Can pharmacoeconomic guidelines be implemented successfully in Asia?

Since the introduction of the first Australian pharmaceoconomic guidelines in 1993, for the pharmaceutical industry to use when preparing a submission for public reimbursement of new drugs1, there has been a gradual and accelerating proliferation of pharmacoeconomic guidelines internationally2. When considering the nature of these published guidelines, they can generally be divided into two major categories: methodology guidelines or drug reimbursement application guidelines. Fundamentally, the rationale for producing these guidelines is the need to provide scientifically robust and economically sound approach in aiding reimbursement or subsidy decision to control drug expenditure, or the need for uniformity in methodological standard when performing economic evaluations. These are unarguably valid and legitimate reasons in view of the rising pharmaceutical expenditure worldwide. However, one notable observation is that these guidelines are essentially published either in Europe or in North America.

Viewing the situation in Asia, there is actually a much stronger rationale for introducing and applying pharmacoeconomic evaluation in drug reimbursement decisions. Many Asian countries share the same concerns about high pharmaceutical expenditures and overuse of medicine due to the nature and funding arrangements of the healthcare system. Many Asian countries, such as Japan, Korea and China, spend a much higher percentage of their national healthcare budget on pharmaceuticals compared with the US and other countries within the Organisation for Economic Co-operation and Development3–5. However, so far, with the exception of a draft guidelines issued by the Chinese Medical Doctor Association in 2004 and a subsequent final version6, there have been no other guidelines available. That is, until the Korean Health Insurance Review Agency issued the Korean Pharmacoeconomic Guidelines in May 2006. Actually, the decision to develop the guidelines was started in early 2003 when the Korean Ministry of Health and Welfare announced its intention to make greater use of pharmacoeconomic evaluations in reaching pricing and reimbursement decisions7. Therefore, Korea has become the first Asian country to officially request economic data for drug reimbursement decisions. In addition, several other countries and jurisdictions in the region, including Thailand and Taiwan, have recognised the benefits of pharmacoeconomics and are likely to develop and introduce formal pharmacoeconomic guidelines in the near future8. Even with this overdue development, a major concern is whether the introduction of such an approach would have positive or negative effects on healthcare delivery in Asia, and the experience in Korea will influence the decision by other countries in the region to use this approach in drug reimbursement decision making. Indeed for any pharmacoeconomic guidelines to be implemented successfully as a mandatory requirement for drug reimbursement or subsidy in Asia, many issues need to be resolved to allow the pharmacoeconomic guidelines to have the desired impact. Among them, conceptual issues such as the scope, level of prescriptiveness and complexity of the guidelines, as well as operational issues such as appropriate resourcing by industry and government, and communication and consultation requirements have been raised9.

Nevertheless, based on personal experience of implementing and applying pharmacoeconomic guidelines and pharmacoeconomic evaluation in Australia and Singapore, the author is of the opinion that the success of applying the cost-effectiveness approach in Asia will be dependent on two major factors: the first being the technical competence of the end users (including pharmaceutical industry and health administrators/decision makers)10; and the second being the transparency of the decision making process. Although the technical competence of the end users may currently be suboptimal, this may be overcome by making the data requirement less stringent at least initially to allow the build up of capacity both in the private and public sector. A suggestion would be to keep the guidelines, at least the early versions, simple and straight forward to reduce any initial teething problems and the burden of the steep learning curve. Hence, it is imperative that all stakeholders, in particular the pharmaceutical industry, academia and professional bodies, be actively involved during the drafting phase of any pharmacoeconomic guidelines for implementation in Asia.

More crucial to the success of applying pharmacoeconomic evaluation in Asia would be the level of transparency in the decision-making process, a major criticism of the process in some European countries. Without an acceptable level of transparency, it is difficult to convince the stakeholders that the decision is made based on sound and consistent principles. This is of particular importance in Asia with the prevailing culture of ‘top-down’ decision making. This would require a change in mind set that can only come about with the government regulators and administrators acquiring a balanced view of the potential of pharmacoeconomic evaluation and its limitations as a tool in assisting the decision-making process, and thus gaining the confidence to defend the reimbursement or subsidy decision. With a change of mindset established, the other important issues about operational requirement and technical competence necessary for the successful implementation of pharmacoeconomic guidelines would then fall into place.

Acknowledgements

Declaration of interest: The authors have declared no conflict of interest and have received no payment in the preparation of this manuscript.