Biologic therapy drugs (reslizumab, benralizumab, mepolizumab and omalizumab) can improve symptoms and reduce asthma attacks in people with severe asthma by helping to stop the body processes that cause lung inflammation.
Biological therapies can transform people’s lives by reducing long-term side effects of oral corticosteroids and can also reduce the number of exacerbations and life-threatening asthma attacks. The aim of this innovation will be to improve patient care and outcomes by providing a better treatment option for patients with severe asthma.
Severe asthma is a subtype of asthma that is difficult to control and categorised by the fact that it does not respond well to typical asthma treatments1. By conservative estimates, severe asthma affects approximately 5-10% of people with asthma worldwide2. People with severe asthma also have more frequent life-threatening asthma attacks, which can have a devastating impact on their lives3. The struggle to breathe can be a day-to-day challenge that overshadows daily activities, resulting in hospital admissions, intensive care and even death(3, 4). Severe asthma also accounts for the majority of health care expenditures associated with asthma; with the relatively small severe asthma patient population estimated to be 50% of all asthma-related costs5.
Compared with patients with milder controlled disease, patients with severe asthma also experience adverse effects from treatments that are used to manage asthma attacks. If oral corticosteroid treatments are used long term, the resulting adverse effects may include weight gain, diabetes, osteoporosis, glaucoma, anxiety, cardiovascular disease, and impaired immunity10. Asthma UK reports that patients “loathe” these treatments and that the substantial adverse effects are a significant reason they do not comply with their prescribed medications, which puts them at risk of experiencing a future asthma attacks(3, 8) .
Guidelines recommend that patients with severe asthma be referred to a specialist respiratory team for correct diagnosis and expert management. This is particularly important to ensure that they have access to newly available biologic treatments. However, many patients with severe asthma can suffer multiple asthma attacks, admission to emergency departments and a wait of up to seven years experimenting with different treatment options before they are diagnosed or referred for specialist care(3, 6, 7, 8).
Research has shown that not all asthma is the same and can have a number of underlying causes and different types of inflammation. For some people, their inflammation may be triggered by environmental allergens, such as dust mites, pollen and moulds. For others, their own body may be turning against them.
In around half of people with severe asthma, a raised level of eosinophils in their bloodstream causes inflammation and swelling in the airways that deliver vital oxygen to the lungs, making it difficult to breathe and increasing the risk of an asthma attack.
Biologic treatment options are now available based on our increased understanding of the causes of the underlying disease which work in a different way to conventional asthma treatments. They target the pathways that lead to lung inflammation help to stop the body’s processes that cause lung inflammation and mean people don’t need to be as reliant on the long-term use of OCS to prevent asthma attacks3.
Currently there are four NICE approved biologics for severe asthma (omalizumab, mepolizumab, reslizumab and benralizumab). Omalizumab is indicated for severe allergic asthma and the other three biologics (mepolizumab, reslizumab and benralizumab) are indicated for severe eosinophilic asthma. They are given as an injection or infusion (depending on which biologic is being taken) regularly in hospital or patients can self-inject at home.
Severe asthma places a significant burden on the NHS and the lives of patients. According to the National Review of Asthma Deaths, a report produced by the Royal College of Physicians, asthma deaths in the UK are among the highest in Europe11. They investigated 195 UK asthma deaths that occurred in one year and found that two in three of the deaths could have been prevented. Amongst the reasons for the asthma attack deaths, 65% of cases were influenced by patient factors that could have been avoided. They also found that 45% died before they had sought medical assistance or before the emergency medical care could be given.
Despite existing treatment guidelines improvements in the quality of care for people with asthma falls behind that achieved for other diseases. For example, after experiencing a heart attack a patient would not be released from the hospital without a plan for follow up and treatment to prevent future attacks. Yet this is the experience of many people hospitalised for an asthma attack, even though they are very likely to experience another attack that could be fatal. Nearly a quarter of those who died from severe asthma had been to a hospital emergency department due to asthma at least once in the previous year11.
During the past 20 years, the introduction of biologics for the treatment of rheumatoid arthritis has transformed the experience of patients with this disease. Steroid therapy is no longer overused. The same revolution is occurring in the treatment of patients with severe asthma, with biologic treatments available that have demonstrated effectiveness in reducing future asthma attacks for patients with defined subtypes of severe asthma12. However, ensuring that patients with severe asthma who may potentially benefit from these new treatments are identified and seen by specialists is fundamental to achieving these improvements.
Asthma UK estimates that the eligible population for asthma biologics is around 60,000 in England but only one in four people eligible for biologic treatment are accessing it.
Health Innovation East convened a range of stakeholders including commissioners, secondary care NHS trusts, pharmacists and the clinical community to deliver the following:
Health Innovation East supported local NHS partners in their applications to the Pathway Transformation Fund (PTF), which provides financial support for integrating asthma biologics into everyday practice and addresses issues such as pathway redesign, training staff and establishing new data collection methods.
The asthma biologics programme aimed to improve patient care and outcomes through enhanced access to diagnostics and treatments for severe asthma. The full impact of the programmes is still being finalised however interim data shows that between April 2021 and February 2023:
The national asthma biologics programme has now completed and have made substantial contributions to the transformation of asthma care in England while significantly increasing the access to and adoption of asthma biologics.
The the Health Innovation Network is now transitioning to support healthcare inequalities as a national priority as part of NHS England’s Innovation for Healthcare Inequalities Programme (InHIP). Building on the transforming asthma pathways work, a number of AHSNs will support the respiratory aspect of the NHS England Core20PLUS5 approach, continuing to utilise the implementation and educational resources developed for the asthma biologics national programme.
The Rapid Uptake Products (RUP) programme has been designed to support stronger adoption and spread of proven innovations. It identifies and supports products with NICE approval that support the NHS Long Term Plan’s key clinical priorities, but have lower than expected uptake to-date. Learn more.
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