12 Apr 2018

Ireland and its fellow EU Member States have been active this year in continuing to build their collaborative approaches to appraising and reimbursing medicines, most recently through the issuance of a Letter of Intent to the Ministers for Health for Belgium, the Netherlands, Luxembourg and Austria, signalling Ireland’s interest in joining the BeNeLuxA Initiative. The decision, according to the Minister for Health, Simon Harris TD, was driven by a desire to secure access to new and innovative medicines in a manner that is affordable and sustainable, in an “increasingly challenging environment of high pricing of medicines by pharmaceutical companies”.


The announcement follows Ireland’s increasing participation at voluntary European forums on the topic of medicines access. Most notably, in May 2017 Ireland announced that it would sign, alongside Spain, Italy, Greece, Portugal, Cyprus, Malta and Romania, the ‘Valletta Declaration’ to explore possible areas for cooperation. We have since witnessed the expansion of the Valletta Group (of which Ireland was a founding member) with the addition of Croatia and Slovenia. It is believed that France will be an observer, considering their latest participation in the work of the Group’s Technical Committee. Some commentators are suggesting that, as a larger country, France will focus on offering examples of good practice in medicine appraisal, rather than participating in joint negotiations with other countries.


What is BeNeLuxA?

In April 2015, the health ministers of Belgium and the Netherlands announced that they would explore possible collaboration on pharmaceutical policy. This included price negotiations with pharmaceutical companies for orphan medicinal products. In September 2015 Luxembourg joined the Belgium-Netherlands project followed by Austria in June 2016. Since then the project has been named ‘BeNeLuxA’.


Its stated aim is to provide sustainable access to, and appropriate use of, medicines in the participating countries. These countries are looking to increase patient access to high-quality and affordable treatments.


To do this, they are working together to anticipate national health challenges by ensuring they :

  • Obtain early insights into new pharmaceutical products and new indications (horizon scanning);
  • Exchange expertise and agree mutual recognition of Health Technology Assessments to increase efficiency of assessments and pricing and reimbursement decisions;
  • Share policy expertise and best practices;
  • Improve payers’ understanding of products, usage and markets and by conducting joint (price) negotiations for specific products;
  • Improve transparency on pricing between the collaborating countries.


The current group of countries has initiated pilot projects in these areas with, to date, limited results.


Is Voluntary Cooperation the future for Pricing & Reimbursement?

With the majority of EU Member States committed to voluntary cooperation, and requesting political support from the European Commission, and with concrete experiences being collected through pilot projects (though unsuccessful), these collaborations are likely to move to the next level and, despite obvious fragmentation, become more operational.


The Valletta countries already understand that conducting joint pricing negotiations on innovative medicines is difficult and the focus is now on mature products such as biosimilars and generics. The Nordic Council is conducting its first pilot project, while Spain and Portugal recently announced their intention to conduct a pilot project on joint tendering of generics and biosimilars.


As for the future of country clusters, these are likely to stabilise within the next months, with each country restricting itself to one of the voluntary co-operations (which is not the case now).


Once a clear process and structure are in place, and successful pilot projects on biosimilars/generics are accomplished, countries will be able to build on their experience and may find it easier to collaborate on innovative medicines. If this happens, collaborative negotiations could become standard practice.


The Nordic Council represents best practice in structure and organisation. With increased dialogue between different clusters its approach might be replicated by others.


What does this mean for Ireland?

In the words of Professor Michael Barry, Clinical Director of the National College for Pharmacoeconomics and the Health Service Executive’s Medicines Management Programme, European harmonisation “is not going to happen any time soon” – indeed the European Commission’s proposed regulation on Health Technology Assessment (HTA) would, if agreed, take six years to come into full force.


For the clear majority of medicines currently in the pipeline for reimbursement, Ireland’s formal entry of the BeNeLuxA initiative will have very little impact and companies continue to grapple with the challenges inherent in the Irish pricing and reimbursement system.


Logistically, cross-country collaboration is exceptionally difficult to achieve due to the differing national health systems and populations – BeNeLuxA’s two-year attempt at a joint assessment of Orkambi did not achieve everything that was expected, while only a handful of pilot projects are currently underway.


There are several obstacles that need to be overcome to secure a successful collaboration on a product between a group of countries and a company. Confidentiality of pricing can present an issue to companies which may have different pricing strategies for each individual country. Prices may also genuinely vary because of differing healthcare costs in each country.


Indeed, a country’s own healthcare costs, such as hospital utilisation and primary care capabilities, can create large variances in the cost-effectiveness of a medicine compared to the cost of alternative treatments.


Very often a final decision on high-cost medicines is influenced heavily by an individual country’s philosophical stance towards equity of access and the corresponding level of clinical uncertainty they are willing to accept.


Collaboration on assessment and negotiation is undoubtedly the logical and positive vehicle for providing access to new medicines across Europe once states have overcome the current barriers.


In the absence of short-to-mid-term likely success however, there is a real danger in Ireland that prudent reform of the HSE’s P&R system will be parked in the expectation that a pan-European solution is forthcoming.