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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 It's final draft guidance is expected to be available on the July 20.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 pembrolizumab in combination with chemotherapy (paclitaxel or nab-paclitaxel) which is said to benefit people with triple negative breast cancer. Clinical trial evidence shows that, compared with paclitaxel, pembrolizumab combination increases how long people have before their cancer gets worse and how long they live. NICE already recommends atezolizumab in combination with chemotherapy for untreated PD-L1-positive, locally advanced or metastatic, triple-negative breast cancer. Atezolizumab combination is recommended by NICE for people with IC equal to or greater than 1%. "This means that some people who can't have atezolizumab combination could be eligible for pembrolizumab combination," said NICE. NICE's independent appraisal committee also agreed that the pembrolizumab combination meets the higher cost-effectiveness threshold for life-extending treatments for people with a short life expectancy. Given by injection every 3 weeks, pembrolizumab (also called Keytruda and made by Merck Sharp and Dohme) is a type of immunotherapy that specifically targets triple negative breast cancer. It works by blocking the activity of a protein known as PD-L1 which is produced in larger amounts on cancerous cells than normal cells. By blocking PD-L1 it helps the person's own immune cells to attack the cancer.

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.

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.

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.

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.

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) today issued a draft guidance recommending dapagliflozin, sold under the brand name Forxiga among others, as an option for treating certain adults with chronic kidney disease (CKD). Dapagliflozin belongs to a group of medicines called sodium glucose co-transporter-2 (SGLT2) inhibitors. It is the first SGLT2 inhibitor to be recommended through NICE's technology appraisal process for CKD. Adding dapagliflozin to current standard care has been shown to significantly reduce the risk of having declining kidney function, end-stage kidney disease, or dying from causes related to the kidneys or cardiovascular system. "Dapagliflozin is a promising treatment for certain people with chronic kidney disease and it has the potential to increase the length of time before the disease gets worse," Meindert Boysen, deputy chief executive and director of the NICE Centre for Health Technology Evaluation, said.

The National Institute for Health and Care Excellence (NICE) has recommended abemaciclib also called Verzenios, made by Eli Lilly, for people with hormone receptor-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence who have had surgery to remove their tumour. The clinical trial result showed that people having abemaciclib with hormone therapy had a more than 30 per cent better chance of their cancer not coming back following surgery compared with people having hormone therapy alone. Helen Knight, interim director of medicines evaluation at NICE, said: "Today's positive draft recommendation, which comes less than a month after abemaciclib received its licence, is fantastic news. The fact that we have been able to produce draft recommendations so quickly is testament to the success of our ambition to support patient access to clinically and cost effective treatments as early as possible. "Until now there have been no targeted treatments for people with this type of breast cancer. Abemaciclib with hormone therapy represents a significant improvement in how it is treated because being able to have a targeted treatment earlier after surgery will increase the chance of curing the disease and reduce the likelihood of developing incurable advanced disease."

More than 100 NHS clinicians have urged the National Institute for Health and Care Excellence (NICE) to change its decision - declining recommendation of romosozumab, the first new osteoporosis medication for over a decade. In a joint letter published on January 2, the clinicians warned of the consequences of barring access to the drug to those who suffer the bone-weakening disease. The joint letter, led by the Royal Osteoporosis Society (ROS), raised concern over the scarcity of the drug pipeline for osteoporosis and lack of public funding for new research. It quoted recent government research that showed the National Institute for Health Research (NIHR) invested less than £1 million in osteoporosis research in 2020-21, against the £4.6 billion per year cost to the NHS of fractures. Craig Jones, chief executive of the Royal Osteoporosis Society said: "We're calling on NICE and the applicant company to get back round the table and work with us to ensure equal access to this important new treatment.

In its first, the National Institute for Health and Care Excellence (NICE) has recommended the use of Pre Exposure Prophylaxis (PrEP) to treat people at the highest risk of catching HIV. The announcement comes along with a consultation on draft guideline by NICE on reducing sexually transmitted infections. NICE's recommendation is backed up by the government's HIV Action Plan to hit zero new transmissions of HIV by 2030. The pill prevents HIV by stopping the virus from crossing into the healthy cells and replicating. According to the UK PROUD study, PrEP reduced the risk of HIV infection by 86 per cent for men who have sex with men. However, people taking the pill must also get regular HIV testing and STI screening done every three months.

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.

'Tepotinib' has been recommended by the National Institute for Health and Care Excellence (NICE) to patients with a specific gene mutation of advanced non-small-cell lung cancer (NSCLC). The new potentially life-extending drug is available from Thursday (14 April). It has been recommended for routine use across the NHS in England through Project Orbis, a programme to review and approve promising cancer drugs helping patients access treatments faster. NICE has published its final appraisal document recommending tepotinib (also known as Tepmetko and produced by company Merck Serono Ltd) as an option for treating advanced NSCLC with METex14 skipping gene alterations in adults. People with METex14 skipping alterations of NSCLC make up between 1-2% of all adults with lung cancer in England. Tepotinib, which requires people to take two tablets once daily, provides a new targeted treatment for adults with METex14 skipping gene alterations. Just over 700 people in England would be eligible to receive tepotinib as either a first or second-line treatment.

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.

Two new medications which fight drug-resistant superbugs could soon become available to NHS patients in England after the National Institute for Health and Care Excellence (NICE) said they offered value for money. NICE said Cefiderocol and ceftazidime-avibactam will be the first antimicrobial drugs to be made available as part of a subscription-style payment model that incentivises research and development of antimicrobials by testing new approaches to evaluating and paying for them. As part of part of a project with the NHS and the Department of Health and Social Care, the new payment model is designed to address the growing threat posed by antimicrobial resistance - a serious global problem - which develops when the pathogens that cause infection evolve to make antibiotics and other antimicrobial drugs less effective or stop them from working altogether.

The current structure of global incentives to develop new antibiotics is insufficient and requires urgent resolution revealed a new report 'Incentivising new antibiotics' by the Office of Health Economics (OHE). OHE analysis demonstrates that on a global level, it is estimated that an effective 10-year incentive would require £3.5bn ($4.2bn) to adequately cover the entire research and development process for a new antibiotic. The report considers how health systems in the UK and around the world can stimulate the research and development (R&D) of new antibiotics. In 2020, the National Institute for Health and Care Excellence (NICE) and NHS England initiated an Antimicrobial Resistance pilot with the aim of incentivising pharmaceutical companies to develop new antibiotics by addressing the issues associated with reimbursement, which historically has deterred companies from pursuing AMR research.

In its first, the National Institute for Health and Care Excellence has recommended the use of long-acting injectable treatment for HIV-1 infection in adults, making around 13,000 people eligible for treatment with cabotegravir with rilpivirine in England. The new treatment aims to keep the number of virus particles in the blood so low that it cannot be detected or transmitted between people. Current treatment for HIV‑1 is lifelong antiretroviral tablets taken each day. Use of cabotegravir with rilpivirine is recommended when there is no evidence tosuspect viral resistance, and no previous failure of other anti-HIV-1 medicines. "Clinical trial results show that cabotegravir with rilpivirine is as effective as oralantiretrovirals at keeping the viral load low," NICE stated. Both are administered as two separate injections every two months, after an initial oral (tablet) lead-in period.

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.