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Home » Topics » Regulatory » NICE

NICE
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Illustration of leg anatomy with target around knee

NICE guardedly optimistic about scaffolds for knee cartilage repair

Sep. 3, 2024
By Mark McCarty
The U.K. National Institute for Health and Care Excellence sees some evidence that single-step insertions of scaffolds for knees with damaged cartilage offer significant benefits, calling for the use of registries for tracking of outcomes data.
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British pound symbol

NICE: No evidence for price differentiation of transcatheter heart valves

Aug. 14, 2024
By Shani Alexander
There is no evidence to support the differences in prices that the U.K.’s national health service (NHS) is paying for transcatheter heart valves from Abbott Laboratories, Boston Scientific Corp., Edwards Lifesciences Corp. and Medtronic plc, according to the National Institute for Health and Care Excellence.
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DNA mutations or genetic disorder concept art

UK’s NICE recommends Genedrive, Genomadix tests for CYP2C19

Aug. 2, 2024
By Mark McCarty
The U.K. National Institute for Health and Care Excellence endorsed the use of testing for the CYP2C19 genotype for management of clopidogrel usage after ischemic stroke and heart attack, but the agency is specific about the use of tests by Genedrive plc and Genomadix Inc. in point-of-care settings as alternatives to lab testing.
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NICE says no to Enhertu, blames price

July 30, 2024
By Mari Serebrov

For the first time in six years, the U.K.’s National Institute for Health and Care Excellence (NICE) is refusing to recommend a breast cancer treatment. It cited price as the issue.


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Syringe, vial with pound currency symbol

UK agrees to payment scheme for costly gene therapy Hemgenix

June 28, 2024
By Nuala Moran
CSL Behring’s expensive hemophilia B gene therapy is to be reimbursed by the U.K. National Health Service, after the company agreed to an outcomes-based payment scheme. The therapy, Hemgenix (etranacogene dezaparvovec), which has a U.K. list price of £2.6 million (US$3.3 million), was approved under a managed access scheme, in which data will be collected over five years to enable both the long-term effectiveness, and any adverse liver toxicity caused by the transgene, to be monitored.
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Therasphere Y-90 glass microspheres

NICE: Radioembolization treatment for neuroendocrine liver cancer

June 3, 2024
By Shani Alexander
The U.K.’s National Institute for Health and Care Excellence recent recommendation that selective internal radiation therapy could be used to treat neuroendocrine tumors that have metastasized to the liver is a boon for patients suffering from the disease. However, there is not yet a clear pathway for these patients to receive the therapy via the national health service.
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Map of Europe, Medical Device Regulation (MDR) text

Team NB sees widening gap between MDR applications, certificates

May 29, 2024
By Mark McCarty
The European Association for Medical Devices of Notified Bodies has issued its survey of member NBs for 2023, which includes data that suggest a diminishing appetite for inspections under the Medical Device Single Audit Program. However, the more concerning metric is that the gap between applications for new or renewed medical devices and the number of completed applications continues to widen, a gap that stood at nearly 10,000 such applications at the end of calendar year 2023.
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Woman holding smartphone coughing

UK’s NICE grants conditional coverage to a single COPD app

May 6, 2024
By Mark McCarty
The U.K. National Institute for Health and Care Excellence has posted an early value assessment review of digital technologies for the management of chronic obstructive pulmonary disease, giving the conditional nod to only one technology — the Mycopd app by London-based My Mhealth Ltd.
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Elekta ProKnow

NICE taking a close look at Elekta’s Proknow systems

March 18, 2024
By Mark McCarty
The U.K. National Institute for Health and Care Excellence (NICE) has released a preliminary health technology assessment for three modules of the Proknow series of software systems by Stockholm-based Elekta AB, which may improve the delivery of radiotherapy services across the U.K. However, NICE indicated it wants to see more evidence regarding the impact of these software modules on radiotherapy treatment plans.
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UK trade group urging faster, equitable access for new therapies

Feb. 23, 2024
By Nuala Moran
Chief executives of U.K. medical research charities have issued a call for speedier uptake and more equitable access to new drugs that have received a cost-effectiveness seal of approval from the National Institute for Health and Care Excellence. In a joint report with the Association of the British Pharmaceutical Industry, the heads of eight charities examined a number of cases where access has been limited and set out recommendations to address the challenges of equity, uptake and health inequalities.
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