The document discusses improving opportunities for patient and consumer engagement in health technology assessment (HTA) in Australia. It notes that while mechanisms exist for patient input, the overall HTA process is not well understood, advocacy groups are under-resourced, and the timeline for submissions is short. It proposes the formation of HTA_AUS, a coalition of interested parties including patient groups, government, industry and others, to address this issue and develop practical solutions like supporting patient submissions and extending deadlines. The coalition aims to increase awareness, education and support for patient engagement in HTA.

1. On the outside looking in
HTA_AUS:
Improving opportunities for patient
and consumer engagement in HTA in
Australia
David Grainger, Global Public Policy Director,
Eli Lilly and Company
(on behalf of the HTA_Aus group)
Copyright Eli Lilly and Company 2012 1

2. On the outside looking in
You've closed a door in front of me
I wait patiently outside
And as the minutes tick away
I feel my anger rise
And who's the object of my rage?
And who's not being fair?
Is it you for your indifference?
Or me for just standing there?
Copyright: Alison Krause and Tim O’Brien2011
Copyright Eli Lilly and Company 2012 2

3. So what is the problem?
• Mechanisms now exist in Australia for patient / consumer
representation on key HTA committees
(Pharmaceutical Benefits Advisory Committee and the Medical
Benefits Advisory Committee)
• PBAC also has provision for patients / consumers to make
submissions related to items listed on the agenda for the next
meeting, via a template available on the DOH website
• But...
– Overall HTA process is not well understood
– Time from agenda publication to submission cut off is short (4 weeks)
– Patient advocacy groups are not well resourced and struggle to develop
submissions that are useful to the PBAC
Copyright Eli Lilly and Company 2012 3

4. Who should contribute to solutions?
• Multiple potential stakeholders with an interest in an improved
process for patient and consumer input:
– patient advocacy groups
– “peak body” for health consumer interests (Consumers Health Forum)
– the Department of Health and Ageing
– the pharmaceutical and devices industry and their associations
Copyright Eli Lilly and Company 2012 4

5. Who should contribute to solutions?
• Multiple potential stakeholders with an interest in an improved
process for patient and consumer input:
– patient advocacy groups
– “peak body” for health consumer interests (Consumers Health Forum)
– the Department of Health and Ageing
– the pharmaceutical and devices industry
– “peak body” for the pharmaceutical industry (Medicines Australia)
• BUT... none of the above appear to have prioritised this issue
– all have had multiple challenges in past 2 years regarding regulatory
and reimbursement reforms
– all have increasingly constrained resources to apply
Copyright Eli Lilly and Company 2012 5

6. The formation of AUS_HTA
• An informal “coming together” of interested parties, under the
umbrella of the HTAi Special Interest Group on patient engagement
• Offering a solution where formal bodies are unable to focus
• Able to act as individuals rather than representing specific positions
or organisations, with a short and medium term agenda
• Includes some key individuals with passion for this topic:
– patient and consumer representatives on the PBAC, MSAC, regulatory
and Prostheses committees
(bring extensive experience)
– past and current chairs of the PBAC
– representatives of 3 individual pharmaceutical companies
– CEO of medical technology association (representing devices and
related technologies)
• No financial commitments at this point, but significant “goodwill”
Copyright Eli Lilly and Company 2012 6

7. Proposed construct for improving engagment
OTHER
MSAC
PBAC
Awareness
Level 1 Response to Agenda
Depth & Proximity to Decision
Education
Level 2 Deliberative Inputs
(e.g. Consumer Impact
Support
Statements)
Level 3 Forward looking
(e.g. Horizon Scanning)
Copyright Eli Lilly and Company 2012 7

8. Definitions
Awareness
• Visibility consumers have of the mechanisms and opportunities available to them to provide input and
feedback.
Education
• HTA: Training provided to consumers explaining health technology assessment and the role they can
play.
• Process: How and in what format are submission summaries provided to consumers for feedback
AND how they are asked to provide feedback.
• Interpretation: Technical assistance provided to consumers to allow them to understand submissions
and provide meaningful input.
Support
• Assist organisations to find, understand and interpret information and to navigate the currently available
options for input.
•Consider and recommend potential improvements to existing processes and development of new ones;
the role of companies as an information source for consumers to provide input; Industry code and
legislative barriers; tools that can be accessed by consumers to help facilitate feedback.
Copyright Eli Lilly and Company 2012 8

9. Practical steps to date
• Established a process for review of PBAC agenda when published,
followed by approach to relevant patient advocacy organisations
• Support for those organisations to consider most relevant
information and organise into a focused submission
• Feedback loop with the Chair of the PBAC committed to provide
post-meeting perspectives on usefulness of patient submissions
• Acknowledgment that the time from publication of the PBAC agenda
to cut off for patient and consumer submissions is too short –
approach has been made to Medicines Australia to gain industry
agreement to extend this
• Acknowledgement that there is scope for formal quality research to
further inform the contribution possible from patients and consumers
Copyright Eli Lilly and Company 2012 9

10. Next steps
• Using a formal description of HTA_Aus and its objectives, develop a
“request for proposals” from academic groups within Australia, to
partner and develop a research agenda
• Considering options for a formal funding grant request under one of
several options in Australia
• Considering how to better deal with “problem areas”, notably
oncology, rare diseases and co-dependent technologies
• Increasing the interactions with stakeholders in the devices,
diagnostics and procedures areas
• Considering available resources for education on “medicines
development, regulatory and reimbursement processes”
Copyright Eli Lilly and Company 2012 10

11. Conclusions
• All stakeholders in a HTA “system” acknowledged the need for
improvement, BUT...
• Constrained resources meant no one was actually moving things
forward
• Possible to create a “coalition of the willing” to substitute for formal
action
• All HTA systems are likely to have room for improvement in regard
to patient and public engagement...
• Careful and selective efforts CAN make a difference!
• Need for caution in regard to perceptions of self-interest and ensure
good governance as the effort grows in size and transparency
Copyright Eli Lilly and Company 2012 11