A third biological treatment looks set to be approved by the National Institute for Health and Care Excellence for treating patients with severe asthma in England and Wales.
NICE said today that the drug benralizumab (Fasenra) was cost-effective for use on the NHS by some adults who have severe eosinophilic asthma and have struggled to control it with inhalers.
“Biological treatments have transformed the lives of some of these sufferers”
Benralizumab, manufactured by AstraZeneca, is a biological therapy which targets and depletes the immune cells (eosinophils) in the blood which cause the condition.
It will be the third biological treatment for severe eosinophilic asthma approved for NHS use by NICE, following mepolizumab in December 2016 and reslizumab in October 2017.
NICE has published a final appraisal document (FAD) for consultation on the drug, with the resulting guidance set to be introduced from 6 February.
It is likely to mean patients eligible for mepolizumab or reslizumab should also be offered benralizumab, noted NICE.
The institute said severe eosinophilic asthma was an “uncommon and relatively uninvestigated” form of the condition that was believed to affect around 100,000 people in the UK.
“This debilitating type of asthma often doesn’t respond well to regular asthma treatments”
The FAD represents in change in policy after NICE’s earlier appraisal consultation document (ACD) had concluded that benralizumab was not cost-effective.
However, an improved financial offer from AstraZeneca – referred to under NICE terminology as a patient access scheme – ultimately made it cost-effective for those already eligible for reslizumab or mepolizumab.
According to the guidance, benralizumab is given as an injection every four weeks for the first three doses, and every eight weeks after that.
This made it potentially more convenient than mepolizumab, which is also injected, and reslizumab, an intravenous infusion, both of which are given every four weeks throughout treatment, noted NICE.
If benralizumab, mepolizumab or reslizumab are equally suitable for a patient, a prescriber should choose the cheapest option first, according to the FAD.
Subject to appeals against the FAD, final guidance will be published next month and the NHS must make the drug available in England within three months of that date.
The list price of a dose of benralizumab is £1,955, but AstraZeneca must supply it at a confidential discounted price for NHS use, according to its commercial agreement.
Meindert Boysen, director of NICE’s Centre for Health Technology Evaluation, said: “People with severe eosinophilic asthma that is inadequately controlled often have a severely impaired quality of life.
“It can hold them back from doing many basic daily tasks, lead to psychological problems including anxiety and depression, and leave them in constant fear of a potentially lethal asthma attack,” he noted.
“By keeping their asthma under better control, biological treatments have transformed the lives of some of these sufferers,” said Mr Boysen.
He added: “This recommendation of a further biological option demonstrates how a competitive pharmaceuticals market combined with NICE’s appraisal process provides the NHS and patients with value-for-money and choice.”
“Benralizumab could offer an easier method of administration than reslizumab, and a more convenient dosing schedule than existing biological treatments,” he said.
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Dr Samantha Walker, director of research and policy at Asthma UK said: “Benralizumab is one of a group of life-changing drugs which have the power to improve the lives of thousands of people suffering from a type of asthma called severe eosinophilic asthma.
“This debilitating type of asthma often doesn’t respond well to regular asthma treatments, so people are forced to take oral steroid tablets that can cause toxic side effects such as diabetes and osteoporosis,” she noted.
“We welcome the approval of another biologic drug for asthma patients. This provides more choice and convenience for patients and clinicians,” she said. ”We need to ensure that people with difficult or severe asthma are referred to specialists promptly so they can be considered for these new treatments.
She added: “More research is needed to see if biological drugs can work well for more people with severe asthma, as there is promising evidence that more patients could benefit in the future.”