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Reportlinker Adds The Impact of US Healthcare Reform on Pharma: Analyzing the Effects

NEW YORK, Sept. 21 /PRNewswire/ -- announces that a new market research report is available in its catalogue:

The Impact of US Healthcare Reform on Pharma: Analyzing the effects

This report carries out a detailed analysis of the provisions of healthcare reform and their effects on the pharmaceutical industry. Strategies for optimizing promotional activities and pipelines for the future are examined.

After a year of debate and negotiation, in 2010, President Obama signed wide-ranging health reform into law. R&D priorities, pharmaceutical promotion, and pricing and reimbursement will all be impacted. The financial impact on pharma will be negative to 2014, then positive between 2014 and 2019 once large numbers of the uninsured gain cover. The net impact is neutral.

This report provides the most detailed review of the effects on the pharma industry available at the time of going to press. Contains a model of the financial impact on the industry. Uses IMS data to model Medicaid and Medicare impact on individual companies.

Key features from reading this report

  • Provides a detailed review of the provisions of US healthcare reform including the time they become effective.
  • Analyses the companies most exposed to Medicare and Medicaid rebates and discounts.
  • Proposes strategies from minimizing the negative impacts of reform.
  • Includes a detailed analysis of the history and background to health reform.
  • Examines trends in pharmaceutical promotion, pricing and reimbursement.

  • Key benefits of this report

  • Understand in detail and anticipate the measures included in healthcare reform.
  • Learn how to adapt promotional strategies to the evolving regulatory and reimbursement environment.
  • Assess R&D priorities against the changing market.
  • Gain insight into the dynamics of the US healthcare system and pharmaceutical market.
  • Develop strategies for efficient compliance with the provisions of healthcare reform.

  • Key questions answered by this report

  • What effects will the changes to Medicare Part D have on the generics and branded drug markets?
  • What effects will the new approval pathway for biosimilars have on the biologics market?
  • How will the changes to the health insurance market affect drug prices and revenues?
  • What will the long-term effects of healthcare reform different parts of the pharma industry?
  • Which strategies will enable pharma companies to adapt to optimize their revenues in the evolving market environment?
  • Which companies will be most impacted by Medicaid rebates and Medicare discounts?
  • How will new transparency rules affect the way pharmaceutical companies promote their products?
  • How will comparative effectiveness affect the pharmaceutical industry?

  • Table of ContentsGC Green 2

    Disclaimer 2

    Executive summary 9

    Healthcare in the US 9

    Healthcare reform measures 10

    Impact of healthcare reform 10

    Future trends and outlook 11

    Chapter 1 Healthcare in the US 13

    Summary 13

    Introduction 14

    Background to healthcare reform 14

    1912 to 1945: Early attempts to provide universal cover 14

    1946 to 1965: Extension of public health and creation of Medicare and Medicaid 15

    1971 to 1989: Cover extended to children, recently unemployed, and emergency cases 15

    1993 to date: Obama succeeds where the Clintons failed - health reform passes 16

    The pharma industry's $80bn deal 19

    The US healthcare system today 20

    High healthcare spending 20

    Pricing and reimbursement 21

    Private healthcare insurance 22

    Medicare 23

    Medicaid 25

    Trends in US pricing and reimbursement 27

    Healthcare infrastructure 28

    The uninsured 30

    Conclusions 32

    Chapter 2 Healthcare reform measures 34

    Summary 34

    Introduction 35

    Reform measures in detail 35

    Manufacturer fees 35

    Increased insurance coverage 36

    Ban on denying coverage based on pre-existing medical conditions 36

    Coverage for children up to the age of 26 for all individual and group policies. 37

    Limits on cost-sharing – boost for preventive medicine 37

    Individual requirement to buy insurance or pay a penalty 37

    Regional insurance exchanges 38

    Health subsidies 38

    Employer requirements 39

    Medicare Part D doughnut hole closure 39

    Medicaid extensions and subsidies 42

    Approval pathway for biosimilars 43

    Overview 43

    Definition 43

    Periods of exclusivity 43

    User fees 44

    FDA guidance documents 44

    Effects on patent legislation 44

    Sunshine provision requiring disclosure of payments by pharma to physicians 47

    No ban on pay-for-delay deals 47

    Expansion of 340B designation 48

    Tax measures 50

    Excise tax on high-value plans 50

    Change in tax treatment of retiree drug subsidy 50

    Tax credit or grant for small companies developing new therapies 50

    Excise tax on medical devices 51

    Chapter 3 Impact of healthcare reform 52

    Summary 52

    Introduction 53

    Effects on coverage 53

    Financial impact on pharma 54

    Effect on individual companies 56

    Effects on the branded drug market 58

    Medicare 59

    Medicaid 61

    Effects on the generics market 63

    Medicare 63

    Medicaid 63

    Pay-for-delay changes 64

    Effects on drug promotion 64

    Compliance burden rising 66

    Volume increase to drive contract manufacturing 67

    Chapter 4 Future trends and outlook 68

    Summary 68

    Introduction 69

    Regulatory environment 69

    Changes at the CMS 69

    Medicare 69

    Effects on R&D 70

    Program prioritization 71

    Cures Acceleration Network 71

    Coverage of clinical trial costs 73

    Tax credits/grants for small companies 73

    Increasing importance of effectiveness 73

    Private health insurance market changes 75

    Transparency is the new watchword 77

    Conclusions 77

    Appendix 79

    Primary research methodology 79

    Business Insights healthcare reform model 79

    Industry fees 79

    Biosimilars 79

    Doughnut hole discounts 79

    Medicaid rebates 79

    US market projections 80

    Doughnut hole upside 80

    Increase due to extra insured parties 80

    Glossary 81

    Bibliography 82

    Table of figuresFigure 1: Healthcare reform timeline, 1912-2010 17

    Figure 2: Healthcare spend as a percentage of GDP, 2008 20

    Figure 3: US healthcare providers by ownership status 28

    Figure 4: Key stakeholders of the US healthcare system 29

    Figure 5: Age profile of the insured and uninsured in the US, 2008 31

    Figure 6: Private health insurance applicants refused cover by age (%), 2008 32

    Figure 7: Medicare Part D benefits and out-of-pocket expenses, 2010 40

    Figure 8: Medicare Part D benefits and out-of-pocket expenses, 2020 41

    Figure 9: Pay-for-delay deals, 2006-2010 48

    Figure 10: Increase in number of insured people (m), 2010-2019 53

    Figure 11: US pharma market with and without healthcare reform ($bn), 2010-2019 56

    Figure 12: Branded and generic market share in the US by value (%), 2009 59

    Figure 13: Percentage of Medicare Part D drug costs payable by enrollees, 2010-2020 61

    Figure 14: The shift to key account management as a promotional model 65

    Figure 15: AHRQ comparative effectiveness funding ($m), 2005-2011 74

    Table of tablesTable 1: Timeline of Barack Obama's healthcare reform, 2008-2010 19

    Table 2: US public heath insurance programs, 2010 27

    Table 3: Portion of branded pharmaceutical sales accountable for fees due under healthcare reform 35

    Table 4: Fees payable by pharmaceutical manufacturers under healthcare reform, 2011-201936

    Table 5: Penalties to individuals for not having medical insurance, 2014-2016 38

    Table 6: Business Insights model of financial impact of healthcare reform, 2010-2019 55

    Table 7: Self reported 2010 healthcare reform estimated impact to major pharma companies 57

    Table 8: Estimated US exposure of top 20 pharma companies, 2010-2015 58

    Table 9: Medicare exposure of major pharma companies, 2009 60

    Table 10: Medicaid exposure of major pharma companies, 2009 62

    To order this report:Healthcare Industry: The Impact of US Healthcare Reform on Pharma: Analyzing the effects

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    Check our Company Profile, SWOT and Revenue Analysis!Nicolas BombourgReportlinkerEmail: nbo@reportlinker.comUS: (805)652-2626Intl: +1 805-652-2626

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