Transcript Avastin-FDA

F.D.A. Revokes Approval of
Avastin for Use as Breast
Cancer Drug
Andrew Pollack
NY Times
November 18, 2011
http://www.nytimes.com/2011/11/19/business/fda-revokes-approval-of-avastin-as-breast-cancer-drug.html?ref=health
Did not help patients
• The commissioner of the Food and Drug
Administration on Friday revoked the approval of
the drug Avastin as a treatment for breast
cancer, ruling on an emotional issue that pitted
the hopes of some desperate patients against
the statistics of clinical trials.
• The commissioner, Dr. Margaret A. Hamburg,
said that clinical trials had shown that the drug
was not helping breast cancer patients to live
longer or to meaningfully control their tumors,
but did expose them to potentially serious side
effects like severe high blood pressure and
hemorrhaging.
Will remain on market
• Avastin will remain on the market as a treatment
for other types of cancers, so doctors can use it
off-label for breast cancer. But insurers might no
longer pay for the drug, which would put it out of
reach of many women because it costs about
$88,000 a year.
• Federal officials said on Friday that Medicare
would still provide coverage for the drug’s use in
breast cancer, though the government plans to
“monitor the issue and evaluate coverage
options.” (???? Why ????)
Genentech’s response
• The drug’s manufacturer, Genentech, which fought long
and hard to retain the approval, said it was
“disappointed.” The decision could cost Genentech and
its Swiss parent company, Roche, up to $1 billion in
annual sales. Use of Avastin has already declined to 20
percent, from 60 percent, of American patients with
newly diagnosed metastatic breast cancer, the condition
for which the drug was approved, according to
Genentech. About 29,000 women each year are found to
have metastatic breast cancer.
• A Genentech spokeswoman said the company would
continue to provide some help to breast cancer patients
in securing insurance coverage. But it will no longer
provide co-payment assistance and will no longer cap
combined expenses for many patients and their insurers
at $58,000 a year.
Why Medicare?
• Medicare is obligated to pay for off-label use of
cancer drugs that are listed in certain
references, like the one published by the
National Comprehensive Cancer Network, an
organization of major cancer hospitals.
• In July a committee of breast cancer specialists
from those centers reaffirmed that Avastin
should remain listed as “an appropriate
therapeutic option for metastatic breast cancer.”
A third of the committee members had financial
ties to Genentech, according to Dr. Hamburg’s
memorandum.
The Economics – Why Regulate Drugs?
• Patent Protection – It is expensive to
develop drugs. What do patents do?
• Information – Drugs can have:
– No impact
– Adverse impact
• Government is asked to pay for drugs
• Regulatory delays may delay:
– Bad things
– Good things
Comments
• Fascinating comments on this one.
• http://community.nytimes.com/comments/
www.nytimes.com/2011/11/19/business/fd
a-revokes-approval-of-avastin-as-breastcancer-drug.html