FDA Guidance for Device Makers and Payor Communications

Information device makers share with payors can potentially run afoul of FDA guidelines.

To clarify what an appropriate communication between device makers and payors look like, the FDA issued a final guidance on June 12, 2018 outlining how companies can share information with payers about medical devices and drugs that have not yet been approved or cleared by the agency.

“Truthful and Non-Misleading”

The guidance says that FDA believes it is critical that information provided by firms to payors about their medical products be “truthful and non-misleading and that appropriate background and contextual information be provided to enable payors to make informed decisions.”

The agency says it understands that medical product firms may wish to provide certain types of information to payors regarding their unapproved products and unapproved uses of those products. “Such information may help payors plan and budget for future coverage and/or reimbursement decisions prior to FDA approval, clearance, or licensure of unapproved products and may also inform coverage and/or reimbursement decisions for new uses of approved/cleared/licensed products.”

If information provided to the payors is “unbiased, factual, accurate, and non-misleading,” the agency does not intend to “object to such communications, nor to use such communications as evidence of a new intended use.” The agency also does not intend to enforce any applicable post marketing submission requirements for these materials.

Appropriate Types of Information

The guidance outlines the types of information the agency had in mind:

• Product information
• Information about indications
• Anticipated FDA approval/clearance timeline
• Product pricing
• Patient utilization projections, and
• Factual presentations of results from studies

For example, the agency describes a firm intending to submit a marketing application for its product for the management of severe pain. “An appropriate communication by the firm to payors may include language such as ‘In a X-week randomized controlled trial comparing PRODUCT to placebo, a statistically significant improvement was observed on the primary endpoint of reduction in mean pain scores from baseline’ in conjunction with a graph and/or table summarizing the numerical study results.”

Inappropriate

On the other hand, the agency said it would not be appropriate for the firm’s communication to contain language “making characterizations or conclusions, such as ‘PRODUCT allows health care providers to optimize pain relief’ or ‘PRODUCT has been demonstrated to provide potent pain relief.’”

Inappropriate communications, according to the agency, would be communications that “represent that an unapproved product is FDA-approved/cleared/licensed, or has otherwise been determined safe or effective for the purpose(s) for which it is being studied.”

Recommended Information

FDA recommends that firms provide the following information to payors when communicating information about unapproved products or about unapproved uses of approved/cleared/licensed products:

• A clear statement that the product is not approved/cleared
• Information related to the state of product development
• Describe materials aspects of study design and methodology and also disclose material limitations related to the study design
• A prominent statement disclosing the indications for which FDA has granted approval or clearance and a copy of the most current labeling

The official FDA Guidance is titled: “Drug and Device Manufacturer Communications With Payors, Formulary Committees and Similar Entities.” You can see the document here.