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‘Big Technology,’ HTA and access: issues and potential approaches
Eugene Salole PhD MPH Principal
Value-Based Access Pty Ltd
Conjoint Associate Professor, Faculty of Medicine, UNSW
3rd Annual Health Technology Assessment Conference, Sydney, 24th-25th November 2014
‘Big Technology’: surgical robots, diagnostic scanners and similar capital equipment.
Opinions expressed here are entirely personal.
‘Universal coverage’ health systems: sustainability concerns
BNHI (2012). National Health Insurance in Taiwan. http://www2.cde.org.tw/action/uploadfile/2012/0724/1.2012; accessed 28/10/13
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
Taiwan population pyramids, 2013 & 2050 [https://www.cia.gov/library/publications/the-world-factbook/geos/tw.html; http://familyinequality.wordpress.com/2010/10/15/children-rarely-born/; accessed 31/10/13]
Population Projections (30th June 2012, base): 2014 & 2050 [http://www.abs.gov.au/websitedbs/d3310114.nsf/home/Population%20Pyramid%20-%20Australia; accessed 07/06/14]
Healthcare expenditure & outcomes
http://data.worldbank.org/indicator/SP.DYN.IMRT.IN; http://apps.who.int/gho/data/?theme=main; accessed 29/06/15.
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Total HC spendper capita
(PPP int.$/100)
Govt. HC spendper capita
(PPP int.$/100)
Life expectancy(years)
Infant mortalityrate
(deaths/1000live births)
AU
IN
KR
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US
‘Universal coverage’ systems: key drivers of expenditure
• Availability of new technologies and procedures
• Increasing consumer demand
– Expectation of immediate access to new technology
• Rising professional expectations
Wariness of ‘innovation’: newly approved new and improved!
http://www.abc.net.au/4corners/stories/2014/05/26/4010089.htm; accessed 20/06/14
The Cost of Living New drugs could extend cancer patients’ lives - by days. At a cost of thousands and thousands of dollars. Prompting some doctors to refuse to use them. Hall SS. New York Magazine, 20th Oct 2013 (http://nymag.com/news/features/cancer-drugs-2013-10/; accessed 13/04/14)
‘Universal coverage’ systems: what policy-makers and payers want…
• Most appropriate healthcare
• Value for money…
• Health technology assessment (HTA) seeks to answer both questions for a new technology, procedure or service
HTA: devices v. pharmaceuticals
• Unlike medicines, device technologies often come to market with little evidence of comparative clinical efficacy and safety
• Because of:
– Differences in R&D processes
– Differences in paths to market
510(k) FDA approvals, low regulatory classifications
– Incremental improvements in product design
Short product lifecycles: 0.5-10 yr, cf., 10-20 yr for pharmaceuticals
HTA: devices v. pharmaceuticals
• Application of rigorous comparative research methodology is difficult because:
–Equipoise usually absent
Ethical issues
– ‘Blinding’ difficult if not impossible to maintain
– Clinical response particularly susceptible to inter-patient variation
– Large sample sizes necessary for statistical rigour
HTA: devices v. pharmaceuticals
– Variation in clinicians’ technical proficiency affects outcomes
‘Learning curve’ a confounder
– Benefits of technology often accrue in the longer term Hard to quantify reliably
– Timeliness of assessment affected by technology diffusion
Perf
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Experience
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Introduction
Obsolescence
Time
‘Early adopters’
Take-off
‘Late adopters’
Maturity
Innovation
HTA, ‘Big Technology’* and access: issues
• Most of the preceding challenges apply – with additional pressures:
– Substantial investment in capital equipment and associated services by service providers
– Specialised technical training and (usually expensive) after-sales support required
– ‘Value’ of technology often sold on its technical attributes (‘features & benefits’) not health outcomes
– Technology associated with specialised clinical services
* Surgical robots, diagnostic scanners and similar capital equipment
HTA, ‘Big Technology’ and access: issues
– Relatively rapid technology adoption and diffusion
E.g., within just 3 yrs (2007-2010) robotically-assisted hysterectomy accounted for 22% of procedures in US*
– Post-marketing data collection limited by relatively small numbers of units in operation
– Reimbursement delayed or denied
– Institutions prepared to invest substantial sums (in capital equipment, consumables, etc.) without reimbursement being available
Consumers apparently willing to pay out-of-pocket
*Wright JD, et al. Robotically assisted vs laparoscopic hysterectomy among women with benign gynecologic disease. JAMA 2013;309:689-698
HTA, ‘Big Technology’ and access: potential approaches
• Federal Department of Health:
– Develop national policy about rational adoption and sustainable funding of ‘Big Technology’
• Public sector:
– State/Territory Departments of Health collaborate on ‘managed introduction’
Sentinel sites for HTA data collection, to inform wider technology adoption (or otherwise)
– Risk-share agreements based on health outcomes
• Private sector:
– Private hospitals and health insurers share relevant (de-identified) patient-level data from their large in-house data collections
• Professional specialist Colleges:
– Foster a research culture amongst membership
– Facilitate development of practicable guidelines, e.g., for referrals to diagnostic services
– Encourage closer involvement by specialist providers in patient management post-procedure
HTA, ‘Big Technology’ and access: potential approaches
• Suppliers:
– Generate the data necessary for speed-to-market access in ‘universal coverage’ health systems
Accommodating Australian needs will probably also satisfy other jurisdictions inclined towards HTA
– Connect early adopters of an innovative technology, with view to international collaboration on HTA and market access
HTA, ‘Big Technology’ and access: potential approaches
HTA in Asia: diffusion and international links
Australia/NZ
EU
CAN
HTA assessments for reimbursement approval and market access are global events - decisions in major markets ripple a long way!
HTA, ‘Big Technology’ and access
• HTA is not a perfect science - other measures of value are important and necessary
• Decision-making must include a broader base
– With wider, and better informed, stakeholder engagement and discussion about ‘value’ in healthcare and the place of innovative technology
HTA, ‘Big Technology’ and access
• The technological imperative will ensure new ‘Big Technologies’ and related procedures continue to become available
• HTA is also here to stay… for as long as
–effectiveness, efficiency and equity of healthcare services remain concerns
– the control of health expenditure a priority
HTA and ‘Big Technology’ – the market access questions (particularly for suppliers)
• What is the product/procedure offering?
• Where is the supporting evidence?
• Who will pay?
• Why should they?
