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| Lundbeck CEO Kåre Schultz |
Lundbeck's new CEO Kåre Schultz just wrapped up his first month on the job, and chances are he's brainstorming about how to jump-start the company's Brintellix launch. And as Forbes' John LaMattina notes, the answer might lie with payers.
Using some telling language, England's cost-effectiveness watchdogs rejected Brintellix earlier this month, saying there was "no convincing evidence to show that vortioxetine was any more or less effective than other antidepressants"--and perhaps most important, Lundbeck hadn't explained how the drug fits into the matrix of depression treatment.
Brintellix had its work cut out from the start. The antidepressant market is packed, and mostly generic, what with knockoff versions of GlaxoSmithKline's ($GSK) Paxil, Pfizer's ($PFE) Zoloft, Eli Lilly & Co.'s ($LLY) Prozac, Valeant's ($VRX) Wellbutrin and so on.
In a way, it's no wonder that Brintellix has sputtered under the blockbuster sales estimates it initially carried: The company itself, along with partner Takeda, put a $2 billion peak forecast on the drug, while Deutsche Bank was a bit more conservative (but only a bit) with $1.85 billion. Its first-quarter 2015 sales, however, amounted to only $14.8 million, its fifth full quarter after FDA approval in September 2013. Full-year 2014 came to $28.4 million, a far cry from the $271 million consensus recorded by EvaluatePharma.
But the thing is, Brintellix has a proven edge--one that recently won backing from European authorities. Lundbeck conducted 30 studies to set Brintellix apart from the crowd, including 8 in Phase III, as LaMattina points out. Those studies included a trial testing Brintellix against cognitive problems, a common depression symptom that's not often addressed. Not only did Brintellix improve thinking, decision-making and attention, but the cognitive effects seemed to be a direct benefit of drug therapy, and not a side benefit of easing depressive symptoms, researchers said at the time.
In another study comparing cognitive benefits of Brintellix with Cymbalta's, Brintellix performed better. That data prompted EU officials to back a new use for the drug, to improve cognitive function in patients with depression.
So why is NICE unimpressed? Perhaps because it can be. As LaMattina notes, payers these days want patients to exhaust all other options before trying a more expensive brand-name drug. In depression, that policy puts a lot of other drugs in line ahead of Brintellix.
Lundbeck obviously has some ammo to use to persuade payers that Brintellix deserves a place in their treatment schemes. NICE's ruling suggests that so far, the company hasn't figured out how to describe that proper place in a convincing way. Sounds like a directive from Schultz just waiting to happen--and like a lesson for other drugmakers looking to get their own meds approved by the folks who pay the bills.
- check out the NICE guidance
- read the Forbes story
Special Report: Top 10 drug brands by payments to doctors - Abilify Maintena | FDA's new drug approvals of 2013 - Brintellix