BILL ANALYSIS Ó
AB 623
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Date of Hearing: May 27, 2015
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Jimmy Gomez, Chair
AB
623 (Wood) - As Amended May 4, 2015
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| |Business and Professions | |13 - 1 |
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Urgency: No State Mandated Local Program: YesReimbursable:
No
SUMMARY:
This bill addresses issues related to abuse of opioid analgesic
drugs. Specifically, this bill:
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1)Requires pharmacists to inform patients receiving an opioid
analgesic drug product on proper storage and disposal of the
drug,
2)Restricts the ability of health plans and insurers to limit
access to abuse-deterrent forms of opioid analgesic drugs.
3)Requires a health plan or insurer to allow a provider to
prescribe, and if otherwise covered, to provide coverage for,
a less than 30-day supply of an opioid analgesic drug product.
FISCAL EFFECT:
1)According to the California Health Benefits Review Program
(CHBRP):
a) $4.4 million to Medi-Cal (GF/federal) and $135,000 to
CalPERS for increased premiums.
b) Increased employer-funded premium costs in the private
insurance market of approximately $1.2 million.
c) Increased premium expenditures by employees and
individuals purchasing insurance of $1.6 million, and
increased out-of-pocket expenses of $450,000.
2)Costs to the Board of Pharmacy to adopt regulations in the
range of $50,000 (Pharmacy Board Contingent Fund).
3)Minor costs to the California Department of Insurance and the
Department of Managed Health Care to verify plans and insurers
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comply with this requirement.
COMMENTS:
1)Purpose. The purpose of this bill is to address some aspects
of opioid addiction. According to the author, given the
availability of abuse-deterrent opioids, health care providers
should be allowed to exercise their judgment in prescribing
them without worrying about cost-related hurdles.
Additionally, better education on storage and disposal would
reduce the supply of opioids available for abuse.
2)Background. According to the federal Food and Drug
Administration (FDA), opioid drugs provide significant benefit
for patients when used properly for pain relief; however,
opioids also carry a risk of misuse, abuse and death. Opioid
products can be abused in a number of ways, including being
swallowed whole; crushed in order to be swallowed, snorted,
smoked; and, dissolved and injected. Abuse-deterrent drugs
work correctly when taken as prescribed, but may be formulated
in such a way that deters misuse and abuse, including making
it difficult to snort or inject the drug for a more intense
high.
The FDA released industry guidance on April 1, 2015 regarding
the evaluation and labeling of abuse-deterrent opioids, citing
the development of abuse-deterrent opioids as a potentially
important step toward the goal of creating safer opioid
analgesics. The FDA also noted that abuse-deterrent
technologies developed to date have not yet proven successful
at deterring the most common form of abuse - swallowing a
number of intact capsules or tables to achieve a feeling of
euphoria. Further, the FDA stated that the science of abuse
deterrence is relatively new, and both the formulation
technologies and the analytical, clinical, and statistical
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methods for evaluating the technologies are rapidly evolving.
3)CHBRP Analysis. Overall, CHBRP finds, based on a review of
the medical literature, that the impact of abuse-deterrent
opioids on abuse is ambiguous. Some studies find they reduce
some forms of abuse, but other studies suggest they shift
abuse to other drugs. CHBRP found the unit cost for opioid
prescriptions would increase by 13% by increasing utilization
of abuse-deterrent formulations by 38%, but that this bill is
unlikely to have a material impact on public health. CHBRP
states it would not affect affect the number of opioid
analgesic overdoses, hospitalizations, and deaths for a number
of reasons, including the fact that the most common form of
abuse (swallowing pills) is not deterred by abuse-deterrent
formulations and the potential for persons addicted to opioids
to turn to heroin instead, or to simply swallow the pills
instead of crushing or injecting them. CHBRP concludes
further study is needed in order to ascertain effectiveness in
preventing abuse.
4)Legislation in other states. At least 15 other bills
expanding coverage and access to abuse-deterrent opioids have
been introduced this year in other states.
5)Support. This bill is sponsored by Power of Pain Foundation
and the U.S. Pain Foundation. It is supported by
biotechnology industry groups, patient advocacy groups,
pharmacists, law enforcement, and Partnership for Drug Free
Kids. Supporters state that misuse and abuse of opioids is a
growing public health problem, and abuse-deterrent opioids
represent a significant opportunity to reduce misuse and
abuse.
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6)Opposition. Health plans and insurers, as well as pharmacy
benefit managers, oppose this bill. The California
Association of Health Plans (CAHP) writes that abuse-deterrent
drugs are fairly new, costly, and have insufficient evidence
about their efficacy in deterrence. The Pharmaceutical Care
Management Association, a national association of pharmacy
benefit managers states that this bill is part of a nationwide
effort to force the use of abuse-deterrent opioids by
disallowing generic substitutions, but abuse-deterrent
formulations are not a quick fix for opioid abuse and will
raise costs. Express Scripts, a pharmacy benefit manager,
estimates that abuse-deterrent opioids cost about three times
as much as non-abuse-deterrent agents.
Analysis Prepared by:Lisa Murawski / APPR. / (916)
319-2081