NICE turnaround for AstraZeneca’s COPD drug Daxas

The National Institute has now issued draft guidance recommending Daxas (roflumilast) in COPD patients whose disease is class as severe and when symptoms continue to worsen despite other treatments, after two new trials showed that it helped ease symptoms not under control with inhalers.

In 2012, the Institute issued guidance that only backed funding for the drug in the research setting because of the limited data available at the time, while draft guidelines issues earlier this year also rejected it for the normal funding stream.

However, taking the new evidence into account, NICE’s committee felt that AstraZeneca’s base-case estimate of £24,976 per QALY gained was a plausible estimate of the cost effectiveness of the Daxas, thus falling within the acceptable range.

According to the company, around 122,000 adults in England with COPD will be eligible for treatment with its drug, an orally administered long-acting selective phosphodiesterase-4 enzyme inhibitor that targets cells and mediators believed to play a key role in the condition.

AZ picked up full ownership of the drug in May last year when it completed its acquisition of Takeda's core respiratory business in a deal worth $575 million.

U-turn for Xiapex
Meanwhile, the Institute also published draft guidance backing Swedish Orphan Biovitrum’s CCH (Xiapex; collagenase clostridium histolyticum) for some people with Dupuytren’s contracture, marking a u-turn on previous final draft guidance not to recommend the treatment except in the context of research.

The new positive recommendation follows a cut in the price of CCH which, for a very specific group of adults with moderate Dupuytren’s contracture, makes the treatment cost-effective compared with surgery.

CCH is the first pharmacological treatment to get a marketing authorisation for treating the condition, which affects the connective tissue beneath the skin in the palm. Collagen deposits eventually form a cord that stretches from the palm to the base of the finger, causing them to contract.