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Barriers to Access to Care: American Society of Addic4on Medicine’s Advancing Access to Addic4on
Medica4ons Ini4a4ve
Na4onal RxDrug Abuse Summit Atlanta, GA
April 22, 2014
Panelists – Commercial Disclosures
Kelly J. Clark, MD, MBA, FASAM -‐ Medical Affairs Officer, Behavioral Health Group -‐ Medical Director, CVS Caremark
Stuart Gitlow, MD, MPH, MBA, FAPA -‐ Consultant; Orexo US (US Medical Director) -‐ Consultant; UNUM, Metlife, Pruden4al
Mark Publicker, MD, FASAM -‐ none
Learning Objec4ves
1. Explain the scien4fic and economic data suppor4ng evidence based medica4on treatment of opioid addic4on.
2. Describe the current barriers for pa4ents in accessing appropriate addic4on treatment.
3. Outline opportuni4es for pa4ents to access treatment.
American Society of Addiction Medicine (ASAM)
Professional society founded in 1954 representing 3,100+ physicians & other associated professionals Mission:
– Increase access to & improve the quality of addiction treatment
– Educate physicians, other health care providers & public – Support research & prevention – Promote appropriate role of the physician in patient care – Establish addiction medicine as a recognized specialty
ASAM Defini4on of Addic4on Addiction is a primary, chronic disease of brain reward, motivation, memory and related circuitry. Dysfunction in these circuits leads to characteristic biological, psychological, social and spiritual manifestations. This is reflected in an individual pathologically pursuing reward and/or relief by substance use and other behaviors.
Addiction is characterized by inability to consistently abstain, impairment in behavioral control, craving, diminished recognition of significant problems with one’s behaviors and interpersonal relationships, and a dysfunctional emotional response. Like other chronic diseases, addiction often involves cycles of relapse and remission.
Without treatment or engagement in recovery activities, addiction is progressive and can result in disability or premature death.
Adopted by ASAM Board of Directors April 12, 2011.
Project Approach: Key Phases
Mission: Advocate for patient access to appropriate evidence-based, cost-effective medication treatment for opioid dependence.
Phase I Start-‐up and
Data Collec4on
Phase II Data Synthesis and Repor4ng
Phase III Collabora4on and Outreach
Project Phases, Cont’d PHASE ONE
1. Patient Advocacy Task Force appointed by ASAM Board Members: Drs. Kraus and Soper (Co-chairs); Drs. Clark, Christiansen, Gaskin, Publicker, Roy, and Shore
2. ASAM secured financial and endorsement support from public and private partners 3. Payer policy and legal research conducted by leading organizations
PHASE TWO 1. Advancing Access to Addiction Medications Report issued June 2013; stakeholder
summit and press conference in Washington, DC 2. Online outreach toolkit developed 3. National Speakers Bureau organized
PHASE III 1. Federal briefing in October 2013; ongoing participation in stakeholder conferences
and briefings 2. Communications strategy approved; outreach continued 3. Targeted policy briefs and payer policy updates under development
AAAM Research
• State Medicaid survey of coverage & access • Commercial insurer survey of coverage &
access
• Literature reviews of clinical and cost effec4veness of medica4ons to treat opioid addic4on
• TRI and Avisa Group retained to do research • Available on ASAM website (www.asam.org)
Advancing Access to Addic4on Medica4ons (AAAM)
May 2011:
Dr. Mark Publicker, an ASAM addic<on
specialist physician, alerted ASAM to
Maine legisla<on that limits pa<ent access
to addic<on medica<ons.
April 2012:
ASAM Board of Directors appointed a Pa<ent Advocacy Task
Force (PATF) to advocate for pa<ent access to evidence-‐based, cost-‐effec<ve medica<on treatment
for opioid dependence.
June 20, 2013:
PATF Stakeholder Summit at The
Na<onal Press Club in Washington, DC; Report results are disseminated.
September 30, 2013:
ASAM Hill Briefing on pharmacotherapy for
opioid addic<on treatment.
October 23, 2013:
ASAM Legisla<ve Day on Capitol Hill; ASAM
members bring awareness of the
issue to policymakers.
What is Medica4on Assisted Treatment (MAT) of Opioid Addic4on?
– Use of medica4on with FDA approved primary indica4on for the maintenance treatment of opioid dependence:
• Methadone in Opioid Treatment Programs (OTPs) • Buprenorphine (Suboxone, Zubsolv brand names) • Extended release naltrexone shots (Vivitrol brand name)
– While we don’t have special alcohol or methamphetamine or cocaine brain receptors, humans do have opioid receptors
– At adequate doses, these three medica4ons sit on the receptors and block their availability for other opioids to be used to “get high”
Clinical provision of MAT
– Methadone • Daily dosing in specially licensed centers (OTPs) • Increasing privileges earned over 4me • Required counseling, call-‐backs, drug tes4ng
– Buprenorphine • Prescrip4ons can be given at a doctor office • Ability to refer to counseling is required
– Extended release naltrexone • Once monthly shot must be procured by and given in provider’s office
Keep in mind:
– Addic4on is a chronic disease
– These medica4ons are FDA approved for Opioid Dependence, and act on the opioid receptors
• We do not expect them to have any significant impact on use of non-‐opioids, even though they “treat addic4on”
• 12 step mee4ngs, individual/group/family counseling , and reward/repercussion systems address other drug sue
What do effec4veness and cost effec4veness mean -‐ Pa4ents
– Health Effec4veness Outcomes: mortality ( not dying), morbidity ( not geing Hep C, HIV, other skin and heart infec4ons, liver disease, etc)
– Interpersonal: Regaining child custody, marriage, func4oning in family system
– Voca4onal: improved work/school func4oning
– Legal: decreased legal involvement
– Financial: money to be used produc4vely rather than on drugs
What do effec4veness and cost effec4veness mean -‐ Community
– Health cost-‐effec4veness: less ED visits, hospitaliza4ons, costs of trea4ng addic4on-‐caused condi4ons
– Interpersonal: ability to parent children ( not orphan them; not involving child services / foster care system)
– Voca4onal: improved workforce contribu4on
– Criminal Jus4ce: decreased legal involvement AND decreased engagement in illegal ac4vi4es
– Financial: money to be used produc4vely rather than fuel drug-‐based economy
Methadone and Buprenorphine:
-‐ Reduce opioid use more than: -‐ No treatment
-‐ Outpa4ent treatment without medica4on -‐ Outpa4ent treatment with placebo medica4on -‐ Detoxifica4on only
-‐ Reduce overall medical costs: -‐ Related to Emergency Department use -‐ Related in inpa4ent hospitaliza4ons
TRI Review of Effec4veness of MAT
• Hundreds of effec4veness studies (methadone)
• All medica4ons have demonstrated modest or beker cost effec4veness in maintenance
• No evidence for effec4veness in detoxifica4on
• All medica4ons are under-‐u4lized
Barriers to Access
– S4gma? – Lack of understanding of the data? – Lack of providers?
• 30/100 pa4ent limit for bupe? State wai4ng lists for methadone? • Lack of geographical access to treatment?
– Cost? – Health Plan coverage? – U4liza4on Management Protocols? – Legisla4ve and/or Regulatory Restric4ons?
AAAM State Medicaid Survey Results
• Every state Medicaid program covers at least one of the FDA-‐approved medica4ons
• Many state Medicaid programs have a variety of authoriza4on requirements which must be met for these medica4ons to be approved
• Requirements for approval range from limited to severe, and may include “fail first” policies or a history of frequent service u4liza4on
Commercial Insurer Findings • No commercial plans covered methadone
• Inclusion in a plan’s formulary does not equate to easy access
• U4liza4on management (UM) can reduce access
• Most common UM requirements are: – Prior authoriza4on – Quan4ty and dosage limits – Step therapy or “fail first” requirements
Coverage of All Three FDA-‐Approved Medica4ons for the Treatment of Opioid
Dependence
Life4me Limits on Prescrip4ons for Buprenorphine
Types of limita4ons:
• Limits on dose
• dura4on of treatment
• number of treatment episodes
• life4me limits
• required tapering schedules
• required ancillary services ( counseling) which may not be covered
Direct Costs
• Methadone = $70-‐$130 per week (includes medica4on, counseling, doctor, urine screens, nursing/pharmacist dispensing service)
• Buprenorphine medica4on = $7 per tab/film. Package insert may be up to 5 individual tab/films per day (2 “large” and 3 “small”)
• Extended release naltrexone $700+ injec4on once per month.
Buprenorphine a “top cost” for Medicaid pharmacy plans
Example: In the State of Michigan buprenorphine products are the #1 cos4ng medica4ons in their Medicaid formulary.
However, note that “pain pills”, like hydrocodone plus acetaminophen, have mul4ple generics and are typically inexpensive. They are “low cost” medica4ons!
Issues of Diversion
• Methadone requires: • random call backs
• urine screens • inges4on in front of nurses • daily dosing un4l earning take home doses
• take home doses must be in locked box • Formula4on (liquid, 5 mg and 40 mg) different
than methadone formula4on for pain (10 mg)
Issues of Diversion
• Buprenorphine: • Reports of pa4ents receiving higher than
necessary doses and selling or sharing “extra” doses
• Payer then is subsidizing this costly diversion • Diversion highest where access is lowest • No counseling, call backs, drug screens, inges4on
in front of staff, specific formula4ons are required
• Extended Release Naltrexone: no diversion poten4al reported
How can we help pa4ent’s access treatment? Educate and Advocate! – For MAT to be including in health plan coverage under Parity as part of the con4nuum of care
– Improving the coordina4on of care throughout the con4nuum of care
– Educa4ng stakeholders about the medical and economic benefits of MAT
– Helping educate stakeholders about what cons4tutes appropriate care for opioid addic4on guideline development
ASAM’s Next Steps
• Partnering on the development of ASAM’s Na<onal MAT Guidelines
• Partnering at the chapter and na4onal level with a variety of concerned stakeholders
• Crea4ng briefs and toolkit from research for use by all for local outreach
• Building and training speakers bureau • Planning for 2014 na4onal outreach day
Thank you!
Stay tuned for next steps.
All reports are available online at:
hkp://www.asam.org/docs/advocacy/Implica4ons-‐for-‐Opioid-‐Addic4on-‐Treatment