Impressive advancements in the pharma industry provide hope to patients affected by debilitating and life-threatening diseases and a chance at an improved quality of life. Rapid access to these potentially life-changing therapies is critical, but they are expensive, and payers are more cost-constrained than ever. Pricing and reimbursement processes in Belgium are designed to take up to 180 days but can take even longer if the submission dossier, or “value dossier”, is considered insufficient by the Belgian reimbursement authority, RIZIV-INAMI.

Belgian reimbursement and price setting timeline - Source: KCE Report 288

Payers, innovators and policymakers across the globe are constantly looking for new approaches to assessing a medicine’s value and deciding the appropriate price to pay for it, while minimising the administrative burden on – and costs to - the healthcare systems that use it. With more and more therapies targeting rare diseases, and some offering potential curative benefits, it is increasingly difficult to meet the typical evidence criteria required for a value dossier. Innovative contracting approaches, also known as Managed Entry Agreements (MEAs), offer patients access to the latest innovations as quickly as possible, while simultaneously allowing payers to continue to assess their value and manage costs. MEAs come in various forms, each with unique sets of pros and cons, but can include gathering additional evidence of a therapy’s efficacy and safety profile, to help payers decide when and how much they will pay for it. 

MEAs in Belgium, the conditions for which are currently set out in Art. 111-117 of the Royal Decree of 1 February 2018, are concluded between the respective pharmaceutical company and the Belgian Minister of Social Affairs and Public Health, who at the time of writing this article is Frank Vandenbroucke. These agreements regulate the specific reimbursement and patient's access to a new and promising medicinal product until sufficient evidence is available to justify the requested reimbursement basis. The practice has become quite successful in Belgium as is apparent from the RIZIV-INAMI’s latest Monitoring Of Reimbursement Significant Expenses (MORSE) report, which includes data up until December 2021:

Source: RIZIV-INAMI MORSE Report (2021)

Unfortunately, MEAs come with an increased administrative burden and other costs, and their increasing use is exerting increasing pressure on the Belgian healthcare budget, something which news outlets and political opponents of the current government are quick to scrutinise. For example, on 16th April 2024, one of Belgium’s most read newspapers, ‘Het Nieuwsblad’, published an article on the amount of MEAs concluded between the pharma industry and current Minister of Social Affairs and Public Health, Frank Vandenbroucke, which – much like in other countries – criticises the confidential nature of MEAs. This type of criticism is not new for Belgium. In its 2017 report 288 concerning MEAs in Belgium, the Belgian Health Care Knowledge Centre (KCE) also pointed out that the confidential nature of MEAs makes external review quite difficult and in particular considered that data collected during the term of the MEA (partly with public funding) should not be confidential.

The rationale for the confidentiality of MEAs and their negotiation process, is to protect the pharmaceutical company’s sensitive data, trade secrets and – to the extent possible - avoid “free riding” from competitors. Another claimed effect of this confidentiality is that this allows the government to negotiate higher rebates, while at the same time creating the risk that the company will request higher prices, especially in countries where external reference pricing is used. Criticism of MEA – and more broadly, pricing – confidentiality, is mounting, however. Belgium is currently in the process of trying to reform its reimbursement procedures and in particular the practice of MEAs. The European Joint Clinical Assessment (JCA) initiative under the Health Technology (HTA) Regulation (EU) 2021/2282, will likely play a role. Other important proposals include increased and more transparent cooperation at the European level and other collaborative efforts, such as the Beneluxa initiative, the provision of more clarity on the architecture of the undisclosed compensation in the public section of the MEA, limiting the duration of (new) contracts, and the expiration of the MEA on the first day of the month following the expiration of exclusivity, i.e., by the expiration of the patent or SPC on the active ingredient, or regulatory data protection, or the exclusivity period applicable for an orphan drug, amongst others. For more information on the Belgian plans to reform the reimbursement landscape, please consult the RIZIV-INAMI March 2023 Roadmap concerning the reform of the Belgian reimbursement procedures.

In conclusion, MEAs continue to be scrutinised in Belgium but remain an important pricing and reimbursement tool for balancing value for money with speedy access to medicines. The procedures and rules concerning MEAs are currently being discussed at both Belgian and European levels with concrete plans for alterations at the Belgian level, which may have a significant impact for players in the industry.
 

At DLA Piper, we keep our clients informed of significant changes in the landscape. Our international team of life sciences experts closely follows up on new trends and provides you with a one-stop shop for all your pricing, reimbursement and access questions and needs. Feel free to subscribe to our Cortex blog for more life sciences updates and do not hesitate to reach out should you want to discuss any of this further.