Author: Kelly Gaffney, PharmD, BCOP, DPLA, Senior Director, Access Experience Team
For years, a vast majority of the conversation around patient access has focused on whether a therapy could be made available. Today, in many health system settings, that question has largely been answered. The challenge is no longer simply allowing access; it’s driving access. The distinction is subtle, but it represents one of the most important realities facing providers, health systems, and pharmaceutical manufacturers.
Looking back a decade or more, formulary management in health systems was fundamentally different. Closed formularies were common, and gaining approval for a new therapy often required significant reviews and restrictions. In various organizations today, particularly in the outpatient environment, formularies have become far more open. If a payer is willing to reimburse for a drug, there is a strong likelihood that the health system will make it available in some capacity.
Changes in operational processes have played a large role in allowing this shift to occur. Health systems have become increasingly sophisticated in how they manage inventory and patient scheduling. Patients are often scheduled days or weeks in advance, prior authorization (PA) requirements are completed before treatment, and financial clearance is confirmed prior to the infusion appointment. Because of these changes, infusion pharmacies can order medications specific to a patient’s appointment instead of the historical practice of having large amounts of expensive inventory sitting on the shelf in anticipation of a patient being identified. Aligning procurement directly with patient demand optimizes inventory and minimizes waste.
The downstream effect is that many therapies — certainly not all, but more than in the past — can be made available to providers. Operational delays may arise from electronic medical record (EMR) builds, J-code availability, nursing education needs, and workflow development, but the access pathway generally exists. In many cases, health systems have evolved from asking, "Can we provide this therapy?" to asking, "When can we operationalize this therapy?"
The real challenge begins once access has been granted.
As healthcare executives, physicians, pharmacists, and administrators, we often spend significant time evaluating cost-effectiveness, operational feasibility, and clinical value. Let's say we identify Drug X as offering equivalent outcomes to Drug Y at a lower total cost of care for both the patient and the health system. If both products are available on formulary, can we realistically expect providers to consistently choose Drug X? In many cases, the answer is no.
Education alone is rarely enough to change prescribing behavior. A provider can hear a message about cost-effectiveness a hundred times, but when they enter orders, other influences frequently take precedence. Perhaps Drug Y appears higher in the medication ordering workflow, or it requires fewer clicks to order. Perhaps a sales representative recently provided education on the product, so it’s top of mind, or it’s simply the medication the provider has historically used. Human behavior and clinical workflow often outweigh theoretical or even proven value discussions.
This is where the distinction between allowing and driving access becomes critically important. Allowing access means making therapies available. Driving access means creating systems, processes, and incentives that guide utilization toward the most appropriate and sustainable options.
Many organizations have recognized this challenge and implemented mechanisms to influence therapy selection. Some examples include:
These approaches can be highly effective; however, they require substantial resources to build and maintain. Clinical pathways must be continually updated as new data emerge, new therapies receive approval, and treatment guidelines evolve. EMR content requires governance, testing, implementation, and ongoing optimization. Stakeholder engagement across physicians, pharmacists, nurses, and administrators requires significant coordination. This work is difficult even in well-resourced organizations, and it becomes much harder in an environment where health systems are being asked to do more with less.
Today, organizations face workforce shortages, increasing regulatory burdens, shrinking margins, and ongoing uncertainty around programs such as 340B. Pathway development and maintenance often fall behind more immediate operational priorities. As a result, many health systems continue to allow access without fully driving it.
This reality means there are considerable opportunities to influence access decisions further upstream. Manufacturers, market access teams, and other healthcare professionals increasingly recognize that access is shaped long before a therapy reaches widespread clinical adoption. Evidence generation, value demonstration, payer strategy, and market access planning all help create favorable conditions for access.
Efforts often remain heavily focused on payer approval, but in reality, coverage is only one step in a much larger process. Access is achieved when the patient ultimately receives the therapy.
Even as electronic PA, automation, and technology-enabled patient support programs continue to reduce administrative burden and streamline payer approval processes, critical access decisions remain. Providers and health systems determine whether a therapy is incorporated into clinical workflows, supported operationally, understood by care teams, and viewed as feasible to prescribe. A medication may have favorable coverage and minimal reimbursement barriers, yet still experience limited utilization if providers encounter operational, administrative, or workflow challenges.
For this reason, conversations about access should begin earlier and extend beyond payer strategy alone. Understanding the practical realities of care delivery and the factors that influence provider adoption may reveal opportunities to improve patient access before the prescription is written.
The next step for pharmaceutical manufacturers is to understand how decisions are made at the point of care and create systems that help guide those decisions toward clinically appropriate and cost-effective outcomes. Manufacturers can implement various tactics to think beyond traditional market access strategies. These include:
This tactic includes real-world evidence, patient stratification data, and practical implementation insights that can help health systems identify where utilization should be concentrated and where the greatest value can be achieved.
A patient’s journey goes beyond a transactional map. Patients are managing a continuous experience that includes monitoring, follow-up care, side effect management, financial challenges, insurance changes, comorbidity management, caregiving responsibilities, and everyday life events. Strategic access planning requires understanding not just how patients start therapy, but how they navigate barriers to remain on therapy.
Operational efficiency, provider adoption, health equity goals, site-of-care considerations, and total cost of care may all influence decision-making.
Order panels, order sets, best practice advisories, and care pathway alignment are all tools needed to ensure medications are readily available for use.
Ultimately, the therapies that create the greatest value go beyond those on formulary; they are the therapies that reach the right patients, at the right time, through systems intentionally designed to support their use.
If you would like to discuss strategies for collaborating with IDNs to direct access to care, connect with our team to continue the conversation.