Microeconomic and Quantitative Analysis of the National Heath Insurance Drug Price System in Japan

• Project/Area Number: 16K03700
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Research Field: Public finance/Public economy
• Research Institution: Nagoya City University (2017-2022); Kyoto University (2016)
• Principal Investigator: Wakutsu Naohiko 名古屋市立大学, 大学院経済学研究科, 准教授 (80638130)
• Project Period (FY): 2016-04-01 – 2023-03-31
• Project Status: Completed (Fiscal Year 2022)
• Budget Amount: ¥4,550,000 (Direct Cost: ¥3,500,000、Indirect Cost: ¥1,050,000); Fiscal Year 2020: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000); Fiscal Year 2019: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000); Fiscal Year 2018: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000); Fiscal Year 2017: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000); Fiscal Year 2016: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000)
• Keywords: 薬価制度 / 研究開発インセンティブ / ドラッグラグ / 医療保険財政 / リスク回避 / ドラッグ・ロス / リスク / リスク回避度 / ドラッグ・ラグ / 医薬品開発ラグ / 製薬企業 / 薬価算定リスク / シミュレーション / 薬価推移

Outline of Final Research Achievements

Due to severe financial conditions and unmet medical needs, the Japanese government must prioritize both R&D incentives and drug prices/expenditures. Hence, it is important to find ways to achieve higher R&D incentives without raising drug prices/expenditures. This study aims at considering such policy measures by conducting microeconomic and quantitative analyses of the National Health Insurance drug price system and pharmaceutical firms operating in Japan with focus on the so-called Price Maintenace Premium introduced in 2010, the development lag between Japan and the United States and risks faced by pharmaceutical firm about market launch in Japan. The results of this study were presented at the international conferences and published in international referred academic journals.

Academic Significance and Societal Importance of the Research Achievements

新薬開発ラグは国民の医薬品アクセスを阻害させるため社会的に重要な問題であるが、近年の開発状況の実証研究はほとんど行われていない。また、持続的な医療保険制度のためには薬価に頼らない研究開発インセンティブの維持・向上策の検討が重要であるが、定量的な分析はこれまでなかった。社会的重要性と研究蓄積において本研究の意義は大きい。

Research Products

• [Journal Article] An Empirical Analysis of Japan's Drug Development Lag Behind the United States (2022)
  • Author(s): Nakamura Hiroshi、Wakutsu Naohiko、Murayama Satoshi、Suzuki Takeshi
  • Journal Title: The Journal of Clinical Pharmacology Volume: - Issue: 7 Pages: 847-854
  • DOI: 10.1002/jcph.2023
  • Peer Reviewed / Open Access
• [Journal Article] Reducing Reimbursement Drug Price Risk to Enhance R&D Incentives without Raising Drug Prices/Expenditures: Implications of Simulations Based on Questionnaire Survey of Pharmaceutical Companies in Japan (2020)
  • Author(s): Hiroshi Nakamura and Naohiko Wakutsu
  • Journal Title: Health Policy Volume: - Issue: 7 Pages: 714-720
  • DOI: 10.1016/j.healthpol.2020.03.010
  • Peer Reviewed
• [Journal Article] Reducing pharmaceutical reimbursement price risk to lower national health expenditures without lowering R&D incentives (2018)
  • Author(s): Nakamura Hiroshi、Wakutsu Naohiko
  • Journal Title: International Journal of Economic Policy Studies Volume: 13 Issue: 1 Pages: 75-88
  • DOI: 10.1007/s42495-018-0002-7
  • Peer Reviewed
• [Journal Article] Reducing Pharmaceutical Reimbursement Price Risk to Lower National Health Expenditures without Lowering R&D Incentives (2018)
  • Author(s): Hiroshi Nakamura and Naohiko Wakutsu
  • Journal Title: International Journal of Economic Policy Studies Volume: 12
  • Peer Reviewed / Open Access
• [Journal Article] 医療保険財政負担軽減と研究開発インセンティブ低下抑制の両立に向けた政策検討における割引率の活用 ―新薬創出等加算のシミュレーションによる経済分析― (2016)
  • Author(s): 和久津尚彦・中村洋・柿原浩明
  • Journal Title: 医療経済研究 Volume: 28 Pages: 88-102
  • NAID: 40021137643
  • Peer Reviewed / Acknowledgement Compliant
• [Presentation] “Does ‘Drug Lag’ Still Exist in Japan? An Empirical Analysis of the Development Lag behind the U.S.” (2020)
  • Author(s): Naohiko Wakutsu, Hiroshi Nakamura, Takeshi Suzuki and Satoshi Murayama,
  • Organizer: EUHEA Conference 2020, Oslo (virtual)
  • Int'l Joint Research
• [Presentation] “An Empirical Analysis of the Development Lag behind the U.S.” (2020)
  • Author(s): Naohiko Wakutsu, Hiroshi Nakamura, Takeshi Suzuki and Satoshi Murayama,
  • Organizer: 19th International Conference of the Japan Economic Policy Association, 広島（オンライン）
  • Int'l Joint Research
• [Presentation] 和久津尚彦・中村洋 (2020)
  • Author(s): 「医薬品開発促進における非価格面／価格面でのリスク低減のインセンティブ・ミックスの重要性」
  • Organizer: 医療経済学会第15回研究大会, 東京（オンライン）
• [Presentation] Reducing Reimbursement Drug Price Risk to Enhance R&D Incentives without Raising Drug Prices/Expenditures: Questionnaire Survey and Simulation Results (2019)
  • Author(s): Naohiko Wakutsu and Hiroshi Nakamura
  • Organizer: 2019 iHEA World Congress
  • Int'l Joint Research
• [Presentation] Does "Drug Lag" Still Exist in Japan? An Empirical Analysis of the Development Lag behind the U.S. (2019)
  • Author(s): Naohiko Wakutsu, Hiroshi Nakamura, Takeshi Suzuki, Satoshi Murayama
  • Organizer: 18th International Conference of the Japan Economic Policy Association
  • Int'l Joint Research
• [Presentation] ドラッグ・ラグは解消したのか？開発ラグに焦点を当てたドラッグ・ラグの実証分析 (2019)
  • Author(s): 和久津 尚彦, 中村洋, 鈴木岳, 村山聡史
  • Organizer: 医療経済学会第14回研究大会
  • Int'l Joint Research
• [Presentation] Reducing Pharmaceutical Reimbursement Price Risk to Lower National Health Expenditures without Lowering R&D Incentives (2017)
  • Author(s): Naohiko Wakutsu and Hiroshi Nakamura
  • Organizer: 12th World Congress of International Health Economics Association
  • Int'l Joint Research
• [Presentation] 医療保険財政・患者負担軽減と研究開発インセンティブ維持・向上の両立に向けた保険償還価格の算定リスクに関する不確実性低下の効果分析と考察 (2017)
  • Author(s): 和久津 尚彦・中村 洋
  • Organizer: 医療経済学会第12回研究大会 2017年
• [Presentation] Reducing Pharmaceutical Reimbursement Price Risk to Lower the National Health Expenditures without Lowering R&D Incentives: Questionnaire Survey and Simulation Results (2017)
  • Author(s): Naohiko Wakutsu and Hiroshi Nakamura
  • Organizer: 16th International Conference of the Japan Economic Policy Association
  • Int'l Joint Research
• [Presentation] Reducing Pharmaceutical Reimbursement Price Riskto Lower National Health Expenditures but not to Lower R&D Incentives (2016)
  • Author(s): Naohiko Wakutsu and Hiroshi Nakamura
  • Organizer: 15th International Conference of Japan Economic Policy Association
  • Place of Presentation: Hokaido University of Education
  • Year and Date: 2016-10-29
  • Int'l Joint Research
• [Presentation] 医療保険財政・患者負担軽減と研究開発インセンティブ維持・向上の両立に向けた保険償還価格に関するリスク低下の効果分析と考察：予備的研究 (2016)
  • Author(s): 和久津尚彦・中村洋
  • Organizer: 医療経済学会
  • Place of Presentation: 早稲田大学
• [Book] 薬価の経済学 (2018)
  • Author(s): 小黒 一正、菅原 琢磨
  • Total Pages: 304
  • Publisher: 日本経済新聞出版社
  • ISBN: 9784532134860