Since 2015 there has been substantial growth in the number of multi-country collaborations across Europe, driven primarily by the increasing cost of health care and influx of expensive new drugs into the market. By joining together, countries can combine their resources to potentially increase the efficiency of their health technology assessment (HTA) processes and achieve greater bargaining power with pharmaceutical companies during drug price negotiations. For example, BeNeLuxA brings together Austria, Belgium, Ireland, Luxembourg and the Netherlands to give a combined total population of ~43 million, comparable to Spain (one of the big ‘EU5’ markets).
BeNeLuxA is just one of a range of such initiatives, each with different member countries, objectives and scopes. In this news article, we discuss the scope and recent developments of four of the most advanced: BeNeLuxA, the Valletta Declaration, and the Nordic Pharmaceuticals Forum and FINOSE.
The first successful BeNeLuxA joint HTA / pricing agreement was completed in July 2018
BeNeLuxA was initially created in 2015, with a focus on delivering sustainable access to innovative therapies, particularly orphan drugs. BeNeLuxA has four main objectives:
- Horizon scanning
- Information exchange, including information relating to pharmaceutical markets, prices and ‘best practices’
- Health technology assessments
- Joint negotiations on pricing
Horizon scanning aims to identify, filter and prioritise new health care technologies with a considerable predicted impact on health, costs, society and the healthcare system before they reach the market. BeNeLuxA’s horizon scanning objective includes both joint horizon scanning by the BeNeLuxA members, as well as a separate International Horizon Scanning Initiative to be commissioned in 2019, which does not require full participation in BeNeLuxA to be a part of.
Pharmaceutical companies are able to able to opt for a joint HTA only, or a combined joint HTA and price negotiations. The first successful joint BeNeLuxA HTA appraisal and price negotiation was completed in July 2018 for Spinraza in spinal muscular atrophy. The Spinraza deal was negotiated with Belgium and the Netherlands alone (excluding Austria, Ireland and Luxembourg – Ireland had not joined the collaboration at this point), although notably the deal is not the same for each country. In the Netherlands treatment is only reimbursed for children of a certain age, while for Belgium reimbursement covers all age groups. Confidential price agreements have also been put in place, which could be up to 85% of the list price based on feedback from the Zorginstituut Nederland (ZIN), the Dutch HTA agency.
The Spinraza deal has placed BeNeLuxA somewhat at the forefront of HTA and pricing collaborations between EU countries. Other countries such as Switzerland, France and Italy have expressed an interest in participating, and there has been recent interest in patient registry collaborations. However, challenges remain with keeping commercially sensitive information confidential, addressing language barriers and overcoming the technical and political challenges associated with these registries.
The Valletta Declaration is at an early stage, with six pilot projects ongoing
The Valletta Declaration is an alliance of southern EU member states originally signed in May 2017, comprising Croatia, Cyprus, Greece, Italy, Ireland, Malta, Portugal, Romania, Slovenia and Spain. The declaration has a broad focus that includes:
- Performing joint clinical assessments and economic evaluations
- Running joint price negotiations for selected medicines (typically innovative, high-cost drugs for an area of high unmet need)
- Sharing information to input into price negotiation and contracting
- Sharing information and best practices around biosimilar pricing and reimbursement
- Sharing pharmaco-therapeutic / effectiveness assessments of drugs
- Horizon scanning
Any joint outcomes would then need to be implemented in each member country according to their own respective legal frameworks.
No product has yet passed through Valletta’s joint clinical, economic or price negotiation processes, but six drugs have been prioritised and seven meetings of the Valletta Technical Committee have taken place so far. It should be noted that if a national reimbursement dossier is submitted in any of the member countries of Valletta, it will no longer be possible to submit to Valletta. This may present challenges for pharmaceutical companies in terms of coordinating the activities of local affiliate vs. regional / global teams. In addition, several other challenges have been highlighted by the Valletta Technical Committee, including: exactly which prices are to be negotiated (e.g. a maximum price, fixed price or price range); concerns about how any joint outcomes would be implemented nationally; and how to guarantee confidentiality during the process. Work for joint assessment and the negotiation of candidate products is continuing, as is a discussion on a proposal for an institutional framework to enhance member state cooperation.
The first FINOSE joint assessment between Finland, Norway and Sweden was completed in 2018
Two main areas of collaboration exist between Nordic countries in terms of ensuring drug supply and securing better drug prices: FINOSE, and the Nordic Pharmaceuticals Forum.
FINOSE is a collaboration between three Nordic HTA bodies: Sweden’s Dental and Pharmaceutical Benefits Agency (TLV), the Norwegian Medicines Agency (NoMA) and the Finnish Medicines Agency (Fimea). FINOSE aims to increase the efficiency of the HTA process in these three countries by producing joint assessment reports. A pharmaceutical company would need to submit simultaneously to Fimea, NoMA and TLV (on either NoMA’s or TLV’s template), with individual national steps taken in parallel. There is currently no standard FINOSE assessment procedure, with the technical details of each pilot agreed on a case-by-case basis. Companies should also be aware that for outpatient drugs in Finland, a FINOSE assessment does not replace the normal pricing and market access process; an application to the Pharmaceutical Pricing Board must be submitted as well.
FINOSE’s first joint assessment was completed in 2018, of Xtandi for non-metastatic castration-resistant prostate cancer. No cost-effectiveness figure was stated in this assessment, and FINOSE concluded that the long-term survival gain and modelled QALY gain for Xtandi were not justified.
The Nordic Pharmaceuticals Forum was established in 2015 and comprises Denmark, Iceland, Norway and Sweden. It has the following main areas of focus:
- Horizon scanning
- Ensuring the security of drug supply
- Joint procurement of old drugs
- Joint price negotiations for new, expensive drugs
Pilot projects are focusing on collecting data as to whether joint Nordic procurement is leading to lower drug prices or improvements in supply security. In addition, in September 2018 Denmark and Norway entered into a political agreement to develop the conditions for joint price negotiations, and a dialogue has begun on a future joint Nordic tender for selected drugs. It is anticipated that other Nordic countries would join this agreement once the framework has been established. However, it should be noted that the decision on which drugs to use in each respective country would remain a national one.
Implications and future
It is too early to be able to confidently assess the impact of EU HTA and pricing cooperation, or its future. The fact that both BeNeLuxA and FINOSE have successfully completed joint assessments indicates a willingness from both payers and pharmaceutical companies to engage in the process, and there is evidence that additional larger countries are seeking to get involved. Furthermore, there is obviously a desire and political will at the governmental level to undertake joint assessments, as 18 EU countries are now members of joint pricing/HTA initiatives.
However, there is still some uncertainty as to how such joint assessments will translate into patient access in the individual countries, and manufacturers will be keen to avoid the unnecessary duplication of work that these initiatives are aiming to avoid. Furthermore, navigating pharmaceutical company confidentiality concerns is a consistent challenge, and it is unclear how this will be addressed moving forwards. Finally, as the collaborations are expanded to include more countries, navigating duplications / overlaps of country membership will become a further topic for discussion.