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U.S. Health Care Reform

An economic perspective on its development and structure, key components of the law, and implications for stakeholders across the life sciences industries.

Our economists and consultants take a comprehensive look at the trends that are redefining health care, including:

A new emphasis on comparative effectiveness programs will affect outcomes research.
The move toward personalized medicine will challenge scientific methodologies and test market demand.
The pathway for biosimilars will take shape, redrawing the competitive landscape for biotechnology.
A greater reliance on performance metrics will increasingly define contracts between manufacturers and payers.

NEW GUIDELINES

Comparative Effectiveness

CER received a significant boost when President Obama signed reform legislation in 2010. The new law outlined financial and statutory guidelines and created the Patient-Centered Outcome Research Institute, underscoring the importance of this evidence-based approach in health care.

See this special issue of PharmacoEconomics on CER edited by members of our Health Care practice, with an introduction from the editors, Vice President Dave Nellesen, Principal Howard G. Birnbaum, and Managing Principal Paul E. Greenberg.
In the article “The Fruits of Comparative Effectiveness,” Managing Principals Edward Tuttle and Anita Chawla examine the impact of CER on pharmaceutical firms.
In their article “Comparative Effectiveness Research without Head-to-Head Trials,” published in PharmacoEconomics, Managing Principal Eric Q. Wu and Manager James Signorovitch describe a new statistical method for comparing treatments across separate clinical trials.

PRICING AND CONTRACTING

Defining Pricing and Payer Strategies

Click on this exhibit to learn how the pricing strategy for a new drug or medical device must take into account the interdependencies among price, access, and share. As Managing Principal Andrew Parece explains, there are effective, systematic ways to consider the effect of price on access alongside the effect of access on share.

Comparative effectiveness is here to stay, although the issue will likely remain controversial and a critical area of concern for regulatory, industry, and clinical stakeholders. The adoption of a robust CER paradigm will require health care companies in particular to emphasize supporting research for their products and thorough, independent analyses to interpret the CER results. Packaged Content Right Quote Red

– Principal Howard G. Birnbaum and
Managing Principal Paul E. Greenberg

DEVELOPMENT OF THE U.S. HEALTH CARE PLAN

How has health care reform evolved in this country? MIT economist, health care expert, and Analysis Group affiliate Jonathan Gruber describes how various elements of the health care plan came together, and the challenges of cost control and maintaining a mandate.

NEXT-GENERATION CHALLENGES

Biosimilars

From our Fall/Winter 2010 Health Care Consulting Bulletin, an overview of how the market for biosimilars might develop, and a survey of the emerging issues in litigation.
In an FDLI Update article, Managing Principals Genia Long and Carla Mulhern outline the litigation issues that may emerge from biosimilar development.

OFF-LABEL PROMOTION

Litigation

Federal and state reimbursement authorities have heightened their attention to manufacturer pricing practices as well as off-label promotion practices. The stakes involved in these investigations are enormous.

Managing Principal Paul E. Greenberg addresses critical issues in off-label investigations

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