The use of observational data in health economic models of medical devices: science, art or both?

Professor Brendon Kearney

Australia

Australian HTA agencies

TGA

PBAC

MSAC

Protheses & Devices Ctte

Health PACT

Drugs

PBAC

Clinical trials

Reimbursement

AAA Stenting

Interim funding subject to data collection by RACS

ASERNIPS funded to collect data

Results compared with RCT

Full funding implemented

Deep Brian Stimulation Parkinsons Dystonia Essential tremor

No trials but case serries

Interim funded

Data collection from 4 sites

RCTs published

Full funding

Capsule Endoscopy

Case series only

MSAC funded an evaluation based on operator data collection

Data collection and report considered poor but MSAC felt it could not recommend withdrawal of funding

Implementation managed with description of service use

PET Scanning

Interim funding for several indications subject to data collection agreed to by ANZAPAM

Very few RCTs

Data collection not helpful

Worldwide roll out

Funding for a number of indications with restrictions

Some but not enough RCTs

Cost of HTA versus service

BNP assay

One fair quality RCT

Limited to emergency department

Funded but with restrictions

Indication creep

Hyperbaric O2

Interim funding for broad indications

Review

Lack of RCTs led to restriction in indications

High Sensitivity Troponin Sensitivity Specificity

Used in the same way but lower cut offs

RCT – three groups

1. Acute Coronary Syndrome

with high risk of major cardiac event

2. ACS with risk of MCE

greater than one month

3. Negative for ACS

RCT required to use new technology for best outcomes from patient care

Tavi

Not on ARTG

SAS or CTN approval

Used in patients unsuitable for cardiac surgery

Ethics approval but no coordinated implementation

Variation in rate

Small numbers in some units

Need to manage introduction of new technologies where there is:

high cost

high volume

patient safety and outcomes

1. RCT

2. Managed introduction with evaluation

Lessons

Possible but data has to be good quality

Funding of data collection

Data collection quality

Currently not supported