NICE To Seek Candidates For New-Tech Evaluation Program In First Half Of '10

Article reprinted from "The Gray Sheet" - December 21, 2009

Device and diagnostics companies should start thinking about products they would like to offer for evaluation under a new program in the U.K. Read more...

NICE To Seek Candidates For New-Tech Evaluation Program In First Half Of '10

Article reprinted from "The Gray Sheet" - December 21, 2009

Device and diagnostics companies should start thinking about products they would like to offer for evaluation under a new program in the U.K.

The program, called the Evaluation Pathway Programme for Medical Technologies, is being developed by Britain's National Institute for Health and Clinical Excellence (NICE) with the goal of more quickly identifying and promoting adoption of innovative new devices and diagnostics (The Gray Sheet' July 13, 2009).

NICE plans by mid-2010 to begin accepting applications from manufacturers who would like to have their technologies reviewed and potentially recommended for adoption by the National Health Service, the publicly funded health care system in the U.K.

As an independent institute that advises Britain's health system, NICE has for many years performed evaluations of medical products and procedures. What is changing is that it will now have two brand-new, separate processes specifically for reviewing devices and diagnostics (The Gray Sheet' Dec. 7, 2009).

In the past, devices and diagnostics have only occasionally been evaluated, and then only through programs designed primarily for drug therapies and interventional procedures, explained Bruce Campbell, chairman of NICE's newly created Medical Technologies Advisory Committee (MTAC).

"NICE has never before concentrated on devices or diagnostics," Campbell said.

A number of details are still being worked out, including the criteria for routing a technology down one evaluation path versus another, and the methodologies that will be used to assess devices and diagnostics.

"At the moment, industry [players] should simply be aware that this program is about to become active and should consider what new technologies they might wish to submit so that they can start to prepare their case," Campbell told "The Gray Sheet."

To qualify for evaluation, devices and diagnostics must have a European CE mark, must be available in the U.K. or about to be launched there, and must not have had a previous NICE review.

Of most interest, said Campbell, is whether the technology offers advantages over products currently used by the National Health Service, such as better patient outcomes, ease of use or fewer visits to the hospital. Other advantages might be the ability to treat a larger number of patients or a particularly disabling disease, or the ability to treat or diagnose people on an outpatient basis.

Cost is also an important consideration, Campbell admitted. "Obviously, if the technology works as well as or better than the current technology and it's cheaper, that's good value for the health service."

- Monica Hogan

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