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

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OHE Consulting Report for PhRMA 5 January 2011 markets, but it is 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 above 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 (c) 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. In Brazil, the CITEC sometimes appears to work slowly and to be under-‐resourced. This has the effect of delaying reviews of, and decisions on, access to new technologies. (A new law, about to be signed, would place a 180-‐day limit for CITEC review reflecting a recognition that the process has been too slow as well a societal willingness to address these access decisions.) There are aspects of the HTA process that could be improved, notably around transparency of process and of selection criteria. However, it is also unclear how the role of CITEC fits alongside a constitutional right of access to healthcare (which is clearly not consistent with the levels of funding available) and regulation by the ANS of the minimum requirements of the private insurance package. If emerging markets allow marketing authorisation, their citizens will have 14
OHE Consulting Report for PhRMA 5 January 2011 expectations of access. The situation in Brazil exemplifies this, as once products are approved for marketing authorisation and for innovative products, an initial price is set via external reference pricing rules (and adjusted subsequently by SUS/CMED for inflation, affordability, etc.), then citizens can sue for access even though the public system has not yet approved the product for use in the public plan. In Taiwan, the role of HTA appears to be exclusively in the area of drug reimbursement, and here it is unclear how it fits logically alongside an international reference price system. In theory, drugs showing incremental value can get higher prices within the range of reference price comparisons. There are also some issues around process such as the degree of transparency of the assessment and the relationship between the assessment and the drug licensing process. Our understanding is that expertise for the conduct of pharmacoeconomic assessments is drawn from the licensing body but used separately. However, this arrangement clearly causes concern for the industry that assessments of safety and efficacy may be conflated in some way with assessments of relative effectiveness and cost-‐effectiveness. Issues for PhRMA in developing public policy positions The PhRMA, EFPIA, and IFPMA principles for good practice in HTA and Evidence-‐based Medicine provide a consistent approach to “micro HTA” and continue to provide a solid framework for approaching HTA issues globally. They are intended to be applied in a reactive way – in the event of a payer and/or government proposing the use of “micro HTA”. We have sought to develop a framework for putting such a position into the context of health care system development and HTA evolution. Our key points are that HTA is resource intensive and that an appropriate initial focus for skilled people may well be on “macro HTA” or other health system issues rather than “micro HTA”. This gives rise to several issues: As compliance with good HTA principles is resource-‐intensive for governments (and for industry), countries may seek to “free ride” on the systems of other countries to avoid using scarce skills and resources. Indeed, as we have noted earlier, the global public good nature of much evidence means that “not reinventing the wheel” can make sense and be efficient. However, use of alternative “low resource” options may be less efficient than an efficient use of HTA. For example, the use of international reference pricing to countries at a similar stage of income-‐per-‐capita and with similar health care systems can make sense if the referenced countries have used appropriate methods to derive their prices. However, international reference pricing in practice can lead individual country markets to seek lower-‐than-‐optimal price levels not consistent with long-‐term, global dynamic efficiency (Danzon et al, 2010). HTA may therefore be preferable to international reference pricing if it is used to assess value in a way that reflects local willingness to pay for health gain; The use of therapeutic reference pricing requires less input than HTA but can discourage innovation and reduce the likelihood of efficient use of the product (Drummond et al, 2010). It 15
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