CDE – Center for Drug Evaluation
Taiwan, Republic of China
– Dr. Churn-Shiouh Gau, Executive Director, CDE
History and Structure
The Center for Drug Evaluation (CDE) was established by the Department of Health (DOH) of Taiwan on July 13, 1998. In February 2007, DOH made the decision to establish a new division on Health Technology Assessment (HTA) in CDE to provide evidences on value of new healthcare technologies for decision makers in Bureau of National Health Insurance (BNHI). BNHI is the reimbursement body which now covers 99% of population and contracts with 91.5% of healthcare providers in Taiwan. A proposed structure, working model, and responsibilities of the HTA division in relation to BNHI was suggested and communicated with the officers in DOH, BNHI, scholars in related academia, and people in pharmaceutical industries. Among one hundred and eighteen full time staffs in CDE, there are nine persons working in HTA division in March 2008. Among them 2 hold PhD degree, 1 physician with PhD, 4 with MS degree and 2 with BS degree.
With the vision “Regulatory Science, Service for Life ", CDE plays a pivotal role in enhancing the efficiency and quality of drug evaluation, thus promoting public health and welfare including timely access to innovative medicines.
How CDE/HTA Works
CDE performs regulatory evaluation of clinical trial protocols, marketing application dossier of new drugs and medical devices, and offers related consultation services under the delegation and commission of DOH. Furthermore, CDE develops pharmaceutical regulatory science and makes timely recommendations to meet the need of policy development. Thus CDE contributes to the national public health system and ensures that the public can obtain safe and effective innovative new drugs in a timely manner through the efforts of a team of full-time professionals.
For the newly established HTA division in CDE, more than 40 events have been held to communicate the planning of HTA functions in CDE with DOH, BNHI, academia, and pharmaceutical industries in the first 6 months of initiation of HTA division. One of the primary functions is to provide evidences to the decision makers in BNHI for new drugs reimbursement listing. HTA reports or clinical guidelines from CADTH (Canada), PBAC (Australia), NICE (UK), and other organizations were referred and summarized by HTA/CDE as supportive information to the Drug Benefit Committee (DBC) in BNHI for making the listing recommendation to the BNHI. Thirty eight cases of new drug application for reimbursement were evaluated by the team from October 2007 to March 2008.
Two types of report are prepared by HTA in CDE: the evaluation report for new drug application for reimbursement, and research project reports. The reports for application of new drug reimbusement listing were for BNHI internal use only. It will be kept by BNHI together with the comments of two leading reviewers of DBC and the meeting minutes. There is no regular publication plan for public communication so far. On the other hand, most of the research projects are budget impact analysis for a group of treatment requested by DBC. We will look for the opportunity to release research findings and reports through media, website, symposium and peer-reviewed literature as appropriate. The first research project report would be expected in November this year. Website homepage of HTA division will be established in May 2008.
- Potential budget impact of revision of treatment target of lipid lowering medication to hyperlipidemia patients without other cardiac risk factors
- Evaluation of guaifenesin clinical outcomes
- Potential budget impact of revision of proton pump inhibitor (PPI) drugs reimbursementguidance on treatment of gastric esophagus reflex desiese (GERD)
- Cost-effectiveness of 3 anti-cancer drugs in Taiwan: imatinib, bortezonib and cetuximab
- Cost-effectiveness of glitzaone in treating diabetes mellitus patients
- Cost effectiveness of verteporfin in treating macular degeneration patients
- Cost effectiveness of recombinant human activated protein C in treating septic shock
- Revision of reimbursement guidance of using factor VIII or recombinant factor VIII for treating hemophilia patients
- Revision of reimbursement guidance of pharmaceutical treatment of chronic hepatitis type B and type C
- Review and international comparison of reimbursement guidance of pharmaceutical treatment of osteporosis
- Strengthen the capability of independent systematic review process; revise the guideline for reimbursement submission, conduct indirect comparison, design a dual tract submission process. Following activities will be focused as the first operation year:
- Evidences provision to the decision-maker s in DBC/BNHI on new drugs application for reimbursement listing
- Conduct projects commissioned by BNHI or DOH, such as budget impact analysis on revision of reimbursement guidance of treating patients with gastroesophageal reflux desiese, the use of lipid lowering agents in hyperlipidemia patients, and conduct CEA on new target therapy drugs for cancer patients and recommend an acceptable ICER cut-off point for the decision-makers
- Establish the process and methodology, and identify available resource for carrying out quality scientific HTA for local needs.
- Establish the consultation mechanism for local manufacturers in preparation, designing and conducting HTA for specific needs
- Training and communicating with key players to build up wider capacity and understanding in HTA locally
- Actively looking for the opportunity to participate in international networks of HTA, and inviting global experts for advice
Country: Taiwan, Republic of China
Description of population served: Citizens in Taiwan
Population served (mil): 23
Current HTA budget (mil USD): 0.8
Permanent staff: 28 in HTA division (total of 268 in CDE)
Ongoing TA projects: variable
Executive Director: Dr. Churn-Shiouh Gau
Contact person: Mr. Chi-Kuang Wang
Center for Drug Evaluation
3F, No.465, Sec.6, Zhongxiao E. Rd.,
Taipei 11557, Taiwan, Republic of China