July goal set for final US Medicare drug negotiation guidance
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[April 13, 2023]
By Ahmed Aboulenein
WASHINGTON (Reuters) - The U.S. government aims to publish the final
guidance for its Medicare drug price negotiation program in early July
and is currently talking to companies about its contents, a top health
official said on Wednesday.
The guidance will finalize the details of how President Joe Biden's
signature drug pricing reform will be carried out. The U.S. Centers for
Medicare and Medicaid (CMS) released a draft in March and gave a 30-day
window for public comments. It is unclear how much will change in the
final guidance.
The agency is accepting feedback until Friday and has already been
talking to drugmakers and other stakeholders over the past few months,
CMS Administrator Chiquita Brooks-LaSure said in an interview.
CMS will select in September Medicare's 10 costliest prescription
medicines, based on gross spending, for negotiating price cuts that will
go into effect in 2026.
Companies are trying to get more details around how CMS will measure
what and how big the benefits of their drugs are, she said, as well as
the kind of data they will have to provide.
Other industry concerns, Brooks-LaSure said, include how the negotiation
process will affect drugs in the same class as those that are selected
for negotiation.
"Let's say one of the 10 we choose is for hypertension," she said. "How
will that affect the other drugs in that same class that we won't be
negotiating directly on? What will be some of those implications?"
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Used blister packets that contained
medicines, tablets and pills are seen, in this picture illustration
taken June 30, 2018. REUTERS/Russell Boyce/Illustration/File Photo
The program was established under
the Inflation Reduction Act, signed into law last year. It will for
the first time allow Medicare, the government health insurance
program for Americans age 65 and older, to negotiate prices on
prescription drugs.
In drafting the guidance, Brooks-LaSure said the agency was
deliberately focused on closing potential loopholes companies could
use to get around being selected for negotiations.
The draft guidance showed the agency would include spending on all
formulations or dosage forms of a drug, even if it received a
separate U.S. Food and Drug Administration (FDA) approval for a
different use.
"We are very focused on making sure that at the end of the day, this
negotiation process is effective, and that means that it delivers
lower costs for the people who are on the program, Medicare
beneficiaries, as well as for the program as a whole."
(Reporting by Ahmed Aboulenein; Editing by Michael Erman and Sonali
Paul)
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