Medicare metastatic prostate cancer patients can get a first of its kind treatment has to be approved by the Food and Drug Administration, by a decision of the final cover published today by the Centers for Medicare & Medicaid Services (CMS).
Cellular immunotherapy autologous, clinically called sipuleucel-T, is marketed in the United States as Provenge for the treatment of some forms of cancer of the prostate in seriously ill patients. Today?s decision is effective immediately.
Active Provenge a patient?s immune system to defend against prostate cancer. The treatment consists of a pattern of several days in which white blood cells of the patient are collected and exposed to proteins that direct white blood cells to fight prostate cancer cells. After treatment of the cells of the patient, the patient receives its own cells in her body to stimulate his immune system to fight prostate cancer. This pattern is repeated for several weeks for a total of three treatments.
?We are optimistic that innovative strategies can improve the experience of care for our beneficiaries who have cancer,? said CMS administrator Donald M. Berwick, M.D. ?? CMS is dedicated to ensure that these patients can seek treatment they need in accordance with their wishes.?"
Prostate cancer is cancer of the skin-no more common among men in the United States. The forms of cancer of the prostate, a gland in the male reproductive system, which can spread to other parts of the body and life-threatening. 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 present cancer in older men, with most men diagnosed after only 65, and the median age at diagnosis of 72.
CMS initiated internally the process of national coverage for Provenge for several reasons, including: changes in local coverage; questions about the category of services appropriate for the Provenge; and investigations of the Congress. Is there no CSD screening on this technology and local contractors were generally case-by-case determinations.
CMS called the Medicare evidence development & coverage Advisory Committee (MEDCAC), a group of recognized national medical experts and independent scientists, November 17, 2010 to make recommendations on the evidence. Taken MEDCAC voice in charge of the cover of Provenge for the marked FDA indication and did not cover for non-labelled uses.
Decision of the coverage of today includes coverage of Provenge for FDA approved uses: for the treatment of asymptomatic or minimally symptomatic metastatic neutered resistant (hormone refractory) prostate cancer.
More information for patients and professionals of the health on the Prpvemge FDA approved uses is online here.
?CMS is covering Provenge nationally for these indications of evidence and compatible with the label of the FDA,? said Patrick Conway, MD, MSc, CMS, physician leader and Director of standards & quality clinical Agency. ?Similar to other cases of treatment, patients should discuss the risks and benefits with their doctor to make an individual decision?.
The final decision of the coverage is available on the CMS website.
Source:
Centers for Medicare & Medicaid
View the information on the drug Provenge.
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