Innovative medical treatments are being developed at an astonishing pace. However, rising medical costs are a roadblock to patient access to many of these innovations. Last month, Secretary of Health and Human Services Alex Azar rolled out a blueprint to address this challenge. The blueprint highlights the importance of linking payments for medical treatments to their value and removing regulatory obstacles to value-based purchasing.
The FDA is tasked with deciding whether an appropriate level and type of evidence is available to support safety and effectiveness of a given medical product and if the benefits of using the product outweigh the risks; this information is included in FDA-approved product labeling. While an FDA label provides information regarding efficacy and safety, it often doesn’t contain sufficient information to inform decision-making regarding patient care.
To support the move toward value-based healthcare, the FDA provided recent guidance for manufacturers regarding medical product communications to support patient care decision-making. According to a recent FDA press release, the guidance documents provide greater clarity regarding the FDA’s current thinking in response to questions about how companies may communicate information in a truthful and non-misleading way. The guidance provides answers to questions about the type of data and information that device and drug manufacturers can share with payers to enable payers to make informed decisions about medical products and includes recommendations on communication of information that is not contained in the FDA-required labeling.
The FDA’s goal in publishing these guidance documents is to facilitate company communications that will enable better access and more healthcare options for patients.
The guidance documents are available here:
Now more than ever, payers and providers need unbiased, thorough, and timely assessments of the effectiveness, safety, and cost-effectiveness of approved/cleared medical products. The Hayes Knowledge Center offers easy access to the information needed to make your coverage policy or evidence-based medicine decisions. Unbiased assessments of the peer-reviewed, published literature, performed with scientific rigor, are absolutely crucial to providing care that is both safe and effective. Trust Hayes to keep you informed about the proposed use, regulatory status, and the estimated commercial availability of health technologies.
The Hayes Knowledge center includes many comparative effectiveness reviews and product comparisons to support providers and payers in making value-based decisions. You can read a recent Hayes Medical Technology Directory report, “Comparative Effectiveness Review of Transcatheter Closure of Patent Foramen Ovale for Prevention of Recurrent Cryptogenic Stroke,” here.
A recent Hayes Clinical Research Response, “Generic Versus Name Brand Orthopedic Implants,” is available here.