SummaryOn Feb. 4, the United Kingdom's National Institute for Health and Care Excellence (NICE) published their first Medtech Innovation Briefings (MIB), providing objective information on device and diagnostic technologies to aid local decision-making by clinicians and policymakers.
The MIBs provide a technology description, an assessment of the technical, clinical and economic evidence, and a critical review of the strengths and weaknesses of the published evidence. In contrast to NICE’s technology appraisals, the MIBs do not contain a judgment on the value of the technology and do not constitute a guidance recommendation. NICE anticipates producing up to 40 MIBs per year.
NICE’s first four published MIBs are: 1) the Versajet II hydrosurgery system for surgical debridement of acute and chronic wounds and burns; 2) the PressureWire fractional flow reserve measurement system for coronary artery disease; 3) the neutrophil gelatinase-associated lipocalin (NGAL) Test for early diagnosis of acute kidney injury; and 4) the RhinoChill intranasal cooling system for reducing temperature after cardiac arrest.
NICE uses the following eligibility criteria for MIBs: There is no public comment period for the MIBs. NICE will, however, notify the manufacturer when they select a technology for development of a MIB. NICE will also invite the manufacturer to provide relevant information to support the production of the MIB and will offer the manufacturer the opportunity to comment on the draft MIB. The entire development process for a MIB takes 12 weeks.
- The technology is a medical device or diagnostic test that falls within the scope of the EU Medical Devices and In Vitro Diagnostics directives.
The technology has a CE mark or equivalent regulatory approval or, if not, this is expected within 12 months.
The technology is available in the NHS, or the manufacturer has plans for the launch of the technology in the NHS.
The technology is either new or an innovative modification of an existing technology with claimed benefits to patients and the NHS when judged against the comparator(s)
The technology does not fall under the responsibility of a separate national guidance produce body (e.g. National Screening Committee).
There is an increasing awareness of NICE among U.S. payers and some may even consider NICE guidance in their decision-making processes. The MIBs are not recommendations and do not indicate whether or not the innovative product should be used by the National Health Services (NHS); however, the MIBs include a comprehensive summary of the available clinical and economic evidence as well as a discussion about the strengths and limitations of the evidence. Therefore, they are likely to be referenced by other decision-making bodies evaluating these technologies. In addition, NICE’s focus on developing robust, timely and transparent reports on new diagnostics and devices may prompt other health technology appraisal (HTA) organizations to assess these technologies as well.
The economic assessments in these briefings include both the cost of the device or diagnostic and an assessment of cost and resource consequences associated with use of the technology. Having this information available to the public may facilitate the use of economic evaluations of these technologies by other stakeholders including HTA groups, hospital decision-makers and payers both within and outside the U.S.
To read NICE’s MIB, click here.