ISPOR 2023 drew thousands of leading US and global healthcare researchers and decision-makers. Avalere was at the forefront, with eight experts in attendance to share insights and analysis about the future of evidence strategy following the historic Inflation Reduction Act (IRA).

The agenda was packed with insightful sessions, panels, and posters. Below is a recap of Avalere’s presentations on the implications of the IRA on evidence strategy and an overview of a poster describing the first phase of a novel approach to capturing person-centered disease impacts.

The Day After Tomorrow: Evidence, Value, and Market Access After the IRA

Avalere’s Sarah Alwardt, practice director, Evidence & Strategy, moderated a panel of Avalere experts, including Principal Mike Ciarametaro, Senior Consultant Jordan Banks, and Senior Advisor Kim Caldwell, who previously led the development and implementation of Medicare Part D at the Centers for Medicare and Medicaid Services (CMS).

Panelists shared their latest thinking on how the implementation of the IRA’s Medicare drug price negotiation provision will alter the current healthcare landscape, particularly evidence, value, and access implications. They applied experience engaging with CMS to predict how recent hiring indicates the agency’s likely Pharmacy & Therapeutics Committee-like negotiation model, and how the agency is likely to take a hands-off approach to managing commercial spillover effects. Additionally, Avalere experts noted the significant variation in impact by product type, drug population, and therapeutic area. Even if a product is not selected for negotiation, the establishment of a maximum fair price (MFP) in its drug class or disease area will have an impact. Manufacturers should carefully examine their portfolios and assess how and when IRA negotiation will affect their assets.

One area Avalere experts noted as an opportunity in the current landscape was capturing the patient voice. Initial CMS guidance indicates its intention to consider patient input but also emphasizes the importance of evidence quality considered in the negotiation process. Patient input can be a key differentiator for manufacturers in demonstrating the value of their products, but the industry lacks a systematic method to capture the patient perspective. This leaves a gap for manufacturers that want to share the patient perspective on their products but must prioritize providing peer-reviewed studies with validated methodologies. This is an area of increased interest for further exploration.

Overall, panelists provided insights into how evidence-generation strategies will need to adapt to fit the evidence needs outlined by CMS, including:

• Increasing focus on Medicare beneficiaries by generating evidence solely focused on a drug’s performance for that population rather than just including them as “a line in the descriptive table.”
• Expanding real-world evidence generation from time of launch to after the launch to fill evidence gaps for negotiation, ensuring studies are peer-reviewed.
• Evolving traditional evidence-generation plans across the entire product lifecycle to account for new market requirements; this will require creativity in strategy development and implementation.

IRA Negotiation: Closer to Government Price Setting or Traditional HTA?

Sarah Alwardt also moderated a diverse panel of experts to forecast the alignment of IRA drug price negotiation with traditional health technology assessment (HTA) methods. Mike Ciarametaro joined Peter Neumann, director of the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center, and Emily Freeman, senior director of Patient Engagement Oncology in Global Medical Strategy and Operations at Gilead Sciences.

Panelists shared their perspectives on key differences between evidence evaluation by CMS during IRA drug price negotiation and traditional HTA methods. Panelists agreed that CMS gave itself flexibility for its approach, but they shared unanswered questions with the process outlined in the current initial guidance, including:

• The process for formulating the initial MFP offer is qualitative in nature, and CMS will need to respond to calls for increased transparency in its approach.
• The evidence-assessment approach does not formally integrate the patient perspective, leading to a final MFP that may not be patient centric.
• The narrow definition of unmet medical need that differs from traditional HTA definitions is difficult for negotiation-eligible therapies to meet and may not adequately account for the value provided by certain therapies in high-cost, burdensome diseases.
• The resulting negotiated MFP may have unintended consequences on patient access through decisions that alter coverage, pricing, investments, and drug development.

Additionally, it is unclear how CMS’s negotiation process in the first round in September 2023 could shift in future years. Panelists shared a few key insights on the shift and potential opportunities:

• The process could become more systematic over time as CMS leverages learnings and gains efficiencies; stakeholders can engage CMS early and often to shape the validity and patient-centricity of the process.
• CMS may leverage other metrics and HTA methods as they are developed or evolve over time; stakeholders can develop new metrics and methodologies (whether broad-based or specific to a disease or therapy).
• CMS will need to increasingly consider real-world evidence when it becomes available as manufacturers adapt to evidence needs for IRA negotiation; stakeholders can enhance their evidence strategies to maximize product value.

Does Disease Impact Go Beyond the Healthcare System? Lessons from Generalized Myasthenia Gravis 360°

Also at ISPOR, Avalere experts Amanda Napoles, principal, and Nicole Betor, senior associate, presented a poster highlighting recent patient-centered research in the rare disease generalized myasthenia gravis (gMG). This poster represented the first phase of a study implementing a novel method to capture overall disease burden in a holistic manner.

The findings reveal wide-ranging impacts of gMG beyond the healthcare system-focused burden that is traditionally captured. This research underscores the importance of capturing perspectives from multiple stakeholders to accurately assess disease burden. As outlined above, the industry currently lacks validated tools to systematically capture the patient voice, which stakeholders are increasingly interested in incorporating into value assessment processes. Conclusions from the gMG 360° study lead naturally to a conversation about how to capture the total disease burden and account for the patient perspective in healthcare decision making.

Industry Call to Action: Rethink Evidence Strategy to Translate Insights into Implementation

At ISPOR 2023, stakeholders across the healthcare industry discussed the importance of evidence and value, emphasizing the need to translate evidence into interventions that lead to healthcare system changes. Stakeholders must think strategically about why evidence is generated and how to interpret and act on the evidence once developed. Manufacturers who invest in evidence strategies and execution will be better positioned to demonstrate their value of their product(s) after IRA implementation.

Avalere is an end-to-end partner from evidence strategy development and generation to implementation. Avalere’s experts in evidence strategy, health economics and outcomes research, policy, market access, and patient-centered value can help you understand what the IRA means for your organization and the industry overall. To better prepare for the changing healthcare landscape in 2023 and beyond, connect with us.