BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | SB 671|
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THIRD READING
Bill No: SB 671
Author: Hill (D)
Amended: 5/5/15
Vote: 21
SENATE BUS, PROF. & ECON. DEV. COMMITTEE: 7-0, 4/13/15
AYES: Hill, Bates, Block, Galgiani, Hernandez, Jackson,
Wieckowski
NO VOTE RECORDED: Berryhill, Mendoza
SENATE HEALTH COMMITTEE: 9-0, 4/29/15
AYES: Hernandez, Nguyen, Hall, Mitchell, Monning, Nielsen,
Pan, Roth, Wolk
SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8
SUBJECT: Pharmacy: biological product.Pharmacy: biological
product
SOURCE: Author
DIGEST: This bill authorizes a pharmacist to substitute an
alternative biological product when filling a prescription for a
prescribed biological product under specified circumstances.
ANALYSIS:
Existing law:
1)Enacts the Food, Drug and Cosmetics Act (FDCA) which requires
drug manufacturers to obtain approval of new drugs from the
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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)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))
5)Clarifies that state law governs how and when pharmacists may
make prescription drug substitutions. (1 Food and Drug Admin.
Sec. 13:197 (2011))
6) 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." (Business and Professions Code
(BPC) § 4073)
7) 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
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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:
1)Updates permitted functions for pharmacists to allow a
pharmacist to substitute an alternative biological product
only for a prescribed biological product if the alternative
biological product is interchangeable; the prescriber has not
personally indicated, either orally or in his or her own
handwriting "Do not substitute" or words of similar meaning;
and within a reasonable time following the dispensing of a
biological product, a dispensing pharmacist or the
pharmacist's designee communicates 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; and provides
that otherwise, the pharmacist or pharmacist's designee shall
communicate the name of the biological product dispensed to
the prescriber using facsimile, telephone, electronic
transmission or other prevailing means.
2)Clarifies that communication is not required to be made to a
prescriber when either there is no interchangeable biological
product approved by the FDA or a refill prescription is not
changed from the product dispensed on the prior filing of the
prescription.
3)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
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incurred in filling a prescription for a biological product
prescribed by name.
4)Removes liability of a prescriber for an act or omission by a
pharmacist in selecting, preparing or dispensing an
alternative biological product.
5)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.
6)Requires a communication also be made to the patient when an
alternative biological product is substituted for a biological
product.
7)Requires the Board of Pharmacy to maintain a link to the
current list, if available, of biological products determined
by the FDA to be interchangeable, on its Internet Web site.
8)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.
Background
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 not widespread but
rather used as specialty drugs to treat very ill patients.
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.
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.
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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 in the same way that small
molecule drugs like pills, which are not as structurally complex
and are instead relatively simple can be exactly duplicated.
Generic pills are exact copies of originator drugs. 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.
Currently, only one biosimilar product has been approved by the
FDA. On March 6, 2015, the FDA approved, Zarxio
(filgrastim-sndz). There are currently no interchangeable
biological products approved by the FDA and the timeline for
approval of an interchangeable biological product is unknown.
Out-of-pocket costs to patients are typically higher to receive
biologics than for generic drugs and biosimilars are seen 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 BPCIA, direct spending by the federal government
would decrease by
$46 million over 2009-2013 period, and by $5.9 billion over the
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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 $66 billion. 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.
FISCAL EFFECT: Appropriation: No Fiscal
Com.:YesLocal: Yes
SUPPORT: (Verified5/19/15)
AIM at Melanoma
Alliance for Patient Access
Alliance of Specialty Medicine which includes the American
Academy of Facial Plastic & Reconstructive Surgery, American
Association of Neurological Surgeons, American College of Mohs
Surgery, American Gastroenterological Association, American
Society of Cataract and Refractive Surgery, American Society
of Echocardiography, American Society of Plastic Surgeons,
Coalition of State Rheumatology Organizations, Congress of
Neurological Surgeons, North American Spine Society, Society
for Cardiovascular Angiography and Interventions and Society
for Excellence in Eyecare
American Cancer Society
Amgen
Arthritis Foundation
Association of Northern California Oncologists
Biotechnology Industry Organization (BIO)
BIOCOM
California Healthcare Institute
California Rheumatology Alliance
Crohn's & Colitis Foundation of America
Express Scripts
Genentech
Hospira
International Cancer Advocacy Network
Johnson & Johnson
Kidney Cancer Association
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Lilly USA
Medical Oncology Association of Southern California
Merck
National Black Nurses Association
National Kidney Foundation
Novartis
Novo Nordisk
Pharmaceutical Research and Manufacturers of America
Sandoz
Sanofi
State Building and Construction Trades Council
UCB, Inc.
U.S. Pain Foundation
OPPOSITION: (Verified5/18/15)
Academy of Managed Care Pharmacy
America's Health Insurance Plans
California Association of Health Plans
California Pharmacists Association
California Retailers Association
CVS Health
Kaiser Permanente
National Community Pharmacists Association
National Association of Chain Drug Stores
Pharmaceutical Care Management Association
Walgreens
ARGUMENTS IN SUPPORT: Supporters believe 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.
Supporters state 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. According to supporters, this bill ensures
that all biologics are treated equally in California and ensures
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that all patients taking biologic medicines are afforded the
same patient protections.
ARGUMENTS IN OPPOSITION: Opponents believe that pharmacists
will not be able to comply with provisions in the bill related
to communication to a prescriber about the substitution of a
bioloigical product for an alternative biological product, that
the bill creates hurdles that would discourage the dispensing of
biosimilar products and 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. Opponents also state that 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. According to opponents,
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, the majority of pharmacies
dispensing interchangeables. Opponents also believe that this
bill creates a false impression about the safety of biologics,
will hinder their use and creates unnecessary burdens
Prepared by:Janelle Miyashiro / B., P. & E.D. / (916) 651-4104,
Sarah Mason / B., P. & E.D. / (916) 651-4104
5/21/15 9:03:55
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