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NICE recommends GSK’s “first-in-class” asthma drug

pharmafile | November 30, 2016 | News story | Sales and Marketing GSK, NICE, Nucala, asthma 

NICE has announced its recommendation of GSK’s “first-in-class” biologic Nucala (mepolizumab) as an extra option for the treatment of adults suffering from severe forms of asthma.

The decision follows a submission of additional evidence as well as a price cut. The institute rejected the previous attempt to bring the drug to market in England and Wales on the basis that the evidence GSK put forward to support the case suggested it would be used in less than severe cases, preventing it from being a cost-effective use of resources. The drug received US and EU approval at the end of last year.

The draft guidance recommends Nucala as an add-on treatment via monthly injection for those whose eosinophil levels do not respond to conventional medicine.

Mepolizumab is unique for a biologic in that it operates by targeting eosinophils, specific white blood cells which are a trigger for common asthma symptoms.  Higher levels of these cells can worsen symptoms in some patients. Mepolizumab nullifies their ability to produce signal molecule IL-5, which means the cells are not able to congregate in large numbers within airways.

Professor Carole Longson, director of the NICE centre for health technology evaluation said of the announcement: “Around 100,000 people in England and Wales have severe asthma that cannot be controlled with their regular medicines. Symptoms such as constant breathlessness can make it hard to carry out simple day-to-day activities. Asthma attacks can come without any warning so people often live in fear, afraid to go out. If they do suffer from an attack, it may lead to hospitalisation and in the worst cases death.

“People with severe asthma have had limited treatment options. Many end up taking oral corticosteroids for prolonged periods which can cause further complications such as diabetes, high blood pressure and mood swings. Many of these people will soon have access to an extra treatment option to help them take control of their asthma.”

NICE is also currently appraising Teva’s Cinqaero (reslizumab) for the same indication after knocking it back on lack of cost-effectiveness data.

Matt Fellows

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