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A recent FDA approval of a
label expansion for Roche’s Evrysdi put the three marketed therapies for
spinal muscular atrophy (SMA) on equal footing for the youngest patients. And
a recent survey from Zitter Insights found that many payers are covering sequential use of the
costly agents, including a gene therapy.
Most payers don’t allow
combination therapies for SMA
- On May 30,
2022, the FDA expanded the Evrysdi’s SMA label to include the treatment
of infants less than 2 months old. That label expansion meant that
Evrysdi joined two other therapies — Biogen’s Spinraza and Novartis’
Zolgensma — in being indicated for infants with the most severe type of
SMA.
- In a survey
conducted before Evrysdi’s label expansion, Zitter Insights polled 25
neurologists. Eighty percent had prescribed Spinraza over the 12 months
prior to the survey, 68% had prescribed Evrysdi, and 44% had written a
script for Zolgensma.
- During the same
time frame, Zitter Insights also polled 36 commercial payers with 117.1
million covered lives and 26 Medicare payers with 38.6 million lives.
Respondents covering 92% of commercial lives said that they do not allow
the use of more than one SMA therapy at the same time.
- “Currently,
there are no published clinical trials that demonstrate the
effectiveness of combination therapy, so this survey result is not
surprising,” says Dea Belazi, Pharm.D., M.P.H., president and CEO of
AscellaHealth. “Since Evrysdi and Spinraza have similar mechanisms of
action, there currently does not appear to be a documented clinical
rationale supporting concurrent therapies.”
Evrysdi could edge out
Spinraza
- “The new
expanded indication now places Evrysdi on even indications with
Zolgensma with respect to starting age,” points out Winston Wong,
Pharm.D., president of W-Squared Group. “Evrysdi can be seen as an oral
form of Spinraza, impacting the SMN2 gene; is less expensive than Spinraza;
and potentially more effective than Spinraza.”
- “In my mind,
the market will continue to sequence between Zolgensma and Evrysdi,”
Wong continues. “I do not need see a niche for Spinraza.…Due to
Zolgensma correcting the SMN1 gene, over Evrysdi’s SMN2 gene, I see
Zolgensma being used first and then sequencing over to Evrysdi” except
in situations where “Zolgensma is not indicated due to the mutation not
meeting the indication criteria.”
- Evrysdi’s
broadened indication “expands the opportunity to begin treatment at home
rather than having to have to use the intrathecal (Spinraza) or the
infusion (Zolgensma) routes of administration,” observes Belazi.
- “Payers will
typically restrict these therapies through prior authorization using the
criteria from the pivotal clinical trials, which is typically more
restrictive than the FDA-labeled indication,” he explains. With the new
approval, “payers may need to review current coverage policies to
address both the current age requirement, as well symptomology and
symptom severity criteria.”
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