The UK’s National Institute for Health and Care Excellence (NICE) has issued its first draft guidance for AstraZeneca ’s Fasenra (benralizumab), in which it recommended the drug be funded by the NHS in England, Wales and Northern Ireland for severe asthma, but with restrictions.
Benralizumab was approved by the European Commission in January this year, based on positive results from six phase 3 trials in the Windward programme.
The drug is indicated for ‘add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β-agonists.’
The drug works by binding directly to the IL-5α receptor on eosinophil, which are white blood cells that can build up and cause airway inflammation and hyper-responsiveness, and attract natural killer cells to induce apoptosis on the cell.
The restrictions imposed by NICE include stipulations that a suitable patient must have recorded a high count of eosinophils, a minimum of 400 cells per microlitres, in the past 12 months, must have had three exacerbations in the past 12 months and treatment with GlaxoSmithKline’s (GSK) Nucala (mepolizumab) is not an option.
The final condition is linked to NICE’s assessment that benralizumab is not more cost-effective than GSK’s drug. AstraZeneca’s product costs £1,955 per 30mg pre-filled syringe, but is available to the NHS at a discount due to a commercial arrangement.
Additionally, there is no evidence that benralizumab is more clinically effective than its major competitors, mepolizumab or Teva’s reslizumab.
However, NICE’s positive recommendation was linked to clinical results that showed that benralizumab plus standard treatment reduced exacerbations and the use of oral corticosteroids compared to the placebo.
It can also offer an easier method of administration compared to existing treatment. Benralizumab is administrated in 30mg doses every four weeks for the first three doses and then every eight weeks, whereas mepolizumab and reslizumab are injected every four weeks.
Benralizumab was approved in the US in November 2017 and Japan in January 2018.
AstraZeneca global medicines development executive vice-president and chief medical officer Sean Bohen said: “The approval of Fasenra, our first respiratory biologic medicine, in Japan closely follows the recent US and EU decisions and brings us another step closer to achieving our ambition of transforming care for severe asthma patients around the world.”