About the Authors
Christen Roy, PharmD, is a senior principal product manager of product strategy at Inovalon in Portland, Maine.
Holly Wieneke, RPh, is a senior principal product manager of product strategy at Inovalon.
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Evolving Business Models in Specialty and Infusion Pharmacy
Hospitals and health systems are adapting specialty and infusion pharmacy strategies to meet evolving payer mandates, rising costs, and shifting care models by expanding biosimilar use, optimizing prior authorizations, and integrating technology to enhance patient access and operational efficiency.
Specialty and infusion health care delivery once followed a well-established model. However, the rise of biosimilars, the emergence of specialty-lite therapies, payer-imposed site-of-care mandates, and changing reimbursement models are reshaping the process, opening a door for hospital and health system pharmacies to explore another revenue stream with enhanced rigor and purpose.
As the US population ages, the health care industry faces challenges that increase the overall cost in the system, with contributing factors, such as high inflation rates, labor shortages, and constrained funding.1 To preserve patient access to critical therapies and remain competitive, it is imperative that hospitals and health systems adapt their pharmacy business models and operational structures.
The Evolving Specialty Landscape
In response to the changes in the industry, hospitals and health systems are increasingly investing in their own specialty and infusion pharmacy capabilities. A key area of focus is greater participation in the limited drug distribution (LDD) application process. Traditionally led by manufacturers, this process has often favored large specialty pharmacies aligned with pharmacy benefit managers (PBMs), leaving smaller and mid-sized providers struggling to compete.
In recent years, hospitals and health systems have strengthened their policies and procedures to meet not only the core standards of The Joint Commission, but also the specialized accreditation requirements and performance metrics set by manufacturers. This strategy has helped increase their credibility and access within the specialty pharmacy space. In fact, hospitals and health systems now operate 27% of accredited specialty pharmacies, up significantly from just 15% in 2017.2
This growing market share has led to the need for operational changes. Specialty medications routinely require prior authorization, and the complexity of these requirements typically increases with the intricacy of the therapy and its administration. In the infusion space, medical reimbursement becomes even more complex, involving factors such as billing for infusion nurse services and daily per-diem billing for acute therapies. To reduce the administrative burden on provider offices and accelerate time to therapy for patients, many organizations have established prior authorization teams and adopted systems with hospital and health system electronic health record (HER) connectivity.3
In the specialty and infusion space, even a paid claim can still present a financial barrier to care for patients. Having processes in place for both copay assistance and non-profit foundation support is essential—especially since copays above $100 have abandonment rates as high as 75% for some therapies.4
After the initial prior authorization, creating a proactive renewal process can significantly improve patient adherence by reducing delays in authorization submission.5 Timely therapy initiation and sustained adherence are critical performance metrics for securing contracts with both payers and manufacturers. These metrics demonstrate the pharmacy’s commitment to patient outcomes and operational efficiency—factors that can earn more favorable reimbursement rates, and benefit both patients and providers.
Pills falling around a person walking. Image Credit: © Geekminds - stock.adobe.com
Economic and Operational Disruption in Specialty and Infusion
Patients are increasingly seeking more technology and automation tools to help manage chronic conditions so they can actively participate in their care. Nearly 50 million Americans already use remote patient monitoring (RPM) devices, and 80% express a willingness to incorporate RPM into their medical care.6 In response to patient preferences, specialty pharmacies are creating processes that more closely resemble the convenience and responsiveness of the retail pharmacy model while still maintaining the consistent monthly touch points needed to ensure proper administration, dosage, and length of therapy. Typically, these high touch points in the specialty and infusion journey prohibited the patient experience from being as streamlined as the retail experience. Technology is the key to meeting patient expectations.
The growing availability of biosimilars, particularly for therapies with simpler administration methods, is driving the shift toward more cost-effective, less labor-intensive models that are “specialty lite.”
Specialty lite typically refers to pharmaceuticals with a wholesale acquisition cost between $500 and $2500 per month (or $6000 to $30,000 annually) and defined service-level requirements. While these therapies are generally less complex than traditional specialty drugs, they are still managed by payers and often require prior authorization,7 underscoring the need for technology to support access and adherence.
While biosimilars hold long-term potential for reducing health care costs, the initial savings may fall short of public expectations. Research shows that the first biosimilar entrant typically offers only a 15% to 16% discount compared to the originator’s list price.8 However, as more competitors enter the market over time, prices may decline further, similar to the trends for generic medications.
One of the most pressing challenges for pharmacies is whether their software system can support seamless transitions to biosimilars, especially given that some are designated as interchangeable by the FDA, while others are not. This marks a fundamental difference between the biosimilar and generic drug pathways, and one that the industry is still trying to navigate.
A new care model is emerging where the traditional specialty, infusion, and hospital and health system pharmacies all find their new footing and ways to collaborate to bring an even better seamless patient journey to light. Many of these new drugs may cross the boundary of infusion vs specialty and the ultimate route of administration will determine the category it falls into.
As the biosimilar market expands, it makes sense that payers and pharmacies could consider a shift of lower cost, less complex therapies to a specialty lite model. This could set the stage for specialty and infusion pharmacies to partner more closely and help make room for the new drugs coming to market in the infusion space which may require the unique expertise of both specialty and infusion staff.
Ultimately, the future of specialty and infusion care is hybrid, decentralized, and aligned with payer priorities. Hospitals and health systems that fail to evolve their pharmacy strategies in response to these shifts risk falling behind.
REFERENCES
Singhal S, Patel N, Jain A, What to expect in US healthcare in 2025 and beyond. McKinsey & Company. January 10, 2025. Accessed July 23, 2025. https://www.mckinsey.com/industries/healthcare/our-insights/what-to-expect-in-us-healthcare-in-2025-and-beyond
Fein AJ. The Top 15 Specialty Pharmacies of 2024: How PBMs, Health Systems, and Independents Are Shaping the Market. Drug Channels. April 16, 2025. Accessed July 23, 2025. https://www.drugchannels.net/2025/04/the-top-15-specialty-pharmacies-of-2024.html
Weiser P. Specialty Drugs: Higher Patient Cost Sharing and Prior Auths Linked to Abandoned Meds, Treatment Delays. Managed Healthcare Executive. May 17, 2023. Accessed July 23, 2025. https://www.managedhealthcareexecutive.com/view/specialty-drugs-higher-patient-cost-sharing-and-prior-auths-linked-to-abandoned-meds-treatment-delays
Ismail WW, Witry MJ, Urmie JM. The association between cost sharing, prior authorization, and specialty drug utilization: a systematic review. J Manag Care Spec Pharm. 2023;29(5):449–463. doi:10.18553/jmcp.2023.29.5.449
Vishwanath S, Tran SN, Pomfret TC, Boss KC, Tesell M, Price M, Alper CJ, Muchnik L, Clements KM, Lenz K. Evaluating proactive outreach for prior authorization recertifications in Medicaid patients. Am J Manag Care. 2021;27(11):e395‑e399. doi:10.37765/ajmc.2021.88783
Intuition Labs. Remote Patient Monitoring in the United States: 2025 Landscape Report. Intuition Labs. April 27, 2025. Accessed July 23, 2025. https://intuitionlabs.ai/articles/remote-patient-monitoring-united-states-2025-landscape
James D. Specialty-Lite Model Goes Beyond Improving Adherence. Pharmacy Times. April 30, 2019. Accessed July 23, 2025. https://www.pharmacytimes.com/view/specialty-lite-model-goes-beyond-improving-adherence
San-Juan-Rodriguez A, Gellad WF, Good CB, Hernandez I. Trends in list prices, net prices, and discounts for originator biologics facing biosimilar competition. JAMA Netw Open. 2019;2(12):e1917379. doi:10.1001/jamanetworkopen.2019.17379
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