The National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Determination (FAD) recommending Dupixent (dupilumab), as an add-on maintenance treatment for severe asthma.
The drug has the potential to transform the lives of the thousands of people living with the severest form of asthma. Asthma UK and the British Lung Foundation are now urging NICE to develop new and clearer guidelines for healthcare professionals, so they are confident on when to refer patients for these life-changing treatments.
Until relatively recently the only treatment option was regular, high-dose steroid tablets which can cause osteoporosis, diabetes and severe weight gain.
Dupilumab (brand name Dupixent) is not a steroid tablet but a biologic drug given as an injection that can give people living with the debilitating effects of severe asthma a completely new lease of life. While the drug was approved by the Scottish Medicines Consortium in Scotland in April 2021, it’s taken NICE three years to approve dupilumab in England, Wales and Northern Ireland due to initial concerns about its cost-effectiveness. However, NICE’s most recent decision now means those people living with severe asthma who are most in need and are eligible for monoclonal antibodies or ‘biologics’ will have a wider range of treatments available to them.
Biologics are genetically engineered proteins that target specific parts of the immune system that fuel inflammation. In clinical trials, dupilumab has been shown to reduce the frequency of asthma attacks and the use of emergency steroid tablets by almost half when combined with standard inhaler treatment.2
However one of the key issues is that the current guidelines from NICE are not clear about when to refer people with severe asthma which means those most at risk are not being referred.
Nicki Ridgway, 38, from Oxford is one of just a few people in England who had been able to access dupilumab early after she was given it in special circumstances because she wasn’t responding to other severe asthma treatments. Responding to today’s news, she said:
“I couldn’t be more thrilled that NICE has finally recommended dupilumab, a wonder drug that has totally turned my life around. My asthma was so bad that I spent my late twenties and early thirties being blue-lighted to hospital regularly with life-threatening asthma attacks, rigged up to machines to help me breathe and not knowing if I was going to see my 35th birthday. I couldn't walk anywhere due to breathlessness and had severe asthma attacks without warning. My plans for starting a family were put on hold because I was too ill and the only thing that offered any kind of relief was long-term steroid tablets, but these caused me to rapidly put on weight and I was still in and out of hospital continuously. My partner had begun to feel like my carer and I was losing my independence.
“Since I have been on dupilumab, I feel like a new woman. I’ve taken part in cycling challenges, love walking my dogs, have a fantastic new job in health research and able to finally contemplate starting a family.
“It was a difficult process for me to get access to dupilumab but I know I’m one of the lucky ones – some people wait years for referrals and this can have a huge impact on their lives. It’s vital people get referred if they’re ever going to reap the benefits of this potentially life-changing treatment.”
Dr Samantha Walker, Director of Research and Innovation at Asthma UK and the British Lung Foundation, said:
“Today’s news could be a real game-changer for the thousands of people with severe asthma across England, Wales and Northern Ireland who live in constant fear of a life-threatening asthma attack happening at any time.
“Severe asthma can have a colossal impact on people’s lives. People are stuck in a never-ending cycle of hospital visits, which has a serious and debilitating impact on their home, work and social life.
“While NICE’s decision to recommend dupilumab is cause for celebration, the sad fact is that four in five people3 with suspected severe asthma are not being referred to specialists for the treatments that could transform, and even save, their lives. Asthma UK and the British Lung Foundation is calling for NICE to develop new, clear guidelines so healthcare professionals are confident about when to refer patients with possible severe asthma to get the specialist care they so desperately need."
