BILL ANALYSIS Ó
SENATE COMMITTEE ON
BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT
Senator Jerry Hill, Chair
2015 - 2016 Regular
Bill No: SB 671 Hearing Date: April 13,
2015
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|Author: |Hill |
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|Version: |February 27, 2015 |
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|Urgency: |No |Fiscal: |Yes |
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|Consultant|Sarah Mason, Janelle Miyashiro |
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Subject: Pharmacy: biological product.
SUMMARY: Authorizes a pharmacist to substitute an alternative
biological product when filling a prescription for a prescribed
biological product under specified circumstances.
Existing Federal law:
1)The Food, Drug and Cosmetics Act (FDCA) requires drug
manufacturers to obtain approval of new drugs from the federal
Food and Drug Administration (FDA).
(21 U.S.C. Sec. 355)
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). (42
U.S.C. Sec. 262)
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). (42 U.S.C. Sec. 262 (k))
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. (42
U.S.C. Sec. 262 (k)(2))
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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. (42 U.S.C. Sec. 262(i)(2)(A) and
(B))
6)Clarifies that state law governs how and when pharmacists may
make prescription drug substitutions. (1 Food and Drug Admin.
Sec. 13:197 (2011))
7)States that new drugs cannot be introduced into interstate
commerce unless an approval of an application is filed by
either:
a) Full report of investigations to be filed with an
application to the Secretary and which have been made to
show:
i) Whether or not the drug is safe and effective
for use.
ii) A full list of the components and composition
of the drug.
iii) A full description of the methods used in, and
the facilities and controls used for the
manufacturing, processing, and packing of the drug.
iv) Specimens of the labelling proposed to be used
for the drug.
v) Any assessments required under Section 355c.
(21 U.S.C Section 355(b))
a) Abbreviated application of a new drug to be filed with
the Secretary and which must contain:
i) Information to show that the conditions of use
prescribed, recommended or suggested in the labeling
proposed for the new drug have been previously
approved.
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ii) Information to show that the new drug has the
same active ingredient(s) as the listed drug referred
to.
iii) Information to show that the route of
administration, the dosage form, and the strength of
the new drug are the same as those of the listed drug
referred to.
iv) Information to show that the labeling proposed
for the new drug is the same as the labeling approved
for the listed drug referred to unless the new drug
and listed drug are produced or distributed by
different manufacturers. (21 U.S.C Section 355(j))
1) Defines a biological product as a virus, therapeutic serum,
toxin, antitoxin, vaccine, blood, blood component or
derivative, allergenic product, protein (except for any
chemically synthesized polypeptide), or analogous product.
(42 U.S.C. Section 252i(1))
2) Classifies insulin as a hormone and therefore regulates these
endocrine system derived drugs under the FDCA and not as
biological products under the PHSA.
3) States that a drug intended for use is limited to use under
the professional supervision of a practitioner licensed by
law to administer the drug. (21 U.S.C. Section 353(b))
Existing California law:
1)Establishes the Food and Drug Branch (FDB) within the
California Department of Public Health (CDPH) 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
SB 671 (Hill) Page 4
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from human or animal tissues or micro-organisms. (Health and
Safety Code § 1600.1)
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). (Business and Professions Code
(BPC) § 4000 et seq.)
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. (BPC §
4059)
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." (BPC § 4073)
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
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."
(BPC § 4052.5)
This bill:
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1)Defines "biological product" according to the definition
within the federal PHSA.
2)Defines "interchangeable" as a biological product that the FDA
has determined meets the standards set forth in the BPCIA 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 (known
as the Orange Book).
3)Defines "prescription", with respect to a biological product,
as a prescription for a product compounded in an outsourcing
facility can qualify for exemptions from the FDA approval
requirements, under Section 503B of the FDCA.
4)Updates permitted functions for pharmacists to allow a
pharmacist to substitute an alternative biological product
only for a prescribed biological product only if :
a) The alternative biological product is interchangeable.
b) The prescriber has not personally indicated, either
orally or in his or her own handwriting "Do not substitute"
or words of similar meaning. Clarifies that a prescriber
may still check a box on the prescription marked "Do not
substitute" if the prescriber personally initials the box
or checkmark. Clarifies that for electronic data
transmission prescriptions, a prescriber may indicate "Do
not substitute" or words of similar meaning, or may check a
box on the prescription marked "Do not substitute" but is
not required to manually initial this indication.
c) Within a reasonable time following the dispensing of a
biological product, a dispensing pharmacist or the
pharmacist's designee shall communicate to the prescriber
the specific biological product provided to the patient,
including the name of the biological product. Provides
that the communication shall be conveyed by making an entry
into an interoperable electronic medical records system,
through electronic prescribing technology, or a pharmacy
record that is electronically accessible by the prescriber.
Provides that otherwise, the pharmacist or pharmacist's
designee shall communicate the name of the biological
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product dispensed to the prescriber using facsimile,
telephone, electronic transmission or other prevailing
means.
5)Clarifies that communication is not required to be made to a
prescriber when either there is no FDA-approved
interchangeable biological product or a refill prescription is
not changed from the product dispensed on the prior filing of
the prescription.
6)Provides that selection of an alternative biological product
is within the discretion of the pharmacist except when a
prescriber indicates "Do not substitute". States that a
pharmacist who selects the biological product according to the
provisions of this bill assumes the same responsibility for
substituting an alternative biological product as would be
incurred in filling a prescription for a biological product
prescribed by name.
7)Removes liability of a prescriber for an act or omission by a
pharmacist in selecting, preparing or dispensing an
alternative biological product.
8)Prohibits a pharmacist 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,
including any professional fee that may be charged by the
pharmacist.
9)Applies the provisions to all prescriptions, including those
presented by or on behalf of persons receiving assistance from
the federal government or pursuant to the Medi-Cal Act
(Welfare and Institutions Code, Section 14000-14199.2 et.
seq.).
10)Requires a communication be made to the patient when an
alternative biological product is substituted for a biological
product.
11)Requires the Board to maintain a link to the current list, if
available, of biological products determined by the FDA to be
interchangeable, on its website.
12)Clarifies that a pharmacist may still give immunizations
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pursuant to a protocol with a prescriber.
13)Clarifies that a disability insurer or health care service
plan is not prohibited from requiring prior authorization or
imposing other appropriate utilization controls in approving
coverage for any biological product.
14)Adds all of the above provisions to the section of Pharmacy
Law specifying actions for substitution of a generic drug.
FISCAL
EFFECT: Unknown. This bill has been keyed "fiscal" by
Legislative Counsel.
COMMENTS:
1.Purpose. The Author is the Sponsor of this bill. According to
the Author, "SB 671 updates California law so when the federal
Food and Drug Administration (FDA) approves interchangeable
biosimilars, California pharmacists can substitute lower cost
biosimilars for brand name biologics." According to the
Author, "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." The Author notes that "in order to reflect the
emerging technology of biosimilars and allow for them 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."
According to information provided by the Author, this bill
allows a pharmacist to substitute a biosimilar medication for
a brand biologic when the biosimilar is deemed interchangeable
by the FDA which mirrors California's patient protections for
generic pill substitution and adds a provision that requires a
pharmacist, within a reasonable amount of time after the
substitution is made, to enter information about the biologic
product dispensed into an interoperable patient record system
or record system accessible to the prescriber. If that cannot
be done, the pharmacy will be required to communicate
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information about the dispensed product to the patient's
prescriber. The Author states that no communication is
required if no interchangeable biosimilar is available or for
a refill of an existing prescription.
According to information provided by the Author, "a
communication to the prescribing physician after dispensing
does not alter the policy goal of offering a lower cost option
for patients. The purpose of prescriber communication is to
provide a record of the substitution, in the event of an
adverse reaction, or other clinical responses to the
biologic." Background information from the Author notes that
there is nothing in this legislation that will impact a health
plan's ability to make changes to its preferred drug lists or
formularies or any other aspect of a health plans' commercial
business. Existing law and current practice afford health
plans the ability to structure their prescription drug
benefits in such a way, either through tiered coverage and/or
preferred drug lists that would incentivize or require the
dispensing of the biosimilar drug product over the biologic.
In that background information, the Author adds that, for
example, health plans could limit their prescription drug plan
coverage to biosimilars or charge higher co-payments for the
biologic. In that instance, the health plan formulary would
eliminate the substitution issue completely, as the biosimilar
would be a "preferred" drug product in the policy. The Author
states that ultimately, through use of their formularies,
health plans will be able to drive utilization of biosimilars.
This is how health plans currently incentivize the use of
generic drugs or lower cost therapeutically similar drugs over
certain branded drugs.
2.Biologics. Biologic medicines are sensitive medications that
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 physician's
offices, oncology clinics, specialty pharmacies, hospitals or
dialysis centers. Biological products are generally derived
from living material, human, animal, or microorganism and FDA
regulations specify that biological products include
blood-derived products, vaccines, in vivo diagnostic
allergenic products, immunoglobulin products, products
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containing cells or microorganisms, and most protein products.
These treatments are not widespread but rather used as
specialty drugs to treat very ill patients; according to a
MarketScan report, there were almost 380 million pills
dispensed in California in 2011, with only 1.7 biologic
prescriptions dispensed per week from the over 5,000 retail
pharmacies in California, representing just 13 percent of all
prescriptions dispensed by retail pharmacies.
According to the FDA, biologics are regulated under the
federal PHSA while drugs, including insulin and other hormone
therapies, are regulated under the FDCA. Both the FDA's
Center for Drug Evaluation and Research and Center for
Biologics Evaluation and Research have regulatory
responsibility for therapeutic biological products, including
premarket review and oversight. Following initial laboratory
and animal testing that show the use of a particular
biological product in humans is reasonably safe, biological
products (like other drugs), can be studied in clinical trials
in humans under an investigational new drug application. If
trials and studies demonstrate that a product is safe and
effective for its intended use, the FDA may then approve the
market of a biologic by granting a biologics license. There
are some individuals who are not good candidates for use of
therapeutic biological products, such as those who are
immunocompromised. Individuals can also have or develop
allergic or other adverse reactions to biological products.
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. The FDA produces a publication titled "Approved Drug
Products with Therapeutic Equivalence Evaluations" (the List,
commonly known as the Orange Book) which identifies drug
products approved on the basis of safety and effectiveness
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under the FDCA. According to the FDA, since February 2005 it
has been providing daily Electronic Orange Book (EOB) updates
as a means of providing product information for new generic
drug approvals. FDA notes that daily generic updates provide
the consumer with the current list of approved generic
products which is important for substitution purposes.
3.Alternative Biological Products - Biosimilars. Biologics,
often referred to as originator biological products or
reference biological products, when discussing
interchangeability and therapeutic equivalence, are large,
complex protein molecules used in the treatment, diagnosis or
prevention of disease. These are quite different from small
molecule drugs, pills, which are not as structurally complex
and are instead relatively simple, organic substances produced
by chemical methods. Biologic medicines, on the other hand,
are made in living organisms to produce proteins by
genetically modifying cell constructs or cell lines.
Biologics are grown, cultivated and purified and are typically
administered as injectables.
Biosimilars are similar but not identical versions of the
original biologic. The active ingredient of a biosimilar is
expected to closely resemble that of the original biologic and
unlike generic pills which require the active ingredient to be
identical, the exact manufacturing process of an original
biologic cannot be exactly duplicated. Biosimilars are not
clinically identical to their reference products. Biosimilars
have been defined by the World Health Organization as "a
biotherapeutic product which is similar in terms of quality,
safety and efficacy to an already licensed biotherapeutic
product," by the European Medicines Agency as a "copy version
of an already authorized biological medicine product with
demonstrated similarity in physiochemical characteristics,
efficacy and safety, based on a comprehensive comparability
exercise," and by the FDA as a biological product which is
"highly similar to the reference product notwithstanding minor
differences in clinically inactive components and for which
there are no clinically meaningful differences between the
biological product and the reference product in terms of
safety, purity and potency of the product."
In response to increases in an aging population and larger
numbers of patients suffering from chronic disease, there has
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been a rise in use of biologics, and accordingly a rise in the
production efforts of biosimilars. Biosimilars go through an
extensive review process and manufacturers are required to
submit immense studies and data demonstrating a products'
efficacy and ensuring it is safe for use by consumers.
Manufacturers also have to establish ongoing monitoring
programs to ensure the safety of biosimilars. While
biosimilars are currently available in the EU, and other
nations are in the process of adopting guidelines and
regulatory processes, biosimilars are still a relatively new
option in the larger health care delivery and treatment
conversation.
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 under section 351(k)(7) of the PHSA. The
Purple Book is analogous to the Orange Book. 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 biosimilar to or
interchangeable with a reference biological product (an
already-licensed FDA biological product). Biosimilar and
interchangeable biological products licensed under section
351(k) of the PHSA will be listed under the reference product
to which biosimilarity or interchangeability was demonstrated.
These lists will be updated periodically when FDA licenses a
biological product and/or makes a determination regarding date
of first licensure for a biological product licensed under the
PHSA.
Currently, only one biosimilar product has been approved by
the FDA. On March 6, 2015, the FDA approved, Zarxio
(filgrastim-sndz). Zarxio is manufactured by Sandoz, Inc. and
is biosimilar to Amgen Inc.'s Neupogen (filgrastim).
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Filgrastim is used to treat patients undergoing chemotherapy
by stimulating the body's neutrophil (white blood cell)
production. Zarxio has been approved as biosimilar to
Neupogen but not as an interchangeable product. The FDA
approved Zarxio based on structural and functional
characterization, animal study data, human pharmacokinetic and
pharmacodynamics data, clinical immunogenicity data and other
clinical safety and effectiveness data that demonstrated
Zarxio is biosimilar to Neupogen.
There are currently no interchangeable biological products
approved by the FDA and the timeline for approval of an
interchangeable biological product is unknown.
4.The Prescription Drug Pinch on Californians' Wallets and
Potential Cost Savings From Biosimilars. Costs of
prescription medication have skyrocketed over the past number
of years. According to a 2008 report issued by the Kaiser
Family Foundation on prescription drug trends, spending in the
U.S. for prescription drugs was $216.7 billion in 2006, more
than 5 times the $40.3 billion spent in 1990. In response,
many consumers are turning to a variety of methods to reduce
their prescription costs including requesting cheaper drugs or
generic drugs from their physicians and pharmacies, using the
Internet and other sources to make price comparisons, using
the Internet to purchase drugs, buying at discount stores,
buying over-the-counter instead of prescribed drugs, buying
drugs in bulk and pill-splitting, using mail-order pharmacies,
and using pharmaceutical company or state drug assistance
programs. The report stated that 62 percent of physicians say
they switch patients to less expensive drugs after discussing
out-of-pocket costs of medicines with patients. This
financial burden leads to many patients with legitimate
chronic illnesses to forgo prescribed medications and
adversely affect their health.
According to a 2005 Federal Trade Commission report on
Pharmacy Benefit Managers (PBMs) and mail-order pharmacies,
many health plan sponsors offer their members prescription
drug insurance and hire PBMs to manage these pharmacy benefits
on their behalf. As part of the management of these benefits,
PBMs assemble networks of retail and mail-order pharmacies so
that the plan sponsor's members can fill prescriptions easily
and in multiple locations. When a consumer fills a
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prescription at a local pharmacy, the pharmacist usually asks
whether the consumer has insurance to cover the prescription's
cost. If there is coverage, the consumer provides the
insurance card to the pharmacist. While the pharmacist fills
the prescription, sophisticated computer interactions between
the pharmacy and the PBM ensure that the prescription is
filled according to the insurance coverage provided by the
plan sponsor. According to the report, the consumer usually
is unaware of these processing interactions, and the
consumer's only additional responsibility is to pick up the
filled prescription and pay the retail pharmacy the copayment
that is due.
A 2013 New York Times article noted that drugs account for
about 15 percent of the nation's health care expenditures and
that while there appear to be small decreases in spending on
prescription drugs, costs associated with specialty drugs like
biologics increased almost 20 percent. Out-of-pocket costs to
patients are typically higher to receive biologics than for
generic drugs and while biosimilars may provide significant
cost savings, they will not be discounted at near the rate as
generic drugs. Biosimilars are still seen, though as playing
an important part in medication cost reductions by providing
cost-effective alternatives to very expensive originator
biological products and are anticipated to play a key role in
the treatment of illnesses and chronic conditions in the U.S.
According to a 2007 Congressional Budget Office (CBO) report
issued when the BPCIA was being considered in Congress, "In
recent years, total spending on biologics has grown rapidly,
with nominal spending growth averaging roughly between 15
percent and 20 percent annually; spending amounted to about
$40 billion in 2006." The CBO report noted that BPCIA would
reduce total expenditures on biologics by $0.2 billion over
the 2009-2013 period, and by about $25 billion over the
2009-2018 period. (Over that 10-year period, such savings
would equal roughly 0.5 percent of national spending on
prescription drugs, valued at wholesale prices.) The report
estimated that as a result of the Act, direct spending by the
federal government would decrease by $46 million over
2009-2013 period, and by $5.9 billion over the 2009-2018
period. A November 2014 RAND study similarly identified a
$44.2 billion reduction in direct spending on biologic drugs
from 2014 to 2024, or about 4 percent of total biologic
spending over the same period, with a range of $13 billion to
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$66 billion.
5.Similar Legislative Efforts in Other States. In the past two
years, at least twenty-three 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.
6.Prior Related Legislation. SB 598 (Hill) of 2013 would have
authorized pharmacists to substitute a biosimilar for a
biologic under specified circumstances, including a
requirement that notification of the substitution be provided,
and defined "biological product," "biosimilar," and
"interchangeable" according to their definitions within the
PHSA. ( Status: The bill was vetoed by Governor Brown who
noted that "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, which has jurisdiction for approving all
drugs, has not yet determined what standards will be required
for biosimilars to meet the higher threshold for
"interchangeability.")
AB 1139 (Lowenthal) of 2013 would have authorized 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. ( Status: The bill was never heard in a
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policy committee of the Legislature.)
7.Arguments in Support. The Alliance of Specialty Medicine , a
coalition of national medical specialty societies representing
more than 100,000 physicians and surgeons, is supportive of
this bill with amendments, stating that this bill addresses
key policy issues to ensure patient safety is preserved,
including physician authority to prevent substitutions and
ensuring that the treating physician is notified if another
version of the biologic medicine is substituted for the
version prescribed by the doctor but remains concerned that
the bill fails to define reasonable time regarding the timely
notification of a substitution to the prescriber and asks that
the Author further define "reasonable time".
According to the Arthritis Foundation , 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 (BIO ) 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.
According to Johnson & Johnson , this bill updates Pharmacy Law
to allow for substitution of a new class of FDA-approved
medicines and will do so in a manner than 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
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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 National Black Nurses Association, Inc. (NBNA) encourages
state legislators and regulators to incorporate strong
language requiring active pharmacist-prescriber communication
and states that it is critical for prescribing physicians to
have knowledge of which biologic has been dispensed to a
patient as a means of supporting patient care. NBNA
highlights 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.
According to the National Kidney Foundation , 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. The kidney community is especially cautious
regarding the possibility of substituting or alternating
between reference drugs and biosimilars or between biosimilars
based on allergic reactions in patients not seen during
clinical trials for treatments used by kidney patients.
According to Novartis Pharmaceuticals , 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. Novartis states that many
provider and patient groups have studies the issue of
biologics and interchangeable biologic substitution and agree
with the principles for substitution included in this bill.
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
SB 671 (Hill) Page 17
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substitution, should the FDA grant such a designation, are
treated the same in its defined substitution process. The
bill bridges the four year gap (since FDA approval pathways
merge in 2020) by creating a substitution process for all
protein medications considered biologics per guidance from
FDA.
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.
8.Arguments in Opposition. The California Pharmacists
Association (CPhA) is opposed to this bill unless amendments
are taken. According to CPhA, pharmacists and other
healthcare providers must be allowed to work together, using
their professional judgment to ensure optimal medication
therapy for their patients, unhindered by burdensome or
unnecessary statutory frameworks. CPhA notes 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. The group 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.
According to the California Retailers Association (CRA) , which
is also opposed to this bill unless it is amended, this bill
creates new and unnecessary requirements for the substitution
of interchangeable biosimilar products, effectively putting
into place additional hurdles that would discourage the
SB 671 (Hill) Page 18
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dispensing of biosimilar products. While CRA appreciates use
of the verb "communicate" over prior efforts using
"notification", the organization still believes this 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 is also opposed to this bill unless amended,
writing 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. CVS Health believes that once the standard for
interchangeable is met, pharmacists, health plans and patients
should find their path to the least expensive therapy
unencumbered.
The National Association of Chain Drug Stores (NACDS) , 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. NACDS also
believes that it is important to maintain focus on patient
care issues that need resolution, and not to overwhelm
prescribers with information that is likely irrelevant for the
vast majority of patients and is not guaranteed to make it
into patients' charts.
According to the Pharmaceutical Care Management Association
(PCMA) , 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
SB 671 (Hill) Page 19
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states that will make the notification process workable.
Walgreens is also opposed to this bill unless it is amended,
stating that it supports updating state laws to recognize and
allow for substitution of interchangeable biosimilars
consistent with current practice for generic drugs, however it
does not support efforts like this bill or efforts in the 22
other states considering identical legislation sponsored by
pharmaceutical manufacturers that impose special notification
for products the FDA has approved as interchangeable.
According to Walgreens, the passive notification process
accessible to providers by using an interoperable electronic
medical records system as this bill proposes is used for the
majority of retail chain prescriptions dispensed but not all
prescriptions. Walgreens adds 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.
The groups above requesting amendments to this bill have
proposed language that permits the entry of information into a
pharmacy benefit management system to constitute a
communication (which has been accepted in some of the other
legislation throughout the nation similar to this bill) and
exempts biological products paid for in cash from being
subject to the notification requirements set forth in this
bill.
According to the Academy of Managed Care Pharmacy (AMCP) ,
which is opposed to this bill, the 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.
AMCP states that at this time, the use of an interoperable
health records system or other means of electronic interchange
between prescribers and pharmacists is not the primary method
of communication and adds that the burdensome restrictions in
this bill are intended to discourage substitution.
SB 671 (Hill) Page 20
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America's Health Insurance Plans (AHIP) is opposed to this
bill, stating that the notification requirement in this bill
creates a false impression about the safety of biologics, will
hinder their use and creates unnecessary burdens. According
to AHIP, 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.
According to the California Association of Health Plans , which
also opposes this bill, 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 Association (NCPA) is also
opposed to this bill, stating 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.
9.Recommended Amendments the Author May Wish to Take in the
Senate Committee on Health.
a) The bill outlines a "reasonable time frame" by which
communication must be made to a prescriber when a
pharmacist has dispensed an alternative biological product.
To ensure clarity for pharmacists as well as for Board
enforcement purposes, the Author may wish to further define
a time frame by assigning a number of days. The Committee
suggests five days as a reasonable amount of time for the
communication to be made following substitution of an
alternative biological product for a biological product.
On page 2, line 11, strike "a reasonable time" and replace
with "five days".
(b) Within a reasonable time five days following the
dispensing of a biological product, a dispensing
SB 671 (Hill) Page 21
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pharmacist or the pharmacists' designee shall
communicate to the prescriber the specific biological
product provided to the patient, including the name of
the biological product and the manufacturer. The
communication shall be conveyed by making an entry
into an interoperable electronic medical records
system, through electronic prescribing technology, or
a pharmacy record that is electronically accessible by
the prescriber. Otherwise, the pharmacist or the
pharmacist's designee shall communicate the name of
the biological product dispensed to the prescriber
using facsimile, telephone, electronic transmission,
or other prevailing means, except that communication
shall not be required in this instance to the
prescriber when either of the following apply:
b) The bill creates a new definition of prescription for
prescriptions of biological product. Within this
definition, the bill refers to Section 503B of the FDCA.
Section 503B deals with outsource facilities and
compounding drugs. It appears that the Author's intention
is instead to reference Section 503(b) of the FDCA which
refers to labeling and dispensing of prescription drugs
thus the Author may wish to clarify that reference in this
bill.
On page 4, line 20, strike "503B" and replace with
"503(b)"
(3) "Prescription," with respect to a biological
product, means a prescription for a product that is
subject to Section 503B 503 (b) of the federal Food,
Drug, and Cosmetic Act (21 U.S.C. Sec. 353(b)).
c) The bill clarifies that its provisions do not prohibit
pharmacists from administering immunizations (biological
products in some instances) and references authority for
pharmacists to do so in BPC § 4052. Advanced practice
pharmacists (APPs) were also provide authority to
administer immunizations in 2013 (SB 493, Hernandez,
Chapter 469, Statutes of 2013). The Author may wish to add
reference to that authority for APPs administering
immunizations.
SB 671 (Hill) Page 22
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On page 4, line 23, after "4052" add " and 4052.8"
(i) This section shall not prohibit the administration
of immunizations, as permitted in Section 4052 and
4052.8 .
NOTE : Double-referral to Senate Committee on Health.
SUPPORT AND OPPOSITION:
Support:
Arthritis Foundation
Biotechnology Industry Organization (BIO)
BIOCOM
California Healthcare Institute (CHI)
Express Scripts
Genentech
Hospira
Johnson & Johnson
Lilly USA, LLC
Merck & Co., Inc.
National Black Nurses Association, Inc.
National Kidney Foundation
Novartis Pharmaceuticals
Novo Nordisk, Inc.
Sandoz
UCB, Inc.
Support if Amended:
Alliance of Specialty Medicine
Oppose Unless Amended:
California Pharmacists Association (CphA)
California Retailers Association (CRA)
CVS Health
National Association of Chain Drug Stores (NACDS)
Pharmaceutical Care Management Association (PCMA)
Walgreens
SB 671 (Hill) Page 23
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Opposition:
Academy of Managed Care Pharmacy (AMCP)
America's Health Insurance Plans (AHIP)
California Association of Health Plans
Kaiser Permanente
National Community Pharmacists Association
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