Description of Health Care System
In Taiwan, health insurance program is managed by the Bureau of National Health Insurance (BNHI) and it covers 99% of the population. Citizens pay the premium and in exchange are granted the right to access any physicians or hospitals as he/she desires. In 2007, the national health expenditure is around 6.2% of GDP. About 85% of the hospitals and 98% of the primary clinics are private. Health care providers are reimbursed under the global budget system and fee-for-service mechanism the healthcare providers claim for services provided. For more details on the BNHI, please see http://www.nhi.gov.tw/english/index.asp.
In Taiwan, all new drugs are evaluated and get approved by the Bureau of Pharmaceutical Affairs within the Department of Health. Subsequently, the reimbursement of a new drug is decided by the BNHI. In 1996, BNHI established the Drug Benefit Committee (DBC) which is responsible to make three recommendations to the BNHI regarding new drug reimbursement: 1) whether a new drug is listed or not; 2) any restrictions on coverage and 3) a new products reimbursement price. If a product is approved by BNHI, it is automatically added to the reimbursement list which allows for the prescribing of the new drug at any healthcare facility in Taiwan. Patients are required to pay a copayment of the prescription which is determined by the total dollar amount of the drug and is usually less than 18%. If a product is not listed by BNHI it will not be reimbursed but a patient can self-pay for the drug.
Reimbursement and Pricing Approval Process
The Drug Benefit Committee consists of 24 members, 5 officers and 19 medical professionals, including physicians from different specialties, pharmacists, and economist. The Committee has monthly meeting to discuss new drug cases submitted by the manufacturers. Each new drug submitted for reimbursement, the case will be assigned to two major reviewers selected from the 19 medical professionals. During the following two weeks, the reviewers will write and submit a one- to two-page report for the Committee appraisal meeting. Usually, it will take around 4~6 months to schedule the meeting to discuss a new case. IIn early 2007, the Minister of Health announced the government’s intention to create an evidence-based decision making process but insisted upon not prolonging the timeline of the process. Starting early 2008, the revised process with the new Health Technology Assessment (HTA) component was established and the whole process shortened to have the case discussed in an average of 3 months duration.
In December 2007, the new division of HTA was officially established in the Center for Drug Evaluation (CDE), a private not–for-profit, non-governmental organization)), to provide evidence on the value of new healthcare technologies for decision makers in BNHI. Cases of four kinds of new drugs (new chemical entities, new indications, new dosage form, new combinations) are sent to the HTA division for assessment. Two reviewers are assigned to each case who conduct independent searches of evidence from CADTH (Canada), NICE (UK), PBAC (Australia), SMC (Scotland), the Cochrane library, PubMed, EMBASE, et al. A report is completed and double checked in 42 days and then sent to BNHI for the DBC meeting.
Timeline of the whole process (estimated draft)
The new drug submission process requires a pharmaceutical manufacturer to complete a New Product Application form. A manufacturer can only submit an application after receiving marketing approval granted by the Bureau of Pharmaceutical Affairs. The submission form and guidance notes on how to complete the form are provided on the BNHI website. Economic information is not currently mandatory. Guidelines for the content of the submission dossier are as follows:
- Regulatory information of the technology
- Information for the marketing license of the product
- Brand name of the product
- Active ingredient(s)
- Category (OTC drug/Prescription drug)
- Therapeutic class
- Formulation and its properties (excipient, convenience of the formulation, manufacturing process…etc)
- Strength and the package
- Side effects/ contraindications
- Mode of action
- Information for manufacturing site (name and address)
- Patent information
- Burden of Disease, mortality, prevalence
This section is not specified in the submission dossier but is necessary for developing a budget impact analysis. In order to estimate the potential target patient population of the product, the prevalence of the disease should be addressed.
- Current treatment options for disease
This section is not specified in the submission dossier. However, the information of the main comparator(s) (alternative treatments) should be provided.
Efficacy data from clinical trial reports should be provided.
- Comparative safety
Safety data from clinical trial reports should be provided. However, there is no requirement for the comparative data or source of the data (from a head to head RCT, from an indirect comparison of two sets of RCTs involving a common comparator, or from non-randomized studies.)
- Clinical effectiveness
This section is not specified in the submission dossier. However, it can be provided as a supporting document if any.
- Cost effectiveness
This section is not specified in the submission dossier. HTA/CDE will gather evidence from the available resources. However, if a local PE study/data can be presented, it may be of great help in supporting the submission.
- Budget impact
Submission must include:
- Reference prices of 10 advanced countries of the product
- Reference prices of products from same category (comparators)
- Cost analysis of the product by estimating the following (reference data is needed):
- The potential target population
- The monthly amount of usage per capita
- The monthly cost per capita
- The monthly total cost
- The annual total amount of usage
- The annual total cost
All new drug submissions are assessed by the HTA division who provides an evidence report to the BNHI. Manufacturers are not able to review the report at this moment, however, the issue of transparency is under discussion within BNHI. Manufacturers are informed of the final decision and there is an appeal process for failed cases in the first Committee meeting. It is possible to make a re-submission to BNHI if new data becomes available which impacts the comparative or cost effectiveness of the product.
BNHI: Bureau of National Health Insurance. Reimbursement and pricing body in the government and is responsible for running the health insurance programs in Taiwan.
BPA: Bureau of Pharmaceutical Affairs. Regulatory body in the government and is responsible for licensing new drug marketing approval.
CDE: Center for Drug Evaluation. It was commissioned by the Department of Health (DOH) of Taiwan on July 13, 1998, as a non-governmental, not-for-profit organization. CDE evaluates new drugs and new medical devices for regulatory requirements and offers consultation services to related parties. Main tasks of CDE include: review of new drug application, evaluation of pre-marketing approvals and clinical trial protocols for medical devices, review of clinical trial protocols for new drugs, bridging study evaluation, Taiwan’s critical path program (of bio-medical product development), and consultation. Through these, CDE plays a pivotal role to enhance the quality and efficiency of drug evaluation for appropriate and timely access to innovative medicine, thus promoting health and welfare of public.
DBC: Drug Benefit Committee. Organized inside BNHI and is responsible for making recommendations on listing, coverage and pricing of the new drug products submitted by the manufacturers and all other drug-related reimbursement issues.
- HTA division: The Health Technology Assessment Division was officially approved by the Board of CDE on December 20, 2007, and was 100% funded by the DOH on annual basis starting 2008. The major functions of HTA division are to provide the evidences report to the decision makers in BNHI for every new drug submitted to BNHI for reimbursement purpose, and to provide research reports to those temporary raised issues during DBC appraisal meeting. The HTA division is not assessing non-drug technologies at this moment.
Reimbursement Organization/ HTA Organizations
The Bureau of National Health Insurance is the reimbursement organization and the appraisal meeting of the Drug Benefit Committee is making the listing and pricing recommendations. Health technology assessment division under Center for Drug Evaluation is conducting assessment on all new drug products; the report will provide the DBC as part of the evidences.
- Pharmacoeconomic Guidelines around the World at http://www.ispor.org/PEguidelines/index.asp
- Value in Health 2004;7:518. Use of Cost-Effectiveness Analysis in Health-Care Resource Allocation Decision-Making: How are cost-effectiveness thresholds expected to emerge?
- Undertaking systematic reviews of research on effectiveness: CRD’s guidance at http://www.york.ac.uk/inst/crd/report4.htm
- Guidelines for Conducting Pharmaceutical Budget Impact Analyses for Submission to Public Drug Plans in Canada. Pharmacoeconomics 2008; 26 (6): 477-495.
- Scottish Intercollegiate Guidelines Network 2008, SIGN 50 at http://www.sign.ac.uk/guidelines/fulltext/50/index.html
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