Abstract
Introduction
The United States dominates the world' s pharmaceutical markets, not least
because it offers pharmaceutical companies a speedy, effi cient drug
registration process and unrivaled freedom to negotiate drug prices and
reimbursement-but a rising chorus of complaint about the high cost of branded
drugs is driving public and private sector policy changes, and companies must
prepare to deal with diffi cult challenges. This report features a summary of
12 areas of change and identifi es the implications of those trends for the
U.S. drug industry.
Get the Answers You Need to Shape Your Strategy
- One of the most attractive features of the U.S. market for pharmaceutical
companies is the unrivaled freedom of its pricing and reimbursement
environment. How has the Defi cit Reduction Act of 2005, in effect since
January 2007, changed drug manufacturers' "best-price" calculations? How are
pharmacy benefi t management (PBM) companies' relationships to drug companies
evolving in response to widespread criticism? What are CMS and commercial
insurers doing to curb expenditure on provider reimbursement?
- Medicare drug spending is forecast to grow from just $2 billion in 2000 to
$153 billion in 2016-a 7,550% increase. How will this enormous growth in
Medicare' s share of total U.S. drug expenditures affect private insurers? Will
it encourage employers to reduce or eliminate retiree benefi ts? How might the
2008 Medicare drug benefi t design infl uence drug design in the non-Medicare
market?
- Cost-containment pressures will continue to intensify and force all payers
to look for substantial economies. Will patient copayment and coinsurance
rates rise? What other methods are health plans using to control costs? Will
Congress enact a regulatory framework for biogenerics approval in 2008? How
will these efforts impact the pharmaceutical industry?
- The most radical changes to the U.S. pharmaceutical market could result
from the outcome of the 2008 presidential and congressional elections. How do
the contending parties differ on the question of universal health insurance?
How do they differ on ways to control health care costs, particularly drug
costs?
Scope
- U.S. health care system: Organization and funding, Medicare, Medicaid,
private insurance, military and other federal health care programs.
- Pharmaceutical prices in the United States: Relative to other major
markets, public and private sector pricing, generics pricing.
- Provider reimbursement: Medicare, commercial insurers.
- Coverage decision making: Public and private sectors.
- Cost-containment measures: Multitier formularies, patient copayments and
coinsurance, use of generics, therapeutic substitution, step therapy, prior
authorization, specialty pharmacy.
- U.S. pharmaceutical market outlook: Slower growth, impact of Medicare Part
D, intensifying costcontainment pressures, insurers' growing use of
comparative drug effectiveness data, possible market entry of biogenerics by
2009.