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incentive to build more or convert existing centers. “I don’t expect infusions will be a problem for those who want them,” says Phyllis Ferrell, vice president and global development leader for Alzheimer’s disease at Lilly, although she says the “experience” will need to be tailored to Alzheimer’s patients and the caregivers who bring them and wait—typically 30 to 60 minutes for the infusion process.
The big elephant in the room is cost. “Antibodies are going to be expensive,” says Morgan of the University of South Florida. Biogen’s Scangos has said publicly that, all told, Biogen will end up spending $2.5 billion on aducanumab development. After backing Biogen’s big bets in Alzheimer’s and other neurology indications, shareholders will likely push for ample reward.
While assessing those prices, payers will be pulled by the emotional appeal of a new Alzheimer’s drug, on one hand, and the calculus of how much benefit the drug provides. Because of the large over-65 population who would be taking the drugs, Medicare’s decisions will be key. But private insurers will be involved, as well, with younger patients showing tell-tale signs. “There are days we don’t see a person over 60,” says Rachelle Doody, director of the Alzheimer’s Disease and Memory Disorders Center at the Baylor College of Medicine in Houston, which has about 2,500 people in its care.
“If any treatment shows incremental value, people will be clamoring for it,” says Andy Behm, vice president, office of clinical evaluation and policy, at Express Scripts (NYSE: ESRX), the nation’s largest drug-buying middleman. “But if those benefits are in fact modest or incremental, you’ll probably see payers put guardrails around access.”
The pressures could be huge. “If Lilly blows the doors off” with fantastic data for solanezumab later this year, the temptation for doctors and patients “will be to think about it from a preventative standpoint,” says Behm, which would mean giving the drug to younger people with, say, a family history of the disease but not showing symptoms yet. “Ethically it’s going to be a challenging area.”
Medicare’s outlook is hard to parse. “Speculating is not in our best interest,” says Lilly’s Ferrell, noting Medicare’s decision not to cover the PET scan technology Lilly bought in 2010. “That surprised us,” she says. (A spokesperson for the Center for Medicare and Medicaid Services did not respond to my questions by press time.)
Morgan says that in the drug-price debate, the biggest factors should be whether a drug works well enough to keep people out of costly residential care facilities and boosts patients’ and family members’ work productivity.
Alzheimer’s is notoriously slow to develop. Clinical trials to measure a drug’s effectiveness over many years would be prohibitively expensive, so it’s possible regulators could approve a drug conditionally, then monitor it. Insurers could do the same. “Sometimes you’ve got to get the product on the market to understand its full benefit,” says Behm of Express Scripts. It’s a hint that flexibility and creativity will be necessary if and when an Alzheimer’s drug approval unlocks demand. But getting the drug to the right patients within the right window of time won’t be possible without a ton of preparation.