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Home » Topics » Regulatory » NICE

NICE
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UK map and pharmaceuticals

NICE says no to five COVID-19 treatments in the UK

Nov. 16, 2022
By Lee Landenberger
Britain’s National Institute for Health and Care Excellence (NICE), a key gatekeeper on the path to the U.K. market, is backing away from five COVID-19 treatments. No longer recommended in a draft guidance were Ronapreve (casirivimab + imdevimab) from Roche Holding AG, Xevudy (sotrovimab) from GSK plc, and Evusheld (tixagevimab + cilgavimab) from Astrazeneca plc. NICE also recommended discontinuing use of Lagevrio (molnupiravir) from Merck and Co. Inc. and Veklury (remdesivir) from Gilead Sciences Inc.
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NICE recommends clinical trial-only use for bioresorbable coronary artery scaffolds

Aug. 10, 2022
By Mark McCarty
The notion of a device that disappears from the human body once its work is done has driven massive investments in bioresorbable coronary artery scaffolds and stents, but these devices have had a difficult time getting to and staying on the market. The U.K. National Institute of Health and Care Excellence determined recently that these devices are not ready for routine use and should be deployed only in clinical trials.
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3D heart illustration showing tricuspid and bicuspid valves

NICE not sold on devices for tricuspid valve repair, annuloplasty

Aug. 9, 2022
By Mark McCarty
The U.K. National Institute for Health and Care Excellence (NICE) issued a pair of health technology assessments related to regurgitation of the tricuspid valve, one each for valve leaflet repair and for valve annuloplasty.
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U.K. flag on stethoscope

NICE inks guarded recommendation for aortic root support for Marfan syndrome patients

May 24, 2022
By Mark McCarty
Those who are burdened with Marfan syndrome face a lifetime of multi-organ system issues including potential aortic aneurysm, but help may be on the way in the U.K. The National Institute of Health and Care Excellence (NICE) has issued a recommendation that these patients be treated with personalized external aortic root support (PEARS) to treat both aortic root expansion and aortic dissection, although the agency indicated that this procedure is not quite ready for routine use in the National Health Service.
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Clock with woman awake in bed in background

NICE recommends Sleepio digital app over sleeping pills for insomnia

May 20, 2022
By Nuala Moran
Primary care doctors in England have been told by the National Institute for Health and Care Excellence (NICE) to prescribe a digital therapeutic instead of sleeping tablets for patients suffering with insomnia. Sleepio, an app developed by London-based Big Health Ltd. that uses an algorithm to provide personalized cognitive behavioral therapy (CBT), could benefit up to 800,000 people, according to NICE. It is recommending use of the app as an effective alternative to drugs such as zolpidem and zopiclone, after weighing evidence from 28 studies, including 12 randomized controlled trials.
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Sentimag device in office

Cost, site of service prompts new NICE endorsement of Magtrace and Sentimag

May 20, 2022
By Mark McCarty
Detecting the spread of cancer is a high priority for most health systems, but the U.K. National Health Service currently has a limited range of options when it comes to detecting breast metastases. That may change soon thanks to a review by the National Institute of Health and Care Excellence (NICE), which may endorse the use of the Sentimag system with Magtrace.
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U.K. flag and capsules

Pharma calls for reform to combination therapy funding in UK

May 4, 2022
By Richard Staines
A lack of funding for combination therapies in the U.K. could hold back investment in the country’s biopharma sector – but there are moves afoot to find ways around the issue, pinned by industry on the way the National Institute for Health and Care Excellence (NICE) assesses the value of drugs.
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Antibiotic-capsules-in-blister-packs.png

Pfizer, Shionogi antibiotics in first guidance for UK fixed-fee plan

April 12, 2022
By Nuala Moran
The U.K. plan to fix the market failure in antibiotics has taken a significant step forward with the publication of guidance estimating the value of two drugs to the National Health Service.
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Lung cancer illustration

NICE okays Amgen’s groundbreaking lung cancer pill Lumykras

March 3, 2022
By Richard Staines
Amgen Inc.’s pioneering lung cancer drug, Lumykras (sotorasib), is set to become available to NHS patients in England, after cost-effectiveness body NICE recommended financing from the Cancer Drugs Fund (CDF) in final draft guidance.
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U.K. flag on stethoscope

NICE sees limited role for intramedullary distraction for lengthening of lower limbs

March 2, 2022
By Mark McCarty
Differential leg length is perhaps not the most common orthopedic problem in the medical literature, but the U.K. National Institute of Health and Care Excellence (NICE) sees a place for some sort of improvement over the standard of care.
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