The legislative and regulatory environment governing proactive communication between manufacturers and payers continues to evolve, according to experts at the AMCP Annual Meeting.
Insights and challenges for better communication on pharmaceuticals were the topics of a presentation by Jay Jackson, PharmD, MPH, senior vice president of consulting services at Xcenda, Kat Wolf Khachatourian, PharmD, MBA, vice president of strategic care transformation at QualChoice Health Plan Services, Nneka Onwudiwe, PharmD, PhD, MBA, PRO/PE scientific reviewer for the U.S. government, and Soumi Saha, PharmD, JD, director of pharmacy & regulatory affairs at AMCP.
According to the 2017 U.S. Food and Drug Administration (FDA) draft guidance for medical and device product communication, factors involved in approved communication include:
- How the information compares with the information about those conditions in the FDA-required labeling.
- Whether the representations or suggestions in the communication increase the potential for harm to health, relative to the information reflected in FDA-required labeling.
- Whether the directions for use in the FDA-required labeling enable the product to be safely and effectively used under the conditions represented and suggested.
According to a survey conducted by Xcenda, healthcare economic information (HCEI) was ranked as “somewhat” to “extremely” important for formulary or medical policy decisions by 79% of respondents in 2016 and by 84% in 2017. Almost two-thirds of 2016 and 2017 respondents perceived a gap between needed and available HCEI, and about half (53% in 2016 and 46% in 2017) said that addressing this gap would “very much” or “extremely” improve formulary decision-making.
Only 21% of 2017 respondents said they “often” or “frequently” receive HCEI, while 43% reported an increase in HCEI communication over the past year. When asked about a preferred way to communication with manufacturers about HCEI, 59% said in-person meetings and 48% said through an AMCP dossier or other medical information requests.
Dr. Wolf Khachatourian discussed best practices for proactive communication. Recommendations from an AMCP workshop on the topic concluded that communication timelines must be flexible and are dependent on several key determinants, such as the market dynamics of an agent (such as a first-in-class), timing in conjunction with the payer’s budget and planning cycles, the amount of data available, and the anticipated Prescription Drug User Fee Act date.
Communications should begin at least 24 months in advance of FDA approval and should increase in intensity as the anticipated approval date approaches. She concluded, “Sooner is always better, flexibility is key, timelines are dependent on several factors.”
Dr. Saha advised that for these communications to be truly effective, the person presenting and the person receiving the information should be on an even playing field. “Discuss in advance who will be in the room so that competencies can be aligned,” she noted. “Be a credible messenger, and have a credible recipient.”
Delivery of a credible message include:
- Based on identified best practices, not regulatory requirements
- Desirable skills and competencies are similar pre- and post-approval
- Actual job titles will vary based on the size and structure of the manufacturer—do not say, “I will only speak with a person with a certain title.”
- May require a team of individuals with complementary areas of expertise
- Labels of “promotional” and “non-promotional” personnel should not limit the ability to communicate
- Individuals should be trained to communicate at the top of their scope of practice
Ultimately, improving communication will help the patient by improving access to emerging therapies, making evidence-based formulary and coverage decisions with real-world evidence, better budgeting and forecasting, and moving toward value-based healthcare.
Presentation L4: Best Practices to Implementing Proactive Communications Between Manufacturers and Payers. AMCP Annual Meeting 2018.