Merck VP for Global Market Access & Pricing Strategic Planning Marco Rauland examines the trend of collaboration between European countries looking to pool their resources on HTA, procurement, pricing, and reimbursement. Rauland compares the five most advanced such collaboration agreements currently active in Europe and the challenges and opportunities inherent in such initiatives.
In recent years, an increasing number of countries have joined forces to work together on various technical areas such as health technology assessment (HTA), procurement, pricing and reimbursement with the ultimate aim of improving affordable and continuous patient access to important medicines and therapies.
Since 2012, substantial growth in the number of multi-country collaborations in the European region has been observed, primarily driven by the increasing cost of healthcare and the influx of expensive new drugs into the market. By joining together, countries are aiming to combine their resources to potentially increase the efficiency of their HTA processes and achieve greater negotiating power with pharmaceutical companies.
This article focuses on the five most advanced collaborations in the European region, ranging from the Valletta Declaration grouping of ten countries with approximately 163 million inhabitants to the Baltic partnership with three countries representing about six million inhabitants.
Baltic Procurement Initiative
In 2010, the prime ministers of the Baltic states decided to facilitate more efficient and sustainable healthcare services to their people via greater levels of inter-country collaboration. In 2012 all three countries (Estonia, Latvia & Lithuania) signed the first EU cross-country agreement for joint procurement of medicines and medical devices3. The main aim was to improve the joint procurement of medicines and the Initiative is currently working on vaccines to reduce public procurement expenditure.
The first joint procurement was held in 2015 for the BCG vaccine against tuberculosis which was unsuccessful because the manufacturer was not interested in participating in a joint procurement process3. In 2017, the first successful joint tender took place between the Estonian Social Ministry and the Latvian Health Ministry to purchase the rotavirus vaccine, as a result of which both countries saved money. In 2018, Latvia purchased pneumococcal vaccines jointly with Lithuania4.
In 2014 the health ministers of Belgium and Netherlands signed a declaration on pharmaceutical policy at an informal meeting. In 2015, Luxembourg joined the grouping5, followed by Austria in 2016 and Ireland in 2018. The main aim of the BeNeLuxA Initiative is to provide first grade and economical medicinal drugs to participating countries6. The focal point of the collaboration was joint negotiations for orphan drugs but the issue of high priced medicines has also now been taken up.
Joint Price Negotiation
In 2017, the Netherlands and Belgium ended their joint negotiation for Orkambi (a drug for cystic fibrosis) with the manufacturer, because they failed to reach an agreement on a cost-effective price8. In July 2018, the collaboration declared a successful joint negotiation of orphan drug Spinraza (Nusinersen, a drug for muscular atrophy) by Belgium and Netherlands. Both countries will temporarily reimburse Spinraza to a particular patient population at least until December 2020, thereafter the Belgium reimbursement committee will re-evaluate the medicine5,7.
Joint HTA Assessment
After conditional approval of Zolgensma (onasemnogene abeparvovec) for the treatment of patients with 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the SMN1 gene from the European Commission in May 2020, the initiative plans dialogue with the company AveXis/Novartis on access and affordability of the product in each country. Belgium, Ireland and the Netherlands aim to undertake a joint HTA assessment of Zolgensma with Austria acting as an expert reviewer during the procedure. Based on the outcome of the HTA assessment, countries will decide if the joint assessment will be followed by a joint price negotiation or not9.
Joint Horizon Scanning
In October 2019, BeNeLuxA initiated the International Horizon Scanning Initiative (IHSI) with the objective of building a “permanent horizon scanning system that can support countries and institutions in policy planning and their decision making regarding the reimbursement of new pharmaceuticals”. The IHSI aims to create a large database bringing together all publicly available information on drugs from which “High Impact Reports” will emerge that will help analyze which treatments stand to have a potentially significant impact. This will help the authorities to appraise innovative treatments beforehand for which they can then:
- prioritize drug spending
- take into account the arrival of new alternatives when evaluating existing products
- determine the place of new treatments in existing directives
- set up specialized centres and train health professionals
- identify areas in which too few treatments are available (unmet medical need)
As the IHSI has now officially been created, a call for tenders was launched in Spring 2020 to find a partner to develop the large database for the IHSI. The choice should be made at the end of 2020.22
Nordic Pharmaceutical Forum and FiNoSe
In 2015, technical experts of Amgros established the Nordic pharmaceutical forum (Nordisk Laegemiddel Forum). The main aim was to set up an informal space, join forces and expand the purchasing power of better supply in larger markets. The collaboration is also intent on working over joint procurement for hospital medicines which include new costly medicines as well as older medicines and horizon scanning. Currently, representatives from Iceland, Norway, Sweden and Denmark are taking part in the Forum. Denmark holds the chairmanship of the forum.
FiNoSe is a pilot collaborative effort among Finland, Norway, and Sweden first launched in 2018 that allows for the joint evaluation of innovative therapies. The objective of FiNoSe is to increase knowledge of a product through joint evaluation and align HTA methodologies and evidence requirements, but it does not play any role in access and reimbursement decisions.
In September 2018, Norway & Denmark entered into an agreement to increase cooperation, including a joint tendering procedure and price negotiations with the aim of reducing prices and ensuring a better supply of medicines13,14. Since 1 January 2020, the Danish Medicines Council has taken over the task of assessing the applicants’ cost analyses, validity and relevancy from Amgros15.
Joint Tendering of Older Hospital Medicines
The Nordic countries, due to their smaller market sizes, are often considered less attractive for suppliers and thus experience medicine shortages. To ensure the security of supply the Nordic collaboration issued its first joint tender for selected hospital products with Denmark as the lead country17,18. According to the Norwegian newspaper Dagens Medisin, the countries are informally cooperating on the procurement of methotrexate, anagrelide, meropenem, ondansetron, gentamycin, and paracetamol23.
Joint Negotiation on Access to Zynteglo
bluebird bio’s Zynteglo will be the first new drug to enter into joint Nordic collaboration to ensure quick and equal access to its gene therapy Zynteglo (autologous cd34+ cells encoding BAT87Q-globin gene). Finland, Norway, and Sweden conducted a joint health economic assessment of Zynteglo through FiNoSe which will be followed by a joint price negotiation.
Visegrad – “Fair & Affordable Pricing” (FAAP)
At an informal meeting in 2016, Poland laid out a manifesto to the health ministers of four countries (Czechia, Hungary, Poland, and Slovakia) and added Lithuania and Croatia to its grouping in 2017. The first memorandum of understanding (MoU) was signed with a maximum of five designated experts in the field of pricing and reimbursement with health ministries as governing bodies.
The main aims of the collaboration are: voluntary exchange of information on pricing and reimbursement through expert meetings, joint pilot negotiations in the area of pricing and reimbursement with the manufacturers of orphan drugs, expensive medicines and product with high budgets, and HTA10,11
The major development of the FAAP initiative include: the signing of a second memorandum of understanding in 2019 between countries; assessment regarding how countries can work together on HTA; technical consultation on specific disease areas (e.g. Breast Cancer)12
In May 2017, ministers of Cyprus, Greece, Italy, Malta, Portugal and Spain formed a collaboration and signed the “Valletta declaration” in a meeting hosted by Malta and Italy in Valletta18. The group has also included Croatia, Ireland, Romania and Slovenia. The group has provided observer status to France for group meetings to play an advisory role19. The collaboration works by performing horizon scanning, identifying and hierarchizing activities related to HTA and joint negotiation and executing practices on pricing and reimbursement which ultimately aims to provide economical and productive medicines and therapies20
The major outcomes and development of Valletta Declaration include:
- Collaborative identification of products for joint price negotiation
- Joint assessments for products initiated, although companies did not participate and submitted reimbursement application/s in individual countries
- Joint negotiations of medicinal products (under consideration)
- Efforts to support initiatives that enable increased transparency of prices between member countries
The Valletta declaration is at an early stage and no product has yet passed through Valletta’s joint clinical, economic or price negotiation processes22. The group has a particular focus on oncology drugs, treatments for autoimmune diseases, orphan drugs, biosimilars and products with a potentially substantial budget impact (e.g., DPPIV inhibitors, oral anticoagulants). As of the end of 2018, the group had identified six priority treatments, one of which is reported to be a CAR-T-cell therapy.19
Challenges and Opportunities
Several cross-border initiatives have emerged in Europe over the last few years that despite joint procurement for hospital medicines may help ensure sustainable access specifically to new innovative and expensive drugs.
So far, noteworthy results have been achieved only by the BeNeLuxA initiative and to some extent by the Nordic Pharmaceutical Forum. This shows the challenges associated with orchestrating and aligning countries with different healthcare systems, treatment pathways and specifically in the Valetta case with significant differences in GDP and healthcare spending per capita and hence ability to pay.
Cross-country collaborations also need to develop an agreement on a pricing framework which considers the different levels of willingness and ability to pay of the member countries, potentially replacing other country-individual price-setting measure such as external reference pricing.
Key factors for successful cross-country collaborations include the strong support and commitment of political leaders, functioning governance and working structure, and the provision of adequate resources because collaborative action is time- and resource-intensive. The successful joint assessments from the BeNeLuxA indicate a willingness from both payers and pharmaceutical companies to engage in the process. Furthermore, the fact that many EU countries have become members of joint pricing/HTA initiatives clearly indicates a desire and political will at the governmental level to undertake joint assessments.
However, it is seemingly challenging to develop a sustainable cross-border collaboration in procurement as there is still some uncertainty on how such joint assessments will translate into patient access in the individual countries and mitigate any duplication of work for manufacturers. Furthermore, there is a consistent challenge to address the concerns associated with pharmaceutical company confidentiality, and it is unclear how this will be managed moving forwards. Finally, as the collaborations are expanded to include more countries, overlaps of country membership will result in further discussions to the future of market access.