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National Institute for Health and Care Excellence (NICE)'s diagnostic advisory committee has recommended the use of HM-JACKarc or OC-Sensor quantitative faecal immunochemical tests (FIT) in a draft guidance release for consultation on Wednesday (5 July). Under existing NICE guidance, FIT was already offered to some people presenting to primary care with symptoms suggestive of colorectal cancer, while others were immediately referred on the suspected cancer pathway. The new draft guidance will now see everyone receive a FIT. A sample is sent in the post to a laboratory where the amount of blood in the faeces is measured. The results are usually available within a week and people with 10 or more micrograms of haemoglobin in their faeces should then be referred for further investigation. Further assessment using colonoscopy, or CT colonography, is required to diagnose cancer. The tests cost between £4 and £5 per sample, and can correctly identify about 9 out of 10 people with colorectal cancer. The committee agreed it is important that GPs can refer people for colonoscopy without a positive FIT result if they think it is necessary and where symptoms persist. The institute believes that the recommendation of the tests should reduce the number of unnecessary colonoscopies, thus freeing up appointments for more non-urgent referrals. This should lead to 50% fewer referrals for urgent colonoscopies being made by GPs in primary care settings each year.

Modulator therapies, manufactured by Vertex Pharmaceuticals (VRTX.O), may no longer be available for new cystic fibrosis (CF) patients in the UK. A draft guidance recently published by the National Institute for Health and Care Excellence (NICE) stated that it would not recommend the use of Kaftrio, Symkevi and Orkambi on new CF patients. Kaftrio and Symkevi are currently recommended for the treatment of cystic fibrosis in patients aged 6 years and older, while Orkambi is used for patients aged 1 and older. The NICE draft guidance highlighted medicine costs and the strain on resources and finances faced by the National Health Service (NHS) as reasons for removing these drugs.

The Association of the British Pharmaceutical Industry (ABPI) has welcomed the National Institute for Health and Care Excellence's leadership in introducing a new approach to the evaluation of antibiotics. On Tuesday (12 April), NICE published a draft guidance to tackle antimicrobial resistance under which two new antimicrobial drugs - cefiderocol and ceftazidime-avibactam - became the first to be made available as part of the UK's innovative subscription-style payment model. Commenting on the announcement of the new draft guidance, Richard Torbett, chief executive of the ABPI, said: "This is an important milestone in the UK's global leadership on AMR. Antibiotics underpin modern medicine, but the increasing threat of antibiotic resistance remains one of the biggest global health challenges we face. "To tackle this, it is critical that the appropriate frameworks are in place for companies to invest the billions of pounds required to discover the new antibiotics needed for patients.

The National Institute for Health and Care Excellence (NICE) has released conclusive draft guidance, suggesting Pfizer's Vydura (rimegepant) as a choice for treating acute migraines in adults with or without aura. However, there is a caveat. This recommendation applies exclusively to individuals with a prior history of migraines, meeting one of the following criteria: At least 2 triptans were tried and they did not work well enough or Triptans were contraindicated or not tolerated, and nonsteroidal anti-inflammatory drugs (NSAIDs) and paracetamol were tried but did not work well enough. This drug was developed by the US-based Biohaven Pharmaceuticals, acquired by Pfizer in 2022, in an $11.6 billion deal. Nurtec ODT is the commercial name for the drug in the US, while the European Union approved the drug under the name Vydura in April 2022. NICE recommended rimegepant, an oral lyophilisate (dissolving wafer) and the first oral calcitonin gene-related peptide (CGRP) receptor antagonist for acute migraine treatment, to be taken at the onset of a migraine attack. Migraine affects one in seven people in the UK, often with a debilitating impact, Pfizer UK said in a statement. The condition entails symptoms such as head pain, vomiting, nausea, altered vision, fatigue, and heightened sensitivity to light, sound, and odours.

The National Institute for Health and Care Excellence (NICE) has issued draft guidance on 'Evusheld' which is not recommended for vulnerable adult with high risk of severe Covid-19 on Thursday (16 February). The draft guidance is open for public consultation until 9 March 2023. The committee will consider any comments received at a meeting currently due to take place on 4 April 2023. It comes after last month's decision by the US drug regulator to withdraw its emergency use authorisation for Evusheld as a preventative treatment for Covid-19, which said there was insufficient evidence that Evusheld is effective against the dominant variants of Covid-19 in the US. NICE's independent appraisal committee has reached the same conclusion having considered evidence which shows Evusheld is unlikely to prevent infection with most of the variants circulating in the UK now and in the near future. It has also announced that it is developing a new review process to update recommendations on the cost-effectiveness of Covid-19 treatments so they can be made available more quickly to patients if they show promise against new variants and are found to be cost-effective.

The National Institute for Health and Care Excellence (NICE) has rejected the use of olaparib on the NHS for treatment of adults with hormone-relapsed prostate cancer with BRCA1 or BRCA2 mutations which has spread to other parts of the body. In a draft guidance issued today (January 5) NICE said evidence around the drug made by AstraZeneca was uncertain and approving it would not be a good use of NHS funds. Current treatment for metastatic prostate cancer that no longer responds to hormone therapy is chemotherapy with docetaxel, cabazitaxel, or radium 223 dichloride - a treatment option for people with symptomatic bone metastases who have already had docetaxel or cannot have it. NICE said: "Clinical trial evidence showed that people taking olaparib have more time before their disease gets worse, and live longer overall, than people having retreatment with abiraterone or enzalutamide. However, retreatment with abiraterone or enzalutamide is not considered effective and is not standard care in the NHS.

The National Institute for Health and Care Excellence (NICE) has recommended icosapent ethyl also called Vazkepa manufactured by Amarin for adults who have cardiovascular disease with controlled LDL-C levels taking a statin. It's final draft guidance is expected to be available on the July 20. Nearly half a million people are expected to benefit from the first licensed treatment shown to reduce the risk of heart attacks and strokes in people with controlled low-density lipoprotein cholesterol (LDL-C - sometimes called "bad" cholesterol) who are taking a statin and who have raised levels of triglycerides. NICE said: "Clinical trial evidence suggests that for people with raised triglycerides who have LDL-C levels controlled by statins, and who have cardiovascular disease, icosapent ethyl reduces their risk of cardiovascular events by over a quarter compared with placebo. Helen Knight, interim director of medicines evaluation at NICE, said: "Icosapent ethyl is the first licensed treatment of its kind for people who are at risk of heart attacks and strokes despite well controlled LDL cholesterol because they have raised blood fats. And although lifestyle changes, including diet and exercise, can help to reduce their risk, these may not work for everyone.

The National Institute for Health and Care Excellence (NICE) has recommended Enhertu for people with advance breast cancer. "There is not enough evidence yet to show how much longer people live with Enhertu compared with trastuzumab emtansine because the clinical trial is still ongoing. This means the cost-effectiveness estimates are highly uncertain and Enhertu cannot be recommended for routine use in the NHS," said NICE. The independent appraisal committee concluded that Enhertu could be cost-effective if further evidence from the ongoing trial and from NHS practice can show how much longer people live with treatment. Helen Knight, director of medicines evaluation at NICE, said: "Today's draft guidance is good news for people with this type of advanced breast cancer, who often experience severe and debilitating symptoms.

Patients suffering from chronic and episodic migraine attacks are set to benefit from a groundbreaking recommendation by the National Institute for Health and Care Excellence (NICE) regarding a new medication. The atogepant, a first-of-its-kind preventive drug for migraine, offers hope for those grappling with this debilitating condition and can be taken orally. Published as part of the final guidance draft, NICE has greenlit the atogepant, also known as Aquipta and manufactured by AbbVie, as an option for preventing both chronic and episodic migraines in adults. Specifically, this recommendation is for individuals who have experienced at least four migraine days per month and have failed to find relief with at least three previous preventive treatments. With approximately 4.5 million people in the UK affected by various forms of migraine, this new recommendation marks a significant advancement in migraine management as the condition significantly impacts patients' day-to-day activities as well as places a heavy burden on the NHS and the wider economy.

The National Institute for Health and Care Excellence (NICE) has recommended first new treatment - 'romosozumab' for osteoporosis for over a decade. Thousands of people in England and Wales with severe osteoporosis who are at high risk of fracture are set to benefit from a new treatment - romosozumab - after NICE published the final draft guidance. Over 20,000 people could be eligible for the treatment according to the company. Clinical trial evidence showed that romosozumab (also known as EVENITY and made by UCB) followed by alendronic acid is more effective at reducing the risk of fractures than alendronic acid alone. Osteoporosis is a disease that causes bones to become thin and fragile. Many people with osteoporosis show no symptoms, but they may be at increased risk of fracture. Osteoporosis leads to nearly 9 million fractures around the world each year, and over 300,000 people per year attend hospitals in the UK with fractures caused by osteoporosis.

The National Institute for Health and Care Excellence (NICE) has recommended elosulfase alfa for routine use in the NHS for the treatment of mucopolysaccharidosis type 4A (also known as MPS 4A and Morquio A syndrome). Elosulfase alfa, also called Vimizin and made by BioMarin, becomes the first disease modifying treatment recommended by NICE for routine NHS use for people with this rare, severely life-limiting condition. NICE's final draft guidance follows the collection of 'real-world' data from 69 people who received NHS-funded treatment since 2015 as part of a managed access agreement. Clinical trial evidence and data collected as part of the managed access agreement, along with expert clinical opinion, shows some long-term benefits with elosulfase alfa treatment which suggest it slows progression of MPS 4A.

The UK's National Institute for Health and Care Excellence (NICE) has published a draft guidance recommending the use of electroCore's gammaCore device on the National Health Service (NHS).

National Institute of Health and Care Excellence (NICE) has not recommended 'Tirzepatide', also known as Mounjaro, developed by Eli Lilly, in its draft guidance issued on Tuesday (27 June) for treating type 2 diabetes in adults alongside diet and exercise. The independent NICE committee recognised the importance of new treatment options given that fewer than two-thirds of the adults with type 2 diabetes have adequate glucose control when using current treatment options. Evidence submitted to the committee from clinical trials showed the use of tirzepatide at any dose resulted in better glucose control and lower weight compared with semaglutide or insulin therapy. The weight reduction was more pronounced with higher doses of tirzepatide, while the effect on glucose levels seemed less dose-dependent. Similar effects were observed against all GLP-1 receptor agonists in company's network meta-analysis, but this was uncertain. The committee have asked the company to provide more data to address the uncertainties in the clinical evidence, when compared to all relevant alternative treatments.

The National Institute of Health and Care Excellence has recommended that surgeons working in hospitals with limited or no access to a radiopharmacy department could now use Magtrace and Sentimag as an option to locate sentinel lymph nodes in people with breast cancer. The recommendation in draft NICE medical technology guidance could see a change in NHS standard care for the first time in years. The technology could also mitigate the reliance on radioactive isotope tracers shipped in from outside Great Britain. The magnetic liquid tracer - Magtrace - is a non-radioactive dark brown liquid. It is both a magnetic marker and a visual dye. The Magtrace is injected into the tissue around a tumour. The particles are then absorbed into the lymphatic system, following the route that cancer cells are most likely to take when they spread from the primary tumour and become trapped in sentinel lymph nodes. The Sentimag probe moves over the skin emitting sounds of different pitches as it passes over the Magtrace tracer, in a similar way to a metal detector locating metal in the ground. The nodes often appear dark brown or black in colour, which also helps with identification.