No question, Biogen Idec's ($BIIB) new multiple sclerosis pill charged out of the gate. Tecfidera is selling so well that it's expected to break the blockbuster barrier by next year. But the launch has hit a few bumps, The Wall Street Journal reports, putting CEO George Scangos under pressure to smooth Tecfidera's path.
In a way, Tecfidera has been a victim of its own success. Patients and doctors had been eagerly awaiting its debut, and there just wasn't enough of the drug to go around. Pent-up demand "overwhelmed" some pharmacies, Scangos told the WSJ. It didn't help that supply chain and manufacturing snags interfered with distribution.
Meanwhile, some insurers have been slow to approve reimbursement for Tecfidera, doctors say. Some patients have waited several weeks for the go-ahead. Some payers want proof that patients have failed on other drugs before they'll foot the bill for Tecfidera. "I'm surprised with the amount of stuff I'm dealing with in this launch, compared to other ones," the University of Pennsylvania Multiple Sclerosis Center's director, Clyde Markowitz, told the Journal. To ease the way, Biogen has offered Tecfidera for free to patients who have to wait longer than two weeks for reimbursement.
One problem could be the drug's price. It's $54,900 a year. That's slightly less than its only other oral competitor, Novartis' ($NVS) Gilenya, but more than older injectable treatments, such as Biogen's own Avonex. And gaining reimbursement nods for expensive drugs, even convenient oral treatments, could be even tougher as generics hit the market. Scangos himself figures that price increases in MS are "probably not sustainable," the WSJ says.
Some obstacles facing Tecfidera--including a launch delay in austerity-minded Europe--aren't unique. Drugmakers are rolling out pricier therapies these days, at a time when payers are increasingly vigilant about controlling their drug costs. Reimbursement hurdles are common. No wonder drugmakers are thinking about reimbursement earlier and earlier, before regulatory approval is imminent.
- read the WSJ piece (sub. req.)
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