 |
Boehringer Ingelheim and Roche's ($RHHBY) meds for idiopathic pulmonary fibrosis (IPF) may have won FDA approval on the same day, but in Europe, BI's contender, Ofev, has been playing catch-up since snagging its regulatory green-light. On Friday, though, it got a boost from British cost watchdogs could help it out in that department.
The U.K.'s National Institute for Health and Care Excellence (NICE) supports the use of Ofev in IPF patients, it said in draft guidance. The thumbs is based on a pact with Boehringer to provide the drug at a discount under a so-called patient access scheme, which companies often have to offer up to get their treatments through the door.
Beyond the discount, though, the cost-effectiveness gatekeeper has a couple other conditions for backing Ofev, PharmaTimes reports. It should only be covered in patients whose forced vital capacity--the max amount of air one can expel after inhaling--falls into the 50% to 80% range, NICE stipulated, and treatment should be stopped if a patient's condition worsens in any 12-month period.
Now, the draft guidelines are up for discussion until Sept. 29. But if NICE stands by its position in final guidance, it'll put the Boehringer drug on more even footing with Roche's rival, Esbriet. That drug--which snagged EU regulatory favor back in 2011--received a final "yes" from NICE in March of 2011. Boehringer's drug, on the other hand, only won the EMA's blessing this January.
On the other side of the pond, the drugs have been battling it out since last October, when the FDA handed down same-day approvals for the nemeses. Shortly thereafter, Boehringer began fielding a team of 100 to 200 sales reps and associated nursing professionals to get the word out on the drug, bringing in its existing COPD field forces for backup, too.
- get more from PharmaTimes
Special Reports: The top 10 pharma companies by 2013 revenue - Roche | Top 20 orphan drugs by 2018