Download Support for Ohio House Bill 248 Chairwoman Gonzales, Vice Chair

Support for Ohio House Bill 248
Chairwoman Gonzales, Vice Chair Huffman, Ranking Member Antonio and members of the
Committee, thank you for the opportunity to testify in support of House Bill 248. My name is
Tom Brownlie. I am a Director of US Policy with Pfizer’s Global Policy team, and I am here
today on behalf of Pfizer in full support of this legislation.
Pfizer is a research-based global pharmaceutical company dedicated to the discovery and
development of innovative medicines and treatments that improve the quality of life for people
around the world. We have a broad portfolio of pain medicines, which includes over-the-counter
pain relievers, non-opioid prescription medicines, and an abuse-deterrent opioid. We are also
investing in the research and development of an additional abuse-deterrent opioid and other nonopioid therapies, including a novel monoclonal antibody therapy that selectively targets nerve
growth factor (NGF), a regulator of pain processing and sensitivity that increases as a result of
injury or inflammation and in chronic pain states.
I won’t review all of the statistics on opioid abuse. Everyone here understands the gravity of the
issue, and I believe others here can speak more personally to its devastating effects on families,
friends, and neighbors. Instead, I will address issues pertaining to the policy question you are
being asked to consider: Should abuse-deterrent opioids that the FDA has determined are likely
to deter or reduce abuse be part of the solution here in Ohio?
Pfizer believes these technologies can play an important role and should be part of a
comprehensive approach to tackling opioid abuse. When incorporated into existing opioids, they
have been shown to reduce their misuse and abuse, and lower prices drug dealers can command
on the street, while still achieving their primary objective of providing pain relief to patients.
Economic analyses also suggest potential cost-savings due to lower health care costs from fewer
ambulance trips, emergency room visits, hospital stays, substance abuse treatment services, and
outpatient visits.
To help you understand our position and formulate your own, I will address the following three
areas:
1. What are abuse-deterrent opioids?
2. What is the evidence they reduce abuse?
3. How can abuse-deterrent opioids reduce cost?
1. What are Abuse-Deterrent Opioids?
Abuse-deterrent opioids contain the same pain relieving ingredient as opioids currently on the
market; however, they also contain technologies designed to deter unintentional misuse such as
1
chewing and intentional misuse or abuse by drug abusers seeking the “high.” Abuse deterrent
opioids provide the needed pain relief to patients, but deter those who are chewing and
swallowing, or crushing the pills to snort or smoke, or dissolve and inject.
The FDA has recognized that the development of opioids containing abuse-deterrent properties is
an important step towards the goal of creating safer opioid analgesicsi. In fact, FDA deputy
director for regulatory programs, Douglas Throckmorton, M.D., stated that the, “development of
abuse-deterrent opioid analgesics is a public health priority for the FDA."ii And the Office of
National Drug Control Policy included expediting the “development of abuse-deterrent
formulations (ADFs)” in its action steps for responding to the prescription drug epidemic.iii
In 2013, the FDA took an important step forward by releasing draft guidance to industry on
evaluation and labeling, and shortly afterward approved the first drug with labeling stating the
deterrent technology is likely to reduce or deter abuse. Earlier this year, the FDA finalized the
guidance.iv
The FDA defines abuse-deterrent properties as those properties shown to meaningfully deter
abuse, even if they do not fully prevent abuse. They further note that they will allow labeling
regarding abuse-deterrent properties and associated claims if:
1. The product has attributes intended to discourage its abuse that have undergone studies in
one or more FDA-specified categories, AND
2. The results of those studies meet or exceed the current FDA performance criteria and,
therefore, are expected to result in or have demonstrated a meaningful reduction in abuse.
The FDA also provided a framework for categorizing abuse-deterrent formulation, which
includes seven groups (Table 1).i Opioids currently approved by the FDA as likely to reduce or
deter abuse incorporate two types formulations: Physical/chemical barrier and agonist/antagonist
formulations.
Formulations with physical barriers can prevent chewing, crushing, cutting, grating, or grinding
of the dosage form. Formulations with chemical barriers, such as gelling agents, can resist
extraction of the opioid using common solvents like water, simulated biological media, alcohol,
or other organic solvents. Physical and chemical barriers can limit drug release following
mechanical manipulation, or change the physical form of a drug, rendering it less amenable to
abuse.
Agonist/antagonist formulations incorporate an opioid antagonist that interferes with, reduces, or
defeats the euphoria associated with abuse. The antagonist can be sequestered and released only
upon manipulation of the product. For example, a drug product can be formulated such that the
2
substance that acts as an antagonist is not clinically active when the product is swallowed, but
becomes active if the product is crushed and injected or snorted.
Table 1: Abuse-Deterrence Categories from FDA Guidancev
Category
Physical/ chemical
barriers
FDA Description
Physical barriers can prevent chewing, crushing, cutting, grating, or grinding of the
dosage form. Chemical barriers, such as gelling agents, can resist extraction of the opioid
using common solvents like water, simulated biological media, alcohol, or other organic
solvents. Physical and chemical barriers can limit drug release following mechanical
manipulation, or change the physical form of a drug, rendering it less amenable to abuse.
Agonist/antagonist
combinations
An opioid antagonist can be added to interfere with, reduce, or defeat the euphoria
associated with abuse. The antagonist can be sequestered and released only upon
manipulation of the product. For example, a drug product can be formulated such that the
substance that acts as an antagonist is not clinically active when the product is swallowed,
but becomes active if the product is crushed and injected or snorted.
Substances can be added to the product to produce an unpleasant effect if the dosage form
is manipulated or is used at a higher dosage than directed. For example, the formulation
can include a substance irritating to the nasal mucosa if ground and snorted.
Certain drug release designs or the method of drug delivery can offer resistance to abuse.
For example, sustained-release depot injectable formulation or a subcutaneous implant
may be difficult to manipulate.
Aversion
Delivery System
(including use of
depot injectable
formulations and
implants)
New molecular
entities and prodrugs
Combination
Novel Approaches
The properties of a new molecular entity (NME) or prodrug could include the need for
enzymatic activation, different receptor binding profiles, slower penetration into the
central nervous system, or other novel effects. Prodrugs with abuse-deterrent properties
could provide a chemical barrier to the in vitro conversion to the parent opioid, which
may deter the abuse of the parent opioid. New molecular entities and prodrugs are subject
to evaluation of abuse potential for purposes of the Controlled Substances Act (CSA).
Two or more of the above methods could be combined to deter abuse.
This category encompasses novel approaches or technologies that are not captured in the
previous categories.
An objection you are likely to hear is that these technologies are too new to be proven. However,
abuse-deterrent technologies are not new. In fact, they have been in development for over 30
years. The first drug with abuse-deterrent properties was introduced in 1983 with Talwin NX in
response to an increase in abuse, diversion, overdose and death. Since then, companies have
continued to develop and improve deterrent technologies. The only thing that is new is
regulatory guidance from the FDA defining the evaluation process required for companies to
obtain labeling claims regarding the impact of these technologies.
The guidance was a critical step forward that allows, for the first time, doctors, patients, and
insurers to differentiate between opioids that simply contain a deterrent technology and those the
3
FDA has determined are likely to deter or reduce abuse. This differentiation is critical and we
believe should be foundational to any policy related to abuse-deterrent opioids.
2. What is Evidence They Reduce Abuse?
What is most critical is the impact these technologies have on misuse and abuse. What benefit do
they confer to individuals, families, and communities? Some of the best, real-world data emerged
after the introduction of a reformulated version of OxyContin® with abuse-deterrent properties.
The reformulated version was introduced into the market in 2010. And at the same time, the nonabuse-deterrent version was removed from the market. This created a “natural experiment” that
allowed researchers to assess misuse and abuse rates, as well as changes in health care
expenditures, related to a single drug before and after it was abuse-deterrent.
The findings from these studies are compelling. The researchers found that abuse rates of
OxyContin™ decreased significantly across a range of patient types and insurers, including:
 49% decrease in abuse among a subset of opioid abusers (23.69% to 12.12%, p<0.0001);
 41% decrease in abuse among all individuals (4.06% to 2.41%, p<0.0001);
 22% decrease in abuse among commercially insured (3.6% to 2.8%; p<0.001); and
 18% decrease in abuse among Medicaid patients (6.2% to 5.1%, p=0.034).vi
These were not isolated findings. After introduction of the abuse-deterrent OxyContin™, calls to
poison centers involving abuse, therapeutic errors affecting patients, and accidental exposures
associated with the drug decreased by 36%vii; street value decreasedviii; and there was a 50% drop
in demand for OxyContin™ during pharmacy robberies documented in a nationwide database.ix
Collectively, these findings provide strong evidence that the abuse-deterrent technology did, in
fact, deter and reduce abuse in real-world settings.
Let me address two other objections you will likely hear: Abuse-deterrent opioids “don’t work”
and they are not a viable solution because they don’t deter the most common form of abuse,
swallowing too many pills. We believe the real-world data, the study data provided to the FDA,
and the fact that the FDA has approved labeling claims stating that they are likely to reduce or
deter abuse, debunk the argument that they don’t work.
With respect to second objection, indeed, abuse-deterrent technologies cannot prevent abuse by
taking too many pills. Instead, they deter the most dangerous routes of administration – smoking,
snorting and injecting – which are associated with elevated risk of morbidity and mortality.x No
solution is perfect and we recognize that abuse-deterrent opioids are not a panacea. Prescription
drug monitoring programs and substance abuse treatment services cannot eliminate abuse either,
but we understand the value of these solutions and are using them to the extent possible. The
same approach should apply to abuse-deterrent opioids.
4
3. How Can They Reduce Cost?
The other common question regarding abuse-deterrent opioids as a partial solution to the opioid
abuse crisis is, “How much do they cost?” Given that health care costs and insurance premiums
have been steadily increasing, this is a valid and important question. Contrary to what others may
suggest, this is not a simple calculation solely based on the price of an abuse-deterrent opioid
versus a generic opioid without such technologies. To accurately answer the question, an
evaluation must, at a minimum, account for cost/price of the medicines, the scope of
prescriptions likely to be affected, current expenditures on opioid abuse, and the cost-savings of
deterring or reducing abuse.
Price?
Let me start by answering the first question often posed: What is the price of an abuse-deterrent
opioid? A starting dose for a patient without insurance paying cash is approximately $7 per day
for an abuse-deterrent opioid compared to $1 per day for a generic extended release opioid
without abuse-deterrent properties. xi If the dose is increased by the prescriber three times, the
prices would go up to approximately $16 per day and $3 per day, respectively.
Note that patients with private insurance or Medicaid would pay a co-pay rather than these
prices. Furthermore, they do not reflect any discounts or rebates private insurers might negotiate.
And they do not reflect what the Ohio Medicaid program would pay since federal law requires,
at minimum, a 23.1% rebate and the state shares the cost of coverage with the federal
government.
Additionally, these prices reflect the market today, which has three competitors. The FDA
approved another abuse-deterrent opioid last month, which is expected to enter the market in
early 2016.xii And there are multiple innovative biopharmaceutical companies and generic
manufacturers developing such drugs, with approximately 30 abuse-deterrent opioids in various
stages of development by innovator and generic manufacturers. The FDA has also stated they
will release draft guidance for generic manufacturers soon. All of these factors will increase the
market competition, putting more pressure on pricing and negotiations.
Assessing the Correct Scope of Impact
It is important to put the size of the abuse-deterrent market in context. It is assumed or implied
by those in opposition to abuse-deterrent opioids that legislation like HB 248 will transform the
entire opioid market. That is not true. Opioids are available in immediate- or extended-release
formulations, which are used different clinically and prescribed at different rates. The majority of
opioids prescribed in the United States are immediate-release, accounting for approximately 90%
of all opioid prescriptions.xiii Abuse-deterrent opioids are in the extended-release category, where
5
tampering is more common, and account for only 10% of opioid prescriptions.xiv Therefore, any
fiscal analyses must account for replacement of drugs only in the extended-release segment.
Cost of Opioid Abuse Currently in Our Premiums
Direct medical costs of opioid abuse are estimated to contribute $72.5 billion in annual cost to
health insurers.xv These costs come from more frequent and more intensive use of medical
services, and are currently factored into premiums by insurers. For reference, the costs of opioidrelated medical services are estimated at:






$13,398 for each opioid abuse related hospitalization;
$5,745 for each substance abuse treatment service;
$5,400 for each complication associated with injection drug-use, such as hepatitis and
HIV;
$1,175 for each opioid substance abuse treatment service;
$1,160 for each emergency department visit; and
$727 for each outpatient visit.xvi
There are also indirect costs due to loss of productivity and increased criminal activity. Criminal
justice cost was estimated to be $5.1 billion annually, which are born by a range of individuals,
groups, and institutions, including statesxvii:
 Correctional facilities accounted for the largest share with $2.3 billion; nearly two-thirds
of these costs were incurred at the state level;
 Police protection contributed $1.5 billion;
 Legal and adjudication costs accounted for $726 million; and
 Property lost due to crime accounted for $625 million.
Impact of Abuse-Deterrent Opioids on Cost
Researchers tracking the impact of the re-introduction of OxyContin® as an abuse-deterrent
version found that health care costs decreased by $9,456 and $11,501 per patient for diagnosed
abusers insured by commercial carriers and Medicaid, respectively, and health care costs
decreased by $7,565 and $6,856 per patient for undiagnosed abusers insured by commercial
carriers and by Medicaid, respectively.xviii Overall, the introduction of the reformulated abusedeterrent extended-release (ER) oxycodone is estimated to have saved $430 million in annual
health care costs.xix
Another economic analysis of the impact of shifting to abuse-deterrent opioids estimated that,
after accounting for differences in drug cost and health care savings due to reduce opioid abuse,
the net health care savings would range between $1,757 per patient and $4,033 per patient,
depending upon price and insurance coverage assumptions.
6
These findings highlight the need to assess cost and savings of abuse-deterrent opioids
holistically, rather than focusing on one part of the equation. It also suggests that the only way to
assess the validity of arguments in opposition to these innovations is to have answers to the
following questions:
What is the average health care cost of an opioid abuser enrolled in your plan?
How much do you spend annually and per patient on each medical service?
What would be the savings of reducing abuse by 10%? … 20%? … 50%?
Like other policy solutions Ohio is investing in to tackle the opioid abuse crisis, such as the
PDMP, we believe abuse-deterrent opioids may confer the dual benefit of reducing abuse, which
is what our family and friends care most about, and saving the state money, which is your
fiduciary responsibility to constituents.
Conclusions
Pfizer recognizes that solving the opioid crisis is extremely difficult and that there is no magic
bullet. Abuse-deterrent opioids will not be the sole solution, but we believe they can play an
important role as part of a comprehensive approach that addresses misuse and abuse from
prevention to treatment to overdose rescue.
Ohioans are currently paying for opioid abuse, personally and financially. The state is also
paying for opioid abuse through higher medical costs, criminal costs, and losses in productivity.
Maintaining the status quo means we all continue to pay these costs.
We believe this bill is a positive step forward for tackling the opioid abuse issue in Ohio, and
encourage you to vote to pass HB 248. Thank you again for the opportunity to speak today. I’d
be happy to answer any questions.
Tom Brownlie
Director, US Policy
Global Policy
Pfizer, Inc.
FDA. Guidance for Industry Abuse-deterrent Opioids – Evaluation and Labeling. Draft Guidance January 2013.
FDA. FDA approves abuse-deterrent labeling for reformulated OxyContin. FDA News Press Release. April 16, 2013. Available at:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm348252.htm. Last accessed November 4, 2014.
iii
The White House. The Administration’s Response to the Prescription Drug Epidemic: Action Items. Available at:
http://www.whitehouse.gov/sites/default/files/ondcp/issues-content/action_items_response_to_the_prescription_drug_epidemic.pdf. Last
accessed November 4, 2014.
iv
FDA, Guidance to Industry: Abuse-Deterrent Opioids – Evaluation and Labeling. April 2015.
v
Ibid.
vi
Butler S.F., et al. J of Pain (2013). 14(4): 351-358.
vii
Conlon P.M., et al. Pharmacoepidemiol Drug Saf (2013). 22(12): 1274-1282.
i
ii
7
Addiction Treatment Forum. “New Research Shows Significant Decrease in Street Value of OxyContin.” September 23, 2013. Available at
http://atforum.com/2013/09/new-research-shows-significant-decrease-in-street-value-of-oxycontin/. Last accessed November 4, 2015.
ix
John Burke. Pharmacy Times. April 14, 2015. Available at http://www.pharmacytimes.com/publications/issue/2015/april2015/paying-forabuse-deterrent-formulations-a-good-idea. Last accessed November 4, 2015.
x
Katz N et al. Am J Drug Alcohol Abuse. 2011;37(4):205-217.
xi
Data from GoodRx.com. Analysis conducted on November 1, 2015. Prices subject to change. Lowest available dose for Embeda = 20
mg/0.8mg , Hysingla ER = 20 mg, OxyCotin = 10 mg, and generic morphine ER = 10 mg. Higher doses for Embeda = 60 mg/2.4 mg, Hysingla
ER = 60 mg, OxyContin = 60 mg, and generic morphine ER = 60 mg.
xii
PR Newswire. Inspirion Delivery Technologies Receives FDA Approval for MorphaBond™ (morphine sulfate) extended-release tablets CII, an
Opioid Analgesic Formulated with Abuse-Deterrent Properties. October 5, 2015. Available at http://www.prnewswire.com/newsreleases/inspirion-delivery-technologies-receives-fda-approval-for-morphabond-morphine-sulfate-extended-release-tablets-cii-an-opioidanalgesic-formulated-with-abuse-deterrent-properties-300153910.html. Last accessed November 4, 2015.
xiii
Food and Drug Administration. Outpatient Prescription Opioid Utilization in the U.S., Years 2000-2009. July 22, 20010. See Slide 7:
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndLifeSupportDrugsAdvisoryCommittee/
UCM220950.pdf.
xiv
Butler S.F., et al. J of Pain (2013). 14(4): 351-358.
xv
CDC, MMWR Vital Signs, Overdoses and Prescription Opioid Pain Relievers --- United States, 1998 – 2008. November 4, 2011. Available at
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6043a4.htm. Last accessed November 3, 2015.
xvi
White A.G., et al., Appl Health Econ Health Policy. 2009; 7(1): 61-70.
xvii
Birnbaum H.G., et al., Pain Medicine. 2011;12:657-667.
xviii
White et al. Applied Health Economics and Health Policy. 2009;7(1):61-70.
xix
Rossiter et al. Journal of Medical Economics. 2014;17(4):279-287.
viii
8