Addiction Is A Disease, Not A Choice, And Should Be Treated As SuchPresenters: 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 PolicyFrank Vocci, PhD, President of Friends Research Institute

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.

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.

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)

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

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

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

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

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

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

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)

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

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”

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

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

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

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

Conclusion

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