› Forums › General Melanoma Community › Stage IV Complications – Need Help!
- This topic has 51 replies, 8 voices, and was last updated 12 years, 11 months ago by
NYKaren.
- Post
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- March 1, 2013 at 9:31 pm
Please forgive me if I am being redundant in my posts. You have been helpful and I've learned a lot in a pretty short period of time. But things in our household are changing so rapidly and we are so scared, I need some help and reassurance about what we're doing and what else we should be doing.
Please forgive me if I am being redundant in my posts. You have been helpful and I've learned a lot in a pretty short period of time. But things in our household are changing so rapidly and we are so scared, I need some help and reassurance about what we're doing and what else we should be doing.
My wonderful husband, Don, was diagnosed just 2 short months ago (1/17/13) with Stage IV Metastatic Melanoma. We thought he had a bad disk (back pain). No history of melanoma (couple of basal cell spots removed in earlier years). We were just getting ready to retire and spend a winter in Florida. Never found primary.
He had one asymptomatic lesion in his left frontal lobe; Cyberknife performed 2/8/13. Two pelvic masses and another lesion at the base of his spine, received 12 radiation treatments in attempt to alleviate pain (helped a little). Other tumors in muscle along his spine, at base of neck, adrenal gland, small nodules in lungs, and recently discovered one or two in stomach/esophogus.
His disease is pretty widespread. He's being treated at Dana Farber, who wanted him on Zelboraf. Insurance company denied it because he is BRAF V600R, not V600E. It is now in third appeal in Washington (he has a BC/BS Federal Plan). I AM LOOKING FOR ANY RESEARCH/SUCCESSFUL EXPERIENCE/KNOWLEDGE OF ZELBORAF'S EFFECTIVENESS ON V600R MUTATION THAT MIGHT HELP IN THIS APPEAL!
On 2/15/13, Don was given his first infusion of Yervoy. A few days later, it seems all hell broke lose. His right leg became almost paralyzed, his right arm extremely weak, and he was overcome by extreme exhaustion. He spent a week in Brigham & Women's Hospital. They felt he had tapered too quickly off the steroids, so they gave him high dose injections and he's now on 16mg a day. His red blood count was so low, they gave him two units of blood. This is when we found out that he has mets in his stomach/esophogus which are "seeping" blood. The brain met is now larger than it was a month ago and there is inflammation around it, so they are now suggesting surgery to remove the brain tumor.
I have so many questions. This is all so fast! Brain surgery is scheduled for Tuesday, March 5. Don is an otherwise healthy, robust man; 6-foot 1-inch, 200 pounds. I have to lift his right leg for him to get into/out of the car, up the stairs, etc. He can barely sign his name with his weakened right hand.
I need to help save this man's life, as he is MY life. I'm so confused about the treatments and the clinical trials. Some say no brain mets, others say brain mets allowed. What meds and trials should I be asking his melanoma oncologist about? I believe she knows what she's doing, but I know I have to be our own advocate!
Thanks for helping! I'm so scared.
Janet
- Replies
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- March 1, 2013 at 10:17 pm
Yes, Janet, this IS all so fast! The first month or so after a Stage IV diagnosis is stressful for everyone even if the disease remains fairly stable. But in Don's case, you're being bombarded with one blow after another. I am so sorry for your distress!
My brother (multiple brain mets) had a crisis similar to Don's a few days after his first Yervoy. His oncologist (at Moffitt) thinks that the immune system was attacking the brain tumors which made the brain swell and provoked the crisis. That actually could be a positive thing in the rest of the body, but not the brain. So surgery to remove the brain met would probably be a very good idea. Then keep praying the the Yervoy is being equally effective on his other tumors.
The problem vis a vis the insurance is that the V600R mutation is so rare that there will probably never be a clinical trial to test that specific mutation. All the "evidence" you are likely to get will be individual case reports or large studies that include only a few V600R patients–not enough for statistical analyses. Your emotional and physical strength is probably being stretched to the maximum just dealing with the current medical crises. Is there anyone who can help you fight the insurance company? A friend or relative? They could contact Catherine Poole at the Melanoma International Foundation for you. Or the AIM For a Cure organization. Contact the manufacturer of vemurafenib (Zelboraf) and dabrafenib (very similar BRAF inhibitor) and ask for help with the insurance and/or for financial help. If you don't have anyone to help you fight this battle, I would go to an insurance litigation lawyer for help. Maybe just having the lawyer write a letter threatening a lawsuit will be enough to tip the balance in your favor.
And remember NYKaren's reply to your last post (reprinted below):
"Janet, I received my January Zelbarof for $100 using the card provided below.
If the link doesn't work, just google Genentech Zelbarof access solutions. I didn't go through my insurance at all due to some miscommunication with the ins. co. In Dec. I had received it through my ins co's specialty pharmacy. This card works, do not take no for an answer. If need be, ask Genentech for assistance finding a pharmacy that will accept the card. It worked very easily for me–they ask you 3 or 4 questions and give you a printable card until yours comes in the mail.
I believe all pharmacy options will be mail-order specialty pharmacies and mine gives free overnight delivery. The first customer-service rep I spoke with didn't know what to do, but the pharmacist sure did.http://www.genentech-access.com/zelboraf/hcp
Hope this helps,
Karen
Sorry you didn't know her, but as our beloved Boots would say: Don't give up–Don't back down!" -
- March 1, 2013 at 10:17 pm
Yes, Janet, this IS all so fast! The first month or so after a Stage IV diagnosis is stressful for everyone even if the disease remains fairly stable. But in Don's case, you're being bombarded with one blow after another. I am so sorry for your distress!
My brother (multiple brain mets) had a crisis similar to Don's a few days after his first Yervoy. His oncologist (at Moffitt) thinks that the immune system was attacking the brain tumors which made the brain swell and provoked the crisis. That actually could be a positive thing in the rest of the body, but not the brain. So surgery to remove the brain met would probably be a very good idea. Then keep praying the the Yervoy is being equally effective on his other tumors.
The problem vis a vis the insurance is that the V600R mutation is so rare that there will probably never be a clinical trial to test that specific mutation. All the "evidence" you are likely to get will be individual case reports or large studies that include only a few V600R patients–not enough for statistical analyses. Your emotional and physical strength is probably being stretched to the maximum just dealing with the current medical crises. Is there anyone who can help you fight the insurance company? A friend or relative? They could contact Catherine Poole at the Melanoma International Foundation for you. Or the AIM For a Cure organization. Contact the manufacturer of vemurafenib (Zelboraf) and dabrafenib (very similar BRAF inhibitor) and ask for help with the insurance and/or for financial help. If you don't have anyone to help you fight this battle, I would go to an insurance litigation lawyer for help. Maybe just having the lawyer write a letter threatening a lawsuit will be enough to tip the balance in your favor.
And remember NYKaren's reply to your last post (reprinted below):
"Janet, I received my January Zelbarof for $100 using the card provided below.
If the link doesn't work, just google Genentech Zelbarof access solutions. I didn't go through my insurance at all due to some miscommunication with the ins. co. In Dec. I had received it through my ins co's specialty pharmacy. This card works, do not take no for an answer. If need be, ask Genentech for assistance finding a pharmacy that will accept the card. It worked very easily for me–they ask you 3 or 4 questions and give you a printable card until yours comes in the mail.
I believe all pharmacy options will be mail-order specialty pharmacies and mine gives free overnight delivery. The first customer-service rep I spoke with didn't know what to do, but the pharmacist sure did.http://www.genentech-access.com/zelboraf/hcp
Hope this helps,
Karen
Sorry you didn't know her, but as our beloved Boots would say: Don't give up–Don't back down!" -
- March 1, 2013 at 10:17 pm
Yes, Janet, this IS all so fast! The first month or so after a Stage IV diagnosis is stressful for everyone even if the disease remains fairly stable. But in Don's case, you're being bombarded with one blow after another. I am so sorry for your distress!
My brother (multiple brain mets) had a crisis similar to Don's a few days after his first Yervoy. His oncologist (at Moffitt) thinks that the immune system was attacking the brain tumors which made the brain swell and provoked the crisis. That actually could be a positive thing in the rest of the body, but not the brain. So surgery to remove the brain met would probably be a very good idea. Then keep praying the the Yervoy is being equally effective on his other tumors.
The problem vis a vis the insurance is that the V600R mutation is so rare that there will probably never be a clinical trial to test that specific mutation. All the "evidence" you are likely to get will be individual case reports or large studies that include only a few V600R patients–not enough for statistical analyses. Your emotional and physical strength is probably being stretched to the maximum just dealing with the current medical crises. Is there anyone who can help you fight the insurance company? A friend or relative? They could contact Catherine Poole at the Melanoma International Foundation for you. Or the AIM For a Cure organization. Contact the manufacturer of vemurafenib (Zelboraf) and dabrafenib (very similar BRAF inhibitor) and ask for help with the insurance and/or for financial help. If you don't have anyone to help you fight this battle, I would go to an insurance litigation lawyer for help. Maybe just having the lawyer write a letter threatening a lawsuit will be enough to tip the balance in your favor.
And remember NYKaren's reply to your last post (reprinted below):
"Janet, I received my January Zelbarof for $100 using the card provided below.
If the link doesn't work, just google Genentech Zelbarof access solutions. I didn't go through my insurance at all due to some miscommunication with the ins. co. In Dec. I had received it through my ins co's specialty pharmacy. This card works, do not take no for an answer. If need be, ask Genentech for assistance finding a pharmacy that will accept the card. It worked very easily for me–they ask you 3 or 4 questions and give you a printable card until yours comes in the mail.
I believe all pharmacy options will be mail-order specialty pharmacies and mine gives free overnight delivery. The first customer-service rep I spoke with didn't know what to do, but the pharmacist sure did.http://www.genentech-access.com/zelboraf/hcp
Hope this helps,
Karen
Sorry you didn't know her, but as our beloved Boots would say: Don't give up–Don't back down!"-
- March 2, 2013 at 6:19 pm
I've contacted Catherine Poole at the Melanoma International Foundation; her contacts at Genentech said they have nothing for us because of the V600R. I've tried the card, but we are ineligible; kind of a catch-22 — he's not currently on the Z so can't get a card; plus, if you happen to earn >$100k (total household) your chances almost disappear. I just don't see how people say they're paying only $100/month. I hit a dead end no matter which way I turn. Dana Farber has tried various avenues to Genentech, and they also come up empty-handed.
Your comments regarding your brother's experience realy help… We'll have the tumor removed Tuesday. But I'm really concerned about Don getting good systemic treatment as soon as possible. He's now taking 16mg of decadron/steroids a day; and doc says he needs to be on no more than 6-8 in order to get his next Yervoy treatment. Seems like vicious circle.
Thanks for the help!
Janet
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- March 2, 2013 at 6:19 pm
I've contacted Catherine Poole at the Melanoma International Foundation; her contacts at Genentech said they have nothing for us because of the V600R. I've tried the card, but we are ineligible; kind of a catch-22 — he's not currently on the Z so can't get a card; plus, if you happen to earn >$100k (total household) your chances almost disappear. I just don't see how people say they're paying only $100/month. I hit a dead end no matter which way I turn. Dana Farber has tried various avenues to Genentech, and they also come up empty-handed.
Your comments regarding your brother's experience realy help… We'll have the tumor removed Tuesday. But I'm really concerned about Don getting good systemic treatment as soon as possible. He's now taking 16mg of decadron/steroids a day; and doc says he needs to be on no more than 6-8 in order to get his next Yervoy treatment. Seems like vicious circle.
Thanks for the help!
Janet
-
- March 2, 2013 at 6:19 pm
I've contacted Catherine Poole at the Melanoma International Foundation; her contacts at Genentech said they have nothing for us because of the V600R. I've tried the card, but we are ineligible; kind of a catch-22 — he's not currently on the Z so can't get a card; plus, if you happen to earn >$100k (total household) your chances almost disappear. I just don't see how people say they're paying only $100/month. I hit a dead end no matter which way I turn. Dana Farber has tried various avenues to Genentech, and they also come up empty-handed.
Your comments regarding your brother's experience realy help… We'll have the tumor removed Tuesday. But I'm really concerned about Don getting good systemic treatment as soon as possible. He's now taking 16mg of decadron/steroids a day; and doc says he needs to be on no more than 6-8 in order to get his next Yervoy treatment. Seems like vicious circle.
Thanks for the help!
Janet
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- March 2, 2013 at 3:21 am
Re: I need to help save this man's life, as he is MY life
Janet, send me a email at gogenegogene@gmail.com
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- March 2, 2013 at 3:21 am
Re: I need to help save this man's life, as he is MY life
Janet, send me a email at gogenegogene@gmail.com
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- March 2, 2013 at 3:56 am
Janet, somehow my gmail is not working 🙁 so send me an emai to
sparkcheckers@yahoo.com please put MELANOMA in the subject due to all of the spam!
Best wishes, Gene
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- March 2, 2013 at 3:56 am
Janet, somehow my gmail is not working 🙁 so send me an emai to
sparkcheckers@yahoo.com please put MELANOMA in the subject due to all of the spam!
Best wishes, Gene
-
- March 2, 2013 at 3:56 am
Janet, somehow my gmail is not working 🙁 so send me an emai to
sparkcheckers@yahoo.com please put MELANOMA in the subject due to all of the spam!
Best wishes, Gene
-
- March 2, 2013 at 3:21 am
Re: I need to help save this man's life, as he is MY life
Janet, send me a email at gogenegogene@gmail.com
-
- March 2, 2013 at 4:25 am
Janet:
I am sorry to hear about your situation.
As you know, V600r is a rare mutation. A few studies have been done, however. Preclinical work suggests the V600r mutation will respond to BRAF inhibitors and in one study 5 out of 6 patients with V600r responded to a BRAF inhibitor. Here is a link to the article: http://www.ncbi.nlm.nih.gov/pubmed/23237741
We work closely with Genentech and I am happy to make some inquiries on your behalf it that is useful. Also, GSK is close to having their BRAF inhibitor approved and I know the person developing that drug. I can ask him if they have any programs open that would include V600r. (I suspect, though, that the team at Dana Farber would be familiar with that.)
Feel free to reach out to me offline if you want me to help.
Tim–MRF
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- March 2, 2013 at 4:25 am
Janet:
I am sorry to hear about your situation.
As you know, V600r is a rare mutation. A few studies have been done, however. Preclinical work suggests the V600r mutation will respond to BRAF inhibitors and in one study 5 out of 6 patients with V600r responded to a BRAF inhibitor. Here is a link to the article: http://www.ncbi.nlm.nih.gov/pubmed/23237741
We work closely with Genentech and I am happy to make some inquiries on your behalf it that is useful. Also, GSK is close to having their BRAF inhibitor approved and I know the person developing that drug. I can ask him if they have any programs open that would include V600r. (I suspect, though, that the team at Dana Farber would be familiar with that.)
Feel free to reach out to me offline if you want me to help.
Tim–MRF
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- March 2, 2013 at 7:30 pm
Dear Tim,
Thanks for the link to the article re: V600R response. I had found that and sent it with my appeal to OPM.
People at Dana Farber have contacted Genentech, so has Catherine from the other melanoma website. If you think you can do anything, please, please, please do!
I would appreciate suggestions on other systemic treatments. More than 6 weeks after this catastropic diagnosis, we still have no systemic treatment plan in place. Once the brain tumor is removed, how long is it going to take to taper Don off the steroids in order to re-start the Yervoy? Or will it be too late for Yervoy by then?
Janet
-
- March 2, 2013 at 7:30 pm
Dear Tim,
Thanks for the link to the article re: V600R response. I had found that and sent it with my appeal to OPM.
People at Dana Farber have contacted Genentech, so has Catherine from the other melanoma website. If you think you can do anything, please, please, please do!
I would appreciate suggestions on other systemic treatments. More than 6 weeks after this catastropic diagnosis, we still have no systemic treatment plan in place. Once the brain tumor is removed, how long is it going to take to taper Don off the steroids in order to re-start the Yervoy? Or will it be too late for Yervoy by then?
Janet
-
- March 2, 2013 at 7:30 pm
Dear Tim,
Thanks for the link to the article re: V600R response. I had found that and sent it with my appeal to OPM.
People at Dana Farber have contacted Genentech, so has Catherine from the other melanoma website. If you think you can do anything, please, please, please do!
I would appreciate suggestions on other systemic treatments. More than 6 weeks after this catastropic diagnosis, we still have no systemic treatment plan in place. Once the brain tumor is removed, how long is it going to take to taper Don off the steroids in order to re-start the Yervoy? Or will it be too late for Yervoy by then?
Janet
-
- March 2, 2013 at 4:25 am
Janet:
I am sorry to hear about your situation.
As you know, V600r is a rare mutation. A few studies have been done, however. Preclinical work suggests the V600r mutation will respond to BRAF inhibitors and in one study 5 out of 6 patients with V600r responded to a BRAF inhibitor. Here is a link to the article: http://www.ncbi.nlm.nih.gov/pubmed/23237741
We work closely with Genentech and I am happy to make some inquiries on your behalf it that is useful. Also, GSK is close to having their BRAF inhibitor approved and I know the person developing that drug. I can ask him if they have any programs open that would include V600r. (I suspect, though, that the team at Dana Farber would be familiar with that.)
Feel free to reach out to me offline if you want me to help.
Tim–MRF
-
- March 2, 2013 at 5:20 am
Janet;
Please read my responses to:
Input needed regarding treatment options – stage IV
Another thing to followup on is whether or not Florida is one of the 50% of states that have Laws that require the if a drug is FDA approved for any cancer and the use the Doctor wants it for has been written up in one per review Journal, then the Insurance company is required to cover it on an "Off label" basis. So if a peer reviewed journal article can be located. Wish I had wideband and could search faster.
-
- March 2, 2013 at 5:20 am
Janet;
Please read my responses to:
Input needed regarding treatment options – stage IV
Another thing to followup on is whether or not Florida is one of the 50% of states that have Laws that require the if a drug is FDA approved for any cancer and the use the Doctor wants it for has been written up in one per review Journal, then the Insurance company is required to cover it on an "Off label" basis. So if a peer reviewed journal article can be located. Wish I had wideband and could search faster.
-
- March 2, 2013 at 6:38 am
Another thing to followup on is whether or not Florida is one of the 50% of states that have Laws that require that if a drug is FDA approved for any cancer and the use the Doctor wants it for has been written up in one per review Journal, then the Insurance company is required to cover it on an "Off label" basis. See if a peer reviewed journal article can be located. Wish I had wideband and could search faster.
-
- March 2, 2013 at 6:38 am
Another thing to followup on is whether or not Florida is one of the 50% of states that have Laws that require that if a drug is FDA approved for any cancer and the use the Doctor wants it for has been written up in one per review Journal, then the Insurance company is required to cover it on an "Off label" basis. See if a peer reviewed journal article can be located. Wish I had wideband and could search faster.
-
- March 2, 2013 at 12:03 pm
Janet, Jerry had an excellent suggestion. According to the National Cancer Institute, both Massachucets and Flordia have laws that require insurance companies to pay for "off label" use of cancer drugs UNDER CERTAIN CIRCUMSTANCES. The NCI web site is: http://www.cancer.gov/clinicaltrials/learningabout/approval-process-for-cancer-drugs/page5
As I said before, I don't think there is any way that you can physically or mentally handle both the medical issues and these insurance issues without help. If you do not have a family member or close friend who will go to bat for you, I will. Email me at poweinberg@hotmail.com
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- March 2, 2013 at 12:03 pm
Janet, Jerry had an excellent suggestion. According to the National Cancer Institute, both Massachucets and Flordia have laws that require insurance companies to pay for "off label" use of cancer drugs UNDER CERTAIN CIRCUMSTANCES. The NCI web site is: http://www.cancer.gov/clinicaltrials/learningabout/approval-process-for-cancer-drugs/page5
As I said before, I don't think there is any way that you can physically or mentally handle both the medical issues and these insurance issues without help. If you do not have a family member or close friend who will go to bat for you, I will. Email me at poweinberg@hotmail.com
-
- March 2, 2013 at 7:55 pm
I followed this link to the cancer.gov, but I can only find references to state laws requiring insurance coverage for clinical trials. Any help in finding the requirement for insurance companies to pay for "off label" use would be very helpful. I think giving Don Zelboraf for the V600R BRAF mutation would be considered "off label."
Janet
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- March 2, 2013 at 7:55 pm
I followed this link to the cancer.gov, but I can only find references to state laws requiring insurance coverage for clinical trials. Any help in finding the requirement for insurance companies to pay for "off label" use would be very helpful. I think giving Don Zelboraf for the V600R BRAF mutation would be considered "off label."
Janet
-
- March 2, 2013 at 8:04 pm
Janet:
Yes, giving vemurafenib for V600r would be off label, unless he happened to test positive using Roche's diagnostic.
Federal legislation from 1993 requires coverage of off-label use for cancer drugs if a peer-reviewed study shows benefit. This needs to be worked out with the treatment team.
You should call our toll-free help line. It is staffed with oncology social workers who deal with reimbursement all fo the time. i don't know for sure that they have expertise in this area, but they may.
The helpline is staffed Monday through Thursday 9 to 7, and Friday from 9 to 5: 1 (877) 673-6460
Tim–MRF
-
- March 2, 2013 at 8:04 pm
Janet:
Yes, giving vemurafenib for V600r would be off label, unless he happened to test positive using Roche's diagnostic.
Federal legislation from 1993 requires coverage of off-label use for cancer drugs if a peer-reviewed study shows benefit. This needs to be worked out with the treatment team.
You should call our toll-free help line. It is staffed with oncology social workers who deal with reimbursement all fo the time. i don't know for sure that they have expertise in this area, but they may.
The helpline is staffed Monday through Thursday 9 to 7, and Friday from 9 to 5: 1 (877) 673-6460
Tim–MRF
-
- March 2, 2013 at 11:48 pm
Tim, The 1993 federal legislation only applies to Medicare. Individual state laws may have some restrictions, such as it bing a state regulated insurance company, not being a self insured employer, etc. Each state has to have it's cancer off label drug laws looked at individually.
The federal law says:
Off-label uses may include giving an approved treatment:
- for a disease other than the disease it is approved for,
- at a different dose or frequency than specified in the product's labeling, or
- to treat a child when the product is approved to treat adults.
********************************
UNITED HealthCare says that while Virginia off label usage laws follows the medicare guidlines that they refuse to provide the 800 mg/day for 30 days that the Novartis brochure lists for Gleevec to be used for the FDA approved C-kit cancers for off label usage. They will only provide a 15 day supply for a full monthly co-pay. They initially told me that Novartis refused to allow more than 400 mg a day to be prescribed. They will however provide a thirty day supply for two monthly copays a month, but only a 15 day supply per shipment. They then often argue and tell me that I have to wait three weeks after one shipment to order the next 15 day shipment. After I sent UHC the Novartis shipment brochure, their speciality pharmacy stopped sending the Novartis instruction sheet out and made up their own sheet. My Onccologist has spend hours every year for four years now trying to get me a 30 day per shipment supply. Sometimes takes several days and several hours of calling to get the next shipmeent. Very frustrating, but at least I am still alive.
-
- March 2, 2013 at 11:48 pm
Tim, The 1993 federal legislation only applies to Medicare. Individual state laws may have some restrictions, such as it bing a state regulated insurance company, not being a self insured employer, etc. Each state has to have it's cancer off label drug laws looked at individually.
The federal law says:
Off-label uses may include giving an approved treatment:
- for a disease other than the disease it is approved for,
- at a different dose or frequency than specified in the product's labeling, or
- to treat a child when the product is approved to treat adults.
********************************
UNITED HealthCare says that while Virginia off label usage laws follows the medicare guidlines that they refuse to provide the 800 mg/day for 30 days that the Novartis brochure lists for Gleevec to be used for the FDA approved C-kit cancers for off label usage. They will only provide a 15 day supply for a full monthly co-pay. They initially told me that Novartis refused to allow more than 400 mg a day to be prescribed. They will however provide a thirty day supply for two monthly copays a month, but only a 15 day supply per shipment. They then often argue and tell me that I have to wait three weeks after one shipment to order the next 15 day shipment. After I sent UHC the Novartis shipment brochure, their speciality pharmacy stopped sending the Novartis instruction sheet out and made up their own sheet. My Onccologist has spend hours every year for four years now trying to get me a 30 day per shipment supply. Sometimes takes several days and several hours of calling to get the next shipmeent. Very frustrating, but at least I am still alive.
-
- March 2, 2013 at 11:48 pm
Tim, The 1993 federal legislation only applies to Medicare. Individual state laws may have some restrictions, such as it bing a state regulated insurance company, not being a self insured employer, etc. Each state has to have it's cancer off label drug laws looked at individually.
The federal law says:
Off-label uses may include giving an approved treatment:
- for a disease other than the disease it is approved for,
- at a different dose or frequency than specified in the product's labeling, or
- to treat a child when the product is approved to treat adults.
********************************
UNITED HealthCare says that while Virginia off label usage laws follows the medicare guidlines that they refuse to provide the 800 mg/day for 30 days that the Novartis brochure lists for Gleevec to be used for the FDA approved C-kit cancers for off label usage. They will only provide a 15 day supply for a full monthly co-pay. They initially told me that Novartis refused to allow more than 400 mg a day to be prescribed. They will however provide a thirty day supply for two monthly copays a month, but only a 15 day supply per shipment. They then often argue and tell me that I have to wait three weeks after one shipment to order the next 15 day shipment. After I sent UHC the Novartis shipment brochure, their speciality pharmacy stopped sending the Novartis instruction sheet out and made up their own sheet. My Onccologist has spend hours every year for four years now trying to get me a 30 day per shipment supply. Sometimes takes several days and several hours of calling to get the next shipmeent. Very frustrating, but at least I am still alive.
-
- March 2, 2013 at 8:04 pm
Janet:
Yes, giving vemurafenib for V600r would be off label, unless he happened to test positive using Roche's diagnostic.
Federal legislation from 1993 requires coverage of off-label use for cancer drugs if a peer-reviewed study shows benefit. This needs to be worked out with the treatment team.
You should call our toll-free help line. It is staffed with oncology social workers who deal with reimbursement all fo the time. i don't know for sure that they have expertise in this area, but they may.
The helpline is staffed Monday through Thursday 9 to 7, and Friday from 9 to 5: 1 (877) 673-6460
Tim–MRF
-
- March 2, 2013 at 7:55 pm
I followed this link to the cancer.gov, but I can only find references to state laws requiring insurance coverage for clinical trials. Any help in finding the requirement for insurance companies to pay for "off label" use would be very helpful. I think giving Don Zelboraf for the V600R BRAF mutation would be considered "off label."
Janet
-
- March 2, 2013 at 12:03 pm
Janet, Jerry had an excellent suggestion. According to the National Cancer Institute, both Massachucets and Flordia have laws that require insurance companies to pay for "off label" use of cancer drugs UNDER CERTAIN CIRCUMSTANCES. The NCI web site is: http://www.cancer.gov/clinicaltrials/learningabout/approval-process-for-cancer-drugs/page5
As I said before, I don't think there is any way that you can physically or mentally handle both the medical issues and these insurance issues without help. If you do not have a family member or close friend who will go to bat for you, I will. Email me at poweinberg@hotmail.com
-
- March 2, 2013 at 6:38 am
Another thing to followup on is whether or not Florida is one of the 50% of states that have Laws that require that if a drug is FDA approved for any cancer and the use the Doctor wants it for has been written up in one per review Journal, then the Insurance company is required to cover it on an "Off label" basis. See if a peer reviewed journal article can be located. Wish I had wideband and could search faster.
-
- March 2, 2013 at 5:20 am
Janet;
Please read my responses to:
Input needed regarding treatment options – stage IV
Another thing to followup on is whether or not Florida is one of the 50% of states that have Laws that require the if a drug is FDA approved for any cancer and the use the Doctor wants it for has been written up in one per review Journal, then the Insurance company is required to cover it on an "Off label" basis. So if a peer reviewed journal article can be located. Wish I had wideband and could search faster.
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- March 2, 2013 at 12:42 pm
Janet, I am so sorry for everything you both are dealing with right. I don’t know anything about getting Zelboraf or the V600R mutation. But, my husband, Phil did have brain surgery and recuperation at Brigham and Women’s hospital in Boston, and we can’t say enough good things about the nurses and his care there. Before surgery, due to the tumor location, my husband was unable to walk unassisted and couldn’t talk correctly, it was super scary for me! The surgeon got the tumor that was causing these issues, and Phil woke up able to talk and walk just like normal, it was amazing. Quick hospital stay, and fairly easy recuperation. Please know that there can be light from out of this tunnel, Phil’s brain surgery was in October 2011 and he is still doing well. Just take one step at a time, and take care of yourself! Please keep us posted! Valerie (Phil’s wife) -
- March 2, 2013 at 12:42 pm
Janet, I am so sorry for everything you both are dealing with right. I don’t know anything about getting Zelboraf or the V600R mutation. But, my husband, Phil did have brain surgery and recuperation at Brigham and Women’s hospital in Boston, and we can’t say enough good things about the nurses and his care there. Before surgery, due to the tumor location, my husband was unable to walk unassisted and couldn’t talk correctly, it was super scary for me! The surgeon got the tumor that was causing these issues, and Phil woke up able to talk and walk just like normal, it was amazing. Quick hospital stay, and fairly easy recuperation. Please know that there can be light from out of this tunnel, Phil’s brain surgery was in October 2011 and he is still doing well. Just take one step at a time, and take care of yourself! Please keep us posted! Valerie (Phil’s wife) -
- March 2, 2013 at 12:42 pm
Janet, I am so sorry for everything you both are dealing with right. I don’t know anything about getting Zelboraf or the V600R mutation. But, my husband, Phil did have brain surgery and recuperation at Brigham and Women’s hospital in Boston, and we can’t say enough good things about the nurses and his care there. Before surgery, due to the tumor location, my husband was unable to walk unassisted and couldn’t talk correctly, it was super scary for me! The surgeon got the tumor that was causing these issues, and Phil woke up able to talk and walk just like normal, it was amazing. Quick hospital stay, and fairly easy recuperation. Please know that there can be light from out of this tunnel, Phil’s brain surgery was in October 2011 and he is still doing well. Just take one step at a time, and take care of yourself! Please keep us posted! Valerie (Phil’s wife) -
- March 2, 2013 at 4:09 pm
Janet. –
DF has a good reputation but they should have explained that Yervoy often makes things worse before they get better. That is definitely what happened to me. Things got scary.This is all some great advice. It sounds like there is a plan to get him stabilized so take this one day at a time. Melanoma is scary and awful, just take it day by day. So often things are out of our control. You are not alone. Amazing group of people on here.
Keep fighting!Prayers, Amy
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- March 2, 2013 at 4:09 pm
Janet. –
DF has a good reputation but they should have explained that Yervoy often makes things worse before they get better. That is definitely what happened to me. Things got scary.This is all some great advice. It sounds like there is a plan to get him stabilized so take this one day at a time. Melanoma is scary and awful, just take it day by day. So often things are out of our control. You are not alone. Amazing group of people on here.
Keep fighting!Prayers, Amy
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- March 3, 2013 at 3:01 am
Hi Janet,
I’m so sorry you are both going through this.
DF should have given you detailed info about Yervoy. If not, please go to its website, http://www.yervoy.com.
There should be leeway as to when your husband receives his next infusion. He has time to taper down to the 7.5mg/day of steroids permitted in order to receive the infusion.
I hope this helps a little.
There is a lot of great advice here, I hope it helps you find a solution.
Too bad you have no way of knowing in advance if your husband would respond to Zel.
Warm wishes,
Karen -
- March 3, 2013 at 3:01 am
Hi Janet,
I’m so sorry you are both going through this.
DF should have given you detailed info about Yervoy. If not, please go to its website, http://www.yervoy.com.
There should be leeway as to when your husband receives his next infusion. He has time to taper down to the 7.5mg/day of steroids permitted in order to receive the infusion.
I hope this helps a little.
There is a lot of great advice here, I hope it helps you find a solution.
Too bad you have no way of knowing in advance if your husband would respond to Zel.
Warm wishes,
Karen -
- March 3, 2013 at 3:01 am
Hi Janet,
I’m so sorry you are both going through this.
DF should have given you detailed info about Yervoy. If not, please go to its website, http://www.yervoy.com.
There should be leeway as to when your husband receives his next infusion. He has time to taper down to the 7.5mg/day of steroids permitted in order to receive the infusion.
I hope this helps a little.
There is a lot of great advice here, I hope it helps you find a solution.
Too bad you have no way of knowing in advance if your husband would respond to Zel.
Warm wishes,
Karen
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- March 2, 2013 at 4:09 pm
Janet. –
DF has a good reputation but they should have explained that Yervoy often makes things worse before they get better. That is definitely what happened to me. Things got scary.This is all some great advice. It sounds like there is a plan to get him stabilized so take this one day at a time. Melanoma is scary and awful, just take it day by day. So often things are out of our control. You are not alone. Amazing group of people on here.
Keep fighting!Prayers, Amy
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