The Asembia AXS26 Summit convened health care leaders to address a rapidly evolving specialty pharmacy landscape. The first day’s sessions highlighted the convergence of regulatory pressures, advanced therapeutic scaling, and the integration of artificial intelligence, providing a roadmap for stakeholders navigating an increasingly complex environment.

Session 1: Navigating the Reshaping of US Drug Pricing and PBMs

In a session¹ from April 27, 2026, presenters examined the cascade of forces currently transforming pharmacy benefit manager (PBM) operations and drug pricing. Experts from Avalere Health identified 3 regulatory pillars reshaping the landscape: FTC settlements with Express Scripts and CVS Caremark, which mandate fee-based compensation and restrict spread pricing; the Department of Labor’s proposed transparency rules for ERISA plan sponsors; and the Consolidated Appropriations Act (CAA) of 2026. The CAA is particularly significant as it delinks PBM revenue from drug prices in Medicare Part D, though a Medicaid spread pricing ban was ultimately excluded due to budget scoring.

Experts Lisa Joldersma, senior advisor, Avalere Health; Mike Ciarametaro, managing director, Avalere Health; and Mina Allo, managing director, Avalere Health, noted that although PBM reforms aim to discourage rebates, drug pricing mechanisms such as the maximum fair price (MFP) remain heavily reliant on rebate-type arrangements. On the pricing front, the Inflation Reduction Act (IRA) is moving into 2028 negotiations, marking the first time Medicare Part B immunology products are included. Simultaneously, the administration has advanced Most Favored Nation (MFN) pricing through the GLOBE and GUARD initiatives, coupled with 100% tariffs on patented pharmaceuticals manufactured outside the US—though exemptions for manufacturers with MFN agreements remain ambiguously defined.

Market strategy is shifting toward a more integrated global view of asset launching. Manufacturers are exploring ways to separate US and ex-US prices through outcomes-based contracting to obscure net prices from the government. With the 2026 midterms approaching, the session concluded that the policy environment is structurally unsettled, demanding active strategy rather than simple monitoring.

Session 2: Scaling Cell and Gene Therapy as The Future of Specialty Pharmacy

As cell and gene therapies (CGTs) move from niche to mainstream, panelists discussed² the urgent need to scale distribution and payment models. Although current systems function for small patient volumes, experts questioned if they would break when treating 100 patients per month rather than 1. With approximately 50 FDA-approved CGTs and a robust pipeline in neurology and hematology, the industry is entering an era compared to the invention of penicillin.

“We haven't seen today, I should say, a situation where drugs launch and you've got 100,000 patients in the door right [on] that first day. These launch curves take some time,” Morgan Olson, senior vice president of biopharma business development for Orsini, said in the session.

The financial stakes are massive, including treating 50,000 patients at $3 million per treatment would consume a significant portion of total US drug spend. Consequently, the value story for CGTs must evolve as they transition from ultra-rare disease treatments to therapies for more common conditions with established standards of care. Distribution models are also shifting. Although some manufacturers initially used a buy-and-bill channel, many are now outsourcing to specialty pharmacies to manage the financial risk and complex insurance claims associated with these high-cost assets.

There were 2 prevailing distribution frameworks, including the flash title model, where manufacturers retain risk until delivery, and the specialty pharmacy drive-by model, where pharmacies handle the financial transaction and risk without physically possessing the therapy. As outpatient administration grows, specialty pharmacies are becoming essential partners for manufacturers who want to ensure patient access while mitigating the $3 million risk per dose.

“There's adoption that has to happen across the centers, providers as well as the patients, to feel comfortable and want to take this on,” Olson said.

Session 3: The Trust Gap: Navigating AI Integration in Specialty Pharmacy

Another session³ addressed the integration of artificial intelligence (AI), noting that although the technology is deeply embedded in workflows, a significant trust gap remains. AI is currently streamlining prior authorizations and member services, reducing call wait times and improving data availability. However, a shift is occurring from ambient AI, or background assistance, to agentic AI, which can execute complex workflows autonomously.

Regulatory fragmentation poses a major challenge. In the absence of federal guardrails, states are creating their own rules, such as Utah’s AI sandbox, which allows AI to prescribe refills for 150 drugs without a pharmacist. From a safety perspective, experts warned that AI-assisted medical records could distort safety signals. If AI over- or underrepresents clinical events in documentation, it could lead to false results that threaten drug access or patient safety.

To address these concerns, the Utilization Review Accreditation Commission launched the first Health Care AI Accreditation Program in September 2025. This program offers modular tracks for both developers and users to ensure AI systems follow quality principles without requiring the disclosure of trade secrets.

The panel urged organizations to move beyond basic technology policies and establish dedicated AI governance, encouraging stakeholders to actively engage in the policy-writing process rather than "driving the car by looking in the rearview mirror.”

REFERENCES

1. Steinzor P. Rebates, Reference Pricing, and the Road to 2026 Midterms. American Journal of Managed Care. April 28, 2026. Accessed April 28, 2026. https://www.ajmc.com/view/rebates-reference-pricing-and-the-road-to-2026-midterms

2. Wehrwein P. The mainstreaming of cell and gene therapy and what that means for price and distribution | Asembia AXS26 Summit. Managed Healthcare Executive. April 28, 2026. Accessed April 28, 2026. https://www.managedhealthcareexecutive.com/view/the-mainstreaming-of-cell-and-gene-therapy-and-what-that-means-for-price-distrubtion-asembia-axs26-summit

3. Hohmann E. The Cat Is Out of the Bag: AI's Impact on Specialty Pharmacy Quality. Pharmacy Times. April 28, 2026. Accessed April 28, 2026. https://www.pharmacytimes.com/view/the-cat-is-out-of-the-bag-ai-s-impact-on-specialty-pharmacy-quality