› Forums › General Melanoma Community › IPI use, cost and insurance approval
- This topic has 4 replies, 2 voices, and was last updated 13 years, 8 months ago by Ranisa.
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- March 25, 2011 at 9:55 pm
It is good news that IPI was approved by the FDA as another tool for some melanoma patients. For those of you that want the factual, nitty-gritty, flyspeck print from manufacturer written insert …………………..here it is http://packageinserts.bms.com/pi/pi_yervoy.pdf
It is good news that IPI was approved by the FDA as another tool for some melanoma patients. For those of you that want the factual, nitty-gritty, flyspeck print from manufacturer written insert …………………..here it is http://packageinserts.bms.com/pi/pi_yervoy.pdf
There will be, in the ensuing days, much trumpet blaring, hand wringing and chest beating about Yervoy, and much of it will be sensational and lacking factual details, so I would encourage anyone contemplating this drug to read the prescribing information FIRST before racing to the Cancer Clinic of your choice shouting "I want IPI".
At 30k per infusion through a 4 infusion protocol, it is indeed pricey. But on balance, my Intron drug alone, sans the 30 day induction, sans the hospital costs of clinical visits, scans and mitigation of side effects, cost 154K for 48 weeks, and my high dose IL-2 was 8k per infusion, sans the "installation" costs while in ICU, the mitigation of side effects, scans and all that other jazz. According to BMS, they have raised their patient assistance program to a maximum annual income of 150-175K for uninsured or co-pay assistance for users of Yervoy. The drug alone will be in the range of 120K.
That means that with clinical pre-screening of lab work, scans ,and follow up, the actual true cost is probably more around the 175K-200K range.
As far as insurance approval, I have a Case Manger with my now 11 year health insurance provider (by the way, I encourage patients with chronic, acute and major health problems to call your insurance company and request a Case Manager)………….Anyway, my Case Manager and I have had conversations about the "treatment approval" for IPI and they have preliminary plans for approval ONLY with in-network providers who have been in the clinical trial process. This is due mainly to the adverse reactions associated with IPI and they are not going to let rookies administer this drug.
Also in the conversation is the "for patients who have unresectable disease or who failed conventional treatments"………..that leaves a huge amount of gray area for discussion and consideration from the insurance company,; Is it truly unresectable and what is considered a failure? Also, insofar as it has a 15% to date response rate and about a four month stated life extension, to what end is it viable in the general population?
I have all ready made my own decision relative to Yervoy and am neither pro nor con about the drug, though I do welcome it's availability and it does prove that Melanoma is finally on the cancer radar of treatment development and I personally know several people that it has been the silver bullet so far, , but, as always encourage patients to work the problem and not be swayed by the "game changer, seismic shift" sensational headlines that are sure to follow, but juuuuuuuuuuuuuuuuust keep sledding, do your homework, get the facts as best you can, ask questions, and make your own INFORMED decisions.
Cheers,
Charlie S
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- March 25, 2011 at 10:05 pm
Charlie thanks for the great info – especially on getting a case manager. One thing I read today is that Ipi was approved for first and second line treatment of melanoma so you dont have to fail a treatment first:
http://online.wsj.com/article/BT-CO-20110325-711045.html
Bristol-Myers Squibb Co. (BMY) Chief Executive Lamberto Andreotti said Friday the U.S. Food and Drug Administration approved skin-cancer drug Yervoy for a broader patient population than originally expected.
The FDA approved Yervoy for people with advanced melanoma who have received prior treatment, as well as for those with no prior treatment. Yervoy had been expected to be approved initially as a second-line treatment because results of a clinical trial in that setting formed the basis of Bristol's FDA application last year.
But Bristol said earlier this week the drug showed a survival benefit in a separate study in previously untreated patients. Although Bristol hasn't released full results of this study yet, Andreotti said the FDA had asked for some of the data as part of its review.
"It was their decision to include the full population" in the drug's prescribing label, Andreotti said in an interview Friday.
Best,
Emily
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- March 25, 2011 at 10:05 pm
Charlie thanks for the great info – especially on getting a case manager. One thing I read today is that Ipi was approved for first and second line treatment of melanoma so you dont have to fail a treatment first:
http://online.wsj.com/article/BT-CO-20110325-711045.html
Bristol-Myers Squibb Co. (BMY) Chief Executive Lamberto Andreotti said Friday the U.S. Food and Drug Administration approved skin-cancer drug Yervoy for a broader patient population than originally expected.
The FDA approved Yervoy for people with advanced melanoma who have received prior treatment, as well as for those with no prior treatment. Yervoy had been expected to be approved initially as a second-line treatment because results of a clinical trial in that setting formed the basis of Bristol's FDA application last year.
But Bristol said earlier this week the drug showed a survival benefit in a separate study in previously untreated patients. Although Bristol hasn't released full results of this study yet, Andreotti said the FDA had asked for some of the data as part of its review.
"It was their decision to include the full population" in the drug's prescribing label, Andreotti said in an interview Friday.
Best,
Emily
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