2023 was an eventful year for the life sciences industry, with the Inflation Reduction Act (IRA) and game-changing technology like ChatGPT dominating the headlines. Will biopharma’s constrained budgets, reorganizations, and reductions in force continue in 2024, or will there be a healthy rebound from these prunings? Only time will tell. There are positive developments on the horizon as well, such as continued vaccine innovation; new cell and gene therapies to treat cancer, rare diseases, and life-threatening conditions; new sources of real-world data; and an overall commitment to diversity, equity, and inclusion in treatment access.
Here are our predictions for what life sciences organizations can expect and four trends to watch in 2024.
1. Continued impact of the IRA:
In 2024, manufacturers will continue to wrestle with the effects of the IRA on their business plans and revenue streams. In September, Medicare selected the first batch of 10 drugs for its price negotiation program, a provision of the IRA which allows Medicare to negotiate the prices of certain high-cost, single source drugs without generic or biosimilar competition. Manufacturers have submitted their evidence to the Centers for Medicare and Medicaid Services (CMS) and patients also had their say via CMS listening sessions in October and November of this year.
In the first quarter of 2024, the results of the price negotiation program will become public. Both policy makers and drug manufacturers will be considering whether the outcome is transparent and makes sense; how it will impact patients’ access and out-of-pocket spending; what the next treatments in line for price negotiation are; and what CMS is learning from the process. Medicare is focusing on drugs with no generic alternative that have been on the market for a long time (more than nine years for small-molecule treatments, and 13 years for biologics). Manufacturers are using real-world evidence (RWE) to demonstrate as much value as they can for their treatments versus comparative treatments to secure the most desirable price point. Although some of the IRA’s impacts are still uncertain, RWE is an important tool for manufacturers in navigating the road ahead, as it will help them demonstrate the value and comparative effectiveness of their treatments, and help patients get access to the treatments they need.
2. Machine learning and AI’s role in increasing efficiency:
Machine learning (ML) and artificial intelligence (AI) platforms like ChatGPT are making their mark in the life sciences industry as powerful tools in analyzing patient data and improving the precision and efficiency of evidence generation, a trend that will become even more tangible in the next year. ChatGPT is helping life sciences professionals do their jobs more efficiently, ML is helping transform analytics, and throughout the life sciences job market, training in both AI and ML will be more important than ever.
In 2024, we expect researchers, regulatory institutions, and patients to embrace AI and ML to a greater extent. ML helps life sciences organizations push the boundaries of their research and uncover insights that will impact patient lives. As ML has become more widely used, researchers have realized its benefits in augmenting traditional analytical methods, reducing biases, and strengthening results.
AI, meanwhile, can be useful for discovering new drugs, understanding emerging diseases, and improving efficiencies in study design and execution.
3. The importance of transparency and replication of RWE:
Throughout 2023, real-world evidence helped regulatory agencies assess the safety, effectiveness, and value of new or existing products in the context of new indications. Heading into 2024, as more data are automated, there will be a need for greater transparency of data collection methods as well as transparency of data provenance, quality, relevance and reliability. Replication of findings in different populations and/or different data sources is a powerful tool in establishing a cause-and-effect relationship between a treatment and various outcomes, intended or otherwise.
4. Global health technology agency developments:
One of the main topics discussed at the ISPOR EU 2023 conference in November was Europe’s Health Technology Assessment regulation, which will take effect in 2025 and aims to create a joint EU perspective on the clinical aspects of drugs, in vitro diagnostics and high-risk medical devices.
Although the European Union has health technology agencies (HTAs) independent of their governments to assess the safety, effectiveness and value of treatments, no such agency exists yet in the U.S. As of now, CMS is acting as the de facto HTA through its drug price negotiations under the IRA, but it’s still a government agency tasked with delivering and paying for care, and therefore not independent. How a single HTA framework across the 27 EU member states comes together, and what will happen in terms of an HTA in the U.S., is a trend to watch in 2024. Without a doubt, harmonized HTA frameworks will speed the delivery of innovative treatments to all manner of patients around the globe. The US may well ‘take a page’ from the EU joint HTA playbook to aim for stronger, more comprehensive evidence with more timely, accurate, and transparent decision-making.
Only time will tell
In the life sciences industry, new technologies, new regulations and potentially tough economic conditions seem likely to dominate in 2024. For these organizations, being equipped to handle future challenges with the right data and careful planning will certainly be beneficial, no matter what the new year brings.
For more information on how Panalgo can support your team’s RWE efforts, contact us today.