Bridgewater, NJ
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mholloway@dmhbiopharm.com

Medical Affairs

Workshops For Medical Affairs

In 1997 section 114 of the Food, Drug and Cosmetic Act (FDAMA 114) sought to provide direction for the dissemination of Health Care Economic Information (HCEI) by drug manufacturers to formulary committees.  Unfortunately, the direction was vague, and thus companies were hesitant to the extent that they could move forward without further clarification.

It took 18 years, but in May of 2015, the 21st Century Cures Act was approved, which contained a provision (Section 3037) which amended FDAMA 114 and expanded the permissible scope of drug manufacturer’s promotion of HCEI.

In the wake of the Cures Act, the FDA on January 18, 2017, released its long-await draft guidance on the proactive communication of HCEI to payors and formulary committees. The draft guidance is thorough in its scope and contains important changes that affect key stakeholders in medical affairs, HEOR, access teams, compliance and legal.

The timing of this comes at a critical point as payors are looking for real-world HCEI evidence and evidence-based value rationale from the field medical and account team. And as a result of new laws and state mandates, population health decision makers are under strict evaluation timelines evaluate their plan designs, formularies and rates 12-18 months before the beginning of the intended plan year.

Manufacturers who provide timely HCEI to Payors will have a competitive advantage.

DMH offers a variety of training programs specifically designed around the FDA’s new draft guidance. Below is a list of our most popular workshops.

Primer 1.0 - The FDA's New Draft Guidance on the Proactive Communication of HCEI Data to Payors and Formulary Committees

This workshop is designed for key leaders of Medical Affairs, Access, HEOR, Compliance, and Legal.  

The workshop explains the FDA’s new draft guidance on the proactive communication of Health Care Economic Information (HCEI) with payors and formulary committees in an organized, easy to understand format.  You’ll be given the tools and checklists you need to ensure a comprehensive understanding of the FDA draft guidance and how to implement the changes to ensure you meet the FDA’s evidentiary standards in your revised HCEI strategy.  

DMH also provides a roll down of this workshop to your account teams and ancillary HCEI teams – See primer 2.0.

To learn more and view an example of the training simply contact us below and we will set up a brief webinar to show you the materials.

Primer 2.0 - The FDA's New Draft Guidance on the Proactive Communication of Health Care Economic Information to Payors and Formulary Committees

This workshop is designed for the field medical and access teams.  The workshop explains the FDA’s new draft guidance on the sharing of HCEI with payors and formulary committees in an easy to understand format that is customized to the field based medical role and level of responsibility.

The Delivery of Effective and Compliant HCEI Presentations to Customers

Compliance challenges may occur in the communication of Health Care Economic Information (HCEI) and Real World Evidence (RWE) by your field based medical team.  The objectives of this workshop are to enhance:

  • Knowledge of presentation risks in communication Health Care Economic Information (HCEI)
  • The delivery of effective and compliant HCEI to payors
  • The sharing of effective and compliant customer insights with internal colleagues
  • MSL presentation skills

Additional Workshops

Additional Workshops For Your Field Based Medical Team

Please see “Field Based Medical Training” for additional options for your field medical teams.