Prince of Wales clinical school and Lowy cancer research centre Decision making – square pegs in round holes: the Australian HTA experience Professor Robyn Ward Director POW Cancer centre, Clinical Associate Dean UNSW Chair of Medical Services Advisory Committee and Member PBAC
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Robyn Ward - Dept of Health and Aging: Decision Making – Square Pegs In Round Holes: The Australian HTA Experience
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Prince of Wales clinical school and Lowy cancer research centre
Decision making – square pegs in round
holes: the Australian HTA experience
Professor Robyn Ward
Director POW Cancer centre, Clinical Associate Dean UNSW
Chair of Medical Services Advisory Committee and Member PBAC
Pharmaceuticals
$8 billion pa
Non-
pharmaceuticals
$16 billion pa
Reimbursement of health care through
the public purse
PBAC MSAC
“In theory there is no
difference between
theory and practice HTA of drugs and other
health interventions
In practice there is”
Yogi Berra
Overview of talk
The MSAC process
• review the steps
• coordination with TGA, PBAC, PLAC
Three case studies
• Prepare for the future
• Follow the money
• Exit strategy
The future
The MSAC process
• review the steps
• coordination with TGA, PBAC, PLAC
Overview of the reimbursement process
Positioning and dialogue
Preparing the submission
Appraisal of evidence
Implementation
Submission
lodgement
• Complete short application form
• Protocol advisory committee
Define the question for public subsidy Define the bellwether issue – evidence, economics, data Consultation – with HESP, public, competitors and allies
PASC is not compulsory but its functions are
Positioning and dialogue
Preparing the submission
• Contracted assessment
OR
• Prepare your own
Evidence should be fit for purpose
• RCT
• Observational studies
• MBS data
for utilisation
for patterns of care
• Grey literature
• Consumer voice
• TGA submissions
• PLAC evaluations
• Submissions to other HTA bodies
“Any belief that the controlled trial is the only
way … to generate evidence would mean
not that the pendulum had swung too far but
that it had come right off the hook”
Bradford Hill the architect of the RCT
Lodgement of the submission
• External critique of submission
• Review by evaluation subcommittee
• Policy input
• Opportunities for rebuttal
• MSAC consideration and
recommendations, outlining way forward
• Public summary documents
Appraisal of the evidence
Implementation - departmental work, government decision and
release to the wild
• Potential time savings because
policy input and MBS costing now
part of the MSAC process
The MSAC process
• review the steps
• coordination with TGA, PBAC, PLAC
Prepare application
Evidence appraisal
Government decision
Health system
Diagnostic
& pharmaceutical company
PBAC and MSAC
PBD & MBD
Opportunities for coordination co-dependent technologies
Coordination is possible
test and drugs
• Melanoma - BRAF testing and dabrafenib
• Colorectal cancer - KRAS and anti-EGFR
antibodies
• Lung cancer – TKIs and EGFR testing
Egs
• Botox for bladder dysfunction
• Sculptra for lipoatrophy
Coordination is possible
drugs and services
Success factors
• Role (responsibility) delineation
• Taking genetic testing seriously
• Champions in government
• Commitment to making the system work
Case studies
1. Prepare for the future
esp. for co-dependent test/drug
2. Follow the money
3. Exit strategy
Case 1 – prepare for the future
The idea of a single target - single
treatment model (for cancer) is a
conceptual fallacy
Case 1 - Pre-existing state
EGFR antibodies and KRAS testing reimbursed for
patients with metastatic colorectal cancer
History
2004 - FDA approved companion diagnostic in
DakoCytomation EGFR pharmDx immunostaining
(detects overexpression of EGFR)
2008 – KRAS mutations a negative predicator of
response to anti-EGFR antibodies
Case 1 - The catalyst for change: Testing for KRAS status is not good enough
Other activating RAS mutations may
also be negative predictive biomarkers
for anti-EGFR therapy.
September 2013
Case 1 – Consequences, lessons learnt
• Yet again reinforces the conceptual fallacy of single target -
single treatment model
• Yet again shows that the net benefits of a co-dependent test
and drug are negated if incorrect test assignment exposes
patients to inferior treatments
• Yet again reinforces the importance of providing preclinical
data on drug/target interactions (biological plausibility)
• Yet again highlights the importance of including a plan for
updating evidence – esp. emerging molecular data and impact