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Reimbursement review process
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Reimbursement review process

TAIWAN

Description of Healthcare System

In Taiwan, health insurance program is managed by the Bureau of National Health Insurance (BNHI) and it covers 99% of the population. Citizens need to pay the premium and have the right to access any physicians or hospitals at his/her choice. 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. Using 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 need to be approved by the Bureau of Pharmaceutical Affairs, Department of Health before entering Taiwan’s market. However, the reimbursement of the 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: listing or not, any restrictions on coverage, and its reimbursement price. If a product is accepted by BNHI, it will be added to the reimbursement list. For the prescription ordered by a physician, patient needs to pay the copayment of the prescription determined by the total cost of the drugs. Such co-payment is usually less than 18% of total drug cost. If a product is not listed by BNHI, it will be paid out of patient’s pocket.

Reimbursement Review Process and Time Frame

The DBC consists of 24 members, i.e.: 5 officers and 19 medical professionals, including physicians of different specialties, pharmacists, and economists. The Committee has monthly meeting to discuss new drug cases submitted by the pharmaceutical companies. For each new drug submitted for reimbursement, the case will be assigned to two principle reviewers selected from the 19 medical professionals. The principle reviewers will write up a one- to two-page report within two weeks review time for the Committee appraisal meeting. Usually, it will take around 3~4 months after submission to be scheduled for discussion in the meeting. In early 2007, the DOH decided to create an evidence-based decision making process without prolonging the timeline of the existing process. Therefore, starting early 2008, the revised process with HTA component added was established.

In December 2007, the new division of HTA was officially established in CDE (a not–for-profit, non-governmental organization) to collect evidences on values of new healthcare technologies for decision makers in BNHI. Cases of four kinds of new drugs (new chemical entities, new indications, new dosage form, and new combinations) are sent to HTA division for assessment. Two reviewers are assigned to each case and conduct independent clinical and economic assessment. Reports or papers from CADTH (Canada), NICE (UK), PBAC (Australia), SMC (Scotland), Cochrane library, PubMed, EMBASE, et al are collected reviewed and summarized. An assessment report is completed and double checked in 42 calendar days and sent back to BNHI for the DBC meeting.

Timeline of the whole process (estimated draft)

The new drug reimbursement application process requires pharmaceutical manufacturer to complete a New Product Application form. Manufacturer can only submit the application after he received the marketing approval granted by the DOH. The submission form, and guidance notes on how to complete it, is provided on the BNHI website. Economic information is not mandatory at current process. The content of submission dossier remains the same with the previous requirements from BNHI for pricing and reimbursement submission, as following:

1. Information of the drug product

  • 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
  • Indication(s)
  • Side effects/ contraindications
  • Mode of action
  • Pharmacokinetics
  • Information for manufacturing site (name and address)
  • Patent information

2. Burden of disease, mortality, prevalence

This section is not specified in the submission dossier. However, in the budget impact analysis, in order to estimate the potential target patient population of the product, the prevalence of the disease should be addressed.

3. 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.

4. Efficacy

Efficacy data from clinical trial reports should be provided.

5. 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 randomized clinical trial (RCT), from an indirect comparison of two sets of RCTs involving a common comparator, or from non-randomized studies.)

6. Clinical effectiveness

This section is not specified in the submission dossier. However, it can be provided as a supporting document if any.

7. 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.

8. Budget impact

Submission must include:
‧Reference prices of 10 medical 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):
o The potential target population
o The monthly amount of usage per capita
o The monthly cost per capita
o The monthly total cost
o The annual total amount of usage
o The annual total cost

All new drug submissions are assessed by the reviewers in HTA division,CDE, who provides an assessment report to the BNHI. Companies are able to review the report at this moment, however, the transparency issue is under discussion within BNHI. Manufacturers are informed of the final decision and there is an appeal process for failed cases or cases with decision not accepted by companies . 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.

Useful Links
‧Health Technology Assessment Division/ CDE: http://www.cde.org.tw/hta/main.htm