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Press Releases

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

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.

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.

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

12th April 2024

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.

In conversation with consultant rheumatologist Professor Paul Emery

10th April 2024

Professor Paul Emery’s illustrious career has seen him influence diagnostics and treatment interventions for rheumatoid arthritis (RA) and improve patient outcomes across the globe. Here, he speaks to Helen Quinn about his career trajectory – including his recent CBE – how best practice has evolved in RA and his hopes for the future of the disease.

It is not an exaggeration to say that Professor Paul Emery has revolutionised the field of rheumatology. His pioneering research has changed not only treatment pathways and clinical outcomes but also the way clinicians think about rheumatoid arthritis (RA).

Throughout his career, Professor Emery has championed strategies for early intervention, pioneered biologic therapies for inflammatory conditions and developed the use of imaging techniques in the musculoskeletal field to prevent or slow the progression of RA. His research and clinical work have led to new treatment interventions which have been adopted worldwide, ultimately allowing patients to live without pain for much longer.

Since 1995, Professor Emery has been Versus Arthritis UK (formerly ARC) professor of rheumatology at the University of Leeds and was director of the Leeds NIHR Biomedical Research Centre from 2009-22. He has published over 1,250 peer-reviewed research articles, and in January 2024, he was appointed Commander of the British Empire (CBE) in the King’s New Year Honours for his outstanding contribution to rheumatology.

From his office in Leeds, Professor Emery says he was delighted but taken aback to be awarded the CBE – following his OBE in 2018 – which recognised his work in the UK and internationally. ‘One of the things I like is that I was given it for services to rheumatology, which is rather unusual. I’m quite proud of that. I was very surprised,’ he explains.

Making waves in rheumatology

Professor Emery studied at the University of Cambridge, and for the first five years of his career, he practised general medicine, mainly at Guy’s Hospital and at the Royal Brompton Hospital in London. For a year he ran the intensive therapy unit at Lewisham Hospital, which he believes served him well for a career in rheumatology as it involves treating many systemic diseases.

‘I think it was a great help,’ he recollects. ‘I was lucky that I did a great deal of medicine, so I had experienced nearly all the specialties.’

Rheumatology appealed to him because of all the unanswered questions. ‘Compared to other specialties, you had so much freedom to do things because it was a relatively new speciality, and no one had devised protocols or algorithms of how to treat things. You could look at everything from afresh and first principles,’ he says. 

After two years in Australia as head of rheumatology at the Walter and Eliza Hall Institute and a consultancy post at the Royal Melbourne Hospital, he returned to the UK in 1987 to become a senior lecturer at the University of Birmingham. Here, he began his research into early intervention and began to make waves in rheumatology, which would fundamentally change how the disease is treated and understood.

Prevention of disability through research

Professor Emery says his ‘obsession’ was to treat patients before they developed a disability. ‘Our mission statement was actually prevention of disability through research,’ he says.

To improve patients’ lives and treat early, the referral system for RA required a huge overhaul. Professor Emery set to work in Birmingham. Every three months, he would write to over one thousand GPs to convince them to refer RA patients earlier so the disease could be prevented or at least held back. Usually, patients with inflammatory arthritis would only see a specialist after suffering for years with the disease, and by this point, there was much less that could be done to help them.

‘There was this huge inertia initially. It was very difficult to convince GPs it was worth referring patients urgently to a rheumatologist because they just thought rheumatologists can’t really diagnose them. And even if they can, they can’t treat them, so what’s the point of urgent referral,’ Professor Emery recalls.

Today, clinicians around the world use a standard clinical assessment developed by Professor Emery and his team to refer RA patients at the earliest stage possible. At specialist early arthritis clinics, patients are then assessed and, where appropriate, biomarkers are used to predict how their condition will develop.

Imaging innovations in RA

Early intervention was, in part, made possible by the development and advancement of imaging techniques. With his colleagues in Leeds, Professor Emery set out to make imaging part of the RA treatment pathway. And, despite being told by ultrasound (US) manufacturers that there was no future for musculoskeletal ultrasound, he persisted.

‘They couldn’t see what it was going to do,’ he says. ‘They hadn’t spoken to anyone who was trying to treat or cure rheumatoid arthritis.’

Professor Emery eventually persuaded an American company to give him a machine, which he brought back to the UK and began researching the use of US in RA.

As he anticipated, US and magnetic resonance imaging (MRI) proved to be much more sensitive than conventional X-rays since clinicians can non-invasively detect any swelling inside the joint, something Professor Emery notes is incredibly difficult to do without imaging at an early stage of disease. X-rays measure structural changes as a result of past inflammation, whereas US and MRI measure both structural damage and current inflammation. Thus, X-rays are historical whereas US and MRI are predictive of the future, he says.

After leading a targeted US initiative (TUI) in 43 countries, ultrasound is now routinely used in most arthritis clinics around the world to predict patient outcomes. Professor Emery and his team have also introduced MRI to examine bone abnormalities alongside ultrasound imaging for tissues.

‘These imaging modalities are diagnostic at the start of the disease,’ he says. ‘They’re used for assessment and MRI in particular can be used for understanding pathogenesis. If you find subclinical synovitis on ultrasound or MRI, you can tell which [patients] will progress.’

Remission as the outcome of choice

Early diagnosis and aggressive treatment of the disease meant that, for the first time, the disease could be put into remission with a complete suppression of synovial and systemic inflammation. This turned treatment on its head. In the past the aim had been to simply treat symptoms as they emerged to reduce or manage pain.

The Leeds-based research team led the first international trials of anti-TNF therapy using monoclonal antibodies with very early disease and showed that biologic therapy could induce remission in patients. Professor Emery’s research has resulted in remission being accepted as the outcome of choice for patients with an early diagnosis.

One of his biggest challenges today is not getting enough patients into long-term remission and not targeting the patients in most need in the early stages of RA, despite the research providing evidence of best practice.

‘We still don’t see patients early enough, and we’re not allowed by NICE to necessarily use the best drugs at the earliest moment,’ he says. He believes 70-90% of RA patients could be put into long-term remission from the current research findings. A RCT of personalised medicine with biologiscs has just been completed at Leeds, which hopefully influence this issue, he says.

Working collaboratively with different specialties has been essential in both Professor Emery’s research and clinical work. In his clinics, he works with neurologists, immunologists, respiratory physicians, renal pysicians, cardiologists and dermatologists and he’s the first to admit that this multidisciplinary approach has enhanced his practice. ‘I’ve learned more from other specialties than I do from my own speciality, and I think they do as well,’ he says.

Professor Emery hopes his continued research will move the field even further, and he’s keen to work with colleagues in other specialities to support this. He finds running research ideas by them particularly beneficial.

The road to RA prevention

In the last decade it has been realised that RA is the end point of a continuum. RA patients go through a ‘pre-clinical’ phase characterised by autoimmunity, with or without subclinical joint and systemic inflammation, and thus, RA is initially a systemic disease. Furthermore, the first musculoskeletal involvement frequently is not the joint but the tendon and, specifically, peritendon of the interossei.

For the last 17 years Leeds has run a national study of individuals at risk of RA. ‘We’ve developed, probably, the most definitive risk score, so we can very accurately tell GPs which at-risk patients to refer,’ Professor Emery explains. ‘We’ve got very accurate predictors now of not only who will get rheumatoid arthritis, but when.’

The Leeds team is currently involved in a prevention study examining how a patient’s gene expression affects the efficacy of medications. The next steps, Professor Emery says, will be to identify those with gene expression abnormalities and tie them to a specific drug, identifying individual groups of patients for particular treatment regimens.

Prevention of RA is the ultimate goal. ‘We don’t cure the patients, we don’t prevent it – or we haven’t until now,’ he says. ‘I never thought we’d get to prevention. That’s what I wanted to do the first day I saw a rheumatoid patient, to try and prevent it, and that was a long, long time ago. It’s only now that people are waking up to the fact that this is possible, and I think in the next few years it’ll become a routine process.’

Consultant strikes end as pay package accepted alongside reform of pay review body

5th April 2024

Consultants in England have voted to accept the Government’s latest pay offer and put an end to recent strikes, with 83% voting in favour of the revised package (turnout 63%) on behalf of the profession.

The accepted pay offer represents an improvement on the offer that was rejected by consultants in January. It includes reform of the consultant pay scale backdated from 1 March 2024, reducing the time it takes to get to the top, which aims to reduce the gender pay gap in medicine. A 2.85% (£3,000) uplift for those who have been consultants between four to seven years was also agreed.

This offer is in addition to the 6% pay uplift awarded during the Review Body on Doctors’ and Dentists’ Remuneration (DDRB)’s process last summer and is separate to the pay award following the outcome of the review body process for 2024/25.

The deal also includes the reform of the DDRB, which advises the Government on rates of pay for doctors and dentists.

Changes, which will be implemented from next year, will include greater involvement from unions in the process of appointing to the DDRB, considering ‘long-term trends’ and changes to doctors’ pay over the years, and that the Government will not be able to ‘constrain’ its remit with reference to inflation and economic evidence.

Commenting on the agreement, the British Medical Association’s consultants committee chair Dr Vishal Sharma said it is ‘the end of the beginning’ in consultants’ efforts to restore their pay to 2008 levels as there is ‘still some way to go’ to achieve this.

‘The last year has seen consultants take unprecedented strike action in our fight to address our concerns about pay and how the supposedly independent pay review process was operating,’ Dr Sharma said.

‘After years of repeated real-terms pay cuts, caused by government interference and a failure of the pay review process, consultants have spoken and now clearly feel that this offer is enough of a first step to address our concerns to end the current dispute.’

He also stressed that it is ‘imperative’ for the DDRB to utilise its independence to restore doctors’ pay and prevent future pay disputes.

Chief executive of NHS Confederation, Matthew Taylor, said NHS leaders would ‘breathe a sigh of relief’ at the news of the pay deal.

‘The health service relies heavily on its consultant workforce and these professionals have helped to keep the most life-critical services afloat including over the difficult winter period and the recent junior doctors’ walkouts,’ he said.

However, he warned the NHS would still face the impact of further junior doctor strikes, after 98% voted earlier this year to continue industrial action between April and September after no pay deal was reached.

‘While NHS organisations have worked tirelessly to fill rota gaps and keep patients safe, more than 1.4 million appointments and operations have been cancelled over the last year of industrial action, with even more patients joining waiting lists,’ Mr Taylor said.

‘This [pay] agreement between the BMA consultant committee and Government shows that a sensible middle ground can be reached through negotiations, and we urge the BMA junior doctors committee and Government to quickly re-enter negotiations to reach a similar agreement to stop further damaging strike action by junior doctors.’

Sir Julian Hartley, chief executive, NHS Providers, added that the consultant pay deal was ‘welcome’ news, but that ‘we aren’t out of the woods yet’.

‘Hugely disruptive and costly strikes in the NHS can’t become “business as usual”,’ he said. ‘Remaining concerns must be resolved. Industrial action takes a toll on patients, staff and stretched services. We urge politicians and unions to find a way to end all disputes.’

In January 2024, NHS England issued post-strike priorities to reduce elective long-waits and meet cancer 62-day backlog targets following this month’s strike action.

And in March, NHS 2024/25 priorities and operational planning guidance set an overall priority for the NHS in England over the next 12 months as the ‘recovery of core services and productivity following the Covid-19 pandemic’ continues.

A version of this article was also published by our sister publication Healthcare Leader.

Cladribine indication expansion to allow for earlier treatment in MS

4th April 2024

Cladribine tablets (brand name Mavenclad) have been granted a label extension by the Medicines and Healthcare products Regulatory Agency (MHRA) to expand access for additional patient populations with multiple sclerosis (MS), its manufacturer Merck has announced.

It is now indicated for the treatment of adult patients in Great Britain with relapsing forms of MS with active disease as defined by clinical or imaging features.

The expanded label means more newly diagnosed patients will be eligible for treatment with cladribine earlier in their disease course. Since 2017 it has been approved for use in patients with highly active relapsing MS as defined by clinical or imaging features.

Its latest approval makes cladribine the only short-course oral treatment for active relapsing MS available in Europe.

Cladribine tablets, which can be taken at home, are taken for a maximum of 20 treatment days in each of years 1 and 2 with no further treatment required in years 3 and 4.

This low administrative burden can offer advantages to a patient’s quality of life over other types of MS treatment, which can require drugs to be administered via regular self-injections, as an infusion in hospital, or as daily tablets, Merck said.

Speaking about the approval, Dr Wallace Brownlee, consultant neurologist and multiple sclerosis specialist, said: ‘The expansion of the label for cladribine tablets could improve patient outcomes and quality of life for many MS patients with active relapsing MS in Great Britain by allowing us to use cladribine tablets earlier in the treatment pathway.

‘This will be the first high-efficacy oral short-course treatment to be available for this patient group in Europe and could provide clinicians with an additional treatment option which also provides patients with treatment which has a low monitoring and administration burden.’

This approval by the MHRA follows a robust review of the current evidence around the benefit-risk profile of cladribine tablets for this patient group. The pre- and post-approval studies considered in the review included:

  • The CLARITY (Cladribine Tablets Treating MS Orally) study
  • The CLARITY extension study
  • The ORACLE MS (Oral Cladribine in Early MS) study
  • The ONWARD (Oral Cladribine Added ON to Interferon beta-1a in Patients with Active Relapsing Disease) study
  • The PREMIERE (Prospective Observational Long-term Safety Registry of Multiple Sclerosis) study

The review concluded that there is a favourable benefit-risk profile to warrant use in this wider population.

Dr Doina Ionescu, managing director of Merck Healthcare UK and Ireland, said: ‘We know from our long history of working in the field of MS that there is still an unmet need for many patients to have access to a high-efficacy oral treatment which can be used early in the course of the disease.

‘Since the NICE approval in 2017, cladribine tablets have treated globally over 80,000 patients which has been supported by data from both our pivotal studies and real-world evidence we have shared. More patients could benefit from cladribine tablets than before, so we look forward to applying for NHS reimbursement with urgency.’

Hospital trusts now require ‘designated lead‘ to improve primary-secondary care interface

Every hospital trust will be required to have ‘a designated lead for the primary-secondary care interface’ and integrated care boards asked to ‘regularly review progress’, according to NHS England’s newly published ‘2024/25 priorities and operational planning guidance’.

Delayed since December due to funding discussions, the guidance sets an overall priority for the NHS in England over the next 12 months as the ‘recovery of core services and productivity following the Covid-19 pandemic’ continues.

According to the guidance, streamlining the patient pathway by improving the interface between primary and secondary care is ‘an important part of recovery and efficiency across healthcare systems’.

By introducing a designated lead for the primary-secondary care interface, it is hoped that trusts will deliver on the four key areas set out in the access to primary care recovery plan and endorsed by the Academy of Medical Royal Colleges: onward referrals, complete care (fit notes and discharge letters), call and recall and clear points of contact.

Commenting on this interface, David Wiliams, head of policy and strategy at NHS Providers, said his organisation is already ‘seeing the advantages’ of leaders of NHS trusts and local health systems ‘working closely with primary care partners to improve how they cooperate to benefit patients’.

And he said this was ‘playing out in a variety of ways as system working matures and care pathways are being transformed, often at a very local level’.

He added: ‘Designated primary care leads will be welcome support in the drive to achieve closer working, but given the pressure of day-to-day operations, trusts and primary care providers will need national support to focus on the long-term to deliver further improvements.’

Improving care, discharge and waiting times

Improving emergency department waiting times compared to 2023/24 is another core focus of the planning guidance, with a target for A&E staff of a minimum of 78% of patients being seen within four hours in March 2025.

The Royal College of Emergency Medicine (RCEM) had described a previous target of 76% of patients being seen within four hours as ‘unambitious’. On the latest target, RCEM president Dr Adrian Boyle said the ‘small percentage improvements in four-hour access performance are difficult to endorse when there are so many people waiting for 12 hours or longer’.

He also highlighted the incentive scheme for major emergency departments that ‘achieve the greatest level of improvement’ and/or are able to see 80% of patients within four hours outlined in the planning guidance as being ‘potentially divisive’ and uneconomical.

‘We would prefer a quarterly approach to incentivise improved performance, perhaps using the Commissioning Quality Incentive payment system,’ he said.

Dr Boyle did, however, welcome the planning guidance focus on bed occupancy, saying: ‘It is critically important to reduce the dangerous occupancy levels we are currently seeing.’

Dr Boyle noted NHS England data showing that total bed occupancy levels in hospitals across the country reached 95.1% on 20 March 2024.

He said: ‘Overcrowding and patients who are technically ready to go home but haven’t got the right care provision in place, is really adding to the delay problems faced by ambulance staff and we need to ensure that staff in Emergency Departments are able to offer patients the care that they deserve.

“Bed occupancy is still too high and seems to be increasing which is not a good sign that any improvement in that area is forthcoming.’

Nevertheless, the planning guidance outlines an ambition to reduce the number of patients who are still in hospital beyond their discharge-ready date, as well as the length of delay.

It is hoped that continuing to develop services that shift activity from acute hospital settings to settings outside an acute hospital for patients with unplanned urgent needs, supporting proactive care, admissions avoidance and hospital discharge will also be of benefit, the guidance said.

Other priorities outlined in the planning guidance include reaching a 77% faster diagnosis standard (FDS) target for cancer this year as an interim step toward meeting the target of 80% by March 2026, reducing Category 2 ambulance response times to an average of 30 minutes across 2024/25, as well as improving the working lives of all staff and increasing staff retention and attendance through systematic implementation of all actions and best practice made available through the NHS retention hub.

’Floor not ceiling of ambitions’

Acknowledging that many of these ambitions will be ‘stretching’ and require ‘a relentless focus on improvement, fewer delays and unnecessary processes’, NHS chief executive Amanda Pritchard said the guidance ‘should be seen as the floor, rather than the ceiling, of our collective ambition to be a better and more responsive employer’.

Royal Colleges and NHS partner organisations have expressed concerns about how this will work in practice.

Looking at the guidance as a whole, Matthew Taylor, chief executive of the NHS Confederation, called the ambitions ‘very challenging for the health service’.

‘We are concerned that the NHS is entering the new financial year in a worse underlying position, with the risk of further strike action over the next six months… compounded by the financial crisis facing many local councils.’

He also criticised the timing of the publication, saying that while the Confederation understood the impact the wider political context is having on long term decision making, ‘we need to get back to a position where the planning guidance is released months and not days ahead of the new financial year’, and that ‘this short-term approach risks holding back the NHS and with it, the wider health and care system’.

Also picking up on the strikes, Sally Warren, director of policy at The King’s Fund, warned that the plan is ‘built upon an assumption that there will be no industrial action throughout the year despite the fact negotiations are still ongoing’.

She added: ’This means it’s quite possible the Government will need to step in to find additional funding if industrial action continues or new pay deals are agreed, assuming it wants the NHS to deliver on the expectations and targets that have been set out.’

Research grants for patient safety and workforce wellbeing topics open for applications

2nd April 2024

The MPS Foundation is inviting healthcare professionals to register their interest and submit proposals for research grants focusing on patient safety and the wellbeing of healthcare professionals and teams, both medical and dental.

Applications for the grants – which are worth £5,000 to £200,000, or equivalent in local currency, depending on the scale, focus and duration of the proposal – are open to both Medical Protection Society members and non-members from countries including the UK and Ireland.

To be eligible, the research projects must be academically robust, evidence-based and address the MPS Foundation’s key research priorities, including:

  • The impact of human factors on patient safety, outcomes and risk
  • The impact of processes and delivery modes on patient safety, outcomes and risk
  • The personal and professional wellbeing of healthcare professionals and teams
  • The impact of digital integration and technology on patient safety, outcomes and risk
  • The impact of the effectiveness of teaching and learning innovations upon patient safety, outcomes and risk.

Dr Graham Stokes, MPS Foundation chair, said: ‘We are delighted to launch our third grant programme to support research projects on patient safety and the wellbeing of healthcare professionals. Funding for research in this area has been limited but our grant programmes have been changing that. Projects that we have supported in previous years have shown great success in promoting best practise and wellbeing across several countries.‘

He added: ‘Our aim is simple: to fund research that improves safety for patients and the wellbeing of healthcare teams.

‘If you have a research project that you think is suitable, register your interest and join our growing community of grant recipients. I strongly encourage healthcare professionals to consider applying for support whatever the scale of the proposal and to make the most of the additional resources available to support applicants this year.’

Applicants can register interest for the grants and apply via the MPS Foundation online grant portal, which also includes a guide for applicants, frequently asked questions and tips on creating a good application.

Calls for expressions of interest are open until 5pm BST on 3 May 2024.

Projects awarded MPS Foundation funding in 2023 included a study aimed at improving safety in gastrointestinal endoscopy, research examining the effects of patient suicide on clinicians, and a project to better understand the role patients’ relatives play in ICU decisions and how the Mental Capacity Act can lead to better outcomes for patients, families and healthcare professionals.

The MPS Foundation is part of the Medical Protection Society – an organisation that aims to protect and support the professional interests of more than 300,000 doctors, dentists and healthcare professionals across the UK, Ireland, South Africa, New Zealand, Australia, Hong Kong, Singapore, Malaysia, the Caribbean and Bermuda.

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