Our view on the new AUS-CAN-UK
Australian, Canadian and UK agencies (the Australian Government Department of Health and Aged Care, the Canadian Agency for Drugs and Technologies in Health [CADTH] the National Institute for Health and Care Excellence [NICE], Healthcare Improvement Scotland, Health Technology Wales, and the All Wales Therapeutics and Toxicology Centre) recently announced an AUS-CAN-UK Collaboration Arrangement. The six members in this Collaboration Arrangement will in future decide whether to admit new members to the group. The current agreement will be reviewed after 2024.
The Collaboration Arrangement will focus on issues aimed at improving healthcare world-wide. The following five priority areas have been selected and working groups will be assigned:
The partners will share information about their ways of working with regulators, how they prioritize topics, their strategies for managing medicines with no marketing authorization, and how they plan for health technology assessments (HTAs), as well as their approaches to economic modelling.
Future-proofing HTA systems
The partners will exchange ideas on the technological and methodological challenges involved in HTA, and how HTA processes could better anticipate these issues. They will also collaborate on scientific and methodological topics to address these challenges.
Collaborating with regulators
The partners will explore ways of implementing joint approaches to engage with regulatory agencies in the UK, Canada and Australia, which will help to identify and advance opportunities to improve collaboration between HTA and regulatory agencies.
Work-sharing and efficiency gains
The partners will assess the feasibility of recognizing or using each other’s HTA information. Notably, they will aim to pilot a joint clinical assessment.
Digital and artificial intelligence
Advances in evaluating digital health technologies including technologies that involve artificial intelligence will be shared among partners.
The working groups will review the progress they are making on a quarterly basis. All partner organizations will meet annually to discuss activities and will realign them as needed.
Background to this collaboration
In February 2019, when the discussion on the new European Union (EU) regulation on HTA was ongoing, NICE and CADTH had already started to collaborate by offering parallel scientific advice to the life sciences industry. These five new priority areas resemble the joint HTA efforts that are now being implemented in the EU. In the sections below, Daniel Gladwell, Sallie Latimer, and Suzette Matthijsse share their thoughts on these collaborations.
How do the EU HTA Regulation and AUS-CAN-UK Collaboration Arrangement compare?
The obvious differences between the EU HTA Regulation and the AUS-CAN-UK Collaboration Arrangement are their legal foundation and overarching objectives. The Collaboration Arrangement is intended to deliver local improvements in HTA processes through sharing of best practice and joint solution planning to address common challenges. There will be no legally binding rights or obligations resulting from the Arrangement. In comparison, the EU HTA Regulation is a binding legislative act that must be applied in its entirety across the EU and is intended to support a more efficient use of resources and strengthen the quality of HTA across Europe and its long-term sustainability.
The number of countries involved is also a clear difference. The AUS-CAN-UK group is not only smaller, but perhaps as a result, more conceptually aligned in its approach to HTA. Each country member of the group shares a relatively pragmatic ‘decision maker’ focus with regards to its consideration of evidence when undertaking HTA. For example, when justified by the disease area and line of therapy, they are likely to be more open to drawing judgements from non-RCT data. By contrast, in the EU group there is much greater diversity in different member states’ HTA approach. There is also far greater disparity in both the resources within each health care system and the resources available to support collaborative HTA.
How do the potential impacts of the EU HTA Regulation and AUS-CAN-UK Collaboration Arrangement compare?
It is too early to comment with any real conviction on how the potential impacts of these initiatives compare. The AUS-CAN-UK Collaboration Arrangement may be more agile to change as the inevitable hurdles appear and could be faster paced considering the non-binding nature of the Arrangement and the smaller number of countries involved. However, it remains to be seen if there will be any concrete efficiencies or changes to local processes resulting from this Arrangement. For example, while there is an intent to explore running a pilot for a joint clinical assessment in the AUS-CAN-UK Collaboration Arrangement, it is too early to tell whether the proposed assessment will pose the same questions as those arising in the current EU HTA Regulation consultation. These centre around the true benefit of an assessment that makes no conclusions on value judgement, optimal positioning, relative effectiveness or general health benefit to timely access of medicines to patients.
What we can hope is that the precedence set by the like-minded agencies involved in the AUS-CAN-UK Collaboration Arrangement continues in their joint working and that any resulting outcomes are drawn in additional collaboration with key stakeholders and in consideration of the pragmatism required in the evolution of evidence-based decision making for healthcare. Ultimately, both initiatives are intended to facilitate broader access to innovative medicines which should be welcomed by all.
Is this the response we were expecting to the EU HTA Regulation?
We would view this not necessarily as a response, but rather further progress in cross-country HTA cooperation which has been discussed for many years. Having made the top ten list of ISPOR trends for 2022–2023 for the first time and being practically recognized by key HTA markets, with the EU HTA Regulation and the AUS-CAN-UK Collaboration Arrangement it finally feels like larger scale cross-country HTA cooperation is becoming a reality.
This larger scale cross-country HTA cooperation will likely build on another complementary trend for collaboration to increasingly align evidence needs between Regulators, HTA Bodies and Payers. This alignment could potentially be a result of the collaboration seen during the COVID-19 pandemic, and as such one of the implications of Priority 1 on COVID-19 related intelligence sharing. During COVID-19, a lesson drawn by the Medicines and Healthcare Products Regulatory Agency/NICE/NHS England was how to make better decisions faster. The regulatory/HTA element of this collaboration is even clearer with Priority 3 – ‘Collaborating with regulators’. Brexit of course has its continuing impact – both in releasing the UK to be involved in an international regulatory collaboration (Project Orbis) and, in the related need to ensure the UK remains a priority launch market. Over time increasingly aligning with the Australians and Canadians may support the UK’s objective to remain a priority at launch.
But as mentioned above, the actual impact of these initiatives remains to be seen. It will be interesting to see how these collaborations in turn trigger the joining of other (non-EU) countries or even new alliances. With the EU regulation on HTA starting to apply to oncological and advanced therapy medicinal products in 2025, we will soon see!
More from Lumanity on the EU HTA Regulation
Want to find out more about the EU HTA Regulation and how it will affect pharmaceutical companies bringing new products to market in Europe? Head over to Lumanity’s dedicated webpage where you can find all our updates on the Regulation so far, as well as key contacts and details of our training program.