Novartis' Zolgensma Approved for Sale in U.S. to Treat SMA in Infants at $2.125 Million, Payable Over 5 Years -- Update
May 24 2019 - 1:40PM
Dow Jones News
By Maria Armental
Novartis AG's gene therapy to treat a rare muscle-wasting
disease that typically kills babies before age 2 was approved for
sale in the U.S., setting off a potentially fierce and costly
competition.
Zolgensma, a one-time injection to treat spinal muscular atrophy
in children younger than 2, comes with a record price of $2.125
million -- slightly above analysts' projections.
Novartis -- which added Zolgensma when it bought AveXis Inc.
last year for $8.7 billion -- said it would offer the option to pay
the cost over a period of up to five years.
"We are offering a pay-over-time model for this one-time
treatment to accommodate the current structure of the U.S.
healthcare system and we have also established outcomes-based
agreements with payers because we believe in the long-term value of
Zolgensma and are willing to stand behind the therapy," AveXis
President Dave Lennon said in a statement.
The Institute for Clinical and Economic Review, an independent
nonprofit that had concluded that Zolgensma should cost no more
than $1.5 million, on Friday endorsed the price.
"Zolgensma is dramatically transforming the lives of families
affected by this devastating disease, and given the new efficacy
data for the presymptomatic population, the price announced today
falls within the upper bound of ICER's value-based price benchmark
range," Dr. Steven D. Pearson, the president of ICER, said in a
statement. "Insurers were going to cover Zolgensma no matter the
price."
ICER's updated value-based price benchmark for Zolgensma assumes
that the treatment's effectiveness will be long lasting, and that
the US widely and rapidly adopts the recommendation to add
screening for SMA to routine newborn screening.
Zolgensma will compete with Biogen Inc.'s Spinraza, a life-long
treatment that requires an injection every four months.
Spinraza, until now the only approved treatment in the U.S. for
children and adults, is priced at $750,000 for the first year and
$375,000 a year after that.
SMA, as the hereditary disease is known for its acronym, is the
leading cause of infant deaths.
There are four primary types of SMA based on age when symptoms
first appear and highest milestone achieved. Many children with SMA
type 1, a severe form and most common type, don't survive past the
age of 2.
Write to Maria Armental at maria.armental@wsj.com
(END) Dow Jones Newswires
May 24, 2019 14:25 ET (18:25 GMT)
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