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The Impact of US Healthcare Reform on Pharma

  • Publication Date:August 2010
  • Publisher:Business Insights
  • Product Type: Report
  • Pages:82

The Impact of US Healthcare Reform on Pharma

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?
  • GC Green
  • Disclaimer
  • Executive summary
  • Healthcare in the US
  • Healthcare reform measures
  • Impact of healthcare reform
  • Future trends and outlook
  • Chapter 1 Healthcare in the US
    • Summary
    • Introduction
    • 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
    • Medicare
    • Medicaid
    • Trends in US pricing and reimbursement
    • Healthcare infrastructure
    • The uninsured
    • Conclusions
  • Chapter 2 Healthcare reform measures
    • Summary
    • Introduction
    • Reform measures in detail
    • Manufacturer fees
    • 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
    • Health subsidies
    • Employer requirements
    • Medicare Part D doughnut hole closure
    • Medicaid extensions and subsidies
    • Approval pathway for biosimilars
    • Overview
    • Definition
    • Periods of exclusivity
    • User fees
    • 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
    • Tax measures
    • 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
    • Summary
    • Introduction
    • Effects on coverage
    • Financial impact on pharma
    • Effect on individual companies
    • Effects on the branded drug market
    • Medicare
    • Medicaid
    • Effects on the generics market
    • Medicare
    • Medicaid
    • Pay-for-delay changes
    • Effects on drug promotion
    • Compliance burden rising
    • Volume increase to drive contract manufacturing
  • Chapter 4 Future trends and outlook
    • Summary
    • Introduction
    • Regulatory environment
    • Changes at the CMS
    • Medicare
    • Effects on R&D
    • Program prioritization
    • 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
    • Conclusions
    • Appendix
    • Primary research methodology
    • Business Insights healthcare reform model
    • Industry fees
    • Biosimilars
    • Doughnut hole discounts
    • Medicaid rebates
    • US market projections
    • Doughnut hole upside
    • Increase due to extra insured parties
  • Glossary
  • Bibliography
  • 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,
    • 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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