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 (2 '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."
Diagnostics Get Their Own Pathway
Selections of devices and diagnostics to be evaluated will be made by MTAC. The committee will also decide which review pathway the products will take.
Pathways include NICE's existing technology appraisal program, which looks at clinical and cost effectiveness, and interventional procedures program, which looks at safety and efficacy.
Other options will be the new device-specific Evaluation Pathway for Medical Technologies, where evaluations will be performed by MTAC itself, and the new program dealing solely with diagnostics.
"We're very excited about the [diagnostics] program," said Mark Samuels, director of medical and public affairs for Roche Diagnostics and co-chair of the committee that helped create the new evaluation program.
Giving diagnostics a distinct evaluation pathway provides a level of focus crucial to the fast-moving area, said Samuels, who is also an executive committee member for the British In Vitro Diagnostics Association.
Funding new diagnostic products in the U.K. is particularly problematic because hospitals receive a block grant for diagnostics, Samuels explained. "So when an exciting, new high-tech diagnostic comes through, there's no mechanism in place to provide the funding for that," even, he lamented, when a new test might offer substantial benefits for patients and save hospitals money.
Samuels is particularly encouraged by the new collaborative relationship that has been forged between NICE and industry during the creation of the program.
Industry Has Concerns Over Methodology, Evidence
Mike Wallace, health economics and reimbursement director for Johnson & Johnson Medical, U.K., and co-chair of the committee that developed the new evaluation pathway for NICE, said the program could prove significant for the device industry.
"We are developing here a more appropriate way of assessing devices, which focuses on the specific characteristics of devices," he said.
But Wallace said industry still has concerns about the assessment methodologies that will be used.
Because the decision to evaluate a product is based in part on cost characteristics, for example, new products that do not yet have data on their cost-saving potential for the national health system could suffer.
And because medical devices cover such a broad range of technology, it may be difficult to come up with a standard analytical approach, Wallace said.
The upside, according to Wallace, is that MTAC recognizes that "medical devices are different than pharmaceuticals in the way they are developed, in the way they are regulated, in the market conditions, in the rapid price erosion, the short intellectual property, and also the existence of the learning curve."
Given that recognition, he suggested, NICE is unlikely to apply the same evidence standards to devices as it does to oncology and other drug therapies, where very strong evidence based on randomized clinical trials is expected.
Yet because the methodologies have yet to be determined, uncertainty remains over whether there will be "a very high evidence hurdle for industry," Wallace said.
Another question is how MTAC will handle any uncertainty that emerges during a review of available clinical data. In some cases, MTAC Chairman Campbell said, the committee may recommend more research.
"We would hope to be able to forge collaborations between research institutions related to the NHS and manufacturers in a way that perhaps hasn't been done before," Campbell said.
"It might involve [technology] being used in some selected centers in the NHS, with collection of more data in order to furnish further NICE guidance about whether the technology should be adopted in the longer run," he explained.
In the U.S., CMS plays a leading role in evaluating medical technology, although there is no national health care system as there is in the U.K. For example, manufacturers can seek a more definitive reimbursement status for their technology through a national coverage analysis at CMS.
When there is not enough evidence to support national coverage for a newer technology, the agency can spur further research through its coverage-with-evidence-development program.
In the U.K., industry remains concerned over how well NICE recommendations will be translated into practice within the National Health Service.
"There's the potential that even if the entire evaluation program itself worked perfectly, if it isn't then linked into the [relevant] systems within the NHS, then we're missing the point of what we're trying to achieve," Wallace said.
First Technologies May Have Been Selected
Although MTAC will not take applications from manufacturers for the new program until it finalizes the application process, committee members have already selected some devices and diagnostics they want to see evaluated, according to Campbell.
The identities of those items will remain secret until the committee obtains agreements from the manufacturers to have the products evaluated.
When MTAC meets in January, it will review briefing documents on the first devices or procedures selected for review.
"I am keen that the first few meetings should be developmental and evolutionary," said Campbell, "to be sure that the committee gets the information which is of most value to it presented in the way which is most helpful."
- Monica Hogan ( 3 m.hogan@elsevier.com )
This article first appeared in The Gray Sheet on Dec 21, 2009.
