HTA is a systematic evaluation of the health technologies regarding the operational performance, effectiveness and impact of the technology. It is an analytical framework which uses multidisciplinary methodologies. The two major domains of HTA are clinical effectiveness analysis, i.e. efficacy analysis; and economic analysis, which includes cost-effectiveness analysis and budget impact analysis. HTA does not take any default positions during the assessment process, and its perspective is policy-oriented. The main function of HTA is to provide policymakers advisory opinions purely based on scientific evidence during the decision-making process. Based on the HTA results, policymakers will be able to comprehend the value of technological innovation, deal with uncertainties, effectively manage opportunities and challenges caused by health technologies and make appropriate resource allocation.

To get the formal HTA definition by the World Health Organization (WHO), please go to http://www.who.int/health-technology-assessment/en/.

Most of the health services require the support of health technologies such as: diagnostic imaging, drugs, biological agents, medical devices, treatment by internal medicine or surgery (e.g. coronary angiography or cholecystectomy) and supported systems (e.g. computerized medical records systems, electronic healthcare systems, blood banks or clinical laboratories). From a simple wooden tongue depressor to a complicated organ transplant, anything used in healthcare service is considered as a health technology. HTA can be applied in a wide range, however, most countries use it in the introducing new technology such as new drug into the reimbursement system of health insurance. For both developed and developing countries, a common dilemma on providing healthcare is the reasonable allocation of healthcare resources under a limited budget. Regardless of the decision-making strategy, the core belief of healthcare policymakers is to make decisions that are most beneficial to the health and well-being of the public. In other words, the policymakers have to ensure that every cent spent can generate the greatest health benefit, and the provided healthcare must at least be effective.

In a Department of Health executives' consensus meeting held in early 2007, the Minister Sheng-Mou Hou decided to set up a HTA Division within the Center for Drug Evaluation (CDE) to assist the decision making of Bureau of National Health Insurance (now National Health Insurance Administration) when a new drug was introduced into the market. The HTA Division was officially established on Apr 1, 2008, funded by government grant. Its mission was to establish a transparent, evidence-based health technology assessment system in Taiwan. Its function was to perform efficacy and economic analysis (including comparative clinical efficacy, cost-effectiveness and budget impact analysis), gathering relevant scientific evidence and performing local applicability analysis on pharmaceutical reimbursement applications submitted to the National Health Insurance Administration (NHIA) of the Ministry of Health and Welfare (MOHW), Executive Yuan. The HTA analysis results were used to assist the decision making process for reimbursement listing

Currently, the health technology assessment cases handled at the CDE HTA Division include the following categories:

1. Pharmaceutical reimbursement applications to NHIA, including drugs and medical devices. 
2. Research projects with specific health technologies commissioned by the NHIA.
3. Government-funded research project on specific healthcare or welfare intervention. 

When the CDE receives pharmaceutical reimbursement applications from the NHIA, an evaluation team will be set up for each case. Two primary reviewers will be assigned to perform the comparative clinical efficacy evaluation and economic evaluation, respectively. Besides reviewing the documents submitted by the applicants, primary reviewers will also conduct searches and compilation of evidence data. Data regarding efficacy and cost-effectiveness are gathered from public sources such as HTA reports from the UK, Canada and Australia; and electronic databases (e.g. Cochrane Library, PubMed, EMBASE etc).

After the primary reviewers’ complete assessments, their report will be confirmed by their secondary reviewers, respectively. Based on the assessment schedule, the assessment report will be completed in 32 days, and the CDE will submit the report as an official document to the NHIA within 42 days. All reports are written in Chinese. For new drug case, the assessment report of the HTA Division will be used to support the decisions on NHI listing at the Pharmaceutical Benefit and Reimbursement Scheme Joint Meeting (PBRS).

By law (the second-generation NHI Act), the PBRS is a joint appraisal committee composed of 29 members from government officials, health professionals, healthcare providers and consumer representatives (employers and beneficials).

The consideration regarding this issue is that the provided service and expense of local healthcare structure may be different from that of other countries. Thus, the cost-effectiveness comparison of the proposed new drugs to other NHI-listed drugs in Taiwan scenario might be completely different from that of other countries.In addition, if there are ethnic differences in efficacy and safety for new drugs submitted for NHI listing, it will be more reasonable to perform HTA based on local usage condition.

Furthermore, the Ministry of Health and Welfare-approved indications, local disease epidemiological data and the likely impact on the NHI's finances must be taken into considered. Such data cannot be obtained from assessment reports from other countries. Another issue is that the objectivity and integrity of the translated data need to be confirmed. In conclusion, there is a different level of actual demand in Taiwan for performing technology assessments on new drugs NHI listing. However, assessment results from other countries are important references to significantly reduce the time spent on searching and compiling relevant raw data from scratch.
 

Globally, tools used for assessing the quality of economic evaluation studies include Drummond’s checklist, SIGN 50, BMJ Guidelines and Chiou's checklist etc. However, these assessment tools are mainly used for assessing general economic evaluation studies, and not for assessing if the study fulfills local situation.

Thus, the CDE has taken relevant guidelines and quality assessment tools of various countries into consideration, and developed a cost-effectiveness quality assessment tool suitable for Taiwan. In addition to quality assessment items used worldwide, the tool also contains an aspect assessing the study's representativeness of the local situation. The tool can be used in the pharmacoeconomic evaluations for new health technologies NHI listing. This quality checklist was previously known as the "Quality assessment report for locally implemented pharmacoeconomic evaluation studies".

In 2012, after pre-test on actual studies, discussion and revision by experts, call for public opinions and consultation of international experts, the abovementioned quality assessment report was discussed at the 18th Meeting of the 9th Term Drug Benefit Committee held on Sep 6, 2012, and subsequently announced in the meeting minutes. If pharmaceutics or research institutes are keen to carry out local pharmacoeconomic evaluations, it is recommended to refer to the methodology guidelines in the following link http://nihta.cde.org.tw/Service/rule_more?id=8.

The National Health Insurance (NHI) scheme in Taiwan is highly estimated among internal communities, especially NHI’s achievement on maintaining service quality at relatively low cost. This shows that our system has its merits and should be valued. On the other hand, detailed planning on utilization is very important under limited resource.

The ultimate purpose of HTA is to spend money wisely and to make every cent count. Unless there is a lack of treatment option, items which are not cost-effective should be avoided. Based on the foundation of the NHI program, we should progressively develop a HTA system and platform where decision makers and stakeholders can discuss and reach consensus on the utilization of healthcare resources.