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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 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 In a draft guidance issued today (January 5) NICE said evidence around the drug made by AstraZeneca was uncertain and approving it would not be a good use of NHS funds.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 It's final draft guidance is expected to be available on the July 20.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 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 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.

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.

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.

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)'s independent committee has called for more research to ensure liposuction for treatment of chronic lipoedema is safe and effective enough for use on the NHS. Lipoedema is more prevalent in women and very rarely affects men. It is characterised by an abnormal, usually symmetrical, accumulation of fat in the legs, hips, buttocks, and occasionally arms. It is a separate condition to obesity and lymphoedema. The cause of lipoedema is unknown, but hormonal changes, weight gain and genetics are thought to be involved. The size and shape of legs, and the resultant mobility issues and pain, can have a profoundly negative effect on quality of life, and physical and mental health. The interventional procedures advisory committee reviewed evidence from several sources, including eight before-and-after studies. The committee was informed that several different liposuction techniques are used and that they may have different safety and efficacy profiles.

NICE has recommended use of tucatinib as an option to treat HER2-positive breast cancer that has spread in people who have already tried 2 or more anti-HER2 treatments. The move is set to benefit around 400 people with advanced breast cancer. Tucatinib works by blocking a specific area of the HER2 gene in cancer cells, which stops the cells from growing and spreading. The medicine is taken as two 150 mg tablets twice daily along with anti-cancer medicines trastuzumab and capecitabine. Helen Knight, programme director in the NICE Centre for Health Technology Evaluation, said: "Unfortunately there is no cure for breast cancer that has spread to other parts of the body. There is also a lack of additional anti‑HER2 treatments which can postpone the need for chemotherapy, especially for people whose cancer has spread to their brain because their treatment options are even more limited.

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."

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.

Novo Nordisk, the Danish drug manufacturer, has launched Wegovy, a weight-loss drug, in the UK market. This semaglutide injection will be available through specialist NHS weight management services for those who meet the National Institute for Care and Excellence (NICE) criteria or privately through registered healthcare professionals. Novo Nordisk allocated a portion of the available supply of Wegovy for NHS services, while confirming the existing shortage of semaglutide and projecting continued constraints in the foreseeable future. The drug can be obtained through the NHS and is additionally accessible for private purchase at pharmacies in the UK. The pricing for a one-month supply varies, ranging from £73.25 to £175.80, depending on the dosage. "We are committed to expanding treatment options for individuals with obesity and share the Government's goal of improving access to obesity care in areas of high unmet medical need," the company said in a statement. "We are closely monitoring Wegovy demand and collaborating with regulators and providers to ensure access to and continuity of treatment for people living with obesity."

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.

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.

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.

Britain plans to launch a pilot programme exploring how new weekly weight-loss shots such as Novo Nordisk's Wegovy can be given to obese patients by general practitioners even as the drug's market launch remains unclear. The government's announcement on the £40 million pilot programme comes after drug cost-effectiveness watchdog NICE in March recommended the use of Wegovy in adults with at least one weight-related condition and a body mass index of 35, but only within the NHS specialist weight management scheme. The timing of Wegovy's launch in Britain - which would be only the fourth country to use it - is uncertain, however, after Novo last month rationed starter doses to secure supply to U.S. patients already on the regimen, after it was overwhelmed by demand there. British Prime Minister Rishi Sunak said on Wednesday (May 7) the pilot and fighting obesity-related diseases could reduce pressure on hospitals. It would also support "people to live healthier and longer lives, and helping to deliver on my priority to cut NHS waiting lists". The NHS endured a tough winter in England in particular, with waiting lists hitting record highs and staff striking for higher pay amid double-digit inflation.