00476-ASAM 06 Final Results

8/14/2019 00476-ASAM 06 Final Results

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Arlene Stanton, Ph.D. Task Order Officer, CSATCaroline McLeod, Ph.D. Project DirectorBill Luckey, Ph.D. Principal Investigator

Wendy B. Kissin, Ph.D., Senior Analyst/PsychologistL. J. Sonnefeld, Senior Analyst

Westat

SAMHSA/CSAT Evaluation of theBuprenorphine Waiver Program

Expanding Treatment of Opioid Dependence:Initial Physician and Patient Experiences with the

Adoption of Buprenorphine

American Society of Addiction MedicineMay 5, 2006


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Provide brief background on DATA and contextfor the related SAMHSA evaluation.

Share highlights of FINAL results including:

Characteristics of patients treated under the WaiverProgram and the doctors who treated them Patients receptivity to, satisfaction with and success

under the Waiver program (6-month data) Issues and challenges related to adoption of this new

medication under the DATA Waiver Program Conclusions

Goals of this PresentationGoals of this Presentation


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Background


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Drug Addiction Treatment Act of 2000

(DATA) DATA establishes a program of waivers that permit qualified

physicians to dispense or prescribe schedule III, IV, and V narcoticdrugs or combinations of such drugs approved by the Food andDrug Administration (FDA) for the treatment of addiction to opioids.

Buprenorphine (BUP) is the first medication to be eligible for useunder the Waiver Program.

DATA also specifies that the Secretary of the Department of Healthand Human Services (HHS), in conjunction with the AttorneyGeneral, may make determinations concerning whether: Treatments provided under the Waiver have been effective forms of

maintenance and detoxification treatment in clinical settings; The Waiver has significantly increased the availability of maintenance

treatment and detox treatment; and/or Such Waivers have adverse consequences for the public health.


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5

Per the supporting legislation the Drug Addiction Treatment Act of 2000 (DATA) describe the impact of the Waiver programupon:

AVAILABILITY of detoxification and maintenancetreatments;

EFFECTIVENESSof these treatments; and Potential adverse PUBLIC HEALTH

CONSEQUENCES , including DIVERSION activities.

Key GoalsKey Goals

of the SAMHSA Evaluationof the SAMHSA Evaluation


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Medication Assisted Treatment (MAT)

Sites by Region, 2002 and 2003

0100200300400500600

700800900

1,000

2 0 0 2

2 0 0 3

2 0 0 2

2 0 0 3

2 0 0 2

2 0 0 3

2 0 0 2

2 0 0 3

N u m

b e r o f

M e d

i c a t i o n

A s s

i s t

T r e a t m e n

t S i t e s

Other Sites with Waivered Physicians

OTPs with Waivered Physicians

OTPs

Northeast South West Midwest

Sites are unique addresses where MAT is providedSecondary Data Report

Total MAT sites increased from 1,080 to 2,564


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C i f MAT Si Af h W i


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Concentration of MAT Sites After the WaiverProgram (OTPs and BUP Waiver Sites) byState, 2003

BWNS & N-SSATS

SAMHSA/CSATs Evaluation of the Buprenorphine Waiver Program 2002-2005


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The PhysiciansThe Physicians


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Number of Waivered Physicians and

Estimated Number Prescribing

0.00.5

1.01.52.02.53.03.54.04.55.0

Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1

N u m

b e r o

f P h y s i c i a n s w

h o H a

R e c e i v e

d W a i v e r s ( i n T h o u s a n d s )

BUP ApprovedOct. 2002

52% Prescribing(Addiction Physician Survey)

2002 2003 2004 2005

67% Prescribing*(Waivered Physician Survey)

Source: CSATs Buprenorphine Waiver Notification System


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Half of Waivered Physicians Had No

Previous Experience Providing MAT, 2005

Yes43%

No Answer4%

No53%

Have you ever provided medication assisted treatment for opioiddependence using methadone?

n=1,568


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Specialties Reported by Waivered

Physicians, 2005

AddictionPsychiatry

14%

AddictionPsychiatry &

AddictionMedicine

5%AddictionMedicine

25%

NonaddictionSpecialty

56%

56% Not Addictions Specialists

n =1,560Waivered Physician Survey 2005


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Highlights:Highlights:

What Treatment Looked LikeWhat Treatment Looked Like


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Patients Inducted per Prescribing

Physician, 2005

0

50

100

150

200

250

300

350

400

450

500

550

0 ' 1 - 9

' 1 0 - 1 9

2 0 - 2 9

3 0 - 3 9

4 0 - 4 9

5 0 - 5 9

6 0 - 6 9

7 0 - 7 9

8 0 - 8 9

9 0 - 9 9

1 0 0 - 1

0 9

1 1 0 - 1

1 9

1 2 0 - 1

2 9

1 3 0 - 1

3 9

1 4 0 - 1

4 9

1 5 0 - 1

5 9

1 6 0 - 1

6 9

1 7 0 - 1

7 9

1 8 0 - 1

8 9

1 9 0 - 1

9 9

2 0 0 - 2

0 9

2 1 0 - 2

1 9

2 2 0 - 2

2 9

2 3 0 - 2

3 9

2 4 0 - 2

4 9

2 5 0 - 2

5 9

2 6 0 - 2

6 9

2 7 0 - 2

7 9

2 8 0 - 2

8 9

2 9 0 - 2

9 9 3 0

0 +

Number of Patients Inducted (Cumulative)

N u m

b e r o

f P h y s i c i a n s

( W e

i g h t Prescribing for Detoxification Only

Prescribing for Maintenance and Detoxification

Waivered Physician Survey 2005

More than 50 physicians reported inducting more than 300 patients

Twenty three Percent of Prescribers Use


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Twenty-three Percent of Prescribers UseBUP for Detoxification but not for

Maintenance in 2003 and 2005

Maintenance

and/orDetox77%

Detox,No Maint.

23%Maintenance

and/orDetox62%

Detox,No Maint.

38%

Patients Treated inEach Type of Practice

Physicians ProvidingEach Type of Treatment

Detox,No Maint.

32%Maintenance

and/orDetox

68%

Detox,No Maint.

21%Maintenance

and/or

Detox79%

2003

2005


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Patient Reports of Visits to Physician

Providing BUP in First 30 Days of Treatment

28%

10%14%

3% 3% 0%2%5%0%

35%

0%5%

10%

15%20%25%30%

35%40%

0 1 2 3 4 5 10 20 30 31+

Number of Visits per Patient

P e r c e n

t o

f P a t

i e n

t S a m p l e

n =347Patient Study


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Patient Reports of Substance Abuse and Mental

Health Counseling Sessions in First 30 Days

4% 4% 3%

8%

12%10%10%

6%

41%

2%0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

0 1 2 3 4 5 10 20 30 31+

Number of Counseling Sessions per Patient

P e r c e n

t o

f P a t

i e n

t S a m p l e

Patient Study n =347


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The PatientsThe Patients


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Cumulative Estimate of Number of

Patients Inducted

0

20,000

40,000

60,000

80,000

100,000

120,000

N u m

b e r o f

P a t

i e n t

Treatment Provided by PhysiciansProviding Detox No Maintenance

38%

34%63,204

32%

104,640

December 2003 March 2005Mean # of Patients/Physician 57 46

SD 6 147Range 1-800 1-1011Addiction Physician Survey 2003Waivered Physician Survey 2005


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Patients Inducted by Setting and

Treatment Offered

19,322

34,078

12,360 12,209

1,509

14,651

5,097 3,640 3,847 3,940

4,485

3,791

8,896

5,538

10,862

5,2433,462

13,542

2,867 2,114

0

5,000

10,000

15,000

20,000

25,000

30,000

35,000

40,000

2003 2005 2003 2005 2003 2005 2003 2005 2003 2005

N u m

b e r o f

P a t i e n t s

T r e a

t e

Detox Only

Maintenance and/or Detox

IndividualPractice Hospital OTPSpec. Sub. AbuseTreatment Clinic OtherSetting

SettingAddiction Physician Survey 2003Waivered Physician Survey 2005


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Characteristics of Patients Treated Under

the Waiver Program

0%

20%

40%60%

80%100%

New toSubstance

AbuseTreatment

New toMedication-

AssistedTreatment

Transitionedfrom Methadone

Addicted to Non-Heroin Opioids*

P e r c e n t o f P a t i e n t s T r e a t e d

Longitudinal Patient Study

Addiction Physician Survey

* In P atient Study, drug of abuse


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Physicians Report Few BUP Patients

Are Willing to Attend OTPsOnly 10% of physicians believed that at all or most of their

patients would seek treatment at an OTP.

0%

5%

10%

15%

20%

25%

30%

35%

40%

All or Most About Half A Few None NA/Don'tKnow

P e r c e n

t o f P r e s c r i

b i n g

P h y s

i c i

n = 940Waivered Physician Survey 2005


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Primary Opioid Abused And the Regular

Problematic Use of Other Opioids

0

50

100

150

200

250

300

Heroin (41%) Other Opioids (59%)

N u

m b e r o f P a t i e n t s

Heroin(Primary)plus Other

Opioids

Other OpioidsOnly

Other Opioids(Primary) plus

Heroin

HeroinOnly

40% of the samplelimit th eir abuse tonon-heroin opioids.

Individuals w ithabuse limited tonon-heroin opioidsmay represent adistinct patientsubpopulationseeking treatmentin BUP sites .

Prim ary Opioid Abused 30 Days Prior


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Patients Abusing Substances Other

Than OpioidsWaivered Physician

Survey 2005

No46% Yes

54%

Estimates based on physicians reportof proportion of inducted BUP patientshaving comorbid substance abuse

disordersn = 1,034 physicians

Proportion of Patient Study samplereporting at least one day of use in thepast 30 of nonopioid drugs or binge

alcohol

Patient Study 2004-05

No35%Yes65%

N = 433 patients


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Chronic Pain Patients Are an Important

Subpopulation Treated With BUP

Waivered PhysicianSurvey 2005

No66%

Yes34%

Patient Study 2004-05

No68%

Yes32%

Proportion of Patient Study samplereporting that they had been diagnosed

with chronic pain (lifetime).n = 411 patientsn = 1,034 physicians

Estimates based on physicians report ofproportion of inducted BUP patients who

suffered from a chronic pain syndrome.


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Patients Are Satisfied With BUP

Treatment at 6 Months

"Overall, how would you

rate the helpfulness of BUPas a medication for opioid

addiction?"

22%

4%1%

73%

"Would you recommend

BUP treatment to a friendsuffering from opioid

addiction?"

97%1%

1%

1%

Extremelyhelpful Very

helpful

Somewhathelpful

Not helpful

YesNo

Maybe

Dont Know

n = 386Patient Study


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6 Month BUP Treatment Outcomes:

Abstinence From Drugs During Past 30 Days

22%

19%

59%

59% Abstinent From All Drugs

81% Abstinent FromOpioids (except BUP)

Abstinent FromAll Drugs

Used Non-Opioid

Substances, Not Opioids

(Self-Reported)

UsedOpioidsOtherThanBUP

n = 381Patient Study


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BUP Treatment Retention at 30 Days

0%

20%

40%

60%

80%

100%

Heroin Only Rx Opioid Only Mixed Opioids

Still in Treatment Completed TreatmentDropped From Treatment Not Available for Followup

n =105 n =218 n =110

89% 93% 90%Retention Rate

P e r c e n

t o

f P a

t i e n

t S a m p

l e

Patient Study


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BUP Treatment Retention at 6 Months

0%

20%

40%

60%

80%

100%

Heroin Only Rx Opioid Only Mixed Opioids

Still in Treatment Completed TreatmentDropped From Treatment Not Available for Followup

n =105 n =218 n =110

71% 77% 74%Retention Rate

P e r c e n

t o

f P a

t i e n

t S a m p

l e

Patient Study

P i O


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Patient Outcomes:

Employment at Baseline and 6 Months

0%

10%

20%

30%

40%

50%

Full Time Part Time Unemployed Not in LaborForce

P e r c e n t o f P a t i e

nBaseline 6 Months

Patient Study n = 386

P ti t O t


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Patient Outcomes:

Specific Criminal ActivitiesIn the past 30 days were you involved in any of the

following activities?

16%

10% 10%

1% 1%1%2%

1%

3%

0%

5%

10%

15%

20%

Drug Dealing Prescription Fraud Other Crimes

Baseline 30 Day 6 Month

P e r c e n

t o

f P a t i e n

t S a m p l e

n =379Patient Study

P ti t O t P t f P ti t


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Patient Outcomes: Percent of Patients

Acquiring Drugs on the Street

20%

4%

67%

0%

20%

40%

60%

80%

100%

Baseline 30 Day Followup 6 Month Followup

P e r c e n

t o

f P a t i e n

t S a m p l e

Patient Study n =379

f


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Prescribing Physicians* Perceptions of BUP

Effectiveness, 2005

*Views of physicians who reported some experience treating for that length of time

40%

74%34%

41%

22%15% 12%

32%

19%7%

4%

0%

20%

40%

60%

80%

100%

1 Month

Very Effective Somewhat EffectiveNot at All Effective Don't Know/No Response

By Length of Treatment

N = 556 N = 557 N = 682

Waivered Physician Survey

Summary on Outcomes &


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Summary on Outcomes &

Effectiveness Most prescribing physicians perceived BUP to be

effective, particularly for longer treatment lengths. Positive treatment outcomes were observed amongpatients treated in a range of real-world practicesettings.

Outcomes are consistent with and comparable to theresults of numerous clinical trials that have found BUP tobe effective in research contexts. In addition:

BUP appeared to be somewhat more effective for patientsdependent on prescription opioids than for those primarilydependent on heroin.

BUP appeared to be as effective for persons with chronic pain asfor those who had not been diagnosed with chronic pain.


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Adverse Events, Public & Individual


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Patient Reports of Diversion , 2005

64% 65%

10% 10%3%

21% 23%

4%

0%

20%

40%

60%

80%

100%

Methadone OxyContin

Don't Know/RefusedEasier

Same/TooSoon to SayHarder

Responseswere similarat baseline

and 6 monthfollowup.

P e r c e n

t o

f P a

t i e n

t S a m p

l e

n =411

Compared to OxyContin or methadone , how easy or hard do youthink it is to buy or sell BUP on the street?

Patient Study

Ph i i R t f S Ad


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Physicians Report of Severe AdverseReactions to BUP Treatment are Rare: 2005

Physicians Report

0.5% of PatientsExperienced SevereAdverse Reactions

Physicians reported 217 patients with severe adverse reactions, out of a total 47,664 patients inducted (unweighted).

Specific Reactions

Reported (unweighted): Withdrawal: 103 Allergic reactions: 12

Respiratory depression: 9 Drug interactions: 9 Liver problems: 2 Renal insufficiency (or

aggravation of it): 2 Unspecified: 80


BUP Is Rarely Mentioned in DAWN


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BUP Is Rarely Mentioned in DAWNEmergency Department Visits , 2004

Overall, opioids were reported in only 13% of drug-related emergencydepartments visits, often in combination with other substances

Other opioids

(87%)

Methadone(1 7 %)

Buprenorphine( 0 % )

Only 108 ED visitsinvolved BUP (0.04%)

30 adverse reactions 21 seeking detox 9 overmedications 1 accidental ingestion

Drug Abuse Warning Network (DAWN)


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Patient Outcomes: Risky Behaviors

5%

1%

6%

2%

0%

7%

0%

2%

4%

6%

8%

10%

Needle sharing More than 1 sex partner

Baseline 30 Day Followup 6 Month Followup

P e r c e n

t o

f P a

t i e n

t S a m p

l e

n =381Patient Study

Summary on Public HealthSummary on Public Health


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Su a y o ub c ea ty

ConsequencesConsequences

Early after the start of the DATA WaiverProgram, the Evaluation found noindication of significant diversion of BUP.

Severe adverse reactions were rare. There were significant reductions in risky

health behaviors.


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Top Challenges to Prescribing BUP andReasons for Reducing Number of Patients


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Reasons for Reducing Number of PatientsTreated, 2005

0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50%

Percent of Prescribing Physicians Endorsing

Led to reduced prescribing

Overall

*Item only asked for one category

Cost*

Challenges ofInduction

Few Patients/Referrals

30 Patient LimitCompliance/Retention

Other Drug Abuse*

Patients Resistance toCounseling

Challenges most frequently mentioned by prescribing physicians

Waivered Physician Survey 2005 n =1,059

Barriers to Prescribing Reported by BUP


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a e s to esc b g epo ted by UNon- prescribers, 2005


0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50%

Percent of Non-Prescribing Physicians Endorsing

Few Patients/ ReferralsCost of Treatment/

Medication

Difficult Treatment Setup

DEA Concerns

Need More Information

Medication Scarce

BUP Ineffective

State Regulations

Adverse Effects

n = 509

Challenges most or least frequently mentioned by NON-prescribing physicians

Most Prescribing Physicians Treat


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g yWell Below 30 Patient Limit, 2005

0%

10%

20%

30%

40%

50%

N o R e

s p o n

s e

* N A (

O T P ) 0 1 - 5 6 - 1

0 1 1

- 1 5 1 6

- 2 0 2 1

- 2 5 2 6

- 2 9 3 0 P e r c e n

t o

f P r e s c r i

b i n g

P h y s

i c i a n s

Number of BUP Patients in Treatment per Practice, 2005


*Opioid treatment programs are not subject to the 30 patient limit.n = 1,059

Physician Comments on the 30 Patient


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yLimit, 2005

Comments P rovided by Respondents to the W aivered Physician Survey Phy sicians say the 30-Patient Lim it Restricts Access to Treatmen t.

The 30 patient limit...has been a major problem limiting treatment. I constantly have a waiting list of 15-20. So do all the other waivered physicians in the area. This limit has to be removed to provide betteraccess to care.

It is a crime and unethical to continue to deny access to so many patients. Can you in good conscience notopen up access to this life-saving treatment to thousands?

We have been at 30 for months with only a 1 or 2 pt per month attrition rate. The demand is huge. Wework with vulnerable populations (HIV, homeless, non-English speaking, chronic psych) and the referrals

keep pouring in. Physicians are forced to change treatment practices.

I would like the patient to be able to continue maintenance BUP if possible, but there are not manyphysicians in the area to do so because of the 30 patient limit.

I don't know any surgeons who limit appendectomies at 30! BUP is to my opioid addicts what SSRI's are tomy depressed patients.

I no longer can offer maintenance therapy thus resulting in high relapse rate. The limit is definitelyadversely affecting patient care. The government is committing malpractice with limit. The health value of BUP greatly outweighs the risks of diversion.

Physicians say it is not necessary. Until BUP is treated like any other prescription with no additional constraints placed on doctors, both

doctors and patients will continue to stigmatize this area of medical care.

It is akin to placing limits on cardiac or diabetic patients. When are we truly going to acknowledge thisproblem as a disease and let those of us who practice addiction medicine full time do what we are trainedfor? It is unconscionable to turn patients away because of some bureaucratic limits.

Waivered Physician Survey

Organizational Perspectives on the 30


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g pPatient Limit and Low Patient Demand

Prior to the change in law regarding group practices,physicians organized as large health care group practiceswere reluctant to provide BUP treatment due to theresources required to track the number of BUP patientstreated simultaneously among members of the group.

Due to the 30 patient limit on individual physicians,managed care network managers have reported difficultyfinding physicians with open treatment slots. They havealso reported encountering physician preference for

detox instead of maintenance. Tracking Study respondents reported patient and

physician demand for BUP treatment in the third-partypayment system was low but increasing.


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Summary of Issues & Challenges

Top challenges to providing BUP treatment

under the Waiver Program include: Cost of BUP medication Concerns about the logistics of induction 30 patient limit Low patient demand in some areas

Other challenges that were rarely endorsedincluded: Risk of diversion Concern about adverse reactions


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Coming Up.

Kissin, W., McLeod, C., Sonnefeld, J., & Stanton, A. (in press). Experiences of a national sampleof qualified addictions specialists who have andhave not prescribed buprenorphine for opioiddependence. Journal of Addictive Diseases.


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Documents

00476-ASAM 06 Final Results