In executive orders released July 24, the Trump administration
renewed its push toward a signature campaign issue: lowering drug prices. The
three executive orders call for regulations allowing drugs to be imported from
other countries, requiring Federally Qualified Health Centers to make insulin
and epinephrine available to low-income members of the public at the discounted
prices set by the 340B Drug Pricing Program, and removing safe harbor
protections under the Anti-Kickback Statue for prescription drug rebates in
Medicare Part D.
"I think that what you have here is a collection of
policies that are intended to make noise, but will have little to no practical
effect on drug prices before the election," Avalere founder Dan Mendelson
says.
Marc Samuels, CEO of ADVI, says that the proposals seem
half-baked, and will likely draw strong opposition. "These executive
orders are consistent with the previous [drug pricing] blueprint adopted by the
Administration and debated in part in Congress. But having the authority to
make quick changes doesn’t mean doing so is a good idea, especially so close to
an election," he says.
The idea of importing drugs from other developed countries, and
relying on their drug safety inspection regimes, has popped up in the past.
Mendelson, who ran the health division of the Office of Management and Budget
between 1998 and 2000, says that although the Clinton administration considered
the idea seriously, it found that it wasn't feasible.
"We looked at it and rejected the policy because we were
concerned that it wouldn't work, and that in fact it would not only compromise
the pharmaceutical supply chain but also likely be rejected by the very
countries we would want to import the drugs from," Mendelson explains.
The rebate order addresses a persistent challenge for the
administration. And Citi analyst Ralph Giacobbe is skeptical that the proposal will
actually manifest substantial changes in the way PBMs do business.
"While this will resurrect some debate on the PBM business
model, we see the likelihood as either low or limited in scope," Giacobbe
wrote in a note. "Additionally, [with] the language of HHS having to
confirm that this action does not increase federal spending, Medicare
beneficiary premiums or out-of-pocket cost may make it a moot point since
premiums will definitively rise, in our opinion."
A fourth executive order would tie drug prices to their list
prices in countries with Most Favored Nation status. That order has not yet
been released, but could be in the coming weeks.
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