Key Insights from ISPOR Europe 2024: Trends in Evidence Generation Framework and Digital Transformation

The vibrant city of Barcelona played host to the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2024 European Conference from November 17-20, where experts from around the world gathered to share their research and expertise from diverse perspectives.

Centred around the theme “Generating Evidence Toward Health and Well-Being,” the event explored several topics shaping market access. In this blog, we dive into some key insights from the conference and highlight Indegene’s contribution to ISPOR Europe 2024.

The aim of the JCA is to harmonize HTA evaluation processes across the EU, reduce duplication of efforts and improve decision-making timeliness. Core to the JCA is the PICO (Population, Intervention, Comparator, Outcome) framework, which intends to provide a standard format for the definition of a research question.

Companies developing oncology therapies and ATMPs have started to prepare for the JCA. However, there remains considerable uncertainty around the implementation - starting with PICOs ability to guide an existing evidence generation plan as well as the future ability to address and continually update the relevant PICOs. Speakers presented the complexity and challenges likely to arise with multiple PICOs; especially where treatment patterns vary considerably across member states.

In addition to evidence submission requirements, the other key JCA debate is whether it will accelerate or further delay market access. Divergent views were presented by speakers from different countries especially given that the JCA is not a binding document and local pricing/ reimbursement decisions are still the remit of individual countries.

Both industry and payer representatives agreed that 2025 was likely to be a milestone year with some landmark reforms likely to change European HTA and the market access landscape. Although the JCAs intent is to address inequities in patient access, panel members from Eastern European countries highlighted that success would largely depend on the timing of P&R dossier submission. The pending EU pharmaceutical legislation was also raised in this context with some key provisions that incentivise timely and equitable access across Europe.

Another key topic at the conference was the evolution in the use of AI in Systematic Literature Research (SLR) and mapping of dossiers. Industry experts cited some examples of ongoing initiatives within their companies, while representatives from agencies like the UK’s NICE (National Institute for Health and Care Excellence) presented their statement of intent and position statement regarding the appropriate use of AI in HTA to create efficiencies. While these initiatives are new, as other national HTA agencies begin to produce their own guidelines, AI assisted SLR, and dossier development is likely to grow at a rapid pace.

Our study reviewed all injectable oncology therapies that were both: 1) approved by the EMA between 2020 to 2022 and 2) approved/available in the US and Europe as of May 2024. Only the ten injectable oncology therapies that met these criteria were included in the final price benchmarking analysis.

Our research found substantial differences in not only the list prices but also net prices of injectable oncology therapies in the US and key European countries. Indexing an average WAC of $100 in the US at launch translated into a visible ex-factory average price of $76 in Italy and $64 in Germany. However, post negotiations, the difference was more profound with the average net price in the US indexed depending on the public price benchmark at $88 (FSS) to $98 (ASP), while it was down to an average of $34 in Italy and $44 in Germany (post AMNOG negotiation).

While European countries continue to search for ways to achieve net price reductions, similar efforts are underway in the US. For instance, Medicare now has the power to negotiate drug prices due to the Inflation Reduction Act (IRA). Only one oncology drug, Imbruvica (blood cancer), was included in the first negotiation. Medicare negotiated a 38% discount, which while significant is well below the Italian and German benchmarks in our analysis

It remains to seen how US discussions on IRA and Most-favoured-nation (MFN) approaches might be revived and / or evolve as a part of a new Trump administration’s approach to pricing of bio/pharmaceuticals in the US and warrants continued monitoring.

In Europe, on the other hand, despite discussions about price transparency, net prices are difficult to access. This is also changing, for instance, Germany, which has so far been in the forefront of publishing negotiated prices, is transitioning towards provisions allowing for confidentiality of net prices if certain conditions are met. The dynamic nature of pharmaceutical market access tied to health policy makes it a fascinating area that is constantly evolving.

If you have any questions or would like to learn more about our research and contributions, don’t hesitate to reach out. We’d love to connect and discuss further!