On 22 June 2018, Ireland joined the Beneluxa Initiative on Pharmaceutical Policy. What has the initiative accomplished to date, and what will the addition of a fifth member mean for the future?

Introduction to the Beneluxa Initiative

The Beneluxa Initiative aims to improve patient access to innovative drugs in Belgium, the Netherlands, Luxemburg, Austria and now Ireland, while maintaining affordable prices. This is done by conducting joint horizon scanning for new medicines, sharing policy information and expertise, mutually recognising health technology assessments and, finally, conducting joint pricing and reimbursement negotiations. By collaborating during negotiations, Beneluxa countries hope to gain more leverage than if they were to have separate discussions with manufacturers.

Earlier this year, Beneluxa reported the first positive outcome of a joint pricing and reimbursement negotiation: Belgium and the Netherlands entered a joint discussion with Biogen regarding the spinal muscular atrophy drug Spinraza® in February 2018. Four months later, in July, the initiative announced that Spinraza would be reimbursed under similar conditions in both countries. Building on this success, the Beneluxa Initiative aims to perform several joint HTA procedures per year and already have several ongoing pilot discussions with manufacturers on managed entry agreements.

Welcome to Ireland

The addition of Ireland as a fifth member of the initiative strengthens the negotiating power of the group, which can now speak on behalf of over 50 million patients. The hope is to increase its negotiating power and improve affordability and patient access to medicines across multiple countries. Should Beneluxa fulfil its ambition to perform more joint HTA procedures, patients in member countries are also likely to benefit from quicker access to selected drugs, as manufacturers only need to engage in one, rather than five, submission procedures. The joint initiative could also benefit manufacturers as in theory, companies would not have to invest staff resources in completing multiple HTA procedures and can could achieve faster access to Beneluxa markets compared with negotiations with each member country individually. However, until more products have gone through joint negotiations it is difficult to tell whether the price reduction will be offset by the decreased work load, earlier access and theoretic volume trade off.

The addition of another member country raises another question: to what extent can separate countries harmonise their HTA processes and healthcare policies? Only time will tell whether country differences in healthcare systems, clinical guidelines – and therefore the costs associated with treatments – will limit either the number of joint HTA procedures that can be undertaken, or the number of additional countries that can join the initiative

If you would like to learn more about how we can assist in HTA processes, call us on: +44 (0) 20 3750 9833 or email us at: discover@validinsight.com