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Medicare News

Medicare Bites Bullet to Cover Expensive Provenge, Prostate Cancer Drug for Bad Cases

CMA 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.


Related Archive Stories


Battle Lines Form for Fight over Medicare Pay to Docs; Cost Controls Irk Healthcare Industry

Medicare is 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 Kaiser Health News' Daily Report. Read more...


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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 – Click here.

“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 website – Click here.

Some of this information was reprinted from with permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Health Policy Report, search the archives and sign up for email delivery. © Henry J. Kaiser Family Foundation. All rights reserved.


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