Teva’s Cinqaero to challenge Nucala after clearing NICE

Both drugs target eosinophils, the immune cells which trigger severe asthma symptoms in some patients.

Teva gained the prized recommendation after confidential discount persuaded NICE to change its mind from an earlier ‘no’ ruling.

The cost-effectiveness body rejected Cinqaero (reslizumab) in the autumn, citing uncertainties in clinical data provided by Teva.

But Teva’s discount and further cost-effectiveness analysis has changed NICE’s mind, as laid out in a final draft document.

NICE’s decision follows a favourable decision from price regulators in Germany earlier this month. The German Federal Joint Committee (G-BA) ruling that Cinqaero confers additional benefit over standard of care means Teva will have more leeway in pricing negotiations with a national umbrella body representing insurers.

While NICE did not reveal further details of its calculations, it said that the drug fell within its cost-effectiveness threshold of £20,000-£30,000 per Quality Adjusted Life Year.

At full price the infused drug cost £499.99 per 10mg vial, or £124,99 per 25-mg vial, excluding VAT, although the manufacturer was unable to provide annual cost-per-patient information.

This compares to the £840 per dose (pre-discount) price of GSK’s Nucala – though these actual prices are likely to be much closer together once their respective confidential discounts are factored in.

Restrictions

NICE has also added extra restrictions to the drug’s use on top of its licensed use in severe eosinophilic asthma, inadequately controlled in adults on high-dose inhaled corticosteroid-based maintenance therapy.

The drug will be funded at the discounted price in patients with high eosinophil count, who have had three or more exacerbations in the past 12 months.

They must stop the drug at 12 months if the asthma has not responded, and the response will be assessed each year to ensure it is still working.

NICE has defined an adequate response as a "clinically meaningful" reduction in severe exacerbations, or clinically significant reduction in continuous oral corticosteroid use while maintaining or improving asthma control.

The restricted use was based on evidence provided by Teva in its revised cost-effectiveness analysis.

While clinical trials had assessed patients with a single exacerbation in the past year, clinical experts said that patients with several exacerbations per year were more likely to continue to have problems.

Because of a lack of evidence, NICE was also unable to compare Cinqaero with Nucala (mepolizumab).

Ian Pavord, professor of respiratory medicine at Oxford University, said: "Despite the availability of current treatment options, many patients with severe eosinophilic asthma still experience uncontrolled symptoms and serious asthma attacks."

"The NICE decision will be welcomed by the clinical community as it provides access to a new treatment option for these patients."