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Asembia Trends: The IRA, High-Cost Drugs and Personalized Care


At the beginning of May, almost 8,000 attendees descended on Las Vegas for Asembia’s AXS24 Summit. While all of the session speakers discussed the future of healthcare in one way or another, MMIT noticed a few common trends about the state of the industry today.

If you missed the conference, read on for an overview of three key areas, along with a few of our thoughts:

IRA Sharpens Focus on Maximizing Drug Lifecycle Revenue

Since the passing of the Inflation Reduction Act (IRA), there’s been much speculation about how the new regulations will impact pharmaceutical companies, from revenue concerns to the fear of squelched innovation to the potential increase in drug prices.

At Asembia, the shock of the IRA seemed to have worn off, and presentations were focused on topics ranging from how pharma can plan for better payer engagement in a post-IRA world to strategic launch planning and pricing to how manufacturers can adjust PAP eligibility criteria in light of the Part D out-of-pocket cap.

All Asembia presenters acknowledged that the IRA is a watershed moment for the industry, as it is pushing pharma companies to reframe how they plan for the revenue lifecycle of new drugs. Many speakers touched on the fact that payer costs are set to increase beginning in 2025, and shared expectations that formularies will constrict in response.

Indeed, MMIT research conducted for a spring 2024 IRA Special Report echoes that prediction, indicating that payers representing 78% of Medicare lives have considered leveraging a skinnier formulary by targeting certain therapeutic areas. Of the top non-oncology therapeutic areas targeted for formulary restructuring, payers were most likely to focus on migraines, diabetes, rheumatoid arthritis, and asthma.

However, all Medicare payers that expect the IRA will have a high to very high impact on their management of new agents (29% of Medicare lives) anticipate a much greater use of prior authorizations, step therapy, and a preference for biosimilars rather than disadvantaged formulary placement or increased exclusions.

Regardless of how payers ultimately choose to control costs, Asembia presenters agreed that maximizing the revenue potential of a drug should now begin as early as clinical development. Pharma companies with multi-indication therapies will need to develop indications simultaneously rather than in succession. Pharma companies will also need more clinical evidence and cost effectiveness research well before launch to ensure a higher price point at entry.

Asembia presenters also discussed the likelihood of greater utilization management restrictions, particularly for high-cost specialty therapeutics, across the board.

According to the IRA Special Report, payers representing 21% of commercial lives have already incorporated coverage, restriction, and tier placement changes implemented in their Medicare plans into their commercial line of business. Of those who haven’t yet made changes, payers representing 51% of commercial lives report that they are moderately to extremely likely to do so—most (95%) within the next two to three years.

Growth of More Personalized Healthcare

With the advent of precision medicine, we’re finally picking up steam as we move toward a more personalized healthcare system. The push for patient-centricity can be seen not only in genetic testing and targeted therapies, but in the type of care delivery and coordination patients now require.

On the second day, one of Asembia’s featured presentations was from LeaderLogic’s Nick Webb, who discussed how the growth of complete medical verticals is showing us how thoroughly consumerism has been bolted to the process of healthcare. “In a time of hyper-consumerism, the expectation of value and frictionless experience has grown ten-fold,” said Webb. “If you don’t have an updated strategy, you might be operating in a substandard way.”

Several presentations touched on how specialty pharmacies will need to provide additional services to accommodate growing patient needs and expectations. More than half of the recently approved influx of specialty drugs require careful clinical monitoring of patients before, during, and following therapy. There is an opportunity for specialty pharmacies to improve outcomes and “experiential value” by offering customized patient care services such as clinical reviews, concierge services for scheduling home healthcare visits, and medication adherence reminders and education.

Presentations on the growth of value-based care partnerships emphasized the need for participants to fully understand the patient journey before endeavoring to close gaps in care. Extending the reach of multi-pronged population health initiatives to large-scale patient populations impacted by chronic conditions like diabetes and heart failure is on the rise.

Specialty pharmacist interventions, high-touch care pathways, lifestyle coaching and medication management programs are proving their ROI, as they not only improve outcomes but also lower the overall cost of care.

Momentum to Reduce the Impact of High-Cost Therapies

There were several presentations about the future of cell and gene therapies, orphan drugs, and GLP-1s, including many that focused on creating new payment models for high-cost treatments. Some presenters highlighted the slew of new orphan drugs (40% of which cost $100k per patient per year) expected to enter the market in the next few years, while others focused on the high cost of emerging cell and gene therapies. Many presenters noted that as the clinical pipeline matures, cell and gene therapies are targeting diseases with much larger patient populations.

Several presenters discussed the considerable market for obesity GLP-1s (more than half of U.S. adults), with the consensus that obesity is becoming a top five global market driver that will have a profound effect on spending across multiple areas. Many mentioned that new indications in the GLP-1 pipeline—from sleep apnea to Alzheimer’s disease—meant that usage will increase across conditions, and discussed how payers will determine coverage for these therapies.

All presenters agreed that drug pricing today is both unchecked and opaque, with misaligned incentives and concentrated market power among a few middlemen, especially PBMs. Calls for greater transparency, payer/manufacturer partnerships and value-based agreements were consistent across presenters.

Several presenters discussed how manufacturers can best demonstrate the value of their therapy across a patient’s lifespan, relative to the alternatives (or lack thereof). One session covered the role of ICER in assessing drug value and cost effectiveness, and discussed the role of ICER reports in CMS negotiations—and the eventual impact of CMS influence on ICER frameworks.

One interesting presentation, from Matthew Majewski, VP at Charles River Associates, focused on payer and public perception of what is a “fair price” for a rare disease therapy. His research into pricing dynamics found that payers believe a higher price is more reasonable for smaller patient populations, pediatric populations, and curative therapies. Other presenters noted negative payer perceptions about unsupported drug price increases and drugs with significant price variations depending on the indication to be treated.

Some presenters discussed how payers and providers are continuing to drive site-of-care shifts for medical benefit therapies like infusions, and addressed the cost savings delivered by site-of-care interventions. Other presenters shared the results of patient-centric programs for finding low-cost prescriptions and physician transparency tools for determining coverage and out-of-pocket costs.

Of course, with three full days of programming, Asembia sessions covered a wealth of other topics, from specialty drug distribution trends to provider engagement strategies to the biosimilar pipeline and more. For manufacturers, presenters shared best practices for how to pressure-test payer messaging, run a successful patient support program, and identify areas of high provider opportunity.

Notably, there were several presentations on the role of AI in specialty pharmacies, payer organizations, and pharma companies. Discussions revolved around generative AI, the use of conversation data, and how to use AI to improve patient education, medication adherence, and patient support programs.

MMIT’s Dinesh Kabaleeswaran and The Dedham Group’s Jen Klarer also presented the results of our annual market access survey. Learn more about their research in last week’s blog post, From Pipeline to Patient: Understanding Barriers to Access in 2024 and Beyond.

For a 360-degree view of payer and prescriber behavior, learn how our Patient Access Analytics solution can help you identify and address barriers to access.

© 2024 MMIT


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