The FDA has approved the cancer drug Provenge for use in men with advanced prostate cancer

bdhilton
bdhilton Member Posts: 803 Member
edited March 2014 in Prostate Cancer #1
It is offical...Provenge has been approved for use in patients with advanced prostate cancer by the FDA. It is the first of several promising immunotherapeutic agents to make it to the clinic.

Comments

  • erisian
    erisian Member Posts: 107
    Where do I sign up?
    I've been waiting for this for two and a half years!

    http://www.pcf.org/prostatecancer/spotlight/provenge

    Good article about Provenge here:

    http://www.zerocancer.org/site/News2?page=NewsArticle&id=11509
  • randy_in_indy
    randy_in_indy Member Posts: 496 Member
    This is GREAT!
    Headway being made in prevention and cure. Also on that same page in the margin is a 32 page guide from several renown doc's on exercise and nutrition....can download into a pdf and print right off for free...I'm going to read it now.

    It's on this page right hand lower margin:

    http://www.pcf.org/prostatecancer/spotlight/provenge
  • HeartofSoul
    HeartofSoul Member Posts: 729
    From what i have read on
    From what i have read on approval of Provenge, I was curious to know how it will play out.
    I beleive its a big step towards finding a preventative vaccine against prostate cancer.

    I have a question

    1. How resistent will medical insurance companies be in their authorization of using it? The vaccine will cost $93,000 for a series of 3 shots of Provenge. Will the insurance company justify the cost of paying for Provenge if they see a increase of 4 months to a patients life expectancy? A chemo drug called docetaxel is currently standard treatmet for men whose tumors don't respond to hormone therapies and helps patients live about 2.4 months longer. The difference then is 2 months to what Provenge would add with the benefit of not being on chemo and all of its harsh effects
  • Kongo
    Kongo Member Posts: 1,166 Member

    From what i have read on
    From what i have read on approval of Provenge, I was curious to know how it will play out.
    I beleive its a big step towards finding a preventative vaccine against prostate cancer.

    I have a question

    1. How resistent will medical insurance companies be in their authorization of using it? The vaccine will cost $93,000 for a series of 3 shots of Provenge. Will the insurance company justify the cost of paying for Provenge if they see a increase of 4 months to a patients life expectancy? A chemo drug called docetaxel is currently standard treatmet for men whose tumors don't respond to hormone therapies and helps patients live about 2.4 months longer. The difference then is 2 months to what Provenge would add with the benefit of not being on chemo and all of its harsh effects

    Provenge and Insurance
    I suspect that initially, most insurance companies (especially HMOs) will continue to classify this as an experimental drug and exculude it from coverage. As it is, this drug is only FDA approved for late stage prostate cancer. Those who can be treated with more conventional options should probably pursue those rather than holding out for this drug. The exciting thing about the announcement is that for the first time, the FDA has approved a drug that is individually tailored to a specific individual and their unique cancer conditions. In the future, this may be the way all cancers are treated.
  • mrshisname
    mrshisname Member Posts: 186
    Kongo said:

    Provenge and Insurance
    I suspect that initially, most insurance companies (especially HMOs) will continue to classify this as an experimental drug and exculude it from coverage. As it is, this drug is only FDA approved for late stage prostate cancer. Those who can be treated with more conventional options should probably pursue those rather than holding out for this drug. The exciting thing about the announcement is that for the first time, the FDA has approved a drug that is individually tailored to a specific individual and their unique cancer conditions. In the future, this may be the way all cancers are treated.

    THankful
    We arrived home from my husband's DaVinci prostatectomy yesterday and were listening to the news, and this news comes on. What a great piece of news on a particularly momentous day for us as a couple.
    I suspect, like Kongo, that initially the insurers will do their darnedest to avoid giving approval for this hugely expensive drug. They will likely expect miles of documentation to support the use in a particular patient, and use that as a stalling technique. But as we all know, eventually these advances become more standard therapy and the insurers are forced to accept them. I am currently on a drug for rheumatoid arthritis that costs $5000 a month. Years past it was an arduous process for approval, not now. Without it I would be unable to work.
    This is indeed a huge victory for men with prostate cancer, and from what I hear, will lead to therapies for other cancers as well. We are indeed making strides!!
  • jimbeam50
    jimbeam50 Member Posts: 47

    THankful
    We arrived home from my husband's DaVinci prostatectomy yesterday and were listening to the news, and this news comes on. What a great piece of news on a particularly momentous day for us as a couple.
    I suspect, like Kongo, that initially the insurers will do their darnedest to avoid giving approval for this hugely expensive drug. They will likely expect miles of documentation to support the use in a particular patient, and use that as a stalling technique. But as we all know, eventually these advances become more standard therapy and the insurers are forced to accept them. I am currently on a drug for rheumatoid arthritis that costs $5000 a month. Years past it was an arduous process for approval, not now. Without it I would be unable to work.
    This is indeed a huge victory for men with prostate cancer, and from what I hear, will lead to therapies for other cancers as well. We are indeed making strides!!

    I was all excited about the
    I was all excited about the news too until I saw the price tag. Sheila
  • erisian
    erisian Member Posts: 107

    THankful
    We arrived home from my husband's DaVinci prostatectomy yesterday and were listening to the news, and this news comes on. What a great piece of news on a particularly momentous day for us as a couple.
    I suspect, like Kongo, that initially the insurers will do their darnedest to avoid giving approval for this hugely expensive drug. They will likely expect miles of documentation to support the use in a particular patient, and use that as a stalling technique. But as we all know, eventually these advances become more standard therapy and the insurers are forced to accept them. I am currently on a drug for rheumatoid arthritis that costs $5000 a month. Years past it was an arduous process for approval, not now. Without it I would be unable to work.
    This is indeed a huge victory for men with prostate cancer, and from what I hear, will lead to therapies for other cancers as well. We are indeed making strides!!

    $$$
    I don't think the insurance companies could deny coverage, because the treatment is no longer experimental, it is FDA approved. Anyway, chemo ain't cheap either! When I was on docetaxel, the total drug tab was running up at the rate of $16,000 PER MONTH. 10 3-week cycles of that costs more than Provenge. Also, with the improvement in median survival, Provenge could take the standard of care slot away from docetaxel. If that happens, insurance will have to cover it.

    Here's the FDA information page for Provenge:
    http://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm210012.htm

    It's a little hard to find because it's not a "drug".
  • NCEllen
    NCEllen Member Posts: 115
    erisian said:

    $$$
    I don't think the insurance companies could deny coverage, because the treatment is no longer experimental, it is FDA approved. Anyway, chemo ain't cheap either! When I was on docetaxel, the total drug tab was running up at the rate of $16,000 PER MONTH. 10 3-week cycles of that costs more than Provenge. Also, with the improvement in median survival, Provenge could take the standard of care slot away from docetaxel. If that happens, insurance will have to cover it.

    Here's the FDA information page for Provenge:
    http://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm210012.htm

    It's a little hard to find because it's not a "drug".

    Husband starting chemo on Friday
    Hi - My husband will start chemo on Friday (docetaxel). We're meeting with his oncologist first for a recommended treatment plan. We were on vacation when the Provenge announcement was made and his Dr. had mentioned something about him being first on his list to get this treatment if possible and feasable for his situation. I'll keep you posted how our ins. coverage will react. My husband was diagnosed 2002, Gleason 8, radical pros. surgery, radiation a year later, multiple hormone therapies, ketoconazole - all of which now has become hormone refractive. PSA in Jan. was @22 and last one in April was 64. Not sure what the current one will be. His bone scans have been clean as he has been on a clinical trial study of demasubab. It protects the bones from becoming pourous, and that study is ending this month. This treatment may be FDA approved and available this summer for osteoporosis. His CT scans show multiple lymph tumors in the pelvic/lower back area that are growing, but no mets to any bone or organ at this time.
    PC sucks. His reoccurance comes on the heals of my recovering from Stage3 ovarian cancer last year. So far, my numbers are low, I'm in remission and feeling great.
    My turn to take care of him and hoping this chemo treatment is not to bad. Just found out we're going to be first time grandparents in December, so that alone will keep his will strong (and faith). Take care, keeping the hope of a cure always in my heart for all of you dealing with this - Ellen
  • lewvino
    lewvino Member Posts: 1,010
    NCEllen said:

    Husband starting chemo on Friday
    Hi - My husband will start chemo on Friday (docetaxel). We're meeting with his oncologist first for a recommended treatment plan. We were on vacation when the Provenge announcement was made and his Dr. had mentioned something about him being first on his list to get this treatment if possible and feasable for his situation. I'll keep you posted how our ins. coverage will react. My husband was diagnosed 2002, Gleason 8, radical pros. surgery, radiation a year later, multiple hormone therapies, ketoconazole - all of which now has become hormone refractive. PSA in Jan. was @22 and last one in April was 64. Not sure what the current one will be. His bone scans have been clean as he has been on a clinical trial study of demasubab. It protects the bones from becoming pourous, and that study is ending this month. This treatment may be FDA approved and available this summer for osteoporosis. His CT scans show multiple lymph tumors in the pelvic/lower back area that are growing, but no mets to any bone or organ at this time.
    PC sucks. His reoccurance comes on the heals of my recovering from Stage3 ovarian cancer last year. So far, my numbers are low, I'm in remission and feeling great.
    My turn to take care of him and hoping this chemo treatment is not to bad. Just found out we're going to be first time grandparents in December, so that alone will keep his will strong (and faith). Take care, keeping the hope of a cure always in my heart for all of you dealing with this - Ellen

    First Congrats on becoming
    First Congrats on becoming Grandparents! I wish my two sons (both married) Would get something going there! LOL.

    Second Sorry to hear about you and your hubby. Keep the faith and keep surviving!

    Larry