New ALS drug’s price will be $158,000 per year, maker says
A new medication for Lou Gehrig’s disease, the devastating neurological disorder that causes paralysis and death that is also known as ALS, will have a list price of $158,000 a year, its manufacturer disclosed Friday.
The treatment, to be marketed as Relyvrio, is a combination of two existing drugs and will be available to patients in the United States in about four to six weeks, according to officials of the company, Amylyx Pharmaceuticals.
Relyvrio was approved by the Food and Drug Administration on Thursday, even though the agency’s analysis concluded there was not yet sufficient evidence that the medication could help patients live longer or slow the rate at which they lose functions like muscle control, speaking or breathing without assistance.
The agency said that although the evidence of effectiveness was uncertain, “given the serious and life-threatening nature of ALS and the substantial unmet need, this level of uncertainty is acceptable in this instance.”
ALS, or amyotrophic lateral sclerosis, often strikes patients in the prime of life and frequently causes death within two to five years. It is diagare nosed in about 6,000 people worldwide each year, and Amylyx estimates that there are about 29,000 people living with the disease in the United States.
Amylyx officials predicted that most patients would pay little or nothing for the treatment because the company expects insurers, private and public, to cover it. Amylyx plans to provide it free to uninsured patients experiencing financial hardship.
Still, the list price is much higher than that recommended by the Institute for Clinical and Economic Review, a nonprofit organization that evaluates the value of medicines. In a statement, the group’s chief medical officer, Dr. David Rind, said that while “there clear benefits to patients with a rapidly fatal disease to have early access to a safe therapy,” his organization had concluded that “an annual price of $9,100 to $30,700 would be reasonable if the therapy actually works.”
During an investor conference call Friday, Justin Klee, a founder of Amylyx, said the price was chosen after meeting with insurers, patients, doctors and others. He said the company considered what would allow it to “invest in new treatments so that ALS first becomes a manageable chronic condition and ultimately is cured,” and added that the price “allows Amylyx to sustain programs to help people who can benefit from Relyvrio access it.”