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

More documents

Recommendations

Info

OHE Consulting Report for PhRMA 5 January 2011 characteristics. This limits the appropriateness of generalising to all emerging markets: ‘when you’ve seen one health care system, you’ve seen one health care system’. Especially with respect to understanding the interplay of incentives that drive behaviours regarding the adoption of new health care technologies, the relevant considerations are the particular, and often very complex, combinations of system-‐wide and local reimbursement arrangements facing the ‘players’ in the market, and the regulatory framework that guides and limits their behaviours. In our model we described these factors as the ‘architecture’ of the health care system, in itself can be thought of as a set of related technologies, i.e., a state of knowledge about the way health care can be delivered and provided. That state of knowledge is imperfect: there is no single, agreed, ‘best’ way to organise a health care system. Each system comprises a ‘second best’ set of arrangements. This has implications for the role HTA can and should have. Lesson 5: There is no single prescription for HTA methods and processes which will be welfare-increasing in all contexts. Further, trade-‐offs between competing objectives are likely if not inevitable; and health care systems may differ in the relative value placed on them, for example, the achievement of equity goals; technical efficiency; cost containment; and patient choice. Every health care system is on a slightly different trajectory: as it develops, and as spending increases, the way that HTA evolves will be a reaction to the possibilities and pressures that new technologies present. The key message is that the relevance and positioning of any role for HTA in a health care system depends on the development stage and structure of that health care system. 9.2 Options for the development of HTA in the three markets In positioning HTA it is important to understand that its value depends on the existing architecture of the health care system. This will in turn reflect the type of HTA that is appropriate. We have categorised HTA into three types: “macro-‐level” HTA which is about the “technologies” or architecture of the health care system, e.g. incentive systems or configurations of facilities. Issues around the effectiveness of, or reform options for, system level technologies arise at all stages of health system development either for government as a regulator or, more typically, for government as a direct owner of, and/or a purchaser of, health care services; micro-‐level” HTA aimed at appraisal of individual technologies, or groups of related technologies. Initially, some sort of market entry or licensing requirements are introduced for certain technologies (notably drugs and some devices), but at some point a greater understanding of value may be sought, either in the sense of relative or comparative effectiveness, or of incremental cost-‐effectiveness. In theory, again, these assessments could be generated and adopted by clinicians in self-‐pay markets, but it hard to see how this type of HTA would be funded in such a situation given its public good characteristics and the asymmetry of information between doctors and patients. More typically, it is generated by public bodies and 62
OHE Consulting Report for PhRMA 5 January 2011 used by public and private sector payers to either (i) support doctors and patients making treatment choices or (ii) to define the boundaries of the “benefit package.” Use to inform listing or reimbursement can be as part of a “passive” fee-‐for-‐service system or more “active” purchasing. “micro-‐level” HTA aimed at developing clinical practice guidelines or the way in which individual technologies are combined within a delivery system to manage patients efficiently. Designing clinical practice guidelines becomes an issue in systems that are seeking to actively manage chronic disease. In theory, these could also be generated and adopted by clinicians in self-‐pay markets, but it hard to see how this type of HTA would be funded in such a situation given its public good characteristics and the asymmetry of information between doctors and patients. More typically, developing guidelines becomes an issue for a health system when one or both of variability in treatment patterns and poor health outcomes becomes apparent. All of these uses of HTA make sense in the right context if the five lessons we set out in section 8.1 are observed. The bottom line is that HTA uses scarce resources. To be of value it has to deliver improved resource allocation and resource use that exceeds the opportunity cost of the effort involved in undertaking the HTA. If skills are scarce, as is often the case in an emerging market health care system, the opportunity cost may substantially exceed the wages and overheads associated with the HTA body. Many elements of HTA—both in terms of process and findings-‐-‐are not only public goods, but global public goods. Clinical benefit-‐risk determination for an individual drug, for example, is likely to be similar in different countries. If both the FDA and EMA have decided that a product’s benefit-‐risk balance is favourable enough to allow a product on the market, it makes sense for emerging markets not to spend substantial scarce resources to re-‐address this question in their local context. The ‘efficient’ solution will involve some degree of free-‐riding on this information. In the case, however, of a drug or other technologies comparative effectiveness or cost-‐effectiveness, local evidence will be needed to supplement reviews of evidence by HTA bodies elsewhere. Likewise with clinical practice guidelines, it makes sense to draw on relevant research from elsewhere. In the case of “macro-‐HTA” even more care is needed. Reforms to health system delivery or payment and incentive structures that appear to have worked in another country may not translate into other health care systems. All three case study markets demonstrate the use of HTA is at its early -‐ emergent – stages, albeit with some early signs of consolidation in Brazil. In China, there are a number of reforms to health system architecture underway and others are needed. Where HTA seems to be emerging as important is in the key area of clinical practice guidelines. The initiative with the UK NICE appears to be targeted at generating evidence-‐based clinical practice guidelines. The safety and efficacy of drugs is assessed by the SFDA. HTA in the sense of appraising the cost-‐effectiveness of individual drugs is not used. It could, in theory, be used by: (a) MoH in determining listings for inclusion in the EDL; (b) MoHRSS in setting reimbursement prices or determining reimbursement decisions for drugs to be covered in the two schemes it administers; or 9c) the NRDC in setting prices for pharmaceuticals not covered by its cost-‐plus formula. None of these uses have been proposed to our knowledge although there is interest in the use of HTA on the part of all three Ministries and leading academics continue to promote dialogue on guidelines for good practice. Furthermore, to our knowledge there is no use of HTA for other individual technologies outside of drugs. 63
Page 1 and 2:
Consulting Report 1 The Evolution
Page 3 and 4:
OHE Consulting Report for PhRMA 5 J
Page 5 and 6:
Page 7 and 8:
Page 9 and 10:
Page 11 and 12: OHE Consulting Report for PhRMA 5 J
Page 61: OHE Consulting Report for PhRMA 5 J
Page 113 and 114:
Page 115 and 116:
Page 117 and 118:
Page 119:
show all

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

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?