Provenge - Early use question (PROTECT trial)

Melg,

"I guess I was really wondering at what point would it be worth doing provenge? Never - because it's not proven?   When it is covered by insurance? When a met appears?"  I go back to my original post.  We don't have an answer for this and it's been a very long time not knowing...some docs say earlier is better; some say that they are not impressed with Provenge..."

"If it only cost $10, would people do it before mets and hormone therapy?"   Very much so...I would even pay $11.  Just wouldn't pay $93,000.  Everyone will land somewhere between these two ranges, but would probably do it if cost weren't the issue.

"Are scans worth it at a psa this low?"  Normally, a PSA at that low of level will not show anything on scan.  I am an exception to the rule.  I had a PSA of .09 and then 2 mets were found on my pelvis.

 

Jerry

The description of eligibility and coverage on the CMS.gov site states that off-label use of Provenge (i.e. for early stage) is "left to the discretion of the local Medicare Administrative Contractors."

Has anyone had experience with the process of getting a pre-approval ruling on coverage?

I've copied the relevent info below:

Indications and Limitations of Coverage
B. Nationally Covered Indications
Effective for services performed on or after June 30, 2011, The Centers for Medicare and Medicaid Services (CMS) proposes that the evidence is adequate to conclude that the use of autologous cellular immunotherapy treatment - sipuleucel-T; PROVENGE® improves health outcomes for Medicare beneficiaries with asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone refractory) prostate cancer, and thus is reasonable and necessary for this on-label indication under 1862(a)(1)(A) of the Social Security Act.
C. Nationally Non-Covered Indications
N/A
D. Other
Effective for services performed on or after June 30, 2011, coverage of all off-label uses of autologous cellular immunotherapy treatment – sipuleucel-T; PROVENGE® for the treatment of prostate cancer is left to the discretion of the local Medicare Administrative Contractors.
(NCD last reviewed June 2011.)

http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=344&ncdver=1&NCAId=247&IsPopup=y&bc=AAAAAAAAAgAAAA==&