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Pharmaceuticals Market Access Taiwan

  • Published: November 2012
  • Region: Taiwan
  • 76 Pages
  • Just Pharma Reports

January 2013 will see implementation of Taiwan’s “second generation” national health insurance law bringing important changes to the market for prescription medicines in one of Asia’s booming tiger economies. The new drug pricing process will be modified and the importance of health technology assessment (HTA) reaffirmed. The Cross-Strait Co-operation Agreement on Medicine and Public Health Affairs with mainland China might be of even greater significance in the longer term as this potentially leads to progressive mutual recognition of clinical trial results. R&D companies active in Taiwan will then have easier access to the 1.3 billion consumers speaking the same language waiting just across the Strait.

Written with the understandable detail and objectivity you require, Market Access Taiwan provides the answers needed for product introduction and life-cycle management in the sixth-largest market in Asia-Pacific:

- How the drug categorisation, launch pricing, price-volume agreement and price revision processes work, with data sources, timelines, examples and results.

- HTA policies by the Center for Drug Evaluation explained, with data READ MORE >

Executive Summary
Acknowledgements

1. Market Introduction
Healthcare System
Health Insurance
Healthcare Providers
Foreign Exchange Rates

2. Pharmaceutical Sector
Clinical Trials and Marketing Authorisation
Reimbursement
Hospital Formularies
NHI Pharmaceutical Expenditure
Pharmaceutical Industry
Leading Companies
Market
Leading Classes
Leading Products
Orphan Drugs
Taiwan Drug Relief Foundation

3. Introductory Pricing of New Drugs
Drug Benefit Committee
Data Requirements
Timelines
Product Categorisation
Category 1
Category 2
Additional Strengths
New Fixed-dose Combination Products
Orphan Drugs
Price-Volume Agreements
Outcome of Negotiations
Views by Industry
Price Information

4. Health Technology Assessment
Center for Drug Evaluation
Assessment Reports
Effectiveness Evaluation
Economic Evaluation
Guidelines
Checklist
Case Studies of Final BNHI Assessments
Avastin
Lucentis

5. Price Revision
Early Developments
Drug Price Gap
Price-Volume Surveys
Generic Grouping
Case Study: Enalapril Tablets

6. Generics
Intellectual Property Protection
Generic Pricing
Generic Prescribing
Generic Substitution
Generic Companies
Strategy
Biosimilars

7. Demand-Side Controls
Prescribing Controls
Patient Co-payment
Outpatients
Inpatients
Exemptions
Chronic Illness Refill Scheme
Rare Disease Patients

8. Payment of Providers
Global Budgets
DRGs
Pay-for-performance Plans

9. Distribution
Separation of Prescribing and Dispensing
Distributors
Pharmacies
Remuneration
Pharmaceutical Care

10. Prospects for Change
Reforms to NHI
Drug Expenditure Target
Changes to Drug Pricing
Importance of HTA Re-affirmed
Cross-strait Co-operation with Mainland China
China to Reference Taiwan Prices?

List of Tables

Outpatient visits by disease type
Package costs for common surgical procedures undertaken privately
Evolution of national health expenditure
Statistics on pharmaceutical licences, 2010
Prescription/non-prescription drug breakdown by licences, 2010
Drug expenditure from new additions to the positive list
Evolution of pharmaceutical expenditure under NHI, 1997-2011
Distribution structure of the market by customer type
Top-10 foreign-affiliated pharmaceutical companies, 2010
Top-10 domestic pharmaceutical companies, 2010
Year-to-year sales trend by product type
Top-10 best selling therapeutic classes, 2010
Top-10 best selling products from foreign-affiliated companies, 2010
Top-10 best selling imported products, 2010
Top-10 best selling products from domestic companies, 2010
Sources for A10 prices
HTAs by CDE, 2008-2012
Published HTA reports by CDE
Key features of pharmacoeconomic guidelines
Across-the-board price cuts following price-volume surveys
Impact of PVS-based price cuts by company type
Impact of PVS-based price cuts by product type
Evolution of NHI price and drug price gap with enalapril tablets
Basic outpatient registration fees and medical co-payments charges
Co-payment for medicines
Co-insurance rates for inpatients
Global budget payment system
Dispensing fees for pharmacies, 2012

Figures

Taiwan reimbursed pharmaceutical market breakdown, 2010
NT$ per USD, 2008-2012

Appendices

NHI prices of specimen leading brands in Taiwan vs Japan and Korea
CDE’s quality checklist for local pharmacoeconomic evaluations
Rare diseases qualifying for special NHI subsidy
Taiwan-designated orphan drugs with market authorisations

References
Glossary of Abbreviations and Acronyms

Change to DET System in Taiwan in 2013 ‘Unlikely’

Despite strong industry lobbying it now seems unlikely that the 8th round of price reductions following the biennial cycle of price-volume surveys can be avoided in Taiwan, the 6th-largest market for medicines in Asia-Pacific. Cuts are due to take effect in December 2013. The R&D sector proposed and government supported an alternative approach – an annual drug expenditure target (DET) with an industry-wide payback in the event of an overrun.

The matter was supposed to have been decided at September’s meeting of the Department of Health’s Medical Expenditure Negotiating Committee, but no consensus was reached. DET did not resurface for discussion at either MENC’s October or November meeting.

According to local sources, hospital associations – with strong representation on MENC - were fearful of DET giving them less control over their budgets. Industry believes that hospitals would in fact see advantages as DET would create a more stable drug market. Following each round of price cuts, hospitals undertake large scale revisions of their drug inventory. Such changes inconvenience physicians and patients, and necessitate extensive price negotiations by the hospitals with suppliers of replacement products.

Important changes are definitely on the way in Taiwan, however. January 2013 sees implementation of the “second generation” national health insurance law. As a result the new drug pricing process will be modified and the importance of HTA reaffirmed.

The Cross-Strait Co-operation Agreement on Medicine and Public Health Affairs with mainland China might be of even greater significance in the longer term as this potentially leads to progressive mutual recognition of clinical trial results. R&D companies active in Taiwan will then have easier access to the 1.3 billion consumers speaking the same language waiting just across the Strait.

These and many other issues are discussed in a new Justpharmareports’ title, Market Access Taiwan. Based on interviews with key market participants and data collection conducted in Taipei during autumn 2012 it provides the answers companies need for product introduction and life-cycle management in one of Asia’s tiger economies.

Donald Macarthur

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