Best Practices for Navigating Drug Pre-approval Information Exchange

By Kerri Fitzgerald - Last Updated: April 30, 2019

Preapproval information exchange is the communication between biopharmaceutical companies and population health decision-makers on topics such as phase III clinical trial data, pharmacoeconomic data, and patient-reported outcomes prior to a product’s approval and launch.

This communication can provide benefits to both payers and manufacturers, as plans can more accurately forecast formularies and manufacturers can provide factual, accurate, and nonmisleading information on products or indications that are not yet approved, according to Elisabeth Brisley, MPH, legislative analyst at AMCP, who provided a presentation on the topic at the AMCP Annual Meeting, along with Amy Duhig, PhD, vice president of consulting services at Xcenda, LLC, in Palm Harbor, Florida, and Sheila M. Thomas, PharmD, global head of patient insights and engagement strategy at Sanofi, Inc, in Bridgewater, New Jersey.

Dr. Duhig discussed the findings of a survey of 47 U.S. payers to gauge their opinion on preapproval information exchange. The survey included 30 questions, and respondents included payers from managed care organizations (66%) and pharmacy benefit managers (26%). More than half (57%) were part of regional plans, and many (62%) were pharmacy directors. Combined, the respondents covered 203 million lives.

The researchers found that the most important types of preapproval information were product pricing information (89%), study results (77%), possible timelines for Food and Drug Administration (FDA) approval/clearance/licensure (77%), and indication information (74%). Some respondents (40%) said the frequency of this type of information has increased, but most (68%) said the quality of the information has remained the same.

Payers reported some gaps in the communication, including topics such as plans for further trials/subgroup analyses, pricing, place in therapy, other indications in pursuit, health resource utilization/outcomes data, dosage strength/product size, and more. Approximately half of those who perceived a proactive information gap said that formulary decision-making could be improved if this gap were closed. Many respondents said the preferred timing of proactive information is six months prior to approval. A majority (93%) said their preferred source of this information is a medical science liaison.

Dr. Thomas then provided outcomes from a survey of 41 U.S. manufacturers to gauge their opinion on preapproval information exchange. The survey included 10 questions, and respondents were from small- to large-sized companies, most (56%) of which conducted health economics and outcomes research. Respondents were split when asked if there was a process in place to deal with preapproval information exchange materials: 37% said yes, while 39% said no, but a process was under development. Most said they shared information through an account manager (67%) and health economic outcome liaison (60%).

She then discussed best practices for delivering a credible message: “The focus should not be on who but should be on the what and ensuring appropriate skills and competencies of individuals delivering the information.” Dr. Thomas’ tips include:

  • Know your audience
  • Desirable skills and competencies are similar pre- and post-approval
  • Job title will likely vary based on size and structure of manufacturer
  • May require a team of individuals with complementary areas of expertise
  • Labels of “promotional” versus “nonpromotional” personnel should not limit the ability to communicate
  • Individuals should be trained to communicate at the top of their scope of practice

Dr. Thomas said that it is important to stay educated on the latest FDA Final Guidance surrounding this type of communication. Firms should develop and implement a robust internal training plan for communicating this type of material and provide timely updates when information has changed. Lastly, flexibility is a necessity!

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