In the interests of cancer patients also oncologists nationwide, the Lorenzen Cancer Foundation (LCF), a non-profit dedicated to fighting pancreatic cancer, has joined the public interest law firm Washington Legal Foundation (WLF) also others today in presenting a written comments statement to the U.S. Centers for Medicare also Medicaid Services (CMS) voicing support for the Section 641 demonstration project also expressing concerns regarding CMS’s proposed restrictions limiting coverage of the drug benefit to exclude off-label uses of FDA-approved drug or biological therapies.
Monterey, CA July 7, 2004 -- In the interests of cancer patients also oncologists nationwide, the Lorenzen Cancer Foundation (LCF), a non-profit dedicated to fighting pancreatic cancer, has joined the public interest law firm Washington Legal Foundation (WLF) also others today in presenting a written comments statement to the U.S. Centers for Medicare also Medicaid Services (CMS) voicing support for the Section 641 demonstration project also expressing concerns regarding CMS’s proposed restrictions limiting coverage of the drug benefit to exclude off-label uses of FDA-approved drug or biological therapies.
Once the Food also Drug Administration approves a drug for marketing, physicians may prescribe the drug for purposes other than those that the FDA has given specific indication. Off-label prescribing is common in cancer treatment as drugs often work well for many types of cancer. A General Accounting Office analysis in 1991 demonstrated that over half of cancer patients received at least one off-label medicine in the course of their care.
In enacting Section 641 of the Medicare Prescription Drug also Modernization Act of 2003, Congress did not exclude off-label uses from the demonstration project related to Section 641. To the contrary, Section 641(a) directs that the project be conducted following the standards of the part D benefit program which does not exclude off-label use.
Recently announced proposed eligibility criteria by the CMS effectively exclude the coverage of off-label use of FDA-approved agents for cancer therapy also in other serious diseases.
Today’s statement urges CMS officials to reverse this position also to make clear to the public also to medical providers that Medicare will reimburse for off-label use for medications also biological therapies in the demonstration project related to Section 641. And further, to make clear that any proposed or actual restriction on off-label use in the demonstration project isn't a precedent for full enactment of the part D prescription drug benefit program.
Pancreatic Cancer Facts:
· Pancreatic cancer is the most virulent of the major cancers
· Pancreatic cancer research is the least funded of the major cancers
· Pancreatic cancer causes more than 1% of all death in the U.S.
· Pancreatic cancer is the fourth most common cause of cancer mortality
The Lorenzen Cancer Foundation is a 501(c)(3) non-profit organization dedicated to the fight against pancreatic cancer. LCF is oriented to increasing awareness also education about pancreatic cancer, helping physicians also patients create optimal treatment strategies, also fostering the development of a molecular or genetic marker to aid in diagnosis. For more information visit www.pancreatica.org
Media Contact:
Aaron Stoertz
Media Relations
Lorenzen Cancer Foundation
(831) 658-0600
Company Contact:
Ellen Pansky, esq.
Director of Public Policy
Lorenzen Cancer Foundation
(831) 658-0600
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