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

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.
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