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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	
  

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Web only rx16-adv_tues_330_1_elliott_2brunson_3willis_4dean
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Rx16 treat wed_200_group_falkinburg_miller
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Rx16 prevent wed_200_1_cairnes-wertnepy_2arnoldRx16 prevent wed_200_1_cairnes-wertnepy_2arnold
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Web only rx16 len wed_200_1_augustine_2napier_3darr - copy
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Web only rx16 len wed_200_1_augustine_2napier_3darr - copy
 
Rx16 heroin wed_200_1_parker-daley_2guarino-luongo_3taylor
Rx16 heroin wed_200_1_parker-daley_2guarino-luongo_3taylorRx16 heroin wed_200_1_parker-daley_2guarino-luongo_3taylor
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Rx16 federal visionsession_200
Rx16 federal visionsession_200Rx16 federal visionsession_200
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Rx16 clinical wed_200_1_hall_2green
Rx16 clinical wed_200_1_hall_2greenRx16 clinical wed_200_1_hall_2green
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Tx 2 joint presentation

  • 1. 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  
  • 2. 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  
  • 3. 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.    
  • 4. 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
  • 5. 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.
  • 6. 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  
  • 7. 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
  • 8. 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)  
  • 9. 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.    
  • 10. 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”  
  • 11. 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  
  • 12. 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  
  • 13. 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  
  • 14. 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  
  • 15. 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  
  • 16. 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    
  • 17.
  • 18. 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?  
  • 19. 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  
  • 20. 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  
  • 21. Coverage  of  All  Three  FDA-­‐Approved   Medica4ons  for  the  Treatment  of  Opioid   Dependence  
  • 22. Life4me  Limits  on  Prescrip4ons  for   Buprenorphine  
  • 23. 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  
  • 24. 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.  
  • 25. 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!  
  • 26. 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)  
  • 27. 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  
  • 28. 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  
  • 29. 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  
  • 30. Thank  you!   Stay  tuned  for  next  steps.   All  reports  are  available  online  at:   hkp://www.asam.org/docs/advocacy/ Implica4ons-­‐for-­‐Opioid-­‐Addic4on-­‐Treatment