NICE says yes to AstraZeneca’s Fasenra, but only when its GSK rival can’t be used

AstraZeneca
AstraZeneca’s Fasenra won a severe asthma approval from the FDA last November. (AstraZeneca)

It hasn’t been an easy couple of months for AstraZeneca when it comes to challenging GlaxoSmithKline’s Nucala (mepolizumab) with newcomer Fasenra (benralizumab). And in England, that ambition just took another hit.

The National Institute for Health and Care Excellence (NICE) said in draft guidance that it would recommend the AZ med only under certain conditions—and only in patients who can’t use Nacala.

Why the preference for the GSK drug? It’s simple: price. The cost watchdog acknowledged that there hasn’t been a head-to-head between the two drugs and that an “indirect comparison” of the drugs showed “no difference” in asthma exacerbations. But “compared with mepolizumab, when this is a treatment option, benralizumab is not cost effective and cannot be recommended as an alternative to mepolizumab,” NICE said.

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On the other hand, Fansenra represents a cost-effective alternative to Teva’s Cinqair, another therapy in the severe asthma picture. So in Cinqair-eligible patients—who have a certain blood eosinophil count and have had at least three episodes of sudden asthma worsening in the past year—Fasenra is a go, NICE said. But again, as long as Nucala isn’t an option.

RELATED: Discount helps NICE flip-flop on Teva's severe asthma contender, Cinqair

Unsurprisingly, AstraZeneca is not thrilled with the guidance, but this isn’t the end of the line for the British drugmaker. If the company can improve on the confidential discount it’s already offered up to NICE on Fasenra’s £1,955 list price, the cost-effectiveness gatekeeper is likely to change its mind, just as it did with Cinqair.

“AstraZeneca is disappointed by this decision for a limited patient population and will continue to engage with NICE to enable access to benralizumab for a wider group of patients in England, Wales and Northern Ireland,” the company told Pharmafield in a statement.

When Fasenra hit the U.S. scene last November, AZ was ready to rumble. Ahead of its FDA approval, company respiratory VP Tosh Butt said in an interview that the launch would be “very, very competitive” in terms of “field force size, marketing dollars, educational dollars.”

RELATED: AstraZeneca's Fasenra fails its second COPD trial, handing rival GSK a win

In May, though, a pair of failed COPD trials put a damper on things, dashing the company’s hopes of expanding beyond asthma into COPD. Nucala, on the other hand, is awaiting word from the FDA after posting positive trial results last year.

“These results are disappointing,” AstraZeneca R&D Chief Sean Bohen said in a statement at the time.