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12th February 2025
The long-awaited UK national joint guidelines for chronic asthma were launched at the 2024 Winter British Thoracic Society meeting. In this first of two articles, Ravijyot Saggu explores the key updates and implications of the new guidelines for practice, including diagnosis and monitoring, with a focus on chronic asthma in adults.
Previous iterations of asthma guidelines have been produced either by the National Institute for Health and Care Excellence (NICE) or the British Thoracic Society (BTS) in conjunction with the Scottish Intercollegiate Guidelines Network (SIGN), but these have sometimes conflicted, confusing their application in practice.
Earlier guidance has steered practitioners towards initial treatment of asthma or suspected asthma and infrequent wheeze, with short-acting beta-agonists (SABA) – usually salbutamol. These have traditionally been called ‘reliever’ inhalers, reinforcing the patient associating ‘relief’ with using SABA and inadvertently encouraging SABA reliance rather than inhaled corticosteroid (ICS) use as the mainstay of treatment.
For the first time, the NICE, BTS and SIGN have come together to produce one unified guideline and initiate a move away from SABA-only prescribing. This ensures consistent messaging and a change in treatment approach.1
The joint guideline is evidence-based and considers cost-utility analysis. It was developed with an expert committee and broad stakeholder consultation at the draft stage and is intended for use in patients with suspected or already diagnosed asthma.
The scope of the joint guideline was restricted to the diagnosis, monitoring and treatment of chronic asthma. Therefore, other areas, such as acute or severe asthma, have not been updated in this iteration.
Asthma care is still suboptimal in children and young people, leading to avoidable harm and mortality, with roughly one related death every four weeks. A recent national report on deaths of children and young people from asthma and anaphylaxis has highlighted key contributory themes and recommendations for action to prevent future asthma-related harm.2
Similarly, the National Review of Asthma Deaths (NRAD) 2014 report highlighted failures of basic asthma care.3 Sadly, many of the deaths reviewed were deemed to have been preventable.3
NRAD identified SABA overuse as one of the contributory factors to these preventable deaths. Some 39% were prescribed more than 12 SABA inhalers in the year before they died, while 4% had been prescribed more than 50 reliever inhalers. Those prescribed more than 12 reliever inhalers were likely to have had poorly controlled asthma.
There was also evidence of under-prescribing of preventer medication and inappropriate prescribing of long-acting beta-agonist (LABA) bronchodilator inhalers, including LABA monotherapy without ICS preventer treatment.3 LABA monotherapy is not recommended for the treatment of asthma.
Since NRAD, there has been more focus on SABA overprescribing as a flag for uncontrolled disease, with thresholds ranging from three to six SABA inhaler prescriptions per year as a marker of overprescribing, underutilisation of ICS and poorer asthma control.4,5
Despite the NRAD report findings, we still have poor asthma-related mortality and outcomes in the UK over 10 years later. An all-party parliamentary group (APPG) report in 2020 highlighted that asthma attacks in the UK had increased by a third in the decade prior.6
It is widely known that incidence and mortality of respiratory disease are generally higher in disadvantaged groups and areas of social deprivation. Asthma attacks kill three people in the UK each day – the highest level in Europe – and every 10 seconds someone has a potentially life-threatening asthma attack.7
Although some patients may perceive asthma as a cyclical condition, it is a chronic, inflammatory condition that can be well managed with the correct treatment and adherence. While SABA provide temporary bronchodilation, they do not target airway inflammation,6 which requires ICS.
ICS are an effective, evidence-based and largely well-tolerated part of asthma management.
Asthma may be uncontrolled for various reasons, such as non-adherence, undertreatment or a specific type of inflammation that requires specialist review and investigation, and, in some cases, potentially treatment with biologics. To address poor control, the correctable factors should be modified and optimised, including consideration of additional diagnoses and optimal comorbidity management.
A useful pathway for recognising and optimising inadequately controlled asthma has been developed. It can be used in any setting to focus patient care promptly and ensure that the fundamentals are addressed early before appropriate referral to specialist care.
Uncontrolled asthma can lead to exacerbations and may result in hospital admission or emergency department attendance and an increased utilisation of health resources.
Some exacerbations may be severe or life-threatening, and it is essential to be able to recognise and assess signs of severe and life-threatening asthma, including exhaustion, cyanosis, inability to complete sentences in one breath, altered consciousness and reduced peak expiratory flow.
It is important that exacerbations are prevented and asthma control well managed. Management usually involves temporary increased SABA use, a short course of oral corticosteroids (OCS) and often accompanying antibiotics if a bacterial infection is suspected.
Additionally, it is prudent to limit the cumulative OCS and antimicrobial exposure that ensues with exacerbations to minimise side effects and antimicrobial resistance.
There is often a negative association of steroids being harmful, which may be a factor in patient non-adherence to therapy.7,8
ICS differ from OCS, but limiting the overall steroid burden, especially for OCS, and avoiding secondary adrenal insufficiency is important.
Many of the commonly known side effects associated with steroids, such as weight gain, osteoporosis and diabetes are related to OCS and their longer-term or repeated use, reiterating the importance of good disease control to prevent exacerbations.
Side effects with ICS are more local in comparison. They can be minimised by the correct inhaler technique and using an inhaler device best matched to the person’s inhalation ability, which includes using a spacer with a metered dose inhaler where appropriate.
It is important to be able to rule asthma in or out, using objective tests supported by a good clinical history and considering alternative and additional diagnoses. Key updates have been made to the diagnosis and monitoring of asthma in the new joint guideline and are discussed below.
There is no gold standard test to diagnose asthma. In adults aged 16 years and above, the new guidance recommends sequential use of the following tests to confirm a diagnosis of asthma:1
Additionally, the below considerations may support diagnosis or clinical review, especially where asthma may be uncontrolled; these are important to address before escalating therapy:
Please note that diagnosis is slightly different for children aged five to 16 years and this is outside the scope of this article, but see the algorithm for further information.
A key change in the new guidance is a move away from what is traditionally associated with monitoring asthma. Routine monitoring of PEF is now not recommended, although a small cohort of patients may still require this. A validated symptom questionnaire such as the Asthma Control Test can be considered at asthma-related reviews such as annual reviews.
Patient perceptions of disease severity, control and risk may not correlate with clinical state.3,9 It is important to explore the patient’s perceptions and the results of validated questionnaires, as they may contradict each other.7 Perceptions and illness beliefs also impact treatment adherence.
As FeNO is an indicator of airway inflammation, the joint guidelines suggest considering the measurement of FeNO at review, as well as before or after changing pharmacological therapy.
This may also be useful to support patient discussions on the level of disease control, in particular where their perception of it contrasts with the objective test, although various factors can impact FeNO levels.
As with diagnosis, a structured clinical history is vital to elicit the relevant information about symptoms, disease control and triggers. At patient review, ask about the following:
The new joint guidelines herald a radical change in diagnosis, treatment and monitoring and have been welcomed as a much-needed improvement in chronic asthma care. They represent a move to a more straightforward pathway and offer a new and pragmatic approach to implementation.
Read part 2 of this series, which focuses on the joint guideline recommendations for the pharmacological management of adult chronic asthma.
Ravijyot Saggu
Respiratory pharmacist, London, UK, and chair of the UK Clinical Pharmacy Association Respiratory Committee and NICE Medicines and Prescribing Associate
28th November 2024
Long-awaited joint UK guidelines for chronic asthma have been finalised, overhauling diagnosis and treatment recommendations in an effort to better manage the condition in primary care and reduce pressure on hospitals.
The final chronic asthma guidance from the National Institute for Health and Care Excellence (NICE), British Thoracic Society (BTS) and the Scottish Intercollegiate Guidelines Network (SIGN) is designed to support clinicians in making accurate diagnoses, promoting good practice, and providing effective, personalised treatment to control and prevent acute asthma attacks.
This is the first time the organisations have collaborated to produce joint UK-wide guidance on the diagnosis and management of chronic asthma for adults, young people and children.
Alongside its publication, NICE, BTS and SIGN have also developed a new joint asthma pathway. This digital resource collates tools and information for in a central hub, providing ‘a seamless user journey across the newly published guideline and existing asthma guidance‘.
In June, draft guidance revealed significant changes to the current treatment approaches. This included replacing the sole use of short-acting beta agonist (SABA) when asthma is first diagnosed with a low-dose combination of inhaled corticosteroids (ICS) and formoterol, which the final guidance has now reinforced.
Indeed NICE emphasised that healthcare professionals should ‘always prescribe maintenance or combination treatments’ rather than the ‘familiar blue “reliever-only” inhaler, when asthma is first diagnosed’.
This is based on evidence which ‘showed that using the combined ICS and formoterol inhalers when required led to people suffering fewer severe asthma attacks’.
The final chronic asthma guidance has also confirmed changes to recommendations on testing for asthma, with a new recommendation to use peak expiratory flow (PEF) variability as a method for diagnosis, which has been added following consultation.
It advised healthcare professionals to use a stepwise series of tests including eosinophil count, FeNO, spirometry and bronchial challenge in patients where the condition is suspected on clinical grounds.
However, NICE warned that these tests – recommended for both children and adults – are ‘not routinely carried out in current practice’, with ‘only a minority of GP practices’ having onsite access to FeNO tests, while bronchial challenge testing is not available at all in primary care.
As such, NICE recognised that there will be a ‘capacity problem’ and that implementing the recommended diagnostic pathway into clinical practice would ‘require significant investment’.
Another addition to the joint guidance following consultation was a recommendation to consider providing an additional metered SABA inhaler plus spacer for emergency use for children under 12 years who may be unable to activate a dry powder inhaler during an acute asthma attack.
NICE’s chief medical officer Professor Jonathan Benger said the new guidance aims to ‘ease pressure’ on the NHS by ‘reducing hospital admissions due to asthma and lowering the use of less effective monitoring tests’.
He continued: ‘Having one clear set of national asthma guidelines is vital to ensure people receive consistent and effective asthma care across the health service, so people across the UK receive the right diagnosis and treatment for them.’
BTS chair Dr Paul Walker said the changes to recommendations for testing ‘will simplify diagnostic processes and help with current diagnostic delays for adults, children and young people’.
‘The treatment changes represent a true pivot in the principles of asthma care and will contribute to improved outcomes,’ he added.
Dr Andy Whittamore, GP and Asthma and Lung UK clinical lead, said the new guidelines ‘have the potential to make a real difference’ to the 7.2 million people in the UK living with asthma.
He said the recommendation to ‘move away from over-reliance’ on SABA inhalers, which is a ‘key driver of poor asthma control’, is ‘particularly welcome’.
Dr Whittamore also highlighted that the changes to diagnostic recommendations will ‘need to be accompanied by good clinician education to ensure they can confidently and reliably work within the new diagnostic pathway’.
On resourcing for testing, he added: ‘It is very positive that the guidelines acknowledge the difficulties in diagnosing asthma correctly and identify poor access to FeNO and spirometry testing as a barrier that can block safe, good quality care.
‘Funding must be made available to support healthcare professionals to deliver these tests and make them available for every person with suspected asthma.’
Chair of the Primary Care Respiratory Society Dr Katherine Hickman, who is also a GP in Bradford, said the new guidelines ‘introduce a systematic and evidence-based approach to diagnosis’ and she is ‘confident these recommendations will help ensure more accurate assessments and better patient care’.
She continued: ‘One of the most promising advancements is the move towards anti-inflammatory reliever therapy (AIR) and maintenance and reliever therapy (MART).
‘This innovative approach marks a significant shift in asthma treatment, offering new hope to patients and healthcare providers alike. It has the potential to transform how we manage asthma by reducing the burden on primary and secondary care, saving lives, and restoring control to patients over their condition.
‘The guidelines give me real hope for the future of asthma care. They represent a critical step in not only improving patient outcomes but also reshaping how asthma is managed at every level of the healthcare system.’
However, Dr Hickman advised GPs that no patient should be switched to a new inhaler without an ‘informed discussion’.
Professor Azeem Majeed, a GP and professor of primary care and public health at Imperial College London, said the recommendation to replace SABA inhalers alone with combination inhalers ‘reflects evidence that this approach can improve overall asthma control’.
He also said the new recommendations on testing will ‘help reduce misdiagnosis and ensure that treatment is appropriate’, but he warned that implementing the joint guideline will ‘require significant investment to ensure widespread access’ to diagnostic methods such as FeNo and spirometry.
Professor Majeed continued: ‘Another concern is ensuring that all patients, regardless of where they live, have equitable access to the recommended tests. Currently, geographic disparities exist in diagnostic capabilities, which could lead to unequal implementation and outcomes between areas.
‘Overcoming capacity and implementation challenges will require investment in diagnostic infrastructure; workforce expansion and training; and collaboration across primary and specialist care.’
Earlier this month, a report from UCLPartners revealed that an app to assist with asthma self-management could save the NHS up to £25m in a year if it were used by 100,000 patients for three months.
In February 2024, the BTS and Primary Care Respiratory Society published a position statement on integrated respiratory care models and the importance of putting patients at their centre.
A version of this article was originally published by our sister publication Pulse.
5th August 2024
Selective internal radiation therapy has recently been given the green light by NICE, offering a less-invasive, non-surgical treatment option for neuroendocrine tumours (NETs) that have metastasised to the liver. Here, Drs Brian Stedman and Sachin Modi discuss the treatment landscape of NETs, the significance of this recommendation for patients in England, Wales and beyond, remaining challenges and the importance of the multidisciplinary team in the planning and delivery of this treatment.
New interventional procedures guidance from the National Institute for Health and Care Excellence (NICE) recommends the consideration and use of selective internal radiation therapy (SIRT) for neuroendocrine tumours that have metastasised to the liver.
The treatment involves injecting tiny radioactive spheres into the blood vessels that supply the liver metastases to control the growth of these tumours and reduce symptoms, all while limiting exposure to healthy surrounding tissue.
The guidance highlights that while there are well-recognised and infrequent serious complications with SIRT, this treatment may be better tolerated in some people than other available options.
As such, patient selection for SIRT should be carried out by an experienced multidisciplinary team – much like the one led by Dr Brian Stedman, consultant interventional radiologist, and Dr Sachin Modi, consultant interventional radiologist and oncologist at University Hospital of Southampton.
Dr Stedman: Neuroendocrine cancer is typically a tumour that’s diagnosed late because patients present with very vague symptoms that are often overlooked or confused with irritable bowel symptoms and dyspepsia.
A lot of patients will have spent years seeing primary care physicians with fairly nondescript symptoms and never getting an accurate diagnosis. Often, it’s when patients end up having a CT scan that the diagnosis is made because the CT appearance is pathognomonic.
The tumours can be either very indolent – that is they can stay without progressing for 10 years – or they can be aggressive, and people can die within three months of diagnosis. There’s such a broad range of biology and behaviours, it can be hard to select the right way of managing patients.
Dr Stedman: With disease management, there’s a shift towards more aggressively managing metastatic disease by removing primary tumours surgically, whether they are in the bowel or in the pancreas, because there’s good evidence now that patients live better and longer. Systemic chemotherapies have been shown to be effective in the most aggressive neuroendocrine tumours.
There’s also been the development of peptide receptor therapy where you use a radio isotope attached to a peptide receptor that can be useful for treating the differentiated tumours. These are the indolent tumours that are demonstrating or displaying these receptors.
Dr Stedman: Looking at our local practice, we get the impression that there are quite a lot of reasonably well, middle-aged people who are working, have young kids and are living fairly normal lives despite having metastatic cancer. Males and females are affected.
Like most cancers, the age demographic is more common for those in their 60s and 70s. However, we are now seeing a lot of patients in their late 20s, early 30s presenting with metastatic neuroendocrine tumours.
There is a bit of a lead time: many more people in their 20s and 30s are having CT scans and quite a lot of these tumours are detected incidentally on those scans. Now those patients would have probably presented five years later with symptoms, but we’re picking them up at a stage when sometimes the diagnosis is just made, incidentally, almost by luck, because these patients are having increased amounts of cross-sectional imaging.
Dr Modi: About 10-15 years ago there was a lot more reliance on clinical acumen. If a patient came in with abdominal pain, they would be seen by someone, and a diagnosis would be made although not necessarily with imaging. Now when someone comes into a A&E with abdominal pain, it’s almost certain they’re going to have some form of imaging whether that’s ultrasound or CT.
Dr Stedman: A good example would be people having trauma scans, or patients who have renal colic who think they’ve got kidney stones. Both of those are common areas where we pick up these tumours.
Dr Modi: SIRT has been around for about 10 to 12 years, but it has shown some significant advances over the last couple of years, particularly in the field of dosimetry.
This treatment essentially involves delivering radiation loaded onto glass beads into the liver arteries These beads are attracted to the liver tumours because the tumours tend to take their blood supply from the liver arteries.
The aim is to deliver millions of these beads in and around the tumour so that they have a radiation effect essentially from the inside out. They all emit a beta emission of radiation between one to two millimetres, which in theory kills the tumour from the inside out.
We’ve been delivering this therapy in Southampton for the last 10 years. We’ve significantly developed our technique in terms of the radiation dose that we can safely give to patients using software, which enables us to tailor therapy to kill a tumour and not damage the surrounding background liver. We work as part of a collaborative team with oncologists and nuclear medicine physicians to deliver this service safely for our patients.
SIRT is a significant step because it represents another option to treat these patients who have liver tumours that have spread from a primary net cancer. These patients can be quite difficult to manage. Traditional treatments, such as bland embolisation or transarterial chemoembolisation, involve multiple visits to hospital, which can have some side effects on patients in terms of their quality of life.
SIRT is a very well-tolerated, minimally invasive treatment in our experience. Clinicians have the opportunity to give patients a one-off treatment that benefits them without affecting their quality of life and, in fact, patients’ quality of life returns pretty much back to baseline very soon after SIRT.
Dr Stedman: Despite NICE advocating the use of SIRT and it’s an independent panel saying this is probably the most effective treatment for this group of patients, there’s still currently no NHS funding or commissioned service in place. NHS patients cannot get access to this therapy due to a lack of funding from NHS England.
One of the challenges is that the breadth of experience and breadth of clinicians that are required to deliver this service. You need medical oncologists, radiation oncologists, medical physicists and a radiopharmacy. You need access to gamma cameras, which provide specialised nuclear medicine imaging, and you need an interventional oncology unit which is trained up and certified for the delivery of these services.
Around the country quite a lot of centres struggle to get that team up and running; you only need to lose one of those key players and the service falls down.
With this technology, it takes two to three years to get a SIRT centre commissioned and up and running. Costs run between £0.5m and £1m in terms of equipment and staff facilities. There’s a big implicit risk here if commissioning is turned off even for a short period of time – expertise gets lost.
Dr Modi: The other barrier is geographical discrepancy in England in terms of centres that can deliver SIRT. There are some areas where the services are deficient due to a lack of local expertise especially with nuclear physicists.
Dr Stedman: It would be nice to see the expert clinicians around the table to decide on what they think is the most appropriate therapy. At the moment the experts around the table at a multidisciplinary team (MDT) meeting are being limited in the treatment options because there isn’t a commissioned service.
It would be much better to allow expert clinicians in specialist centres the ability to decide what’s the most appropriate treatment for patients. I would like to see those decisions given over to the MDT since NICE has recommended SIRT.
Now, it may be that the NHS will put some limits and caveats on which patients they think will benefit most from it. The NICE guidance is fairly broad, but there’s a danger of commissioners bringing up arbitrary barriers.
On a personal level, I would like commissioners to trust the expertise of the MDT: they have an anxiety about the volume of patients that get treated, but that’s a discussion between the manufacturers and the acute trusts that deliver this service about volume and value. If we expanded access to this treatment by increasing the volume, we should be able to drive down the cost and make it a more streamlined and efficient service and, therefore, more patients should benefit.
Dr Stedman: Looking at the European model, they have an independent panel of experts in health economics and public health which has reviewed the data and advocate for SIRT treatment in this patient group. That’s quite a useful benchmark for clinicians in Europe because there’s a lot of vested interest in medicine: a lot of societies and specialist medical groups will come forward with guidelines, but they’re not truly independent.
NICE evaluations are seen as a gold standard. I think it will have an impact on European guidelines going forward as NICE has so strongly come down in favour of recommending this therapy.
Scotland and Northern Ireland have limited SIRT centres, and they also have European neuroendocrine tumour centres of excellences. They do have the expertise and I’m sure they will look at the NICE guidance.
Dr Modi: The biggest unmet need is commissioning. As previously mentioned, despite the NICE recommendation for SIRT, we still find ourselves in a position unable to offer this treatment to patients in our centre.
Dr Stedman: The NHS needs to get more robust about how they commission specialist services so that all patients with complex cancers get access to specialists. Patients with neuroendocrine tumours should be discussed at a super-regional specialist neuroendocrine cancer centre.
That doesn’t mean that all their care needs to be delivered there; I think there’s nothing wrong with cancer care, surgical oncology and medical oncology being delivered locally.
But I think patients miss out by not having their case discussed by a specialist team that has knowledge and insight into all the latest therapies such as SIRT.
I think it’s such a specialised area of medicine now that small regional hospitals managing these patients without getting a specialist review are probably prejudicing some patients’ treatment.
17th July 2024
NICE has recommended a new digital tool which could speed up ADHD diagnoses and help clinicians rule out more cases.
In new draft guidance, the National Institute for Health and Care Excellence (NICE) approved NHS use of the computer-based QbTest, alongside a standard clinical assessment, for diagnosis of attention deficit hyperactivity disorder (ADHD) in children and young people.
QbTest tracks the movement of participants while measuring the three main symptoms – inattention, impulsivity, and hyperactivity – and the results are then compared to a control group.
A previous clinical trial showed that QbTest led to a larger proportion of patients receiving a diagnostic decision within six months of their first assessment appointment.
NICE has said that use of the test also resulted in ‘clinicians being able to rule out ADHD in more cases’ and that the technology provides a ‘quicker diagnosis’.
ADHD diagnoses are usually made by specialist psychiatrists or paediatricians, and the NHS has seen a large rise in GP referrals for diagnosis in recent years.
A report earlier this year argued that demand for ADHD assessments is increasing at such a rate it has surpassed the ability of the NHS to keep up.
GP leaders across the UK recently called for locally commissioned NHS ADHD services and for patients to be able to self-refer to those services, without the requirement to consult their GP.
During the process to recommend QbTest, NICE heard from patient experts that long waiting times for ADHD assessment – sometimes lasting ‘many years’ – are a ‘significant issue’, and that many patients are seeking private care instead.
The recommendation for the use of digital technologies is limited to children and young people aged six to 17 for now, while further research is carried out for adults.
NICE’s diagnostics advisory committee emphasised that the QbTest should ‘only be used to supplement professional judgement, and not replace it’.
Director of NICE’s HealthTech programme Mark Chapman said children ‘deserve to receive a diagnosis in a timely manner’ and that there are ‘challenges’ in the current NHS pathway.
He continued: ‘This technology has the potential to generate tangible benefits to the lives of those waiting for an ADHD diagnosis.
‘Evidence presented to our committee showed the QbTest could increase the number of children and young people who get a diagnostic decision within six months of starting assessment.’
Dr Jessica Eccles, chair of the Royal College of Psychiatrists’ neurodevelopmental special interest group, said people often have to wait ‘months or even years’ for an ADHD assessment, and that any new ‘evidence-based tools’ should be used to reduce these ‘unacceptable waiting times’.
She added: ‘It’s critical that these tests are administered by a fully trained and qualified professional who can accurately interpret the information they provide. They must not be used in isolation but as part of a broader assessment.
‘The challenges facing ADHD services will not be solved by new technology alone. There is still a clear need for targeted resources to help them meet rising demand and provide vital care.’
A consultation on NICE’s draft guidance, which applies to England and Wales, is now open until 6 August.
ADHD is estimated to affect between 1% and 2% of children and young people in the UK, when using the World Health Organization’s diagnostic criteria.
The NHS recorded a large jump in the number of medicines prescribed for ADHD in 2023/24, which included a 28% rise for adults and a 9.9% increase for children and followed a steadily rising trend since 2015/16 when the annual report on mental health drugs was first compiled.
A version of this article was originally published by our sister publication Pulse.
4th June 2024
NICE has recommended five devices that can be used at home to diagnose and assess the severity of obstructive sleep apnoea/hypopnoea syndrome, freeing up clinician time and helping to reduce waiting lists.
The draft guidance which applies to those over the age of 16 could help the NHS identify people with the condition more easily, NICE said.
More research is needed on the home-testing devices before they can be used in children, the committee added.
Evidence should also be collected on how accurately the devices assess obstructive sleep apnoea in people with black or brown skin, NICE said.
In making the recommendations, the committee said minimal or no help is needed from a healthcare professional to use and attach the devices, which may give a clearer picture because they allow for a more natural night’s sleep.
This contrasts with current systems that have multiple wires and a cannula inserted into the nose and can require a hospital appointment for the person to be shown how to use them.
These may not be suitable for everyone depending on a person’s comorbidities, the committee noted.
Expert clinical advice provided to NICE suggested that hospital sleep testing capacity has reduced since the pandemic, creating more reliance on home testing as the primary approach to sleep diagnostics.
It is thought around 5% of the population has undiagnosed obstructive sleep apnoea hypopnoea syndrome, which is linked to hypertension, diabetes, stroke and heart disease that can shorten life expectancy.
Two of the devices are strapped to the wrist with sensors attached to the finger and chest, another has a wireless sensor attached to the throat. One of the devices is worn as a belt around the waist whilst the last one uses a wireless sensor attached to the finger to detect symptoms using oxygen saturation, body movement and pulse rate.
Some devices require internet and smartphone compatibility, but for others the data is downloaded after the designated monitoring period.
Mark Chapman, director of the Health Technologies Programme at NICE, said: ‘Having obstructive sleep apnoea can cause serious health issues which could be managed if diagnosed and treated.
‘Many people don’t even know they have this condition which is why it is important to be able to receive a diagnosis quickly and efficiently.
‘It is promising that some of the new devices could have the potential to further improve detection of sleep apnoea for people with black or brown skin, but further evidence is needed to show this.’
He added: ‘Another added benefit to these new devices includes the fact they are less invasive, more comfortable to wear, and could cut waiting times because they are easier to use, thus speeding up diagnosis and freeing up clinician time.’
The recommendations are out for consultation until 5 June, with an expected publication date of 11 September 2024.
A version of this article was originally published by our sister publication Pulse.
12th April 2024
Tisagenlecleucel (brand name Kymriah) has been recommended for routine rollout on the NHS by the National Institute for Health and Care Excellence (NICE), its manufacturer Novartis has announced.
Final draft guidance for the treatment, which has been available through the NHS Cancer Drugs Fund (CDF) since December 2018, recommends tisagenlecleucel for children and young adults up to and including 25 years of age who have B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse.
A chimeric antigen receptor (CAR) T-cell therapy, tisagenlecleucel is administered as a one-off infusion into the blood stream.
Dr Sara Ghorashian, consultant in paediatric haematology at Great Ormond Street Hospital for Children NHS Foundation Trust, said: ‘During its time in the CDF, tisagenlecleucel has changed the way in which people with relapsed or refractory B-ALL have treatment.
‘It offers a chance of durable remissions and prolonged overall survival for people who often have no other option. The CDF has enabled us to build robust real-world evidence and I’m delighted that NICE has recommended that children and young adults should continue to have access to this treatment.’
The recommendation and final draft guidance from NICE for the routine rollout of this CAR T-cell therapy is based on data collected from its use in the NHS as well as additional clinical trial evidence from three studies.
Presented to NICE as a pooled dataset, the ELIANA, ENSIGN and B2101J trials showed people treated with tisagenlecleucel lived for longer and without experiencing relapse or progression, and improved overall survival for people compared with standard treatment.
For example, the median overall survival was 48 months, compared with a median overall survival for two other standard treatments of 7.5 months for blinatumomab and a median overall survival of three months for salvage chemotherapy.
Data collected from ELIANA have been published in the Journal of Clinical Oncology.
NHS use data found that the 24-month overall survival was 72% following treatment.
According to Novartis, tisagenlecleucel was used to treat 133 children and young adults while in the CDF between 2018 and September 2023.
Atogepant (brand name Aquipta), the first oral drug for chronic and episodic migraine prophylaxis where other treatments have failed should be available on the NHS, according to final draft guidance from NICE.
Up to 170,000 people could be eligible for atogepant, which is manufactured by AbbVie, under the recommendations.
This follows the approval of atogepant by the European Commission in August 2023 for chronic and episodic migraine prophylaxis in adults. The Scottish Medicines Consortium also accepted atogepant for restricted use in suitable patients in October 2023.
With this latest recommendation, it is expected that use of the drug, which works by blocking the calcitonin gene-related peptide receptor (CGRP), will be initially managed in secondary care, under a commercial agreement agreed with NICE.
But in the evidence provided to the appraisal process, drug manufacturer AbbVie noted there was potential for it to be monitored in primary care, and for follow-up appointments to be done by GPs.
Patient and professional organisations also told the committee that the availability of atogepant through GPs would improve access to treatment and reduce NHS costs.
The committee said that while atogepant would initially be prescribed and monitored in secondary care, ‘there would be interest in being able to use it in primary care’.
Under the recommendations outlined in the final draft guidance, the oral, once-daily atogepant will be an option for chronic and episodic migraine prophylaxis in adults who have had at least four migraine days per month.
To be eligible for the drug, patients must also have tried at least three previous preventive treatments.
Atogepant may be useful for those who cannot tolerate current fourth-line injectable treatments or who have contraindications to them, the guidance said.
The drug should be stopped after 12 weeks if the frequency of migraine attacks does not stop by at least 50% for episodic migraine and at least 30% for chronic migraine, NICE said.
It is also considered to be one of a range of suitable treatments and, after discussing the advantages and disadvantages of all the options, the least expensive should be used, NICE added.
Professor Peter Goadsby, honorary consultant neurologist, King’s College Hospital, said: ‘We know that people living with migraine may battle for years without an effective treatment to mitigate the daily struggles of living with this debilitating condition.
‘The decision by NICE should have a positive impact on patients who are eligible to receive atogepant as the treatment has been shown to reduce significantly the number of mean monthly migraine days in pivotal trials.
‘This welcome news increases the treatment options available that clinicians can offer to suitable patients, providing them with access to an additional preventive treatment that is now available on the NHS in England and Wales.‘
The NICE recommendation is supported by data from three pivotal Phase 3 clinical studies evaluating atogepant 60 mg once-daily in adults living with episodic (ADVANCE and ELEVATE) and chronic (PROGRESS) migraine.
In the three trials, the treatment met the primary endpoint of a change from baseline in mean monthly migraine days across 12 weeks versus placebo. Additionally, the treatments achieved significant reductions from baseline in several secondary efficacy endpoints compared to placebo: mean monthly headache days and mean monthly acute medication days, along with an additional achievement of ≥50% reduction in three-month average of monthly migraine days in the ELEVATE study.
Atogepant was also found to be generally well tolerated.
The most commonly reported adverse reactions in the ADVANCE and PROGRESS trials were nausea (7%), constipation (7%) and fatigue/somnolence (5%).
For the ELEVATE study, treatment-emergent adverse events were reported by 81 participants (52%) in the atogepant group (n=156). The most common (≥5%) were constipation (10%), Covid-19 (8%), nausea (7%), and nasopharyngitis (5%).
NICE director of medicines evaluation Helen Knight said: ‘[The] final draft guidance demonstrates our commitment to focusing on what matters most and getting the best care to people while ensuring value for the taxpayer.
‘Currently, the most effective options for people with chronic migraines who have already tried three preventative treatments are drugs that need to be injected.
‘The committee heard from patient experts that some people cannot have injectable treatments, for example because they have an allergy or phobia of needles. So, some people with chronic migraines would welcome an oral treatment. Atogepant also offers more choice for people with episodic migraine.’
Rob Music, chief executive of the Migraine Trust, added: ‘A migraine attack can be incredibly debilitating. Symptoms can include intense head pain, loss of or changes to senses and lack of ability to carry out day to day life.
‘It is positive to see even more therapies emerging for people with migraine after many still rely on treatments developed for other conditions. We now need to ensure access to the newer treatments is swift, so that migraine patients can benefit from them.‘
If there are no appeals, the final NICE guidance is expected to be published on 15 May 2024.
Last year, NICE recommended rimegepant as the first oral treatment for episodic migraine and acute migraine, in draft guidance published in June and September, respectively.
14th March 2024
Etrasimod (brand name Velsipity) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) and recommended by the National Institute for Health and Care Excellence (NICE) for treating eligible patients with ulcerative colitis (UC).
It is approved for patients aged 16 years and older with moderately to severely active UC who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biological agent.
The recommended dose of etrasimod is one 2 mg tablet taken once daily with food for the first three days. After this, it can be taken each day with or without food.
The approval of etrasimod in the UK follows its marketing authorisation by the European Commission in February 2024 for the same indication.
This was the first time an oral advanced UC therapy had been approved for use in older adolescents.
Commenting on the recommendation, Helen Knight, director of medicines evaluation at NICE, said: ‘Severe ulcerative colitis is a debilitating lifelong condition; etrasimod provides a new convenient and effective treatment option that will make a positive difference for thousands of people.
‘I’m very pleased we have been able to publish our final guidance recommending the treatment on the day the MHRA granted it a licence. We are determined to continue getting the best care to patients fast.’
NICE has noted that just over 25,000 people in England are now eligible to receive the new treatment, which was evaluated using a simpler technology appraisal process.
As a result, the full final NICE guidance was available up to eight weeks faster than would have been the case under standard process.
The MHRA and NICE approvals of etrasimod were based on results from the phase 3 ELEVATE UC 52 and ELEVATE UC 12 trials.
These randomised, double-blind, placebo-controlled trials involved 743 patients aged 16 years and over for whom standard treatment or other treatments did not work well enough or could not be used.
They evaluated the safety and efficacy of etrasimod 2 mg once daily on clinical remission.
The coprimary endpoints in ELEVATE UC 52 were the proportion of patients who achieved clinical remission at Week 12 (induction period) and Week 52 (maintenance period).
The primary endpoint for ELEVATE UC 12 was the proportion of patients in clinical remission at the end of the 12-week induction period.
Taken together, the results from the studies showed that, after 12 weeks of treatment, 26% (129/496) of those who received etrasimod had achieved clinical remission compared with 11% (27/247) of those who received the placebo.
ELEVATE UC 52 also found that 32% (88/274) of people taking etrasimod achieved clinical remission after 52 weeks compared with 7% (9/135) for those receiving the placebo.
Both studies also achieved all key secondary efficacy endpoints, with a favourable safety profile consistent with previous studies of etrasimod.
The most common side effects of the were found to be bradycardia, hypertension, urinary tract infection and lower respiratory tract infection.
NICE also noted that indirect comparisons suggest etrasimod is likely to work better than adalimumab and may be similarly effective to other usual treatments for moderately to severely active UC.
The monoclonal antibody dostarlimab (brand name Jemperli) has been recommended by the National Institute for Health and Care Excellence (NICE) for use in combination with platinum-based chemotherapy for eligible patients with endometrial cancer.
The final draft guidance recommends dostarlimab for the treatment of primary advanced or recurrent endometrial cancer with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR) in adults who are candidates for systemic therapy.
Dostarlimab is already approved by NICE for previously treated advanced or recurrent endometrial cancer with MSI-H or dMMR. This new approval moves dostarlimab to an earlier line of therapy, so the drug can be given in combination with chemotherapy instead of after disease progression following first-line treatment.
As MSI-H or dMMR endometrial cancer is more likely to respond to immunotherapy treatment than chemotherapy, offering this treatment earlier in the pathway will help to reduce the risk of reoccurrence, NICE said.
Clinical trials show that dostarlimab improves life expectancy and delays worsening of endometrial cancer in the short-term. Until research shows its long-term benefits, the treatment will be offered via managed access through the Cancer Drugs Fund (CDF) to NHS patients with recurrent or advanced endometrial cancer only. It is not recommended for routine use in the NHS.
Dostarlimab is delivered by intravenous infusion in hospital over 30 minutes and it is thought that it the decision by NICE will affect 540 patients in the UK.
The treatment was granted marketing authorisation in the EU in December 2023 for the same indication and was authorised by the Medicines and Healthcare products Regulatory Agency’s global partnership Project Orbis in October 2023.
Commenting on the decision, Helen Knight, director of medicines evaluation at NICE, said: ‘Advanced or recurrent womb cancer has a devastating effect on quality of life and there are limited treatment options available.
We are focused on delivering what matters most and getting care to those who need it fast, so I am delighted this treatment option will be made quickly available through the CDF, enabling people with this type of cancer to enjoy more precious time with their families and loved ones’.
NICE’s approval represents the fourth treatment option or indication for endometrial cancer available via NHS commissioning or through the CDF since the organisation’s inception in 1999.
Publication of the final guidance is expected on 3 April 2024.
27th February 2024
The Janus kinase (JAK) inhibitor ritlecitinib has been recommended by NICE for the treatment of severe alopecia areata in adults and children aged 12 and over.
Treatment with ritlecitinib is a one-a-day capsule that has been shown in clinical trials to reduce inflammation and hair loss at the follicle for up to two years, the final draft guidance says.
The NHS approval of the treatment for people aged 12 years and older comes after an initial rejection by the committee in September.
NICE said the position had changed after a public consultation, additional information from the drug manufacturer Pfizer and an improved discount on the cost of the medicine.
The list price of the drug is £949.41 per pack of 30 capsules but the details of the commercial agreement with the NHS is confidential.
In discussions, the committee noted there is no standard treatment for severe alopecia areata, and access to treatment varies widely. Hair loss can cause severe psychological distress.
Another JAK inhibitor, baricitinib, is licensed for severe alopecia areata in Great Britain but is not available for severe alopecia areata on the NHS, NICE said.
It is thought that up to 14,000 people with alopecia areata could benefit from the drug after the NICE recommendation.
Helen Knight, director of medicines evaluation at NICE, said: ‘Our committee heard how severe alopecia areata can have a significant impact on people’s health and quality of life.
‘I’m delighted that we are now able to recommend this innovative treatment, the first time a medicine for severe alopecia areata has been recommended by NICE for use in the NHS.
‘It is especially pleasing that we have been able to recommend ritlecitinib just 16 weeks after it was granted a licence by the Medicines and Healthcare products Regulatory Authority, demonstrating NICE’s commitment to getting the best care to patients fast.’
Sue Schilling, the chief executive of Alopecia UK, said the decision was a monumental day for those with the condition.
‘For far too long, patients with alopecia areata have gone without a licensed treatment option available via NHS pathways.
‘If new treatments are only available privately, it becomes a case of the “haves and the have nots”. This latest NICE recommendation will go some way to address this.’
But she said people with alopecia still face substantial barriers including difficulties in getting a dermatology referral from their GP, unacceptable dermatology waiting times, and even some NHS trusts making the decision not to allow dermatology appointments for alopecia patients.
She added: ‘There is no longer the excuse of there being no licensed treatment available. I urge key decision-makers within the NHS to keep referral pathways open for patients with alopecia areata.’
A version of this article was originally published by our sister publication Pulse.
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