The FDA has released two documents finalising both the methods medical device and drug makers should take when communicating to payors, and how they should stay consistent with FDA labelling.
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The documents clarify the FDA’s thinking and recommendations for how certain medical devices should be communicated to payors, which include insurance companies, formulary committees and similar organisations.
FDA commissioner Scott Gottlieb, states that the documents are being provided in the ‘era of ‘big data’, where ‘scientists, drug makers, regulators, payors and others have unprecedented access to new sources of information'.
The first guidance is designed to inform market participants developing contracts that include value-based arrangements how to communicate information about how drugs or devices might impact outcomes in a hospital, endpoints of which are not directly expressed in a product’s labelling.
The documents recognise that payors seek a range of information on the effectiveness, safety and cost-effectiveness of approved and cleared medical products.
“This information may overlap with, but differ from, the information that the FDA reviews in making regulatory decisions. We have heard from some manufacturers that in the absence of clear guidance from the agency, they were inhibited from sharing certain economic and other information and, potentially, even from generating additional rigorous data for payors to evaluate in determining the value of a product to their health plans and their beneficiaries, and then to tie value-based contracts to these measures,” Gottlieb said.
The final document on communication includes recommendations on how medical device companies can communicate truthful, non-misleading and appropriate information to insurers across a product’s lifecycle.
The FDA hopes that the document helps advance public health benefits, including increased cost savings and informed and appropriate coverage and reimbursement decisions.
“In this way, we can help ensure patients have more timely access to cutting-edge medical technologies. We can facilitate access by helping to reduce the overall cost of providing these benefits to patients. And in promoting access, we will advance important public health goals,” Gottlieb said.
The second guidance guides manufacturers on how communication information that is not contained in the FDA-required labelling for their products, but is consistent with those guidelines.
Manufacturers labels are subject to content requirements and limitations that ensure they effectively communication certain information.
“It’s not intended to exhaustively address all that’s known about a product for its approved or cleared uses. Consequently, there are types of information that are not in the labelling, but that are consistent with the labelling, which medical product companies also may want to share. This information, such as data from post-market studies and surveillance of a product’s approved uses, or additional information from the pre-market studies that were used to support approval of the product, may help inform decision-making regarding patient care,” Gottlieb said.
In particular, the document answers questions including: What types of information are considered consistent with FDA-required labelling? & How does the FDA recommend companies communicate this information in a truthful and non-misleading way?
The Advanced Medical Technology Association (AdvaMed) responded to the guidance, with president and CEO Scott Whitaker, saying: “AdvaMed commends FDA's recently issued final guidance on communications between medical technology companies and payers.
"We have long supported medical device communications that are truthful, accurate, scientifically sound and support the overall public health. The guidances released today support these goals by providing much needed clarity regarding the appropriate sharing of medical device information with payers and other health care entities. We believe such communications are critical to support continued advances in medical technology and high quality, optimal care for patients.
"We thank FDA Commissioner Gottlieb and CDRH Director Shuren for their leadership on this issue."