Recent FDA Drug and Device Guidelines for Sharing Pre-Approval Information

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Communication of Pre-approval Information by Drug and Device Manufacturers to Payers in the US

In the US, once a drug or medical device has been approved or received clearance, payers can request a wide range of information from manufacturers. They can ask for data on product effectiveness, safety, and cost-effectiveness to support formulary management, coverage, and reimbursement decisions.  Manufacturers often respond to these unsolicited requests from payers using evidence requirements outlined in the Academy of Managed Care Pharmacy (AMCP) Format for Formulary Submissions. 

Payers have also indicated that they would like to have information from manufacturers about unapproved products or uses. This information could help payers plan for coverage and reimbursement decisions far in advance of approval decisions. As a result, the FDA has now released guidance to help manufacturers share pre-approval information with payers. 

Manufacturers who discuss reimbursement with payers before approval may improve their product access by allowing payers to plan and budget for products in development. Sharing pre-approval/clearance information with payers is especially important for manufacturers developing what are expected to be high-cost treatment options in the future (e.g., cell and gene therapies). 

For manufacturers who plan to set up outcomes-based or risk-sharing payment schemes, pre-approval/clearance communication will also be important. Negotiations for such value-based contracts often require lengthy discussions. Pre-approval communication can help manufacturers set up these agreements before an approval decision and accelerate their time to market launch. 

Pre-approval communication with payers may include the following types of “unbiased, factual, accurate, and non-misleading” information:

  • Product information such as drug class, device description, and features
  • Information about indications sought, such as information from clinical study protocols about endpoints being studied and the patient population under investigation
  • Anticipated timeline for possible FDA approval of the product or of the new use
  • Product pricing information
  • Patient utilization projections such as epidemiological data projection on incidence and prevalence
  • Product-related programs or services (e.g., patient support programs)
  • Presentations of results from studies, including clinical studies of drugs or devices or bench tests that describe device performance (language making characterizations or conclusions such as claiming superiority, potency, or “drug of choice” should be avoided)

The recent FDA guidance opens up a communication channel that hasn’t existed before. For help understanding how to develop effective and appropriate dossiers for exchange of pre- and post-approval information with payers, contact one of our market access experts.