Legislature(2017 - 2018)BELTZ 105 (TSBldg)
03/07/2017 01:30 PM Senate LABOR & COMMERCE
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| Audio | Topic |
|---|---|
| Start | |
| SB16 | |
| SB32 | |
| Adjourn |
* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
+ teleconferenced
= bill was previously heard/scheduled
| *+ | SB 16 | TELECONFERENCED | |
| + | SB 32 | TELECONFERENCED | |
| + | TELECONFERENCED | ||
SB 32-PRESCRIPTIONS FOR BIOLOGICAL PRODUCTS
2:10:18 PM
CHAIR COSTELLO reconvened the meeting and announced the
consideration of SB 32. She noted that this is the first
hearing. The intent is to hear from the sponsor, take questions,
and hear public testimony.
2:11:16 PM
SENATOR SHELLY HUGHES, Alaska State Legislature, sponsor of SB
32, introduced SB 32 speaking to the following sponsor
statement:
Senate Bill 32 allows for Alaskans to have access to
safe, new, and effective treatment options called
interchangeable biological products. Under current
state law, pharmacists are allowed to substitute a
generic product for drugs that are identical to their
proprietary product, but cannot do the same with
interchangeable biological products. Under SB 32,
pharmacists will be able to dispense an FDA approved
interchangeable product as a substitute for the
proprietary biological product.
Due to the complexity and nature of biological
products, an exact replication of these drugs is
impossible, so a new category of interchangeable
products was created by the FDA. This category of drug
allows for pharmaceutical companies to create safe and
affordable substitutes for drugs that help treat
conditions including cancer, multiple sclerosis,
severe rheumatoid arthritis, heart disease, and other
immune system, neurological and hematologic disorders.
In addition to the clear benefits to patients, the
lower costs and competition should also bring
measurable costs savings to Alaska's Medicaid program
and budget. The Center for Medicare and Medicaid
Services recommends that state Medicaid programs "view
the launch of biosimilar biological products as a
unique opportunity to achieve measurable cost savings
and greater beneficiary access to expensive
therapeutic treatments for chronic conditions."
SB 32 allows pharmacists to dispense interchangeable
biological products if they communicate this with the
prescribing doctor. This bill only allows a pharmacist
to substitute an interchangeable product if it is
approved by the FDA, and it allows for doctors to
require the pharmacist to only dispense the
proprietary product if they feel it is a more
effective option.
Patient consent will also be required before any
substitution is made for an interchangeable over the
proprietary product. Senate Bill 32 allows for
Alaskans to have access to safe, new, and effective
treatment options called interchangeable biological
products. Under current state law, pharmacists are
allowed to substitute a generic product for drugs that
are identical to their proprietary product, but cannot
do the same with interchangeable biological products.
Under SB 32, pharmacists will be able to dispense an
FDA approved interchangeable product as a substitute
for the proprietary biological product.
It is important for Alaska to address this issue now
as more interchangeable products become available to
patients. Senate Bill 32 will allow for new and
effective options at a lower cost, without
jeopardizing patient safety, and will allow for
measurable Medicaid and budget savings for the State.
Please join in supporting access to an affordable
medication option for Alaskans.
SENATOR HUGHES said there has been a lot of talk about the
balance between pharmacists and physicians and their respective
ability to prescribe interchangeable biological products. An
agreement is that the physician retains control about whether or
not an interchangeable biological product can be prescribed. The
pharmacist can make the substitution with consent from the
doctor.
CHAIR COSTELLO asked if biologics can be offered now.
SENATOR HUGHES said not yet, but a number are in the pipeline.
The reason not to wait on this legislation is to ensure that
pharmacists can provide the biologic to patients once there is
one available.
CHAIR COSTELLO asked about the types of conditions for which a
biologic would be prescribed.
2:19:01 PM
SENATOR HUGHES listed serious conditions: cancer, Lupus,
multiple sclerosis, rheumatoid arthritis, autoimmune diseases,
and neurological disorders.
2:19:13 PM
SENATOR STEVENS asked why a pharmaceutical company would create
cheaper [biologics].
SENATOR HUGHES said they realize how helpful and affordable
biologics are. The expectation is this could help states with
their Medicaid budgets.
SENATOR STEVENS asked if drug companies will be willing to lower
costs.
2:21:12 PM
AIMEE BUSHNELL, Staff, Senator Shelley Hughes, Alaska State
Legislature, said part of the reason for the legislation is to
open up competition and eventually bring about lower prices.
SENATOR STEVENS said he would like a better explanation.
SENATOR HUGHES deferred the question to Rylan Hanks with Amgen.
SENATOR GARDNER said her understanding is these are often
expensive drugs that are used as a last resort.
SENATOR HUGHES said that's correct and added that biosimilars
have changed people's lives. "It is definitely something we want
the people in Alaska to have access to."
2:24:52 PM
MS. BUSHNELL provided a sectional analysis for SB 32 speaking to
the following document:
Sec. 1 - AS 08.80.030
Adds a new subsection requiring the Board of Pharmacy
to have a link on the board's website to the United
States Food and Drug Administration's (FDA) list of
approved interchangeable biological products.
Sec. 2 - AS 08.80.294
Amends this section by requiring a pharmacist to
include on the label of a biological product container
the proprietary or proper name of the biological
product. This section also includes language to
differentiate between drugs that are and are not
biological products to ensure that statutes regarding
equivalent generic drugs are not substantively
changed.
Sec. 3 - AS 08.80.294
Adds a new subsection to define the term "proper name"
being the name that reflects scientific
characteristics of a biological product. This new
subsection also defines "proprietary name" which is
the trademarked and registered name of the product.
Sec. 4 - AS 08.80.295
Adds language to differentiate between equivalent drug
products and interchangeable biological products.
Sec. 5 - AS 08.80.295
Adds new subsections to provide guidelines as to how
pharmacists or their designee will need to communicate
with a prescribing doctor when dispensing a biological
or interchangeable biological product if an
interchangeable product is available.
Under subsection (c), a pharmacist must communicate to
the prescribing doctor the name and manufacturer of
the biological product provided to the patient. This
communication must happen within three days after
dispensing the product by an entry through an
interoperable electronic medical records system, an
electronic prescribing technology, a pharmacy benefit
management system, or a pharmacy record. If an entry
under this subsection is not possible, the pharmacist
may communicate by e-mail, telephone, fax, or by any
other prevailing means.
Under subsection (d) provides an exception to the
communication requirement under (c) if the dispensed
biological product is a refill of the prescription and
is the same biological product. Subsection (e)
provides that communication provided under (c)(1) of
this section is providing notice to the prescribing
doctor. Under subsection (f), a pharmacist is required
to maintain a record for two years after a biological
product is dispensed. Finally, subsection (g) defines
"designee" as an agent or employee of a pharmacist who
has been authorized to communicate information under
subsection (c).
Sec. 6 - AS 08.80.480(34)
Changes language, and gives option to change the term
"drug" and "equivalent drug" to "biological product"
and "interchangeable biological product".
Sec. 7 - AS 08.80.480
Adds new subsection (37) to define term "biological
product".
Adds new subsection (36) to define term
"interchangeable biological product" as a biological
product as determined by the United States Food and
Drug Administration.
Under subsection (A) provides that it meets the
standard for interchangeability under US code
(Regulation of biological products, Safety standards
for determining interchangeability).
Under subsection (B) provides that it is
therapeutically equivalent in the most recent edition
of the United States Food and Drug Administration
evaluations.
Sec. 8 - AS 08.80.480
Amends this section by adding transition regulations
if necessary to implement changes made by this Act.
Having changes take place in accordance with AS 44.62
(Administrative Procedure Act) but not before the
effective date of this Act.
Sec. 9 - AS 08.80.480
Adds language that section 8 of this Act takes effect
July 1, 2017.
Sec. 10 - AS 08.80.480
Adds language that this Act will take effect January
1, 2018, except for a provided in section 9.
2:26:57 PM
MS. BUSHNELL noted SB 32 follows model consent language which
has been agreed to by numerous patient advocacy, prescriber, and
pharmacy groups throughout the country. Biologics are used
primarily for treating specialty and serious conditions. There
has also been significant outreach and discussion with Alaska
stakeholders. The bill preserves the ability for the prescriber
to have control over what their patient is taking, but it also
allows options for the patient if there are other things they
could be taking.
She said there aren't any approved interchangeables because the
regulations were only recently released.
SENATOR GARDNER asked who Section 1 is for.
MS. BUSHNELL said it is to be used by the public as well as
prescribers.
2:29:26 PM
CHAIR COSTELLO opened public testimony on SB 32.
2:29:46 PM
ASHLYN ANTONELLI, representing herself, testified in support of
SB 32. She is a brain cancer survivor who believes that Alaska
should follow the lead of the states that have passed similar
legislation. She described how expensive her drug treatment will
be without this option. She expressed surprise that Senator
Giessel did not support this legislation when it was heard in a
previous committee. This class of drugs has been around for 10
years, yet there are no studies being done in the U.S.
CHAIR COSTELLO explained that this is the first time the
committee has taken up the bill and there is a process to
follow.
MS. ANTONELLI asked the committee to represent the interests of
people like herself. In response to Senator Stevens' question,
she explained that drug companies usually have a return on
research and development in two years and can afford to sell the
drugs at a lower rate.
SENATOR STEVENS noted that the committee has honest questions
that need to be answered before moving the bill forward.
MS. ANTONELLI voiced appreciation for the committee's time and
efforts.
2:35:22 PM
BECKY HULTBERG, President and CEO, Alaska State Hospital and
Nursing Home Association (ASHNHA), testified in support of SB
32. She commented that ASHNHA consulted with hospital-based
pharmacists and physicians to ensure that SB 32 would supply the
guidance needed to ensure safe and effective treatment for
patients while providing the potential to lower pharmaceutical
costs. Following this consultation, they made the decision to
support the bill. Critical to their support is the communication
that is needed in a variety of settings, including a three-day
timeline for the pharmacists to notify the prescribing
physicians. The bill offers flexibility in communication
methods. SB 32 strikes the right balance for notification and
communication. Biosimilars and interchangeable biological
products offer potential for increasing accessibility and
affordability, as well as competition. SB 32 protects patients
and will benefit Alaska.
CHAIR COSTELLO asked if biologics are available in a prepackaged
Mediset.
MS. HULTBERG said she didn't know.
2:38:04 PM
MARK GUIMOND, Director, State Legislative Affairs, Arthritis
Foundation, testified in support of SB 32. He distinguished
between biologics and other medications. Biologics have the
ability to change lives. Biosimilars offer the opportunity for
biologics to come to market, and because they are copies or are
similar to the original product and they cost less and are more
available. He explained that a biologic is a very complex
product derived from living cells. They are not chemical
compounds and not pills, and they are infused or injected. There
is a very small market of biologics in Alaska. A concern is that
a doctor must understand what they are prescribing for a person
who has other prescriptions and therapies. He spoke in favor of
the notification provisions in the bill.
CHAIR COSTELLO asked whether Mr. Guimond feels there could be a
higher level of patient protection.
MR. GUIMOND said there are two levels of protection; one is
inherently the initial dispense as written. If the prescriber
wants only the referenced brand name product, he/she can request
it. If there is an opportunity for a biosimilar to be used, the
prescriber can allow it. The order to "dispense as written"
cannot be changed.
CHAIR COSTELLO asked if the 13 biologic prescriptions in Alaska
are statewide or centered in a particular area.
MR. GUIMOND said he does not have that data, but most are
distributed from specialty pharmacies. They are extremely
expensive because they are derived from living cells.
2:42:49 PM
SHAINA SMITH, Director, U.S. Pain Foundation, testified in
support of SB 32. She read testimony into the record from the
chronic pain patients, Robert Toms and his wife from Wasilla.
Ms. Smith described his treatment with a biologic for chronic
pain.
CHAIR COSTELLO asked Ms. Smith to provide that written testimony
to her office and it will travel with the bill.
2:46:24 PM
PHIL SCHNEIDER, Associate Dean and Professor, University of
Arizona Health Sciences, College of Pharmacy, and Chair,
Advisory Board, Alliance for Safe Biologic Medicine, testified
in support of SB 32. He said, as a pharmacist, he believes that
interchangeable biosimilars are not generic biologics because of
their molecular complexities. They are a new category of drugs.
Historically, pharmacists have been able to substitute generic
simple molecules without communication or prior approval from a
physician. Without this bill a pharmacist would need to contact
the prescriber before any change could be made. This results in
delays in patient care. SB 32 will provide an efficient way for
pharmacists to substitute interchangeable biosimilars that are
less expensive.
He discussed the amount of work that has gone into crafting this
bill, and the importance of the "dispense as written" provision
that is included. He concluded that the bill retains control
amongst health care providers and the patients they serve. He
encouraged the committee to support SB 32.
2:50:46 PM
SENATOR STEVENS asked if these drugs would typically be used in
an urban setting.
MR. SCHNIEDER said you'd be surprised how widespread the use of
these drugs already is. There is also the potential for at home,
self-administration.
2:53:04 PM
CAREY MCCLELAND, Healthcare Advocate, testified in support of SB
32. He described his colon cancer and said if it recurs he will
consider a biologic and would like to be able to have access
here in Alaska.
2:55:12 PM
LEIF HOLM, Member, State Board of Pharmacy, testified in support
of SB 32 if the language in Section 5 is amended. In particular,
the language in Section 5 undermines the intent of federal
legislation, [the Biologics Price Competition and Innovation
Act], which is to increase access to biologics. He stressed the
importance of the difference between an interchangeable
biological and a biosimilar. He opined if a medication is
interchangeable, it is substitutable. The Board sees the benefit
of this legislation and wants it to pass, but the language in
Section 5 of having to notify the physician of use of an
interchangeable biologic, needs to be amended.
SENATOR HUGHES asked if most pharmacists have the electronic
system that provides notification of an interchangeable
biologic.
MR. HOLM said it will work if everyone has access to electronic
medical records. If their software is not able to do that, it
would be an extra step of notifying a physician of an
interchangeable.
SENATOR HUGHES said this will be infrequent at best, not even
one per month.
MR. HOLM said he sees the point that it could be infrequent, but
his goal is to increase access. He did not agree with the
assumption that interchangeables are inferior.
SENATOR HUGHES said she appreciates the concern, but defended
the consensus language in the bill.
3:02:03 PM
DR. DAVID CHARLES, Chair, Alliance for Patient Access, testified
in support of SB 32. He said he is a neurologist and he
prescribes biologics every week. This bill is timely because it
will get at the interchangeable aspect of biosimilars. He
clarified the issue between the pharmacists and the physicians
and stated support as it is listed in the bill. He explained the
importance of notification to the physician of a switch in
medication. The bill strikes the right balance with three days
after dispensing for the pharmacist to provide the notification.
SENATOR STEVENS asked him to describe how the notification
occurs.
DR. CHARLES said it could be a variety of ways, including
telephone call, fax, email, or via electronic medical record.
3:08:20 PM
RYLAN HANKS, Pharmacist and Director of Policy, Amgen, Inc.,
testified in support of SB 32. He related that he was formerly
with the Food and Drug Administration (FDA) in the Office of
Generic Drugs. He explained the history and the science behind
the intent of the bill, which was ease and affordability. In
2010 Congress passed the Biologics Price Competition and
Innovation Act which allowed for the FDA to designate and
approve biosimilars. The intent of the BPCI Act was to increase
competition and affordability for medicine. He emphasized that
generic drugs are not the same as interchangeable biologics and
biosimilars.
MR. HANKS said SB 32 is important now in order to have
guardrails in place for the use of interchangeable biologics and
biosimilars. He discussed the fact that the FDA has disclosed
that there are 64 biosimilar programs under development to 23
difference reference products and 10 are currently under active
review. Having proper legislation is key.
He noted it is important to make clear how biosimilars should
not be used, such as being inadvertently substituted. He said
the bill is balanced and patient-centric and would provide cost
savings to Alaskans.
3:13:16 PM
SENATOR STEVENS asked him to address the issue whether he finds
the three-day notification onerous.
MR HANKS said, as a pharmacist, he does not find that onerous or
burdensome.
CHAIR COSTELLO pointed out that there is a provision that
addresses notification options, including the telephone.
3:15:16 PM
CHAIR COSTELLO closed public testimony on SB 32 and held the
bill in committee for further consideration.