Abstract
Introduction
Over the past two decades, the German pharmaceutical market has undergone a
greater number of radical reforms than any other major drug market. With the
German government exerting pressure on all sectors of the pharmaceutical
market, the resulting reimbursement and prescribing restrictions continue to
place a considerable burden on drug manufacturers. The result of such
cost-containment mandates has led pharmaceutical companies to seek greater
control of their destiny by establishing innovative systems to handle all
aspects of the country' s reimbursement restrictions. This report features
several illustrated tables that provide an overview of the country' s health
care reform initiatives and the fi nancial impact such reforms have had on the
pharmaceutical industry over the last two decades.
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- Pharmaceutical companies seeking to do business in Germany must contend
with many cost controls imposed by the government. How will manufacturers
deal with these increasingly restrictive cost controls in the coming years?
What new reimbursement deals will companies attempt in order to secure market
access?
- Manufacturers of novel-or potentially risky-therapies will undoubtedly
face vexing barriers to market access. What new restrictions will the
country' s governing agencies introduce in this market? What strategies will
companies explore to overcome these restrictions?
- The German government will continue to rely heavily on its most enduring
cost control-reference pricing. How will the probable expansion of this
cost-containment system affect patent-protected agents in the new few
years?
Scope
- The German government will overhaul the funding of the German health
care system in January 2009: statutory health insurance funds will no
longer be free to set their own premium rates; governmental reforms, which are
often partisan, have stymied the pharmaceutical industry as it struggles to
keep up with the frequency of such reforms.
- Reference pricing is the country' s most enduring cost-containment
strategy: drug manufacturers object to a system whereby health insurance
funds are responsible for setting reference prices for the products they
reimburse; from 2005 through 2008, the government has expanded considerably
the list of reference-priced products; a 2006 change in the method by which
reference prices are calculated has resulted in substantially lower reference
prices.
- Reimbursement of hospital medicines is based on a diagnosis-related
group system that began in 2004: a key objective is to shorten the length
of hospital stays; the new system presents the pharmaceutical industry with
both opportunities and challenges.
- Off-label prescribing is a controversial subject in Germany:
reimbursement of off-label therapy must meet specifi c requirements; drugs
used off label in clinical trials must satisfy legal requirements; physicians
can face substantial fi nes for improper off-label prescribing.
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