ISPOR US 2023: Key Topics and Themes

Last month, Trinity attended the ISPOR 2023 conference in Boston. The main theme of the conference was “Impacting Innovation, Value and Healthcare Decision Making”, which facilitated unique discussions and workshops across different stakeholders in the life sciences, including manufacturers, regulatory leaders and health economists. Topics included discussions on the role of artificial intelligence (AI) in HEOR, innovation in evidence generation, the latest trends in health policy and a myriad of others.

A highlight for Trinity Life Sciences was presenting 12 posters and two plenary sessions focused on the impact of innovative evidence to demonstrate therapeutic value and on the evolving digital therapeutics landscape. Trinity’s team was also present throughout the conference to hear the latest from other researchers, industry leaders and sponsors – here are our key takeaways from ISPOR 2023:

1. The Inflation Reduction Act (IRA) will transform the role of CMS within the global biopharma landscape and create long-term pricing pressure in the U.S. for pipeline and existing therapies
   • The introduction of mandatory minimum-discount negotiations through the IRA’s maximum fair price (MFP) program will curb long-term revenue opportunity for novel therapies with lengthy lifecycle potential. The biopharma landscape will look to CMS to see how it determines the level of required discount applied to negotiated therapies, with manufacturers likely adapting their global strategy in response.
2. The IRA will increase the importance of cohesive and up-to-date maintenance of brand value across its lifecycle and strong evidence generation for biopharma therapies, creating a newfound importance of real-world, post-launch data
   • Manufacturers with products selected for the IRA’s MFP program will be required to submit evidence about their therapy’s use, costs and indication landscape, necessitating the creation of meaningful evidence packages demonstrating the product’s value clearly. While it is unclear exactly how CMS will determine the required MFP discounts, the IRA instructs CMS to consider submitted data and potentially assign lower discounts to therapies demonstrating their value through defined characteristics, including comparative effectiveness. More information about the IRA MFP program is expected to be published by CMS in July 2023.
3. Payers, physicians, patients and caregivers have an increasing interest in the value of patient relevant improvements beyond the classic clinical indicators offered by therapies, though it remains to be seen what impact they will have as drivers of pricing and access
   • Payers and manufacturers are exploring non-traditional indicators to understand the value of new treatments for both patients and caregivers. Experts explain how improvements in quality of life (QoL) are not limited to the patient but should also be considered for caregivers and family members in the evaluation of new treatments.
   • Additionally, newer technologies like wearable technologies can replace subjective self-reported outcomes to address limitations in outcome measurement, while new data collection methods can help capture the patient voice to inform treatment design.
4. AI is emerging in evidence generation and HEOR, showing promise for improving market access in the future as a tool to enable large-scale pharmacoeconomic data generation and analysis
   • In the rapidly evolving field of healthcare, the transformative power of artificial intelligence, machine learning (ML) and advanced data analytics has emerged as a game-changer. Experts explore the use of AI in evidence generation, focusing on the integration of evidence plans early in the asset lifecycle, the generation of health economic evidence, optimizing patient access and addressing ethical considerations.
   • AI will help us collect and analyze real-world data to identify patient relevant outcomes more efficiently and accurately than ever before.
5. Digital therapeutics and health technologies (DTxHT) are continuing to expand the ways in which patients receive care, interact with their clinicians and utilize treatment – though evidence in support of these interventions and tools is growing, it is still unclear how they best fit within existing regulatory and access/reimbursement frameworks
   • Novel DTxHT, ranging from prescription digital therapeutics, wellness apps and wearable monitoring devices have continued to generate data illustrating their effectiveness at producing positive patient outcomes with reduced health care resource utilization (HCRU) costs, using unique real-world and clinical study approaches to demonstrate cost-effectiveness.
     1. For example, Sleep.io, an app to treat insomnia, was recommended for NHS funding by NICE based on pre/post cost-effectiveness studies compared to supportive care. However, in the U.S., more robust evidence has not necessarily resulted in coverage and patient access, as evidenced by the limited uptake of Pear Therapeutics’ ReSET.  

Authors: Maximilian Hunt, Ismail Ismailoglu, Grace Mock, Cameron Lam and Alexis Bryan