Clinical Trials,
Journal Year:
2024,
Volume and Issue:
unknown
Published: July 24, 2024
Provisions
of
the
Inflation
Reduction
Act
mandating
drug
price
negotiation
by
Centers
for
Medicare
&
Medicaid
Services
have
been
criticized
as
a
threat
to
pharmaceutical
innovation.
This
study
models
potential
impacts
on
approvals
based
differential
contributions
large
companies
and
smaller
biotechnology
firms
clinical
trials
availability
capital.
Transplantation Direct,
Journal Year:
2025,
Volume and Issue:
11(6), P. e1805 - e1805
Published: May 12, 2025
Background.
A
major
contributor
to
increased
healthcare
spending
in
the
United
States
is
drug
pricing,
as
US
prices
are
nearly
3×
higher
than
those
other
countries.
This
cross-sectional
study
aimed
investigate
current
global
price
differences
liver
transplant
medications
and
provide
potential
cost
savings
for
Medicare
Part
D
if
international
reference
pricing
was
adopted.
Methods.
Publicly
available
formularies
Canada,
Kingdom,
Japan,
France,
Germany,
Italy,
Australia
were
used
collect
2024
8
commonly
(mycophenolate
mofetil,
mycophenolate
sodium,
sirolimus,
tacrolimus,
Advagraf,
Envarsus,
everolimus,
cyclosporine).
obtained
from
UptoDate’s
listed
representative
average
wholesale
D’s
2022.
Results.
The
spend
originator
4.1×
6.8×,
respectively,
G7
countries
Australia.
Adopting
per
dose
may
lead
an
estimated
$26
141
463
year
Medicare.
generic
2.76×
3.75×,
prices.
$363
538
474
Conclusions.
demonstrates
significantly
greater
financial
burden
that
patients
face
compared
with
7
industrial
Future
adoption
of
help
bridge
this
disparity.
Expert Review of Pharmacoeconomics & Outcomes Research,
Journal Year:
2024,
Volume and Issue:
24(4), P. 477 - 486
Published: Jan. 26, 2024
Introduction
As
drug
prices
are
viewed
to
be
opaque,
there
have
been
increasing
societal
demands
on
policy
and
decision
makers
implement
initiatives
that
promote
price
transparency.
The
Inflation
Reduction
Act
(IRA)
of
2022
contained
landmark
provisions
authorizing
government
to
negotiate
a
“maximum
fair
price”
for
selected
Medicare
Part
D
drugs
considering
the
manufacturer’s
research
and
development
costs,
federal
support
discovery
development,
extent
which
address
unmet
medical
needs,
other
factors.
This
working
paper
describes
investment
in
ten
price
negotiation
first
year
IRA
as
well
health
value
created
through
spending
on
these
drugs.
We
identified
$11.7
billion
NIH
funding
basic
or
applied
leading
approval
with
median
costs
$895.4
million/drug.
early
public
provided
cost
savings
industry
$1,485
million/drug,
comparable
reported
levels
by
industry.
From
2017-2021,
spent
$126.4
(median
$10.7
billion)
products
before
rebates.
Excluding
two
diabetes,
was
$97.4
total
650,940
QALYs
$67.7
(WTP/QALY=$104K)
representing
negative
residual
-$29.7
(before
rebates).
argue
that
negotiated
should
provide
returns
both
private
investments
commensurate
scale
risk
investments,
principal
return
sector
being
(net
price)
accruing
those
using
product.
These
empirical
data
basis
negotiating
rewards
innovation
provides
social
public.
JAMA Health Forum,
Journal Year:
2024,
Volume and Issue:
5(3), P. e240265 - e240265
Published: March 22, 2024
3][4][5]
The
JAMA
Network
recently
announced
the
call
for
candidates
to
serve
as
next
Editor
in
Chief
of
Health
Forum.
6I
strongly
encourage
colleagues
with
relevant
experience
who
are
passionate
about
advancing
health
policy
and
services
research
apply.Compared
2022,
7
total
number
manuscript
submissions
journal
increased
by
25%
1255
2023,
submitted
manuscripts
(Original
Investigations,
Brief
Reports,
Research
Letters)
also
rose
894
(Table
8
-15
).With
robust
growth
submissions,
journal's
acceptance
rate
has
dropped
from
26%
JAMA Internal Medicine,
Journal Year:
2023,
Volume and Issue:
183(6), P. 581 - 581
Published: April 17, 2023
Importance
Allowing
the
US
Centers
for
Medicare
&
Medicaid
Services
to
negotiate
prescription
drug
prices
may
improve
affordability.
Objective
To
estimate
savings
from
price
negotiation
under
Inflation
Reduction
Act
(IRA)
and
examine
opportunities
increase
savings.
Design,
Setting,
Participants
This
cross-sectional,
population-based
study
used
data
2020
claims.
The
was
conducted
were
analyzed
in
2022.
Exposures
Eligibility
IRA
alternative
criteria.
Main
Outcomes
Measures
Minimum
IRA’s
eligibility
criteria
estimated
compared
with
within
scenarios,
including
(1)
selecting
drugs
based
on
net
spending
after
rebates
rather
than
gross
spending;
(2)
extending
biosimilar
or
generic
competitors;
(3)
reducing
minimum
years
since
Food
Drug
Administration
approval
eligibility;
(4)
changing
2
3
of
these
factors.
Estimated
calculated
at
different
levels
scale-up
IRA,
10
Part
D
2026
60
B
2029.
Gross
using
dashboard.
Rebates
SSR
Health
data.
Information
FDA
approvals,
generics,
biosimilars
obtained
websites.
Results
Under
rules,
would
be
$3.2
billion.
For
2029
drugs,
$16.0
Selecting
associated
$4.6
billion
(a
45%
increase)
$18.9
(an
18%
Including
competitors
an
$6.6
109%
$24.9
56%
Making
both
changes
$9.5
200%
$28.3
77%
A
sensitivity
analysis
suggested
that
required
number
marketing
by
increased
4%
when
are
negotiated
12%
negotiated.
Changing
all
greatest
(119%
93%
drugs).
Conclusions
Relevance
results
this
cross-sectional
suggest
adjusting
permit
inclusion
a
promising
approach
substantially
Frontiers in Immunology,
Journal Year:
2023,
Volume and Issue:
14
Published: Sept. 26, 2023
Perioperative
(neoadjuvant
and
adjuvant)
pembrolizumab
has
shown
favorable
efficacy
in
patients
with
early-stage
non-small
cell
lung
cancer
(NSCLC).
This
study
aims
to
evaluate
the
cost-effectiveness
of
this
treatment
from
perspective
United
States
healthcare
payers.We
established
a
Markov
model
compare
perioperative
that
neoadjuvant
chemotherapy
21-day
cycles,
utilizing
data
phase
3
KEYNOTE-671
trial.
Additional
were
extracted
other
publications
or
online
sources.
Sensitivity
analyses
conducted
robustness
findings.
A
willingness-to-pay
threshold
$150,000
per
quality-adjusted
life-years
(QALYs)
gained
was
established.
The
main
outcomes
measurement
QALYs,
overall
costs,
incremental
ratio
(ICER),
net
monetary
benefit
(NMB).During
10-year
time
horizon,
total
costs
control
$224,779.1
$110,026.3,
respectively.
QALYs
4.19
2.97
for
two
treatments,
respectively,
which
led
an
ICER
$94,222.29
QALY
gained.
NMB
at
WTP
$67,931.3.
One-way
sensitivity
analysis
identified
cost
as
primary
factor
influencing
cost-effectiveness.
Probabilistic
indicated
97.7%
probability
being
cost-effective
threshold.From
payers,
is
NSCLC.
JACC Basic to Translational Science,
Journal Year:
2024,
Volume and Issue:
9(8), P. 1029 - 1040
Published: Feb. 21, 2024
Cardiovascular
disease
(CVD)
is
the
leading
cause
of
mortality
worldwide.
Therapeutic
agents,
such
as
those
that
lower
low-density
lipoprotein
cholesterol,
have
been
a
critical
factor
in
mitigating
CVD
event
risk
and
demonstrate
important
role
drug
discovery
plays
reducing
morbidity
mortality.
However,
rapidly
rising
development
costs,
diminishing
returns,
an
increasingly
challenging
regulatory
environment
all
contributed
to
declining
number
cardiovascular
(CV)
therapeutic
agents
entering
health
care
marketplace.
For
pharmaceutical
companies,
traditional
outcomes
trial
(CVOT)
can
be
major
financial
burden
impediment
CV
agent
development.
They
take
long
decade
conduct,
delaying
potential
investment
return
while
carrying
failure.
patients,
lengthy
CVOTs
delay
accessibility.
Without
cost-effective
CVOTs,
innovation
may
compromised,
with
patients
bearing
consequences.
This
paper
reviews
approaches
for
making
more
cost-effective.
Pharmacy,
Journal Year:
2023,
Volume and Issue:
11(6), P. 187 - 187
Published: Dec. 17, 2023
In
this
review,
we
examine
the
impact
of
Inflation
Reduction
Act
(IRA)
2022
on
pharmaceutical
drugs
in
United
States,
drawing
a
diverse
range
sources
to
understand
perceptions
multiple
stakeholders
and
professionals.
Findings
suggest
that
Act,
while
aiming
control
price
inflation,
has
had
multifaceted
sector.
Stakeholders,
including
companies,
healthcare
providers,
patient
advocacy
groups,
policymakers,
offered
varied
perspectives:
some
laud
for
its
potential
controlling
runaway
drug
prices
making
more
accessible,
others
raise
concerns
about
possible
reductions
innovation,
disruptions
supply
chains,
sustainability
smaller
companies.
The
review
identified
four
underlying
constructs
(themes)
literature
surrounding
stakeholders'
IRA's
upon
prescription
drugs:
pricing
and/or
dictation
issues,
topics
related
patent
law
pharmaceuticals,
processes
(2022)
rules
regulations,
threats
industry
concerning
research
development
future
medications.
complex
interplay
Act's
implications
underscores
importance
ongoing
assessment
iterative
policy
refinements
as
implementation
endures.