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Centers for Medicare & Medicaid Services

National Coverage Analysis (NCA) Tracking Sheet for Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer (CAG-00422N)

CMS received informal inquiries for a national coverage determination (NCD) for autologous cellular immunotherapy treatment of prostate cancer. This interest arose upon the recent FDA approval of the Sipuleucel T treatment regimen, marketed as Provenge®.

As described on the FDA website at, "PROVENGE® (Sipuleucel T, APC8015) is an autologous cellular immunotherapy product consisting of peripheral blood mononuclear cells (PBMCs) obtained from patients by leukapheresis and activated in vitro with a recombinant fusion protein (prostatic acid phosphatase fused with GM-CSF)…FDA will require the sponsor to complete a post marketing study to evaluate the risk of stroke in patients who receive sipuleucel-T."

Provenge® has FDA approved labeling for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

We are opening this national coverage analysis to determine whether or not autologous cellular immunotherapy is reasonable and necessary under sections 1862(a)(1)(A) and/or 1862(a)(1)(E) of the Social Security Act.

Requestor Name(s)Internally generated by CMS
Formal Request Accepted and Review Initiated06/30/2010
Expected NCA Completion Date06/30/2011
Public Comment Period06/30/2010 - 07/30/2010
Proposed Decision Memo Released03/30/2011
Proposed Decision Memo Public Comment Period: 03/30/2011 - 04/29/2011 
Decision Memo Released06/30/2011
Comments for this NCA:View Public Comments
Lead Analyst(s)
  • Leslye Fitterman, PhD
  • Eileen Pencek
Lead Medical Officer(s)
  • Lori Paserchia, MD

June 30, 2010

CMS opens this NCA for autologous cellular immunotherapy treatment of prostate cancer. CMS is requesting public comments on the evidence regarding the effects of this treatment on health outcomes in patients with prostate cancer. The initial 30-day public comment period begins with this posting date, and ends after 30 calendar days. CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the subject under review.

CMS is commissioning a technology assessment from an external entity and plans to convene a meeting of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) in 2010.

Instructions on submitting public comments can be found at You can also submit a public comment by clicking on the highlighted word comment in the title bar at the top of this page. We strongly urge that all public comments be submitted through this website. Please do not submit personal health information in public comments. Comments with personal health information may not be posted to the website.

August 31, 2010

CMS announces MEDCAC meeting date for November 17, 2010.

March 30, 2011

CMS posts the proposed decision memo.

June 30, 2011