BILL ANALYSIS Ó
AB 623
Page 1
Date of Hearing: April 21, 2015
ASSEMBLY COMMITTEE ON HEALTH
Rob Bonta, Chair
AB 623
(Wood) - As Amended March 26, 2015
SUBJECT: Abuse-deterrent opioid analgesic drug products.
SUMMARY: Prohibits a health care service plan (plan) or health
insurer (insurer) from requiring the use of opioid drug products
that have no abuse-deterrent properties in order to access
abuse-deterrent opioid drug products; requires pharmacists to
provide a patient receiving an opioid drug product information
about proper storage and disposal of the drug; and, authorizes a
provider to prescribe a less than 30-day supply of opioids
analgesic drugs. Specifically, this bill:
1)Prohibits, where an abuse-deterrent opioid analgesic drug
product is available, a plan or insurer from requiring the use
of opioid analgesic drug products without abuse-deterrent
properties first before allowing access abuse-deterrent opioid
analgesic drug products.
2)Provides that this bill shall not be construed to prevent a
plan or insurer from applying prior authorization requirements
to abuse-deterrent opioid analgesic drug products, provided
that those same requirements are applied to versions of those
opioid analgesic drug products without the abuse-deterrent
properties.
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3)Defines "abuse-deterrent opioid analgesic drug product" as a
brand or generic opioid analgesic drug product approved by the
federal Food and Drug Administration (FDA) with
abuse-deterrent labeling claims that indicate the drug product
is expected to result in a meaningful reduction in abuse.
4)Defines "opioid analgesic drug product" as a drug product in
the opioid analgesic drug class that is prescribed to treat
moderate to severe pain, or other conditions, whether in
immediate release or extended release or long-acting form and
whether or not combined with other drug substances to form a
single drug product or dosage form.
5)Authorizes a health care provider to prescribe a less than
30-day supply of an opioid analgesic drug product, and
requires a plan or insurer to cover a less-than 30-day supply
if otherwise covered.
6)Requires a pharmacist to inform a patient receiving an opioid
analgesic drug product on proper storage and disposal of the
drug, and authorizes the information to be provided as part of
an oral consultation, as specified.
EXISTING LAW:
1)Establishes the Knox-Keene Health Care Service Plan Act of
1975 (Knox-Keene Act), which provides for the licensure and
regulation of health care service plans by the Department of
Managed Health Care, and provides for the regulation of health
insurers by the California Department of Insurance (CDI).
2)Pursuant to DMHC regulations, states that a plan may require
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step therapy and requires a plan to have an expeditious
process in place to authorize exceptions to step therapy when
medically necessary.
3)Requires plans and insurers to include information on
cost-sharing tiers and utilization controls, including prior
authorization or step therapy requirements, for each covered
drug.
4)Prohibits health plans that cover prescription drugs from
limiting or excluding coverage for a drug on the basis that
the drug is prescribed for use different from that for which
the drug has been approved by the FDA, provided that specified
conditions have been met, including that the drug is
prescribed by a participating licensed health care
professional for the treatment of a chronic and seriously
debilitating condition, the drug is medically necessary to
treat that condition, and the drug is on the plan formulary.
5)Prohibits health plans that cover prescription drugs from
limiting or excluding coverage for a drug for an enrollee if
the drug was previously approved for coverage by the plan for
a medical condition of the enrollee and the plan's prescribing
provider continues to provide the drug for the medical
condition, provided that it is safe and effective for
treatment.
6)Prohibits plans that cover prescription drugs from limiting or
excluding coverage for a drug on the basis that the drug is
prescribed for a use different from the use for which the drug
has been approved by the federal FSA, provided that specified
conditions have been met, including that the drug is
prescribed by a participating licensed health care
professional for the treatment of a chronic and seriously
debilitating condition, the drug is medically necessary to
treat that condition, and the drug is on the plan formulary.
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7)Provides for the licensure and regulation of pharmacists by
the California Board of Pharmacy.
8)Requires, under existing regulations, a pharmacist to provide
oral consultation to a patient in all care settings under the
following circumstances:
a) Upon request by the patient;
b) Whenever the pharmacist deems a consultation is
warranted in the exercise of his or her professional
judgment;
c) When the prescribed drug has not previously been
dispensed to a patient; and,
d) When the prescription drug is dispensed that has not
been previously dispensed to a patient in the same dosage,
strengths, or with the same directions.
FISCAL EFFECT: This bill has not yet been analyzed by a fiscal
committee.
COMMENTS:
1)PURPOSE OF THIS BILL. According to the author, not enough is
being done to curb the growth of opioid abuse, and health care
providers and parents need tools to help guard against the
abuse of opioid medication. The author cites education for
patients on the proper storage and disposal of opioids, as
well as the development and availability of abuse-deterrent
opioids, which are formulated to prevent manipulation of the
drug for the purpose of misuse, as strategies that should be
encouraged to combat opioid abuse. The author states that
crushed or dissolved opioids account for 30% of opioid abuse,
and this form of abuse is what results in the majority of
emergency room visits, hospitalizations, and deaths. The
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author states that abuse-deterrent opioids are currently
available on the market, that we should allow health care
providers to exercise their judgment in prescribing
abuse-deterrent opioids currently available on the market
without worrying about cost-related hurdles. The author
concludes by stating that the more widespread abuse-deterrent
opioids become, the greater positive impact we can have on
opioid abuse, and that increased availability of
abuse-deterrent opioids and competition in the drug market
will lead to reduced cost.
2)BACKGROUND.
a) Opioids and opioid abuse. Opioids are a class of
narcotic drugs that include medications such as hydrocodone
(e.g. Vicodine), oxycodone (e.g., OxyContin, Percocet),
morphine (e.g., Kadian, Avinza) codeine, and other related
drugs. Taken as prescribed, opioids can be used to manage
pain safely and effectively. However, opioids may also
produce other effects, and according to the National
Institute on Drug Abuse (NIDA), some individuals experience
a euphoric response to opioid medications since these drugs
affect the regions of the brain involving reward response.
NIDA states that those who abuse opioids may seek to
intensify their experience by taking the drug in ways other
than those prescribed. For example, Oxycontin is an oral
medication used to treat moderate to severe pain through a
slow, steady release of the opioid. However, NIDA states
that people who abuse the drug may crush or dissolve the
drug in order snort or inject it, thereby increasing their
risk for serious medical complications, including overdose.
NIDA states that when abused, even a single large dose of
opioids can cause severe respiratory depression and death.
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According to the California Department of Public Health
(DPH), in the past, prescription opioids were prescribed
for relieving short-term, acute pain. However, today, they
are increasingly being used for long-term (chronic) pain
management. As a result, sales of opioid pain relievers
quadrupled in the past 10 years. By 2010, enough opioid
pain relievers were sold to medicate every American adult
(about 240 million people) every four hours for an entire
month. DPH states that in California, deaths involving
opioid prescription medications have increased 16.5% since
2006. In 2012, there were more than 1,800 deaths from all
types of opioids - 72 percent involved prescription
opioids.
b) Abuse-deterrent opioids. According to the FDA, 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. Opioids formulated
with abuse-deterrent properties are designed to be more
difficult to abuse, while retaining the same clinical
effectiveness. For example, abuse-deterrent opioids may be
formulated in ways that prevent chewing, crushing, grating,
or grinding. Others may be formulated with agents that can
make the drug resistant to dissolving by turning the drug
into a gel-like substance when manipulated. Other
formulations can reduce or defeat euphoria associated with
the drug, or result in an unpleasant effect if the drug is
manipulated.
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, and considers the development of
abuse-deterrent opioids a high public health priority. The
FDA also noted that abuse-deterrent technologies developed
to date have not yet proven successful at deterring the
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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
methods for evaluating the technologies are rapidly
evolving.
In order for a drug to be approved as having an
abuse-deterrent formulation, a drug manufacture must seek a
label as such from the FDA. There are four general tiers
of labeling claims available to describe the potential
abuse-deterrent properties of a drug:
i) Tier 1 - The drug is formulated with barriers to
abuse.
ii) Tier 2 - The drug is expected to reduce or block the
effect of the opioid when manipulated.
iii) Tier 3 - The drug is expected to result in a
meaningful reduction in abuse.
iv) Tier 4 - The drug has demonstrated reduced abuse in
the community.
According to the author, four opioids have been approved
for abuse-deterrent labeling, each of which meet the
requirements for Tier 3, and there are a number of generic
and brand opioid products with different types of
abuse-deterrent technologies that seek labeling. One of
the four currently approved is OxyContin, which, in 2010,
was reformulated as an abuse-deterrent opioid. It was
approved for ADF labeling in April 2013, indicating that
the product has physical and chemical properties that are
expected to make abuse via injection difficult and to
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reduce abuse via snorting. OxyContin's manufacturer
replaced the original OxyContin formulation in 2010 with
its abuse-deterrent formulation, and upon approval of the
labeling in 2013, the FDA stopped accepting applications
for generics that rely upon the approval of original
formulation of OxyContin. Under this bill, plans would be
required to cover abuse-deterrent opioids that meet Tier 3.
In terms of the public health impact of abuse-deterrent
opioids, the author cites research published in 2014 in the
journal "Pain Management" which estimated that
abuse-deterrent formulation of OxyContin reduced overall
health care costs by $430 million annually in the U.S.,
with an indirect cost savings of $605 million. The
research study determined that these savings represented
1.8% of $58.4 billion in overall societal costs of
prescription opioid abuse. The author also cites a study
by Econostats that compared the cost between generic
opioids without abuse-deterrent properties, and brand name
abuse-deterrent opioids, finding that the price gap between
the average patented cost of the brand name opioid and the
average generic opioid cost was $140.
Other research has been conducted on abuse-deterrent
opioids, including a study published in the New England
Journal of Medicine in 2012 which found that
abuse-deterrent formulations successfully reduced abuse of
specific opioid, but resulted in increased use of heroin as
a replacement for the drug, which could reduce societal
cost savings.
c) Legislation in other states. At least 15 other bills
regarding abuse-deterrent opioids have been introduced this
year in other states, including Colorado, Connecticut,
Florida, Kansas, Maryland, Mississippi, Oklahoma, Rhode
Island, Tennessee, Vermont, and Virginia. In 2014,
legislation on this topic was introduced in New Jersey.
The requirements of the bills vary across states, with some
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bills containing similar requirements as those proposed in
this bill, but overall, the bills aim to expand coverage
and access to abuse-deterrent opioids.
d) Step Therapy. Step therapy is a utilization management
technique sometimes applied to prescription drugs by a
health plan or insurer. Health plans and insurers employ
utilization management for a variety of reasons, including
clinical considerations, and to control the cost of
prescription drugs, particularly in therapeutic classes
where generic version of the drugs exist. When implemented
by a health plan or insurer, an enrollee may be required to
first try an alternative medication (often a generic
alternative) prior to receiving coverage for the final
medication (often a brand-name medication).
3)SUPPORT. The Power of Pain Foundation (POPF), a co-sponsor of
this bill, states that we must find a balance between the pain
patients who truly need opioid medication for daily living,
and those who are abusing the medication. POPF states that
misuse and abuse of opioids is a growing public health problem
that is driving up health care, criminal justice, and
workplace costs, and that abuse-deterrent opioids represent a
significant opportunity to reduce misuse and abuse. The
Partnership for Drug-Free Kids (Partnership) writes that one
in four teens reports having misused or abused a prescription
drug, and nearly two-thirds of teens who have abused pain
relievers say they get them from family members and friends.
Partnership states that insurance coverage for abuse-deterrent
opioids will lead to a larger share of abuse-deterrent
medications in medicine cabinets, and also encourage companies
to innovate in this direction.
The California Academy of Physician Assistants and the
California Academy of Eye Physicians and Surgeons state that
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this bill would prevent a plan or insurer from imposing
barriers to access to abuse-deterrent opioids, if such drugs
are deemed the most appropriate option by the prescriber. Law
enforcement organizations state the abuse of prescription
drugs continues to increase, particularly among minors who use
medicine meant for therapeutic purposes for non-medical
reasons. The organizations state that this bill represents a
significant step forward in the effort to end potentially
deadly prescription drug abuse by making meaningful changes to
reduce opioid abuse through proper storage and disposal,
allowing prescriptions for small quantities, and reducing
barriers for doctors to prescribe opioids with abuse-deterrent
formulations.
4)OPPOSITION. The California Association of Health Plans (CAHP)
opposes this bill, stating that it is a coverage mandate for
one form of drug, abuse-deterrent opioids, of which expensive
brand drug manufacturers dominate the market. CAHP argues
that the California Health Benefits Review Program (CHBRP)
should analyze this bill before it is considered, and fiscal
estimates of this proposal in other states have demonstrated
increases in premiums. CAHP contends that the value of
abuse-deterrent drugs is still being evaluated by the FDA, and
while the bill attempts to allow prior authorization for
abuse-deterrent products, it only does so if the same
protocols apply to the non-abuse products which results in
micromanagement of the formulary and could lead the prescriber
to default to the more expensive abuse-deterrent option even
though the effectiveness is still unproven and may be
unnecessary. CAHP concludes by stating that plans must retain
their ability to design drug benefits that are affordable and
based on the evidence, particularly as drug costs continue to
increase, and 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 (PBM) states that
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this bill is part of a nationwide effort to force the use of
abuse-deterrent opioids by disallowing generic substitutions,
but that 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, and that the bill would restrict them from using step
therapy to promote the use of lower cost, equally effective
generics before more expensive brand medications.
5)RELATED LEGISLATION. AB 73 (Waldron) provides that drugs in
specified therapeutic drug classes that are prescribed by a
Medi-Cal beneficiary's treating provider are covered Medi-Cal
benefits, and require that a Medi-Cal managed care plan cover
the drug upon demonstration by the provider that the drug is
medically necessary and consistent with federal rules and
regulations for labeling and use. AB 73 is pending in the
Assembly Health Committee.
6)PREVIOUS LEGISLATION.
a) AB 1814 (Waldron) from 2014 would have established that
a prescriber's reasonable professional judgment prevails
over the policies and utilization controls of the Medi-Cal
program, including the utilization controls of a Medi-Cal
managed care plan, in prescribing a pharmaceutical from
specified therapeutic drug classes. This bill was held in
the Assembly Appropriations Committee.
b) AB 831 (Bloom) from 2013 would have required, until
January 1, 2016, the California Health and Human Services
Agency (CHHSA) to convene a temporary working group to
develop a state plan to reduce the rate of fatal drug
overdoses and appropriates $500,000 from the General Fund
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(GF) to CHHSA to provide grants to local agencies to
implement drug overdose prevention and response programs.
This bill was held in the Assembly Appropriations
Committee.
c) AB 889 (Frazier) of 2013 would have prohibited a plan
and insurer that provides coverage for medications pursuant
to step therapy or fail first protocol from requiring an
enrollee or insured to try and fail more than two
medications before allowing the enrollee or insured access
to the medication originally prescribed by their provider,
and would have required plans and insurers to have an
expeditious process in place for step therapy exceptions
and that the duration of step therapy be consistent with
up-to-date evidence-based outcomes and current published
peer-reviewed medical and pharmaceutical literature. This
bill was held in the Senate Appropriations Committee.
d) AB 369 (Huffman) of 2012 would have prohibited plans and
insurers that restrict medications for the treatment of
pain from requiring a patient to try and fail on more than
two pain medications before allowing the patient access to
the pain medication, or its generic equivalent, prescribed
by his or her physician. This bill was vetoed with the
Governor's veto message stating that a doctor's judgment
and a health plan's clinical protocols have a role in
ensuring prudent prescribing of pain medications, and any
limitations on the practice of step therapy should better
reflect a health plan or insurer's legitimate role in
determining the allowable steps.
e) AB 1826 (Huffman) of 2010 would have required a plan or
insurer that covers prescription drug benefits to provide
coverage for a drug that has been prescribed for the
treatment of pain without first requiring the enrollee or
insured to use an alternative drug or product. This bill
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was held in the Senate Appropriations Committee.
f) AB 1144 (Price) of 2009 would have required plans and
insurers to report to DMHC and CDI specified information
related to chronic pain medication management, including
when the plan or insurer requires an enroll to use of more
than two formulary alternative medications prior to
providing access to a pain medication prescribed by a
provider, or to use pain medication other than what was
prescribed for more than seven days prior to providing
access to the prescribed pain medication. This bill was
held in the Assembly Appropriations Committee.
7)POLICY COMMENTS.
a) Bill will be reviewed by CHBRP. The committee submitted
a request to CHBRP, housed within the University of
California, to review this bill and perform an analysis of
the clinical efficacy, cost-effectiveness, and public
health impact of its provisions. CHBRP is established in
state statute to assess legislation that proposes or
repeals a mandated benefit or service for public health,
medical and financial impact. Committee rules provide that
the committee may not hear such bills until CHBRP's
assessment is received and has been reviewed by committee
staff. Since this bill does not propose a mandate for a
new benefit, but rather would require plans and insurers to
cover a different formulation of a drug that is already
covered, this bill may be heard by the committee without
the CHBRP analysis.
CHBRP's independent analysis will likely provide valuable
information about the potential impact of this bill and
inform the Legislature on key policy questions regarding
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the bill. For example, as a part of its role in
determining the cost-effectiveness and public health
impacts of the bill, the CHBRP analysis may estimate the
cost implications of requiring brand name abuse-deterrent
opioids over generic opioids without abuse-deterrent
properties. Additionally, the bill would not require
abuse-deterrent drugs to actually demonstrate reduced abuse
in the community before requiring plans to cover them where
available. As such, the CHBRP analysis may provide insight
into the actual or potential public health impact of
abuse-deterrent opioids in the community through an
evaluation of a broader set of available evidence.
b) Bill would impact Medi-Cal managed care plans. Most
Medi-Cal managed care plans are Knox-Keene licensed, and,
as such, will have to meet the requirements of this bill.
c) Current law does not prohibit providers from prescribing
a less than 30-day supply of opioids. This bill would
authorize a provider to prescribe a less than 30-day supply
of opioids. It does not appear that there are any
provisions in statute that would prevent providers from
doing this today.
8)DOUBLE REFERRED. This bill is double referred. Upon passage
by this Committee, it will be referred to the Assembly
Committee on Business and Professions.
REGISTERED SUPPORT / OPPOSITION:
Support
Power of Pain Foundation (sponsor)
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U.S. Pain Foundation (sponsor)
Alliance for Patient Access
American GI Forum
Biocom
California Academy of Eye Physicians and Surgeons
California Academy of Physician Assistants
California Healthcare Institute
California Hepatitis C Task Force
California Pharmacists Association
California Police Chiefs Association
California State Sheriff's Association
Familia Unida
Neuropathy Action Foundation
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Partnership for Drug Free Kids
Peace Officers Research Association of California
Opposition
California Association of Health Plans
California Chamber of Commerce
Express Scripts
Pharmaceutical Care Management Association
Analysis Prepared by:Kelly Green / HEALTH / (916) 319-2097