AZ suffers setback as NICE slaps restrictions on Fasenra

NICE has recommended in a draft decision that AstraZeneca’s latest lung drug Fasenra can be funded by the NHS in severe asthma – but only in patients that are ineligible for GlaxoSmithKline’s rival.

AstraZeneca’s Fasenra (benralizumab) is one of a group of new drugs it hopes will revive its sales after it fell over one of the worst patent cliffs in pharma – but things are not going that well for the lung drug.

At the end of May its biologics arm MedImmune announced Fasenra had failed in a phase 3 trial in chronic obstructive pulmonary disease (COPD), saying it did not provide a statistically significant reduction in exacerbations.

The trial results mean that a COPD indication is highly unlikely – but there are also problems in its already approved asthma use.

In its home market in England and Wales, cost-effectiveness body NICE has recommended in first draft guidance that NHS organisations should fund Fasenra in England, Wales and Northern Ireland – but only with some tough restrictions.

NICE said Fasenra is an option for treating severe eosinophilic asthma that is inadequately controlled in adults despite maintenance therapy with high-dose inhaled corticosteroids and long-acting beta agonists - but only if patiens meet certain criteria.

Patients must have had a high count of cells called eosinophils for the past year, must have had at least three exacerbations in the last 12 months, and treatment with GSK’s Nucala (mepolizumab) must not be an option.

AZ has offered a confidential discount to the list price of £1,955 per 30mg pre-filled syringe – but this has not been enough to convince NICE that Fasenra is cost-effective.

The company said that it is disappointed in the decision to limit the patient group eligible for the drug, but said it will continue to engage with NICE to make the drug available across the NHS.

In other words, it will probably have to cut the price further, or provide some more data for NICE in time for a second final draft due later this year.

Fasenra has a convenience advantage over Nucala and Teva’s rival Cinqaero (reslizumab) as it is given every eight weeks, after the first three doses administered four weeks apart.

Both Nucala and Cinqaero, also from the interleukin-5 inhibitor class, which are injected every four weeks.