A new drug for patients with severe asthma has taken a significant step towards being made available on the NHS, following a change of heart by the medicines regulator.
The National Institute for Health and Care Excellence has published draft guidance that now recommends reslizumab (Cinqaero) for adult patients with severe eosinophilic asthma.
“Exacerbations are very frightening and can happen without warning”
It represents a change from an earlier decision after the NICE appraisal committee asked the drug’s manufacturer, Teva, to clarify specific points on the effectiveness of reslizumab in patients who had multiple asthma attacks and the full costs associated with administering the drug.
Severe eosinophilic asthma is a severe form of asthma where inflammation and narrowing of the airways can result in uncontrolled symptoms and serious asthma attacks.
NICE said: “Inadequately controlled severe eosinophilic asthma is a distressing and socially isolating condition.
“Exacerbations are very frightening and can happen without warning. They can result in frequent hospital visits and in severe cases are life-threatening, which may require intensive care support including intubation,” it said in its Final Appraisal Determination on the drug published this week.
It also highlighted the current standard treatment for the condition, corticosteroids, were often effective at controlling exacerbations but their long-term use were associated with complications.
“Reslizumab has the potential to dramatically improve the quality of life for some people”
NICE said it understood that patients would welcome treatment options that replaced the need for, or reduce the dose of, oral corticosteroids.
It said its committee had heard that treatments such as reslizumab reduced the number of exacerbations and were also expected to reduce oral corticosteroid use.
It concluded that inadequately controlled severe eosinophilic asthma was associated with “substantial morbidity” and that there was a need for alternative treatment options.
Reslizumab is a humanized interleukin-5 (IL-5) antagonist monoclonal antibody for use as add-on therapy where the respiratory condition is inadequately controlled, despite high-dose inhaled corticosteroids plus another medicinal product for maintenance treatment.
NICE gives changes mind in backing to drug for severe asthma
NICE said it could be used under these circumstances where the blood eosinophil count was recorded as 400 cells per microlitre or more, the patient has had three or more exacerbations in the past 12 months and the company provided reslizumab with the discount agreed.
The discount agreed between Teva and the Department of Health is confidential, noted NICE.
The recommended dose is an intravenous infusion of 3mg/kg body weight once every four weeks.
After 12 months, NICE said prescribers should stop reslizumab if the patient’s asthma had not responded adequately or continue it if it had done so, and then assess the response each year.
NICE added that its new recommendations were not intended to affect treatment with reslizumab that was started in the NHS before the guidance was published.
Adults having treatment outside the new recommendations “may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop”, said the institute.
Kay Boycott, chief executive of Asthma UK, said: “Reslizumab has the potential to dramatically improve the quality of life for some people living with severe asthma, and we are delighted that it has been recommended for use on the NHS.
“New monoclonal antibody treatments, which have shown success in clinical trials are likely to be effective in treating around 30-40% of those living with severe asthma, so it is imperative that they are made available,” she said.
But Ms Boycott added: “While today’s news is an encouraging step forward, it’s important to note that these treatments will only benefit a certain group of people.
“There remain many thousands more for whom no effective treatments are available,” she said. “More research is needed so that in the future all people with severe asthma will have an effective treatment option.”
Final guidance on the drug is expected to be published by NICE in August.