Social values and health priority setting in Australia: an analysis applied to the context of health technology assessment.

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Social values and health priority setting in Australia: An analysis applied to the context of health technology assessment Jennifer A. Whitty a,b,∗ , Peter Littlejohns c a b c

School of Pharmacy, The University of Queensland, St Lucia, Brisbane, Queensland, Australia Population and Social Health Research Program, Griffith Health Institute, Griffith University, Logan, Queensland, Australia Division of Health and Social Care Research, Faculty of Life Sciences and Medicine, King’s College London, UK

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Article history: Received 6 May 2013 Received in revised form 1 September 2014 Accepted 7 September 2014 Keywords: Australia Social values Health technology assessment Health priority setting Resource allocation

a b s t r a c t Objective: To describe the role of social values in priority setting related to health technology assessment processes and decision-making in Australia. Approach: The processes and decision criteria of the Pharmaceutical and Medical Benefits Advisory Committees are described based on literature and policy sources, and analysed using a framework for identifying social values in priority-setting. Findings: Transparency and accountability of processes are apparent. Participation balances inclusiveness and effectiveness of decision-making, but presents an opportunity to enhance priority setting processes. Clinical and cost-effectiveness are important content considerations. Social values related to justice/equity are considered, without quantification of criteria weights for equity relative to other factors. HTA processes support solidarity through subsidising approved technologies for all Australians, whilst retaining autonomy by permitting non-subsidised technologies to be accessed privately, leading to possible tension between the values of solidarity, autonomy and equity. Conclusions: Priority setting related to health technology subsidy incorporates a range of inter-related social values in the processes and content of decision-making. Participation in decision-making could arguably be improved if a patient and public engagement policy were to be formulated alongside more widespread changes across processes to assess social values using approaches such as the Citizens’ Jury. © 2014 Elsevier Ireland Ltd. All rights reserved.

1. Introduction Priority-setting in healthcare decision-making is a necessity. Limited health resources, a steady growth in health expenditure combined with an ageing population,

∗ Corresponding author at: School of Pharmacy, The University of Queensland, Pharmacy Australia Centre of Excellence, 20 Cornwall Street, Woollongabba, Brisbane, QLD 4102, Australia. Tel.: +61 07 334 61978; fax: +61 07 334 61999. E-mail address: [email protected] (J.A. Whitty).

and technological advances, have contributed to this pressure. Perhaps the most prominent examples of prioritysetting processes have been those related to health technologies. Many countries now have a specific and accountable process in place to make recommendations around the availability and public funding of new (and continued use of existing) health technologies, based on the principles of procedural justice [1–3]. Health technology assessment (HTA) has been defined as “a multidisciplinary field of policy analysis” which “studies the medical, social, ethical, and economic implications of development, diffusion, and use of health technology” (emphasis added) [4]. Much of the focus

http://dx.doi.org/10.1016/j.healthpol.2014.09.003 0168-8510/© 2014 Elsevier Ireland Ltd. All rights reserved.

Please cite this article in press as: Whitty JA, Littlejohns P. Social values and health priority setting in Australia: An analysis applied to the context of health technology assessment. Health Policy (2014), http://dx.doi.org/10.1016/j.healthpol.2014.09.003

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of HTA during its establishment has been on the medical and economic implications of decisions around technologies. However, there is an increasing recognition of the importance of the social and ethical implications of health technology decision-making for society. Historically, Australia has been at the forefront of the establishment of priority-setting processes globally; particularly those related to HTA and decision-making [5]. Australia has a two stage process for assessing health technologies. The first stage relates to marketing approval; this has been undertaken since the 1970s by the Therapeutic Good Administration (TGA) [5], based on an appraisal of the safety, efficacy and quality of pharmaceuticals and medical devices. After TGA approval, a pharmaceutical or medical device can be marketed in Australia and supplied as a private prescription or service, but is not yet subsidised by the Government. Separate processes make recommendations around Government subsidy. The Pharmaceutical Benefits Advisory Committee (PBAC) was established in 1954 to make recommendations to the Minister for Health and Ageing (now the Minister for Health) on which pharmaceuticals should be subsidised under the Pharmaceutical Benefits Scheme (PBS) [6]. Non-pharmaceutical technologies have been assessed by a range of Committees, most notably The National Health Technology Advisory Panel, which was established in 1982, and later subsumed by the Australian Health Technology Advisory Committee (in 1990) and then by the Medical Services Advisory Committee (MSAC) since 1998. Whilst these marketing and subsidy stages were historically sequential, recent changes have supported concurrent assessment by the TGA and either the PBAC or MSAC, to reduce any delays in the time to subsidy [7]. The PBAC in Australia was the first HTA process to consider evidence on cost-effectiveness in its recommendations when this became a mandatory requirement in 1993 [5,8,9]. In 1998, the creation of a parallel HTA process for new medical services required evidence of sufficient cost-effectiveness alongside safety and effectiveness to support recommendations by the MSAC [10], and many countries now similarly use economic evaluation methods to assess the value of health care interventions [11]. A value-based pricing approach, now being implemented in the United Kingdom (UK) [12], has formed the basis of reference-based pharmaceutical pricing policy in Australia for many years. It is clear that clinical and economic evidence is carefully considered in decision-making around the subsidy of health technologies in Australia [13–16]. However, what constitutes value is likely to extend beyond the measures of clinical benefit that are conventionally assessed in clinical trials [17] and included in an economic evaluation; exactly what characteristics of a technology should be considered when assessing value is a normative decision for societal consideration [1]. It is much less clear whether, and to what extent, desirable characteristics of a health technology other than clinical and cost-effectiveness might be considered in assessing the overall societal value that might be associated with a new technology. Several recent policy reviews in Australia have placed an explicit focus on the importance of engaging the general

public and patients and considering their preferences in healthcare priority-setting. In 2008, the Prime Minister and Minister for Health and Ageing established a National Health and Hospitals Reform Commission; their remit was to develop a longterm health reform plan [18]. Their final report made 123 reform recommendations and reaffirmed the need for the publically funded health system to “deliver the best health outcomes, while reflecting the values and priorities of the community” (Recommendation 2) [18]. The Commission highlighted the need for a “systematic mechanism to formulating health care priorities that incorporates clinical, economic and community perspectives through vehicles like citizen juries” (Recommendation 93). At a similar time, the Australian Government Department of Health and Ageing, now known as the Department of Health (DoH) reviewed HTA processes in Australia, and emphasised the importance of “encouraging a consumer and patient focus without increasing regulatory burden” [19]. Thus, social values are considered to be an important consideration for priority-setting in Australia. In 2012, a themed issue of the Journal of Health Organisation and Management focussed on social values and healthcare priority-setting. One of the key papers in this journal was Clark and Weale’s conceptual framework for the analysis of social values relating to the process and content of priority-setting decisions [20]. This framework has been used to review the association between social values and health technology decision-making in Thailand [21], Korea [22], China [23], England [24], Germany [25], the USA [26] and Latin America [27]. However, despite Australia’s early involvement and relative prominence in the establishment of priority setting processes globally, only limited attention has been given to the application of social values in health priority setting decisions in Australia [11,28]. This paper describes the role of social values in priority setting in Australia, as they relate to health technology assessment (HTA) processes and decision-making. We use Clark and Weale’s conceptual framework to describe the values of decision-making in Australia [20]. Other frameworks promoting fair priority setting processes are available, the most widely known being Daniels and Sabin’s Accountability for Reasonableness Framework [2,3]. Clark and Weales’ Framework considered Daniels and Sabin’s Framework in its development [20], and is applied here as it has an explicit focus on social values that extends to the content as well as the process of decision-making.

2. Methods and approach The processes and decision criteria of the PBAC and MSAC are described and analysed against Clark and Weale’s framework for identifying social values in priority-setting. As the State and Territory Governments are principally responsible for the provision of public hospital and health services, priority setting related to HTA also occurs at a state level. However, much less is generally known about these processes [5] and there is potential variability between states. Therefore, this descriptive analysis will focus on the more substantial national level processes of the PBAC and MSAC.



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Table 1 Clark and Weale’s Framework of analysis for social values and health priority setting. Dimension and characteristic

Related social values

The process of decision-making

Transparency Accountability Participation

Institutional setting Rules of decision making Accountability for decisions Participation in decision-making The content of decision-making

Clinical effectiveness Cost effectiveness Justice/equity Solidarity Autonomy

Cost and clinical effectiveness Social value judgements Cost-sharing

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3. Findings: social values and priority-setting for the Australian community The institutional setting for the PBAC and MSAC processes in Australia is described in the Supplementary Appendix, to provide important context to assist the reader who may be unfamiliar with the Australian health system. In this section, we describe the role of the seven social values included in Clark and Weale’s Framework [20], using the two overall dimensions of “process” and “content” of decision-making. Following presentation of our findings, we then discuss the implication of our findings for the application of social values in priority setting in Australia. 3.1. Dimension 1: values related to the process of decision-making

Adapted from Clark and Weale [20].

The term “social values” refers to those values that are considered important by the society that is affected by the decision-making process. Clark and Weale present a conceptual framework for describing the role of social values in priority setting [20]. They outlined the key process and content values in health priority setting, and applied a normative analysis to identify the key features and interaction between these values. Their framework of analysis for social values and health priority setting consists of two domains; the processes and the content of decision making (Table 1). Each domain has a number of characteristics which are described. The process of decision-making considers the institutional setting, rules of decision making, accountability for decisions, and participation in decision making. Clark and Weale consider that outlining and analysing these characteristics for any single priority setting process provides insights into the interrelated process social values of transparency, accountability and participation. The content of decision-making considers the role of cost and clinical effectiveness, social value judgements and cost-sharing in decision making. Clark and Weale consider these characteristics reveal information on the social values of clinical and cost effectiveness, justice/equity, solidarity and autonomy. We use Clark and Weale’s conceptual framework to describe how decisions on health priority setting are made by the PBAC and MSAC, mapping this against the eight social values under the two overall dimensions of “process” and “content” of decision-making [20]. The descriptive analysis was principally informed by two information sources: (1) a search of the published literature in August 2014, to identify key sources on the PBAC and MSAC processes, and the potential role of social values in PBAC and MSAC processes and recommendations; and (2) a search of the PBAC, MSAC and DoH websites in August 2014, to identify key policy documents providing insights into the application of social values in decision-making. These key information sources were used alongside the broader literature on social values in priority setting to describe the role of social values in health technology priority setting policy, processes and decisions in Australia.

3.1.1. Transparency Clark and Weale emphasise the importance of transparency in decisions and, to support the legitimacy of decisions, of transparency in the reasoning and criteria underlying decisions. The PBAC and MSAC publish extensive guidelines detailing the evidential requirements for listing submissions and outlining a range of decision criteria that are relevant for their considerations (these criteria are discussed under content values) [13,29]. The MSAC has published it’s assessment reports and a one page summary since it’s establishment in 1998. The PBAC do not publish submissions or commentaries evaluating the submissions. However, since 2005, an individual Public Summary Document has been published on the DoH website for each pharmaceutical considered for inclusion. The Public Summary Document provides a summary of the requested listing, evidence considered, the Committee’s recommendation and its basis. Thus, the decision is transparent. However, the PBAC is bound by confidentiality clauses in the Australian National Health Act 1953, leading to submissions and data provided by the sponsor being treated as “Commercial in Confidence” [5]. Thus, although at the process level the criteria underlying decisions have been explicitly stated in Guidelines, there are some limitations in transparency of the underlying evidence base and rationale for individual decisions, as the public summary document is unable to publish confidential data supporting the decision. Clark and Weale also emphasise the need for an iterative process in which “to uphold the value of transparency, decisions should be revised openly”. Following the enactment of the Australia-USA Free Trade Agreement in 2005, the PBAC introduced a mechanism to request an independent review of their decisions [30]. Any applicant whose submission to the PBAC has not resulted in a positive recommendation to list or extend the indication of the pharmaceutical on the PBS can make a submission to the Independent Review process, which is managed by a Convenor [31]. The MSAC does not have a specific independent review process [19], which suggests that the only potential course of action open to applicants to seek review of a recommendation is a resubmission.



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3.1.2. Accountability Clark and Weale describe being accountable in health priority setting as having the obligation to answer questions regarding decisions about which interventions are prioritised and why [20]. They raise three questions in relation to accountability: who is accountable and does the holding to account; what are they accountable for; and how are they accountable, both for decisions and their justification. In regards to who is accountable, both the PBAC and MSAC are advisory; the Minister for Health is the final decision-maker. In the case of the PBAC, the Minister can decide not to list a pharmaceutical on the PBS even when the PBAC has recommended listing. This has occurred infrequently; although, one example was the refusal to list sildenafil on the PBS for erectile dysfunction in 2002, despite a positive recommendation from the PBAC [32]. The Minister cannot list a product without a positive recommendation from the PBAC [6,33]; however, there are examples where the Minister has established a separate funding programme when a positive recommendation was not given (such as trastuzumab for selected indications in breast cancer) [32]. Although the PBAC does not operate within a fixed budget, financial impact to the PBS is considered in decision-making [6,34]. Approval of the Cabinet is required for any listing that is expected to increase the cost to either the National Immunisation Programme (NIP) or PBS by $10 million or more in any of the first four years of listing (PBAC Guidelines [p. 229 13, 35]). Thus, the PBAC and MSAC are accountable for recommendations, and the Minister and Cabinet are accountable for decisions. The PBAC, MSAC and Minister are accountable to groups who have a stake in the subsidy of health technologies, including the public and patients, health professionals, and the pharmaceutical and medical devices industries. It is these groups who are most likely to hold the PBAC, MSAC and Minister to account. Media pressure has been used as a conduit to hold decision-makers to account [36]. Industry has challenged decisions though judicial review [28]. The PBAC, MSAC and Minister are accountable for the public funds raised through taxation, which are used to support the PBS and MBS, and by extension, for the sustainability of the PBS and MBS into the future. As highlighted by Clark and Weale [20], they are also accountable for the value judgements that are either implicitly or explicitly made in decision-making. In regards to how decision-makers are accountable, this is closely linked to transparency and occurs in two ways [20]. Firstly, the PBAC and MSAC are accountable for providing information on decisions (i.e. through the provision of public summary documents). Secondly, they are also held to account as described by Clark and Weale for providing explanation and justification of their decisions, which might involve a two-way dialogue with stakeholders when explanation and justification is requested and offered. A two-way dialogue occurs during multiple stages of the assessment process, with draft reports sent to applicants for comment. Unlike the PBAC, the MSAC meeting minutes are routinely published and made publicly available.

3.1.3. Participation Clark and Weale raise three largely normative questions in relation to participation; why is it a value, who should participate, and how is effective participation conducted. In the Australian context, members of both the PBAC and MSAC consist of a range of professionals predominantly with clinical, epidemiological and/or health economic expertise. Each committee includes a consumer advocate. Thus, the committees could be said to be trying to balance inclusiveness with effectiveness of decisionmaking [20]. During the assessment process, the processes of both the PBAC and MSAC seek engagement from stakeholders and invite comment at all stages. This is sought via the websites, and through advocacy groups such as patient support groups and craft associations for health professionals for specific technologies. However, despite the key principle of HTA to be consultative and reflective of Australian community values [19], it could be argued that only the most proactive members of the general public or those interested in a specific topic are likely to provide input to the HTA processes. Whether this is an ideal approach to eliciting community values is a normative question. Australian HTA decision-makers do not have a formal and systematic approach to eliciting social values from the general public, akin to the Citizens’ Council approach utilised by the National Institute for Health and Care Excellence (NICE) in England and Wales. Committee members consider and deliberate the detailed evidence provided by the submission, independent academic groups who review each submission, and stakeholder responses, when making their recommendation. Participation in the initiation of a technology assessment is also an important consideration–without initiation, there is no priority setting decision to make. Anyone can make a submission for consideration of a technology for inclusion in either the PBS or MBS [37]. Until recently there was no financial fee to make a submission. However, in 2010 a cost recovery fee (AU$128,056 per submission for a new pharmaceutical or indication at 1 July 2014) was introduced into the PBS processes [38]; exemptions are applied in some circumstances notably for applications related to orphan drugs [39]. There is no direct fee for submission to the MSAC [40]. Applicants to MSAC can choose from one of two assessment pathways; either undertaking the technology evaluation and compiling evidence themselves at their own cost, or requesting the DoH to contract the evaluation to an independent consultant at a cost to the government (estimated to be approximately AU$150,000). Whilst this latter pathway has no direct cost for the applicant; the assessment schedule timing is potentially restricted. In practice, the evidence and resource requirements associated with a submission mean it is usually the manufacturer or in the case of the MBS occasionally a craft group who sponsor a technology [6,41]. The capacity of patient or public groups to initiate an assessment or review is arguably limited. The PBAC and MSAC processes do not at this time have a specific patient and public involvement policy or systematic structure for assessing social values around priority-setting. However, the emphasis placed on public engagement in the recent health reform recommendations




in Australia [18,19] may serve to drive the development of such a policy for HTA processes in Australia. 3.2. Dimension 2: values related to the content of decision-making 3.2.1. Clinical effectiveness Comparative clinical effectiveness is important to the PBAC and MSAC when making recommendations around health technology subsidy. The PBAC and new draft MSAC Guidelines are largely aligned in that they are both divided into six sections (A to F), requiring information and evidence on the context of the submission, primary clinical evidence, premodelling studies to translate the primary evidence to the context for the submission, an economic evaluation, budgetary implications, and other relevant information for decision-making including evidence related to social values [13,29]. The guidance is detailed and prescriptive, but does not include a standard methodological reference case. Clinical effectiveness is assessed relative to a comparator, defined as the therapy or service that is most likely to be replaced with the proposed pharmaceutical or service if it is subsidised [Section A of Guidelines 13, 29]. Where a comparative net clinical benefit is claimed, an economic evaluation can be presented to support a request for a higher price [Section D of Guidelines 13, 29]. Therefore, if a gain in comparative health benefit is considered to be associated with innovation, this value based pricing system can be considered to implicitly place a value on innovative as compared to established interventions. Clark and Weale highlight the importance of balancing a reduction in uncertainty around the clinical effectiveness (e.g. by collecting further clinical evidence) with a need to avoid an unreasonable delay to listing [20]. The PBAC has introduced a managed entry scheme to achieve this [42]. When there is uncertainty in the clinical or cost-effectiveness of a service, the MSAC can recommend interim funding with data collection to inform a re-assessment [37]. 3.2.2. Cost effectiveness Australian priority-setting processes have been innovators in placing a strong and explicit emphasis on value for money as a decision criterion. Indeed, the Australian Government explicitly emphasises cost-effectiveness as an important consideration with its vision for HTA at a national level: “Australians have timely, equitable and affordable access to the cost-effective health technologies needed to manage their health” [43]. Both the PBAC and MSAC consider comparative cost-effectiveness in their decision-making; the PBAC is required to do so by law [33]. Use of the quality adjusted life year (QALY) as an outcome measure is encouraged, but not mandatory [29,44]. The use of the QALY is consistent with the approach taken by many health technology priority setting processes globally [11], but is necessarily associated with the acceptance of a number of implicit value judgements and related challenges, which have been outlined elsewhere [20,45,46]. A key concern is the possible limitation in drawing fair conclusions when comparing technologies or competing

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sources for funding, resulting from the lack of comparability of a range of different methodological approaches and preference populations used to derive the QALY [20,44,47]. Inconsistency in the methodological approaches employed in funding submissions to the PBAC has been reported [44,47]. Neither the PBAC nor MSAC operate within a fixed budget, and neither explicitly state a cost-effectiveness threshold for their decision-making. Nevertheless, studies reviewing past PBAC decisions [14,15] or eliciting the stated preferences of members of the PBAC and it’s economics subcommittee [16] suggest there is an implicit threshold range that might be considered to provide acceptable value for money, and confirm that other criteria such as severity of illness are important considerations alongside cost-effectiveness. Whilst other factors are clearly considered, these supplement rather than substitute for evidence-based considerations of comparative clinical and cost-effectiveness [48]. No information is specified in the Guidelines to indicate the relative weight or importance of different criteria to the PBAC or MSAC recommendation. Indeed, the PBAC acknowledge that it’s decision-making processes are reflective and evolving over time. The PBAC declare that individual factors are not weighted equally in their decision-making process, with different criteria having a different level of importance in different situations; “in other words, the importance of any particular factor cannot be quantified” [PBAC Guidelines p. 36; 13]. 3.2.3. Justice/equity Clark and Weale outline a number of considerations in the content of decisions that relate to justice or equity. Some of the criteria that might potentially be considered here are controversial, such as an individual’s contribution to society (in terms of labour or carer status); the age of patients which can be linked to arguments related to “fair innings” [49] or productivity; and lifestyle choices which can be related to an individual’s risk-taking attitudes and responsibility for their own illness. As highlighted by Clark and Weale [20], the issue of equity and social value judgements is complex, as many of these characteristics can be thought of as equity criteria, but may also be related to capacity to benefit in terms of a health improvement from an intervention. The majority of the PBAC and MSAC submission guidelines focus on the clinical and economic evidence [13,29]. However, there are a range of other decision criteria potentially related to equity that are important considerations for PBAC and MSAC (Box 1) [PBAC Guidelines Section F and Appendix 2; MSAC draft Guidelines Section F and Appendix 1; 13, 29]. Sponsors are invited to submit evidence supporting these additional considerations. The range of relevant criteria suggests that the PBAC and MSAC recognise the importance of social values broadly and justice/equity specifically in their decision-making. Nevertheless, there is generally little explicit information available on how these social values are derived, how they are considered in decision-making relative to clinical and cost-effectiveness, or what contexts might engender particular values such as equity to be considered.



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Box 1 Criteria considered by PBAC and MSAC in decisionmaking

Box 2 Example applications of the Rule of Rescue by PBAC resulting in a positive recommendation

• • • •

• Sapropterin for the treatment of hyperphenylalanaemia in patients demonstrated to have tetrahydrobiopterin deficiency (November 2012) [85]. • Dasatinib for the treatment of acute lymphobastic leukaemia, expressing the Philadelphia chromosome or transcript BCR-ABL kinase, who are resistant to or intolerant of prior therapy (July 2007) [85]. • Riluzole for the treatment of amyotrophic lateral sclerosis (March 2003, Amended restriction November 2006) [6,85,86]. • Imatinib for the treatment of chronic myeloid leukaemia and gastrointestinal stromal disorders (September 2003) [85]. • Imatinib for the treatment of accelerated and blast phases of chronic myeloid leukaemia (September 2001) [6,86].

• • • • • • •

-

Comparative health gain (effectiveness, safety) Comparative cost effectiveness Patient affordability in absence of PBS/MBS subsidy Financial implications for PBS, MBS and government health budgets Severity of medical condition treated Presence of effective alternatives Ability to target therapy to those likely to benefit most Uncertainty Equity (including affordable access and equity assumptions implicit in the economic evaluation) Development of resistance (antimicrobial agents) “Rule of Rescue” – may be favourable to listing as a supplement to other considerations in exceptional circumstances, where all of the following apply: No alternative treatment exists in Australia Condition is severe, progressive and expected to lead to premature death Condition applies to only a very small number of patient The proposed drug provides a worthwhile clinical improvement sufficient to qualify as a rescue from the medical condition

(The more severe the condition, younger the age at which a person might die, closer a person with the condition is to death, fewer the patients, or greater the rescue, the more influential the rule of rescue might be). Source: PBAC Guidelines 2013 [Section F and Appendix 2; 13] and MSAC draft revised Guidelines 2013 [Section F and Appendix 1; 29]

One notable social value included in the PBAC’s decision criteria is the “Rule of Rescue”. This term was created to describe a perceived imperative to rescue individuals who are identifiable when they face avoidable death, with disregard for the opportunity costs of doing so [50]. The PBAC operationalises the Rule of Rescue to apply for pharmaceuticals that provide a worthwhile clinical benefit for a rare, severe condition with no alternative treatment [51]. Thus, the concept is related to justice in redressing inequalities in Clark and Weale’s framework [20], by prioritising those that are worse off in terms of health and who are disadvantaged by having a rare condition (for which there might be less commercial imperative to develop treatments). However, there are few recorded examples where its application in decision-making has led to a positive recommendation (Box 2). The PBAC was the first HTA Committee to explicitly include the Rule of Rescue in decision-making [52]. The MSAC has adopted the Rule of Rescue as a decision criterion in the 2013 draft revision to their Guidelines [29] (awaiting release of a final version as at August 2014 [53]); it was not explicitly included in their previous 2005 Guidelines [54,55]. Other organisations now allow factors related to the Rule of Rescue to offset value for money in some circumstances. Notably, NICE will

Dates represent PBAC meeting dates.

permit a higher cost-effectiveness threshold for end-of-life technologies [52]. In addition to providing advice related to the listing of pharmaceuticals on the PBS, the PBAC also provide advice on the inclusion of pharmaceuticals on the Life Saving Drugs Programme (LSDP), which is currently under Ministerial Review [56]. This is an alternative administrative arrangement for access to pharmaceuticals, that aims to provide subsidised access to expensive and life-saving drugs for serious and rare medical conditions [57]. There are eight criteria for a pharmaceutical to be funded under the LSDP, all of which must apply [57]. These criteria include acceptable evidence that the disease causes a significant reduction in age-specific life expectancy and that a patient’s lifespan is predicted to be substantially extended as a consequence of the pharmaceutical, that the pharmaceutical is clinically effective but rejected for PBS listing because it fails to reach the required cost-effectiveness criteria, lack of a suitable alternative pharmaceutical on the PBS or therapeutic modality, and the cost of the pharmaceutical would constitute an unreasonable financial burden for the patient or their guardian. Thus, the LSDP applies when a pharmaceutical for a rare condition with likely substantial impact on life expectancy fails to be considered to have acceptable cost-effectiveness, a legal requirement for the PBS, and applies similar social values and equity principles to the “Rule of Rescue” criteria in this circumstance. It provides a potential funding arrangement for orphan drugs. As well as considering principles related to justice and equity as content for decision-making at the individual technology decision level, Clark and Weale’s framework also applies the idea of justice to how healthcare (and in this case health technology) is financed, and the implications for social or health inequalities [20]. Australia optimises equity in healthcare financing through progressive taxation (the Medicare Levy and related exemptions and surcharges depend on income and private insurance status [58]) and




the availability of supplementary private health insurance schemes that are community rather than risk based [59]. There are substantial out of pocket costs [60], which are potentially inequitable as the highest financial burden is borne by those with poorest health and the socioeconomically disadvantaged [61,62]. The value of justice/equity overlaps with solidarity, which is discussed next.

3.2.4. Solidarity Clark and Weale consider the content value of solidarity to imply a commitment that “all members of society will stand together and will not leave anyone behind, no matter how needy or disadvantaged”, and extend this concept to include the sharing of financial risk for healthcare through membership of a welfare or insurance package [20]. More generally, they also apply it to decisions where priority is given to those who are worse-off in terms of their health–that is, the more severely ill. Hence, this concept overlaps with the content value of justice/equity, and the consideration of severity of illness, as occurs for PBAC and MSAC recommendations [13,14,16,29], suggests some degree of the social value of solidarity is applied in priority setting. Clark and Weale highlight the issue of cost-sharing or co-payment to be central to the application of the value of solidarity in priority setting [20]. Whilst Australia has a universal health care system, services are not always free at the point of delivery, and there can be substantial gaps and out of pocket expenses, including for pharmaceuticals and other health technologies [60]. This can be associated with substantial financial burden for consumers [63,64]. The co-payment for PBS items is relatively high compared to co-payments for medicines in other countries including Canada, New Zealand and the UK [65]. The co-payment is mitigated to some extent for those who are worse off in terms of health, by an annual PBS safety net threshold which is family based (AU$1421.20, or AU$360.00 for concession card holders, at 1 August 2014) [66,67]. There are also special access and funding schemes in place to address barriers experienced by Aboriginal and Torres Strait Islander peoples with chronic illness and those living in remote areas of Australia; eligible Australians can receive medicines under these schemes without a copayment (consistent with the justice/equity principle of addressing inequality) [68–70]. These special cost sharing arrangements indicate social values, and in particular those related to justice/equity and solidarity, can be applied to programme access as a whole as well as to listing decisions. However, these co-payment and cost-sharing considerations relate to the MBS and PBS schemes more broadly, and not HTA specifically. Nevertheless, there are issues of solidarity specific to HTA in Australia that sit within Clark and Weale’s framework. Notably, individuals can by-pass the potential subsidy barriers by paying privately outof-pocket to access technologies that are not subsidised under the public schemes. Further, new technologies may diffuse more rapidly in the private sector, leading to differences in access according to socioeconomic status [71,72]. This threatens the solidarity of the HTA system and raises

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concerns over equity of access to health technologies in Australia [73,74]. 3.2.5. Autonomy The final content value in Clark and Weale’s framework concentrates on the degree to which individuals are able to be self-directed and make their own decisions in healthcare [20]. Clark and Weale refer to several potential conflicts between autonomy, solidarity and justice/equity. However, we note here that the Australian system could potentially be seen as supporting a balance of autonomy with other competing values through the PBAC and MSAC assessment and recommendation processes themselves. These processes prioritise the public funding of technologies ensuring those that are considered to be of acceptable cost-effectiveness are available for all Australians, whilst still permitting non-listed technologies to be accessed by choice privately in a more market driven approach. Nevertheless, this latter point conflicts with the social values of solidarity and equity, leading to possible tension between these values as raised by Clark and Weale. 4. Discussion Priority setting processes for the subsidy of health technologies in Australia incorporate, either explicitly or implicitly, a range of social values related to both the process and the content of decision-making. As anticipated by Clark and Weale [20], our analysis finds overlap between the values included in their framework. Transparency is closely linked to accountability; a desire to achieve both is apparent in Australian health technology priority-setting processes and decision-making. However, the commercial-in-confidence nature of assessments may limit the capacity of the system to achieve complete transparency of the underlying reasons for decisions. Compared to a previous study published in 2006 in which Mitton and colleagues evaluated Australian PBAC processes against the Accountability for Reasonableness Framework [3,28], the transparency and accountability of PBAC processes has improved. However, the value of participation was not explicitly explored in this previous study and appears to present an opportunity for further enhancement of processes in Australia. Australian HTA processes seem to strive for a balance between inclusiveness and effectiveness in decision-making; both important considerations. However, whilst stakeholder engagement is strong, proactive participation by the public is less apparent. Participation in decision-making could arguably be improved if a patient and public engagement policy were to be formulated across all HTA processes in Australia, as well as more widespread changes across HTA processes to assess community values around technology assessment using approaches such as the Citizens’ Jury that have been implemented with some success in other jurisdictions [75]. Recent policy reviews have recognised the need to develop a systematic and transparent process for considering social values in priority setting, alongside the clinical and economic evidence [18]. Previous studies have established a range of social values are important to Australian society in the context of priority setting [16,76–79]. We



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should continue to develop our understanding of the relative importance of these values in priority setting decisions to both Australian society and decision-makers, to support an assessment of the extent to which decisions reflect community values and the implementation of such a process in Australia [16]. Importantly, our analysis suggests there is a need to consider how these values might be incorporated in priority setting processes and decision-making. NICE has arguably been a world-leader in considering social values in their HTA processes, through establishment of a Citizens’ Council, based on a similar approach to that used in a Citizens’ Jury. Might this provide an appropriate mechanism for exploring and considering social values in Australia? Reform recommendations in Australia have named Citizens’ Juries as one potential approach to engaging the public [18]. Deliberative engagement processes such as the Citizens’ Jury can be resource intensive to run, in terms of financial and administrative support and expertise. However, substantial public funds are expended on health technologies and medical services through the MBS (AU$18.6 billion in 2011/12) and PBS (AU$8.4 billion in 2011/12) [80]. Therefore, establishment of such a process in Australia would seem a reasonable approach to support the process values of transparency, accountability and participation, and to encourage legitimate decisionmaking that is aligned with community values. One single Citizens’ Jury process could be established across the multiple HTA processes in Australia, since social values are unlikely to vary substantially across the technologies under consideration. The marginal cost of running such an engagement process, whether accrued to Government or passed on to industry, is likely to be small relative to the cost recovery submission fee of AU$128,056 to consider a single pharmaceutical for listing on the PBS (with approximately 80 major submissions considered for listing per year [81]). The content values of clinical and cost-effectiveness are clearly and explicitly important in decision-making in Australia. Other values related to justice/equity, such as the “rule of rescue” and reducing health inequality in society are also important. The experience of decision-makers in Australia suggests it is difficult and/or perceived as undesirable to quantify the relative importance of values across technologies or contexts. This reinforces the need for a deliberative decision-making process and would seem to indicate a possible mismatch between the needs of the health technology decision-maker and current attempts to quantify decision weights to support HTA recommendations (e.g. [76,79,82]). Nevertheless, combined deliberative and weighting approaches that individualise core social value criteria weights to specific technologies, for example through multi-criteria decision analysis, might provide an appropriate systematic approach to considering social values in HTA decision-making [83]. We do not seek to present a systematic review of either the published literature or policy in this area, or a direct comparison across countries. There is the potential that we have missed relevant literature or policy in Australia; this could be considered a limitation of this study. However, we do seek to comprehensively describe national health technology assessment processes in Australia, against an

established framework for analysing social values in health priority setting. This framework has previously been used to analyse social values in a number of other countries. By applying this framework to health technology assessment processes in Australia, we seek to contribute to the growing understanding and international research agenda into the breadth of consideration of social values in priority setting [84]. Declaration JW was previously a member of an independent academic group contracted by the DoH to undertake evaluations of submissions for the listing of pharmaceuticals and other health technologies on the PBS and MBS and has previously been contracted by the DoH to provide advice on review of existing items on the MBS. JW has also been the recipient of a Fellowship funded by the Queensland Government and Queensland Health to explore community preferences for HTA decision criteria and to provide evaluations within their HTA processes. This article contains the personal opinions of the authors and does not reflect, in any way, the views of the DoH, the Pharmaceutical or Medical Benefits Advisory Committees, or the Australian or Queensland governments. Conflict of interest The authors are not aware of any conflicts of interest directly related to this manuscript. Acknowledgements The authors are grateful to Xanthe Golenko for assistance with website reviews and to Professor Paul Scuffham and Professor Albert Weale for reviewing an initial draft of this paper. Appendix A. Supplementary data Supplementary data associated with this article can be found, in the online version, at http://dx.doi.org/10.1016/ j.healthpol.2014.09.003. References [1] Rawlins MD. Pharmacopolitics and deliberative democracy. Clinical Medicine 2005;5:471–5. [2] Daniels N. Accountability for reasonableness: establishing a fair process for priority setting is easier than agreeing on principles. British Medical Journal 2000;321:1300–1. [3] Daniels N, Sabin J. Setting limits fairly: can we learn to share medical resources? New York: Oxford University Press, Inc.; 2002. [4] International Network of Agencies for Health Technology Assessment (INAHTA). HTA resources. International Network of Agencies for Health Technology Assessment (INAHTA); 2013. Available from: http://www.inahta.net/ [accessed 15.04.13]. [5] Hailey D. The history of health technology assessment in Australia. International Journal of Technology Assessment in Health Care 2009;25(Suppl. 1):61–7. [6] Sansom L. The subsidy of pharmaceuticals in Australia: processes and challenges. Australian Health Review 2004;28:194–205. [7] Department of Health and Ageing. Framework for the introduction of parallel TGA and PBAC processes. Australian Government; 2013. Available from: http://www.pbs.gov.au/info/




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Jennifer A. Whitty is Associate Professor with the School of Pharmacy, University of Queensland, and holds an Adjunct position with the Centre for Applied Health Economics, School of Medicine, Griffith University. She has extensive research expertise in measuring patient, community and decision-maker preferences and choices around health care. Her research interests also include valuing quality of life, applied health economic evaluation, pharmacoeconomics and health technology assessment and decision-making. Peter Littlejohns is Professor of Public Health at King’s College London. In the past he was Director of the NHS R&D funded Healthcare Evaluation Unit at St Georges, University of London and Chief Scientist on a European project, which developed the AGREE critical appraisal instrument for clinical guidelines. Between 1999 and 2012 he was the founding Clinical and Public Health Director of the National Institute for Health and Care Excellence (NICE). He is a Fellow of the Royal College of Physicians, the Faculty of Public Health and the Royal College of General Practitioners. He is currently leading an international research programme addressing the role of “values” in the fair allocation of health care resources.


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