GSK’s severe asthma drug Nucala recommended by NICE

England’s cost effectiveness body NICE has recommended GSK’s new severe asthma treatment Nucala, reversing an earlier decision to reject it.

Nucala (mepolizumab) is the first biologic treatment to target specific white blood cells called eosinophils, which are responsible for symptoms in thousands of asthma patients.

Given by injection every four weeks, the drug offers an extra option for patients with the most severe symptoms, including those who suffer multiple asthma attacks.

In April, NICE’s appraisal committee issued a ‘not recommended’ draft decision on the drug, ruling that the evidence presented by GSK suggested the drug would be used in less severe cases of asthma, and would not therefore be cost effective.

GSK was able to persuade NICE to change its mind after it provided further analyses on its use, as well as an additional price reduction.

The drug’s list price is £840 per dose, but the price offered to the NHS will now be much lower than this, but is confidential.

Around 100,000 people in England and Wales have severe asthma that cannot be controlled with their regular medicines, and can lead to hospitalisation or even death.

Current standard treatment is oral corticosteroids, but taking these for prolonged periods which can cause further complications such as diabetes, high blood pressure and mood swings.

In some patients, the condition is brought on by increased levels of eosinophils. These are triggered by the IL-5 molecule, which Nucala blocks and helps reduce the number of eosinophils in the airways.

NICE have set out restrictive guidelines for the drug’s use. It is recommended as an add-on treatment when people have a certain level of eosinophils in their blood despite taking their regular medicines, and only recommended if the patients has had 4 or more attacks in the previous 12 months, or if they are taking maintenance oral corticosteroids.

It also stipulates that the treatment should be reviewed annually, and if the patient’s  asthma is not benefitting from treatment, treatment should be stopped.

Nucala has not enjoyed spectacular sales since it was launched in the US in December last year and in Europe earlier this year, earning just £58 million ($72.5m) in the first nine months of 2016.

NICE is also appraising Teva’s rival treatment Cinqaero (reslizumab) to treat severe eosinophilic asthma.  But after the first appraisal meeting NICE asked Teva to provide more information on the cost-effectiveness of reslizumab for the appraisal committee to consider again.

Meanwhile, AstraZeneca is set to file its own competitor in the field, benralizumab. It could have an edge over its rivals as it may be approved for dosing every 8 weeks, instead of every 4 weeks.

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