Embed Size (px)
Citation preview
New Device Technologies: Issues and Opportunities
Eugene Salole PhD MPH
Principal
Value-Based Access Pty Ltd, Sydney Conjoint Associate Professor, Faculty of Medicine, UNSW Future of Health Policy Reform Summit, Sydney, 26th -27th October 2015
DISCLAIMER
Opinions expressed
in this presentation
are entirely personal.
2
Medical device/Medical technology/Medtech
• A product intended to be used for diagnosis, prevention, monitoring, alleviation, compensation or treatment of injury, disease or deficiency in anatomical or physiological processes – and which does not achieve its intended action by pharmacological or physiological means
Medical devices in Australia
• 2% of AUD$210+ billion global market for medical technology
• Over 75% of medical devices used are imports
– Over 35% from the USA; about 30% from Europe
• Sophisticated healthcare market - relatively fast adoption of new technology
• Over 41,000 medical devices currently licensed by TGA for supply
Medical devices in Australia
• About 655 companies, 55 listed on the ASX
– 30% had innovative activity in 2013, cf. under 25% for all Australian businesses*
– AU ranked 13th in medtech patents globally, comparable to China
• Over 50% of Australian companies grown from start-ups
*http://www.abs.gov.au/AUSSTATS/[email protected]/ Latestproducts/8158.0Appendix12012-13?opendocument&
tabname=Notes&prodno=8158.0&issue=2012-13&num=&view=; accessed 24/10/14
Medical devices in Australia
• About AUD$2 billion worth of product annually
• Growing at 15% a year
• Sector employs over 19,000
– 50+% tertiary educated
– 20+% with postgraduate qualifications
*http://www.abs.gov.au/AUSSTATS/[email protected]/
Latestproducts/8158.0Appendix12012-13?opendocument& tabname=Notes&prodno=8158.0&issue=2012-13&num=&view=;
accessed 24/10/14
Medical devices: issues*
• Value propositions unclear or unsubstantiated
• Approach to innovation fragmented
• Support for home-grown industry fragmented
• Awareness of medtech within the general community low
* (a personal list)
‘Universal coverage’ health systems: key issues
• Rising professional expectations
• Continual availability of new technologies and clinical procedures
• Increasing consumer demands – Expectation of immediate access to new technology
• Equity of access
‘Universal coverage’ health systems: concerns about sustainability
Commonwealth (2010). Intergenerational Report 2010: Australia to 2050: Future Challenges. http://archive.treasury.gov.au/igr/igr2010/report/pdf/IGR_2010.pdf; accessed 25/02/10
Australian population pyramids, 2014 and 2050 (30 June 2012, base) [http://www.abs.gov.au/websitedbs/d3310114.nsf/home/Population%20Pyramid%20-%20Australia; accessed 07/0/614]
9
National Commission of Audit report, 1st May 2014*
• “…health care spending… the federal government’s single largest long-term fiscal challenge…”
• “Putting health care on a sustainable footing will require fundamental changes to all the components …”
*Towards Responsible Government. Report of the National Commission of Audit. Phase 1. Canberra: Commonwealth of Australia; 2014 February. p.xxi
‘Universal coverage’ health systems: policy-makers and purchasers want…
• The most appropriate healthcare
• Value for money
• Enter health technology assessment (HTA) -
aka ‘the 4th Hurdle’…!
Discovery research
Exploratory development
Full development
Licensed to be sold in Australia, i.e., inclusion in the Australian Register of Therapeutic Goods
Accessible to patients in Australia, i.e., listed on the PBS or MBS
and reimbursed by Government or private health insurers
Health technology assessment (HTA)
• Strong focus on:
– Systematic review of all the evidence
– Quality of the evidence
– Health outcomes
– Assessment of ‘value’
Comparative analysis of benefit and cost
COSTS
Treatment costs
Hospital costs
BENEFITS
Mortality
Morbidity
Quality-of-life
Reimburse-ment policy: HTA processes for market access
[http://www.health.gov.au/internet/hta/publishing.nsf/Content/commonwealth-1; accessed 28/05/14]
HTA, devices & value: limitations
• Medical devices often launched with insufficient health outcomes data to adequately assess their value
– Comparative clinical efficacy and safety data uncommon
• Reasons:
– Sector’s traditional approach to R&D
Incremental improvements in product design
– Short lifecycles: 0.5-10 years (cf., 10-20 years for pharmaceuticals)
– Product class-specific regulatory requirements
Cohort studies
Case Control studies
Case Series
Case Reports
Animal research
In vitro research
Professional opinions
Randomised, controlled, double-blind trials
Systematic reviews and meta-analyses of RCTs
Clinical evidence: ‘hierarchy of quality’
15
HTA, devices & value: timeliness of assessment & ‘learning curve’
• Variation in clinician’s technical proficiency affects outcomes – The ‘learning curve’
a major confounder
• Benefits of technology often accrue in the longer term – Long-term benefits are
hard to quantify reliably
• Timeliness of assessment affected by technology diffusion
Perf
orm
an
ce
Experience
A
B
Introduction
Obsolescence
Time
‘Early adopters’
Take-off
‘Late adopters’
Maturity
Innovation
Innovation and support
Medical devices: opportunities
• Establish clear value propositions
• Coherent approach to innovation
• Coherent and sustainable support for home-grown industry
• Raise level of awareness of medtech within the general community
National Medical Technology Policy
• Based on experience from implementation of the National Medicines Policy
• Objective: to improve health outcomes for Australians through access to, and wise use of, medical technology
• A cooperative endeavour, based on meaningful partnerships between all stakeholders
National Medical Technology Policy: four pillars
• Timely access to the medical technologies Australians need - at a cost individuals and the community can afford
• Availability of medical technologies meeting appropriate standards of quality, safety and efficacy
• Quality use of medical technologies
• Maintenance of a responsible and viable medical technology industry
Quality use of medical technologies
• Judicious selection of treatment options, including choosing between medical technology, pharmaceutical and no treatment
• Appropriate selection of medical technology, when required, within and across product categories
• Safe and efficacious use of medical technology
• In short: when medical technologies are the right option, use them wisely and safely
What might a national medtech policy achieve?
• Principally: establish a frame of reference endorsed by all relevant stakeholder-partners, who also accept shared responsibility for achieving objectives, for deliberations and negotiations about the various factors impacting medical technology
• Lift medtech up to its rightful place as an important, often critical, component of Australian healthcare
What might a national medtech policy achieve?
• Facilitate establishment of clear value propositions
– HTA is not a perfect science…other measures of value are also important and deserve to be developed
• Facilitate a coherent approach to innovation and support for home-grown industry
– Facilitate the provision of rewards for genuine innovation
• Facilitate quality use of devices through engagement with clinicians and consumers
