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VIDEO: Fundamentals of Access to Duchenne Therapies

Navigating access to approved therapies can be both time consuming and daunting. The time between approval by FDA to the day of a patient’s first commercial dose can vary depending on which insurance you have, your age and disease progression, and even where you live. With two products approved by FDA, one going through the appeal process, and the hope for more to come, PPMD wanted to provide an overview of the fundamentals of access and the basics of navigating insurance to improve care.

In a two-part webinar series, moderated by PPMD's Annie Kennedy, we invited PPMD’s consultant and expert, Michael Adelberg with FaegreBD Consulting, to a conversation on a number of topics:

  • What are the major differences with Medicaid vs private insurance?
  • What is the process for appealing a denial, what are the layers of appeal?
  • What are Medical vs. Drug Benefits
  • What is the role of a PBM’s or Pharmacy Benefit Managers?
  • Types of Insurance Coverage?
  • What are formularies?


These webinars are non-product specific, but can provide you with a basic understanding about the path to access.

Part 1: Exploring drug approval and health insurance coverage overview



Part 2: Navigating health insurance to improve access



About Mike Adelberg:

Mike Adelberg has 25 years of progressive experience with Medicare, Medicaid and the Health Insurance Exchanges that provide health care coverage for well over 100 million Americans. He is a thought leader on health care reform and health insurance regulation who is often quoted in the press and is frequently invited to speak at conferences. Before joining Faegre Baker Daniels Consulting, Mike held several senior positions within the Centers for Medicare and Medicaid Services (CMS), including concurrently serving as the director of the Insurance Programs Group and the acting director of the Exchange Policy and Operations Group in the Center for Consumer Information and Insurance Oversight (CCIIO).


For more information and resources on access:


Please visit our Access Resource Center at  ParentProjectMD.org/AccessResources.

We recognize that nothing has come easily for our community and that many of the access frameworks we are now seeing for the first approved Duchenne therapies have come in the form of ‘outcomes based contracts’ that require a redetermination at a pre-specified time point (in some cases as early as 6 months). For some families this now means that even once the complex path to access has been successfully navigated once, it must again been navigated 6 months later. PPMD will continue to expand our Access Resource Center and webinar series to provide tools and resources to support families and clinical providers working to advocate for access to approved therapies.

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