NEW YORK, Sept. 21 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
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
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
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
Trends in US pricing and reimbursement 27
Healthcare infrastructure 28
The uninsured 30
Chapter 2 Healthcare reform measures 34
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
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
Effects on coverage 53
Financial impact on pharma 54
Effect on individual companies 56
Effects on the branded drug market 58
Effects on the generics market 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
Regulatory environment 69
Changes at the CMS 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
Primary research methodology 79
Business Insights healthcare reform model 79
Industry fees 79
Doughnut hole discounts 79
Medicaid rebates 79
US market projections 80
Doughnut hole upside 80
Increase due to extra insured parties 80
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
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