Holland & Knight Health Law Team, Led by Michael Gaba, Obtains Medicare Coverage for Actelion’s Drug Zavesca
October 10, 2005
Michael M. Gaba- Washington
WASHINGTON, D.C. – Holland & Knight’s Health Law team successfully
obtained Medicare coverage of Zavesca® --- an oral drug for patients suffering
with mild to moderate type 1Gaucher Disease for whom enzyme replacement therapy
is not a therapeutic option --- under the Medicare Replacement Drug
Demonstration on behalf of the firm’s client Actelion Pharmaceuticals USA, Inc.
The Health and Human Services (HHS) initiative through the Medicare Modernization Act,
known as the Medicare Replacement Drug Demonstration, is aimed at creating early
access to certain drugs before the new Medicare Part D drug benefit rolls out in
2006. It is also intended to save seniors and disabled Americans substantial
money. The Centers for Medicare & Medicaid Services grants coverage to drugs
that meet five criteria for coverage as a replacement drug according to the June
29, 2004 Federal Register announcement of the demonstration. According to
HHS, Medicare beneficiaries who can take advantage of this demonstration could
save as much as 86 percent of their annual drug costs. The cost for Zavesca® can
exceed $100,000 annually.
Medicare’s decision will not only save seniors money. More importantly, it will improve the
quality of life for those Medicare patients suffering with this orphan disease
by making this drug, a tablet patients can take on their own, available now,”
said Partner Michael Gaba, who led the team in this matter.
About Holland & Knight’s Health Law Team: The Health Law Team at Holland & Knight
takes a comprehensive, multidisciplinary approach to serving the needs of pharmaceutical, biotechnology and medical device manufacturers. We have the
range of legal experience essential to dealing effectively, throughout a product’s life cycle, with today’s increasingly complex regulatory and policy
challenges. This experience includes business planning and startup, finance and M&A; health care regulatory matters, including public and private reimbursement
issues; federal and state legislation/appropriations; intellectual property; litigation (including mass tort defense); and strategic communications.
About Holland & Knight LLP: Holland & Knight is a global law firm with more than 1,250 lawyers in 26 U.S. offices. Other offices around the world are
located in Mexico City, Tokyo and Beijing, with representative offices in Helsinki, Caracas and Tel Aviv. Holland & Knight is among the world’s 15 largest
firms, providing representation in litigation, business, governmental law, real estate and private-wealth services. Our interdisciplinary practice groups and
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Contact: Katherine Magnuson, (212) 843-8298