Compounded ingredient costs: PBMs take action
In response to rising compounding drug costs, pharmacy benefit
managers, such as Express Scripts, have made moves to restrict their coverage
for active ingredients used by compounding pharmacies.
The Wall Street Journal reported
that Express Scripts will block coverage for about 1,000 active ingredients that
are used by compounding pharmacies.
But more important than the issue of cost/waste with compounds is
a rapidly growing concern relative to the safety of individuals for whom these
products are prescribed, according to FormularyWatch clinical editor
David Calabrese, RPh, MHP, vice president and chief pharmacy officer for
Catamaran.
“Compounds are not FDA approved and as such they are not subject
to the same rigorous standards of quality, potency, purity and stability in the
manufacturing process as commercially-produced drugs,” Calabrese said.
“Additionally, there is typically very little, if any, evidence
from sound clinical studies supporting the safety and effectiveness of these
products,” he said. “And, as compound use has risen, many organizations are
seeing compounding practices that are certainly raising eyebrows for all
stakeholders as cause for concern.”
According to Calabrese, these practices include, but are not
limited to:
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Utilizing active ingredients in compounds that have never been FDA evaluated or even tested in a dermatologic route of administration (eg, anticonvulsants, antidepressants, narcotics)
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Combining upward of 10 to 15 different active ingredients into a single compounded product
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Combining different drugs from the same drug class in a compound
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Production of topical compounds with potency of active ingredients 10- to 20-fold that of a commercially manufactured, FDA-approved alternative
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Bribes/kickbacks to doctors by compounding pharmacies to prescribe compounded products
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