HTA in Australia

EDITORIALS

Health technology asssment in Australia: challenges ahead

Terri J Jackson

Australia is well placed to again lead the world in health technology asssment

ustralia led the world in 1993 when it introduced the so-

called “fourth hurdle” of economic evaluation into the

approvals process for drugs (in addition to the usual regula-

tory “hurdles” of quality, safety, and efficacy).

1

We are among the

dozen or so developed countries that had invested in health

technology asssment (HTA) since the early 1980s, but it was the

requirement of a favourable economic evaluation that attracted

2

While economic evalu-international attention to HTA in Australia.

The Medical Journal of Australia ISSN: 0025-

ation had always been considered a component of HTA, a policy

729X 3 September 2007 187 5 262-264

3

requiring evidence of cost-effectiveness was groundbreaking.

©The Medical Journal of Australia 2007

In 1998, the federal Minister for Health created a parallel HTA

EditorialS

process for new medical rvices. Evidence of sufficient safety,

effectiveness and cost-effectiveness to be included in the Medicare-

subsidid benefits package now forms the basis for coverage

recommendations to the Minister by the Pharmaceutical Benefits

Advisory Committee (PBAC) for drugs, and the Medical Services

Advisory Committee (MSAC) for medical rvices and technolo-

gies (Box).

5

In contrast to most other countries, HTA in Australia has been

woven into the fabric of health rvices funding, giving it greater

impact on the introduction of new treatments. Our approach is

similar to that of the United Kingdom’s National Institute for

Health and Clinical Excellence

6

but differs from Canada’s more

“hands off” implementation approach, both described in this issuethan evaluation of medical rvices. Surgical interventions

710,14

of the Journal (page283 and page286, respectively).provide their own unique challenges to evaluation methods, and

Most other countries have structured their HTA process to bethe Australian Government has funded ASERNIP-S (Australian

“advisory” to doctors and health care rvices. It is unclear whetherSafety and Efficacy Register of New Interventional Procedures —

this paration of advice from funding is more effective than theSurgical) to conduct HTAs under the sponsorship of the Royal

direct application of HTA to coverage decisions en in AustraliaAustralasian College of Surgeons.

and the UK, but a common lament from academics and policy-Funders at each level of the system (federal and state) have

makers in such systems is that HTA findings are not “taken up” bydiffering responsibilities and interests, probably best rved by

health care providers. Separating HTA from coverage decisiondedicated evaluation efforts, but there has been considerable

8,9

making may lead to less contention with professional groups andsynergy in the development of HTA among the stakeholders. The

the biotechnology industries, but perhaps also reduces the impact

of the HTA effort.

Becau of their direct impact on government coverage deci-of different HTA urs.

sions, and the still novel requirement for an acceptable incremen-Through the Australian Health Ministers’ Advisory Committee

tal cost-effectiveness ratio, both the PBAC and MSAC have been(AHMAC), the states pool funds to sponsor HealthPACT (Health

subject to industry and political scrutiny. The most comprehensivePolicy Advisory Committee on Technology) which performs “hori-

inquiry was a 2005 Productivity Commission report on advances and shares cretariat

in medical technology in Australia. The PBAC was a major focusand other functions with MSAC. This mechanism alerts the

10

of negotiation leading to the Australia–United States Free Tradefunders of public hospitals to emerging medical technologies with

Agreement, and the MSAC has conducted an internal review andpotential to influence their health care systems. The states together

11

consultation process, in part as a respon to industry criticismdetermine HealthPACT’s budget and work program. In addition,

12

of delays in the asssment process.

4

A third article in this issue ofAHMAC has delegated to MSAC a role in advising on Nationally

the Journal by Petherick and colleagues (page289) examines theFunded Centres (NFC). The are rvices where the volume of

evolution and shortcomings of systematic reviews in publishedrelevant cas is not sufficient to justify more than one or two units

MSAC asssment reports since 1998.in the country — historically, the have been transplant units. The

13

Although the Australian system is apparently fragmented (medi-

cines versus rvices, federal versus states, public versus private

systems), differing characteristics of each may justify parate

approaches. It is clear that the longer history of drug safety

regulation makes pharmaceutical evaluation more straightforwardClinical Practice and Technology was t up in 2004 to under-

EDITORIALS

take a variety of HTA activities, including horizon scanning,therapies in developed countries. Monitoring drug safety and

asssment and monitoring for the Victorian Department offunding the collection of randomid evidence are possible in

Human Services. State-bad committees commonly consider

applications for high-price and/or high-volume drugs, devices and

procedures, and create a mechanism to approve funding for novel

or statewide specialty rvices outside normal hospital funding

arrangements.

Hospitals and regional health rvices in Queensland, Western

Australia, South Australia and Victoria have established internal

HTA committees to overe the introduction of new drugs and

medical procedures, with examples from Bayside Health and

Southern Health in Victoria cited by the Productivity Commission

in its report.

10

Public hospitals, with their role in medical educa-

tion and rearch, may need to focus on different technologies at

different stages of the product development cycle than do private

hospitals and health insurers.

In contrast to Australia, the HTA efforts of Canada and the UK

have a unified approach to drugs and other technologies. The UK

National Institute for Health and Clinical Excellence has an

advantage over MSAC and PBAC in tting its own agenda, the so-

called “needs-led” prioritisation of HTA topics. Canadian HTA

organisations em to balance the needs of the system as a whole

against tho of particular interests, including tho of funders,

7

but probably come clor to HealthPACT’s ur-led prioritisation.

All jurisdictions grapple with the politically charged problem of

“disinvestment” — that is, ceasing to support therapies who

effectiveness (and/or cost-effectiveness) cannot be demonstrated.

Both the UK and Canada have successfully pioneered “rapid

respon” methods for HTA urs requiring timely answers to

tightly framed clinical questions, an approach not yet common in

Australia.

Clinical evidence for HTA is derived from systematic reviews,

and the in turn rely on randomid controlled trials (RCTs).

Evidence-bad medicine has refined the tools available for evalu-

ating evidence of clinical benefit; basic physiological evidence of

efficacy can come from trials in any country. However, evidence of

real-world effectiveness is dependent on the medical culture,

workforce and referral patterns of a particular health system, and

economic evaluation is even more dependent on the organisational

forms of health care, including the skills mix and relative wages of

different professional groups. Generally economic asssments u

decision–analytic models, with key outcomes costed locally to

determine the cost-effectiveness of an intervention in each health

care system.

None of the national HTA process described has the capacity

to commission new clinical rearch, and there is little articulation

with existing medical rearch priority-tting process. This

often results in rejecting new technologies becau there is no RCT

evidence of their efficacy or effectiveness, rather than evidence that

they are ineffective.

4

Both the UK and the US are trialling “coverage

with evidence” approaches to funding new medical technologies as

a way of bridging current gaps in evidence. The allow intro-

18

duction of new rvices or biotechnologies on the condition that

patients are entered into rigorous clinical trials, and with the

understanding that continued funding will depend on the evi-

dence from the trials.

The coming of molecular medicine with its individualid and

gene-bad therapies will exacerbate the lack of clinical evidence

from RCTs.

19

EDITORIALS

8Oliver A, Mossialos E, Robinson R. Health technology asssment and its

influence on health-care priority tting. Int J Technol Asss Health Care

2004; 20: 1-10.

9Harris A, Buxton M, O’Brien B, et al. Using economic evidence in

reimburment decisions for health technologies: experience of 4 coun-

tries. Expert Rev Pharmacoeconomics Outcomes Res 2001; 1: 7-12.

10Productivity Commission. Impacts of advances in medical technology in

Australia. Melbourne: Productivity Commission, 2005.

11Harvey KJ, Faunce TA, Lokuge B, Drahos P. Will the Australia–United

States free trade agreement undermine the Pharmaceutical Benefits

Scheme? Med J Aust 2004; 181: 256-259.

12Australian Government Department of Health and Ageing. Medical

Services Advisory Committee (MSAC). /inter-

net/msac//Content/review-1 (accesd Aug 2007).

13Petherick ES, Villanueva EV, Dumville J, et al. An evaluation of methods

ud in health technology asssments produced for the Medical Serv-

ices Advisory Committee. Med J Aust 2007; 187: 289-292.

14Henry DA, Hill SR. Asssing new health technologies: lessons to be

learned from drugs. Med J Aust 1999; 171: 554-556.

15Royal Australasian College of Surgeons. ASERNIP-S (Australian Register

of Safety and Efficacy — Surgical). /Content/

NavigationMenu/Rearch/ASERNIPS/ (accesd Aug 2007).

16Australian Government Department of Health and Ageing. Australia and

New Zealand Horizon Scanning Network — about horizon scanning. The

Health Policy Advisory Committee on Technology (HealthPACT).

/internet/horizon//Content/healthpact-

2 (accesd Aug 2007).

17State Government of Victoria, Australia, Department of Human Services.

Victorian Government Health Information. New Technology/Clinical

Practice program 2005–06. Victorian Policy Advisory Committee on

Clinical Practice and Technology. /newtech/

(accesd Aug 2007).

18US Department of Health and Human Services. CMS (Centres for

Medicare and Medicaid). Medicare coverage databa. National cover-

age determinations with data collection as a condition of coverage:

coverage with evidence development. 7 December 2006.

/mcd/ncpc_view_?id=8 (accesd Aug

2007).

19Hall WD, Ward R, Liauw WS, et al. Tailoring access to high cost,

genetically targeted drugs. Asssment of real cost effectiveness, with

data linked to individual health outcomes while protecting patient

privacy, is an esntial challenge we need to meet. Med J Aust 2005; 182:

607-608.

20Cutler DM. The demi of the blockbuster? N Engl J Med 2007; 356:

1292-1293.

21Kelman CW, Pearson SA, O’Day R, et al. Evaluating medicines: let’s u

all the evidence. Med J Aust 2007; 186: 249-252.

22Glasziou P. Support for trials of promising medications through the

Pharmaceutical Benefits Scheme. A proposal for a new authority cate-

gory. Med J Aust 1995; 162: 33-36.

23Etheredge LM. A rapid-learning health system. Health Aff (Milwood)

2007; 26: w107-w118.

(Received 25 Apr 2007, accepted 23 Jul 2007)

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264MJA•Volume 187 Number 5•3 September 2007