Jason McDonough | Article

Effective decision making in early asset development and commercialization

clinical commercial patient valueOne of the greatest challenges in the early stages of asset development is the data and evidence gap; development teams’ foundation of known clinical outcomes in a fixed treatment landscape. As teams make crucial decisions on when and how to take an asset forward, they have to rely on assessments of the current situation and predictions of what the future landscape may look like in five-to-10 years, to determine the potential value of a new asset to patients, physicians, and payers.

Given the current evolving environment, it is likely that both the treatment paradigm and reimbursement landscape will have shifted by the time of launch. Physicians, patients, payers, and regulators will all be looking for different pieces of information to justify the role and value of a new therapy, particularly as that space inevitably becomes more crowded. Teams developing assets for conditions with only one or two approved therapies today are likely to face an environment with seven or eight approved medications in 2021, which presents an altogether more competitive reimbursement challenge. Thus, teams need to consider how to demonstrate an asset’s value to all key stakeholders clearly and supported with evidence.

The challenge in making these decisions about the future is the data gap; with phase 3 data years away, the constantly evolving landscape and shifting reimbursement requirements, how can development teams determine the future value of an asset?

Answering that question requires evaluation of three distinct sources of value: clinical, patient and commercial. Though some consider these value streams independently, the only way to understand how they interact with, and amplify, each other is to review them collectively.

To learn about our recommendations on defining the three sources of value, and evaluating them collectively read the full article at PharmaPhorum Effective decision making in early asset development and commercialisation.