HTA Consultation Services
Synopsis
The CDE established the HTA team on April 1, 2008. The main task of the HTA team is to perform scientifically-based assessment, as commissioned by the competent authority, on the applications of NHI reimbursement for new health technologies. The remit of the HTA team includes establishing the SOP for different types of HTA projects, promoting international HTA cooperation and training programs, and undertaking policy researches on drug reimbursement priorities and rationality through the assessment of HTA projects and the assessment of NHI reimbursement applications. The ultimate goal of HTA is to help the health authority to use new health technologies in an efficient and rational manner so as to maximize the public health benefits.At present, the types of assessments carry out by the HTA team include: General new drugs refer to the drug which preparations having new medical entities, new dosage forms or new administration routes as approved by the competent authority; Breakthrough New Drugs refer to the Category 1 New Drugs classified by NHIA and claimed by sponsors; New Specified Medical Devices; and HTA-related researches.
New Drugs and New Medical Devices
After receiving the NHIA’s commission for assessing a new drug or medical device application, the HTA team has to collect information for efficacy and economic assessment (including comparative clinical efficacy, cost effectiveness and budget impact) evaluate the applicability in Taiwan and produce a scientifically-based analysis report. The assessment report has to be completed within 42 days and be submitted to the NIHA to support the decisions on NHI reimbursement made by the NHI Joint Meeting for Pharmaceutical Benefits and Reimbursement Scheme.-
The required contents of the application forms, by different application type
Category 1 New Drug Category 2 New Drug Basic drug information
Drug related information
Comparison table with reference products
Drug prices in reference countries
Latest reimbursement regulations in other countries
information of locally-conducted clinical trials on ethnic-specificity and safety
Domestic pharmacoeconomic data
HTA reports in the UK, Australia and Canada
Summary of the literature review on economic evaluations
nalysis of financial impact for the listing of the new drug (must be provided)
Evidence of the significance improvement on the effectiveness of this ‘breakthrough’ new drug
Summary and compilation of worldwide cost-effectiveness analyses resultsBasic drug information
Drug-related information
Comparison of efficacy with reference products
Drug prices in reference countries
Latest reimbursement restrictions in other countries
information of locally-conducted clinical trials on ethnic-specificity and safety
Domestic pharmacoeconomic data
HTA reports in the UK, Australia and Canada
Summary of the literature review on cost-effectiveness analysis
Analysis of financial impact for the listing of the new drug (must be provided)
Consultation Services
- For online consulting service instructions and applications, please see attached files.
- Online service website as follows:
- https://www1.cde.org.tw/workflow/cons/applyform.php?drug_type=checked_hta
- Consulting Service Application Form