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Stuart Gitlow, MD, MBA, MPH, FAPA
 President, American Society of Addiction Medicine
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Follow us on Twitter and online
 @addictionmeds #addictionmeds
 http://www.asam.org/advocacy/aaam
Federal Partners
 Office of the Assistant
Secretary for Health
 Center for Substance Abuse
Treatment, SAMHSA
 National Institute on Drug
Abuse
 Executive Office of the
President, Office of National
Drug Control Policy
Sponsors
 Alkermes
 Behavioral Health Group
(BHG)
 Cigna
 Covidien
 Millennium Laboratories
 Orexo
 Pfizer Inc.
 Reckitt Benckiser
Pharmaceuticals Inc.
 Titan Pharmaceuticals, Inc.
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Mark Kraus, MD, FASAM (Co-Chair)
Richard Soper, MD, JD, FASAM, DABAM (CoChair)
Kelly Clark, MD, MBA, FASAM
Mark Publicker, MD, FASAM
Ken Roy, MD, FASAM
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Every state Medicaid program covers at least one of the four
FDA-approved medications for the treatment of opioid
dependence
Many state Medicaid programs have implemented a variety
of authorization requirements which must be met in order for
payment for these medications to be approved.
Requirements for approval can range from limited to severe,
and may include “fail first” policies or a history of frequent
service utilization
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Written Medicaid criteria for authorization of a medication may
actually be implemented either with flexibility or rigidity by
different state Medicaid agencies. The survey on which this
report is based could only review the written criteria. Actual
implementation of written criteria may vary.
Accuracy of the survey results was degraded by an unknown
amount by the lack of knowledge of state Medicaid respondents
about policies in areas outside of their immediate sphere of
understanding. Review of survey responses indicated that many
Medicaid agencies contain separate medical, pharmacy and
Opioid Treatment Program (OTP) “silos”.
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* See Appendix to Report for complete data including Alaska and Hawaii
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One Western state Medicaid FFS program offers both Suboxone® and
Subutex® (film and tablets) as on its Preferred Drug List, and also offers
Vivitrol® on that same drug list, although in a non-preferred status
One Mid Western state Medicaid FFS program allows providers to offer all
of the medications in its OTP's, many of its criminal justice facilities and is
planning to expand availability that to Community Mental Health Centers
next year.
A New England Medicaid FFS program has a unique, Medicaid-supported
MAT hub (OTP) and spoke ( 200 office based physicians) regional specialty
system that provides methadone and buprenorphine statewide
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Payment for FDA-approved addiction medications by state
Medicaid programs hinges on compliance with often
complicated authorization requirements.
Medicaid agencies reported widely varying authorization
requirements for each FDA-approved medication for the
treatment of opioid dependence.
There is little agreement among state Medicaid agencies
regarding this life-saving, evidence-based set of interventions.
CMS and/or other federal authorities interested in addressing
the spread of addiction to prescription narcotics and other
opioids may need to consider intervening to limit such
disparities and inequities in the accessibility of these
medications to patients covered by Medicaid.
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Most plans cover pharmacotherapies for opiate
dependence
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Coverage is complex
 Significant regulation of methadone and
buprenorphine
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Inclusion in a plan’s formulary does not equate to
easy access
Utilization management (UM) can reduce access
Most common UM requirements are:
 Prior authorization
 Quantity and dosage limits
 Step therapy or “fail first” requirements
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Most widely available is Suboxone
New formulations may make Suboxone even
more available
 Generic formulation approved by the FDA in March,
2013 is already available in about 50% of plans studied
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While methadone is available in Opioid
Treatment Programs (OTPs) study found no
commercial coverage
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Although clinical services are covered as a
benefit, few plans required clinical services in
parallel with medications
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Clinical services in conjunction with medications
is an evidence-based practice that should be
required by commercial health plans
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Recession decreased spending on behavioral
health treatment significantly from 7.2 % of total
health spending to 2.7% largely due to
unemployment
(Levit, I. et al. 2013).
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Between 2001-2009 share of spending by
commercial insurers increased to 16% from
about 12% and spending on medications was
about 4% from an undetectable amount in
2001.
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Commercial health plans were reluctant to
respond to the survey
CEOs who were contacted by their Medical
Directors about the survey directed them not to
respond
In the “health marketplace” transparency will be
critical so individuals can compare plans
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Em0ployers may be key to assuring coverage and
benefits for medications and clinical services
Limitations on behavioral health benefits may
increase employers non-behavioral direct and
indirect healthcare costs
(Nat’l Bus. Grp. On Health, 2005)
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Education of employer groups is needed
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Under-utilization has been driven by:
 State licensing requirements that restrict hiring of
physicians
 Restrictions on use of some medications in specific
settings
 Cultural and attitudinal issues in the workforce
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Plans are working to engage treatment providers
to improve use of medications in treatment
Plans view this as cost-saving and evidencebased
Plans are creating internal programs to assist
patients and providers with access problems
ASAM-TRI Review
of Medications for Treatment of
Opioid Addiction
Effectiveness and Cost-Effectiveness
1. All databases searched – Emphasis on post 2005
2. Cochrane methods – 2 independent reviewers
3. Results
1. Effectiveness
a) 642 candidate articles = 75 analyzed
2. Cost-Effectiveness
a) 362 candidate articles = 20 analyzed
1. Patient engagement & retention
2. Reduction of opioid use
3. Reduction of non-opioid drug use
4. Reduction of opioid-related health and social
problems
a) HIV and other infections
b) Crime
c) Unemployment
Benefits/Effectiveness Shown:
• Engaging and retaining patients
• Reducing opioid use
• Reducing opioid related health/social problems
Side Effects:
• Abuse cases increase with increased availability
• Overdose incidents and deaths with methadone
Benefits/Effectiveness
• Reducing and even eliminating opioid use
• Reducing opioid related health/social problems
Side Effects
• Oral naltrexone has significant withdrawal effects
if administered <72 hours following detoxification
Benefits/Effectiveness Shown:
• Engaging and retaining patients
• Reducing opioid use
• Reducing opioid related health/social problems
Side Effects:
• Abuse cases increase with increased availability
• Overdose incidents and deaths with methadone
1. Meds have little effect on non-opioid
substance use
a. Naltrexone-alcohol an exception
2. Medication effects enhanced with good
health/social supports
a) Patients rarely get these services
b) Thus medications are consonant
with recovery-oriented care.
3. Medication benefits only shown for
maintenance – NOT for detoxification
a) This has been a source of public
disappointment
b) BUT – medications are both
effective and cost-effective when
used for long-term maintenance
1. Cost-Effectiveness = Cost per unit of
effectiveness on a single outcome measure.
– e.g. cost per drug-free day
2. Cost-Benefit = Total dollar costs to deliver an
intervention divided by the total benefits realized
expressed in dollars
3. Cost-Offset = Savings from an intervention –
Costs of that intervention
1. Methadone = economic evaluations since 2006
continue to show cost-effectiveness – and also
showing cost-effectiveness for HIV-prevention
2. Buprenorphine = far fewer economic evaluations
than for Methadone – but results are very
encouraging as cost-effective treatment
3. Naltrexone = no meaningful economic evaluations
since 2006 supporting cost-effectiveness – but
cost-analysis studies are encouraging
1. Less than 30% of treatment programs offer
medications for opioid dependence
2. And less than half of patients in these
programs receive them
3. The numbers are far lower in non-specialty
treatment (i.e. primary care)
1. Maybe they aren’t attractive to Patients?
a) Methadone and Buprenorphine –
definitely no – waiting lists in many cities
b) Naltrexone – Yes – particularly oral
naltrexone
2. Maybe they aren’t effective?
a) Definitely No
1. Maybe they cost too much?
a) Methadone cost/ month = ~$40
b) Buprenorphine cost/month = ~ $140
c) Oral Naltrexone cost/month = ~$60
d) XR Naltrexone cost/month = ~$700
e) Insulin cost/month = ~$200
1. It appears that the underutilization is
attributable to Other Reasons:
a) Physician Availability and Training
b) Official and de-facto Regulations
c) Specialty Care Limitations - ideology
d) Patient/Employer Demand
Treatment Research Institute
www.tresearch.org
215-399-0980
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Zenger Room, with live feed to Holeman Lounge
Speakers
 Stuart Gitlow, MD, President of ASAM
 Tom McLellan, PhD, Executive Director of Treatment
Research Institute, former Deputy Director of the White
House Office of National Drug Control Policy
 Michael Botticelli, Deputy Director of the White House
Office of National Drug Control Policy
 John O’Brien, Senior Policy Advisor, Center for Medicare &
Medicaid Services (invited)
 Whitney, patient taking buprenorphine
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Michael Botticelli, Deputy Director, Office of National Drug Control Policy
Barbara A. Cimaglio, Deputy Commissioner, Alcohol and Drug Programs,
Vermont Department of Health
H. Westley Clark, MD, JD, MPH, CAS, FASAM, Director, Center for
Substance Abuse Treatment, Substance Abuse and Mental Health Services
Administration
Andrea Kopstein, PhD, MPH, Director, Division of Services Improvement,
Center for Substance Abuse Treatment, Substance Abuse and Mental Health
Services Administration
Douglas Nemecek, MD, MBA, Board Member, Association for Behavioral
Health and Wellness and Chief Medical Officer, Cigna
Jack Stein, PhD, Director, Office of Science Policy and Communications,
National Institute on Drug Abuse
Mark Stringer, MA, Director, Missouri Division of Behavioral Health
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Capitol Hill Briefing: September 30
ASAM Speakers’ Bureau
Clinical Guideline
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All reports are available online at
http://www.asam.org/docs/advocacy/Implication
s-for-Opioid-Addiction-Treatment