LS&HC Horizons 2023 - Flipbook - Page 67
Hogan Lovells | 2023 Life Sciences and Health Care Horizons | United States
67
Market access planning in the aftermath of the IRA
The U.S. Inflation Reduction Act of 2022 (IRA)
includes major provisions adding complexity
to market access, highlighting even more that
the first price set for the first version of
a product sets the pace.
A call to order
A pre-commercial product often has multiple
possible uses in development. The first
indication approved and launched can lock
in and limit the coverage, reimbursement,
and pricing options for subsequent indications.
And, now, in a post-IRA world, that first
approval also is likely to start the IRA’s nine(NDA) or thirteen- (BLA) year clock that
determines when price controls can
be imposed.
Medicare beneficiaries? New liabilities
and a discount
Medicare has different rules regarding
the coverage and reimbursement of drug
products, depending on whether a drug is to be
physician-administered or self-administered.
The IRA adds new rebate liabilities for
manufacturers in the form of Medicare Part B
and Part D inflation rebates.
The IRA also redesigned the Medicare Part
D benefit, lowering the beneficiary out-ofpocket threshold and replacing the current
manufacturer “coverage gap” discount program
with a new manufacturer discount program,
which will require manufacturers participating
in Part D to provide certain discounts off the
Part D negotiated price for applicable drugs.
Drug Price Negotiation Program (DPNP)
The IRA’s DPNP seeks to lower the prices
of certain high Medicare spend drugs without
generic/biosimilar competition. Qualifying
single source drugs – which are certain NDA
drugs at least seven years post-approval by
the selection date, and certain BLA biologics
at least eleven years post-licensure by the
selection date, with no generic/biosimilar on
the market (an “authorized generic drug” does
not count) – are eligible for selection under the
program. Orphan drugs for a single rare disease
are exempt.
A key takeaway is that a product’s first FDA
approval starts a potential nine- (NDA) or
thirteen- (BLA) year clock for “negotiation”.
This makes it even more important to
understand which indications, dosage forms,
and product strengths to pursue for a target
molecule, and in what order.
Melissa K. Bianchi
Partner, Washington, D.C.
Ken Choe
Partner, Washington, D.C.
Alice Valder Curran
Partner, Washington, D.C.
Beth L. Roberts
Partner, Washington, D.C.
Read our Engage article
for more insight on
impacts of the IRA.
