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 Contents

GC 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 figures

Figure 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 tables

Table 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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Nicolas Bombourg


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