What the Beneluxa Group is aiming for next

BeNeLuxA collaboration is a joint initiative on drug pricing and reimbursement between the governments of Belgium, The Netherlands, Luxembourg, Austria and Ireland, with the aim of giving smaller countries greater negotiating power in discussing drug pricing with international drug firms. The group was started by the Belgian and Dutch health ministers in 2015. They were joined by Luxembourg in 2015 and Austria in 2016. Ireland joined in June 2018.

The BeNeLuxA initiative aims to make new treatments and so-called orphan drugs available earlier and at an affordable price to patients in participating countries.

The current developments of the BeNeLuxA group include negotiation of price and reimbursement of three new medicines, however, their names are being kept confidential until the end of the process, mentioned Diane Kleinermans, adviser to Belgium’s Minister of Social Affairs, Public Health in charge of the BeNeLuxA cooperation, at the ‘Performance-driven payments in Europe’ conference in Berlin on 18th September 2019.1

BeNeLuxA’s first, and up till now only, major negotiation is the successful price negotiation in 2018 with the pharma company Biogen for the orphan drug Spinraza, used to treat a special type of spinal muscular atrophy. As a result of the negotiation, Belgium and the Netherlands will reimburse the medication until at least 2020.

BeNeLuxA has defined eligibility criteria for a drug to enter joint HTA and pricing negotiations. The product must be a drug for a high unmet medical need, for which no reimbursed procedure has started in any of the participating countries. Negotiations can be opened with some of the BeNeLuxA’s members, not necessarily with all five and the company must be planning to commercialise in all countries participating in the negotiations.

The candidate drug first goes through a joint health technology assessment (HTA). According to Kleinerman around 15 HTAs have been carried out so far.

The BeNeLuxA website provides insights on previous decisions in the joint HTA scheme: 2

  • A joint report on Intercept’s Ocaliva (obeticholic acid), used in the treatment of primary biliary cholangitis, was discontinued at the company’s request in 2017. The Dutch and Belgian HTA agencies subsequently used the initial draft joint assessment as the basis for their national assessments.
  • Re-use of (parts of) assessments by national HTA bodies was also done for the following products: XERMELO (telotristat); RAVICTI (phenylbutyrate) (ZIN-reports used by RIZIV-INAMI) as well as TAGRISSO (osimertinib); VERZENIOS (abemaciclib) (LBI-reports used by RIZIV-INAMI).2

Joint price and reimbursement negotiation take place only on drugs which have gone through joint HTA ending with joint conclusions. Negotiations are made with representatives of each of the participating countries. If successful, the price and reimbursement negotiation ends up with a joint decision. However, reimbursed prices will not necessarily be identical in each country, for instance, if epidemiology is not the same from one country to another.

This is “not a bargaining negotiation process” as the aim is “not to get the lowest possible price but a fair price that is sustainable”, Kleinermans said. In addition, BeNeLuxA is a platform for information exchange between member states.

BeNeLuxA collaboration have declared their intention to collaborate on drug policy, including the topic of horizon scanning of pharmaceuticals for Health Technology Assessment (HTA) and price negotiations. Belgian Health Care Knowledge Centre (KCE) was appointed to lead the task force for developing a Horizon Scanning (HS) methodology and a possible model for a joint Horizon Scanning System (HSS)3.

Horizon Scanning is the practice of detecting new and ground-breaking treatments before they reach the market; this is done by analysing data and research output. This procedure allows countries to make more informed decisions for their reimbursement policies. To render this process more effective, a permanent system called International Horizon Scanning Initiative (IHSI) was set up. This project is not limited to participating countries but will be available to any country wishing to join.

Last month, the Dutch Minister for Medical Care, Bruno Bruins, announced that Canada would become a member of IHSI. This month, Bruins announced plans for Sweden to join the initiative. The Dutch minister is hopeful that 10 countries will join the Initiative. An announcement on the countries that will participate in IHSI is scheduled for October 20194. Kleinermans said at the conference that IHSI will officially be launched at the beginning of 2020.1

However, there are critical voices doubting the real impact of the BeNeLuxA due to possible confidentiality issues and companies’ unwillingness to adapt their country-specific pricing strategies, demonstrated by, for example, the failed agreement on the drug Orkambi. 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 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.

 

By – Shivani Shah, Business Analyst and Jack Ziomek, Project Manager, Web Platforms

 

References:

  1. https://www.apmhealtheurope.com/story/17376/65535/beneluxa-negotiating-joint-reimbursement-and-price-on-three-drugs
  2. http://www.beneluxa.org/hta
  3. http://www.beneluxa.org/horizonscanning
  4. https://www.vbb.com/insights/corporate-commercial-regulatory/transatlantic-cooperation-on-medicines-latest-developments