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インドの医療制度における薬価設定と償還制度:薬価償還の低さが自己負担分の増加に

Pricing and Reimbursement of the Healthcare System in India - Low Levels of Drug Reimbursement Lead to a High Out-Of-Pocket Expenditure

発行 GBI Research 商品コード 235094
出版日 ページ情報 英文 57 Pages
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インドの医療制度における薬価設定と償還制度:薬価償還の低さが自己負担分の増加に Pricing and Reimbursement of the Healthcare System in India - Low Levels of Drug Reimbursement Lead to a High Out-Of-Pocket Expenditure
出版日: 2012年03月23日 ページ情報: 英文 57 Pages
概要

当レポートでは、インドの医療制度について調査分析し、インドの薬事規制の詳細とともに、薬価設定と償還プロセスについて検証し、現状と問題点、将来予測なども含めて、概略以下の構成でお届けいたします。

第1章 目次

第2章 イントロダクション

第3章 概要

  • インドの医療制度について
    • 医療費はGDPと連動
    • 公的医療費の推計(GDPとの比較:%)
    • 一人当たり医療費
    • 自己負担の医療費(民間医療費との比較:%)
    • 年齢別人口
  • 公的医療制度
    • 公的部門の医薬品流通
  • 民間医療制度
  • 医療施設における医薬品使用の根拠

第4章 インドの薬事規制の概要

  • インドの製薬業界のPEST分析
  • インドの医薬品部門の規制機関
    • 国家医薬品価格局(NPPA)
    • 医薬品価格規制令(DPCO)
    • 医薬品政策(2002年)

第5章 薬価設定

  • イントロダクション
  • 薬価設定の手順
    • 必須医薬品リスト(EDL)の価格設定
    • 必須医薬品の価格設定の方法
    • 医薬品の価格決定要因
    • 価格管理用の医薬品選定の基準
  • 製剤の価格設定
  • 価格の年末調整
  • 国家医薬品価格政策(2011年)による値下げ販売
  • ブランドのジェネリック医薬品シェア
    • インド固有の価格設定
    • 特許薬に対する価格設定アプローチ
    • オーファンドラッグ(希少薬)の価格設定
    • Jan Aushadhiの店舗

第6章 償還シナリオ

  • イントロダクション
  • 医療保険
  • インドの医療費償還
  • 他国における償還政策
  • 自己負担の医療費
  • 世界の医療費
  • 薬価償還政策の動向

第7章 結論

第8章 付録

図表

目次

Summary

India has a dual system of care: a private fee-for-service based sector where the money is paid Out-Of-Pocket (OOP) by individual households and a tax-based public sector where the providers are salaried. The utilization of insurance under both these systems is partly restricted by the affordability of the individual household and availability of the budget. On the other hand, insurance, as a means of financing, is a far more sophisticated mechanism, requiring a comprehensive understanding of the failures that characterize health insurance markets. Despite the improving health status of the Indian population, healthcare infrastructure in India is far from achieving 100% quality, technology and superior healthcare delivery systems. While the Central Government is limited to family welfare and disease control programs, the state governments are responsible for primary and secondary medical care, with a limited role in specialty care. Looking at the healthcare indicators and the growing prevalence of non-communicable lifestyle related diseases, both the government and private sector realize the need to meet this basic demand. Today, the private sector provides 80 percent of the healthcare service.

Scope

  • Detailed study of the healthcare systems and roles of the key insurance players in the drug reimbursement process
  • Analysis of the major pricing and reimbursement mechanisms in India.
  • Key trends that follow from the recent changes brought about in the pricing and reimbursement mechanism.
  • Build an understanding of the possible major challenges brought about by the enactment of changes in the pricing and reimbursement scene in India.

Reasons to buy

  • Build understanding of the pharmaceuticals related key pricing and reimbursement mechanisms in India and also specifically in some states of India.
  • Optimize your investment through the identification and understanding of the changes in the pharmaceuticals regulatory mechanism in the Indian economy.
  • Develop effective business strategies related to new drug launches through the analytical insight gained from key trends in the pricing and reimbursement scene of India.
  • Improve negotiations with the government agencies to maximize reimbursement on the drugs by understanding the mechanism.

Executive Summary

GBI Research, the leading business intelligence provider, has released its latest research “Pricing and Reimbursement of the Healthcare System in India - Low Levels of Drug Reimbursement Lead to a High Out-Of-Pocket Expenditure”. It provides a comprehensive overview of the healthcare system, and pricing and reimbursement process in India with a detailed analysis of the different regulatory mechanisms used in India. The report closely scrutinizes the major changes in pharmaceuticals related pricing and reimbursement in the recent past and the impact these changes will have in the future. The health insurance is responsible for facilitating demand by making the high-cost prescription drugs more affordable. Although the per capita income is rising in India, the modest income of most of the population keeps the high cost drugs and medicines unattainable. Drugs would become more costly with the enforcement of product patents and so sales of the expensive drugs depend on the growth and the maturity of the health insurance sector. If the health insurance industry does not mature, the market for patented drugs would experience adverse effects. The next three to five years will see significant growth and change in the Indian health insurance industry as new insurance players and insurance products respond to the increased demand.

GBI Research analyzes that the Indian pharmaceutical market is characterized by differences in prices for the same product and high profits, apart from marketing and the selling of unnecessary combinations. Drug pricing is an important issue confronting the Indian government. Due to intense competition, the drug prices are already the lowest in the world. The government should take a holistic view of healthcare costs and pursue a broader set of initiatives to ensure the access and affordability of the medicines to the common people.

High Out-Of-Pocket Expenditure of 78% Limits Healthcare Spending

The figure, above, depicts the breakdown of healthcare expenditure in India, in 2010. Out-of-Pocket (OOP) expenses account for 78% of the total healthcare expenditure followed by government spending at 20%. The insurance sector accounts for 2% of the healthcare expenditure in India. India's per capita healthcare expenditure is low due to its billion-plus population and low per capita income.

Reference Pricing can be Adopted for Generic Products and “Me-Too” Branded Products

One of the major reasons behind the increasing popularity of reference pricing is the increasing pressure felt by the reimbursement agencies for healthcare expenditures. Reference pricing allows a country to set minimum possible rates for a particular drug. It is generally adopted for generic products and "me-too" branded products for which comparable references are present in other geographical regions. Innovative products are generally excluded from reference pricing.

The National Pharmaceutical Pricing Authority (NPPA) has asked the government to negotiate the prices of patented medicines used by a central agency, based on a reference pricing system. The central agency should estimate the market potential of new patented drugs and negotiate their prices based on market levels where the purchasing power parity (PPP) and the per capita income of the people of India are comparable. A reference price should then be set based on the average or the lowest of the reference countries' prices.

Annual Turnover and the Demand of a Drug are the Main Rationale to Fix the Price of a Drug

The annual turnover helps in identifying the drugs of mass consumption; the drugs are selected based on their annual consumption and demand as well as their annual revenues. This leads to the exclusion of those that may not be drugs of mass consumption but still critical or life-saving.

Demand elasticity varies with the form of payment; it is directly proportional to the OOP expenditures. The larger is the proportion of OOP expenditures, the larger the elasticity. In the case of medicines, the elasticity of demand would vary with the urgency of the situation. In all circumstances, the demand for medicines will be less elastic than that for many other consumer products. In the developing countries like India, spending on medicines comes largely from household resources, contributing substantially to OOP expenditures. Therefore, the demand for pharmaceuticals is stronger and less elastic in developed countries like the US and the UK, compared to India.

Table of Contents

1. Table of Contents

  • 1.1. List of Tables
  • 1.2. List of Figures

2. Pricing and Reimbursement in India - Introduction

  • 2.1. GBI Research Report Guidance

3. Pricing and Reimbursement in India - Overview

  • 3.1. Introduction to Healthcare System in India
    • 3.1.1. Healthcare Expenditure Highly Correlated with GDP
    • 3.1.2. Estimated Public Health Spending as a Percentage of GDP
    • 3.1.3. Health Expenditure per Capita
    • 3.1.4. Out-of-Pocket Health Expenditure as a Percentage of Private Expenditure on Health
    • 3.1.5. Demographics by Age
  • 3.2. Public Healthcare System
    • 3.2.1. Drug Distribution in the Public Sector
  • 3.3. Private Healthcare System
  • 3.4. Rationale for Drug Use in the Healthcare Facilities

4. Pricing and Reimbursement in India- Overview of Pharmaceutical Regulations in India

  • 4.1. PEST Analysis of the Pharmaceutical Industry in India
  • 4.2. Regulatory Bodies in the Indian Pharmaceutical Sector
    • 4.2.1. National Pharmaceutical Pricing Authority (NPPA)
    • 4.2.2. Drug Prices Control Order (DPCO)
    • 4.2.3. The Pharmaceutical Policy, 2002

5. Pricing and Reimbursement in India- Pricing of Drugs

  • 5.1. Introduction
    • 5.1.1. Price Registration Process in India
    • 5.1.2. International Price Comparison
  • 5.2. Price Setting Procedures
    • 5.2.1. Essential Drugs List (EDL) Pricing
    • 5.2.2. Pricing Methodology for the Essential Drugs
    • 5.2.3. Factors Determining the Pricing of the Drugs
    • 5.2.4. Criteria for Selection of Drugs for Price Control
  • 5.3. Pricing of Formulations
  • 5.4. Annual Price Adjustments
  • 5.5. Distribution of the Price Reduction Under National Pharmaceuticals Pricing Policy 2011
  • 5.6. Branded Generics Share
    • 5.6.1. India-Specific Pricing
    • 5.6.2. Pricing Approach to Patented Drugs
    • 5.6.3. Pricing of the Orphan Drugs
    • 5.6.4. Introduction of the Jan Aushadhi Shops

6. Pricing and Reimbursement in India - Reimbursement Scenario in India

  • 6.1. Introduction
  • 6.2. Health Insurance
    • 6.2.1. Central Government Health Scheme
    • 6.2.2. Employees State Insurance Scheme
  • 6.3. Medical Reimbursement in India
    • 6.3.1. Reimbursement Plans of Major Insurance Players
    • 6.3.2. Private and Public Sector Insurance Companies in India
  • 6.4. Reimbursement Policies in Other Countries
  • 6.5. Out-of-Pocket (OOP) Expenditures
    • 6.5.1. Co-Payment
    • 6.5.2. Out-of-Pocket Expenditures in India
    • 6.5.3. Comparison of OOP Expenditures
    • 6.5.4. Irrational Drug Usage
  • 6.6. Universal Health Care
  • 6.7. Trends in Drug Reimbursement Policies
    • 6.7.1. Health insurance Scenario in India
    • 6.7.2. Challenges in Health Insurance

7. Pricing and Reimbursement in India - Conclusion

8. Pricing and Reimbursement in India - Appendix

  • 8.1. Market Definitions
  • 8.2. Abbreviations
  • 8.3. Research Methodology
    • 8.3.1. Coverage
    • 8.3.2. Secondary Research
    • 8.3.3. Primary Research
    • 8.3.4. Expert Panels
  • 8.4. Contact Us
  • 8.5. Disclaimer
  • 8.6. Sources

List of Tables

  • Table 1: Pricing and Reimbursement in India, Centre's Expenditure on Health and Family Welfare, 2004-2010
  • Table 2: Pricing and Reimbursement in India, Estimated Public Health Spending (%) of the BRIC nations, the US, the UK and Japan, 2010-2050
  • Table 3: Pricing and Reimbursement in India, Health Expenditure per Capita ($), BRIC, The US, The UK, Japan, 2006-2009
  • Table 4: Pricing and Reimbursement in India, Out-of-Pocket Health Expenditure as a Percentage of Private Expenditure on Health, (%), BRIC, The US, The UK, Japan, 2006-2009
  • Table 5: Pricing and Reimbursement in India, Demography by Age, 2011
  • Table 6: Pricing and Reimbursement in India, Public Healthcare System in India & The US (Rate), 2010
  • Table 7: Pricing and Reimbursement in India, Rationale for Drug Use in India by WHO, 2010
  • Table 8: Pricing and Reimbursement in India, Essential Drugs List, 2011
  • Table 9: Pricing and Reimbursement in India, Categories of Drugs and MAPE, DPCO 1979
  • Table 10: Pricing and Reimbursement in India, Number of Drugs under DPCO, Year-on-Year 1970-2011
  • Table 11: Pricing and Reimbursement in India, Distribution of the Price Reduction of Drug, 2011
  • Table 12: Pricing and Reimbursement in India, Drug Price Comparison, Market Price & Jan Aushadhi Price, 2011
  • Table 13: Pricing and Reimbursement in India, Non-Profit Social Insurance Schemes in India, 2011
  • Table 14: Pricing and Reimbursement in India, Health Insurance Policy of the OICL, 2011
  • Table 15: Pricing and Reimbursement in India, Private and Public Sector Health Insurance Companies, 2011
  • Table 16: Pricing and Reimbursement in India, Reimbursement Policies in the Top Five Countries of Europe, 2011
  • Table 17: Pricing and Reimbursement in India, Co-Payments in Other Countries, 2011
  • Table 18: Pricing and Reimbursement in India, Out-of-Pocket Expenditures in India, 2011
  • Table 19: Pricing and Reimbursement in India, Comparison of OOP Expenditures, 2011
  • Table 20: Pricing and Reimbursement in India, Irrational Drug Usage in India, 2010
  • Table 21: Pricing and Reimbursement in India, Percentage of Untreated Population in India, 2010
  • Table 22: Pricing and Reimbursement in India, Difference between Co-op and Market Price of Generic Medicines, 2011
  • Table 23: Pricing and Reimbursement in India, Trends in Indian Healthcare Industry, 2011

List of Figures

  • Figure 1: Pricing and Reimbursement in India, Healthcare Expenditure in India, 2010
  • Figure 2: Pricing and Reimbursement in India, PEST Analysis of the Indian Healthcare Industry
  • Figure 3: Pricing and Reimbursement in India- Pricing of Bulk Drugs in India, 2011
  • Figure 4: Pricing and Reimbursement in India, Price Registration Process in India, 2011
  • Figure 5: Pricing and Reimbursement in India, Value-Based Pricing, 2010
  • Figure 6: Pricing and Reimbursement in India, Impact Analysis - Reference Pricing, 2010
  • Figure 7: Pricing and Reimbursement in India, Factors Determining the Pricing of the Drugs, 2011
  • Figure 8: Pricing and Reimbursement in India, Pricing of Formulations in India, 2011
  • Figure 9: Pricing and Reimbursement in India, Trends in Drug Prices, 1995-2010
  • Figure 10: Pricing and Reimbursement in India, Branded Generics Share in India, 2010
  • Figure 11: Pricing and Reimbursement in India, India-Specific Pricing, 2010
  • Figure 12: Pricing and Reimbursement in India, Concerns Regarding the Pricing of the Patented Drugs
  • Figure 13: Pricing and Reimbursement in India, Global Pricing of Orphan Drugs, 2010
  • Figure 14: Pricing and Reimbursement in India, Challenges in Indian Healthcare System, 2011
  • Figure 15: Pricing and Reimbursement in India, Health Insurance in India, 2011
  • Figure 16: Pricing and Reimbursement in India, Specific Disorders Not Covered in the Policy, 2011
  • Figure 17: Pricing and Reimbursement in India, Out-of-Pocket Expenditures in India, 2011
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