Asembia Trends: IRA Operationalization and the Future of Specialty Therapies

May 15

By MMIT

At the end of April, more than 8,000 attendees visited Las Vegas for the Asembia Specialty Pharmacy Summit, otherwise known as AXS25. If you missed the conference, here’s an overview of some of the key areas covered this year:

Keeping an Eye on Government Policies

AXS25 featured quite a few presentations on the impact of the new administration on pharma, from a session on What Pharma Must Know About Tariffs, Supply Chains, and Policy Changes to one entitled How the Next 90 Days May Shape the Future of Managed Medicare.

Overall, the conversation focused on recent agency actions, the implications of staffing cuts at the Department of Health and Human Services, and the potential for Medicaid reforms to be proposed as part of the budget reconciliation process. Presenters also talked about lawmakers’ continued interest in increasing transparency throughout the drug supply chain, especially as it relates to more stringent oversight of PBMs.

In one session, presenters discussed the potential for Congressional budget reconciliation to include a provision rectifying the small molecule “pill penalty” of the IRA. Known as the Ensuring Pathways to Innovative Cures (EPIC) act, this act would eliminate the disparity between the length of time small molecule drugs and biologics spend on the market (currently 7 and 11 years, respectively) before becoming eligible for the Medicare Drug Price Negotiation Program.

“The expectation is that this would cost about $10 billion dollars over a ten-year period,” said Lindsay Bealor Greenleaf, J.D., VP and Head of Federal and State Policy at ADVI Health. “In exchange for that, there might be a policy change to lower the negotiated price ceiling on older drugs, that are 16 years past their FDA approval date. . . If they lower the price ceiling from a 60% cut to an automatic 70% cut and start negotiation from there, that could potentially save $10 billion over ten years . . . So that’s the big legislative tweak that we are watching in this upcoming reconciliation package.”

Operationalizing the IRA

While the bulk of last year’s legislative sessions centered on strategies for maximizing profitability in a post-IRA world, this year’s presentations tended to be more focused on the nuts and bolts of IRA operationalization. In one interesting panel on the Challenges in IRA Maximum Fair Price, presenters from Cencora discussed potential models deemed compliant by CMS for maximum fair price (MFP) effectuation. Manufacturers are expected to submit their effectuation plans to CMS by September 1, 2025.

Panelists discussed the differences between two potential models. In the Part D Retrospective Refund model, market prices are essentially left intact. The MFP is effectuated via a backend payment between the manufacturer and the pharmacy. As manufacturers typically rely on distributor pharmacy relationships and do not transact with pharmacies one-on-one, they are naturally concerned about the enormous task of ensuring accurate account reconciliation for an estimated 60,000 U.S. pharmacies.

Under the Part D Prospective Discount model, however, the pharmacy buys MFP drugs at a negotiated price for Medicare patients. This model eliminates the need for a retroactive payment between manufacturing and pharmacy, as distributors transact on an MFP basis and pharmacies purchase at the MFP price on behalf of their Medicare patient population.

As we know, the negotiated MFP for the first ten drugs selected under the Medicare Drug Price Negotiation Program will go into effect on January 1, 2026. While manufacturers have the decision-making power in terms of which method of MFP effectuation they select for their products, there are tremendous operational implications for each. Dispensing entities can begin enrolling in the CMS’s Medicare Transaction Facilitator (MTF) system in June 2025.

In another session on how pharma companies can prepare for Medicare drug price negotiations, presenters from Deloitte and J&J focused on lessons learned from initial price applicability year (IPAY) 2026 that can be applied to future negotiations. As the final selected TAs were commonly more expansive than those proposed by manufacturers, they suggested communicating evidence on the appropriate TAs in the dossier, and including indication-specific volume data to support appropriate weighting across indications.

During the negotiation process, the presenters advised pharma companies to focus on therapeutic alternatives and the product’s comparative clinical value. They also touched on how to ensure compliant MFP effectuation to avoid the risk of penalties if refunds are not promptly transmitted.

Increasing 340B Payment Transparency

Manufacturers are also concerned about the potential for duplicative discounts related to the 340B program. In one presentation on Navigating the 340b Tug-of-War Between States and Pharmaceutical Manufacturers, presenters from the consulting firm Milliman discussed the way 340B discounting works between manufacturers, pharmacies, third-party administrators and covered entities.

As the system currently stands, there is no integration between the 340B process and payer-based commercial rebate process. According to the presenters, this disconnect means manufacturers sometimes end up paying both a covered entity chargeback as well as a payer rebate for the same medication—in many cases, resulting in a significant net loss. The discussion covered state-level 340B laws and the impact of the IRA on 340B transparency before addressing how the use of a traditional rebate model might transform the 340B program.

Specialty Therapies, AI and Analytics

Several presentations were focused on matters pertaining to the rapid year-over-year growth of specialty therapies, which now represent approximately 80% of all new approvals. One session, on the future of outcomes-based specialty contracting, discussed which quality measures best prove value, and reminded the audience that outcomes are more important than rebates and discounts.

Several sessions focused on the rise of AI, omni-channel patient education, and digital tools to improve specialty care delivery. One session focused on how to personalize care for specialty patients via digital prescription tracking and care team support. A session on patient-centered support programs discussed the importance of developing KPIs that measure clinical engagement wait times as well as the efficacy of patient touchpoints.

Another session focused on the use of AI and real-time analytics to help providers prioritize clinical resources and focus more energy on high-risk patients. For providers and pharmacies, the ethical considerations of using AI are top of mind. Presenters discussed the importance of ensuring that AI systems are trained on accurate, representative, and unbiased data sets.

Process transparency was also a key focus, especially when AI is used as a clinical decision support tool. In addition to documenting AI-driven decisions and providing human oversight for these processes, providers should secure a patient’s informed consent that AI tools are playing a key role in their care.

Commercial Challenges and Patient Support in Rare Disease

A few sessions centered on the difficulty of maintaining sustainable and affordable care models within the rare disease space. In many rare diseases, there are now multiple treatments competing for market share, eroding the meaning of the term “orphan drug”.

In this era of ultra rare disease and precision medicines, manufacturers must devote more attention not only to patient identification, but also to patient engagement, education and support.

As patients and caregivers are seeking a more active role in care planning, manufacturers will benefit from investing in ongoing patient disease state education, even before treatment has been determined. Manufacturers also need to ensure that they can identify and capture eligible patients in their own data environment, using clinical triggers to alert their field reps to providers who are ready to make a prescribing decision.

In rare disease, engagement and support programs should focus on engendering a sense of community for patients. Presenters advised manufacturers to create peer mentorship programs and to partner with patient advocacy groups. Product websites featuring useful information like diagnostic testing requirements and clinical studies/evidence can be helpful for both patient and physician education.

Demands of the Cell and Gene Pipeline

Several sessions on cell and gene therapies focused on how to accelerate commercial uptake for these high-cost drugs. In one session focused on the next frontier of precision medicine, presenters discussed the rise of ultra-specialty therapies, such as DNA/RNA therapeutics, or medicines that use monoclonal or recombinant antibodies. According to Evaluate data, the advanced therapy market is entering a period of rapid growth, moving from today’s market of $13.1 billion in sales (for 64 approved therapies) to an anticipated $76.4 billion in sales (for a projected 200+ approved therapies) in 2030.

This robust pipeline will require massive shifts across the industry to improve access and scalability. For example, as many expected cell therapy approvals will be allogeneic rather than autologous, they can be manufactured in larger batches, reducing costs and simplifying the supply chain. Accredited treatment centers will need preparation to manage and administer products, while the supply chain will need rigorous protocols to ensure frozen products are not over-exposed to ambient temperatures. Meanwhile, ongoing reimbursement hurdles will require manufacturers and payers to partner on innovative payment models to reduce costs.

Improving Patient Access

Of course, with three full days of programming, Asembia sessions covered a wealth of other topics, from health equity and SDoH collection to the realities of payer switching. For manufacturers, presenters shared best practices for how to tell a strong value story, how to establish an optimal specialty network, and how to collaborate with payers and IDNS to accelerate patient access to specialty therapies.

On the patient access front, MMIT’s Steve Callahan and The Dedham Group’s Hannah Baxter presented the results of our 2025 State of Patient Access survey. Learn more about this primary research in last week’s blog post, Patient Access Barriers in 2025 and Beyond.

To better understand market access perspectives from payers, PBMs, providers and IDNs, learn more about MMIT’s Payer and Provider Insights solutions.