San Diego-based Acadia Pharmaceuticals set the price of its newly approved Parkinson’s drug at $23,400 per year on Thursday.
Pimavanserin, which will be sold under the brand name Nuplazid, is the first drug on the market specifically designed to treat the hallucinations that can accompany Parkinson's disease. The drug was approved by the U.S. Food and Drug Administration last week, but not without some concerns raised by FDA regulators.
"We have set the price of Nuplazid at a level we believe appropriately reflects the value of the medication," said Acadia’s Chief Commercial Officer Terrence Moore during a conference call Thursday.
"All of our market research indicates payers will view Nuplazid as having a very positive benefit to patients with little impact on their own budgets,” Moore said.
Unlike other antipsychotic drugs, pimavanserin targets brain receptors for serotonin rather than dopamine. Acadia says bypassing receptors for dopamine, which helps control movement, can reduce hallucinations in Parkinson’s patients without making their motor symptoms worse.
Dr. Irene Litvan, a UC San Diego Parkinson's expert, said drugs currently used against psychosis in Parkinson's patients can hurt as much as they help.
She and her patients have been waiting for a drug like pimavanserin that doesn't interact with dopamine, Litvan said.
"The idea that you can have drugs that are more selective is exciting," Litvan said. "I'm just delighted to see that there could be other options."
Pimavanserin isn't a surefire cure for Parkinson's-related psychosis. The drug’s approval was based on one positive phase three clinical trial. Three other human trials conducted to test the drug’s efficacy and safety didn’t satisfy regulators.
Even in the one "robustly positive" trial, patients who took the drug tended to receive only limited benefit. Their improvements were, on average, "quite modest," according to briefing documents.
Regulators also said the drug’s "safety risk is substantial," citing increased morbidity and mortality. In a clinical trial, the rate of serious adverse events was more than two times higher among patients who took the drug compared with those who took a placebo.
Acadia plans to make pimavanserin available to patients starting in June. The drug's price will outstrip the cost of other antipsychotics, including those currently used to treat Parkinson's patients.
Litvan said the price Acadia set for the drug was "unfortunate" and potentially "prohibitive" for many patients.
"This is expensive," Litvan said. "The question is, how much is an insurance company going to subsidize? How much is the patient going to have to pay?"
Acadia says it will help offset the cost of the drug by helping certain patients with their copays, providing the drug for free to some uninsured patients and by making donations to charitable funds for Parkinson’s disease.
Matt Zwolinski, a University of San Diego associate professor of philosophy who has written about the ethics of drug pricing, said in an email the price could be seen as justifiable because "there seems to be good medical reason for regarding this drug as filling a special need."
He said: "It’s important to remember that what patients are paying for is not just the physical drug they consume. They’re paying for the years of research and testing that went into discovering that drug and shepherding it through FDA approval. And they’re paying for all the research and testing of drugs that never made it to market."
About one million Americans suffer from Parkinson’s, and about half of them experience hallucinations or delusions at some point. The company hopes to expand the drug's use for patients with Alzheimer’s.