Tx 2 joint presentation

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