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Senate
File
264
-
Introduced
SENATE
FILE
264
BY
DONAHUE
,
CELSI
,
STAED
,
BENNETT
,
DOTZLER
,
WINCKLER
,
PETERSEN
,
BLAKE
,
TOWNSEND
,
TRONE
GARRIOTT
,
and
ZIMMER
A
BILL
FOR
An
Act
relating
to
prescription
drug
affordability,
including
1
the
creation
of
a
prescription
drug
affordability
board.
2
BE
IT
ENACTED
BY
THE
GENERAL
ASSEMBLY
OF
THE
STATE
OF
IOWA:
3
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Section
1.
NEW
SECTION
.
135S.1
Definitions.
1
As
used
in
this
chapter,
unless
the
context
otherwise
2
requires:
3
1.
“Biologic”
means
a
drug
that
is
produced
or
distributed
4
in
accordance
with
a
biologics
license
issued
under
42
C.F.R.
5
§601.4.
6
2.
“Biosimilar”
means
a
drug
that
is
produced
or
distributed
7
in
accordance
with
a
biologics
license
application
approved
8
under
42
C.F.R.
§262(k)(3).
9
3.
“Brand-name
drug”
means
a
drug
that
is
produced
or
10
distributed
in
accordance
with
an
original
new
drug
application
11
approved
under
21
U.S.C.
§355(c).
“Brand-name
drug”
does
not
12
include
an
authorized
generic
drug
as
defined
by
42
C.F.R.
13
§447.502.
14
4.
“Drug
product”
means
a
brand-name
drug,
a
generic
drug,
a
15
biologic
or
biosimilar,
or
an
over-the-counter
drug.
16
5.
“Employee
retirement
income
security
Act
plan”
or
“ERISA
17
plan”
means
any
self-funded
employee
welfare
benefit
plan
18
governed
by
the
requirements
of
the
Employee
Retirement
Income
19
Security
Act
of
1974,
as
codified
at
29
U.S.C.
§1001
et
seq.
20
6.
“Generic
drug”
means
any
of
the
following:
21
a.
A
retail
drug
that
is
marketed
or
distributed
in
22
accordance
with
an
abbreviated
new
drug
application,
approved
23
under
21
U.S.C.
§355(j).
24
b.
An
authorized
generic
drug
as
defined
by
42
C.F.R.
25
§447.502.
26
c.
A
drug
that
entered
the
market
before
1962
that
was
not
27
originally
marketed
under
a
new
drug
application.
28
7.
“Manufacturer”
means
an
entity
that
engages
in
the
29
manufacture
of
a
drug
product,
or
that
enters
into
a
lease
with
30
another
manufacturer
to
market
and
distribute
a
prescription
31
drug
product
under
the
entity’s
own
name,
and
that
sets
or
32
changes
the
wholesale
acquisition
cost
of
the
prescription
drug
33
product
it
manufactures
or
markets.
34
8.
“Over-the-counter
drug”
means
the
same
as
defined
in
42
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C.F.R.
§447.502.
1
9.
“Prescription
drug
affordability
board”
or
“board”
means
2
the
prescription
drug
affordability
board
created
in
section
3
135S.2.
4
10.
“Prescription
drug
affordability
stakeholder
council”
or
5
“stakeholder
council”
means
the
prescription
drug
affordability
6
stakeholder
council
created
in
section
135S.4.
7
11.
“Prescription
drug
product”
means
a
brand-name
drug,
a
8
generic
drug,
a
biologic,
or
a
biosimilar.
9
Sec.
2.
NEW
SECTION
.
135S.2
Prescription
drug
affordability
10
board.
11
1.
A
prescription
drug
affordability
board
is
created
12
for
the
purpose
of
protecting
state
residents,
particularly
13
patients
experiencing
physical
and
mental
illnesses
and
14
communities
affected
by
the
opioid
crisis;
state
and
local
15
governments;
commercial
health
plans;
health
care
providers;
16
pharmacies;
and
other
stakeholders
within
the
health
care
17
system
from
the
high
costs
of
prescription
drug
products.
18
2.
The
board
shall
be
composed
of
five
members,
appointed
by
19
the
governor,
subject
to
confirmation
by
the
senate,
who
have
20
expertise
in
health
care,
health
care
economics,
or
clinical
21
medicine.
A
member
shall
not
be
an
employee
of,
a
board
member
22
of,
or
a
consultant
to,
a
manufacturer
or
trade
association
23
for
manufacturers.
Any
conflict
of
interest,
including
24
whether
an
individual
has
an
association
such
as
a
financial
25
or
personal
association
that
has
the
potential
to
bias
or
has
26
the
appearance
of
biasing
the
individual’s
decisions
in
matters
27
related
to
the
board
or
the
conduct
of
the
board’s
activities
28
shall
be
disclosed
and
considered
when
appointing
members
to
29
the
board.
30
3.
The
members
shall
serve
five-year
terms
beginning
and
31
ending
as
provided
in
section
69.19.
Membership
on
the
board
32
shall
be
bipartisan
as
provided
in
section
69.16.
Vacancies
33
shall
be
filed
in
the
manner
of
the
original
appointment.
The
34
board
shall
select
a
chairperson
annually.
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4.
The
board
shall
hire
an
executive
director,
general
1
counsel,
and
staff
to
support
the
board’s
activities,
who
shall
2
each
receive
a
salary
as
provided
in
the
budget
for
the
board.
3
Each
member
of
the
board
shall
receive
a
per
diem
and
shall
be
4
reimbursed
for
all
actual
and
necessary
expenses
incurred
in
5
the
performance
of
their
duties
as
a
member.
6
5.
A
majority
of
the
members
of
the
board
shall
constitute
7
a
quorum
for
the
purposes
of
conducting
the
business
of
the
8
board.
9
6.
The
board
shall
meet
in
open
session
at
least
four
times
10
annually
to
review
prescription
drug
product
information.
The
11
following
provisions
shall
also
apply
to
meetings
of
the
board:
12
a.
The
chairperson
may
cancel
or
postpone
a
meeting
if
there
13
is
no
business
to
transact.
14
b.
The
following
actions
by
the
board
shall
be
made
in
open
15
session:
16
(1)
Deliberations
on
whether
to
subject
a
prescription
drug
17
product
to
an
affordability
review.
18
(2)
Any
vote
on
whether
to
recommend
imposing
an
upper
19
payment
limit
on
purchases
and
payer
reimbursements
of
20
prescription
drug
products
in
the
state.
21
(3)
Any
significant
decision
by
the
board.
22
7.
The
board
may
meet
in
closed
session
to
discuss
23
proprietary
data
and
information.
24
8.
The
board
shall
provide
public
notice
of
each
board
25
meeting
at
least
two
weeks
in
advance
of
the
meeting.
26
Materials
for
each
meeting
shall
be
made
available
to
the
27
public
at
least
one
week
in
advance
of
the
meeting.
28
9.
The
board
shall
provide
an
opportunity
for
public
comment
29
at
each
open
meeting
of
the
board.
The
board
shall
provide
30
the
public
with
the
opportunity
to
submit
written
comments
on
31
pending
decisions
of
the
board.
32
10.
The
board
may
allow
expert
testimony
at
its
meetings,
33
including
when
the
board
meets
in
closed
session.
34
11.
a.
Members
of
the
board
shall
recuse
themselves
from
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decisions
related
to
prescription
drug
products
if
the
member,
1
or
an
immediate
family
member
of
the
member,
has
received
or
2
could
receive
either
of
the
following:
3
(1)
A
direct
financial
benefit
of
any
amount
deriving
from
4
the
result
or
finding
of
a
study
or
determination
by
or
for
the
5
board.
6
(2)
A
financial
benefit
from
any
person
that
owns,
7
manufactures,
or
provides
prescription
drug
products,
services,
8
or
items
to
be
studied
by
the
board
that
in
the
aggregate
9
exceeds
five
thousand
dollars
per
year.
10
b.
For
the
purposes
of
this
subsection,
a
financial
benefit
11
includes
honoraria,
fees,
stock,
the
value
of
the
member’s
12
or
immediate
family
member’s
stock
holdings,
and
any
direct
13
financial
benefit
deriving
from
the
finding
of
a
review
14
conducted
pursuant
to
this
chapter.
15
12.
a.
A
conflict
of
interest
shall
be
disclosed
by
the
16
board
when
hiring
board
staff,
by
the
appointing
authority
when
17
appointing
members
to
the
board
and
to
the
stakeholder
council,
18
and
by
the
board
when
a
member
of
the
board
is
recused
in
any
19
final
decision
resulting
from
a
review
of
a
prescription
drug
20
product.
A
conflict
of
interest
shall
be
disclosed
in
advance
21
of
the
first
open
meeting
after
the
conflict
is
identified
or
22
within
five
days
after
the
conflict
is
identified,
whichever
23
is
sooner.
24
b.
A
conflict
of
interest
disclosed
pursuant
to
this
section
25
shall
be
posted
on
the
internet
site
of
the
board
unless
the
26
chair
of
the
board
recuses
the
member
from
any
final
decision
27
resulting
from
a
review
of
a
prescription
drug
product.
Such
28
posting
shall
include
the
type,
nature,
and
magnitude
of
the
29
interests
of
the
member
involved.
30
13.
Members
of
the
board,
the
executive
director,
the
31
general
counsel,
board
staff,
and
third-party
contractors
shall
32
not
accept
any
gift
or
donation
of
services
or
property
that
33
indicates
a
potential
conflict
of
interest,
or
that
has
the
34
appearance
of
biasing
the
work
of
the
board.
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Sec.
3.
NEW
SECTION
.
135S.3
Powers
and
duties
of
the
board.
1
1.
To
the
extent
practicable,
the
board
shall
access
pricing
2
information
for
prescription
drug
products
by
doing
all
of
the
3
following:
4
a.
Entering
into
a
memorandum
of
understanding
with
5
another
state
to
which
manufacturers
already
report
pricing
6
information.
7
b.
Assessing
spending
for
prescription
drugs
in
the
state.
8
c.
Accessing
other
available
pricing
information
based
on
9
state
reporting
and
transparency
requirements.
10
2.
The
board
may
enter
into
a
contract
with
a
qualified,
11
independent
third
party
for
any
service
necessary
to
carry
12
out
the
powers
and
duties
of
the
board.
Unless
permission
is
13
granted
by
the
board,
a
third
party
hired
by
the
board
shall
14
not
release,
publish,
or
otherwise
use
any
information
to
which
15
the
third
party
has
access
under
its
contract
with
the
board.
16
3.
The
board
shall
adopt
rules
pursuant
to
chapter
17A
to
17
administer
this
chapter.
18
Sec.
4.
NEW
SECTION
.
135S.4
Prescription
drug
affordability
19
stakeholder
council.
20
1.
The
board
shall
create
a
prescription
drug
affordability
21
stakeholder
council
for
the
purpose
of
providing
stakeholder
22
input
to
assist
the
board
in
making
decisions
as
required
23
under
this
chapter.
The
stakeholder
council
shall
consist
of
24
nineteen
members
appointed
in
accordance
with
this
section.
25
Members
shall
include
manufacturers
of
brand-name
and
generic
26
prescription
drugs,
health
care
providers
that
dispense
or
27
administer
prescription
drugs,
prescription
drug
suppliers,
28
and
consumers
of
prescription
drugs.
A
single
organization
29
or
entity
shall
not
be
represented
by
more
than
one
council
30
member.
31
2.
a.
Three
members
shall
be
appointed
by
the
majority
32
leader
of
the
senate,
two
members
shall
be
appointed
by
the
33
minority
leader
of
the
senate,
four
members
shall
be
appointed
34
by
the
speaker
of
the
house
of
representatives,
three
members
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264
shall
be
appointed
by
the
minority
leader
of
the
house
of
1
representatives,
and
seven
members
shall
be
appointed
by
the
2
governor,
subject
to
confirmation
by
the
senate.
3
b.
The
members
of
the
stakeholder
council
shall
have
4
knowledge
in
one
or
more
of
the
following
subjects:
5
(1)
The
pharmaceutical
business
model.
6
(2)
Supply
chain
business
models.
7
(3)
The
practice
of
medicine
or
clinical
training.
8
(4)
Consumer
or
patient
perspectives.
9
(5)
Health
care
costs
trends
and
drivers.
10
(6)
Clinical
and
health
services
research.
11
(7)
The
state’s
health
care
marketplace.
12
c.
The
stakeholder
council
shall
select
a
chairperson
and
13
a
co-chairperson
annually
from
the
council
membership.
The
14
members
shall
serve
three-year
staggered
terms.
15
d.
A
member
of
the
stakeholder
council
shall
not
receive
16
a
per
diem
but
shall
be
reimbursed
for
actual
and
necessary
17
expenses
incurred
in
the
performance
of
duties
as
a
member.
18
Sec.
5.
NEW
SECTION
.
135S.5
Drug
cost
affordability
review.
19
1.
The
board
shall
identify
the
following
prescription
drug
20
products
offered
for
sale
in
the
state:
21
a.
Brand-name
drugs
or
biologics
that,
as
adjusted
annually
22
for
inflation
in
accordance
with
the
consumer
price
index,
have
23
a
launch
wholesale
acquisition
cost
of
thirty
thousand
dollars
24
or
more
per
year
or
per
course
of
treatment,
or
a
wholesale
25
acquisition
cost
increase
of
three
thousand
dollars
or
more
in
26
any
consecutive
twelve-month
period.
27
b.
Biosimilar
drugs
that
have
a
launch
wholesale
acquisition
28
cost
that
is
not
at
least
fifteen
percent
lower
than
the
29
referenced
brand
biologic
at
the
time
the
biosimilar
is
30
launched.
31
c.
(1)
Generic
drugs
that,
as
adjusted
for
inflation
in
32
accordance
with
the
consumer
price
index,
have
a
wholesale
33
acquisition
cost
of
one
hundred
dollars
or
more
for
any
of
the
34
following:
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(a)
A
thirty-day
supply
lasting
a
patient
for
a
period
1
of
thirty
consecutive
days
based
on
the
recommended
dosage
2
approved
for
labeling
by
the
United
States
food
and
drug
3
administration.
4
(b)
A
supply
lasting
a
patient
fewer
than
thirty
consecutive
5
days
based
on
the
recommended
dosage
approved
for
labeling
by
6
the
United
States
food
and
drug
administration.
7
(c)
One
unit
of
the
drug
if
the
labeling
approved
by
the
8
United
States
food
and
drug
administration
does
not
recommend
9
any
finite
dosage.
10
(2)
Generic
drugs
that,
as
adjusted
for
inflation
in
11
accordance
with
the
consumer
price
index,
have
a
wholesale
12
acquisition
cost
that
increased
by
two
hundred
percent
or
13
more
during
the
immediately
preceding
twelve-month
period,
as
14
determined
by
the
difference
between
the
resulting
wholesale
15
acquisition
cost
and
the
average
of
the
wholesale
acquisition
16
cost
reported
over
the
immediately
preceding
twelve
months.
17
d.
Other
prescription
drug
products
that
may
create
18
affordability
challenges
for
the
state
health
care
system
and
19
for
patients,
including
drugs
used
to
address
public
health
20
emergencies.
21
2.
a.
After
identifying
prescription
drug
products
as
22
required
by
subsection
1,
the
board
shall
determine
whether
23
to
conduct
an
affordability
review
for
each
identified
24
prescription
drug
product
by
seeking
stakeholder
council
input
25
about
the
prescription
drug
product
and
considering
the
average
26
patient
cost
share
of
the
prescription
drug
product.
27
b.
Relevant
information
for
conducting
an
affordability
28
review
may
include
any
document
or
research
related
to
the
29
manufacturer’s
selection
of
the
introductory
price
or
a
price
30
increase
of
the
prescription
drug
product,
including
lifecycle
31
management,
net
average
prices
in
the
state,
market
competition
32
and
context,
projected
revenue,
and
the
estimated
value
or
cost
33
effectiveness
of
the
prescription
drug
product.
Failure
of
a
34
manufacturer
to
provide
the
board
with
relevant
information
for
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an
affordability
review
shall
not
affect
the
board’s
authority
1
to
conduct
such
a
review.
2
3.
An
affordability
review
conducted
by
the
board
shall
3
determine
whether
the
prescription
drug
product
that
is
fully
4
consistent
with
the
labeling
approved
by
the
United
States
food
5
and
drug
administration
or
standard
medical
practice
has
led
or
6
will
lead
to
affordability
challenges
for
the
state
health
care
7
system
or
high
out-of-pocket
costs
for
patients.
To
the
extent
8
practicable,
in
determining
whether
a
prescription
drug
product
9
has
led
or
will
lead
to
an
affordability
challenge,
the
board
10
shall
consider
the
following
factors:
11
a.
The
wholesale
acquisition
cost
for
the
prescription
drug
12
product
sold
in
the
state.
13
b.
The
average
monetary
price
concession,
discount,
or
14
rebate
the
manufacturer
provides,
or
is
expected
to
provide,
15
to
health
plans
in
the
state
as
reported
by
manufacturers
16
and
health
plans,
expressed
as
a
percentage
of
the
wholesale
17
acquisition
cost
for
the
prescription
drug
product
under
18
review.
19
c.
The
total
amount
of
the
price
concession,
discount,
or
20
rebate
the
manufacturer
provides
to
each
pharmacy
benefits
21
manager
operating
in
the
state
for
the
prescription
drug
22
product
under
review,
as
reported
by
manufacturers
and
pharmacy
23
benefits
managers,
expressed
as
a
percentage
of
the
wholesale
24
acquisition
cost
for
the
prescription
drug
under
review.
25
d.
The
price
at
which
therapeutic
alternatives
have
been
26
sold
in
the
state.
27
e.
The
average
monetary
concession,
discount,
or
rebate
the
28
manufacturer
provides,
or
is
expected
to
provide,
to
health
29
plan
payors
and
pharmacy
benefits
managers
in
the
state
for
30
therapeutic
alternatives.
31
f.
The
cost
to
health
plans
based
on
patient
access
32
consistent
with
the
United
State
food
and
drug
administration
33
label
indications
and
recognized
standard
medical
practice.
34
g.
The
impact
on
patient
access
resulting
from
the
cost
of
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the
prescription
drug
product
relative
to
insurance
benefit
1
design.
2
h.
The
current
or
expected
dollar
value
of
drug-specific
3
patient
access
programs
that
are
supported
by
the
manufacturer.
4
i.
The
relative
financial
impacts
to
the
costs
of
health,
5
medical,
or
social
services
as
can
be
quantified
and
compared
6
to
baseline
effects
of
existing
therapeutic
alternatives.
7
j.
The
average
patient
copay
or
other
cost-sharing
for
the
8
prescription
drug
product
in
the
state.
9
k.
Any
information
a
manufacturer
chooses
to
provide.
10
l.
Any
other
factors
as
determined
by
the
board
through
11
rules
adopted
by
the
board.
12
4.
If
the
board
finds
that
the
spending
on
a
prescription
13
drug
product
reviewed
under
this
section
has
led
or
will
lead
14
to
an
affordability
challenge,
the
board
shall
submit
a
report
15
to
the
general
assembly
of
the
board’s
findings,
including
16
a
recommended
upper
payment
limit
for
the
prescription
drug
17
product.
The
upper
payment
limit
recommendation
shall
be
made
18
after
considering
the
cost
of
administering
the
prescription
19
drug
product,
the
cost
of
delivering
the
prescription
drug
20
product
to
consumers,
and
other
relevant
administrative
costs
21
related
to
the
prescription
drug
product.
22
5.
Any
information
submitted
to
the
board
in
accordance
with
23
this
section
shall
be
subject
to
public
inspection
only
to
the
24
extent
provided
under
section
22.1.
25
6.
This
section
shall
not
be
construed
to
prevent
a
26
manufacturer
from
marketing
a
prescription
drug
product
27
approved
by
the
United
States
food
and
drug
administration
in
28
this
state
while
the
prescription
drug
product
is
under
review
29
by
the
board.
30
Sec.
6.
NEW
SECTION
.
135S.6
Reporting
requirements.
31
1.
On
or
before
December
31,
2025,
and
annually
thereafter,
32
the
board
shall
submit
a
report
to
the
general
assembly
that
33
includes
all
of
the
following:
34
a.
Price
trends
for
prescription
drug
products
sold,
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distributed,
and
administered
in
the
state.
1
b.
Any
recommendations
regarding
further
legislation
needed
2
to
improve
prescription
drug
affordability
in
the
state.
3
2.
On
or
before
July
1,
2026,
the
board
shall
submit
4
a
report
to
the
general
assembly
on
the
operation
of
the
5
generic
drug
market
in
the
United
States,
including
a
review
6
of
physician-administered
drugs,
that
considers
the
prices
of
7
generic
drugs
on
a
year-over-year
basis,
the
degree
to
which
8
generic
drug
prices
affect
yearly
insurance
premium
changes,
9
annual
changes
in
insurance
cost-sharing
for
generic
drugs,
10
the
potential
for
and
history
of
drug
shortages,
the
degree
11
to
which
generic
drug
prices
affect
yearly
state
Medicaid
12
spending,
and
any
other
relevant
issues.
13
EXPLANATION
14
The
inclusion
of
this
explanation
does
not
constitute
agreement
with
15
the
explanation’s
substance
by
the
members
of
the
general
assembly.
16
This
bill
relates
to
prescription
drug
affordability
17
measures,
including
the
creation
of
a
prescription
drug
18
affordability
board.
19
The
bill
provides
definitions
used
in
the
bill.
20
The
bill
creates
the
prescription
drug
affordability
board
21
(board)
for
the
purpose
of
protecting
stakeholders
within
the
22
health
care
system
from
the
high
costs
of
prescription
drug
23
products
(product
or
products).
The
bill
provides
for
the
24
membership
and
functioning
of
the
board;
the
hiring
of
an
25
executive
director
and
other
staff
for
the
board;
salaries,
26
per
diems,
and
reimbursement
of
expenses
of
the
executive
27
director,
general
counsel,
staff,
and
members;
and
other
28
provisions
that
apply
to
the
meetings
of
the
board.
The
board
29
shall
meet
in
open
session
at
least
four
times
annually
to
30
review
product
information,
and
may
meet
in
closed
session
to
31
discuss
proprietary
data
and
information.
The
board
shall
32
provide
public
notice
of
each
board
meeting
at
least
two
weeks
33
in
advance
of
the
meeting,
make
materials
for
each
meeting
34
available
to
the
public
in
advance
of
the
meeting,
provide
an
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opportunity
for
public
comment
at
each
open
meeting
of
the
1
board,
and
provide
the
opportunity
for
the
public
to
submit
2
written
comments
on
pending
decisions
of
the
board.
3
The
board
may
allow
expert
testimony
at
its
meetings,
4
including
when
the
board
meets
in
closed
session.
Members
5
of
the
board
shall
recuse
themselves
from
decisions
related
6
to
products
if
the
member,
or
an
immediate
family
member
of
7
the
member,
has
received
or
could
receive
certain
financial
8
benefits
from
the
work
of
the
board.
The
bill
provides
for
9
disclosure
of
conflicts
of
interest
relative
to
the
work
of
the
10
board,
and
prohibits
the
members
of
the
board,
the
executive
11
director,
the
general
counsel,
board
staff,
and
third-party
12
contractors
from
accepting
certain
gifts
or
donations.
13
The
bill
provides
that,
to
the
extent
practicable,
the
board
14
shall
access
pricing
information
for
products
through
various
15
means
as
described
in
the
bill.
The
board
may
enter
into
a
16
contract
with
a
qualified,
independent
third
party
for
any
17
service
necessary
to
carry
out
the
powers
and
duties
of
the
18
board,
and
shall
adopt
rules
to
administer
the
bill.
19
The
bill
requires
the
board
to
create
a
prescription
drug
20
affordability
stakeholder
council
(council)
to
assist
the
21
board
in
making
decisions.
The
council
shall
consist
of
19
22
members
including
manufacturers
of
brand-name
and
generic
23
prescription
drugs,
providers
that
dispense
or
administer
24
prescription
drugs,
prescription
drug
suppliers,
and
consumers
25
of
prescription
drugs.
Members
are
appointed
by
the
majority
26
leader
of
the
senate,
the
minority
leader
of
the
senate,
the
27
speaker
of
the
house
of
representatives,
the
minority
leader
of
28
the
house
of
representatives,
and
the
governor.
The
members
of
29
the
council
shall
have
knowledge
in
certain
areas
as
specified
30
in
the
bill.
The
bill
provides
for
the
annual
selection
of
a
31
chairperson
and
co-chairperson,
terms,
and
reimbursement
of
32
actual
and
necessary
expenses
of
the
members.
33
The
board
is
required
to
identify
certain
brand-name
drugs
34
or
biologics,
biosimilars,
generic
drugs,
and
other
products
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that
may
create
affordability
challenges
for
the
state
health
1
care
system
and
for
patients,
including
drugs
used
to
address
2
public
health
emergencies.
3
After
identifying
the
products,
the
board
shall
determine
4
whether
to
conduct
an
affordability
review
by
seeking
council
5
input
about
the
product
and
considering
the
average
patient
6
cost
share
of
the
product.
The
bill
specifies
relevant
7
information
that
may
be
included
in
conducting
an
affordability
8
review.
If
the
board
finds
that
the
spending
on
a
product
9
reviewed
has
led
or
will
lead
to
an
affordability
challenge,
10
the
board
shall
submit
a
report
to
the
general
assembly
of
the
11
board’s
findings,
including
a
recommended
upper
payment
limit.
12
The
upper
pay
limit
for
the
product
shall
be
determined
by
13
considering
the
cost
of
administering
the
product,
the
cost
14
of
delivering
the
product
to
consumers,
and
other
relevant
15
administrative
costs
related
to
the
product.
Any
information
16
submitted
to
the
board
in
accordance
with
the
bill
is
subject
17
to
public
inspection
only
to
the
extent
provided
under
the
18
state’s
open
records
law.
19
The
bill
requires
the
board,
on
or
before
December
31,
2025,
20
and
annually
thereafter,
to
submit
to
the
general
assembly
a
21
report
that
includes
price
trends
for
products
in
the
state;
22
and
any
recommendations
regarding
further
legislation
needed
23
to
improve
prescription
drug
affordability
in
the
state.
On
24
or
before
July
1,
2026,
the
board
shall
submit
a
report,
as
25
described
in
the
bill,
to
the
general
assembly
on
the
operation
26
of
the
generic
drug
market
in
the
United
States.
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