As a pharmaceutical company, our commercial success hinges on our ability to optimize each of the elements of the access journey. It does not help us if after a favorable FDA approval, payers restrict drug access, medical associations don’t recommend it on their guidelines, providers don’t place it on formulary, physicians don’t prescribe it, or the patient decides not to pick it up in the pharmacy or ends the treatment early.
It’s essential that we closely evaluate each of the access journey steps to determine what it takes to secure success. Who’s the decision maker and what development strategy and resulting evidence will positively influence that decision?
Each of the access journey steps involves a different set of decision makers with different value preferences and needs. Payers are generally focused on long-term outcomes and related economic impact. They tend to put limited significance on direct clinical metrics unless it has a sustained and long-term health impact. Provider organizations are likely to want to see an impact on quality metrics, such as (re-)hospitalization rates, other outcomes metrics and patient satisfaction. These differences may not seem fundamentally large, but they can have a significant impact on clinical development programs. For example, whether we need evidence of improvement in tumor response rate, progression-free survival or overall survival has large implications on trial design, investment need and probability of success. Similarly, HbA1c management in diabetes and low-density lipoprotein control in hypercholesteremia may be acceptable metrics for success to a clinician, but payers and provider organizations may want to see additional evidence of long-term impact on outcomes and related cost.
Even where stakeholders are aligned on a meaningful metric, the level of evidence required can be very different. Payers typically require head-to-head trials versus an appropriate long-term endpoint. Provider organizations prefer real-world evidence that demonstrates improvements on meaningful outcomes metrics in their specific population. Patients want to feel a response, improvements in their symptoms and confidence in the long-term prognosis.
Understanding what drives decisions for each of the access journey elements is of critical importance when devising a development plan and, ultimately, a launch marketing strategy. We use our benefits analysis methodology to systematically assess priorities to stakeholders. Without going into detail on the methodology, the figure below shows on a high level how the focus on evidence is different between FDA/EMA, payers, provider organizations, prescribing physicians and patients. This is merely a high-level illustration of typical differences in perspectives on value between stakeholders. For individual drugs, a more comprehensive analysis is warranted, which should include a larger set of potential benefits, a complete set of comparators, and all-important stakeholders and their segments. It does, however, illustrate the need to customize value claims and supporting evidence to each of the stakeholders individually.
For a more detailed description of the access journey and how to use this in development and commercialization decision-making, check out my latest article, “Access Journey: A Call for Change in Prescription Drug Commercialization Decision-Making.”