Barely a month after Novartis (NVS) won U.S. regulatory approval for its gene therapy — the most expensive in the world — nearly a dozen insurers are taking steps to restrict coverage, a trend that is concerning for gene therapies more broadly, according to a Wall Street analyst.
At issue is Zolgensma, a gene therapy product for infants with spinal muscular atrophy, or SMA, an inherited disease that causes progressive loss of muscle function. The most severe form of SMA causes infants to die or need permanent breathing support by the age of 2. The “one-and-done” treatment is considered a miracle cure by some, but the $2.125 million price tag is controversial.
And here is one example of how that controversy is playing out. So far, 11 of the 30 largest insurers — which represent about 75% of people who are covered by commercial health plans — agreed to cover the treatment, but most payers have established criteria that are narrower than the approved product labeling, according to Bernstein analyst Ronny Gal, who analyzed the coverage decisions.
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Just as pharma companies have espoused the mantra “we don’t want to leave money on the table,” should we be surprised to observe that the insurers are reticent “to put money on the table.” Two opposites, time will tell where they meet.