臺灣博碩士論文加值系統

藥廠每年在新藥研發上投資許多的時間與金錢。在新藥上市之後可能獲得的最大利潤是藥廠最關心的事。
本研究主要應用系統動力學的原理，利用電腦建立模型的方式來建立屬於藥品市場的模式以預測藥品可能的銷售量。我們選用Powersim (www.powersim.com) 做為應用的軟體。
為了進行模擬，在我們的模式當中需要加入一些與藥業最相關的因素，包含了健保給付有無、流行病學的影響、總病人數等。除此之外，我們假設其它可能在真實世界中發生的狀況，如健保給付政策的改變、競爭產品或學名藥的上市、新適應症核准、新劑型核准上市等情形來進行模擬。在本研究中所有的數據均為假設數據，所選用的藥品為降血壓藥物。我們將數個次模式連結成為最終的進行模擬的模式。利用最後所建立的模式，我們假設了六個不同的情境。由這些情境所模擬出的結果可以看到研究的藥品銷售量曲線會因此而呈現波動起伏。藉由此方式可能可以提供藥廠規劃較適當的行銷策略以獲得最大的利潤。
經由此研究所得到的結果，可知利用系統動力學來模擬藥品市場的方式是可行的。在本研究中我們只討論了處方藥品市場及單一用藥市場，但實際上另有非處方用藥市場及合併用藥市場存在。未來我們可以加入其他與非處方用藥市場及合併用藥市場相關的因素來建立相關的模式。另外我們也可加入其他的因素，如成本效益分析、供應鏈管理等，並模擬這些因素對藥品銷售量的影響。

Pharmaceutical companies invest lots of time and money for developing new drugs every year. What they most concern is how to squeeze every possible profit after launching a new drug to market.
Our study was to apply computer modeling method to build models of pharmaceutical market to simulate the sales volume of drug which was based on System Dynamics (SD). We chose Powersim (www.powersim.com) as the modeling tool.
In order to simulate the models we built, we added some factors which were concerned most related to the pharmaceutical industry into our models. They included whether the drug cost of NHI was covered or not, epidemiologic effect, total patient number, etc. Besides, we assumed other events which may occur in real world, such as the drug cost coverage policy by NHI was changed, launching of competitors’ products or generics, a newly approved indication, a new dosage form was approved, and so on. All data in our study were hypothesized and the drugs we used in our models were anti-hypertensive agents. As a result, the final model has been built with combination of several submodels. With this final model, we set six scenarios with different events assumed. From simulation results of these scenarios, we could see the curves of sales volume of studied drug were fluctuated. Using this method, it may help pharmaceutical companies propose a suitable marketing strategy to make the maximum profits.
Based on the results obtained from this study, it seems that SD is feasible way to simulate the pharmaceutical market. In this study, we only consider the prescription medications market and the single drug treatment market in this study, but there are also the OTC market and the combination therapy with two or more drugs together in the real world. In the future, we can add other factors to build the OTC market and combination drug therapy market. We can also add some factors, such as cost-benefit analysis and supply chains to study their impact on the sale volume of the studied drug.

Table of Contents
Table of Contents....................................I
List of Tables.......................................IV
List of Figures......................................V
Abstract.............................................VII
中文摘要.............................................VIII
1 Introduction.......................................1
1.1 Pharmaceutical Marketing.........................1
1.2 System Dynamics..................................5
1.3 Applications of System Dynamics..................7
1.4 Purpose..........................................8
2 Materials and Methods..............................9
2.1 Modeling of Powersim.............................9
2.1.1 Steps in Modeling..............................9
2.1.2 Variables in Powersim ..........................11
2.2 Factors of Pharmaceutical Marketing...............13
2.3 Components........................................14
2.3.1 The First-One & Only-One........................14
2.3.2 The First-One & Had Competitors or Generics.....15
2.3.3 Drug Cost Coverage Policy by NHI was Changed....16
2.3.4 Approved New Indications or New Dosage Forms....17
2.4 Data and Variables................................18
3 Results .............................................19
3.1 Anti-Hypertensive Drugs...........................19
3.2 Factors...........................................22
3.3 Models............................................32
3.3.1 Model 1 (Base Model)............................32
3.3.2 Model 2.........................................39
3.3.2.1 Submodel 2.1..................................39
3.3.2.2 Submodel 2.2..................................44
3.3.2.3 Submodel 2.3..................................48
3.3.3 Model 3.........................................51
3.3.3.1 Submodel 3.1..................................51
3.3.3.2 Submodel 3.2..................................55
3.3.4 Model 4.........................................58
3.3.5 Model 5.........................................61
3.4 Final Model and Scenarios.........................62
3.4.1 Scenario 1......................................63
3.4.2 Scenario 2......................................64
3.4.3 Scenario 3......................................65
3.4.4 Scenario 4......................................66
3.4.5 Scenario 5......................................67
3.4.6 Scenario 6......................................68
4 Discussions.........................................69
4.1 Included Factors..................................69
4.2 Excluded Factors..................................77
4.3 Model Refinement..................................85
4.4 Model Validation..................................86
5 Conclusion and Future Work..........................88
5.1 Conclusion........................................88
5.2 Future Work.......................................89
References............................................90
Tables................................................96
Figures...............................................106
Appendix A............................................149
All Definitions Used in Our Models
Model 1...............................................150
Model 2...............................................152
Submodel 2.1..........................................153
Submodel 2.2..........................................154
Submodel 2.3..........................................155
Model 3...............................................157
Submodel 3.1..........................................158
Submodel 3.2..........................................159
Model 4...............................................160
Model 5...............................................162
Appendix B............................................164
All Definitions Used in Scenarios
Final Model...........................................165
Scenario 1............................................170
Scenario 2............................................174
Scenario 3............................................179
Scenario 4............................................184
Scenario 5............................................188
Scenario 6............................................193

List of Tables
Table 1.1 Average Cost and Required Time of Each Step for
Developing a New Drug..................................97
Table 2.1 4P and 4C of Marketing in Business and Pharmaceutical Market..................................98
Table 2.2 Factors That May Influence Pharmaceutical Marketing ..............................................99
Table 2.3 All Components in This Study.................101
Table 3.1 Abbreviations of Variables in This Study.....102
Table 3.2 All Scenarios in This Study..................104
Table 4.1 Included and Excluded Factors in This Study..105

List of Figures
Figure 2.1 All Symbols are Used in Powersim............107
Figure 2.2 Flow-Chart of Model Building................108
Figure 3.1.1 Model 1...................................109
Figure 3.1.2 Simulation Results of Model 1.............110
Figure 3.2 Epidemiological Effects.....................111
Figure 3.3 “GRAPH” Function of NHI_DA in Model 1.....112
Figure 3.4.1 Submodel 2.1..............................113
Figure 3.4.2 Simulation Results of Submodel 2.1........114
Figure 3.5 DA%, and DC1% in Submodel 2.1...............115
Figure 3.6 Effect of Launch_DC1 in Submodel 2.1........116
Figure 3.7.1 Submodel 2.2..............................117
Figure 3.7.2 Simulation Results of Submodel 2.2........118
Figure 3.8 DA%, DC1%, and DC2% in Submodel 2.2.........119
Figure 3.9 Effects of Launch_DC1 and Launch_DC2 in Submodel 2.2...........................................120
Figure 3.10.1 Submodel 2.3.............................121
Figure 3.10.2 Simulation Results of Submodel 2.3.......122
Figure 3.11 DA%, DC1%, DC2%, and DGa% in Submodel 2.3..123
Figure 3.12 Effects of Launch_DC1, Launch_DC2, and Launch_DGa in Submodel 2.3.............................124
Figure 3.13.1 Submodel 3.1.............................125
Figure 3.13.2 Simulation Results of Submodel 3.1.......126
Figure 3.14 Effect of Date_Policy in Submodel 3.1......127
Figure 3.15.1 Submodel 3.2.............................128
Figure 3.15.2 Simulation Results of Submodel 3.2.......129
Figure 3.16 Effect of Date_Policy in Submodel 3.2......130
Figure 3.17.1 Model 4..................................131
Figure 3.17.2 Simulation Results of Model 4............132
Figure 3.18.1 Model 5..................................133
Figure 3.18.2 Simulation Results of Model 5............134
Figure 3.19.1 The Final Model..........................136
Figure 3.19.2 Simulation Results of The Final Model....138
Figure 3.20.1 Simulation Results of Scenario 1.........139
Figure 3.20.2 Effects of Drug Cost Coverage Policy by NHI in Scenario 1..........................................140
Figure 3.21.1 Simulation Results of Scenario 2.........141
Figure 3.21.2 Effects of Pt_no_new in Scenario 2.......142
Figure 3.21.3 Effects of Date_new in Scenario 2........143
Figure 3.22 Simulation Results of Scenario 3...........144
Figure 3.23 Simulation Results of Scenario 4...........145
Figure 3.24 Simulation Results of Scenario 5...........146
Figure 3.25 Simulation Results of Scenario 6...........147
Figure 4.1 Patent Duration.............................148

Anonymous, 2003, Prilosec, Nexium and Stereoisomers. Medical Letter on Drugs & Therapeutics. 45, pp 51-52.

Acemoglu, D. and Linn, J., 2004, Market Size in Innovation: Theory and Evidence from the Pharmaceutical Industry. Levine''s Working Paper Archive with number 228400000000000002, UCLA Department of Economics.

Agrawal, M. and Calantone, R.J., 1996, Examining the Applicability of Market Forecasting Models to New Pharmaceutical Products. Health Marketing Quarterly, 13, pp 17-31.

Andersen, M. and Schou, J.S., 1994, Are H2 Receptor Antagonists Safe Over the Counter Drugs? BMJ: British Medical Journal, 309, pp 493-494.

Anderson, J.G., 2002, Evaluation in Health Informatics: Computer Simulation. Computers in Biology and Medicine, 32, pp 151-164.

BMI, 2004, Taiwan Pharmaceuticals & Healthcare Report Q4 2004: Including 4-year industry forecasts by BMI. Business Monitor International.

Borrus, M., 2002, The Global Pharmaceutical Market. International Trade and Competition in High Technology.

Brooks, R.J. and Tobias, A.M., 1996, Choosing the Best Model: Level of Detail, Complexity, and Model Performance. Mathematical and Computer Modeling, 24, pp 1-14.

Buckley, J., 2004, Pharmaceutical Marketing - Time for Change. Electronic Journal of Business Ethics and Organization Studies, 9, pp 4-11.


Canton, E. and Westerhout, E., 1999, A Model for the Dutch Pharmaceutical Market. Health Economics, 8, pp 391-402.

CDER Handbook, produced by: Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Revised: 03/16/98.

Chapman, R.J., 1998, The Role of System Dynamics in Understanding the Impact of Changes to Key Project Personnel on Design Production within Construction Projects. International Journal of Project Management, 16, pp 235-247.

Craig, A.M. and Malek, M., 1995, Market Structure and Conduct in the Pharmaceutical Industry. Pharmacology and Therapeutics, 66, pp 301-337.

Danzon, P.M., Wang, Y.R., and Wang, L., 2005, The Impact of Price Regulation on the Launch Delay of New Drugs – Evidence from Twenty-Five Major Markets in the 1990s. Health Economics, 14, pp 269-292.

DeMonaco, H.J., Ali, A., and Hippel, E.V., 2006, The Major Role of Clinicians in the Discovery of Off-Label Drug therapies. Pharmacotherapy, 26, pp 323-332.

DiMasi, J.A., 2001, Risks in New Drug Development: Approval Success Rates for Investigational Drugs. Clinical Pharmacology & Therapeutics, 69, pp 297-307.

DiMasi, J.A., Hansen, R.W., and Grabowski, H.G. 2003, The Price of Innovation: New Estimates of Drug Development Costs. Journal of Health Economics, 22, pp 151–185.

FDA, http://www.fda.gov.

Fernandez, D.S. and Huie, J.S., 2004, Balancing US Patent and FDA Approval Processes: Strategically Optimizing Market Exclusivity. Drug Discovery Today, 9, pp 509-512.
Forrester, J.W., 1989, The Beginning of System Dynamics. Banquet Talk at the International Meeting of the System Dynamics Society Stuttgart, Germany.

Forrester, J.W., 1991, System Dynamics and the Lessons of 35 Years. A Chapter for the Systemic Basis of Policy Making in the 1990s.

Gavras, I. and Rosenthal, T., 2004, Combination Therapy as First-Line Treatment for Hypertension. Current Hypertension Reports, 6, pp 267-272.

Grabowski, H., 2002, Patents, Innovation and Access: to New Pharmaceuticals. Journal of International Economic Law, 5, pp 849-860.

Joglekar, P. and Paterson, M. L., 1986, A Closer Look at the Returns and Risks of Pharmaceutical R&D. Journal of Health Economics, 5, pp 153-177.

Keith, A., 2000, The Economics Of Viagra. Health Affairs, 19, pp 147-157.

Kendall, D.L. and French, M.T., 1991, Forecasting the Potential for New Industrial Products. Industrial Marketing Management, 20, pp 177-183.

Koda-Kimble, M.A., Young, L.Y., Kradjan, W.A., and Guglielmo, B.J., 2004, Applied Therapeutics: the Clinical Use of Drugs. 8th, USA, Lippincott Williams & Wilkins.

Kontzalis, P., 1992, Identification of Key Attributes, Gap Analysis and Simulation Techniques in Forecasting Market Potential of Ethical Pharmaceutical Products. International Journal of Forecasting, 8, pp 243-249.

Lexchin, J., 2004, The Effect of Generic Competition on the Price of Brand-Name Drugs. Health Policy 68, pp 47–54.
Lilien, G.L., Kotler, P., and Moorthy, K.S., 1992, Marketing Models. Englewood Cliffs, N.J., Prentice-Hall.

Mahajan, V. and Wind, Y. 1988, New Product Forecasting Models: Directions for Research and Implementation. International Journal of Forecasting, 4, pp 341-358.

Marjit, S., Kabiraj, T., and Dutta, A., 2006, Strategic Under-utilization of Patents and Entry Deterrence: The Case of Pharmaceutical Industry. Tarun Kabiraj, Economic Research Unit, Indian Statistical Institute.

Maurer, S.M., 2005, The Right Tool(s): Designing Cost-Effective Strategies for Neglected Disease Research. University of California at Berkeley, http://socrates.berkeley.edu/~gspp/iths/MAURER_DrugRsch.pdf.

MICROMEDEX, http://kmuhmdx.csis.com.tw/.

Oster, G., Huse, D.M., Delea, T.E., Colditz, G.A., and Richter J.M., 1990, The Risks and Benefits of an Rx-to-OTC Switch. The Case of Over-the-Counter H2-Blockers. Medical Care, 28, pp 834-852.

Powersim Studio 2003 User''s Guide.

POWERSIM, http://www.powersim.com.

Robinson, S., 2004, Simulation: the Practice of Model Development and Use. Chichester, West Sussex, England; Hoboken, NJ., John Wiley and Sons, Ltd.

Rodrigues, A. and Bowers, J., 1996, The Role of System Dynamics in Project Management International. Journal of Project Management, 14, pp 213-220.

Ruzicka, M. and Leenen, F.H., 2002, Combination Therapy as First-Line Treatment of Arterial Hypertension. Canadian Journal of Cardiology, 18, pp 1317-1327.
Shah, N. 2004, Pharmaceutical Supply Chains: Key Issues and Strategies for Optimization. Computers and Chemical Engineering, 28, pp 929-941.

Sterman, J.D., 2001, System Dynamics Modeling: Tools for Learning in a Complex World. California Management Review, 43, pp 8-25.

Szalkai, Z. 2004, Relationship Marketing in the Pharmaceutical Market – Analysis of the Hungarian Case. Periodica Polytechnica Social and Management Sciences, 12, pp 177–188.

Trisolini, M.G., 2002, Applying Business Management Models in Health Care. International Journal of Health Planning and Management, 17, pp 295-314.

Cohen, S. and Roussel, J.著; 陳琇玲譯, 2005, 供應鏈策略管理五大修練: 成功落實供應鏈管理，提昇企業營收與純益，締造組織高績效。 初版, 台北市, 麥格羅希爾。

Gorchels, L.著; 戴維儂譯, 2003, 產品經理的第一本書: 完全剖析產品管理關鍵領域,提升企業獲利率與競爭力。 初版, 台北市, 麥格羅希爾。

Kolter, P.著; 高更第譯, 2000, 科特勒談行銷: 如何創造、贏取並主宰市場。 初版, 台北市, 遠流出版事業股份有限公司。

McGrath, M.E.著; 陳正芬、陳儀譯, 2004, 產品研發管理: 加速生產循環、提高製程績效、降低營運成本的全方位指南。 初版, 台北市, 麥格羅希爾。

NHI, http://www.nhiI.gov.tw/.

Robinson, J.著; 廖月娟譯, 2002, 一顆價值十億元的藥丸:人命與金錢的交易。 台北市, 時報出版

Simon, F. and Kolter, P.合著; 李振昌譯, 2005, 打造全球生技品牌。 第一版, 台北市, 天下遠見出版股份有限公司。

巫文玲、湯谷清, 2003, 醫藥產業年鑑. 生物技術開發中心。

專利法, 經濟部智慧財產局, http://www.tipo.gov.tw/.