by Leslie Small
The month of October brought two important developments for
interchangeable biosimilars. On Oct. 15, the FDA approved Cyltezo (adalimumab-adbm), the first
interchangeable biosimilar version of blockbuster autoimmune condition
treatment Humira. And on Oct. 20, Cigna Corp.-owned Express Scripts revealed that it will now prefer Semglee (insulin
glargine-yfgn) — the first FDA-approved interchangeable biosimilar on the U.S.
market — over the branded long-acting insulin Lantus on the PBM’s largest
formulary.
Semglee gets PBM nod:
- Semglee initially was not approved as a biosimilar, and
the original drug had a wholesale acquisition cost (WAC) of $147. The new
interchangeable version has a distinct National Drug Code and a much
higher WAC of $404. Mesfin Tegenu, CEO and chairman of RxParadigm, tells
AIS Health that the drug’s increased price may have helped it get on
Express Scripts’ formulary, since PBMs often favor drugs with high list
prices that can command higher rebates.
- “The potential loser in this case might be the patient,
who potentially can get stuck with a higher copay or deductible. This is
how the rebate to net bubble keeps on inflating drug cost,” he says.
“Unfortunately, even biosimilars are not spared.”
- Still, Express Scripts’ move may have ripple effects,
suggests Elan Rubinstein, Pharm.D., principal at EB Rubinstein Associates.
“Because [Express Scripts] is one of the largest PBMs in the country,
these changes may influence the prescribing preferences of physicians, to
be less favorable to Lantus and Basalgar [an insulin that’s biologically
similar to Lantus], and to be more favorable to Semglee,” he says.
Cyltezo’s impact may be limited:
- The potential implications of Cyltezo’s approval as an
interchangeable biosimilar won’t be felt until at least mid-2023, when the
drug is set to launch in the U.S.
- Even when Cyltezo does launch, Renee Rayburg, R.Ph.,
vice president of specialty clinical consulting at Pharmaceutical
Strategies Group, points out that it is based on Humira’s original
formulation, before AbbVie reformulated it to be “citrate free,” creating
50% less volume of the injectable drug and allowing for a thinner needle.
- Rayburg says she examined drug utilization among a
handful of her firm’s employer clients and noticed that a large majority
of patients taking Humira are now on the citrate-free version. Therefore,
patients and prescribers may be reticent to voluntarily switch to Cyltezo
— and resistant if formulary changes essentially make that decision for
them.
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