• English
  • Korean
  • Chinese
表紙
市場調査レポート - 230024

米国における医薬品代還付制度と薬価設定方法―メディケア未加入の低所得者向け助成金非受給者にジェネリック薬の自己負担分減額がにもたらす利益

Pricing and Reimbursement in the US - Non-LIS Beneficiaries Not Covered by Medicare Coverage Gap to Gain from Reduction in Out-of-Pocket Expenditure for Generic Drugs

発行 GBI Research
出版日 ページ情報 英文 75 Pages
電子版即納可
価格
米国における医薬品代還付制度と薬価設定方法―メディケア未加入の低所得者向け助成金非受給者にジェネリック薬の自己負担分減額がにもたらす利益 Pricing and Reimbursement in the US - Non-LIS Beneficiaries Not Covered by Medicare Coverage Gap to Gain from Reduction in Out-of-Pocket Expenditure for Generic Drugs
出版日: 2012年02月01日 ページ情報: 英文 75 Pages
概要

当レポートは、米国の医療制度と薬価設定・医薬品代還付制度について調査分析し、ここ数年におけるこれらの変化と将来への影響、およびジェネリック薬を含めた治療薬の薬価制定・還付制度に対する官民の方針や努力についてまとめ、概略下記の内容でお届けするものです。

目次

第1章 目次

第2章 イントロダクション

  • GBI調査報告書に関するガイダンス

第3章 米国の医療制度―概観

  • 医療費
    • 医療費とGDP
    • カテゴリー別にみた医療費
  • 医療インフラ
    • 病院
    • 病床
    • 医療専門家
  • 医療保険
    • 補償内容
    • 医療保険提供者
  • 医療制度に影響を及ぼす人口動向
    • 人口統計

第4章 米国の薬事関連法―概観

  • 米国の製薬業界
  • 保健医療関連規則

第5章 米国における薬価設定

  • 概観
  • 主な動向
  • 主な課題

第6章 米国における医薬品代還付制度

第7章 米国における薬価設定と医薬品代還付制度―主な治療分野

第8章 付録

目次

Abstract

Summary

GBI Research has found that expenditures towards healthcare have increased in the US which has led to an increased life expectancy among the Americans. When compared to the top five countries of Europe (France, Germany, the UK, Italy and Spain), the US has the highest per capita expenditures on healthcare. Out-of-pocket spending is minimal in the US, due to a strong reimbursement system provided by the public and private sector, that covers most age groups and communities. A majority of the US population is under insurance coverage, with private health insurance having a larger share than government health insurance. Most of the states have developed their own insurance plans for the benefit of their residents.

With an increase in the working class and ageing population, chronic diseases, age-related diseases and diseases due to sedentary lifestyle are expected to rise in the future indicating increasing healthcare expenditures. The US President has been implementing a number of changes in the reimbursement system in order to reduce national deficits. The Patient Protection and Affordable Care Act (PPACA) has been introduced to take care of the deficits. The US budget has been designed to reduce deficits and bring about major reforms in the healthcare system of the US.

Scope

  • Detailed study of the healthcare systems in the US.
  • Political, economical, social and technological analysis of the US pharmaceutical industry.
  • Analysis of the pricing and reimbursement mechanisms in the US.
  • Key trends that follow from the recent changes brought about in the pricing and reimbursement system.
  • Build an understanding of the possible major challenges that may arise due to the changes in the pricing and reimbursement scene in the US.
  • Insight into various reimbursement programs in the US with case studies.
  • Particular focus on the pricing and reimbursement in major therapy areas with case studies.

Reasons to buy

  • Build an understanding of the pharmaceuticals-related key pricing and reimbursement mechanisms in the US.
  • Optimize your investment through identification and understanding of the changes in the pharmaceuticals regulatory mechanism in the US.
  • Develop effective business strategies related to new drug launches through the analytical insight gained from key trends in the pricing and reimbursement scene of the US.
  • Improve negotiations with the government agencies to maximize reimbursement of drugs by understanding the mechanisms involved.

Executive Summary

GBI Research, the leading business intelligence provider, has released its latest research “Pricing and Reimbursement in the US - Non-LIS Beneficiaries Not Covered by Medicare Coverage Gap to Gain from Reduction in Out-of-Pocket Expenditure for Generic Drugs”. The report provides a comprehensive overview of the healthcare system, and pricing and reimbursement process in the US with key data, information and analysis of pricing and reimbursement decisions across the US. The report closely scrutinizes major changes in pharmaceuticals-related pricing and reimbursement in the US in the recent past and the impact these changes will have in the future. It also describes the efforts taken by the US government and private sector in shaping the pricing and reimbursement policies of brand name and generic drugs. The pricing and reimbursement scenario in some of the major therapy areas of the US has been described with the help of informative case studies.

Focus Shifting Towards Generic Drugs

The global pharmaceutical market is valued at approximately $850 billion, of which the US market is valued at over $300 billion. Sales of generic drugs totaled $43 billion in 2010, in the US. Of all the prescriptions dispensed, generics constituted a majority share of 75% in 2010, in the US. The US President has recently pledged to accelerate the availability of generic drugs in the market and ban pay-for-delay agreements. The availability of generic drugs will be enhanced by preventing companies to enter anti-competitive agreements. The proposal made by the US government accelerates access to affordable generic drugs by granting brand biologic manufacturers seven years of exclusivity replacing the 12 years, while retaining appropriate incentives for research and development (R&D) for the innovation of breakthrough products.

It has been observed that as more generic manufacturers produce a certain drug, prices of the generic drug falls significantly. This reduction in average price of generic drugs is observed every year. The retail price index for generic drugs decreased at an average annual rate of -1.1% over the past two years. Moreover, discounts on generic drugs will increase from 2011 to 2020 as the generic drug costs paid out-of-pocket by non-Low-Income Subsidy (LIS) beneficiaries in the coverage gap will gradually reduce from 93% in 2011 to 25% in 2020. The majority cost sharing will be undertaken by the Medicare Part D (MPD) plan as it will pay 75% of the generic drug costs by 2020.

Increasing Healthcare Expenditures has Improved Life Expectancy of Americans

Healthcare expenditure has increased gradually from 13.7% of GDP in 1995 to 17.4% of GDP in 2009, according to the Organization for Economic Co-operation and Development (OECD). Per capita spending on healthcare has also improved, from $4,703 in 2000 to $7,410 in 2009, in purchasing power parity (PPP) terms. The increased spending towards healthcare has led to an improved life expectancy. Americans had a life expectancy of 75.7 years at birth in 1995, which has increased to 79 years with the increase in healthcare spending.

Huge Deficits Provoking Cuts in Rebates

The Affordable Care Act (ACA) has been implemented to reduce federal deficits by approximately $230 billion over next decade by delivering better healthcare at lesser costs; provisions to fight waste, fraud and abuse; rewards for high quality care; and innovative healthcare delivery systems. In addition, a proposal to cut $320 billion from US health programs was announced by the US President Barack Obama on September 19, 2011.

Medicare Part B reimburses drugs and biologics medicines indicated for cancer and other serious diseases. In order to reduce the US debt limits, $3 billion in cuts towards payments for Part B drugs has been proposed by the government. Medicare Part B reimbursement had been reformed earlier in 2003 as part of Medicare Modernization Act, in which reimbursement for drugs and biologicals covered under Part B had been reduced significantly. Enacting further cuts in payments to the Medicare Average Sales Price (ASP) system, which includes actual prices paid by physicians and other drug purchasers, may hinder Part B-related healthcare services.

Table of Contents

1. Table of Contents

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

2. Pricing and Reimbursement in the US - Introduction

  • 2.1. GBI Research Report Guidance

3. Healthcare System in the US - Overview

  • 3.1. Healthcare Expenditure
    • 3.1.1. Healthcare Expenditure and GDP
    • 3.1.2. Healthcare Expenditure by Category
  • 3.2. Healthcare Infrastructure
    • 3.2.1. Hospitals
    • 3.2.2. Hospital Beds
    • 3.2.3. Healthcare Professionals
  • 3.3. Health Insurance
    • 3.3.1. Health Insurance Coverage
    • 3.3.2. Health Insurance Providers
  • 3.4. Demographic Trends Affecting Healthcare
    • 3.4.1. Population Demography

4. Pharmaceutical Regulations in the US - Overview

  • 4.1. Pharmaceutical Industry in the US
    • 4.1.1. PEST Analysis
  • 4.2. Healthcare Regulation
    • 4.2.1. Highlights of the Budget 2011-2012

5. Pricing of Pharmaceutical Drugs in the US

  • 5.1. Pricing Overview
    • 5.1.1. Regulatory Bodies
    • 5.1.2. Pricing Control
    • 5.1.3. 340B Drug Pricing Program
  • 5.2. Key Trends
    • 5.2.1. Brand Name Drug Prices Increase in the Face of Generic Competition
    • 5.2.2. Significant Decrease in Average Price of Generic Drugs
    • 5.2.3. PPACA Introduced by the US President to Tackle Soaring Prescription Drug Prices
    • 5.2.4. Generic Price War at Retail Sector
  • 5.3. Major Challenges
    • 5.3.1. Reducing Wastage in Healthcare Spending
    • 5.3.2. Government's Cost Rationalization Efforts will make Future Tough for Big Pharmaceutical Companies
    • 5.3.3. Medicaid Pricing for Dual Eligibles of Medicare Part - D
    • 5.3.4. New ICD-10 (International Classification of Diseases) Coding System
    • 5.3.5. Medicare Part B Drug Pricing Does Not Reflect Market Price Accurately

6. Reimbursement of Pharmaceutical Drugs in the US

  • 6.1. Regulatory Bodies
  • 6.2. Prescription Drugs
  • 6.3. Biologics
  • 6.4. Preferred Drug List (PDL)
  • 6.5. Reimbursement by Health Insurance Companies
    • 6.5.1. UnitedHealth Group
    • 6.5.2. WellPoint, Inc.
    • 6.5.3. Kaiser Foundation Group
    • 6.5.4. Humana Group
    • 6.5.5. Aetna Group
  • 6.6. Pharmacy Benefit Managers (PBMs)
  • 6.7. Reimbursement Programs in the US
    • 6.7.1. Case Studies
  • 6.8. Key Trends
    • 6.8.1. Rebate Reforms and Healthcare Cuts to Reduce Federal Deficit
    • 6.8.2. Medicare Part D Changes in Standard Benefit Parameters
    • 6.8.3. Reimbursement of Brand Name Drugs
    • 6.8.4. Reimbursement of Generic Drugs
    • 6.8.5. CMS Finalizes Medicare Hospital Outpatient Payment Rates for 2012
  • 6.9. Major Challenges
    • 6.9.1. New Nationwide Database to Set Healthcare Reimbursement Rates
    • 6.9.2. First DataBank/Medi-Span Settlement and the Impact on AWP
    • 6.9.3. Renewal of Medicaid Drug Payment Policy
    • 6.9.4. Proposed Cuts in Medicare Part B Reimbursement
    • 6.9.5. New Trend in Free Trade Agreements Could Affect Healthcare Programs

7. Pricing and Reimbursement in the US - Major Therapy Areas

  • 7.1. Pricing and Reimbursement in Major Therapy Areas
    • 7.1.1. Heart Diseases
    • 7.1.2. Cancer
    • 7.1.3. Respiratory Diseases
    • 7.1.4. Cerebrovascular Diseases
    • 7.1.5. Other Major Therapy Areas
  • 7.2. Case Studies
    • 7.2.1. Provenge under Medicare Coverage
    • 7.2.2. AstraZeneca Ensures Reimbursement of Brilinta
    • 7.2.3. Financial Assistance for Orphan Drug Letairis
    • 7.2.4. Coverage for Biologic Product Enbrel

8. Pricing and Reimbursement in the US - Appendix

  • 8.1. Market Definitions
  • 8.2. Abbreviations
  • 8.3. Research Methodology
    • 8.3.1. Healthcare System
    • 8.3.2. Pharmaceutical Regulations
    • 8.3.3. Pricing of Pharmaceutical Drugs
    • 8.3.4. Reimbursement of Pharmaceutical Drugs
    • 8.3.5. Pricing and Reimbursement in Major Therapy Areas
  • 8.4. Contact Us
  • 8.5. Disclaimer
  • 8.6. Sources

List of Tables

  • Table 1: Pricing and Reimbursement in the US, Healthcare Expenditure as % of GDP versus Life Expectancy at Birth in Years, 1995-2009
  • Table 2: Pricing and Reimbursement in the US, Comparison of Per Capita GDP and Per Capita Total Expenditure on Health ($ PPP), 2000-2009
  • Table 3: Pricing and Reimbursement in the US, Per Capita Total Expenditure on Health ($ PPP), The US versus Top Five Countries of Europe, 2009
  • Table 4: Pricing and Reimbursement in the US, Total Expenditure on Health as % of GDP, The US versus Top Five Countries of Europe, 2009
  • Table 5: Pricing and Reimbursement in the US, National Healthcare Expenditure ($bn), By Category, 2009
  • Table 6: Pricing and Reimbursement in the US, Per Capita National Healthcare Expenditure ($ PPP), By Type, 2009
  • Table 7: Pricing and Reimbursement in the US, Out-of-Pocket Expenditure on Health (% of Total Healthcare Expenditure), The US versus Top Five Countries of Europe, 2009
  • Table 8: Pricing and Reimbursement in the US, National Healthcare Expenditure (%), Type of Sponsor, 2009
  • Table 9: Pricing and Reimbursement in the US, Type and Number of Hospitals, 2011
  • Table 10: Pricing and Reimbursement in the US, Healthcare Professionals, 2010
  • Table 11: Pricing and Reimbursement in the US, Health Insurance Coverage, Population (in million), 2009
  • Table 12: Pricing and Reimbursement in the US, Public and Private Health Insurance Coverage (% of Population), 2007-2009
  • Table 13: Pricing and Reimbursement in the US, Population Demography (Million), 2000-2010
  • Table 14: Pricing and Reimbursement in the US, Health Indicators, 2000-2010
  • Table 15: Pricing and Reimbursement in the US, Annual Retail Price Index Change in Brand Name Drugs and Generic Drugs (%), 2008-2010
  • Table 16: Pricing and Reimbursement in the US, Annual Price Index Change in Prescription Drugs (%), 2008-2010
  • Table 17: Pricing and Reimbursement in the US, Average Retail Coinsurance Rates (%), By Tier, 2009
  • Table 18: Pricing and Reimbursement in the US, Top Health Insurance Companies, Revenue ($bn), 2010
  • Table 19: Pricing and Reimbursement in the US, Reimbursement Programs, 2011
  • Table 20: Pricing and Reimbursement in the US, State Discount Programs, 2011
  • Table 21: Pricing and Reimbursement in the US, Medicare Part D Changes in Standard Benefit Parameters ($), 2008-2012
  • Table 22: Pricing and Reimbursement in the US, Brand Name Drug Cost-Sharing (%), 2011-2020
  • Table 23: Pricing and Reimbursement in the US, Generic Drug Cost-Sharing (%), 2011-2020
  • Table 24: Pricing and Reimbursement in the US, Major Therapy Areas by Mortality (%), 2009

List of Figures

  • Figure 1: Pricing and Reimbursement in the US, Healthcare Expenditure as % of GDP versus Life Expectancy at Birth in Years, 1995-2009
  • Figure 2: Pricing and Reimbursement in the US, Comparison of Per Capita GDP and Per Capita Total Expenditure on Health ($ PPP), 2000-2009
  • Figure 3: Pricing and Reimbursement in the US, Per Capita Total Expenditure on Health ($ PPP), The US versus Top Five Countries of Europe, 2009
  • Figure 4: Pricing and Reimbursement in the US, Total Expenditure on Health as % of GDP, The US versus Top Five Countries of Europe, 2009
  • Figure 5: Pricing and Reimbursement in the US, National Healthcare Expenditure (%), By Category, 2009
  • Figure 6: Pricing and Reimbursement in the US, National Healthcare Expenditure (% of Total Health Expenditure), By Type, 2009
  • Figure 7: Pricing and Reimbursement in the US, National Healthcare Expenditure (%), By Payer, 2009
  • Figure 8: Pricing and Reimbursement in the US, Out-of-Pocket Expenditure on Health (% of Total Healthcare Expenditure), The US versus Top Five Countries of Europe, 2009
  • Figure 9: Pricing and Reimbursement in the US, National Healthcare Expenditure (%), Type of Sponsor, 2009
  • Figure 10: Pricing and Reimbursement in the US, Total Hospital Beds per 1,000 patients, 2000-2009
  • Figure 11: Pricing and Reimbursement in the US, Health Insurance Coverage (% of Population), 2009
  • Figure 12: Pricing and Reimbursement in the US, Public Health Insurance Coverage (% of Population), 2009
  • Figure 13: Pricing and Reimbursement in the US, Private Health Insurance Coverage (% of Population), 2009
  • Figure 14: Pricing and Reimbursement in the US, Other Private and Government Insurance, 2011
  • Figure 15: Pricing and Reimbursement in the US, Public and Private Health Insurance Coverage (% of Population), 2007-2009
  • Figure 16: Pricing and Reimbursement in the US, Population by Age (Million), 2000-2010
  • Figure 17: Pricing and Reimbursement in the US, Pharmaceutical Industry, PEST Analysis, 2011
  • Figure 18: Pricing and Reimbursement in the US, Healthcare Regulation, Operating Divisions and their Functions, 2009
  • Figure 19: Pricing and Reimbursement in the US, Distribution Channel Logistics and Pricing, 2011
  • Figure 20: Pricing and Reimbursement in the US, Annual Retail Price Index Change in Brand Name Drugs and Generic Drugs (%), 2008-2010
  • Figure 21: Pricing and Reimbursement in the US, Annual Price Index Change in Prescription Drugs (%), 2008-2010
  • Figure 22: Pricing and Reimbursement in the US, ICD-10 Coding System; Features and Benefits
  • Figure 23: Pricing and Reimbursement in the US, Comparison Between Fee for Service, HMO and PPO, 2011
  • Figure 24: Pricing and Reimbursement in the US, Top Health Insurance Companies, Revenue ($bn), 2010
  • Figure 25: Pricing and Reimbursement in the US, Standard Medicare Part D Benefit, 2011-2020
  • Figure 26: Pricing and Reimbursement in the US, Brand Name Drug Cost-Sharing (%), 2011-2020
  • Figure 27: Pricing and Reimbursement in the US, Generic Drug Cost-Sharing (%), 2011-2020
  • Figure 28: Pricing and Reimbursement in the US, Major Therapy Areas by Mortality (%), 2009
Back to Top