The Tensions In Pursuing Drug Price Transparency In Belgium

In Belgium, there are increasing tensions between drug price transparency and getting the best deal for the Belgian government.

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Belgium, along with the Netherlands, founded the BeNeLuxA initiative in 2015. Members now include Austria, Luxembourg and Ireland. That initiative has set out an ambitious goal not only to horizon scan and work on health technology assessments together, but also to negotiate on prices as a group. That is not all, as BeNeLuxA has been discussing the issue of transparency of drug prices too.

In May 2019, BeNeLuxA stated that it “highly values transparency as a key contributor to achieving access to medicines.” The starting point is that, “the first concrete step should be to create price transparency among countries.” But what does that mean in practice?

In July 2018, Belgium and the Netherlands concluded a successful joint negotiation for Biogen Inc.’s Spinraza (nusinersen) for spinal muscular atrophy (SMA). The full details are not in the public domain. For Biogen, the deal likely brought faster market access in these countries. For payers, it resulted in a better financial deal, as well as an agreement for Biogen to collect more evidence. It also suggests that when drug price transparency is talked about, it is transparency on the net prices paid between payers, not for all.

When it comes to being transparent, BeNeLuxA itself has further to go according to Kalipso Chalkidou, director of global health policy and senior fellow at the Center for Global Development. “It’s not clear within initiatives like BeNeLuxa which resources are being pooled, how they are approaching price negotiation, or if different prices could happen even when countries in the initiative work together,” said Chalkidou.

BeNeLuxA continues to discuss drug price transparency. In November 2019, the group’s experts and leaders met to discuss how to respond to the World Health Assembly’s May 2019 resolution to promote drug price transparency. It does not seem to have gone further with any concrete action. Neil Grubert, an independent global market access consultant, noted that, “it’s gone fairly quiet on BeNeLuxA.” 

Push For Transparency On Belgian MEAs

At home, the way that Belgium has approached achieving access at a cost that the system can afford for expensive but promising drugs, has been through the 2010 introduction of the option of a managed entry agreement (MEA). MEAs can be focused on permitting access for a time whilst generating evidence on value in use, but more often than not, MEAs are a way to negotiate a lower price with that price kept confidential.

Katrien De Groote, founder of Belgian-based strategic pricing and reimbursement consultancy INNOSENS BVBA, highlighted how MEAs were a response to delays in access to innovative drugs and to achieve better prices for Belgium. She said, “Historically, added value drugs were blocked; it took too much time to get them on the Belgian market. A lot of innovative drugs were stuck in the pricing and reimbursement procedure because of their price.”

The Belgian Health Care Knowledge Centre – the semi-governmental agency that is commissioned to conduct research by Ministry of Public Health and Social Affairs and the National Health and Invalidity Insurance – suggested that such arrangements are beneficial for both the companies and government. The government pay less than the list price. The company gets to maintain their list price, preventing lower prices cascading to other markets through international reference pricing. De Groote notes that Belgium’s relatively small market size – around 2 to 3% of the global market – alongside Belgium’s list prices being referenced by other countries, meant that companies were not willing to cut prices to get on to the Belgian market. MEAs changed this. “With MEAs the list price stays the same, but the discount is hidden,” explained De Groote.

At the outset the Belgians kept the details of MEAs strictly confidential. This is the case even where the end date for the deal has been and gone. Such deals continued even when competitors came into the market too. In fact, confidentiality has been so strict that the Belgian Health Care Knowledge Centre could not access details – even by promising to keep the details within their research team only – for their study on MEAs in 2017, because companies threatened legal action. The team went ahead with their research but drawing only on publicly available information.

Over time, more details have become available on Belgium’s MEAs. Marc Czarka, general manager, at the Belgian-based market access company, HM3A-VIVACTIS, explained “Now, MEAs are in large part public and transparent.” Yet it is still the case that financial details are kept secret.

There is now pressure for even the financial details to be revealed about MEAs, according to Grubert. He said, “There is pressure for transparency on discounts achieved through Belgium’s MEAs.” That pressure is starting to lead to action. Legislation to allow members of parliament in Belgium to request the Court of Audit to disclose details of price discounts agreed between companies and the Ministry of Health were put forward in October 2019. By February 2020, the State Council had ruled in favor of providing access to the Court of Audit to details on MEAs.

The push for transparency is despite Belgian’s Minister for Health trying to make the case that confidentiality helps “secure good prices for the Belgian system,” according to Grubert. It seems that assertions alone are not enough for the transparency lobby. Grubert explained, “There are those who want more evidence that Belgium has achieved better prices in reaching agreements with companies, and those who want there to be more downward pressure brought to bear on prices.” That is at the heart of the drive to check on the discounts really being achieved.

It is not yet clear when transparency legislation on MEAs could progress or what it will mean in practice. “Given coronavirus, which has inevitably shifted the priority of government, it’s extremely difficult to know when progress with this legislation will be made,” said Czarka. De Groote added, “We don’t yet know how it will be implemented.” 

It is not clear what impact greater transparency on the deals could have, but it may not always be in the best interest of Belgium. According to Czarka, “The trouble is that once companies, who operate in a world of international reference pricing, are obliged to disclose the rebate that they have given, we will see companies either being unwilling to give more than an average discount, or not being interested in the Belgian market.” De Groote adds, “There is a big pressure, including from the World Health Organization, for complete drug price transparency. But that is not necessarily going to offer an advantage to the payer.” Chalkidou, meanwhile, highlighted a further complication given that Belgium is a player in BeNeLuxA. “BeNeLuxA is fascinating. If Belgium were to publish the real price they paid, it might then be hard for BeNeLuxA to negotiate on prices together in future.”