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The Impact of US Healthcare Reform on Pharma
Description: 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
- 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
- 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
- How will comparative effectiveness affect the pharmaceutical industry?
Contents: GC Green
Healthcare in the US
Healthcare reform measures
Impact of healthcare reform
Future trends and outlook
Chapter 1 Healthcare in the US
Background to healthcare reform
1912 to 1945: Early attempts to provide universal cover
1946 to 1965: Extension of public health and creation of Medicare and Medicaid
1971 to 1989: Cover extended to children, recently unemployed, and emergency cases
1993 to date: Obama succeeds where the Clintons failed - health reform passes
The pharma industry’s $80bn deal
The US healthcare system today
High healthcare spending
Pricing and reimbursement
Private healthcare insurance
Trends in US pricing and reimbursement
Chapter 2 Healthcare reform measures
Reform measures in detail
Increased insurance coverage
Ban on denying coverage based on pre-existing medical conditions
Coverage for children up to the age of 26 for all individual and group policies.
Limits on cost-sharing – boost for preventive medicine
Individual requirement to buy insurance or pay a penalty
Regional insurance exchanges
Medicare Part D doughnut hole closure
Medicaid extensions and subsidies
Approval pathway for biosimilars
Periods of exclusivity
FDA guidance documents
Effects on patent legislation
Sunshine provision requiring disclosure of payments by pharma to physicians
No ban on pay-for-delay deals
Expansion of 340B designation
Excise tax on high-value plans
Change in tax treatment of retiree drug subsidy
Tax credit or grant for small companies developing new therapies
Excise tax on medical devices
Chapter 3 Impact of healthcare reform
Effects on coverage
Financial impact on pharma
Effect on individual companies
Effects on the branded drug market
Effects on the generics market
Effects on drug promotion
Compliance burden rising
Volume increase to drive contract manufacturing
Chapter 4 Future trends and outlook
Changes at the CMS
Effects on R&D
Cures Acceleration Network
Coverage of clinical trial costs
Tax credits/grants for small companies
Increasing importance of effectiveness
Private health insurance market changes
Transparency is the new watchword
Primary research methodology
Business Insights healthcare reform model
Doughnut hole discounts
US market projections
Doughnut hole upside
Increase due to extra insured parties
Table of figures
Figure 1: Healthcare reform timeline, 1912-2010
Figure 2: Healthcare spend as a percentage of GDP, 2008
Figure 3: US healthcare providers by ownership status
Figure 4: Key stakeholders of the US healthcare system
Figure 5: Age profile of the insured and uninsured in the US, 2008
Figure 6: Private health insurance applicants refused cover by age (%), 2008
Figure 7: Medicare Part D benefits and out-of-pocket expenses, 2010
Figure 8: Medicare Part D benefits and out-of-pocket expenses, 2020
Figure 9: Pay-for-delay deals, 2006-2010
Figure 10: Increase in number of insured people (m), 2010-2019
Figure 11: US pharma market with and without healthcare reform ($bn), 2010-2019
Figure 12: Branded and generic market share in the US by value (%), 2009
Figure 13: Percentage of Medicare Part D drug costs payable by enrollees, 2010-2020
Figure 14: The shift to key account management as a promotional model
Figure 15: AHRQ comparative effectiveness funding ($m), 2005-2011
Table of tables
Table 1: Timeline of Barack Obama’s healthcare reform, 2008-2010
Table 2: US public heath insurance programs, 2010
Table 3: Portion of branded pharmaceutical sales accountable for fees due under healthcare reform
Table 4: Fees payable by pharmaceutical manufacturers under healthcare reform, 2011-
Table 5: Penalties to individuals for not having medical insurance, 2014-2016
Table 6: Business Insights model of financial impact of healthcare reform, 2010-2019
Table 7: Self reported 2010 healthcare reform estimated impact to major pharma companies
Table 8: Estimated US exposure of top 20 pharma companies, 2010-2015
Table 9: Medicare exposure of major pharma companies, 2009
Table 10: Medicaid exposure of major pharma companies, 2009
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