Industry Analysis: Impact of FDA’s Recent Guidance on Payer Communications

Enacted in late 2016, the 21st Century Cures Act significantly amended the Food and Drug Administration Modernization Act of 1997 (FDAMA) position surrounding communication of health care economic information (HCEI) to payers. In January 2017, the FDA released draft guidance for public comment to explain its thinking around the amended language, which generated significant interest from both the life sciences and managed care industries.

During the public comment period, many stakeholders across the pharmaceutical, medical device, managed care, pharmacy benefit management, and health system sectors submitted questions and voiced concerns to be addressed in the final guidance. FDA has now released final guidance to industry, which will need to quickly establish new policies and procedures to maintain compliance with the new regulations.

Significant changes from the draft guidance (January 2017) to the final guidance (June 2018) include:

• Expansion of scope to include investigational products and unapproved uses of approved products
• Inclusion of compliance and adherence studies as an example of HCEI analyses
• Bench tests and detailed examples on ways to present these studies
• Other information that should be communicated about unapproved products/uses
• Details of study details (design, methodology, full findings)
• Disclosure of how the product/use is not approved, and/or a copy of most recent FDA-required label

While the guidance provides additional clarity not found in the draft guidance, it lacks clarity and definition in a few key areas including a key contention point on scientific exchange versus promotional activity – what, why, how, when, to/by whom, etc. Our experts will explore how manufacturers can successfully implement this guidance and integrate these new communication channels with payers.

This webinar will cover:

• The history of FDAMA section 114 and rationale for amendment legislation
• Differences between the draft and final FDA guidance
• Industry and public concerns and questions
• “CFL guidance” related to consistency of labeling in medical communications
• Challenges with the promotional versus scientific exchange debate
• Key opportunities and considerations for industry

Speakers

Nathan White, CPC, Senior Vice President, Integrated Access and Outcomes Solutions Access, Commercialisation and Communications, ICON

For more than 16 years, Mr. White has provided advice on global, US, and European market access and reimbursement challenges. He began his career at Express Scripts, working in leadership, field-based, and internal operational roles in the specialty pharmacy and reimbursement support program divisions. Mr. White spent more than five years designing and implementing reimbursement operational solutions at PAREXEL Consulting and inVentiv Health, before shifting into global access consulting and value communications roles as Director of Market Access at Nucleus Global, Managing Director and Head of Market Access at eMAX Health Systems, and Global Practice Lead at ApotheCom Access Pathways and Outcomes.

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Sean P. Wagner, MPH, Senior Vice President, Strategic and Client Services, US Market Access & Reimbursement, ICON

Mr. Wagner has over 26 years’ experience in US market access and reimbursement. Beginning at Covance Health Economics and Outcomes Services as Principal Consultant, he assisted clients with reimbursement- and quality-related initiatives, including managing the production of the Kidney Dialysis Outcome Quality Initiative (K-DOQI), a set of over 100 evidence-based clinical practice guidelines on behalf of the National Kidney Foundation. He led a patient registries group for Covance Periapproval and was VP of Operations for Acurian (now PPD), a patient recruitment company. He helped form Maxcess Managed Markets (part of Publicis Healthcare Communications), a payer agency, serving as VP Strategy, and leading account teams for payer agency clients. In 2010, he joined US Market Access & Reimbursement at ICON (formerly MediMedia Managed Markets). As SVP Accounts he led teams that launched six products in seven years, and oversaw several population health initiatives. In his current role, he provides strategic support on payer communications, including above-brand, population health initiatives.

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