsraad

Contact Address: Postbus 16052, 2500 BB Den Haag, The Netherlands. Tel: +31 70 340 7520;Fax: +31 70 340 7523

Contact Name: info@gr.nl

Contact Email: info@gr.nl

Copyright: Health Council of the Netherlands