The Evolution of HTA in Emerging Markets Health-Care ... - TREE

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OHE Consulting Report for PhRMA 5 January 2011 degree of innovation by an examination of relative efficacy and then to use reference pricing to establish a price for the product. Figure 12: The “natural” history of HTA development The set of methods and approaches to clinical and economic evaluation that have come to comprise HTA in developed economies developed alongside (and were shaped by) the particular context and issues encountered in those health systems. The UK NICE, for example, could be thought of as a particular response to issues relevant to the English NHS. The NHS is characterised by public funding, with most health care being ‘free at the point of demand’, but with an increasing shift toward private sector provision. Developing economies and emerging markets typically comprise more complex and varied financing and provision arrangements, and are likely to have different sorts of issues. There is more likely to be a mix of public and private involvement in both financing as well as provision of health care. The way in which the private and public sectors arrangements interact may create specific challenges for the role of HTA. For example, in Brazil it is not clear how the use of HTA by CITEC impacts on the private sector. However, the HTA methods and processes they are likely to consider adopting come ‘fully formed’ – NICE’s processes, for example, have been particularly effectively disseminated. In Taiwan there is use of drug appraisals by NICE and other HTA bodies around the world, although it is not clear exactly how they are used and combined to reach a conclusion. While NICE’s approach to technical appraisal may well be appropriate to some emerging markets, simply transferring those outcomes or indeed those processes in toto raises challenges in terms of local data, expertise, and resourcing (Chalkidou et al., 2010). Moreover, there is a risk that simply adopting influential HTA processes developed elsewhere leads HTA down a path which does not meet the particular needs of local health care systems, and does not reflect locally-‐relevant values and priorities. While there have been attempts to develop key principles for the conduct of HTA (Drummond et al., 2008), there is a lack of consensus among HTA organisations internationally about the importance or relevance of some of these principles (Neumann et al., 2010), as we discuss below. What is clear is that before adopting HTA, countries should be clear about the problems which HTA is intended to address, and should develop or adapt HTA processes to achieve that. 60
OHE Consulting Report for PhRMA 5 January 2011 The sort of HTA processes which are suggested may be different in each case, depending on the particular issues evident in the health care system. For example, in Brazil, the cost-‐effectiveness of services is relevant to addressing resource allocation in the public system and in providing a basis for modifying expectations about entitlement to care. In contrast, in China the principal requirement is for clinical protocols to manage chronic disease and to assist in countering the perverse incentives toward non-‐basic treatments. Lesson 3: ‘One size fits all’ HTA processes and methods are unlikely to be appropriate for emerging markets. There needs to be clarity over the purpose of HTA – and the methods and processes which are adopted need to be fit for purpose. HTA is not an objective ‘tool kit’ that is transferable to any setting. “Value” of new drugs varies, and is subjective and based on local preferences and other values. Real value depends in a “second-‐best” world on the match between costs and the value of all other inputs (hospitals, physician, nurses, equipment, etc.). In particular, it is important to give careful thought to the way in which HTA processes work alongside the pricing and reimbursement systems for health care technologies – which in turn are part of the wider health system ‘architecture’ in each country. HTA processes may need to be tailored to meet the particular means by which pricing regulations work in each country. The outcomes of the health care system, for patients and the public, will be a product of both. Both reference pricing and HTA represent ways of obtaining value for money from new health care technologies. Drummond, et al. (2010) argue that the most efficient approach is likely to comprise a combination of these. Lesson 4: HTA and pricing regulations work hand in hand: the approach to HTA should be appropriate to, and work sensibly in combination with, the particular approach to pricing technologies. For example, HTA based on reimbursement levels in Taiwan ignores what providers actually have to pay for new drugs. This would tend to under-‐estimate real-‐world cost-‐effectiveness. Limits to the lessons that may be drawn Beyond the broad lessons and insights noted above, there are limits on the ability to draw broad conclusions from three case studies about the way that health care systems and HTA are evolving in emerging markets. While the issues we discussed above are common to emerging markets, many more of the observations about issues evident in three countries are specific to the three countries examined. Each has its own particular characteristics in terms of arrangements for funding and provision of health care, and sits in the context of a wider economy which also has its own distinctive 61
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