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PRICE OF CAMBRIDGE BIOTECH’S NEW ALS DRUG CRITICIZED BY WATCHDOG GROUP


IT SAYS THE $158,000 ANNUAL COST PER PATIENT ISN’T JUSTIFIED, BASED ON THE
MEDICINE’S EFFECTIVENESS.

By Jonathan Saltzman Globe Staff,Updated September 30, 2022, 12:23 p.m.
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Amylyx cofounders Joshua Cohen (left) and Justin KleeAssociated Press

The day after federal regulators approved its hotly debated new ALS drug, a
Cambridge biotech on Friday set the annual list price at about $158,000 for the
first year, drawing swift criticism from a nonprofit watchdog group.

Top executives at Amylyx Pharmaceuticals disclosed the price for Relyvrio in a
conference call with analysts. In Canada, where the drug received its first
approval in June, the company has proposed a price roughly equivalent to
$165,000 a year.

Justin Klee and Josh Cohen, the company’s co-CEOs, said in a statement that
Amylyx consulted every major US health insurer, doctors, and people living with
amyotrophic lateral sclerosis, a devastating progressive neurological disorder.
They also said that the price was less than Radicava, another ALS drug, approved
by the US Food and Drug Administration in an oral form this year. That costs
about $171,000 a year.

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“Taking all of that into account, we made the decision to price Relyvrio below
the latest FDA-approved product available to people with ALS,” the executives
said.

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The company has promised to provide the drug at no cost to patients who are
uninsured or underinsured and meet certain financial criteria and have exhausted
other options.



Nonetheless, the price tag drew fire from a Boston-based drug-pricing watchdog
group, the Institute for Clinical and Economic Review, or ICER. It had recently
said that if the medicine were approved, it should be priced at $9,100 to
$30,700 based on its clinical benefits to patients, which the organization said
ranged from “small to substantial.”

“It’s not surprising, but it’s disappointing,” Dr. David Rind, ICER’s chief
medical officer and an internal medicine specialist at Beth Israel Deaconess
Medical Center, said of the price. A panel of experts assembled by ICER had
considered the possibility that Amylyx might charge $160,000 to $170,000 for the
drug and concluded that “at this price it was low value for the money,” Rind
said.

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Amylyx’s small intermediate-stage clinical trial of 137 patients found that the
drug prolonged survival by a median of 4.8 months compared with a placebo. In
light of that and other considerations, an FDA advisory panel of independent
medical experts voted in March that the firm had not proven the drug was
effective enough to recommend approval. The panel reversed itself in September
after patients with ALS and their families and advocates made impassioned pleas.

Amylyx is conducting a longer, larger trial to confirm the benefits of the
medicine, with data expected in late 2023 or early 2024. In an unusual pledge,
the company has vowed to remove the drug from the market if that study shows it
isn’t successful.

ALS is a rare disease diagnosed in about 6,000 people a year in the United
States, according to the Massachusetts chapter of the ALS Association. It
affects the nerve cells in the brain and spinal cord, gradually robbing patients
of the ability to speak, eat, and, finally, breathe.

Since 1995, only two drugs have been approved to treat the paralyzing and fatal
disorder ― also known as Lou Gehrig’s disease ― and neither works very well.
Amylyx developed a combination of two molecules, sodium phenylbutyrate and
taurursodiol, that it believes helps delay the death of nerve cells.

The ALS Association, a Washington, D.C.-based nonprofit that donated $2.2
million for the development and testing of the drug, said Friday it was grateful
that it won FDA approval.

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“We are glad that Amylyx is offering a financial assistance program and expect
the company to work with payers to ensure everyone can access [Relyvrio]
regardless of their financial situation,” said the association.

In recent years, drug companies have developed a number of cutting-edge
treatments for rare diseases that carry six- and even seven-figure price tags.
They include several gene therapies that patients need take only once and can
transform their lives.

In 2019, ICER concluded that the price of Novartis’s gene therapy for spinal
muscular atrophy, a rare degenerative neuromuscular disease that kills more
infants than any other inherited disorder, was justifiable at $2.1 million
because the one-time treatment was remarkably effective.






--------------------------------------------------------------------------------

Jonathan Saltzman can be reached at jonathan.saltzman@globe.com.

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Run by Black journalists at The Boston Globe, “Black News Hour,” a new radio
program, delivers reliable news that connects with our community and expands on
deeper issues impacting our city.

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