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NICE changes stance on GSK's asthma drug Nucala

A newly-agreed price cut and additional cost-effectiveness data prompt U-turn

Patients in the UK with severe asthma are on course to be able to receive treatment with GlaxoSmithKline's recently approved Nucala drug.

The National Institute for Health and Care Excellence (NICE) issued draft guidance this week reversing its earlier position on Nucala (mepolizumab) thanks to a price cut and new data on cost-effectiveness submitted by GSK.

Under the final draft, Nucala can be used as an add-on therapy for treating severe refractory eosinophilic asthma in adults, provided they have blood eosinophil counts of 300 cells/mL or more and have at least four breakthrough asthma attacks in the last 12 months or have been on continuous oral corticosteroids for six months.

The recommendations also call for treatment with the drug to be stopped after 12 months if there is no significant improvement in asthma attacks or the need for corticosteroids.

"Adults with severe asthma have had limited treatment options," said Prof Carole Longson, director of NICE's centre for health technology evaluation. "Many end up taking oral corticosteroids for prolonged periods which can cause further complications such as diabetes, high blood pressure and mood swings."

Nucala was the first in a new class of interleukin-5 (IL-5) inhibitors to be approved for marketing, getting a green light from the European Medicines Agency (EMA) a year ago.

Since then it has been joined on the market by Teva's Cinqaero (reslizumab), while AstraZeneca's benralizumab candidate is due to be filed for approval before year-end.

Cinqaero is also under review by NICE, which said after its first meeting on the drug it had requested more information on its cost-effectiveness.

Blocking the activity of IL-5 dampens down the activity of eosinophils, an inflammatory cell known to play an important role in the asthma disease process. There are thought to be around 100,000 people in the UK who have uncontrolled asthma.

Nucala is expected to benefit from its first-to-market status, with analysts at Credit Suisse predicting sales of $1.54bn in 2020 given the seriousness of uncontrolled asthma. Its dosing - by subcutaneous injection every four weeks - is seen as an advantage over Cinqaero, which has to be delivered intravenously.

Nucala's list price in the UK is £840 per dose, but the discount provided to the National Health Service (NHS) is under wraps.

Article by
Phil Taylor

1st December 2016

From: Regulatory



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