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Press Releases

Take a look at a selection of our recent media coverage:

Third of patients in favour of AI-supported consultations and clinical documents, study finds

18th April 2024

Over a third of patients are in favour of clinicians using artificial intelligence (AI) in consultations to improve documentation processes such as clinical letters, according to a recent white paper from the Microsoft company Nuance.

Analysing survey responses from 13,500 participants from nine European countries plus the UK and Australia, the white paper explored patients’ recent interactions with clinicians and whether they believed AI would have helped to improve their experience.

The responses highlighted five main challenges that patients felt contributed to an unsatisfactory experience with their clinician: ineffective communication, excessive waiting times, lack of personalisation, insufficient continuity of care and limited accessibility to healthcare information.

An average of 40% of respondents felt that they didn’t receive their physician’s full attention during consultations because they were focused on their computer screens. Of those, 40% said that led to feelings of frustration. In the UK, this frustration peaked at 50% of respondents.

In order to improve this interaction, an average of 34% of respondents said they felt using AI to assist in the clinical documentation process would be a good idea, ranging from 27% in Norway to 48% in Spain.

When considering the age breakdown, respondents from younger age groups were more likely to agree AI would be beneficial. The percentage decreased with each age category from 43% of 18-to-24-year-olds to 26% of those aged 65 and over.

Although the patients surveyed had not yet had any personal experience with AI in healthcare, respondents chose freeing up time for the clinician as the most compelling reason to use AI, with an average of 45% and peaking at 55% for German respondents.

While the survey respondents broadly supported the use of AI, they also raised concerns about the use of AI in clinical settings, with 50% saying they were ‘somewhat concerned’. A further 32% were ‘not very concerned’ and 10% were ‘not concerned’.

The main cause for this concern was a lack of AI regulation at 34%, which increased to 46% in Germany and 48% in the UK. Medical information being recorded was also highlighted, with 17% recording this as a concern.

In response to this, the white paper stated: ‘The regulatory aspect of AI is changing all the time, with most governing bodies in our surveyed countries working on AI roadmaps and specific legislation.

‘Healthcare organisations should ensure they implement tools that are purpose-built for clinical environments to guarantee quality and safety, and that they clearly communicate the benefits to clinicians and patients.’

Writing in the white paper, Dr David Rhew, global chief medical officer and vice president of healthcare, at Microsoft, said: ‘With AI, we can pull together more information than ever before, extracting deeper insights into patient health and treatment options. We can accelerate and automate the workflows clinicians follow, and simplify the tasks that can draw their focus away from the patient. And we can tailor care pathways and treatments to the individual patient’s unique needs.’

The white paper also stated that ‘this total focus on the most meaningful part of their role – working directly with patients – supports clinicians’ professional satisfaction and reduces the likelihood of burnout’.

Earlier this year, the EU-funded METEOR Project highlighted widespread retention issues in Europe with 9% of doctors and nearly 14% of nurses declaring an intention to leave their profession, citing low job satisfaction, growing depersonalisation and emotional exhaustion as the primary factors.

And the recent NHS staff survey revealed that 65.56% of medical and dental staff were unable to meet all the conflicting demands on their time at work.

Previous research from Nuance in 2022 revealed that NHS healthcare professionals in acute, mental and community health settings were spending an average of 13.5 hours per week generating clinical documentation – a 25% increase since 2015.

Consultants were found to spend the longest on clinical documentation at 15.1 hours per week.

A further 3.2 hours per week were spent out-of-hours by healthcare professionals on this task, according to the research.

Some 68% of respondents said they felt it likely or very likely that their notes would be more complete if they had more time to complete them.

In an attempt to help free up doctors’ time to treat more patients and reduce waiting times, the NHS has recently announced the rollout of AI software at 10 trusts in England that aims to reduce missed appointments.

Telemedicine strategy post-acute coronary syndrome drives efficiencies and safety, study finds

17th April 2024

Supporting patients via telemedicine after experiencing acute coronary syndrome (ACS) can reduce emergency department attendance and prevent hospital readmission, according to a new study.

Published in the Journal of the American College of Cardiology and funded by the British Heart Foundation, the study involved 337 patients (86% men) who came to Hammersmith Hospital with ACS over 15 months and were randomly assigned to receive telemedicine or standard care on discharge.

The standard care group of 167 patients were discharged with medication and asked to go to their GP or hospital if they experienced any cardiac symptoms that caused concern.

The 163 patients in the telemedicine group were provided with a blood pressure monitor, a pulse oximeter and a 12-lead electrocardiogram belt device, along with training on how to use the technologies to measure their vital signs. They were told to send their vital signs to their specialist cardiology team if they identified results indicating a potential heart problem.

Using rules developed by the research team, cardiologists then performed a remote clinical assessment to determine the seriousness of the condition, with patients either being reassured, offered a non-urgent follow-up or advised to attend A&E or call 999.

Principal investigator Dr Ramzi Khamis, consultant cardiologist and BHF research fellow at the National Heart and Lung Institute, Imperial College London, said: ‘The approach we designed and tested is focused on sparing valuable time and resources while reaching a well-informed treatment plan for high-risk patients experiencing worrying symptoms.’

The primary outcome was time to first readmission at six-months, with secondary outcomes including emergency department visits, major adverse cardiovascular events and patient-reported symptoms.

The researchers found that the remote monitoring approach meant patients were 76% less likely to be readmitted to hospital within six months (hazard ratio [HR] 0.24; 95% confidence interval [CI] 0.13 to 0.44; p < 0.001) and 41% less likely to attend an emergency department (HR 0.59; 95% CI 0.59; 95% CI 0.40 to 0.89) compared to those receiving the standard care.

What’s more, patients supported via telemedicine had a 15% lower risk of repeat myocardial infarction after nine months, as well as fewer strokes and fewer unplanned coronary revascularisations (3% in telemedicine group versus 9% in standard therapy group).

The occurrence of chest pain (9% versus 24%), breathlessness (21% versus 39%) and dizziness (6% versus 18%) at six-months was lower in the telemedicine group compared to the standard care group.

For those who were readmitted to hospital, the average length of stay was half a day – a third of the average one and a half days in the standard care group.

The researchers concluded that remote monitoring after ACS could help to tackle pressure on health systems worldwide, and reduce emergency department and cardiology ward waiting lists.

Dr Khamis added: ‘The study clearly showed that sending vital information straight to cardiology teams, coupled with a consultation, led to seemingly better care, reductions in admissions, average length of stay and A&E attendance.

 ‘This simple strategy can potentially free up thousands of hospital beds and doctors’ hours across the country whilst keeping patients just as safe. We are now looking at working with the NHS and other healthcare systems globally to adopt this strategy and hopefully improve treatment for future patients.’

Earlier this year, an e-health programme for patients with high blood pressure, cardiac arrhythmias or heart failure was rolled out to patients at Amsterdam UMC’s Heart Centre to supplement their care and support cardiologists.

Previous research found that patients with heart failure who receive remote disease monitoring and consultations experienced short-term cardiovascular and mortality benefits.

International consensus statement on catheter or surgical ablation for atrial fibrillation published

16th April 2024

Treating atrial fibrillation with catheter or surgical ablation is the subject of a new international consensus statement presented at the recent European Heart Rhythm Association (EHRA) Congress 2024.

Also published in the journal EP Europace, among others, the consensus statement sets out best practice standards and defines a contemporary framework for the selection and preprocedural, procedural and postprocedural management of patients considered for, or undergoing, catheter or surgical atrial fibrillation ablation.

It outlines atrial fibrillation pathophysiology, anatomical considerations, evaluation and management of complications, training, and institutional requirements for atrial fibrillation ablation.

And it also highlights the importance of active and healthy lifestyles in reducing the risk of developing atrial fibrillation and to lower the number of recurrences.

The consensus statement was developed by the EHRA, a branch of the European Society of Cardiology which chaired the process; the Heart Rhythm Society; the Asia Pacific Heart Rhythm Society; and the Latin American Heart Rhythm Society.

Lead author Dr Stylianos Tzeis, head of cardiology clinic and electrophysiology and pacing department at the Mitera Hospital in Athens, Greece, noted that technological innovations have made catheter ablation safer and more effective than ever before, with pulsed field ablation and intracardiac echocardiography revolutionising the procedure.

He said: ‘Ablation is the most effective way to prevent recurrences of atrial fibrillation and delay progression to more advanced forms. Pioneering techniques have emerged since the previous consensus in 2017, requiring new advice on who should receive this procedure and how to perform it in the safest and most effective manner.’

The consensus statement emphasises that it ‘is not intended as a guideline’ but ‘aims to document the current expert consensus in the dedicated narrow field of catheter and surgical AF ablation’.

It adds: ‘Healthcare professionals should refer to the latest guidelines for overall structured management of [atrial fibrillation] patients.’

Best practice and the collaborative power of the multidisciplinary team in cardiology

From his base in Leeds, Dr Rani Khatib champions holistic, person-centred approaches and the collaborative power of the multidisciplinary team in cardiac care. Here, the newly appointed fellow of the European Society of Cardiology speaks to Allie Anderson about his innovative services that have enjoyed local, national and international acclaim, and how his own recent experiences as a patient have bolstered his professional work.

Dr Rani Khatib is a trailblazer in cardiology and cardiovascular pharmacy, achieving success locally and nationally through clinical work and research. As well as a consultant pharmacist in cardiology and cardiovascular research at Leeds Teaching Hospitals NHS Trust, he is visiting associate professor at the Leeds Institute for Cardiometabolic Medicine at the University of Leeds.

He has enjoyed acclaimed in Europe, too, sitting on cardiology allied professional groups for the European Society of Cardiology (ESC), and last year Dr Khatib was elected Fellow of the ESC in honour of his distinguished career.

‘It’s a huge recognition and becoming a Fellow of the ESC as a pharmacist rather than a cardiologist is an added bonus,’ Dr Khatib says. ‘The Society includes non-physicians as part of its structure because, simply, the care of patients with cardiology conditions requires input from multiple healthcare professionals.’

Dr Khatib embodies this multidisciplinary approach, not only contributing to but spearheading a number of pharmacy-led services at his Trust – and beyond. At their core are medicines optimisation and managing patient risk. ‘Cardiovascular disease is one of the biggest killers worldwide,’ he explains, ‘so there is a huge opportunity to ensure patients are on the right therapies and to optimise those therapies.’

Optimising medicines and adherence post-MI

Having noted suboptimal secondary prevention medicine (SPM) regimes and low adherence among myocardial infarction (MI) patients, Dr Khatib embarked on a project to ‘re-engineer’ post-MI care. Together with a consultant cardiologist, he established a post-MI multidisciplinary medicines optimisation clinic. Patients who had been hospitalised following an MI could see Dr Khatib, who is an independent prescriber, for a 30-minute consultation post-discharge to discuss any questions or problems they had with their medication.

He could manage patients autonomously but also escalate cases to the consultant cardiologist where necessary. ‘That was important because we worked together to identify the best set-up, so that we have access to each other, we work collaboratively, and we deliver what is best for the patients,’ Dr Khatib says.

Ahead of the clinic, patients were asked to complete a ‘My Experience of Taking Medicines’ questionnaire, known as MYMEDS. This self-reporting tool was designed to assess use of SMPs and to identify modifiable barriers – actual or perceived – to adherence. The completed questionnaire is a starting point for Dr Khatib to dig deeper.

‘It enabled patients to raise concerns about their medicines, whether that’s side effects or fitting medicines into their daily routine,’ he says. ‘Patients will often say “yes”, they remember to take their medicines, but if you have a further conversation using the MYMEDS tool, you might identify that they’re having problems swallowing the tablets so actually, they found taking them challenging.’ After identifying a barrier, Dr Khatib adds, he can work with the patient to overcome them.

The service was piloted between October 2015 and December 2016 among 270 patients. Optimisation of drugs improved significantly, with numbers of patients taking the recommended doses of ACE-inhibitors or ARBs increasing from 16.3% to 73.9%.

Patients reported significantly fewer concerns with their medications, non-adherence rates fell by up to 70.8% and readmission rates decreased.

Building on success to drive holistic cardiac care

In recent years, there has been a sharpened focus on holistic patient care and, with it, more emphasis on tackling multimorbidity. Patients with cardiovascular disease and type 2 diabetes have historically been managed by two distinct teams, but in Leeds, Dr Khatib spotted an opportunity to drive improvements in both specialties.

‘We identified that cardiology patients with type 2 diabetes were not necessarily receiving the best care,’ he says. ‘Newer diabetes medicines like SGLT2 inhibitors and GLP1 agonists also confer significant cardiovascular and renal benefits, so looking at the interplay between cardio-renal-metabolic seemed obvious.’

Dr Khatib established the CaReMe service, which streamlined cardio-renal-metabolic services into a ‘one-stop clinic’ for these comorbid patients. The consultant pharmacist-led clinic, supported by wider multidisciplinary teams, assesses patients six to eight weeks after an MI event.

It uses an adapted version of the MYMEDS tool – MYMEDS-Cardiometabolic – so as well as optimising medicines use and adherence, the consultant pharmacist provides a comprehensive review of the patient’s cardiovascular, diabetes and renal management needs. Such needs include key cardio-renal-metabolic biomarkers; analysis of risk factors; post-MI SPMs; and dietary, weight management and other lifestyle advice.

National adoption of best practice in cardiology

As well as improving patient outcomes, services like these highlight the crucial role of consultant pharmacists in multidisciplinary teams. They also create opportunities to expand input from appropriately trained senior pharmacists. Such initiatives free consultants to deliver other specialist services, thereby increasing capacity.

Moreover, Dr Khatib’s work has been taken further to not only reach patients in Leeds but nationally as well, notably with PCSK9 inhibitors. Designed to treat high cholesterol in patients who are not suitable for or poorly controlled on other lipid-lowering therapies, PCSK9 inhibitors are underused in optimising lipid management according to Dr Khatib.

‘We are always trying to improve access to innovative medicines, and bring what pharmacy can offer into the patient pathway to forward the cardiovascular agenda,’ he comments. ‘So, to improve access to these drugs, we set up another pharmacist-led, multidisciplinary clinic.’

Established in 2017, the clinic – the only service that was prescribing PCSK9 inhibitors in the Leeds area – also provides patient support, education and monitoring to promote adherence, as well as tackling statin intolerance.

The service proved successful and has yielded significant improvements in patients’ total and LDL cholesterol levels that are maintained at 12-month follow-up. It was deemed cost-effective and patient feedback was positive.

Furthermore, the project caught the attention of stakeholders at the Accelerated Access Collaborative (AAC), a UK-wide initiative aimed at extending access to high-quality healthcare, through improving uptake of the best treatments, for example. Harnessing his experience delivering the pharmacy-led service, Dr Khatib worked with NHS England and the AAC to develop a NICE-endorsed national lipid management pathway and the statin intolerance pathway.

‘Our model, uniquely, established a centralised service run by a consultant cardiology pharmacist and advanced cardiology pharmacists. We offered a vehicle for these medicines to be prescribed and demonstrated that lipid optimisation doesn’t have to be managed only by lipidologists,’ Dr Khatib explains. ‘We need to tap into the pharmacy profession more, and through collaboration with cardiology and lipidology colleagues the patient receives the best care, and the pharmacist is well-supported to deliver it.’

Patient-centricity as a priority

Dr Khatib believes that person-centred care must underpin every aspect of pharmacy. ‘As much as we talk about it, it’s often missed because it’s not as easy to apply as we think,’ he comments. However, being on the other side of the patient-clinician partnership has given Dr Khatib a broader understanding of the dynamics.

Having contracted Covid-19 in November 2020, he spent seven months in hospital in what he describes as ‘a terrible ordeal’ that caused multiple organ failures and cardiac arrests. This left him with extensive deconditioning and multiple morbidities – all of which he has documented in a Journal of Cardiac Failure editorial. His book with full reflections and lessons about this experience will soon be published.

‘I continue to live the patient experience and it has opened my eyes to a lot of things you only see as a patient, and not as a healthcare professional,’ he says, adding that it gives him a fresh perspective on patient need when it comes to multidisciplinary working.

‘Often patients said they preferred to see a cardiologist because they felt they’re more likely to get a rounded view, rather than just a medicines-focused discussion, which triggered something in my mind: we need to change the way we do pharmacy-led clinics to a more patient-centred approach,’ he explains.

This requires what Dr Khatib calls a ‘zoom out’ mindset, aided by tools like MYMEDS to support a holistic view. ‘So, when patients tell me about their experiences, I am ready to hear about their anxiety, their challenges going back to work, or how they’re getting on with lifestyle modifications,’ he comments. ‘I may not be able to solve those problems, but I can be considerate of them.’

In that way, Dr Khatib believes, pharmacy-led services can tick patient-centricity boxes while also helping to improve adherence and outcomes. He concludes: ‘I believe this is a better way of delivering the medicines optimisation concept.’

GLP-1 receptor agonists not linked to suicidal thoughts, PRAC concludes

15th April 2024

Available evidence does not support a causal association between glucagon-like peptide-1 (GLP-1) receptor agonists and suicidal and self-injurious thoughts and actions, according to the European Medicine Agency (EMA)’s Pharmacovigilance Risk Assessment Committee (PRAC).

This conclusion follows a review into GLP-1 receptor agonists starting in July 2023 after receiving case reports from the Icelandic medicines agency of suicidal thoughts and thoughts of self-injury from people using liraglutide and semaglutide.

At the time, the EMA said it was ‘not yet clear whether the reported cases are linked to the medicines themselves or to the patients’ underlying conditions or other factors‘.

The PRAC review has since included the results of a recent real-world cohort study looking at the association of semaglutide with risk of suicidal ideation.

Based on a large database of electronic health records, it investigated the incidence of suicidal thoughts in patients with overweight and type 2 diabetes mellitus treated with semaglutide or other non-GLP-1 receptor agonist medicines for diabetes or overweight.

The study found no causal association between the use of semaglutide and suicidal thoughts.

The EMA conducted a separate study based on electronic health records. This examined the risk of suicide-related and self-injury-related events in people with type 2 diabetes mellitus and found no causal association between the use of GLP-1 receptor agonists and this risk.

The PRAC also considered additional data from the marketing authorisation holders for semaglutide (brand names Ozempic, Rybelsus and Wegovy), liraglutide (brand names Victoza and Saxenda), degludec/liraglutide (brand name Xultophy), exenatide (brand names Byetta and Bydureon), lixisenatide (brand name Lyxumia), glargine/lixisenatide (brand name Suliqua), and dulaglutide (brand name Trulicity).

After reviewing the available evidence from non-clinical studies, clinical trials, post-marketing surveillance data and the available studies the PRAC announced that no update to the product information is warranted.

It added that close monitoring by the marketing authorisation holders is required and any new evidence on the issue must be reported.

This mirrors a similar conclusion from the US FDA in January 2024, in which it stated: ‘Our preliminary evaluation has not found evidence that use of these medicines causes suicidal thoughts or actions.‘

Passive smoking linked to increased risk of atrial fibrillation, new study finds

Any level of passive smoking universally elevates the risk of atrial fibrillation, according to new research presented at the recent European Heart Rhythm Association Congress 2024.

The researchers examined the association between secondhand smoke exposure and the long-term risk of incident atrial fibrillation, aiming to add to existing research that has established links between passive smoking and coronary artery disease and premature death.

They found a dose-dependent relationship between passive smoking duration and atrial fibrillation risk, with each increase in the duration of weekly passive smoking linked with an even greater risk of atrial fibrillation.

The study included 400,493 adults aged 40-69 years (55.2% women) who had used the NHS for any reason and were enrolled in the UK Biobank. Current smokers and those with atrial fibrillation at baseline were excluded from the study.

A touchscreen questionnaire was used to ask participants the number of hours they had been exposed to other people’s smoke in a typical week over the past year at home and in other environments.

Participants were then categorised into the ‘exposed group’ if they had any contact with secondhand smoke and the ‘non-exposed group’ if they had no contact with secondhand smoke.

Some 85,984 (21%) participants had been exposed to secondhand smoke in the previous year, with an average exposure of 2.2 hours per week. During a median follow-up of 12.5 years, atrial fibrillation developed in 23,471 (6%) participants.

After adjusting for factors that could potentially affect the relationship, the group exposed to secondhand smoke had a 6% higher risk of incident atrial fibrillation during follow-up compared with the non-exposed group (hazard ratio 1.06, 95% confidence interval 1.03–1.10, p <0.001).

A dose-dependent relationship was observed, with 7.8 hours of passive smoking per week associated with an 11% higher likelihood of the heart rhythm disorder compared with no passive smoking.

The risk of atrial fibrillation for passive smokers was found to be raised in homes and workplaces as well as in outside spaces.

‘According to our study, once exposed to secondhand smoke, the likelihood of developing atrial fibrillation begins to increase, with the risk escalating significantly as the exposure time lengthens,’ said study author Dr Kyung-Yeon Lee of Seoul National University Hospital, Seoul, Republic of Korea.

‘The dangers of secondhand smoke were significant regardless of whether individuals were at home, outdoors or at work, indicating that exposure universally elevates the risk of atrial fibrillation.’

The authors said the results highlight the importance of smoking bans to protect public health and Dr Lee added that everyone should ‘make every effort to avoid spending time in smoky environments’.

He also urged policymakers to take note and ‘further curb smoking in public areas and support smoking cessation programmes to improve public health’.

In March 2023, the Federation of the Royal Colleges of Physicians in the UK warned of ‘significant and avoidable’ demand on NHS due to socio-economic inequalities, which included the impact of smoking.

Last year, questions were raised over whether the risk of atrial fibrillation increased with fish oil supplementation.

Type 2 diabetes drug lixisenatide shows potential in slowing Parkinson’s disease progression

The glucagon-like peptide 1 receptor agonist (GLP-1 RA) lixisenatide, commonly used to treat type 2 diabetes, may slow the progression of Parkinson’s disease symptoms, research suggests.

Investigators evaluating lixisenatide reported less progression of motor disability over a 12-month period in patients taking the drug compared with placebo.

But writing in the New England Journal of Medicine, they said lixisenatide was associated with gastrointestinal side effects in the phase two study and longer and larger trials are now needed to determine the impact and safety of the drug.

It is the second trial of a GLP-1 RA diabetes drug to show an effect in Parkinson’s disease with a 2017 study reporting improvement in motor symptoms in patients taking exenatide.

A larger phase three trial of exenatide, led by UK researchers, is due to report later this year.

The latest study enrolled 156 people with early Parkinson’s disease and no motor complications. All of the patients were taking their usual medication, but half also had a daily injection of lixisenatide and half were given a placebo.

After a year, those given lixisenatide showed no progression of motor problems while those on placebo dropped around three points on the assessment scale – classed as a moderate difference but likely to be clinically meaningful.

The difference was still apparent two months after the trial stopped, the researchers said, suggesting a neuroprotective effect.

Gastrointestinal side effects occurred in more than half the participants receiving lixisenatide, and often led to the dose of the drug being halved, but nausea did not appear to be associated with the magnitude of effect of the drug, they said.

The UK researchers said the study was important given it supports what had previously been found with exenatide.

Professor Tom Foltynie, professor of neurology, at the University College London (UCL) Queen Square Institute of Neurology, said: ‘This cumulative clinical data therefore strongly supports the earlier laboratory and epidemiological data, that GLP1 receptor stimulation in the brain has neuroprotective effects relevant to the neurodegenerative processes of Parkinson’s disease.’

But he said the beneficial effects are likely to be restricted to those GLP1 receptor agonists that can cross the blood-brain barrier which ruled out liraglutide and semaglutide.

Yet it is still not clear whether the drugs simply improve dopaminergic signalling to provide symptom relief or have a neuroprotective effect.

‘Phase 3 trial data of the effects of two years exposure to exenatide in patients with Parkinson’s disease will hopefully address this question and will be available in the second half of 2024,’ Professor Foltynie added.

Professor Masud Husain, who co-leads the dementia research team at the University of Oxford, said the results around lixisenatide were ‘really encouraging‘ for people with Parkinson’s disease.

‘However, the findings do not provide conclusive evidence that the drug has a protective effect on the brain to effectively slow down disease progression. We also have to bear in mind the side effects. Nausea occurred in nearly half and vomiting in 13% of people on the medication.’

Last summer, machine learning models accurately predicted sub-types of Parkinson’s disease based on images of patient-derived stem cells.

A version of this article was originally published by our sister publication Pulse.

NICE recommends tisagenlecleucel for eligible patients with acute lymphoblastic leukaemia

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.’

Improved overall survival with tisagenlecleucel

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.

First oral drug for chronic and episodic migraine prophylaxis gets NICE go-ahead

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’.

Atogepant indication

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.‘

Efficacy and tolerability of atogepant

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%).

More choice for people with chronic migraine

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.

Explore the latest innovations in respiratory care at HHE’s latest Clinical Excellence event

11th April 2024

Kicking off on 1 May 2024, Clinical Excellence in Respiratory Care is a one-day event for the multidisciplinary team exploring the latest advances in respiratory – and registration is now open.

Back for a second year, the Clinical Excellence events series brings together renowned experts from recognised Centres of Excellence and other UK and European hospitals to share their experiences of clinical innovations, examples of best practice and how they are improving patient care.

This year’s spring respiratory care offering has been developed by the team at Hospital Healthcare Europe and Hospital Pharmacy Europe with guidance from industry experts, including event chairs John Dickinson, professor in sport and exercise sciences, head of exercise respiratory clinic at the University of Kent, England, and Garry McDonald, respiratory pharmacist at University Hospital Crosshouse, Scotland.

Topics include diagnostic imaging innovations, what healthcare professionals need to know about occupational lung disease, recognising and managing tuberculosis and respiratory infections, critical care in respiratory medicine and the move towards personalised medicine and updates on targeted therapies.

The work of the multidisciplinary team is a theme running throughout the event, focusing on how respiratory physicians, surgeons, pharmacists, nurses and members of the wider clinical team can effectively and efficiently work together to provide better outcomes for patients.

The event is free to attend and comprises individual presentations, panel discussions and sponsored sessions delivered virtually live and on-demand, all tailored to provide maximum convenience and work around your busy schedule.

Pick and choose sessions most relevant to your clinical practice, specifically tailoring the day to your needs, and gain CPD hours from the comfort of your computer.

With a whole host of fascinating insights and inspiration for improving patient care, it’s not to be missed. Register now to join us on 1 May and on demand.

Don’t forget to check out Hospital Healthcare Europe’s respiratory Clinical Excellence section, brimming with content including interviews with prominent physicians to complement the event’s offering.

More Clinical Excellence events are in development for respiratory care and other specialities, which will be launching throughout 2024 – watch this space.