FDAMA 114 Consulting 2018-08-01T22:48:29+00:00

As the payer conversation shifts from cost to value, manufacturers have to figure out how to explain the value proposition for the brand in terms that will resonate with all the stakeholders in the formulary decision-making process. The Food and Drug Modernization Act of 1997, Section 114 (FDAMA 114) is the guiding document for leading those conversations in a legal and compliant way. Many of the experts working for Peregrine Market Access were the original pioneers in creating FDAMA 114 messaging. We understand how to use it to help inform and influence key decision-makers.

There is no such thing as “clinical value”.  The word “value” implies some type of cost impact. For managed markets and market access formulary decision-makers, discounts are just the beginning of a much more complicated value conversation. At Peregrine, we’ve been doing the math for years. We know that determining the value of a product requires knowing what it does clinically, and how that clinical benefit impacts the overall healthcare cost of both the patient and the member population of which the patient is a part.

There are four areas to focus on when investigating the cost impact of a therapeutic intervention:

  • Drug acquisition cost
  • Dosing variability
  • Cost per outcome achieved
  • Cost per consequence avoided

It’s not enough to find the relevant story; your strategic partner needs to know how to articulate what the FDAMA 114 regulation says, what it means, and how to use it. It’s going to take work for your team to understand the connectivity of indication to impact, the stakeholders, and which cost impact is relevant to which decision-maker.

At Peregrine, this particular part of value proposition creation is our specialty. If you can only explain the clinical benefits of your brand to formulary decision-makers, you’re only telling half the story, and frankly, you’re telling the less influential half. We can help you to dig into your data, examining your brand work with your clinical specialists as well as your organizational health economists. If your organization is small, we can do that work ourselves, all while helping you to better understand what your brand can do. We leverage the strength of your brand, your data, and your organization through workshops, meetings, and collaboration. The end result is a value proposition that addresses each stakeholder’s concerns.