Insights from AXS25 Summit

Asembia’s AXS25 Summit served as a crucial forum for stakeholders to discuss the multifaceted challenges and emerging opportunities within the specialized pharmaceutical landscape. Against a backdrop of evolving recently released regulations, rapid technological advancements and the persistent drive to optimize patient care, the discussions held at the three-day meeting offered valuable insights into the industry’s current state and future trajectory. Applying the principles of managed care — a framework centered on balancing the quality and accessibility of care with cost-effectiveness — provides a powerful perspective through which to interpret and apply the insights shared at the meeting.

Frank Scimeca, Pharm.D., MBA, vice president of pharmacy services at the Florida Cancer Specialists & Research Institute in Fort Myers, Florida.

One of the most pervasive themes throughout the meeting was the economic sustainability of specialty pharmacy, particularly in the context of high-cost, low-incidence rare disease conditions. The fundamental equation of service fees and reimbursement minus operational costs, coupled with the observed shift in margin favorability toward upstream entities, raises significant concerns from a managed care perspective. The challenges discussed included barriers to patient access, intricate rebate and discount structures, and the impact of governmental pricing programs. These challenges have resulted in the development of some managed care strategies utilized today, such as formulary management, prior authorization and negotiation of drug prices and rebates, which are all aspects of managing the cost of healthcare while preserving the quality of care. The need for innovative reimbursement models and greater price transparency becomes even more critical in the realm of high-cost specialty medications. The shift in margins favoring pharmacy benefit managers (PBMs) and wholesalers raises concerns about the sustainability of high-quality specialty pharmacies. Managed care principles would advocate for transparent pricing models, reimbursement structures that adequately compensate pharmacies for their complex services, and ensuring patient access isn’t compromised by unsustainable economics. The challenges of increased drug prices, rebates and governmental discounts are all points of negotiation and management within a managed care framework to optimize the most cost-effective care for patients and stakeholders.

Roger Orr, Pharm.D., director of clinical specialty pharmacy operations at the Florida Cancer Specialists & Research Institute in Fort Myers, Florida.

Additional panel presentations were focused on strategies to decrease financial toxicity for patients. “Best Practices in Free Drug Program
Management” showcased proactive efforts to enhance patient access and adherence, both key objectives within managed care. By optimizing manufacturer-sponsored patient assistance programs, the industry demonstrates a commitment to mitigating financial barriers to treatment, according to the three members of the panel: Sue Farida, RPh, of Homescripts; and Allison Watson, Pharm.D., and Scott MacNider of AcariaHealth Specialty Pharmacy. The emphasis on tailoring pharmacy services to individual patient needs, leveraging technology for improved communication and support, and tracking performance through relevant key performance indicators directly aligns with managed care’s focus on patient-centered care and quality outcomes, they noted. The subtle acknowledgment of the potential impact of recent regulations and the evolving landscape of the Inflation Reduction Act (IRA) on patient assistance programs highlights the dynamic interplay between policy and the practical implementation of managed care principles aimed at ensuring medication access.

IRA and AI

The far-reaching implications of the IRA and its drug price negotiation provisions are intrinsically linked to managed care’s central goal of affordability. The many detailed discussions of the IRA and preparing for the next phase of Medicare’s drug price negotiations emphasize the industry’s need to proactively engage with cost-containment measures. Farida, Watson and MacNider discussed strategies and examples for demonstrating therapeutic alternatives, comparative clinical value and the strength of evidence-based decision-making processes to justify the inclusion of medications on formularies.

The session titled “The Rise of Specialty in Gen Med… Are You Ready?” explored both the opportunities and challenges for managed care. Panelists Kelly Carter, of Amgen, and Kim Plesnarski, Sarah Boyce, Michael Sarshad, MBA, and Adrian Garcia, M.Ed., all of Syneos Health, told the audience about innovations in expanding access to specialty medications through primary care settings that can improve patient outcomes but also demand careful management to ensure appropriate utilization and cost control.” The exploration of artificial intelligence (AI) and machine learning (ML) applications for enhancing patient engagement, streamlining workflows and personalizing care aligns with managed care’s pursuit of efficiency and improved quality while minimizing cost. As more nonspecialists prescribe complex medications, managed care systems will need to adapt their guidelines, educational resources for prescribers and patient support programs to ensure safe and effective use while also managing the potential for increased overall drug spending. This shift highlights the importance of integrated care models, utilization of AI and ML to support general practitioners in monitoring their patients on specialized medication, and continuing to become innovative as our landscape evolves.

The session titled “Challenges in IRA Maximum Fair Price: Effectuation Evaluating the Retrospective and Prospective MFP Models” spotlighted some of the practical hurdles of implementing cost-containment policies within a managed care framework. Panelists Tyler Novotny, MBA; Caleb Debenham; Megan (Law) Glover, MBA; and Whitley Quan, M.P.H., all of Cencora, discussed the trade-offs between the retrospective refund model and the prospective discount model. Areas of concern raised for specialty pharmacies included the operational complexities and potential cash flow delays with the retrospective model. Late payments, dispute resolutions, the risk of duplicate discounts and the potential spillover effects to other pricing mechanisms all highlight the need for careful planning and robust infrastructure within managed care to effectively manage these new regulations. The retrospective refund model involves a manufacturer transfer facilitator payment manager (MTF PM) connecting manufacturers to dispensing entities to facilitate retrospective refunds on market fair price (MFP)-eligible claims. Pharmacies continue to purchase at the wholesale acquisition cost (WAC), with a backend manufacturer payment occurring theoretically within 44 days (though CMS aims to reduce the data processing time to seven days). The four Cencora employees discussed their company’s approach, which offers a prospective solution and exemplifies the industry’s efforts to find practical ways to implement these changes within existing managed care structures. The prospective refund model eliminates the MTF PM between the manufacturer and the pharmacy. This further allows the pharmacy to purchase medications directly from distributors at MFP instead of purchasing at WAC. The prospective solution includes pharmacy enrollment and an automatic MFP calculator.

The session titled “Value/Outcome-Based Specialty Contracting — Where We Are, Where We’re Headed, and What Is the Endpoint/Outcome?” addressed the growing emphasis on value-based care within managed care. The panel included seven members: Burt Zweigenhaft, Ph.D., of FFF Enterprises; John M. O’Brien, Pharm.D., M.P.H., of the National Pharmaceutical Council; Erin Satterwhite, M.S., of Optum Rx; Jayson Slotnick, J.D., of Health Policy Strategies; Nancy Bell, M.H.C.A.F., of Celcuity; Kent Rogers, MBA, of EveryONE Medicines; and Roxanne Schwans, MBA, of Prime Therapeutics. They discussed how the success of value-based agreements hinges on many factors, including all stakeholders trusting the data they are given, adherence, program duration and internal and external stakeholder collaboration. Value-based contracts between payers and drugmakers will move managed care to more outcome-driven payment models. Overcoming the obstacles of data, adherence and duration is essential for the broader adoption of value-based care and payment within managed care, particularly in the complex and often data-limited realm of specialty pharmacy. This panel’s discussion of the subjective nature of pharmacy’s value and the need for greater sharing of clinical data between pharmaceutical companies and payers highlights the harmonization required for successful value-based arrangements within a managed care environment.

The role of the PBMs

The topic of PBMs and the role they play in managed care came up often at the meeting. The observed shift in economic margins favoring PBMs, as highlighted in a session on rare disease economics, raises questions about the value PBMs provide and their impact on pharmacy viability. From a managed care perspective, PBMs are intended to drive cost savings and improve drug utilization. However, the discussions suggest a need for greater transparency in their pricing models and rebate negotiations to ensure that these savings are shared across the healthcare system and do not disproportionately disadvantage pharmacies or hinder patient access. The ongoing debate surrounding PBM practices, including formulary design and prior authorization, directly impacts how managed care organizations manage drug benefits and patient access to specialty medications.

The increasing trend of vertical integration, where payers, PBMs and even providers consolidate, has significant implications for managed care and the specialty pharmacy landscape. Select experts hypothesized that vertical integration leads to greater efficiency and care coordination, but others voiced concern about potential anticompetitive effects and the limits on patient choice. From a managed care standpoint, vertical integration can streamline processes but also requires careful oversight to ensure that cost savings are not achieved at the expense of quality or access, and that fair competition within the pharmacy market is maintained.

The continued growth of specialty drug spending relative to traditional drug spending is a major concern for managed care organizations focused on budget management. The high cost of many specialty medications necessitates sophisticated strategies for utilization management, including rigorous prior authorization, step therapy protocols and the exploration of more cost-effective alternatives when clinically appropriate. The panel discussions at the Asembia meeting addressed strategies for managing this growing spending, such as value-based contracting and the need for clear clinical evidence to support the use of high-cost specialty therapies. Managed care’s role is to ensure that these expensive medications are used judiciously and for the patients who will gain the most value.

The new administration

Another frequent topic at the meeting was the new administration and the healthcare executive orders signed by President Donald J. Trump on April 15. New policies and programs related to drug pricing, Medicare and Medicaid, and healthcare access can significantly alter the regulatory landscape and the operational environment for all stakeholders. Managed care organizations must closely monitor these developments and adapt their strategies accordingly, noted many panelists. There was an emphasis on performance, outcomes and end points, as noted in the IRA impact session, suggesting a potential alignment with managed care’s focus on value and accountability.

Judging from the many conversations at the meeting, it seems the industry will likely continue to grapple with the implementation of the IRA’s drug pricing provisions, the evolving role of PBMs and the increasing integration of specialty care into general medicine. Technology, particularly AI and ML, is expected to play a growing role in patient engagement and operational efficiency.

Looking further down the road, the shift toward value-based care is likely to accelerate, requiring greater data sharing and collaboration among stakeholders. The ongoing debate about drug pricing and access will likely continue, influenced by both policy changes and the continued innovation of high-cost specialty therapies. Managed care organizations will need to be adaptive, focusing on strategies that promote both affordability and optimal patient outcomes.

Dialogue and collaboration

The Asembia meeting offered a wealth of information that can be effectively analyzed through the lens of managed care. The discussions surrounding cost containment, patient access, quality improvement and the shift toward more value-based care contracts resonate deeply with the fundamental principles of managed care. As the specialty pharmacy landscape continues to evolve under the influence of new regulations, technological advancements and increasing therapeutic complexity, managed care will play a crucial role in shaping how these changes are navigated to ensure sustainable, equitable and high-quality care for all patients. The ongoing dialogue and collaborative efforts among stakeholders are essential for effectively applying managed care principles to the unique challenges and opportunities within specialty pharmacy