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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
                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?



Contents:   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, 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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