A Year in Review: Looking Back at 2024

Our experts worked diligently in 2024 to signpost and discuss key issues influencing the global healthcare industry – matters of key concern to drug manufacturers, payers, clinicians and patients topped our agenda for coverage. In this end of year review we look back on 2024 to summarize how the year shaped up in our health economics and outcomes research (HEOR) space. We provide links to our 2024 publications and consider some of the issues we flagged as important for the year ahead.

Revolutionary changes in Europe: EU HTA-R

In 2024, our experts used webinars and thought leadership to track the development of the European Union Health Technology Assessment Regulation (EU HTA-R ). In particular, we returned time and again to how manufacturers, payers and countries were preparing for what is happening right now – the January 2025 implementation of Joint Clinical Assessment (JCA) for new cancer medicines and advanced therapies in Europe. We considered the challenges of having to anticipate  the Population, Intervention, Comparator, Outcome (PICO) framework in upcoming submissions ( Anticipating Your PICOs). We also looked more generally at how other European Union (EU) member states were preparing and we captured those developments in interactive maps: Are EU Member States Ready?

While we reflected on organizational readiness for the EU HTA-R we also looked ahead. We signposted that 10 Joint Scientific Consultations (JSCs) are planned for 2025 alongside two JSC request periods from February 3 to March 3, and June 2 to June 30, 2025. The JSC request periods are designed to give pharmaceutical companies and research organizations access to scientific advice from the regulatory authority or scientific committees. We discussed the fact that the industry wants to see more request periods built in and spread throughout the year. This would give more opportunities for companies to submit their requests in the specified time frames to benefit from expert advice to guide them through the new EU HTA-R process. For more insights, read our detailed ISPOR Europe Diaries. 

Of course, there were other important developments besides the EU HTA-R in Europe in 2024. In January Zorginstituut Nederland (ZIN), the agency responsible for health technology assessment (HTA) in the Netherlands, updated its guidance for the first time in 8 years. We were present at the unveiling of the new guidelines and saw some significant changes, including our own work on structured expert elicitation (SEE) being cited, more on this here. We tracked progress in Spain where the Spanish Ministry of Health proposed a new governance structure to oversee health technology assessment (HTA) Spain Consults on New HTA System Before the EU HTA Regulation Starts to Apply.

Ireland also caught our attention, and we published thought leadership insights from the National Centre for Pharmacoeconomics (NCPE) annual symposium. One of the high points was a discussion about including the patient voice in HTA. The NCPE aims to assist patient organizations in making confident submissions through its national patient education program or by providing ad hoc support. NCPE also wants manufacturers to promote participation through the NCPE’s patient submission process: the full story is here.

The US Inflation Reduction Act

By April our experts had hosted a webinar on preparing for the practical realities of the Inflation Reduction Act (IRA) in the USA and Joint Clinical Assessment (JCA) in the EU. The IRA redesigns Medicare Part D, addresses patients’ ability to afford medication, and allows Medicare to negotiate drug prices. We used the phrase ‘seismic change’ to describe these two unprecedented developments in the biopharma landscape. Our webinar drew on our expert knowledge of policy, regulation, market access integrated evidence planning and real-world evidence to provide insights into the high-impact changes brought in by each of these landmark pieces of legislation, and the resulting implications for pharmaceutical manufacturers. Watch a recording of the webinar here.

UK health technology assessment

While we certainly focused on mainland Europe and the US, we were also mindful of events in the UK, where we covered developments at the National Institute for Health and Care Excellence (NICE). Highlights included the NICE position statement on using artificial intelligence in evidence generation AI in evidence generation – NICE position statement summary; as well as a whitepaper on  NICE’s Proportional Approach to Technology Appraisals (PATT). The PATT whitepaper explained what PATT is and focused on one of its approaches – streamlined cost-comparison appraisal (sCCA). This approach can accelerate patient access to medicines in the UK but is challenging because early preparation and planning is needed.

Real-world evidence

In response to The Professional Society for Health Economics and Outcomes Research (ISPOR) Europe Real-world Evidence (RWE) Summit, held in Barcelona on November 17, 2024, December saw our collaboration with the University of Sheffield’s Centre for Health and Related Research (SCHARR). Our paper on ‘Real World Evidence for Health Technology Assessment’ considered the strengths and challenges and offered projections on the role of RWE for HTA. This partnership combined SCHARR’s academic expertise in RWE generation methodologies with Lumanity’s insights of industry demand and needs; read the full story here.

Our “How to” guides

In August 2024 we launched a series of new “How to” guides covering early HEOR evidence-generation activities.  The first explored how to assess the burden of illness and unmet need; the second focused on why it’s important to develop a value proposition and how to use it to align stakeholders. We closed the year with our third offering: How to conduct an HTA landscaping review. These handy guides are intended to offer key insights in a portable way, with more in the series to come in 2025.

Conclusion

The topics that dominated 2024 included the EU HTA-R, the IRA, RWE, artificial intelligence, accelerated drug approvals, and the patient voice — or patient centricity.

With the start of 2025 we hope to leverage our insights and bring further discussion and analysis as events unfold throughout the year.