Medicare Bites Bullet to Cover Expensive Provenge,
Prostate Cancer Drug for Bad Cases
also to continue expensive breast cancer drug, Avastin; Sipuleucel-T activates immune system to defend
against prostate cancer; first approved autologus cellular immunotherapy
July 1, 2011 - Medicare patients with metastatic
prostate cancer can get a first-of-its kind treatment approved by the
Food and Drug Administration in April, under a final coverage decision
issued yesterday by the Centers for Medicare & Medicaid Services (CMS). Provenge (sipuleucel-T) activates a patient’s own immune system to
defend him against prostate cancer. The majority of the men tested with
the drug were senior citizens - age 65 or older.
CMS agreed to pay
for the new vaccine despite its very high cost.
The Washington Post, reports
that Provenge will cost $93,000 per patient. The agency had said in
March it intended to cover the costly therapy.
reluctant to cover new costly prostate cancer treatment; Hot
low-cost Humana/Walmart Drug plan costly for some
Nov 16, 2010
– Medicare, the health protector for senior citizens, is finding
itself in the center of major battles in these closing days of 2010.
The unfinished fight over cutting the pay of doctors, which has
nothing to do with health care reform, will probably be center
stage. But, Medicare spending cuts in the new health care law are
causing friction with the health care industry that will set off
some fireworks. Below is a roundup of today’s top Medicare news by
News' Daily Report.
The New York Times
reports that Medicare has also agreed to continue coverage of the
expensive breast cancer drug Avastin.
This new autologous cellular immunotherapy with
Provenge is for treating some forms of prostate cancer in seriously ill
patients. Today’s decision is effective immediately.
The treatment consists of a multi-day regimen in
which the patient’s white blood cells are collected and exposed to
proteins that direct the white blood cells to fight prostate cancer
cells. After the patient’s cells are treated, the patient receives his
own cells back into his body in order to stimulate his immune system to
fight the prostate cancer. This regimen is repeated over several weeks
for a total of three treatments.
“We are optimistic that innovative strategies may
improve the experience of care for our beneficiaries who have cancer,”
said CMS Administrator Donald M. Berwick, M.D. “CMS is dedicated to
assuring that these patients can seek the treatments they need in
accordance with their wishes.”
Prostate cancer is the most common non-skin cancer
in men in the United States. The cancer forms in the prostate, a gland
in the male reproductive system, which can spread to other parts of the
body and threaten life.
In 2009, an estimated 192,280 new cases of prostate
cancer were diagnosed and an estimated 27,360 men died. According to the
National Cancer Institute, prostate cancer is most commonly a cancer of
older men, with most men diagnosed after 65 and the median age at
diagnosis of 72.
CMS internally initiated the national coverage
determination process for Provenge for multiple reasons, including:
variations in local coverage; questions about the appropriate benefit
category for Provenge; and inquiries from Congress. There was no prior
NCD on this technology, and local contractors were generally making case
by case determinations.
CMS convened the Medicare Evidence Development &
Coverage Advisory Committee (MEDCAC), a group of nationally recognized
independent medical and scientific experts, on November 17, 2010 to make
recommendations about the evidence. The MEDCAC votes supported coverage
of Provenge for the FDA labeled indication and did not support coverage
for unlabeled uses.
Yesterday’s coverage decision includes coverage of
Provenge for the uses approved by the FDA: for treatment of asymptomatic
or minimally symptomatic metastatic castrate resistant (hormone
refractory) prostate cancer.
More information for patients and health
professionals about FDA’s approved uses of Provenge is in this online
FDA Q&A –
“CMS is covering Provenge nationally only for those
indications supported by evidence and consistent with the FDA label,”
said Patrick Conway, MD, MSc, CMS Chief Medical Officer and Director of
the Agency’s Office of Clinical Standards & Quality.
“Similar to other treatment decisions, individual
patients should discuss the risks and benefits with their physician to
make an individual decision.”
The final coverage decision is available on the CMS
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