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

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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

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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

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.

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.1 Table of Contents1 Table of Contents 31.1 List of Tables 51.2 List of Figures 62 Pricing and Reimbursement in the US - Introduction 72.1 GBI Research Report Guidance 83 Healthcare System in the US - Overview 93.1 Healthcare Expenditure 93.1.1 Healthcare Expenditure and GDP 93.1.2 Healthcare Expenditure by Category 133.2 Healthcare Infrastructure 193.2.1 Hospitals 193.2.2 Hospital Beds 203.2.3 Healthcare Professionals 203.3 Health Insurance 213.3.1 Health Insurance Coverage 213.3.2 Health Insurance Providers 223.4 Demographic Trends Affecting Healthcare 263.4.1 Population Demography 264 Pharmaceutical Regulations in the US - Overview 284.1 Pharmaceutical Industry in the US 284.1.1 PEST Analysis 284.2 Healthcare Regulation 304.2.1 Highlights of the Budget 2011-2012 315 Pricing of Pharmaceutical Drugs in the US 335.1 Pricing Overview 335.1.1 Regulatory Bodies 345.1.2 Pricing Control 345.1.3 340B Drug Pricing Program 355.2 Key Trends 355.2.1 Brand Name Drug Prices Increase in the Face of Generic Competition 355.2.2 Significant Decrease in Average Price of Generic Drugs 365.2.3 PPACA Introduced by the US President to Tackle Soaring Prescription Drug Prices 375.2.4 Generic Price War at Retail Sector 395.3 Major Challenges 405.3.1 Reducing Wastage in Healthcare Spending 405.3.2 Government's Cost Rationalization Efforts will make Future Tough for Big Pharmaceutical Companies 405.3.3 Medicaid Pricing for Dual Eligibles of Medicare Part - D 415.3.4 New ICD-10 (International Classification of Diseases) Coding System 415.3.5 Medicare Part B Drug Pricing Does Not Reflect Market Price Accurately 436 Reimbursement of Pharmaceutical Drugs in the US 446.1 Regulatory Bodies 456.2 Prescription Drugs 456.3 Biologics 466.4 Preferred Drug List (PDL) 476.5 Reimbursement by Health Insurance Companies 486.5.1 UnitedHealth Group 496.5.2 WellPoint, Inc. 496.5.3 Kaiser Foundation Group 496.5.4 Humana Group 506.5.5 Aetna Group 506.6 Pharmacy Benefit Managers (PBMs) 516.7 Reimbursement Programs in the US 526.7.1 Case Studies 536.8 Key Trends 556.8.1 Rebate Reforms and Healthcare Cuts to Reduce Federal Deficit 556.8.2 Medicare Part D Changes in Standard Benefit Parameters 576.8.3 Reimbursement of Brand Name Drugs 596.8.4 Reimbursement of Generic Drugs 606.8.5 CMS Finalizes Medicare Hospital Outpatient Payment Rates for 2012 616.9 Major Challenges 616.9.1 New Nationwide Database to Set Healthcare Reimbursement Rates 616.9.2 First DataBank/Medi-Span Settlement and the Impact on AWP 626.9.3 Renewal of Medicaid Drug Payment Policy 636.9.4 Proposed Cuts in Medicare Part B Reimbursement 636.9.5 New Trend in Free Trade Agreements Could Affect Healthcare Programs 637 Pricing and Reimbursement in the US - Major Therapy Areas 647.1 Pricing and Reimbursement in Major Therapy Areas 657.1.1 Heart Diseases 657.1.2 Cancer 657.1.3 Respiratory Diseases 657.1.4 Cerebrovascular Diseases 657.1.5 Other Major Therapy Areas 667.2 Case Studies 687.2.1 Provenge under Medicare Coverage 687.2.2 AstraZeneca Ensures Reimbursement of Brilinta 687.2.3 Financial Assistance for Orphan Drug Letairis 697.2.4 Coverage for Biologic Product Enbrel 698 Pricing and Reimbursement in the US - Appendix 708.1 Market Definitions 708.2 Abbreviations 708.3 Research Methodology 728.3.1 Healthcare System 738.3.2 Pharmaceutical Regulations 738.3.3 Pricing of Pharmaceutical Drugs 738.3.4 Reimbursement of Pharmaceutical Drugs 738.3.5 Pricing and Reimbursement in Major Therapy Areas 748.4 Contact Us 748.5 Disclaimer 748.6 Sources 74

1.1 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 9Table 2: Pricing and Reimbursement in the US, Comparison of Per Capita GDP and Per Capita Total Expenditure on Health ($ PPP), 2000-2009 10Table 3: Pricing and Reimbursement in the US, Per Capita Total Expenditure on Health ($ PPP), The US versus Top Five Countries of Europe, 2009 11Table 4: Pricing and Reimbursement in the US, Total Expenditure on Health as % of GDP, The US versus Top Five Countries of Europe, 2009 12Table 5: Pricing and Reimbursement in the US, National Healthcare Expenditure ($bn), By Category, 2009 13Table 6: Pricing and Reimbursement in the US, Per Capita National Healthcare Expenditure ($ PPP), By Type, 2009 15Table 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 17Table 8: Pricing and Reimbursement in the US, National Healthcare Expenditure (%), Type of Sponsor, 2009 18Table 9: Pricing and Reimbursement in the US, Type and Number of Hospitals, 2011 19Table 10: Pricing and Reimbursement in the US, Healthcare Professionals, 2010 20Table 11: Pricing and Reimbursement in the US, Health Insurance Coverage, Population (in million), 2009 21Table 12: Pricing and Reimbursement in the US, Public and Private Health Insurance Coverage (% of Population), 2007-2009 25Table 13: Pricing and Reimbursement in the US, Population Demography (Million), 2000-2010 26Table 14: Pricing and Reimbursement in the US, Health Indicators, 2000-2010 26Table 15: Pricing and Reimbursement in the US, Annual Retail Price Index Change in Brand Name Drugs and Generic Drugs (%), 2008-2010 36Table 16: Pricing and Reimbursement in the US, Annual Price Index Change in Prescription Drugs (%), 2008-2010 37Table 17: Pricing and Reimbursement in the US, Average Retail Coinsurance Rates (%), By Tier, 2009 45Table 18: Pricing and Reimbursement in the US, Top Health Insurance Companies, Revenue ($bn), 2010 48Table 19: Pricing and Reimbursement in the US, Reimbursement Programs, 2011 52Table 20: Pricing and Reimbursement in the US, State Discount Programs, 2011 54Table 21: Pricing and Reimbursement in the US, Medicare Part D Changes in Standard Benefit Parameters ($), 2008-2012 58Table 22: Pricing and Reimbursement in the US, Brand Name Drug Cost-Sharing (%), 2011-2020 59Table 23: Pricing and Reimbursement in the US, Generic Drug Cost-Sharing (%), 2011-2020 60Table 24: Pricing and Reimbursement in the US, Major Therapy Areas by Mortality (%), 2009 64

1.2 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 9Figure 2: Pricing and Reimbursement in the US, Comparison of Per Capita GDP and Per Capita Total Expenditure on Health ($ PPP), 2000-2009 10Figure 3: Pricing and Reimbursement in the US, Per Capita Total Expenditure on Health ($ PPP), The US versus Top Five Countries of Europe, 2009 11Figure 4: Pricing and Reimbursement in the US, Total Expenditure on Health as % of GDP, The US versus Top Five Countries of Europe, 2009 12Figure 5: Pricing and Reimbursement in the US, National Healthcare Expenditure (%), By Category, 2009 13Figure 6: Pricing and Reimbursement in the US, National Healthcare Expenditure (% of Total Health Expenditure), By Type, 2009 15Figure 7: Pricing and Reimbursement in the US, National Healthcare Expenditure (%), By Payer, 2009 16Figure 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 17Figure 9: Pricing and Reimbursement in the US, National Healthcare Expenditure (%), Type of Sponsor, 2009 18Figure 10: Pricing and Reimbursement in the US, Total Hospital Beds per 1,000 patients, 2000-2009 20Figure 11: Pricing and Reimbursement in the US, Health Insurance Coverage (% of Population), 2009 21Figure 12: Pricing and Reimbursement in the US, Public Health Insurance Coverage (% of Population), 2009 22Figure 13: Pricing and Reimbursement in the US, Private Health Insurance Coverage (% of Population), 2009 23Figure 14: Pricing and Reimbursement in the US, Other Private and Government Insurance, 2011 24Figure 15: Pricing and Reimbursement in the US, Public and Private Health Insurance Coverage (% of Population), 2007-2009 25Figure 16: Pricing and Reimbursement in the US, Population by Age (Million), 2000-2010 26Figure 17: Pricing and Reimbursement in the US, Pharmaceutical Industry, PEST Analysis, 2011 28Figure 18: Pricing and Reimbursement in the US, Healthcare Regulation, Operating Divisions and their Functions, 2009 30Figure 19: Pricing and Reimbursement in the US, Distribution Channel Logistics and Pricing, 2011 33Figure 20: Pricing and Reimbursement in the US, Annual Retail Price Index Change in Brand Name Drugs and Generic Drugs (%), 2008-2010 36Figure 21: Pricing and Reimbursement in the US, Annual Price Index Change in Prescription Drugs (%), 2008-2010 37Figure 22: Pricing and Reimbursement in the US, ICD-10 Coding System; Features and Benefits 42Figure 23: Pricing and Reimbursement in the US, Comparison Between Fee for Service, HMO and PPO, 2011 44Figure 24: Pricing and Reimbursement in the US, Top Health Insurance Companies, Revenue ($bn), 2010 48Figure 25: Pricing and Reimbursement in the US, Standard Medicare Part D Benefit, 2011-2020 57Figure 26: Pricing and Reimbursement in the US, Brand Name Drug Cost-Sharing (%), 2011-2020 59Figure 27: Pricing and Reimbursement in the US, Generic Drug Cost-Sharing (%), 2011-2020 60Figure 28: Pricing and Reimbursement in the US, Major Therapy Areas by Mortality (%), 2009 64

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