medical advisory secretariat cardiac hta: the ontario experience american heart association...

Medical Advisory Secretariat

Cardiac HTA: The Ontario Experience

American Heart AssociationWashington DC

May 2010

Leslie Levin MB, MD, FRCP (Lon), FRCPCProfessor of Medicine, University of Toronto

Head, Medical Advisory Secretariat, Ministry of Health and Long-Term Care

HTA in Canada & the United States


2

Life-Cycle Based Diffusion Curve

U

TIME

R & D

Diffusion

Steady State

Inflection Point

a

b

c

Unconditional Yes

Uncertainty

Unconditional No

Obsolescence

Field Study

EBA EffectEBA Effect


3

MAS/OHTAC and Associated Structures & Linkages

Outcomes Tracked by MOHLTC with GIS

Outcomes Tracked by MOHLTC with GIS MASMAS

OHTACOHTAC

MOHLTCMOHLTC Ontario Health System

Ontario Health System

Expert PanelsExpert Panels

PATH (McMaster Univ)

THETA (Univ. of Toronto)

PATH (McMaster Univ)

THETA (Univ. of Toronto)

Field Evaluations

Field Evaluations

Recommendations

PhysiciansSchedule of Benefits

PhysiciansSchedule of Benefits

LHINs – Implementation: Hospitals, Community

Agencies, etc…

LHINs – Implementation: Hospitals, Community

Agencies, etc…

Knowledge Transfer

Stakeholder Engagement

Professional, public, and industry feedback loop

Post-market safety evaluation through the Usability Lab

Post-market technology evaluation through PATH ,THETA, ICES

• POC/INR with QMPLS• Intermediate care• Cardiac • Arthritis• PET• Diabetes - Aging - Wound care

RequestsRequests


4

Heath Technologies Reviewed by OHTAC Based on Analyses by MAS, THETA &PATH


5

Mega-Analysis and Policy Economic Modeling

Mega-analysis - disaggregation of technologies around a disease condition or health state and the re-aggregation for comparative effective analysis

Mega-analyses to date:Osteoarthritis of the knee MAS (2005)

Cardiac viability MAS (2005)

Aging in the community MAS/PATH (2008)

Colon cancer screening MAS/PATH (2008)

Diabetes MAS/PATH (2009)

Intermediate care MAS/THETA (2009)

Wound care prevention MAS/THETA (2008)

Cardiac diagnostic tests MAS/THETA (2010)

Robust micro-economic policy decision modelsOntario Diabetes Economic Model (PATH). (2006)

Ontario Cardiovascular Model (THETA). (2009)

Ontario Wound Prevention and Care Models (THETA). (2009)

Ontario Arthritis Model (PATH). (Commenced October 2009)

Ontario COPD Model (PATH). (Commenced April 2010)

Turn-around time ~ 6-8 months


6

Field Evaluation Studies

Post-market assessment in the real world to improve decision making

Influences adoption by physicians who must be engaged

Remaining issues

Generalisability applies to most technologies including drugs

Broaden the scope since the payer absorbs the cost irrespectively?

Study designs needed that do not restrict access and can be conducted within short time


7

Field Evaluations: Process Overview

Conducted by third party (PATH or THETA) who receive:

Core grant support from Ministry of Health (MOHLTC)

Additional funding for each field evaluation

Average funding for each evaluation is $600,000

Additional funding to cover costs of the technology

PATH/THETA responsible for study design, execution, collection and synthesis of data and reporting.

Work with key opinion leaders and Academic Health Science Centres

Average time to completion of most studies 3 years

Since 2003, 19 completed and 17 have resulted in policy decisions. Most published in peer-reviewed journals.


8

Examples of Policy Driven by Evidence to be Presented

Drug Eluting Stents

Cardiac imaging for intermediate risk CAD

CT angiography


9

Drug Eluting Stents (DES): Policy Development in Ontario

200110,339 PCIs

37% increase expected over 5 years

September, 2002

NEJM publishes RCT on Sirolumis DES In (mainly) low risk reported reduced re-stenosis rates from 23% to 7%

2002

MAS gray literature search:

• Anticipated reduced re-stenosis rates for DES (~0-5%) vs. bare metal stents (~23%)

• Incremental cost for DES estimated at $2,500 to $3,840

• Sensitivity analysis: best case scenario in high risk reducing restenosis rates from 45% to 0%

March 2002Cardiologists alerted the Ministry that DES could lead to sudden changes in practice


10

Policy Concerns: Unlimited Diffusion of DES

Off-label creep to high risk

Generalisability

Steep diffusion curve due to:

Policy Decision and Study Design

Enthusiasm amongst end-users and public expectation

Promising technology for a potentially catastrophic disease with high prevalence

Allow immediate diffusion through coverage with evidence development (CED) via a pragmatic study that would not impede access

DES funded for field evaluation CED

PATH worked with 18 leading cardiologists, CCN and ICES

Observational study – registry


11

Cost-Effectiveness Results

Sub-Group

Diff. in TVR %

$ / revasc avoided

$ / QALY gained*

Diabetes, narrow, long 10.4 $17K $428K

Diabetes, narrow, short 8.3 $13K $323K

Diabetes, wide, long 4.4 $37K $912K

Diabetes, wide, short 1.4 $80K $2.0m

Non-diabetes, narrow, long 3.7 $80K $1.5m

Non-diabetes, narrow, short 1.2 $130K $3.1m

Non-diabetes, wide, long 1.9 $98K $2.4m

Non-diabetes, wide, short 0.6 $191K $4.6m

* Excludes mortality impact due to small number of deaths in sub-groups, focus of follow-up

Improving health through Improving health through health technology health technology assessmentassessment

Programs for Assessment Programs for Assessment of Technologies in Health of Technologies in Health (PATH) Research Institute(PATH) Research Institute


12

DES in Ontario - End Product

Study published by Tu, JV et al, NEJM October 2007

35% conversion from bare-metal to DES v 90% in U.S.

Ongoing registry to measure long-term effects including safety


13

Cardiac ImagingCardiac Imaging: Mega-Analysis of Technologies

Research Questions1. What is the diagnostic accuracy

compared to coronary angiography?

2. What is the clinical utility of these non-invasive cardiac tests?

Project Rationale

Use of non-invasive cardiac imaging technologies has risen rapidly

Uncertainty re- appropriate choice, sequence and frequency of tests

In July 2009, MAS was asked to undertake an EBA of effectiveness and cost-effectiveness of cardiac imaging for intermediate risk CAD patients

Technologies reviewed:a) SPECT

b) Stress ECHO without contrast

c) Stress ECHO with contrast agents

d) Cardiac MRI

e) CT Angiography


14

Strategy for Cardiac Imaging Analysis

Technologies were reviewed separately but used consistent study criteria, populations, and outcome measures

Pooled estimates of Sensitivity and Specificity

Summary Receiver Operator Characteristic (SROC) Curves & AUC

Economic analysis – decision analytic models (THETA)

Diagnostic accuracy of the different technologies compared

Expert panel assisted in contextualizing the evidence


15

Example of Results: Stress ECHO and SPECT

= SPECT = Stress ECHO

Type of Stress

No of studies

Sensitivity(%)

Specificity(%)

Stress ECHO

127 0.79

95% CI: 0.77 -

0.82

0.84

95% CI:

0.82 - 0.87

AC SPECT

12 0.86

95% CI: 0.81 -

0.91

0.82

95% CI:

0.75 - 0.89

AC SPECTAUC 0.91

AC SPECTAUC 0.91

Stress ECHOAUC 0.89

Stress ECHOAUC 0.89


16

Overall Results on Diagnostic Accuracy

TechnologyNumber of Studies

(patients) Sensitivity Specificity AUC

CT Angio(Including PATH field evaluation data)

8(1,635)

0.96 0.81 0.96

CT Angio (PATH field evaluation data alone)

1(117)

0.81 0.96 n/a

Cardiac MRI(perfusion)

23(1,993)

0.91 0.80 0.93

Stress ECHO with contrast (wall motion)

15(1,689)

0.84 0.80 0.90

Stress ECHO (exercise + pharma)

127(13, 035)

0.79 0.84 0.89

AC SPECT 12(1,238)

0.86 0.82 0.91

Gated SPECT 19(2,710)

0.84 0.78 0.89

Traditional SPECT 63(7,186)

0.86 0.71 0.88


17

$800

$1,000

$1,200

$1,400

$1,600

$1,800

$2,000

$2,200

5% 20% 35% 50% 65% 80% 95%

Cardiac MRI

SPECT

Stress ECHO

CT angiography

Stress contrast ECHO

WTP

for a

n ac

cura

te d

iagn

osis

from

a no

n-in

vasiv

e di

agno

stic

test

Prevalence of CAD in the population presenting with chest pain

Current accepted payment

Economic Analysis: Cost per Accurate Diagnosis by Coronary Angiography (Stable Outpatients). THETA Analysis


18

Conclusion From Cardiac Imaging Mega-Analysis

Either stress echo or SPECT are equally effective for predicting CAD using CA as a gold standard

Stress echo with contrast and CTCA are the most cost-effective strategies

If contrast stress echo and CTCA are not available, stress echo and SPECT are both cost-effective

QA issues regarding stress ECHO need to be addressed before considering implementation strategies


19

64 Slice CTCA Study (OMCAS) Preliminary Results

Multicentre, multi-vendor, single-blind study

Four Academic Health Science Centres in Toronto and Ottawa

Study Coordination by PATH

Patients booked for CA received a CTCA within 10 days

Group 1 - Valvular heart disease, cardiomyopathy & congenital heart disease

Group 2 - CAD with intermediate probability CAD (10-90%)


20

OMCAS: Methods

CTCA and CA read by two blinded readers at each site. Third consensus read when discrepancies occurred. All readers trained prior to study.

17 segment model of the coronary arteries and 4 point grading score used for evaluation of coronary stenosis:

normal

mild (<50%)

moderate (50-69%)

severe (≥70%)

For CTCA, plaque identified as soft, calcified or both

Obstructive CAD evaluated as stenosis ≥50% and ≥70%


21

Comparison of CTCA Diagnostic Accuracy (≥50% stenosis)

Raff

(2005)

(N=70)

Budoff

(2008)

(N=230)

Meijboom

(2008)

(N=360)

Miller

(2008)

(N=291)

OMCAS

(2010)

(N=169)

Sensitivity 95 (88, 98) 95 (85, 99) 99 (98, 100) 85 (79, 90) 81 (71, 89)

Specificity 90 (80, 94) 83 (76, 88) 64 (55, 73) 90 (83, 94) 93 (86, 98)

Positive Predictive Value 93 (79, 98) 64 (53, 75) 86 (82, 90) 91 (86, 95) 92 (82, 97)

Negative Predictive Value 93 (76, 99) 99 (96, 100) 97 (94, 100) 83 (75, 89) 85 (76, 91)

Number of centres 1 16 3 9 4

Multiple vendors No No Yes No Yes


22

Issues and Options Arising from OMCAS

If OMCAS accuracy data are used:stress contrast echo is the only cost-effective strategy for stable intermediate risk CAD patients

If contrast stress echo is not available, CTCA becomes the most cost-effective strategy

Possible Options:Limit insurability of CTCA to a few AHSCs until accuracy issue resolved

Do not insure CTCA because hospitals may substitute for CA (both are anatomic imaging) and >20% of CAD could be missed

Insure CTCA with an expectation that CA will be performed in patients with a negative CTCA – but many positives and negatives may then undergo CA.

OHTAC recommendation will await final results of OMCAS being reported June 2010


Health Technology Diffusion - Examples

2010 OHTAC Annual Report


24

Artificial Disc Replacement for Degenerative Disc Disease

0

100

200

300

400

500

2003 2004 2005 2006 2007 2008

Cervical Volumes

Lumbar Volumes

Fiscal Year

OHTAC recommendation


25

Bariatric Surgery for Morbid Obesity

0

500

1000

1500

2000

2500

3000

3500

4000

2003 2004 2005 2006 2007 2008 2009 2010 2011

Ontario Volumes

Out-of-country Volumes

Combined

Fiscal Year

In 2007, 75 procedures performed in Ontario were done in diabetics increasing to 135 in 2008.




26

Coil Embolization for Intracranial Aneurysms

0

100

200

300

400

500

600

2003 2004 2005 2006 2007 2008

Coil Embolization Volumes

Surgical Clipping Volumes

Combined (Coil + Clippings)

Fiscal Year



27

Deep Brain Stimulation for Movement Disorders

0

10

20

30

40

50

2003 2004 2005 2006 2007 2008

Fiscal Year



28

Advanced Electrophysiological Mapping and Ablation for the Treatment of Cardiac Arrhythmias

0

200

400

600

800

1000

2003 2004 2005 2006 2007 2008Fiscal Year



29

EVAR for Abdominal Aortic Aneurysms

0

200

400

600

800

1000

1200

1400

1600

2003 2004 2005 2006 2007 2008

EVAR Volumes

Open Surgical Repair Volumes

Combined (EVAR + OSR)

Fiscal Year



30

Lavage and Debridement for Osteoarthritis

0

200

400

600

800

1000

2003 2004 2005 2006 2007 2008

Fiscal Year



31

Midurethral Slings (MUS) for Women with Stress Urinary Incontinence

0

2000

4000

6000

8000

10000

2003 2004 2005 2006 2007 2008

MUS Volumes

Colposuspension Volumes

Combined (MUS + Colpo)

Fiscal Year

There is a 1.4% complication rate associated with the midurethral sling procedure.



32

Bending the Cost Curve - Examples

0

50

100

150

200

250$ Million

PET PSAscreening

Drug-elutingstent

Bariatricsurgery

EBA

No EBA


33

Completed Field Evaluations

TECHNOLOGY(N) OVERSEEN BY

TYPE OF STUDY

REASON FOR FIELD

EVALUATION RESULTPOLICY

DECISIONDrug eluting stents

(DES) (21,000) *PATH with ICES, CCN

Pragmatic registry

Generalisability of RCT evidence and cost effective analysis

Only effective if high risk for restenosis

30% conversion to DES (90% in U.S.A.)

Endovasc. abd. aortic aneurysm repair (EVAR)

(160) *

PATH and single AHSC

Observational Safety assessment of endoleak

No endoleak. Cost ffective for high surg. risk only

Increased funding to high surg. risk

HPV adjunct to cytopath. in cervical cancer screening

(10,233) *

Cancer Care Ontario

Observational feasibility

Feasibility and effects on colposcopy rates

Poor compliance -colposcopy for ASCUS

Delay until compliance issues addressed

64-slice CT angiography (CTA) v coronary angiography (CA)

(350) *

PATH with 12 cardiologists and radiologistsin 4 AHSCs

Intermediate risk CAD referred for CA also have CTA

Uncertainty regarding system impacts and generalizability

Different sensitivity compared to published data

Awaited


34

TECHNOLOGY[PET Studies]

(N] OVERSEEN BYTYPE OF STUDY

REASON FOR FIELD EVALUATION RESULT

POLICY DECISION

PET for head and

neck cancer (400) *OCOG Single arm

prospective cohort

PET in pre surgery assessment post radiation

Accrual completed

Awaiting analysis of results

PET staging locally advanced

NSCLC(310) *

OCOG RCT Clinical utility in radical treatment decisions

Reduced futile chemo

Insured service

PET for staging

NSCLC (322) *OCOG RCT Resolve inconsistencies

to inform funding Reduced futile thoracotomy

Insured service

PET for staging breast cancer

(320) *

OCOG Prospective cohort

Compare PET to sentinel lymph node biopsy

No improvement Service not insured

PET for pre-liver matastatectomy in

colon cancer *

OCOG RCT Utility in surgical decision making

Accrual completed

Awaiting results

6 PET registry studies (1,700)

ICES Prospective observational

Compliance with indications while awaiting licensing

Completed October 2009

Insured service


35

TECHNOLOGY[Economic Models]

(N) OVERSEEN BYTYPE OF STUDY


POLICY DECISION

Ontario CVS Economic Model

THETA working with ICES

Epidemiologic and micro-decision analytic model

Impact of population based CVS interventions. Evaluate cardiac interventions

Completed October 2009

Will evaluate cardiac interventions

Decision analytic diabetes model

PATH, working with Oxford

Micro simulation economic model

To understand long-term effects of diabetes interventions to inform policy

Long time horizon predicting CE and events avoided

Decision re- bariatric surgery, glitazones, mutidisciplinary care

Ontario Pressure Ulcer Model

THETA Micro- decision analytic model

Evaluate preventive interventions

Support surfaces cost saving or effective

Used to estimate cost-effective


36

TECHNOLOGY[Safety Studies]

(N) OVERSEEN BYTYPE OF STUDY


POLICY DECISION

Safety evaluation of CT and MRI

UHN Human Factors Group

Random study of hospitals to assess safety practices

Awareness from colonography EBA. Expanded to study incompatibility of equipment in MRI suites

Significant safety issues

Provincial standards and safety measures

In-room air cleaners(18 AHSCs)

UHN Human Factors Group

Random assessment of compliance with guidelines

Appropriateness of use questioned in addition to safety issues

No utility in droplet infectionCorrect placement not consistent

Communicated to all hospitals

Safety evaluation of smart infusion pumps (SIP)

UHN Human Factors Group and AHSCs

Error rates SIP is complex and not fully computerized ? Safety re-dosing

Concerns re-safety in dosing and use of multiple infusion lines

Communicated to all hospitals Ongoing research on multiple infusion lines


37

TECHNOLOGY(N)] OVERSEEN BY TYPE OF STUDY

REASON FOR FIELD

EVALUATION RESULTPOLICY

DECISION

Barriers to access study for diabetes Random poll of existing data base (750)

ICES Random survey of diabetes patients

Diabetes task force recommended study

Working poor can’t afford access to all devices and drugs

No uptake to date

Determine prevalence and acuity of stress urinary incontinence (SUI) (1,400)

Womens’ Health Council

Random poll of women in target age range

MAS EBA identified less-invasive and safer. Poll to inform needs-based estimate of diffusion

Prevalence of high acuity approx.23,000

Diffusion tracked to assess whether prevalence being addressed

Extracorporeal photopheresis (EP)

(120) *

AHSC Prospective observational

Effectiveness in B-Cell lymphoma and graft v host disease to inform funding tecision

Completed accrual November 2008

G v h service insured. Study for lymphoma extended

medical advisory secretariat cardiac hta: the ontario experience american heart association...

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