A drug hailed as a “step change” in the treatment of chronic eczema has initially failed to win approval from the National Institute for Health and Care Excellence due to concerns about cost.
NICE said it was so far not recommending dupilumab (Dupixent) for treating moderate to severe atopic dermatitis in adults, despite acknowledging clinical evidence showed it was effective.
“Dupilumab does not reflect good use of limited NHS resources”
NICE draft guidance
In draft guidance on the treatment issued today, the institute noted that the treatment was already successfully in use for some patients on the NHS.
Dupilumab – a fully human monoclonal antibody administered via subcutaneous injection – is usually prescribed alongside steroid creams when other treatments stop working, it said.
“The clinical evidence shows that dupilumab is effective when used in this way,” said NICE, which acknowledged the treatment was “innovative and a step change in managing atopic dermatitis”.
However, the institute’s appraisal committee said concerns about cost effectiveness meant it could not recommend the treatment in its draft guidance, which is now out for consultation.
“The most plausible cost-effectiveness estimates for dupilumab plus topical corticosteroids compared with best supportive care range from £29,792 to £77,701 per quality-adjusted life year gained,” said the draft guidance.
“These estimates are higher than NICE normally considers an acceptable use of NHS resources,” it stated.
When other assumptions about how treatment would be delivered were taken into account, the estimated cost could be even higher, warned the committee.
“Therefore, dupilumab does not reflect good use of limited NHS resources,” it said in the draft guidance.
“We encourage the atopic dermatitis and eczema community to review and comment on the guidance”
The medicine has been developed jointly by biopharmaceutical firms Sanofi and Regeneron. It is currently listed in the British National Formulary at a price of £1,264.89 per pack of two 2ml syringes.
However, the guidance also stated that Sanofi had agreed a discounted deal with the Department of Health and Social Care.
Meanwhile, the NICE appraisal committee said its recommendation should not affect those currently being treated with dupilumab.
“This recommendation is not intended to affect treatment with dupilumab that was started in the NHS before this guidance was published,” said the guidance document.
“People having treatment outside this recommendation 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,” it added.
Sanofi said it hoped NICE’s draft position on the treatment would change in the light of further submissions that the company planned to make in support of dupilumab.
“Whilst this is disappointing news, it is only the first step in the NICE appraisal process and we are currently reviewing NICE’s recommendations and the details that led to this initial assessment,” said Jessamy Baird, the company’s director of patient access for the UK and Ireland.
“Dupilumab is an innovative medicine that represents a step change in the management of atopic dermatitis, which the appraisal committee itself acknowledged,” said Ms Baird.
“We appreciate there will be complexities when assessing the cost-effectiveness of such a new treatment approach and will be submitting a formal response to the draft NICE guidance in the next few weeks,” she said.
“Dupilumab is an innovative medicine that represents a step change in the management of atopic dermatitis”
A consultation exercise on the draft NICE guidance will now run until 24 April.
Peter Kuiper, general manager for UK and Ireland for Sanofi Genzyme – the Sanofi division responsible for dupilumab – urged clinicians to take part.
“We are fully committed to achieving a positive final outcome to ensure that dupilumab can be made available on the NHS for appropriate atopic dermatitis patients in England,” he said.
“We encourage the atopic dermatitis and eczema community to review and comment on the guidance so that the real-life impact of atopic dermatitis and treatment with dupilumab can be fully understood and assessed,” he added.
Meanwhile, the institute noted that atopic dermatitis was the most common form of eczema in the UK, affecting around 2.5% of the adult population.
It stated that those with severe atopic dermatitis “may need hospitalisation for treatment”.
“Feedback from patient and professional organisations highlighted that the condition is life-limiting, debilitating and isolating, affecting all aspects of life,” it said.
Moderate to severe atopic dermatitis is characterised by rashes often covering most of the body with symptoms including intense itching, skin dryness and cracking, crusting and oozing.
Other current treatments include eczema creams and lotions, phototherapy and systemic immunosuppressant therapies.