Addiction Is A Disease, Not A Choice, And Should Be Treated As Such. Vision Session presented by Center for Lawful Access and Abuse Deterrence

1. Addiction Is A Disease, Not A Choice,
And Should Be Treated As Such
Presenters:
Genie L. Bailey, MD, DABAM, Associate Clinical Professor of
Psychiatry and Human Behavior at Brown University
Van Ingram, Executive Director of the Kentucky Office of
Drug Control Policy
Frank Vocci, PhD, President of Friends Research Institute

2. Disclosure Statements
• CLAAD’s funders include members of the
pharmaceutical, addiction treatment, and
laboratory industries, and are disclosed on its
website, www.claad.org.
• CLAAD is managed by DCBA Law & Policy. To
avoid conflicts of interest, DCBA adheres to
the District of Columbia Rules of Professional
Conduct §§ 1.7-1.9.

3. Disclosure Statements
• Genie L. Bailey’s institution has received grant support from NIDA, Reckitt-
Benckiser (Indivior) and Braeburn Pharmaceuticals. She has received drug
study in-kind support from Reckitt-Benckiser (Indivior). Dr. Bailey has received
travel support from BioDelivery Sciences International, Inc. and is on the
advisory boards of Braeburn Pharmaceuticals; BioDelivery Sciences
International, Inc.; and Camurus AB. She is on the speakers’ bureau of
BioDelivery Sciences International, Inc.
• Van Ingram has no relevant, real or apparent, personal or professional,
financial relationships with proprietary entities that produce health care goods
and services.
• Frank Vocci has consulted with and received reimbursement for meals and
travel expenses from the following companies: Braeburn Pharmaceuticals,
Demerx, Indivior, and Pinney Associates. He has received travel and meal
expenses from Intratab Labs Inc., and received consulting fees from Alkermes
and Usona Institute. All of Dr. Vocci’s consulting fees go to Friends Research
Institute, Inc.

4. Introduction
• Reductions in supply of medications available for abuse
must be matched by corresponding decreases in demand
• A substance use disorder (SUD) is a disease of the brain and
should be treated as such (NIDA 2015)
• Medication-assisted treatment (MAT) has been shown to
be safe and effective in treating SUDs (HHS, 2015)
• MAT has been shown to be effective in treating opioid use
disorders and reducing drug-related disease and criminal
recidivism (HHS, 2010)
• SUDs exact over $700 billion annually in costs related to
crime, lost work productivity, and health care (NIDA 2015)

5. Need for Greater Demand Reduction
Rx drug overdose deaths increased
2.8 fold between 2001 and 2014
>10,500 heroin-related deaths in
2014; quadrupled between 2002
and 2014

6. Need for Greater Demand Reduction
• Rx opioid-overdose deaths increased 9%
between 2013 & 2014 (CDC 2015)
– Increase likely due to illicit synthetic fentanyl (RADARS,
2015)
• Major drivers of recent heroin use increases &
related deaths
– Increased accessibility
– Lower market price
– High purity

7. State Efforts To Reduce Supply Yield
Progress
• Policy measures
– State-wide opioid prescribing guidelines
– Mandatory prescriber education
– Requiring pain clinics treating with controlled substances to register
with state
– 49 states and D.C. have prescription drug monitoring programs
(PDMPs)
– 29 states require prescriber or dispenser to check PDMP
• Decrease in deaths and hospitalizations in locations that
implemented policies to address rx opioid abuse
– 27% decrease in overdose deaths in FL between 2010 and 2012
– 29% decrease in overdose deaths in Staten Island between 2011 to
2013
– 11% decrease in hospitalizations for overdoses in KY in 2013

8. How To Reduce Demand
• Prevention
– Public awareness
– Prescriber education (also reduces supply)
– Patient counseling
• Therapeutic screenings and interventions for
substance use (e.g., SBIRT)
• Individualized treatment for SUDs

9. SUD Is a Brain Disease
• A chronic, relapsing brain disease that causes
compulsive drug seeking and use, despite harmful
consequences (NIDA 2014)
• Similar to other chronic, relapsing diseases (e.g.,
diabetes, asthma, heart disease)
• Can be managed successfully with treatment (NIDA 2014)
• Relapse
– Not uncommon
– Does not signal treatment failure
– Indicates treatment should be reinstated or adjusted or
alternative treatment is needed

10. Medication-Assisted Treatment
• An evidence-based method that combines
counseling, behavioral therapies, and FDA-
approved meds to treat SUDs
• Approved meds for opioid use disorders
– Methadone (opioid full agonist) – available at
federally regulated opioid treatment programs (OTPs)
– Naltrexone (non-opioid) – available in physician
offices
– Buprenorphine (opioid partial agonist) – available in
physician offices and OTPs

11. Treatment: Effectiveness
• MAT effective in
– Treating opioid use disorders
– Reducing drug-related disease, criminal recidivism, and
morbidity and mortality
– Increasing quality of life (HHS)
• Why?
– Long-lasting changes in brain chemistry can cause difficulty with
abstaining from opioid use; withdrawal symptoms and cravings
can be overwhelming
– MAT can help reduce withdrawal symptoms and curb opioid
cravings that can lead to relapse
– Long-term MAT has greater than 85% chance of reducing overall
mortality among people with opioid use disorders (British Medical
Journal, 2010)

12. Treatment: Research
• Novel meds to treat SUDs are under development
– Six-month subdermal buprenorphine implant for
maintenance treatment of opioid use disorders (action
expected 5/27/16)
– Buprenorphine once-monthly or once-weekly
injectable, each with multiple doses, to cover
initiation through maintenance (phase III)
– Vaccine to prevent synthetic opioids from reaching
brain (The Scripps Research Institute, 2016)
– Hydromorphone NME prodrug (IND filed)
• Designed not to release until metabolized in GI tract
• Clinical program to assess potential to limit oral abuse and
overdose

13. Access to Treatment: Coverage
• Private payers
– Insurers using loopholes to deny coverage (e.g., step therapy – outpatient
before inpatient, cancel coverage after pre-approval, require proof of payment
in full, checks to patients)
• Medicare Advantage plans must ensure access to MAT; prior auth &
adverse tiering requirements prohibited b/c they duplicate DATA 2000 &
REMS safeguards (CMS 2016)
• Medicaid: 2013 ASAM study found widespread problems with MAT access
among Medicaid programs
– Limits on dosage; lifetime limits on MAT, complex prior auth, limits on refills
• Incarcerated individuals
– Private insurance, Medicare, and Medicaid not available to incarcerated
individuals
– Prisons denying MAT to inmates; in Feb. 2015, Obama Administration
announced no fed. funding for drug courts denying access to meds
– 5% die of overdose within two weeks of release from prison
• Learn more on Tuesday at 12:30 at “Ensuring Access to Quality Treatment”

14. Access to Treatment: Federal Law
• Drug Addiction Treatment Act of 2000 (DATA 2000) - 30/100 limit
• HHS to revise regs to expand buprenorphine access (expected 4/8/2016)
• The Recovery Enhancement for Addiction Treatment (TREAT) Act, S.
1455 (Sen. Ed Markey (MA))
– Physicians: treat 100 year 1; unlimited after if:
• Certified & agree to participate in PMP; or
• Obtain 24 hrs of training, agree to participant in PMP, and practice in qualified
setting
– Nurse practitioners & physician assistants to prescribe to 100 pts if:
• Licensed to prescribe c.s. for pain, under physician supervision, training, and
practice in qualified setting (NP only)
• Proposal to provide exemptions for injectables & implantables if
treatment is formulated to last 7 days or more and administered
directly to patient (Sen. Rand Paul (KY))
• Barrier based on duration of treatment during clinical studies

15. Criminal Justice Reform
• Untreated substance use costs $600 billion annually
– $8.2 billion in criminal justice costs
• Cost savings from substance use treatment
– $1 invested = $4 return in health care costs + $7 in law
enforcement & other criminal justice costs
• In 2010, 2.7 mill. U.S. prison inmates (85%) abused
controlled substances
• Only 11% with SUDs receive treatment in prison
• Estelle v. Gamble (Supreme Ct. case from 1976):
inadequate medical care for inmates is
unconstitutional

16. Criminal Justice Reform
• Innovative sheriffs and police chiefs
– TN detention center & recovery center partnership to
provide MAT for pregnant women to prevent effects of
harmful detox
– Worcester County Sheriff’s office received $750K federal
grant to provide substance use and mental health
treatment along with numerous additional pre-release
services to inmates
– Angel Initiative in Gloucester, MA and Operation Hope in
Scarborough, ME allows people with opioid use disorders
to walk into a police station and ask for help
– LEAD in Seattle, WA diverts low-level drug and prostitution
offenders into community-based treatment and support
services instead of jail and prosecution

17. Criminal Justice Reform
• Policy Recommendations
– Provide effective treatment for incarcerated
individuals
– Re-entry and recovery support to reduce
recidivism
– Sen. Ed Markey (MA) legislation: The Supporting
Positive Outcomes After Release Act of 2015
• Suspend (not terminate) Medicaid while incarcerated
• Enable incarcerated individuals to access services more
quickly upon re-entry

18. Conclusion
• Contact CLAAD
– Website: www.CLAAD.org
– Email: policy@claad.org
– Twitter: @claad_coalition
• Thank you