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UK's NICE Establishes New Review Process to Fast-Track Evaluations of Innovative Tests


NEW YORK – The UK National Institute for Health and Care Excellence is in the process of establishing a new program that will quickly assess emerging diagnostics, including molecular tests, that could have an immediate impact on clinical care and thus require expedited evaluation.

NICE, a part of the UK Department of Health and Social Care, evaluates new diagnostics for healthcare professionals, often through its Diagnostic Assessment Program, a process that takes about 14 months to complete. But the institute recently decided to create a new route to evaluate such tests, called the Early Value Assessment program, which has a shortened, six-month timeline.

Mark Chapman, interim director of medical technology at NICE, said via email that the institute embarked on the new program because of a "need to drive innovation into the hands of health and care professionals to enable best practice."

Chapman cited a "multitude of innovation" coming into the healthcare system, which requires the ability to assess more tests and faster.

"What we hope to achieve with the program is to actively draw in digital products, medical devices, and diagnostics which meet a national unmet need," Chapman remarked. "We will do this by providing a quicker assessment of the product's early value to identify the most promising technologies in areas like mental health [and] cancer, and helping the [National Health Service] recover after COVID-19," he said.

NICE recently embarked on 10 pilot evaluations in this new format, including one of Genedrive's MT-RNR1 test for antibiotics-induced hearing loss in infants. A spokesperson for NICE said this week that other topics have been selected to "explore our processes, methods, and collaborative approaches with health system partners and other stakeholders," with a specific focus on mental health, cardiovascular disease, early cancer detection, and technologies that boost healthcare capacity.

Some of the pilot assessments announced so far concern cognitive behavioral therapies for adults with depression, anxiety disorder, and agoraphobia, as well as for children with anxiety or low mood. Evaluations have also commenced for KardiaMobile 6L, a smartphone-based approach for measuring heart rate in people prescribed antipsychotic medication; an artificial intelligence-based method for analyzing chest X-rays to diagnose lung cancer; and two other analytical tools for predicting cardiac risk and for radiotherapy data archiving and management.

The assessment of Genedrive's MT-RNR1 assay is currently the only NICE EVA pilot that explicitly focuses on a molecular test. Genedrive's test relies on a reverse-transcription loop mediated isothermal amplification (LAMP) approach to screen patients for MT-RNR1 m.1555A>G, a variant that predisposes someone to hearing loss when he or she is prescribed gentamicin, a first-line antibiotic given to newborns admitted to intensive care units. The assay runs on the Manchester, UK-based company's Genedrive System, and the firm obtained a CE-IVD mark for the diagnostic in 2019.

According to the spokesperson, NICE has always assessed tests that can be used for therapy selection, also called companion diagnostics. What has changed with the new EVA program is that selected technologies no longer will need to have a large amount of evidence generated before they can be assessed. The program will also indicate what kind of evidence should be generated to produce future guidance on a test's adoption. Previously, test makers had to generate a certain amount of evidence before they could be evaluated by NICE.

In addition to the EVA assessment of Genedrive's test, a second pilot has been announced for "innovative tests for urinary tract infection." The spokesperson said that this project, which has not yet selected technologies to be assessed, will most likely include molecular tests, meaning two of the 10 pilots will be devoted to molecular assays. A list of technologies to be appraised is expected to be published in December.

To be included in a pilot, a test needs to have a CE or UK Conformity Assessment mark, "have the potential for patient and system benefit in an area of national unmet need," and also requires additional data or evidence before it can be recommended for routine adoption, according to NICE.

NICE's spokesperson underscored that the new EVA program is not set in stone. Rather, it is in a preliminary phase, during which the institute will trial how it assesses diagnostics and other digital healthcare products. By offering a faster assessment route, UK patients should be able to benefit sooner, the institute states on a new site devoted to the EVA program.

There is also the fact that more innovative tests continue to emerge and enter the market, but with no clear signal to the UK National Health Service about which ones will make a real difference to patients, according to NICE. By engaging experts via its EVA review process, and at a faster rate, the NHS can therefore adopt new products and services when necessary. This could also prove useful if several tests for a certain indication appear at once, giving the NHS insight into how each assay performs.

However, a favorable assessment by NICE does not guarantee that the NHS will begin reimbursing a test.

NICE said that it intends its 10 pilot evaluations to wrap up in March 2023. The outcome of this trial phase should result in a final design for the institute's future approach for assessing new diagnostics. The new approach will also be documented in a guidance, and the institute plans to provide an update on this process in an interim statement next month.

It is unclear at this time how the outcome of a NICE EVA program evaluation could impact reimbursement within the NHS for a particular test. NICE said on its website that it is engaging NHS England on how the conditional recommendation for use resulting from an assessment could support NHS commissioning decisions.

NICE's spokesperson noted that in general, its guidances are used to inform NHS funding decisions, but said that "there is no funding mandate with these guidance programs."

Genedrive issued a statement about its inclusion in the EVA program at the end of September, in which it noted that the consultation process on its MT-RNR1 assay will happen in February 2023. CEO David Budd commented that the company was "pleased" that the test had been fast-tracked via the new program, which he said, "may allow clinicians and patients to benefit from the test sooner."

Sarah Barnett, Genedrive's marketing director, relayed via email that the "main benefit of the new EVA is for in vitro diagnostics companies to gain feedback and guidance on new products from the expert teams at NICE much faster." This should allow clinicians and patients to access new, innovative technology sooner, Barnett said.

Doris-Ann Williams, chief executive of the British IVD Association, a trade organization that represents UK IVD companies, said this week that BIVDA has been engaging with NICE for more than a decade and continues to be "impressed with the high-quality independent assessments and guidelines they produce."

Williams said that BIVDA welcomes the EVA program as "another indication that the government wants to support innovation, both from the UK and globally." However, she said that there remains a disconnect between the development and evaluation of new tests and their adoption by the NHS.

"Unfortunately, while there is huge support for product development right up to market launch, this is where our system fails," remarked Williams. "While a positive review from NICE is great, there is no requirement to use a product, unlike with drugs, and we suspect the barriers to adoption will remain even using this new initiative." Nevertheless, Williams reaffirmed BIVDA's support for NICE and for its guidelines.