BILL ANALYSIS Ó
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: SB 671
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|AUTHOR: |Hill |
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|VERSION: |April 14, 2015 |
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|HEARING DATE: |April 29, 2015 | | |
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|CONSULTANT: |Melanie Moreno |
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SUBJECT : Pharmacy: biological product
SUMMARY :1. Permits a pharmacist filling a prescription for a biological
product to select an alternative, interchangeable biological
product if the prescriber does not personally indicate "Do not
substitute," or words of similar meaning, as specified.
Existing federal law:
1.Requires drug manufacturers to obtain approval of new drugs
from the federal Food and Drug Administration (FDA).
2.Prohibits a person from delivering for introduction into
interstate commerce any biological product unless a license is
issued pursuant to the Public Health Service Act (PHSA).
3.Creates an abbreviated pathway for biological products that
are similar to or interchangeable with licensed biological
products, known as the Biologics Price Competition and
Innovation Act of 2009 (BPCIA).
4.Requires that, for a biological product to be considered
biosimilar to a reference product, data must be derived from
analytical, animal and clinical studies as specified.
5.Clarifies that a product is biosimilar to a reference product
under the BPCIA if the proposed biosimilar product is highly
similar to the reference product notwithstanding minor
differences in clinically inactive components and that no
clinically meaningful differences exist between the proposed
biosimilar product and the reference product in terms of
safety, purity and potency.
Existing state law:
SB 671 (Hill) Page 2 of ?
1.Establishes the Food and Drug Branch (FDB) within the
California Department of Public Health (DPH) to assure that
foods, drugs, medical devices, cosmetics and certain other
consumer products are safe and are not adulterated, misbranded
nor falsely advertised; and that drugs and medical devices are
effective.
2.Defines biologics as human whole blood; human whole blood
derivatives specified by regulations; serum, vaccine, live
vaccine, killed vaccine, tissue vaccine, autogenous vaccine,
live virus, killed virus, live bacterial culture, killed
bacterial culture, bacterin, hormone, tissue extract, gland
extract, gland preparation, insulin, and similar products made
from human or animal tissues or micro-organisms.
3.Under the Pharmacy Law, provides for the licensure and
regulation of pharmacies, pharmacists and wholesalers of
dangerous drugs or devices by the Board within the Department
of Consumer Affairs (DCA).
4.Specifies certain requirements regarding the dispensing and
furnishing of dangerous drugs and devices, and prohibits a
person from furnishing any dangerous drug or device except
upon the prescription of a physician, dentist, podiatrist,
optometrist, veterinarian or naturopathic doctor.
5.Authorizes pharmacists filling prescription orders for drug
products prescribed by their trade or brand names to
substitute generic drugs for orders if the generic contains
the same active chemical ingredients of equivalent strength
and duration of therapy, subject to a patient notification and
bottle labeling requirement, unless the prescriber specifies
that a pharmacist may not substitute another drug product by
either indicating on the form submitted for the filling of the
prescription drug orders "Do not substitute" or words of
similar meaning or selecting a box on the form marked "Do not
substitute."
6.Authorizes pharmacists filling prescription orders for drug
products prescribed by their trade or brand names to
substitute a drug product with a different form of medication
with the same active chemical ingredients of equivalent
strength and duration of therapy as the prescribed drug
product when the change will improve the ability of the
patient to comply with the prescribed drug therapy, subject to
SB 671 (Hill) Page 3 of ?
a patient notification and bottle labeling requirement, unless
the prescriber specifies that a pharmacist may not substitute
another drug product by either indicating on the form
submitted for the filling of the prescription drug orders "Do
not substitute" or words of similar meaning or selecting a box
on the form marked "Do not substitute."
This bill:
1.Permits a pharmacist filling a prescription for a biological
product to select an alternative biological product only if:
a. The alternative biological product is
interchangeable. Defines "interchangeable" as a
biological product that the FDA has determined meets
standards specified in federal regulations or has been
deemed therapeutically equivalent by the FDA as set
forth in the latest addition or supplement of the
Approved Drug Products with Therapeutic Equivalence
Evaluations; and,
b. The prescriber does not personally indicate
"Do not substitute," or words of similar meaning, as
specified. Specifies that this does not prohibit a
prescriber from checking a box on a prescription
marked "Do not substitute," provided that the
prescriber personally initials the box or checkmark.
For an electronic data transmission prescription,
permits a prescriber to indicate "Do not substitute,"
or words of similar meaning, in the prescription as
transmitted by electronic data, or may check a box
marked on the prescription "Do not substitute." In
either instance, specifies that it is not required
that the prohibition on substitution be manually
initialed by the prescriber.
2.Requires a dispensing pharmacist or the pharmacists' designee,
within five days following the dispensing of any biological
product, to communicate to the prescriber the specific
biological product provided to the patient, including the name
of the biological product and the manufacturer. Requires the
communication to be conveyed by:
a. Making an entry into an interoperable
electronic medical records (EMR) system, through
electronic prescribing technology, or a pharmacy
record that is electronically accessible by the
SB 671 (Hill) Page 4 of ?
prescriber; or,
b. Using facsimile, telephone, electronic
transmission, or other prevailing means. In this
instance, prohibits that communication from being
required to the prescriber when there is no
FDA-approved interchangeable biological product for
the product prescribed or when a refill prescription
is not changed from the product dispensed on the prior
filling of the prescription.
3.Makes a selection of an alternative biological product within
the discretion of the pharmacist, except as provided in b) of
1) above. Requires a pharmacist who selects an alternative
biological product to assume the same responsibility as would
be incurred in filling a prescription for a biological product
prescribed by name.
4.Prohibits any liability on the prescriber for an act or
omission by a pharmacist in selecting, preparing, or
dispensing an alternative biological product.
5.Prohibits the pharmacist, in any case, from selecting an
alternative biological product unless the cost to the patient
is the same or less than the cost of the prescribed biological
product. Requires "cost," for these purposes, to include any
professional fee that may be charged by the pharmacist.
6.Requires this bill to apply to all prescriptions, including
for Medi-Cal enrollees.
7.Requires the substitution of a biological product to be
communicated to the patient.
8.Requires the Board of Pharmacy (BOP) to maintain on its Web
site a link to the current list, if available, of biological
products determined by the FDA to be interchangeable.
9.Specifies that this bill does not prohibit the administration
of immunizations by pharmacists.
10.Specifies that this bill does not prohibit a health plan or
insurer from requiring prior authorization or imposing other
appropriate utilization controls in approving coverage for any
biological product.
SB 671 (Hill) Page 5 of ?
FISCAL
EFFECT : This bill has not been analyzed by a fiscal committee.
COMMENTS :
1.Author's statement. According to the author, SB 671 updates
California law so when the FDA approves interchangeable
biosimilars, California pharmacists can substitute those lower
cost biosimilars for brand name biologics. In order for
biosimilars to be substituted for a biologic, California must
update its Pharmacy Practice Act. The Business and
Professions Code does not define biosimilars and existing
generic pill definitions do not apply. On March 6th, the FDA
approved the first biosimilar, (Zarxio) and there are at least
four more applications in the approval pipeline. Therefore, it
is essential that a bill be passed this year making clear the
procedures for substitution.
2.Generics. The FDA defines a generic drug as the same as a
brand name drug in dosage, safety, strength, how it is taken,
quality, performance, and intended use. Before approving a
generic drug product, FDA requires many rigorous tests and
procedures to assure that the generic drug can be substituted
for the brand name drug. According to the FDA, it bases
evaluations of substitutability, or "therapeutic equivalence,"
of generic drugs on scientific evaluations. Generic drug
products must contain the identical amounts of the same active
ingredient(s) as the brand name product. A drug that is
determined to be "therapeutically equivalent" can be expected
to have equal effect and no difference when substituted for
the brand name product.
3.Biologics. According to the FDA, biologics include a wide
range of products such as vaccines, blood and blood
components, allergenics, somatic cells, gene therapy, tissues,
and recombinant therapeutic proteins. Biologics can be
composed of sugars, proteins, or nucleic acids or complex
combinations of these substances, or may be living entities
such as cells and tissues. Biologics are isolated from a
variety of natural sources - human, animal, or microorganism -
and may be produced by biotechnology methods and other
cutting-edge technologies. Gene-based and cellular biologics,
for example, often are at the forefront of biomedical
research, and may be used to treat a variety of medical
conditions for which no other treatments are available. In
contrast to most drugs that are chemically synthesized and
SB 671 (Hill) Page 6 of ?
their structure is known, most biologics are complex mixtures
that are not easily identified or characterized. Biological
products, including those manufactured by biotechnology, tend
to be heat sensitive and susceptible to microbial
contamination. Therefore, it is necessary to use aseptic
principles from initial manufacturing steps, which is also in
contrast to most conventional drugs. Biologic medicines
typically treat very serious diseases and conditions,
including blood conditions, cancers, immune disorders like
Rheumatoid Arthritis, Psoriasis and Crohn's Disease, and
neurological disorders like Multiple Sclerosis. These
treatments are almost exclusively administered in physicians'
offices, oncology clinics, specialty pharmacies, hospitals or
dialysis centers.
4.Biosimilars. According to the FDA, a biosimilar is a
biological product that is approved based on a showing that it
is highly similar to a FDA-approved biological product, known
as a reference product, and has no clinically meaningful
differences in terms of safety and effectiveness from the
reference product. Only minor differences in clinically
inactive components are allowable in biosimilar products. An
interchangeable biological product is biosimilar to an
FDA-approved reference product and meets additional standards
for interchangeability. An interchangeable biological product
may be substituted for the reference product by a pharmacist
without the intervention of the health care provider who
prescribed the reference product.
5.Regulation of biosimilars. A pathway for biosimilar
regulation in the U.S. was established as a provision of the
2008 Patient Protection and Affordable Care Act (ACA) and in
2012 the FDA issued draft guidelines for biosimilars. The
guidance included which types of studies manufacturers should
undertake in order to ensure product safety, potency and
purity. In addition to the draft guidelines for biosimilars
the FDA has also compiled a list of biological products,
including any biosimilar and interchangeable biological
products licensed by the FDA under the PHSA. This list, known
as the "Purple Book", includes the date a biological product
was licensed under the PHSA and whether FDA evaluated the
biological product for reference product exclusivity. The
Purple Book will enable a prescriber or dispenser of a
biological product to see whether a biological product
licensed under the PHSA has been determined by FDA to be
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biosimilar to or interchangeable with a reference biological
product (an already-licensed FDA biological product).
On March 6, 2015, the FDA approved the first biosimilar:
Zarxio. Produced by Sandoz, the drug is biosimilar to Amgen's
Neupogen (filgrastim), which was originally licensed in 1991.
Zarxio is approved for the same indications as Neupogen, and
can be prescribed for patients:
a. with cancer receiving myelosuppressive chemotherapy;
b. with acute myeloid leukemia receiving induction or
consolidation chemotherapy;
c. with cancer undergoing bone marrow transplantation;
d. with severe chronic neutropenia; and,
e. undergoing autologous peripheral blood progenitor cell
collection and therapy.
1.Similar Legislative Efforts in Other States. In the past two
years, at least 23 states have considered, or are in the
process of considering, legislation similar to this measure
that outlines procedures by which a pharmacist may substitute
a prescribed biologic drug for a biosimilar. The bills and
surrounding conversation in these states mirror what is
pending in California. Like this bill, many of the 2015
versions create requirements related to all biological product
substitution if there is an FDA-approved interchangeable
biological product and many do make specific reference to
"biosimilars" but rather use the term "alternative biological
product." As reported in a recent Pew Charitable Trusts
article, most of the measures proposed this year require
notification to occur after the dispensing of the biosimilar
and that, where possible, notification be made through
electronic medical records. Most of the new bills reduce the
period of time that pharmacies must keep the record of
substitution from five years to two and the new bills use the
word "communicate" rather than "notify," which the article
cites as significant to biosimilar manufacturers who want to
avoid any hint to the public that biosimilars are inferior
products.
2.Double referral. This bill was heard in the Senate Business,
Professions, and Economic Development Committee on April 13,
2015, and passed with a 7-0 vote.
3.Prior legislation. SB 598 (Hill) of 2013 was substantially
SB 671 (Hill) Page 8 of ?
similar to this bill. SB 598 was vetoed by the Governor, who
stated about the prescriber notification provision of SB 598:
This requirement, which on its face looks reasonable, is for
some reason highly controversial. Doctors with whom I have
spoken would welcome this information. CalPERS and other
large purchasers warn that the requirement itself would cast
doubt on the safety and desirability of more cost-effective
alternatives to biologics?The FDA? has not yet determined what
standards will be required for biosimilars to meet the higher
threshold for "interchangeability." Given this fact, to
require physician notification at this point strikes me as
immature.
AB 1139 (Lowenthal) of 2013 would have permitted a pharmacist
to substitute a biosimilar for a biological product if the
product is deemed by the FDA to be interchangeable with the
biological product. AB 1139 was not heard in a policy
committee.
4.Support. The Arthritis Foundation states that this bill takes
a step in the right direction to ensure that both the patient
and the physician are notified and will encourage a high level
of communication between all players on the healthcare team.
The Biotechnology Industry Organization writes that this bill
ensures patients and their physicians remain in control of
their medical treatment options as the market for complex
biologics evolves. Express Scripts notes that it worked
closely with stakeholders on both sides to find consensus and
that this bill takes a very important step forward, ensuring
that less expensive FDA-approved interchangeable biologics can
be automatically substituted by a pharmacist when they become
available. Johnson & Johnson states that this bill updates
Pharmacy Law to allow for substitution of a new class of
FDA-approved medicines and will do so in a manner that ensures
patient access to these important medications while providing
for a communication about the substitution to be shared with
the patient's health care provider. Lilly USA, LLC supports
this bill to ensure that all biologics are treated equally in
California and to ensure that all patients taking biologic
medicines are afforded the same patient protections. Merck &
Co., Inc. and Genentech write that communicating substitution
of an interchangeable biosimilar to a patient's prescriber is
a safeguard that is critical in the event of an adverse
reaction or change in a patient's chronic condition. The
SB 671 (Hill) Page 9 of ?
National Black Nurses Association, Inc. states that the
complexity and variability of treatment paradigms using
biologics which will be a continuing concern to prescribers
serving American Indian and Alaska Native, African-American,
Asian American and Hispanic patients and states that to this
end, both physicians and patients must be aware of which
complex biological product has been dispensed. The National
Kidney Foundation states that differences in composition of
biosimilars compared to the original innovator product are
likely to occur and to monitor for adverse events, it is vital
that patients and physicians know which medication was
dispensed. Novartis Pharmaceuticals writes that California
law already addresses the process pharmacists must follow to
substitute traditional, generic drugs for their branded
equivalent and this bill would create a similar process for
substituting a branded biologic drug with a biosimilar drug
the FDA has designated as interchangeable. Novo Nordisk.,
Inc. states that unless California's Pharmacy Practice Act is
changed, the substitution of several proteins approved under
what is known as the 505b pathway numbering more than 30
product categories will provide difficult given an
inconsistency between state and federal statute. According to
the company, this bill resolves the inconsistency by ensuring
that all proteins eligible for potential therapeutic
substitution, should the FDA grant such a designation, are
treated the same in its defined substitution process. UCB,
Inc. writes that it is important to have state substitution
laws in place to address the following issues that are
critical for patient safety: substitution should only occur
when the FDA has designated a biologic product as
interchangeable; prescribers should be able to prevent
substitution; a pharmacist shall communicate with the
prescriber after a substitution occurs; patients should be
notified when a substitution occurs and; records should be
kept of the substitution.
5.Support if amended. Alliance of Specialty Medicine, in
response to a previous version of this bill, writes that this
bill addresses key policy issues to ensure patient safety is
preserved, and urges the author to define "reasonable time"
for purposes of notifying a prescriber that a biologic had
been dispensed. This bill was amended on April 14, 2015 to
clarify that the notification is required to be made within
five days of a pharmacist dispensing a product.
SB 671 (Hill) Page 10 of ?
6.Opposition. The Academy of Managed Care Pharmacy writes that
this bill is problematic because while the overall health
industry continued to increase its use of electronic
technology, it has not yet reached a level of participation by
a majority of prescribers and pharmacies. America's Health
Insurance Plans states that the notification requirement in
this bill creates a false impression about the safety of
biologics, will hinder their use and creates unnecessary
burdens, and legislation that limits biosimilar or
interchangeable biologic substitution is unnecessary, will
increase costs for consumers and employers and limit access to
crucial therapies and that the price of a biologic should not
be a factor in their use. The California Association of
Health Plans states that the before-the-fact administrative
burdens created in this bill will do little if anything to
ensure public safety and will increase the cost and access to
these life savings drugs. The National Community Pharmacists
states that patients have a long standing, trusting
relationship with their pharmacist and it is clear that this
bill does little more than set cumbersome roadblocks to drive
patients to higher cost products while diminishing the ability
of pharmacists to substitute extensively evaluated and
approved interchangeable cost saving versions of these
products, at the request of the prescribing practitioner.
7.Oppose unless amended. The California Pharmacists Association
(CPhA) states that many pharmacists are unable to send the
electronic communications authorized in the bill due to
current technological limitations, for example, the inability
of electronic prescribing technology to allow pharmacies to
communicate information back to prescribers. CPhA also states
that as the bill is currently drafted, all pharmacists
selecting alternative products or dispensing biological
products for which there is an approved interchangeable
biosimilar product available will face untenable liability
exposure, depending upon whether each individual prescriber
has access to specific electronic records systems and that it
is impossible for pharmacists to know that they are complying
with the bill's mandates unless they first confirm with each
prescriber whether or not they access certain electronic
records systems.
The California Retailers Association (CRA) writes that it
appreciates use of the verb "communicate" over prior efforts
using "notification," the organization still believes this
SB 671 (Hill) Page 11 of ?
creates access challenges, negatively affects the acceptance
of interchangeable biosimilars and slows anticipated
cost-savings, forcing patients to pay more out-of-pocket
costs. CRA is also concerned that the bill does not require
acknowledgement by the prescriber that notification from the
pharmacy was made so it remains questionable whether or not
all of the effort by CRA-member pharmacies will actually be
acknowledged and kept by the prescriber or simply get lost in
a physician's office.
CVS Health writes that any communication potentially delaying
prescriber or patient acceptance or creating doubt as to the
safety and/or efficacy of FDA-approved interchangeable
biosimilars is wholly unnecessary and a disservice to patients
and payers in the U.S.
The National Association of Chain Drug Stores, which has also
taken an oppose unless amended position on this bill, is
concerned that this bill would undermine dispensing of
cost-effective biologic medications and that in requiring
pharmacies to inform physicians of the drug manufacturer and
name for each biologic or biosimilar drug dispensed, this
legislation imposes a corresponding obligation on physicians
to maintain the information provided by pharmacies in
patients' charts, even if not explicitly stated.
According to the Pharmaceutical Care Management Association,
the notifications in this bill are unnecessary and will
prevent cost savings to patients and employers that can be
achieved with the use of interchangeable biosimilar
medications but the group will remove its opposition if the
author accepts amendments using language from another of
states that will make the notification process workable.
Walgreens states that most pharmacies expected to dispense
interchangeable biologics are specialty pharmacies that
dispense high complexity, high cost products for patients with
complex medical conditions to physician offices or clinics
where these can be administered, rather than dispensing to
patients and the system outlined in this bill permitting
communication to a prescriber would in fact be unavailable for
these settings, what Walgreens calls the majority of
pharmacies dispensing interchangeables.
SB 671 (Hill) Page 12 of ?
8.Technical amendment.
On page 3, beginning on line 23
(d) Selection pursuant to this section is within the
discretion of the pharmacist, except as provided in
subdivision (c). A pharmacist who selects the an alternative
biological product to be dispensed pursuant to this section
shall assume the same responsibility for substituting the
biological product as would be incurred in filling a
prescription for a biological product prescribed by name.
SUPPORT AND OPPOSITION :
Support: AIM at Melanoma Foundation
Amgen
Arthritis Foundation
Biocom
Biotechnology Industry Organization
California Healthcare Institute
Chrohn's and Colitis Foundation of America
Express Scripts
Genentech
Hospira
Johnson and Johnson
Kidney Cancer Association
Lilly USA, LLC
Medical Oncology Association of Southern California
Merck and Co., Inc.
National Black Nurses Association
National Kidney Foundation
Novartis Pharmaceuticals
Novo Nordisk, Inc.
Pharmaceutical Research and Manufacturers of America
Sandoz
Sanofi
State Building and Construction Trades Council
UCB, Inc.
Oppose: Academy of Managed Care Pharmacy
America's Health Insurance Plans
Association of California Life and Health Insurance
Companies
California Association of Health Plans
California Pharmacists Association (unless amended)
California Retailers Association (unless amended)
CVS Health (unless amended)
SB 671 (Hill) Page 13 of ?
Kaiser Permanente
Molina Healthcare of California
Mylan
National Association of Chain Drug Stores (unless
amended)
National Community Pharmacists Association
Pharmaceutical Care Management Association (unless
amended)
Walgreens (unless amended)
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