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The National Institute for Health and Care Excellence (NICE) has published a new diagnostic guidance to enhance CYP2C19 genotype testing to guide clopidogrel use for patients who have suffered an ischemic stroke or transient ischemic attack. Published in July, the diagnostic guidance also emphasised the vital role of pharmacists and pharmacies in the implementation of CYP2C19 genotype testing used to guide prescribed antiplatelet medication. According to the NICE guidance, pharmacists with their expertise in pharmacogenomics and patient medication management, will be integral in interpreting test results and recommending appropriate antiplatelet therapy. It also highlighted the need for close collaboration with other healthcare professionals to ensure effective implementation across various care settings for stroke patients. The diagnostics advisory committee, a standing advisory committee of NICE, agreed that it should be possible to gather samples for genotype testing at a location that is convenient for the person having the test and highlighted the role of pharmacies as accessible locations for CYP2C19 genotype testing.The National Institute for Health and Care Excellence (NICE) has published a new diagnostic guidance to enhance CYP2C19 genotype testing to guide clopidogrel use for patients who have suffered an ischemic stroke or transient ischemic attack. Published in July, the diagnostic guidance also emphasised the vital role of pharmacists and pharmacies in the implementation of CYP2C19 genotype testing used to guide prescribed antiplatelet medication. According to the NICE guidance, pharmacists with their expertise in pharmacogenomics and patient medication management, will be integral in interpreting test results and recommending appropriate antiplatelet therapy. It also highlighted the need for close collaboration with other healthcare professionals to ensure effective implementation across various care settings for stroke patients. The d

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 It's final draft guidance is expected to be available on the July 20.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.

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.

The National Institute for Health and Care Excellence (NICE) has made a new recommendation in its final guidance this week that could benefit almost 30,000 adults suffering from moderate to severe symptoms of uterine fibroids. The Department of Health and Social Care's executive non-departmental public body, NICE, has recommended linzagolix, also known as Yselty by Theramex to treat uterine fibroids. Linzagolix is recommended for use as a longer-term treatment (more than 6 months) and is not for people who need short-term treatment, for example, before planned uterine fibroid surgery. According to Jonathan Benger, NICE's Chief Medical Officer and Deputy Chief Executive, expressed his approval of the new recommendation, stating, " What makes Linzagolix particularly noteworthy is its flexibility; it can be taken either with or without hormone therapy. "This means that clinicians can now offer a more personalised approach to care, tailoring treatment to the specific needs and circumstances of each patient. "For many women, this will represent a significant improvement in managing this often challenging and distressing condition."

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."

The MHRA on Wednesday granted a license for Eli Lilly's new Alzheimer's treatment, donanemab, for use in adults with mild cognitive impairment or mild dementia due to Alzheimer's disease. However, the drug will not be available on the NHS, as the National Institute for Health and Care Excellence (NICE) concluded that it "does not currently demonstrate value for the NHS." The health spending watchdog explained that the costs of providing donanemab, including regular infusions and intensive monitoring for serious side effects, outweigh the relatively small benefits it offers to patients, and so it "cannot currently be considered good value for the taxpayer." Helen Knight, director of medicines evaluation at NICE, said: "For NICE to be able to approve a medicine for use in the NHS it must provide additional benefits to patients, and it must also represent a good use of NHS resources and taxpayers' money. Donanemab (also called Kisunla) is a monoclonal antibody drug given by infusion (through a drip in the arm). It targets and reduces beta-amyloid proteins, whose abnormal buildup is associated with Alzheimer's disease. Clinical trial evidence suggests that the monthly injection can slow Alzheimer's disease progression by 4 to 7 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.

Professor Kamila Hawthorne, chair of the Royal College of GPs, has cautioned that while weight loss drugs hold significant potential to enhance many patients' lives, they are not without risks. She also expressed concern that expanding the roll out of tirzepatide at the scale proposed by the National Institute for Health and Care Excellence (NICE) would have "significant practical and resource implications for the NHS and primary care." The final draft guidance from NICE, published on 5 December, suggests that around 220,000 people living with obesity will be offered the weekly injection, along with a reduced-calorie diet and increased physical activity, over the next three years. Marketed under the brand name Mounjaro by Eli Lilly, tirzepatide is recommended for people with a body mass index (BMI) of more than 35 and at least one weight-related illness. Accepting the request from NHS England to roll out the medication over 12 years, the NICE guidance proposes to prioritise those with the highest clinical need.

'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 MHRA on Wednesday granted a license for Eli Lilly's new Alzheimer's treatment, donanemab, for use in adults with mild cognitive impairment or mild dementia due to Alzheimer's disease. However, the drug will not be available on the NHS, as the National Institute for Health and Care Excellence (NICE) concluded that it "does not currently demonstrate value for the NHS." The health spending watchdog explained that the costs of providing donanemab, including regular infusions and intensive monitoring for serious side effects, outweigh the relatively small benefits it offers to patients, and so it "cannot currently be considered good value for the taxpayer." Helen Knight, director of medicines evaluation at NICE, said: "For NICE to be able to approve a medicine for use in the NHS it must provide additional benefits to patients, and it must also represent a good use of NHS resources and taxpayers' money. Donanemab (also called Kisunla) is a monoclonal antibody drug given by infusion (through a drip in the arm). It targets and reduces beta-amyloid proteins, whose abnormal buildup is associated with Alzheimer's disease.

Pregnancy comes with lots of changes, and that that includes wardrobe changes! As the female body undergoes significant physical and physiological changes, many find it difficult to get themselves organized. Many pregnant women seek a guide to maternity clothing, especially when the baby bump starts showing up. You don't have to wait until the baby bump shows up before you start shopping for your maternity outfits. The moment you find out you are pregnant is a good time to start thinking of your maternity outfits. Knowing that it might be difficult for you to shop for items or picture what you would look like in maternity clothing, this article has been created as your ultimate guide to maternity clothing shopping. WHY YOU NEED TO SHOP FOR MATERNITY CLOTHING If you are pregnant, especially if you are a first-time mom, the chances are high that you have asked several questions about maternity and maternity clothing, such as, "Do I really need maternity apparel? Isn't it a waste of money buying maternity apparel?" The fact is that shopping for maternity outfits is not a must, but you'd hardly get past your third trimester without needing certain maternity clothing items. You might be tempted to improvise, but the question you have to ask yourself is, "Is improving safety for my baby and me?" SHOPPING MATERNITY OUTFITS IS A NECESSARY STEP FOR EVERY EXPECTING MOM You need to shop for some basic maternity outfits because, as much as possible, you need comfort when you are pregnant. Pregnancy makes you gain additional weight. Pregnancy is one of the reasons it is easier for women to gain weight and harder for them to lose weight. Expect that your clothes will start getting tight, especially around the abdominal area. This will make you feel restricted. The tight outfit can obstruct the free circulation of blood to all parts of the body and can cause body pain. You already have many pregnancy symptoms like nausea, fatigue and baby kicks to deal with and won

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.

A new report has highlighted that the public places a higher value on medicines for severe medical conditions, such as terminal cancer, than the thresholds currently used by the National Institute for Health and Care Excellence (NICE). The study, conducted by the Office of Health Economics (OHE), found a misalignment between NICE's current 'severity modifier'-which determines whether a medicine is recommended for coverage on the National Health Service (NHS)-and the UK public's preference for prioritising health gains for more severe diseases. The research, commissioned and funded by the Association of the British Pharmaceutical Industry (ABPI), also indicated that the public is willing to pay more for medicines used to treat patients with severe disease. Titled 'Understanding Societal Preferences for Priority by Disease Severity in England and Wales,' the report suggested that NICE's current severity modifier may be limiting access to innovative treatments for NHS patients. The ABPI has called on the government and NICE to adopt a more flexible approach when assessing medicines for severe conditions.