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NICE backs Teva's Cinqaero for severe asthma

Ruling will allow it to compete with GSK's rival IL-5 inhibitor Nucala


Teva's interleukin-5 (IL-5) inhibitor should be made available to patients under the NHS as an add-on therapy for patients with for severe eosinophilic asthma, says the UK's cost-effectiveness agency.

The National Institute for Health and Care Excellence (NICE) issued a green light for Cinqaero (reslizumab) this week, allowing it to compete with GlaxoSmithKline's rival IL-5 inhibitor Nucala (mepolizumab) which was backed by the agency last December.

Like GSK, Teva was able to overturn an earlier negative verdict on its drug by offering a confidential price cut for Cinqaero, which has a list price of 499.99/100mg vial or £124.99/25mg vial and is given as a 3mg/kg dose by infusion every four weeks. According to GSK Nucala's list price in the UK is £840 per dose, but the discount provided to the NHS is also under wraps.

Earlier this month, Germany’s health technology assessment body, the Federal Joint Committee (G-BA), determined that Cinqaero provided "minor additional benefit" in severe asthma as the company started reimbursement negotiations.

Cinqaero was approved by the EMA in August 2016 for use in combination with other medicines for the maintenance treatment of severe eosinophilic asthma in adults, who have had at least one asthma exacerbation in the prior year.

The drug is spearheading a push by Teva into the branded respiratory therapy category, a sector in which GSK already holds a dominant position, and the NICE approval is a boost to that ambition.

According to NICE, Cinqaero is recommended as an option for the treatment of severe eosinophilic asthma that is inadequately controlled in adults despite maintenance therapy with high-dose inhaled corticosteroids plus another drug.

Eligible patients must have blood eosinophil counts of 400 cells/ul or more and have experienced three or more asthma exacerbations in the past 12 months. Treatment with the drug should be stopped after 12 months if there isn't an adequate response to therapy - i.e. a reduction in exacerbations or a reduction in steroid use - and its efficacy should be reviewed each year.

Kay Boycott, chief executive of medical charity Asthma UK, welcomed the decision. "New monoclonal antibody treatments [have shown] in clinical trials they are likely to be effective in treating around 30-40% of those living with severe asthma, so it is imperative that they are made available," she said.

Article by
Phil Taylor

21st July 2017

From: Regulatory



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