by Angela Maas
With the first therapy
north of $1 million gaining FDA approval last month, payers likely will
implement a variety of strategies to manage Zolgensma (onasemnogene
abeparvovec-xioi), a one-time gene therapy from AveXis, Inc., a Novartis
company. For now, many uncertainties exist with respect to the new treatment
and what its place will be in spinal muscular atrophy (SMA) care.
According to Lee
Newcomer, M.D., principal at Lee N. Newcomer Consulting LLC, payers likely will
implement "strict enforcement of the label restrictions, advisory panels
to develop clinical criteria for therapy [and] highly specific provider
networks to ensure that the therapies are given correctly."
When it comes to payer
strategies, "unlike other conditions, where there might be alternatives
that warrant prior authorization or step therapy, here I expect there to be
limited management and more care coordination," Alex Shekhdar, founder of
Sycamore Creek Healthcare Advisors, tells AIS Health.
"If I were a payer,
I would definitely use prior-authorization for this, but given the nature of
the therapy, you can't use step edits — it doesn't really make sense
clinically," says an industry expert who declines to be identified.
"But prior authorization really needs to occur extremely quickly."
"Plans will likely
implement a medical policy to ensure appropriate use and ensure adequate
monitoring," says April M. Kunze, Pharm.D., senior director, clinical
formulary development and trend management strategy at Prime Therapeutics LLC. "This
is a one-time IV infusion; any repeated administration has not been evaluated
and will likely not be covered until there is data to support that use."
One concern among some
payers is whether members will attempt to be treated with both Zolgensma and
Spinraza (nusinersen), another expensive therapy for SMA. "It's not clear
yet if the combination or the sequence is better care until further studies are
completed," says Newcomer.
From RADAR on Pharmacy Specialty
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