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Challenges in Australian policy processes for disinvestment from existing, ineffective health care practices

Challenges in Australian policy processes for disinvestment from existing, ineffective health... Background: Internationally, many health care interventions were diffused prior to the standard use of assessments of safety, effectiveness and cost-effectiveness. Disinvestment from ineffective or inappropriately applied practices is a growing priority for health care systems for reasons of improved quality of care and sustainability of resource allocation. In this paper we examine key challenges for disinvestment from these interventions and explore potential policy-related avenues to advance a disinvestment agenda. Results: We examine five key challenges in the area of policy driven disinvestment: 1) lack of resources to support disinvestment policy mechanisms; 2) lack of reliable administrative mechanisms to identify and prioritise technologies and/or practices with uncertain clinical and cost- effectiveness; 3) political, clinical and social challenges to removing an established technology or practice; 4) lack of published studies with evidence demonstrating that existing technologies/ practices provide little or no benefit (highlighting complexity of design) and; 5) inadequate resources to support a research agenda to advance disinvestment methods. Partnerships are required to involve government, professional colleges and relevant stakeholder groups to put disinvestment on the agenda. Such partnerships could foster awareness raising, collaboration and improved health outcome data generation and reporting. Dedicated funds and distinct processes could be established within the Medical Services Advisory Committee and Pharmaceutical Benefits Advisory Committee to, a) identify technologies and practices for which there is relative uncertainty that could be the basis for disinvestment analysis, and b) conduct disinvestment assessments of selected item(s) to address existing practices in an analogous manner to the current focus on new and emerging technology. Finally, dedicated funding and cross-disciplinary collaboration is necessary to build health services and policy research capacity, with a focus on advancing disinvestment research methodologies and decision support tools. Conclusion: The potential over-utilisation of less than effective clinical practices and the potential under-utilisation of effective clinical practices not only result in less than optimal care but also fragmented, inefficient and unsustainable resource allocation. Systematic policy approaches to disinvestment will improve equity, efficiency, quality and safety of care, as well as sustainability of resource allocation. Page 1 of 8 (page number not for citation purposes) Australia and New Zealand Health Policy 2007, 4:23 http://www.anzhealthpolicy.com/content/4/1/23 other countries, suffers from a legacy whereby many cur- Background The term disinvestment in health care is gaining promi- rently implemented health care interventions were in use nence internationally. It relates to the processes of (par- prior to well-defined standards of cost-effectiveness tially or completely) withdrawing health resources from becoming a criterion for reimbursement. Thus there is any existing health care practices, procedures, technolo- concern that health services of limited effectiveness may gies or pharmaceuticals that are deemed to deliver little or still be in practice nation-wide. The Chief Executive no health gain for their cost, and thus are not efficient Officer of Australia's National Institute of Clinical Studies health resource allocations. The goal of reducing the use (NICS) has stated, of ineffective technologies or practices has been central to Evidence-Based Medicine (EBM) for well over a decade. In We do not know how much of the total healthcare Austral- the early 1990s claims were made that in all areas of ians receive is based on the best available evidence; studies health care, "30–40% of patients do not receive treat- of a number of specific conditions show that there are gaps ments of proven effectiveness" [1], and, "20–25% of between what is known and what happens in practice [5]. patients have treatments that are unnecessary or poten- tially harmful" [2]. Since then, advances have been made While processes such as clinical practice guidelines devel- in Australia, and internationally, to improve primarily the opment and implementation continue to tackle aspects of safety of health care, but also clinical and cost-effective- this problem, disinvestment focuses on a complementary ness. Improvements have been achieved through the col- but parallel facet by examining practices that should be laborative work of national and regional health reduced or in some cases eliminated completely. We clas- departments, health care institutions, professional col- sify the principal challenges for disinvestment as follows: leges, academia and numerous organisations. In Australia these include but are not limited to the National Institute 1) Lack of dedicated resources by key stakeholders to of Clinical Studies (NICS), the Australian Commission on build and support disinvestment policy mechanisms Safety and Quality in Health Care – formerly the Austral- ian Council for Safety and Quality in Health Care, the 2) Lack of reliable administrative mechanisms to identify Australasian Association for Quality in Health Care and prioritise technologies and/or practices with relative (AAQHC), Effective Healthcare Australia (EHA), and the uncertainty as to their clinical and cost-effectiveness National Health and Medical Research Council (NHMRC). Furthermore, health technology assessment 3) Political, clinical and social challenges to removing an consultancy groups such as Adelaide Health Technology established technology (including challenges to limiting Assessment (AHTA) are increasingly involved in support- coverage to specific patients, institutions, or providers) ing current policy processes. 4) Lack of published studies that clearly demonstrate that Considerable effort and resources have been invested in existing technologies/practices provide little or no benefit Australia in developing well-defined criteria and evi- dence-based policy processes for assessing new and emerg- 5) Inadequate resources to support a research agenda to ing health technologies, surgical procedures and advance disinvestment methods pharmaceuticals to gauge their safety, effectiveness and cost-effectiveness [3,4]. Reimbursement approval (and Discussion therefore universal access through Australia's Medicare The following discussion will examine some of the ele- system) for these new services, as well as the withdrawal ments involved in addressing these challenges. The dis- of reimbursement for existing services, rests with the Aus- cussion will highlight what is occurring currently with tralian Government Minister for Health and Ageing under implications for what ought to occur in order to support advice from the Medical Services Advisory Committee effective disinvestment. We will present two brief case (MSAC) and, for pharmaceuticals, the Pharmaceutical studies to illustrate several complexities with accompany- Benefits Advisory Committee (PBAC). The MSAC and the ing recommendations. PBAC employ stringent review processes based on the existence of quality data and evidence that are available at 1) Lack of dedicated resources by key stakeholders to build and the time of assessment. Underpinning the disinvestment support disinvestment policy mechanisms movement, however, is a recognition that these stringent assessment methods are relatively novel, and that the The bearer of financial risk for the cost of healthcare per- processes to date have focused overwhelmingly on new haps has the greatest incentive to drive a disinvestment and emerging practices, technologies and pharmaceuti- agenda. In the USA this might include public and private cals and not on existing services (even though this is payers, purchasers or large employers. Whereas in govern- within the mandate of the MSAC). Australia therefore, like ment managed or mixed-model health care systems it Page 2 of 8 (page number not for citation purposes) Australia and New Zealand Health Policy 2007, 4:23 http://www.anzhealthpolicy.com/content/4/1/23 could be the national insurer and/or the private health or an adverse event register within tertiary care settings. insurance industry. In Australia, the MSAC faces issues in Further compounding this issue is the limited number of its current policy processes and capacity to support effec- groups in Australia (or indeed elsewhere) with a clear tive disinvestment. While for new devices or pharmaceu- directive and sufficient resources or incentive to seek out, ticals the burden for proving effectiveness lies with the identify and investigate potentially redundant/ineffective sponsor, for potentially obsolete technology or practices, procedures. Wilensky has recently intimated that similar the opposite occurs. The regulator or payer (the Australian limitations (and potential for improvement) exist in the government with advice from the MSAC) firstly has to United States of America (USA) [6]. This reflects a view identify or be made aware of a doubtful practice, to com- that substantial additional investment is required to sup- mission reviews, and then to mount a compelling argu- port evidence-based review of not only new and emerging ment for ineffectiveness and/or cost-ineffectiveness. For but also existing health care technologies, including com- illustrative purposes this may be described as somewhat parative studies examining new versus existing practices. analogous to standards of law. That is, adding an item to the schedule of benefits (or its equivalent in international In Australia the incentive pendulum supports diffusion terms) is beholden to a 'balance of probabilities' standard and not retraction or 'disinvestment'. The current MSAC whereas removal of an item requires a standard of evi- model appears geared (and effectively so) toward control- dence that is 'beyond reasonable doubt'. As will be dis- ling the tap as it is turned on, not toward neutralizing the cussed further, this identification and appraisal process is flow through active disinvestment. It is interesting for in itself complex, but even if it were not, the MSAC has a example, that old technologies or practices are not for- full agenda with applications for new and emerging tech- mally de-commissioned as new items are approved. nologies and hence has limited capacity to address exist- Instead, the range of options grows ever larger. And ing services. This is evident in communications with the although some (including at least one of the current MSAC members that highlight their workload, and the authors) purport that many practices simply fade away or focus of that work. At a recent meeting of the MSAC, the die a slow death, the question remains whether this repre- 22 committee members were faced with 700 pages of doc- sents a sound policy approach to resource allocation and umentation to consider. All of that material was for new clinical excellence in health care. and emerging technologies and practices; none was for existing, potentially ineffective health care. In Australia we Currently the MSAC provides advice on whether a pro- therefore appear to be 'stuck with the old and over- posed new service is as or more safe, effective and cost- whelmed by the new'. Irrespective of the successes the effective than a comparator. There is nothing to stop the Australian policy model has had in assessing new and MSAC from recommending the removal of one service as emerging technologies, there appears to be a lack of capac- it recommends addition of another service to the reim- ity to address both new and existing practices. Or arguably bursement schedule should the new service have demon- the capacity exists but is not being appropriately har- strably better cost effectiveness for a given indication. That nessed at present, which may reflect a lack of political will. the comparator is not automatically removed from the In any case disinvestment is limited. This limitation in schedule highlights a challenging issue for a disinvest- capacity may be, in part, a result of the political and pro- ment programme. The new service (even if superior) may fessional complexities associated with disinvesting exist- take time to diffuse into practice and become accepted by ing practices (discussed further below). It also points to the medical profession. Premature disinvestment of the the growing need for a political paradigm shift in order to comparator may disadvantage patients where the new foster policy-driven disinvestment capacity. service was not yet available and thereby raise issues of access and equity. The evidence supporting the new tech- 2) Lack of reliable administrative mechanisms to identify and nology may not go as far as assessing the cost-effectiveness prioritise technologies and practices for which there is relative of disinvestment of its comparator (in terms of capital uncertainty as to clinical and cost-effectiveness investment, training, and changes to clinical workflow). Decision-making in disinvestment must take account of Disinvestment may be easier with pharmaceuticals and/or these factors. when adverse events occur. The process is more complex when individual are not harmed by existing practices but 3) Political, clinical and social challenges to removing an estab- over-treated or ineffectively treated. That is, subjected to lished technology (including challenges to limiting coverage to diagnosis or treatment that is safe but of little or no mean- specific patients, institutions, or providers) ingful clinical benefit (i.e. supported by the existence of compelling clinical- and cost-effectiveness evidence). A For existing technologies or practices there are complexi- register for 'ineffectively-treated' does not exist in the same ties that do not beset those that are new or emerging. way as an adverse event register exists for pharmaceuticals, Page 3 of 8 (page number not for citation purposes) Australia and New Zealand Health Policy 2007, 4:23 http://www.anzhealthpolicy.com/content/4/1/23 These relate to their entrenched status and include for well be a policy-guided process of measured retraction example: including restricting the indications for particular services.  Resistance to change due to established clinical training Important in any disinvestment policy model is recogni- and practice paradigms tion and consideration of perceived threats that may be raised by disinvestment. We have included a case study  Multiple clinical, consumer and political interests involving Assisted Reproductive Technologies (ART) for women over the age of 42 years to explore some potential  Clinical and consumer influence and preferences, and threats and argue that these are legitimate considerations supplier-induced demand in a disinvestment analysis (See Table 1).  Incentive and disincentive mechanisms There is clear evidence of limited effectiveness for ART with increasing maternal age. There are also social, politi-  The sunk costs of human and physical capital which cal and ethical considerations that any disinvestment would thereby become obsolete strategy (and methodological framework) must take into consideration. The complexities involved in any potential Schon describes how social systems work hard to resist disinvestment analysis of this issue support the need for change, a phenomenon he labels 'dynamic conservatism' methodological advances in this area of health services [7]. Research and applied decision making in this area research. Such advances are required if health services must therefore include analysis of the evidence for safety, such as ART are to be moved out of the 'too hard basket' effectiveness and cost-effectiveness as well as social, ethi- and into active assessment, debate and appraisal. cal and political analyses to explain why ineffective health care practices persist. Only then is there scope to address Another barrier to disinvestment is the notion that medi- how ineffective practices can be disinvested. cal technology has provided good value for money over time, and that regulators' efforts to restrict coverage (or For the clinician there is often concern that disinvestment disinvest) may reduce incentives for investment and inno- represents a blunt instrument of rationing, one that may vation, thereby impeding the future flow of valuable tech- restrict clinical autonomy and reduce patient choice. But nologies [8]. We may need to tolerate a certain level of can continued investment in health care occur without payment for low value or relatively ineffective technolo- thoughtful, measured disinvestment? There is an eco- gies and practices because such is the market environment nomic imperative to do so for the sake of sustainability. that makes possible the valuable medical breakthroughs. There is also an ethical imperative for the delivery of qual- ity health care and a best practice imperative for clinical 4) Lack of published studies that clearly demonstrate that exist- purchasers and providers. Disinvestment will free up ing technologies/practices provide little or no benefit resources for those practices that have demonstrated effec- tiveness. Furthermore, disinvestment should not be seen For many technologies and practices there is evidence sup- as an all or nothing approach. Removing a reimbursement porting varying degrees of effectiveness when used in cer- item number from the Schedule of Medical Benefits (or tain contexts (for example to certain patient groups with the equivalent action in international terms) would be an varying degrees of predictive prognoses). However, there extreme example of successful disinvestment. There may are also examples of inappropriate application of other- wise effective technologies or procedures, culminating in Table 1: Case Study 1 Assisted Reproductive Technologies (ART) for women over 42 years of age ART does not specifically affect morbidity or mortality (with some exceptions). The debate has, and continues, to occur prominently in the broad community as well as government. In 2003, age-specific success rates of In Vitro Fertilisation (IVF) cycles using fresh oocytes were [28]: • 27.7% for women aged 25–29 • 24.9% for women aged 30–34 • 17.1% for women aged 35–39 • 6.8% for women aged 40–44 • 2% for women aged ≥ 42 (some clinics have cited success rates of 5–10%) This success rate for women aged 42 years or more has been cited by one Australian clinic as a reason for refusing to treat women of that age [29]. Politicians have also engaged with this debate. In April 2005 the Australian Government Minister for Health and Ageing considered limiting ART funding under Medicare to three cycles per year for women 42 and under, and to three cycles in total for women over this age [30]. Rising expenditure on ART and the low age-specific success rates were cited as justification for this policy. This proposal for reduced support was subsequently abandoned by the Australian Prime Minister in May 2005. Table 3 further explores some of the methodological issues associated with this as a potential case study in disinvestment. Page 4 of 8 (page number not for citation purposes) Australia and New Zealand Health Policy 2007, 4:23 http://www.anzhealthpolicy.com/content/4/1/23 ineffective care and inefficient resource allocation. Nota- In such cases there may be potential for a 'funding with ble examples of this are presented in the work of Wen- evidence generation' mechanism (also called 'only in nberg, disseminated in the Dartmouth Atlas highlighting research' in the United Kingdom (UK) and 'coverage with geographic variation in the use of a range of procedures evidence development' in the USA). This approach is cur- [9]. Under such conditions a degree of measured retrac- rently applied for some emerging technologies but could tion of practice is desirable, with resultant disinvestment. be adapted for existing practices. Here, payers/regulators Clinical practice modification and refinement techniques, may allow ongoing funding only for a defined period of perhaps via clinical practice guideline development and time to allow for the generation and/or analyses of neces- implementation, have demonstrated efficacy. As noted by sary evidence. Currently there is provision for use of this Miles and co workers, approach with new technologies by the MSAC. clinical practice guidelines remain, when certain conditions 5) Inadequate resources to support a research agenda to are met and their limitations fully understood, useful vehi- advance disinvestment policies and methods cles for implementing agreed changes to clinical practice and service provision. Certainly, the process of deriving and The discussion thus far highlights the need for methodo- implementing clinical practice guidelines has developed logical advances to support disinvestment decision mak- into a science in its own [10]. ing. In Australia, health technology assessment groups conduct and present the synthesised, evidence-based However, for some technologies or practices the evidence reviews that support the MSAC and the PBAC reimburse- for effectiveness is either less clear, or is negative, yet the ment decisions for new and emerging technologies and practice persists. In these instances, partial or complete pharmaceuticals. Health Technology Assessment (HTA) removal (from funding) may be necessary. Substantial incorporates multidisciplinary fields of policy analysis, challenges exist, particularly around adequate and timely and has broadened, "from primarily addressing effectiveness definition and acceptable proof of inferiority. This is not and safety issues to covering a broader array of issues such as only conceptually difficult but also limited by data avail- psychological, organizational, ethical and legal aspects" [13]. ability and interpretation. Further complicating this is the HTA studies the medical, social, ethical, and economic lag that often exists in the reliable reporting of health out- implications of development, diffusion, and use of health comes data based on clinical practice. Table 2 (Case Study technologies, practices and services. HTA agencies 2) presents a case highlighting potential complexities of together with health services and policy researchers gener- 'evidence' in disinvestment review decisions. These, ally, are well positioned to take a lead role in supporting together with considerations from the ART example, are the disinvestment of existing, ineffective health care prac- further addressed in Table 3. tices. To do this effectively requires collaborative research and recently announced funding increases from the Within this context there is scope for expanding the capac- National Health and Medical Research Council ity to conduct primary and secondary research of stand (NHMRC) for Health Services Research offers potential alone and comparative effectiveness for existing as well as here. But in Australia HTA groups largely operate as con- new technologies [11,12]. The disinvestment considera- tract research organisations and with relatively short-term tions highlighted in Table 3 require methodological contracts these groups tend to lack capacity to build or advances but also time for thorough and rigorous review. support a broad methodological research agenda for the Table 2: Case Study 2 Upper airway surgical procedures for adult Obstructive Sleep Apnea (OSA) Approximately one in five adults has at least mild OSA and one in 15 adults has OSA of moderate or worse severity [31]. The condition is an independent risk factor for substantial morbidity(ies) with implications also for mortality [32]. Currently, upper airway surgery is a second-line treatment alternative to an established non-surgical gold-standard. A recent meta-analysis of these surgical procedures reported success rates at [33]: • 13% for Phase I procedures (including uvulopalatopharyngoplasty [UPPP], laser-assisted uvulopalatoplasty [LAUP], hyoid suspension [HS], genioglossus advancement [GA], and radiofrequency volume reduction of soft tissue [RFVR]) • 43% for advanced Phase II procedures (maxilla and/or mandible advancement (MMA) requiring up to three days Intensive Care Unit recovery). • Two reports of patient satisfaction highlight that surgery has a high postoperative morbidity rate, a high patient-reported failure rate and a low level of satisfaction with 53% [34] and 61% [35] patient-reported 'regret' rates. • The Cochrane review in this area [36] supports the restricted use of these operations and yet Australian Medicare data highlights that these procedures are widespread and increasing. Despite the existence of these procedures for over a decade, debate regarding their efficacy has recently intensified, as to whether these success rates presented above represent 'highly effective treatment', sufficient enough to confer improved health outcomes [37-39]. Disagreement has occurred primarily between relevant medical specialties (i.e. surgeons and sleep medicine physicians). Importantly, there has been a lag in presentation of the necessary evidence to inform and advance such a debate, principally as no policy group has been assigned a stake in the collection or generation of such evidence, hereto it has accrued via the noble but ad hoc actions of clinical groups. Page 5 of 8 (page number not for citation purposes) Australia and New Zealand Health Policy 2007, 4:23 http://www.anzhealthpolicy.com/content/4/1/23 Table 3: Investigative issues associated with the chosen health care practices Health Care Setting Interest from methodological and Key Issues Technology/Practice policy perspectives* ART ≥ 42 years of age Clinic or Hospital Harmful x - Marginal clinical and cost-effectiveness (on population Clinically Effective x basis) but limiting its use poses problems: it is highly Cost Effective ? beneficial from perspective of concerned individuals Appropriate ? - Therapy has equivocal purpose Socially Valued √ - Highly valued by recipients and potentially by society Universally Accessible ?/x broadly Ethical ? - Ability to pay: user vs society - Equity of access - Medical vs social infertility - Opportunity cost Upper airway surgery Surgical Theatre Harmful ? - Limiting its use should not, in theory, pose any for adult OSA Clinically Effective ?/x problems, but pressures are strong from clinical interest Effective Alternative √ groups Cost Effective x - Complex practice paradigms/incentives Appropriate ? - Small, homogeneous craft group Necessary ? - Equipoise/clinical uncertainty Socially Valued ?/√ - Perspectives of patients who value the potential of a Ethical ? surgical 'fix' - Is this preference based on sound evidence or supplier induced demand? - Opportunity cost *Key: ? = Unsure or in question; x = Limited or evidence in the negative; √ = Evidence in the positive disinvestment of existing, ineffective health care practices. health research and funding highlighted the challenges This phenomenon is not restricted to Australia, and as faced: Lehoux has observed, the involvement of academic insti- tutions in HTA has the potential to bring with it conflict- The delivery of robust scientific appraisal for technologies is ing legitimacies between the production of traditionally coming under increasing challenge as a result of its reliance scientific versus user-oriented knowledge [8]. With con- on methodologies that, it is widely recognized, need further certed capacity building and research initiatives aimed at development, given that Health Technology Assessment improving linkage and exchange between policy advisors/ (HTA) is a relatively new science. Appropriate research is makers and academic researchers (HTA specialists), prior- required to address these challenges. In particular, research ity driven, contextually relevant research would be facili- into methodology for... disinvestment methods ([23], page tated and could support decision-making processes that 103) policy makers need. Moreover, it would contribute much- needed methodological advances and align with the four In the United States the 'Developing Evidence to Inform main characteristics of action research defined by Hart Decisions about Effectiveness' (DeCIDE) Research Net- and Bond [14]: (1) collaboration between researchers and work has been implemented to support the development practitioners; (2) solution of practical problems; (3) of new scientific knowledge through research on the out- change in practice; and (4) development of theory. comes of health care items and services. This is a clear pol- icy directive in line with Section 1013 of the Medicare Collaborative models amenable to disinvestment strate- Modernization Act of 2003. Wilensky has commented gies are increasingly being developed and adopted inter- that a window of opportunity currently exists in the USA nationally, with some based on the priority setting for the development of a Center for Comparative Effec- developments described by Mooney [15,16]). The strate- tiveness, particularly to address pharmaceuticals [6]. We gic 'Linkage and Exchange' and 'Participatory Action believe the greater challenge is to incorporate the assess- Research' programs in Canada [17-21] deal with similar ment of existing health care practices and technologies, as issues. Recently, the UK's National Institute for Clinical well as pharmaceuticals. Fundamental to this is an Excellence (NICE) announced a formal policy agenda to expanded process of medico-vigilance – monitoring of "purge from the NHS treatments that do not improve health or whether the practice/technology is not only safe but effec- are poor value for money" [22]. It is interesting to note how- tive and cost-effective in 'real' use outside the tightly con- ever that subsequent to the NICE disinvestment agenda trolled environments in which initial evidence may have being released, a formal UK Treasury report into UK been collected. Beyond this the social, ethical and politi- Page 6 of 8 (page number not for citation purposes) Australia and New Zealand Health Policy 2007, 4:23 http://www.anzhealthpolicy.com/content/4/1/23 cal complexities must be accounted for as explicit compo- depend less on the availability of resources than on the nents of any disinvestment analysis. political will to support work in this area. Based on this discussion we present the following recom- Summary mendations of initiatives to be implemented in Australia Australia currently has limited systems in place to support (and internationally where appropriate): the disinvestment of currently used ineffective, or inap- propriately applied, health care practices. With the grow- ♣ Government partnerships to involve the professional ing burden of chronic health conditions, addressing this colleges and relevant stakeholder groups (consumer/com- limitation should be recognised as an emerging national munity) to put disinvestment on the agenda including priority area [24]. This discussion piece is intended to awareness, collaboration and improved health outcome stimulate further debate in this area (see also [25-27]). data generation and reporting (ongoing medico-vigi- The potential over-utilisation of less than effective clinical lance). practices and the potential under-utilisation of effective clinical practices not only result in less than optimal care ♣ Dedicated funds and distinct processes (i.e. transparent but also fragmented, inefficient and unsustainable legal framework) within the MSAC and where appropriate resource allocation. Systematic policy approaches to dis- the PBAC to: investment will improve equity, efficiency, quality and safety of care, as well as sustainability of resource alloca- ❍ Identify technologies and practices for which there is tion. Developing health services and policy research relative uncertainty for disinvestment analysis/review methodologies that tackle these complexities to assist pol- icy-makers will advance the disinvestment agenda. This is ❍ Conduct disinvestment assessments/reviews of the a growing area of priority setting in health care that selected item(s) requires national and international perspectives, debate and collaboration. This should involve an expanded capacity for these com- mittees (or others adopting a similar model) to address Competing interests Adam Elshaug received funding for this project from the existing practices in an analogous manner to their current focus on new and emerging technologies, practices and Faculty of Health Sciences of the University of Adelaide. pharmaceuticals. Professor Hiller is director of Adelaide Health Technology Assessment (AHTA). This organisation is contracted to ❍ At this juncture in Australia's health policy landscape, complete evaluations of health technologies. Assoc Prof collaborative links to advance disinvestment should be Moss provides health technology assessments to the Aus- made between the relevant stakeholder bodies, including: tralian Government Department of Health and Ageing as the MSAC/PBAC, state departments of health, the Austral- a consultant. Dr Tunis is the Founder and Director of the ian Commission on Safety and Quality in Health Care, Center for Medical Technology Policy in San Francisco, the National Institute of Clinical Studies (and the where he consults with health care decision makers and NHMRC more broadly). stakeholders to support the rapid evaluation and effective use of new medical technologies. In all other respects the ♣ For existing health care services for which there is rela- authors declare they have no competing interests. tive uncertainty, consideration for the implementation of 'funding with evidence generation'. That is, ongoing reim- Authors' contributions bursement only agreed for a limited number of years AE conceptualised this paper, completed the first substan- pending evidence generation/review processes – with the tive draft and contributed to subsequent draft revisions. possibility of extensions being considered. JH and JM contributed substantively to subsequent draft revisions. ST contributed an international perspective ♣ Dedicated funding and cross-disciplinary collaboration (primarily USA) and substantive editorial comments on to build health services and policy research capacity with two drafts. All authors read and approved the final manu- a focus on advancing disinvestment research methodolo- script. gies and decision support tools for policy stakeholders. Acknowledgements The authors would like to acknowledge and thank the anonymous review- Disinvestment from existing health care practices that ers for their thoughtful and constructive comments on earlier versions of offer little or no health gain is a policy challenge that this paper. requires greater attention, both for quality of care and sus- tainable resource allocation. Disinvestment may well References 1. White KL: Evidence-Based Medicine. Lancet 1995, 346:837-838. Page 7 of 8 (page number not for citation purposes) Australia and New Zealand Health Policy 2007, 4:23 http://www.anzhealthpolicy.com/content/4/1/23 2. Smith R: Where is the wisdom...? The Poverty of Medical Evi- Statistics Unit; Australian Institute for Health and Welfare (AIHW); Cat. No. dence. BMJ 1991, 303:798-799. per 2006, 31:36. 3. Morgan SG, McMahon M, Mitton C, Roughead E, Kirk R, Kanavos P, 29. Overington C: No age limit on IVF funds: Costello. The Austral- Menon D: Centralized drug review processes in Australia, ian Newspaper :3. 2 January 2006 Canada, New Zealand, and the United kingdom. Health Aff 30. Uren D: Limits on IVF access will put women at risk. The Aus- (Millwood) 2006, 25:337-47. tralian Newspaper :4. 25 April 2005 4. O'Malley SP: The Australian experiment: the use of Evidence 31. Young T, Skatrud J, Peppard P: Risk Factors for Obstructive Based Medicine for the reimbursement of surgical and diag- Sleep Apnea in Adults. JAMA 2004, 291:2013-2016. nostic procedures (1998–2004). Aust New Zealand Health Policy 32. Young T, Peppard P, Gottlieb D: Epidemiology of obstructive 2006, 3:. sleep apnea: A population health perspective. Am J Respir Crit 5. Buchan H: Gaps between best evidence and practice: causes Care Med 2002, 165:1217-1239. for concern. Med J Aust 2004, 180:S48-S49. 33. Elshaug AG, Moss JR, Southcott AM, Hiller JE: Redefining success 6. Wilensky GR: Developing A Center For Comparative Effec- in airway surgery for obstructive sleep apnea: a meta analy- tiveness Information. Health Aff 2006. doi: sis and synthesis of the evidence. Sleep 2007, 30:461-467. 10.1377:hlthaff.25.w572. 34. Jones TM, Earis JE, Calverley PM, De S, Swift AC: Snoring surgery: 7. Schon DA: Beyond the stable state: public and private learning in a chang- a retrospective review. Laryngoscope 2005, 115:2010-5. ing society London: Temple Smith; 1971. 35. Hicklin LA, Tostevin P, Dasan S: Retrospective survey of long- 8. Lehoux P: The Problem of Health Technology: Policy Implications for Mod- term results and patient satisfaction with uvulopalat- ern Health Care Systems New York: Taylor and Francis Group; 2006. opharyngoplasty for snoring. J Laryngol Otol 2000, 114:675-81. 9. Wennberg JE: Unwarranted Variations in Health Care: The 36. Sundaram S, Bridgman SA, Lim J, Lasserson TJ: Surgery for obstruc- Dartmouth Atlas of Health Care. [http://www.dartmouthat tive sleep apnoea. Cochrane Database Syst Rev 2005:CD001004. las.org/index.shtm]. 37. Phillips B: Upper airway surgery does not have a major role in 10. Miles A, Polychronis A, Grey JE: The evidence-based health care the treatment of sleep apnea. Journal of Clinical Sleep Medicine debate – 2006. Where are we now? J Eval Clin Pract 2006, 2005, 1:241-245. 12:239-247. 38. Powell N: Upper airway surgery does have a major role in the 11. Tunis SR: A clinical research strategy to support shared deci- treatment of obstructive sleep apnea: "the tail end of the sion making. Health Aff (Millwood) 2005, 24:180-4. dog". Journal of Clinical Sleep Medicine 2005, 1:236-240. 12. Tunis SR, Pearson SD: Coverage options for promising technol- 39. Elshaug AG, Moss JR, Southcott AM, Hiller JE: An analysis of the ogies: Medicare's 'coverage with evidence development'. evidence-practice continuum: Is surgery for Obstructive Health Aff (Millwood) 2006, 25:1218-30. Sleep Apnoea contraindicated? J Eval Clin Pract 2007, 13:3-9. 13. Draborg E, Gyrd-Hansen D: Time-trends in health technology assessments: an analysis of developments in composition of international health technology assessments from 1989 to 2002. Int J Technol Assess Health Care 2005, 21:492-8. 14. Hart E, Bond M: Action research for health and social care: A guide to prac- tice Philadelphia: Open University Press; 1995. 15. Mooney G: Priority setting in mental health services. Appl Health Econ Health Policy 2002, 1:65-74. 16. Mooney G: Communitarian claims and community capabili- ties: furthering priority setting? Soc Sci Med 2005, 60:247-55. 17. Lomas J: Using 'linkage and exchange' to move research into policy at a Canadian foundation. Health Aff (Millwood) 2000, 19:236-40. 18. Mitton C, Donaldson C: Tools of the trade: a comparative anal- ysis of approaches to priority setting in healthcare. Health Serv Manage Res 2003, 16:96-105. 19. Mitton C, Patten S, Donaldson C, Waldner H: Priority-setting in health authorities: moving beyond the barriers. The Calgary experience. Healthc Q 2005, 8:49-55. 20. Lee RC, Marshall D, Waddell C, Hailey D, Juzwishin D: Health tech- nology assessment, research, and implementation within a health region in Alberta, Canada. Int J Technol Assess Health Care 2003, 19:513-20. 21. Wanke MI, Juzwishin D: International comparison and review of a health technology assessment skills program. Int J Technol Assess Health Care 2005, 21:253-62. 22. Kmietowicz Z: NICE is to root out ineffective treatments in NHS. BMJ 2006, 333:. doi:10.1136/bmj.333.7568.568-a. 23. Cooksey SD: A review of UK health research funding London : Her Maj- esty's Treasury; 2006. 24. Medical Services Advisory Committee: Australian Government Publish with Bio Med Central and every Department of Health and Ageing. In Strengthening evidence- scientist can read your work free of charge based health care in Australia Canberra; 2003. 25. Victorian Government Department of Human Services: Future "BioMed Central will be the most significant development for directions for health technology uptake, diffusion and disin- disseminating the results of biomedical researc h in our lifetime." vestment in Victorian public health services (discussion Sir Paul Nurse, Cancer Research UK paper). 2003 [http://www.health.vic.gov.au/newtech/new-tech- workshop-discussion.pdf]. 21 March,2007 Your research papers will be: 26. Jackson TJ: Health technology assessment in Australia: chal- available free of charge to the entire biomedical community lenges ahead. Med J Aust 2007, 187:262-4. 27. Elshaug AG, Hiller JE, Moss JR: Exploring policymakers' perspec- peer reviewed and published immediately upon acceptance tives on disinvestment from ineffective health care practices. cited in PubMed and archived on PubMed Central Int J Technol Assess Health Care in press. accepted 21/09/2007. 28. Waters A, Dean J, Sullivan E: Assisted reproduction technology yours — you keep the copyright in Australia and New Zealand, 2003. Canberra: National Perinatal BioMedcentral Submit your manuscript here: http://www.biomedcentral.com/info/publishing_adv.asp Page 8 of 8 (page number not for citation purposes) http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Australia and New Zealand Health Policy Springer Journals

Challenges in Australian policy processes for disinvestment from existing, ineffective health care practices

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Springer Journals
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Copyright © 2007 by Elshaug et al; licensee BioMed Central Ltd.
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Medicine & Public Health; Public Health; Social Policy
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1743-8462
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10.1186/1743-8462-4-23
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17973993
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Abstract

Background: Internationally, many health care interventions were diffused prior to the standard use of assessments of safety, effectiveness and cost-effectiveness. Disinvestment from ineffective or inappropriately applied practices is a growing priority for health care systems for reasons of improved quality of care and sustainability of resource allocation. In this paper we examine key challenges for disinvestment from these interventions and explore potential policy-related avenues to advance a disinvestment agenda. Results: We examine five key challenges in the area of policy driven disinvestment: 1) lack of resources to support disinvestment policy mechanisms; 2) lack of reliable administrative mechanisms to identify and prioritise technologies and/or practices with uncertain clinical and cost- effectiveness; 3) political, clinical and social challenges to removing an established technology or practice; 4) lack of published studies with evidence demonstrating that existing technologies/ practices provide little or no benefit (highlighting complexity of design) and; 5) inadequate resources to support a research agenda to advance disinvestment methods. Partnerships are required to involve government, professional colleges and relevant stakeholder groups to put disinvestment on the agenda. Such partnerships could foster awareness raising, collaboration and improved health outcome data generation and reporting. Dedicated funds and distinct processes could be established within the Medical Services Advisory Committee and Pharmaceutical Benefits Advisory Committee to, a) identify technologies and practices for which there is relative uncertainty that could be the basis for disinvestment analysis, and b) conduct disinvestment assessments of selected item(s) to address existing practices in an analogous manner to the current focus on new and emerging technology. Finally, dedicated funding and cross-disciplinary collaboration is necessary to build health services and policy research capacity, with a focus on advancing disinvestment research methodologies and decision support tools. Conclusion: The potential over-utilisation of less than effective clinical practices and the potential under-utilisation of effective clinical practices not only result in less than optimal care but also fragmented, inefficient and unsustainable resource allocation. Systematic policy approaches to disinvestment will improve equity, efficiency, quality and safety of care, as well as sustainability of resource allocation. Page 1 of 8 (page number not for citation purposes) Australia and New Zealand Health Policy 2007, 4:23 http://www.anzhealthpolicy.com/content/4/1/23 other countries, suffers from a legacy whereby many cur- Background The term disinvestment in health care is gaining promi- rently implemented health care interventions were in use nence internationally. It relates to the processes of (par- prior to well-defined standards of cost-effectiveness tially or completely) withdrawing health resources from becoming a criterion for reimbursement. Thus there is any existing health care practices, procedures, technolo- concern that health services of limited effectiveness may gies or pharmaceuticals that are deemed to deliver little or still be in practice nation-wide. The Chief Executive no health gain for their cost, and thus are not efficient Officer of Australia's National Institute of Clinical Studies health resource allocations. The goal of reducing the use (NICS) has stated, of ineffective technologies or practices has been central to Evidence-Based Medicine (EBM) for well over a decade. In We do not know how much of the total healthcare Austral- the early 1990s claims were made that in all areas of ians receive is based on the best available evidence; studies health care, "30–40% of patients do not receive treat- of a number of specific conditions show that there are gaps ments of proven effectiveness" [1], and, "20–25% of between what is known and what happens in practice [5]. patients have treatments that are unnecessary or poten- tially harmful" [2]. Since then, advances have been made While processes such as clinical practice guidelines devel- in Australia, and internationally, to improve primarily the opment and implementation continue to tackle aspects of safety of health care, but also clinical and cost-effective- this problem, disinvestment focuses on a complementary ness. Improvements have been achieved through the col- but parallel facet by examining practices that should be laborative work of national and regional health reduced or in some cases eliminated completely. We clas- departments, health care institutions, professional col- sify the principal challenges for disinvestment as follows: leges, academia and numerous organisations. In Australia these include but are not limited to the National Institute 1) Lack of dedicated resources by key stakeholders to of Clinical Studies (NICS), the Australian Commission on build and support disinvestment policy mechanisms Safety and Quality in Health Care – formerly the Austral- ian Council for Safety and Quality in Health Care, the 2) Lack of reliable administrative mechanisms to identify Australasian Association for Quality in Health Care and prioritise technologies and/or practices with relative (AAQHC), Effective Healthcare Australia (EHA), and the uncertainty as to their clinical and cost-effectiveness National Health and Medical Research Council (NHMRC). Furthermore, health technology assessment 3) Political, clinical and social challenges to removing an consultancy groups such as Adelaide Health Technology established technology (including challenges to limiting Assessment (AHTA) are increasingly involved in support- coverage to specific patients, institutions, or providers) ing current policy processes. 4) Lack of published studies that clearly demonstrate that Considerable effort and resources have been invested in existing technologies/practices provide little or no benefit Australia in developing well-defined criteria and evi- dence-based policy processes for assessing new and emerg- 5) Inadequate resources to support a research agenda to ing health technologies, surgical procedures and advance disinvestment methods pharmaceuticals to gauge their safety, effectiveness and cost-effectiveness [3,4]. Reimbursement approval (and Discussion therefore universal access through Australia's Medicare The following discussion will examine some of the ele- system) for these new services, as well as the withdrawal ments involved in addressing these challenges. The dis- of reimbursement for existing services, rests with the Aus- cussion will highlight what is occurring currently with tralian Government Minister for Health and Ageing under implications for what ought to occur in order to support advice from the Medical Services Advisory Committee effective disinvestment. We will present two brief case (MSAC) and, for pharmaceuticals, the Pharmaceutical studies to illustrate several complexities with accompany- Benefits Advisory Committee (PBAC). The MSAC and the ing recommendations. PBAC employ stringent review processes based on the existence of quality data and evidence that are available at 1) Lack of dedicated resources by key stakeholders to build and the time of assessment. Underpinning the disinvestment support disinvestment policy mechanisms movement, however, is a recognition that these stringent assessment methods are relatively novel, and that the The bearer of financial risk for the cost of healthcare per- processes to date have focused overwhelmingly on new haps has the greatest incentive to drive a disinvestment and emerging practices, technologies and pharmaceuti- agenda. In the USA this might include public and private cals and not on existing services (even though this is payers, purchasers or large employers. Whereas in govern- within the mandate of the MSAC). Australia therefore, like ment managed or mixed-model health care systems it Page 2 of 8 (page number not for citation purposes) Australia and New Zealand Health Policy 2007, 4:23 http://www.anzhealthpolicy.com/content/4/1/23 could be the national insurer and/or the private health or an adverse event register within tertiary care settings. insurance industry. In Australia, the MSAC faces issues in Further compounding this issue is the limited number of its current policy processes and capacity to support effec- groups in Australia (or indeed elsewhere) with a clear tive disinvestment. While for new devices or pharmaceu- directive and sufficient resources or incentive to seek out, ticals the burden for proving effectiveness lies with the identify and investigate potentially redundant/ineffective sponsor, for potentially obsolete technology or practices, procedures. Wilensky has recently intimated that similar the opposite occurs. The regulator or payer (the Australian limitations (and potential for improvement) exist in the government with advice from the MSAC) firstly has to United States of America (USA) [6]. This reflects a view identify or be made aware of a doubtful practice, to com- that substantial additional investment is required to sup- mission reviews, and then to mount a compelling argu- port evidence-based review of not only new and emerging ment for ineffectiveness and/or cost-ineffectiveness. For but also existing health care technologies, including com- illustrative purposes this may be described as somewhat parative studies examining new versus existing practices. analogous to standards of law. That is, adding an item to the schedule of benefits (or its equivalent in international In Australia the incentive pendulum supports diffusion terms) is beholden to a 'balance of probabilities' standard and not retraction or 'disinvestment'. The current MSAC whereas removal of an item requires a standard of evi- model appears geared (and effectively so) toward control- dence that is 'beyond reasonable doubt'. As will be dis- ling the tap as it is turned on, not toward neutralizing the cussed further, this identification and appraisal process is flow through active disinvestment. It is interesting for in itself complex, but even if it were not, the MSAC has a example, that old technologies or practices are not for- full agenda with applications for new and emerging tech- mally de-commissioned as new items are approved. nologies and hence has limited capacity to address exist- Instead, the range of options grows ever larger. And ing services. This is evident in communications with the although some (including at least one of the current MSAC members that highlight their workload, and the authors) purport that many practices simply fade away or focus of that work. At a recent meeting of the MSAC, the die a slow death, the question remains whether this repre- 22 committee members were faced with 700 pages of doc- sents a sound policy approach to resource allocation and umentation to consider. All of that material was for new clinical excellence in health care. and emerging technologies and practices; none was for existing, potentially ineffective health care. In Australia we Currently the MSAC provides advice on whether a pro- therefore appear to be 'stuck with the old and over- posed new service is as or more safe, effective and cost- whelmed by the new'. Irrespective of the successes the effective than a comparator. There is nothing to stop the Australian policy model has had in assessing new and MSAC from recommending the removal of one service as emerging technologies, there appears to be a lack of capac- it recommends addition of another service to the reim- ity to address both new and existing practices. Or arguably bursement schedule should the new service have demon- the capacity exists but is not being appropriately har- strably better cost effectiveness for a given indication. That nessed at present, which may reflect a lack of political will. the comparator is not automatically removed from the In any case disinvestment is limited. This limitation in schedule highlights a challenging issue for a disinvest- capacity may be, in part, a result of the political and pro- ment programme. The new service (even if superior) may fessional complexities associated with disinvesting exist- take time to diffuse into practice and become accepted by ing practices (discussed further below). It also points to the medical profession. Premature disinvestment of the the growing need for a political paradigm shift in order to comparator may disadvantage patients where the new foster policy-driven disinvestment capacity. service was not yet available and thereby raise issues of access and equity. The evidence supporting the new tech- 2) Lack of reliable administrative mechanisms to identify and nology may not go as far as assessing the cost-effectiveness prioritise technologies and practices for which there is relative of disinvestment of its comparator (in terms of capital uncertainty as to clinical and cost-effectiveness investment, training, and changes to clinical workflow). Decision-making in disinvestment must take account of Disinvestment may be easier with pharmaceuticals and/or these factors. when adverse events occur. The process is more complex when individual are not harmed by existing practices but 3) Political, clinical and social challenges to removing an estab- over-treated or ineffectively treated. That is, subjected to lished technology (including challenges to limiting coverage to diagnosis or treatment that is safe but of little or no mean- specific patients, institutions, or providers) ingful clinical benefit (i.e. supported by the existence of compelling clinical- and cost-effectiveness evidence). A For existing technologies or practices there are complexi- register for 'ineffectively-treated' does not exist in the same ties that do not beset those that are new or emerging. way as an adverse event register exists for pharmaceuticals, Page 3 of 8 (page number not for citation purposes) Australia and New Zealand Health Policy 2007, 4:23 http://www.anzhealthpolicy.com/content/4/1/23 These relate to their entrenched status and include for well be a policy-guided process of measured retraction example: including restricting the indications for particular services.  Resistance to change due to established clinical training Important in any disinvestment policy model is recogni- and practice paradigms tion and consideration of perceived threats that may be raised by disinvestment. We have included a case study  Multiple clinical, consumer and political interests involving Assisted Reproductive Technologies (ART) for women over the age of 42 years to explore some potential  Clinical and consumer influence and preferences, and threats and argue that these are legitimate considerations supplier-induced demand in a disinvestment analysis (See Table 1).  Incentive and disincentive mechanisms There is clear evidence of limited effectiveness for ART with increasing maternal age. There are also social, politi-  The sunk costs of human and physical capital which cal and ethical considerations that any disinvestment would thereby become obsolete strategy (and methodological framework) must take into consideration. The complexities involved in any potential Schon describes how social systems work hard to resist disinvestment analysis of this issue support the need for change, a phenomenon he labels 'dynamic conservatism' methodological advances in this area of health services [7]. Research and applied decision making in this area research. Such advances are required if health services must therefore include analysis of the evidence for safety, such as ART are to be moved out of the 'too hard basket' effectiveness and cost-effectiveness as well as social, ethi- and into active assessment, debate and appraisal. cal and political analyses to explain why ineffective health care practices persist. Only then is there scope to address Another barrier to disinvestment is the notion that medi- how ineffective practices can be disinvested. cal technology has provided good value for money over time, and that regulators' efforts to restrict coverage (or For the clinician there is often concern that disinvestment disinvest) may reduce incentives for investment and inno- represents a blunt instrument of rationing, one that may vation, thereby impeding the future flow of valuable tech- restrict clinical autonomy and reduce patient choice. But nologies [8]. We may need to tolerate a certain level of can continued investment in health care occur without payment for low value or relatively ineffective technolo- thoughtful, measured disinvestment? There is an eco- gies and practices because such is the market environment nomic imperative to do so for the sake of sustainability. that makes possible the valuable medical breakthroughs. There is also an ethical imperative for the delivery of qual- ity health care and a best practice imperative for clinical 4) Lack of published studies that clearly demonstrate that exist- purchasers and providers. Disinvestment will free up ing technologies/practices provide little or no benefit resources for those practices that have demonstrated effec- tiveness. Furthermore, disinvestment should not be seen For many technologies and practices there is evidence sup- as an all or nothing approach. Removing a reimbursement porting varying degrees of effectiveness when used in cer- item number from the Schedule of Medical Benefits (or tain contexts (for example to certain patient groups with the equivalent action in international terms) would be an varying degrees of predictive prognoses). However, there extreme example of successful disinvestment. There may are also examples of inappropriate application of other- wise effective technologies or procedures, culminating in Table 1: Case Study 1 Assisted Reproductive Technologies (ART) for women over 42 years of age ART does not specifically affect morbidity or mortality (with some exceptions). The debate has, and continues, to occur prominently in the broad community as well as government. In 2003, age-specific success rates of In Vitro Fertilisation (IVF) cycles using fresh oocytes were [28]: • 27.7% for women aged 25–29 • 24.9% for women aged 30–34 • 17.1% for women aged 35–39 • 6.8% for women aged 40–44 • 2% for women aged ≥ 42 (some clinics have cited success rates of 5–10%) This success rate for women aged 42 years or more has been cited by one Australian clinic as a reason for refusing to treat women of that age [29]. Politicians have also engaged with this debate. In April 2005 the Australian Government Minister for Health and Ageing considered limiting ART funding under Medicare to three cycles per year for women 42 and under, and to three cycles in total for women over this age [30]. Rising expenditure on ART and the low age-specific success rates were cited as justification for this policy. This proposal for reduced support was subsequently abandoned by the Australian Prime Minister in May 2005. Table 3 further explores some of the methodological issues associated with this as a potential case study in disinvestment. Page 4 of 8 (page number not for citation purposes) Australia and New Zealand Health Policy 2007, 4:23 http://www.anzhealthpolicy.com/content/4/1/23 ineffective care and inefficient resource allocation. Nota- In such cases there may be potential for a 'funding with ble examples of this are presented in the work of Wen- evidence generation' mechanism (also called 'only in nberg, disseminated in the Dartmouth Atlas highlighting research' in the United Kingdom (UK) and 'coverage with geographic variation in the use of a range of procedures evidence development' in the USA). This approach is cur- [9]. Under such conditions a degree of measured retrac- rently applied for some emerging technologies but could tion of practice is desirable, with resultant disinvestment. be adapted for existing practices. Here, payers/regulators Clinical practice modification and refinement techniques, may allow ongoing funding only for a defined period of perhaps via clinical practice guideline development and time to allow for the generation and/or analyses of neces- implementation, have demonstrated efficacy. As noted by sary evidence. Currently there is provision for use of this Miles and co workers, approach with new technologies by the MSAC. clinical practice guidelines remain, when certain conditions 5) Inadequate resources to support a research agenda to are met and their limitations fully understood, useful vehi- advance disinvestment policies and methods cles for implementing agreed changes to clinical practice and service provision. Certainly, the process of deriving and The discussion thus far highlights the need for methodo- implementing clinical practice guidelines has developed logical advances to support disinvestment decision mak- into a science in its own [10]. ing. In Australia, health technology assessment groups conduct and present the synthesised, evidence-based However, for some technologies or practices the evidence reviews that support the MSAC and the PBAC reimburse- for effectiveness is either less clear, or is negative, yet the ment decisions for new and emerging technologies and practice persists. In these instances, partial or complete pharmaceuticals. Health Technology Assessment (HTA) removal (from funding) may be necessary. Substantial incorporates multidisciplinary fields of policy analysis, challenges exist, particularly around adequate and timely and has broadened, "from primarily addressing effectiveness definition and acceptable proof of inferiority. This is not and safety issues to covering a broader array of issues such as only conceptually difficult but also limited by data avail- psychological, organizational, ethical and legal aspects" [13]. ability and interpretation. Further complicating this is the HTA studies the medical, social, ethical, and economic lag that often exists in the reliable reporting of health out- implications of development, diffusion, and use of health comes data based on clinical practice. Table 2 (Case Study technologies, practices and services. HTA agencies 2) presents a case highlighting potential complexities of together with health services and policy researchers gener- 'evidence' in disinvestment review decisions. These, ally, are well positioned to take a lead role in supporting together with considerations from the ART example, are the disinvestment of existing, ineffective health care prac- further addressed in Table 3. tices. To do this effectively requires collaborative research and recently announced funding increases from the Within this context there is scope for expanding the capac- National Health and Medical Research Council ity to conduct primary and secondary research of stand (NHMRC) for Health Services Research offers potential alone and comparative effectiveness for existing as well as here. But in Australia HTA groups largely operate as con- new technologies [11,12]. The disinvestment considera- tract research organisations and with relatively short-term tions highlighted in Table 3 require methodological contracts these groups tend to lack capacity to build or advances but also time for thorough and rigorous review. support a broad methodological research agenda for the Table 2: Case Study 2 Upper airway surgical procedures for adult Obstructive Sleep Apnea (OSA) Approximately one in five adults has at least mild OSA and one in 15 adults has OSA of moderate or worse severity [31]. The condition is an independent risk factor for substantial morbidity(ies) with implications also for mortality [32]. Currently, upper airway surgery is a second-line treatment alternative to an established non-surgical gold-standard. A recent meta-analysis of these surgical procedures reported success rates at [33]: • 13% for Phase I procedures (including uvulopalatopharyngoplasty [UPPP], laser-assisted uvulopalatoplasty [LAUP], hyoid suspension [HS], genioglossus advancement [GA], and radiofrequency volume reduction of soft tissue [RFVR]) • 43% for advanced Phase II procedures (maxilla and/or mandible advancement (MMA) requiring up to three days Intensive Care Unit recovery). • Two reports of patient satisfaction highlight that surgery has a high postoperative morbidity rate, a high patient-reported failure rate and a low level of satisfaction with 53% [34] and 61% [35] patient-reported 'regret' rates. • The Cochrane review in this area [36] supports the restricted use of these operations and yet Australian Medicare data highlights that these procedures are widespread and increasing. Despite the existence of these procedures for over a decade, debate regarding their efficacy has recently intensified, as to whether these success rates presented above represent 'highly effective treatment', sufficient enough to confer improved health outcomes [37-39]. Disagreement has occurred primarily between relevant medical specialties (i.e. surgeons and sleep medicine physicians). Importantly, there has been a lag in presentation of the necessary evidence to inform and advance such a debate, principally as no policy group has been assigned a stake in the collection or generation of such evidence, hereto it has accrued via the noble but ad hoc actions of clinical groups. Page 5 of 8 (page number not for citation purposes) Australia and New Zealand Health Policy 2007, 4:23 http://www.anzhealthpolicy.com/content/4/1/23 Table 3: Investigative issues associated with the chosen health care practices Health Care Setting Interest from methodological and Key Issues Technology/Practice policy perspectives* ART ≥ 42 years of age Clinic or Hospital Harmful x - Marginal clinical and cost-effectiveness (on population Clinically Effective x basis) but limiting its use poses problems: it is highly Cost Effective ? beneficial from perspective of concerned individuals Appropriate ? - Therapy has equivocal purpose Socially Valued √ - Highly valued by recipients and potentially by society Universally Accessible ?/x broadly Ethical ? - Ability to pay: user vs society - Equity of access - Medical vs social infertility - Opportunity cost Upper airway surgery Surgical Theatre Harmful ? - Limiting its use should not, in theory, pose any for adult OSA Clinically Effective ?/x problems, but pressures are strong from clinical interest Effective Alternative √ groups Cost Effective x - Complex practice paradigms/incentives Appropriate ? - Small, homogeneous craft group Necessary ? - Equipoise/clinical uncertainty Socially Valued ?/√ - Perspectives of patients who value the potential of a Ethical ? surgical 'fix' - Is this preference based on sound evidence or supplier induced demand? - Opportunity cost *Key: ? = Unsure or in question; x = Limited or evidence in the negative; √ = Evidence in the positive disinvestment of existing, ineffective health care practices. health research and funding highlighted the challenges This phenomenon is not restricted to Australia, and as faced: Lehoux has observed, the involvement of academic insti- tutions in HTA has the potential to bring with it conflict- The delivery of robust scientific appraisal for technologies is ing legitimacies between the production of traditionally coming under increasing challenge as a result of its reliance scientific versus user-oriented knowledge [8]. With con- on methodologies that, it is widely recognized, need further certed capacity building and research initiatives aimed at development, given that Health Technology Assessment improving linkage and exchange between policy advisors/ (HTA) is a relatively new science. Appropriate research is makers and academic researchers (HTA specialists), prior- required to address these challenges. In particular, research ity driven, contextually relevant research would be facili- into methodology for... disinvestment methods ([23], page tated and could support decision-making processes that 103) policy makers need. Moreover, it would contribute much- needed methodological advances and align with the four In the United States the 'Developing Evidence to Inform main characteristics of action research defined by Hart Decisions about Effectiveness' (DeCIDE) Research Net- and Bond [14]: (1) collaboration between researchers and work has been implemented to support the development practitioners; (2) solution of practical problems; (3) of new scientific knowledge through research on the out- change in practice; and (4) development of theory. comes of health care items and services. This is a clear pol- icy directive in line with Section 1013 of the Medicare Collaborative models amenable to disinvestment strate- Modernization Act of 2003. Wilensky has commented gies are increasingly being developed and adopted inter- that a window of opportunity currently exists in the USA nationally, with some based on the priority setting for the development of a Center for Comparative Effec- developments described by Mooney [15,16]). The strate- tiveness, particularly to address pharmaceuticals [6]. We gic 'Linkage and Exchange' and 'Participatory Action believe the greater challenge is to incorporate the assess- Research' programs in Canada [17-21] deal with similar ment of existing health care practices and technologies, as issues. Recently, the UK's National Institute for Clinical well as pharmaceuticals. Fundamental to this is an Excellence (NICE) announced a formal policy agenda to expanded process of medico-vigilance – monitoring of "purge from the NHS treatments that do not improve health or whether the practice/technology is not only safe but effec- are poor value for money" [22]. It is interesting to note how- tive and cost-effective in 'real' use outside the tightly con- ever that subsequent to the NICE disinvestment agenda trolled environments in which initial evidence may have being released, a formal UK Treasury report into UK been collected. Beyond this the social, ethical and politi- Page 6 of 8 (page number not for citation purposes) Australia and New Zealand Health Policy 2007, 4:23 http://www.anzhealthpolicy.com/content/4/1/23 cal complexities must be accounted for as explicit compo- depend less on the availability of resources than on the nents of any disinvestment analysis. political will to support work in this area. Based on this discussion we present the following recom- Summary mendations of initiatives to be implemented in Australia Australia currently has limited systems in place to support (and internationally where appropriate): the disinvestment of currently used ineffective, or inap- propriately applied, health care practices. With the grow- ♣ Government partnerships to involve the professional ing burden of chronic health conditions, addressing this colleges and relevant stakeholder groups (consumer/com- limitation should be recognised as an emerging national munity) to put disinvestment on the agenda including priority area [24]. This discussion piece is intended to awareness, collaboration and improved health outcome stimulate further debate in this area (see also [25-27]). data generation and reporting (ongoing medico-vigi- The potential over-utilisation of less than effective clinical lance). practices and the potential under-utilisation of effective clinical practices not only result in less than optimal care ♣ Dedicated funds and distinct processes (i.e. transparent but also fragmented, inefficient and unsustainable legal framework) within the MSAC and where appropriate resource allocation. Systematic policy approaches to dis- the PBAC to: investment will improve equity, efficiency, quality and safety of care, as well as sustainability of resource alloca- ❍ Identify technologies and practices for which there is tion. Developing health services and policy research relative uncertainty for disinvestment analysis/review methodologies that tackle these complexities to assist pol- icy-makers will advance the disinvestment agenda. This is ❍ Conduct disinvestment assessments/reviews of the a growing area of priority setting in health care that selected item(s) requires national and international perspectives, debate and collaboration. This should involve an expanded capacity for these com- mittees (or others adopting a similar model) to address Competing interests Adam Elshaug received funding for this project from the existing practices in an analogous manner to their current focus on new and emerging technologies, practices and Faculty of Health Sciences of the University of Adelaide. pharmaceuticals. Professor Hiller is director of Adelaide Health Technology Assessment (AHTA). This organisation is contracted to ❍ At this juncture in Australia's health policy landscape, complete evaluations of health technologies. Assoc Prof collaborative links to advance disinvestment should be Moss provides health technology assessments to the Aus- made between the relevant stakeholder bodies, including: tralian Government Department of Health and Ageing as the MSAC/PBAC, state departments of health, the Austral- a consultant. Dr Tunis is the Founder and Director of the ian Commission on Safety and Quality in Health Care, Center for Medical Technology Policy in San Francisco, the National Institute of Clinical Studies (and the where he consults with health care decision makers and NHMRC more broadly). stakeholders to support the rapid evaluation and effective use of new medical technologies. In all other respects the ♣ For existing health care services for which there is rela- authors declare they have no competing interests. tive uncertainty, consideration for the implementation of 'funding with evidence generation'. That is, ongoing reim- Authors' contributions bursement only agreed for a limited number of years AE conceptualised this paper, completed the first substan- pending evidence generation/review processes – with the tive draft and contributed to subsequent draft revisions. possibility of extensions being considered. JH and JM contributed substantively to subsequent draft revisions. ST contributed an international perspective ♣ Dedicated funding and cross-disciplinary collaboration (primarily USA) and substantive editorial comments on to build health services and policy research capacity with two drafts. All authors read and approved the final manu- a focus on advancing disinvestment research methodolo- script. gies and decision support tools for policy stakeholders. Acknowledgements The authors would like to acknowledge and thank the anonymous review- Disinvestment from existing health care practices that ers for their thoughtful and constructive comments on earlier versions of offer little or no health gain is a policy challenge that this paper. requires greater attention, both for quality of care and sus- tainable resource allocation. Disinvestment may well References 1. White KL: Evidence-Based Medicine. Lancet 1995, 346:837-838. Page 7 of 8 (page number not for citation purposes) Australia and New Zealand Health Policy 2007, 4:23 http://www.anzhealthpolicy.com/content/4/1/23 2. Smith R: Where is the wisdom...? The Poverty of Medical Evi- Statistics Unit; Australian Institute for Health and Welfare (AIHW); Cat. No. dence. BMJ 1991, 303:798-799. per 2006, 31:36. 3. Morgan SG, McMahon M, Mitton C, Roughead E, Kirk R, Kanavos P, 29. Overington C: No age limit on IVF funds: Costello. The Austral- Menon D: Centralized drug review processes in Australia, ian Newspaper :3. 2 January 2006 Canada, New Zealand, and the United kingdom. Health Aff 30. Uren D: Limits on IVF access will put women at risk. The Aus- (Millwood) 2006, 25:337-47. tralian Newspaper :4. 25 April 2005 4. O'Malley SP: The Australian experiment: the use of Evidence 31. Young T, Skatrud J, Peppard P: Risk Factors for Obstructive Based Medicine for the reimbursement of surgical and diag- Sleep Apnea in Adults. JAMA 2004, 291:2013-2016. nostic procedures (1998–2004). Aust New Zealand Health Policy 32. Young T, Peppard P, Gottlieb D: Epidemiology of obstructive 2006, 3:. sleep apnea: A population health perspective. Am J Respir Crit 5. Buchan H: Gaps between best evidence and practice: causes Care Med 2002, 165:1217-1239. for concern. Med J Aust 2004, 180:S48-S49. 33. Elshaug AG, Moss JR, Southcott AM, Hiller JE: Redefining success 6. Wilensky GR: Developing A Center For Comparative Effec- in airway surgery for obstructive sleep apnea: a meta analy- tiveness Information. Health Aff 2006. doi: sis and synthesis of the evidence. Sleep 2007, 30:461-467. 10.1377:hlthaff.25.w572. 34. Jones TM, Earis JE, Calverley PM, De S, Swift AC: Snoring surgery: 7. Schon DA: Beyond the stable state: public and private learning in a chang- a retrospective review. Laryngoscope 2005, 115:2010-5. ing society London: Temple Smith; 1971. 35. Hicklin LA, Tostevin P, Dasan S: Retrospective survey of long- 8. Lehoux P: The Problem of Health Technology: Policy Implications for Mod- term results and patient satisfaction with uvulopalat- ern Health Care Systems New York: Taylor and Francis Group; 2006. opharyngoplasty for snoring. J Laryngol Otol 2000, 114:675-81. 9. Wennberg JE: Unwarranted Variations in Health Care: The 36. Sundaram S, Bridgman SA, Lim J, Lasserson TJ: Surgery for obstruc- Dartmouth Atlas of Health Care. [http://www.dartmouthat tive sleep apnoea. Cochrane Database Syst Rev 2005:CD001004. las.org/index.shtm]. 37. Phillips B: Upper airway surgery does not have a major role in 10. Miles A, Polychronis A, Grey JE: The evidence-based health care the treatment of sleep apnea. Journal of Clinical Sleep Medicine debate – 2006. Where are we now? J Eval Clin Pract 2006, 2005, 1:241-245. 12:239-247. 38. Powell N: Upper airway surgery does have a major role in the 11. Tunis SR: A clinical research strategy to support shared deci- treatment of obstructive sleep apnea: "the tail end of the sion making. Health Aff (Millwood) 2005, 24:180-4. dog". Journal of Clinical Sleep Medicine 2005, 1:236-240. 12. Tunis SR, Pearson SD: Coverage options for promising technol- 39. Elshaug AG, Moss JR, Southcott AM, Hiller JE: An analysis of the ogies: Medicare's 'coverage with evidence development'. evidence-practice continuum: Is surgery for Obstructive Health Aff (Millwood) 2006, 25:1218-30. Sleep Apnoea contraindicated? J Eval Clin Pract 2007, 13:3-9. 13. Draborg E, Gyrd-Hansen D: Time-trends in health technology assessments: an analysis of developments in composition of international health technology assessments from 1989 to 2002. Int J Technol Assess Health Care 2005, 21:492-8. 14. Hart E, Bond M: Action research for health and social care: A guide to prac- tice Philadelphia: Open University Press; 1995. 15. Mooney G: Priority setting in mental health services. Appl Health Econ Health Policy 2002, 1:65-74. 16. Mooney G: Communitarian claims and community capabili- ties: furthering priority setting? Soc Sci Med 2005, 60:247-55. 17. Lomas J: Using 'linkage and exchange' to move research into policy at a Canadian foundation. Health Aff (Millwood) 2000, 19:236-40. 18. Mitton C, Donaldson C: Tools of the trade: a comparative anal- ysis of approaches to priority setting in healthcare. Health Serv Manage Res 2003, 16:96-105. 19. Mitton C, Patten S, Donaldson C, Waldner H: Priority-setting in health authorities: moving beyond the barriers. The Calgary experience. Healthc Q 2005, 8:49-55. 20. Lee RC, Marshall D, Waddell C, Hailey D, Juzwishin D: Health tech- nology assessment, research, and implementation within a health region in Alberta, Canada. Int J Technol Assess Health Care 2003, 19:513-20. 21. Wanke MI, Juzwishin D: International comparison and review of a health technology assessment skills program. Int J Technol Assess Health Care 2005, 21:253-62. 22. Kmietowicz Z: NICE is to root out ineffective treatments in NHS. BMJ 2006, 333:. doi:10.1136/bmj.333.7568.568-a. 23. Cooksey SD: A review of UK health research funding London : Her Maj- esty's Treasury; 2006. 24. Medical Services Advisory Committee: Australian Government Publish with Bio Med Central and every Department of Health and Ageing. In Strengthening evidence- scientist can read your work free of charge based health care in Australia Canberra; 2003. 25. Victorian Government Department of Human Services: Future "BioMed Central will be the most significant development for directions for health technology uptake, diffusion and disin- disseminating the results of biomedical researc h in our lifetime." vestment in Victorian public health services (discussion Sir Paul Nurse, Cancer Research UK paper). 2003 [http://www.health.vic.gov.au/newtech/new-tech- workshop-discussion.pdf]. 21 March,2007 Your research papers will be: 26. Jackson TJ: Health technology assessment in Australia: chal- available free of charge to the entire biomedical community lenges ahead. Med J Aust 2007, 187:262-4. 27. Elshaug AG, Hiller JE, Moss JR: Exploring policymakers' perspec- peer reviewed and published immediately upon acceptance tives on disinvestment from ineffective health care practices. cited in PubMed and archived on PubMed Central Int J Technol Assess Health Care in press. accepted 21/09/2007. 28. Waters A, Dean J, Sullivan E: Assisted reproduction technology yours — you keep the copyright in Australia and New Zealand, 2003. Canberra: National Perinatal BioMedcentral Submit your manuscript here: http://www.biomedcentral.com/info/publishing_adv.asp Page 8 of 8 (page number not for citation purposes)

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