Specialty pharmacy is undergoing transformative changes, driven by the recognition of the need for a holistic approach to patient care, complexities of new treatments, advancing technologies, and evolving healthcare policies. Amidst these challenges, there is tremendous opportunity to improve patient outcomes, but four key elements must be embraced: integration of medical data, integration of advanced technologies, a focus on patient-centric care, and regulatory frameworks to accommodate the complexities of specialty medications.
The Importance of Medical Data Integration
Integration of medical data such medical history, diagnostic results, and treatment plans would allow specialty pharmacies to assess the “whole patient” rather than just their pharmaceutical needs. Access to this data enables specialty pharmacies to identify potential drug interactions, optimize treatment regimens, and tailor interventions. Studies suggest that integrating medical data and pharmacy records can reduce adverse drug events by 20-25% and improve adherence by 15-20%.1 In addition to having access to medical data, specialty pharmacies must also be able to report on outcomes, both clinical and financial, related to interventions. This capability is key to demonstrating the effectiveness of the specialty pharmacy’s overall clinical management of patients and the associated impact on reducing the total cost of care.
The Role of PBMs in Optimizing Care
As an essential part of the specialty pharmacy ecosystem, pharmacy benefit managers (PBMs) must also have access to comprehensive medical data to optimize care, leading to more accurate medication reviews, tailored benefit designs, reduced costs, and improved outcomes. The pipeline of medical specialty drugs is growing, impacting how and where care is delivered. Patients can now receive home-based care for conditions previously only treated in a healthcare setting, highlighting the need for PBMs to leverage access to data to offer comprehensive channel management and site of care optimization programs. Maintaining a continuous flow of data across PBMs, specialty pharmacies, and healthcare providers can ultimately offer a longitudinal view of patient care that leads to informed decision-making and improved patient outcomes.
Advancing Specialty Pharmacy with AI and Machine Learning
Adoption of Artificial Intelligence (AI) and Machine Learning (ML) in the pharmacy ecosystem has contributed to enhanced drug management, improved patient adherence, and optimized supply chain logistics. Within specialty pharmacy, AI-driven platforms have enabled prediction of patient adherence patterns and personalized interventions, leading to improved health outcomes.2
Shifting to Patient-Centric Care
With the market focused on more patient-centric care, specialty pharmacies need to reshape operations and how they serve patients. Improved speed to therapy, enhanced digital capabilities that align with how we live and work today in a tech-enabled world, and availability of wraparound services that address social determinants of health and other barriers to care will be key to delivering a seamless, best-in-class patient experience. Similarly, accrediting bodies should move beyond current standards of excellence predicated on operational performance only and instead develop outcomes-based requirements to earn seals of approval.
Evolving Regulatory Pathways for Specialty Pharmacy
From the drug development perspective, regulatory pathways have evolved to accommodate the complexity of specialty pharmaceuticals, with special programs introduced by the FDA to support the development of therapies for oncology and rare diseases. The Orphan Drug Act and Priority Review pathway are just two examples of FDA programs that have contributed to getting specialty medications to market faster. Today, approximately 75% of the over 7,000 new drugs in development are specialty drugs.3 The shift in focus to rare disease drug development and enhanced regulatory frameworks present exciting opportunities for patients in need of effective therapies, but it also will require specialty pharmacies to continue innovating and adapting to manage these new therapies. By leveraging connections with healthcare point solutions, access to medical data, and real-world evidence, PBMs are well-positioned to support clinical trials, potentially reducing trial recruitment times and improving overall trial efficiency as well as positioning themselves as the leader in additional indications for existing drugs and new drug approvals.
A Pharmacy First, Not Pharmacy Only Approach
The future of healthcare requires all stakeholders, including specialty pharmacies and PBMs, to adopt a “pharmacy first, not pharmacy only” approach to patient care. Integration of medical data and technological advancements, development of patient-centered programs and services, and continued regulatory frameworks that support treatment innovations will ultimately shape the industry and advance patient care.
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[1] Kozlicki, M., Lynch, B., Donoho, T., Nichols, P., & Zuckerman, A. D. (2023). Development and implementation of a laboratory monitoring dashboard to reduce treatment gaps in inflammatory bowel disease. American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists, 80(Suppl 2), S55–S61.
[2] (2022). AI in Specialty Pharmacy: Enhancing Patient Care and Operational Efficiency.
[3] Jain, S. Navigating the rapid growth of specialty drugs: Opportunities, challenges, and the path ahead. Pharmacy Times. September 14, 2023. Accessed on July 30, 2025.
