› Forums › General Melanoma Community › Insurance paying for Zelboraf?
- This topic has 24 replies, 6 voices, and was last updated 11 years, 9 months ago by
Janet Lee.
- Post
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- March 14, 2013 at 10:47 am
In trying to help Janet Lee and her husband, Don, get insurance coverage for Zelboraf, I looked into what's going on with the FDA and their approval process. It turns out that the manufacturer of Zelboraf, Genentech, only applied to the FDA to use Z in people with the V600E mutation, so that is what the FDA approved. Therefore, Zelboraf is not FDA approved to treat people with other V600 mutations like V600K, or V600D, or V600R.
In trying to help Janet Lee and her husband, Don, get insurance coverage for Zelboraf, I looked into what's going on with the FDA and their approval process. It turns out that the manufacturer of Zelboraf, Genentech, only applied to the FDA to use Z in people with the V600E mutation, so that is what the FDA approved. Therefore, Zelboraf is not FDA approved to treat people with other V600 mutations like V600K, or V600D, or V600R. That is why Don's insurance company would not approve payment– that would be considered an "off label" or "not medically necessary" expense.
That makes me wonder how many people are being denied insurance coverage because they have the "wrong" V600 mutation. How common is this problem, and what did you do to overcome it? If you have a non-V600E BRAF mutation, is your insurance company paying for Zelboraf? Did you have to fight for coverage? How?
- Replies
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- March 14, 2013 at 2:42 pm
This is an important issue and a good question.
One point of clarification–the company applied to the FDA for all V600 mutations but the FDA told them they could not make the application that broad. The FDA had them revise the submission to include only V600e mutations.
My understanding is that this is because Zelboraf was approved with a companion diagnostic–the COBAS test–that is a Roche diagnostic. The COBAS test was developed as a test for V600e, though I believe it picks up some other mutations as well. If I am correct about the label, Zelboraf is approved for treating any melanoma tumor that tests positive with the COBAS, regardless of what the specific mutation.
Tim–MRF
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- March 14, 2013 at 2:42 pm
This is an important issue and a good question.
One point of clarification–the company applied to the FDA for all V600 mutations but the FDA told them they could not make the application that broad. The FDA had them revise the submission to include only V600e mutations.
My understanding is that this is because Zelboraf was approved with a companion diagnostic–the COBAS test–that is a Roche diagnostic. The COBAS test was developed as a test for V600e, though I believe it picks up some other mutations as well. If I am correct about the label, Zelboraf is approved for treating any melanoma tumor that tests positive with the COBAS, regardless of what the specific mutation.
Tim–MRF
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- March 14, 2013 at 3:43 pm
Tim, I don't mean to be argumentative, but the official FDA review (Google "Clinical Review NDA 2020429") and the Zelboraf prescribing information for physicians both say the same thing: "ZELBORAF™ is indicated for the treatment of patients with unresectable or metastatic melanoma with BRAFV600E mutation as detected by an FDA-approved test." In other words, it is ONLY approved for use on V600E mutations. That is why Don Lee's insurance company denied his coverage.
Depending on the whims of the insurance companies, that leaves the 10% of BRAF-positive patients having a different V600 mutation without coverage for Zelboraf. Not only is this important for Zelboraf, I suspect that such a narrow definition of "appropriate mutations" will affect other BRAF inhibitors (like dabrafenib) as well as other targeted chemotherapies. The phramaceutical companies and/or the FDA are only going do clinical trials or grant approval for the most common mutation (90% of melanoma BRAF mutants are V600E) and people who happen to have a less common mutation will be left out in the cold.
That is why I am asking if anyone with a non-V600E mutation has been able to convince their insurance company to pay for Zelboraf. Is there going to be a back door available for the mutationally challenged?
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- March 14, 2013 at 3:43 pm
Tim, I don't mean to be argumentative, but the official FDA review (Google "Clinical Review NDA 2020429") and the Zelboraf prescribing information for physicians both say the same thing: "ZELBORAF™ is indicated for the treatment of patients with unresectable or metastatic melanoma with BRAFV600E mutation as detected by an FDA-approved test." In other words, it is ONLY approved for use on V600E mutations. That is why Don Lee's insurance company denied his coverage.
Depending on the whims of the insurance companies, that leaves the 10% of BRAF-positive patients having a different V600 mutation without coverage for Zelboraf. Not only is this important for Zelboraf, I suspect that such a narrow definition of "appropriate mutations" will affect other BRAF inhibitors (like dabrafenib) as well as other targeted chemotherapies. The phramaceutical companies and/or the FDA are only going do clinical trials or grant approval for the most common mutation (90% of melanoma BRAF mutants are V600E) and people who happen to have a less common mutation will be left out in the cold.
That is why I am asking if anyone with a non-V600E mutation has been able to convince their insurance company to pay for Zelboraf. Is there going to be a back door available for the mutationally challenged?
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- March 14, 2013 at 3:43 pm
Tim, I don't mean to be argumentative, but the official FDA review (Google "Clinical Review NDA 2020429") and the Zelboraf prescribing information for physicians both say the same thing: "ZELBORAF™ is indicated for the treatment of patients with unresectable or metastatic melanoma with BRAFV600E mutation as detected by an FDA-approved test." In other words, it is ONLY approved for use on V600E mutations. That is why Don Lee's insurance company denied his coverage.
Depending on the whims of the insurance companies, that leaves the 10% of BRAF-positive patients having a different V600 mutation without coverage for Zelboraf. Not only is this important for Zelboraf, I suspect that such a narrow definition of "appropriate mutations" will affect other BRAF inhibitors (like dabrafenib) as well as other targeted chemotherapies. The phramaceutical companies and/or the FDA are only going do clinical trials or grant approval for the most common mutation (90% of melanoma BRAF mutants are V600E) and people who happen to have a less common mutation will be left out in the cold.
That is why I am asking if anyone with a non-V600E mutation has been able to convince their insurance company to pay for Zelboraf. Is there going to be a back door available for the mutationally challenged?
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- March 14, 2013 at 2:42 pm
This is an important issue and a good question.
One point of clarification–the company applied to the FDA for all V600 mutations but the FDA told them they could not make the application that broad. The FDA had them revise the submission to include only V600e mutations.
My understanding is that this is because Zelboraf was approved with a companion diagnostic–the COBAS test–that is a Roche diagnostic. The COBAS test was developed as a test for V600e, though I believe it picks up some other mutations as well. If I am correct about the label, Zelboraf is approved for treating any melanoma tumor that tests positive with the COBAS, regardless of what the specific mutation.
Tim–MRF
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- March 14, 2013 at 3:11 pm
We all have our obstacles to over come in dealing with this disease, fighting with your insurance carrier shouldn’t be one of them. I am so happy you are helping Janet Lee and Don.
Holly-
- March 14, 2013 at 9:35 pm
My post is tacked on to the end of JanetLee's thread calling for help with the insurance company. Actually, I didn't have anything to do with Janet's husband getting compassionate use of Zelboraf, that was Tim and Dana Farber. I had just started looking into the situation when Tim came through with the solution. However, my heart was in the right place.
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- March 14, 2013 at 9:35 pm
My post is tacked on to the end of JanetLee's thread calling for help with the insurance company. Actually, I didn't have anything to do with Janet's husband getting compassionate use of Zelboraf, that was Tim and Dana Farber. I had just started looking into the situation when Tim came through with the solution. However, my heart was in the right place.
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- March 14, 2013 at 9:35 pm
My post is tacked on to the end of JanetLee's thread calling for help with the insurance company. Actually, I didn't have anything to do with Janet's husband getting compassionate use of Zelboraf, that was Tim and Dana Farber. I had just started looking into the situation when Tim came through with the solution. However, my heart was in the right place.
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- March 14, 2013 at 3:11 pm
We all have our obstacles to over come in dealing with this disease, fighting with your insurance carrier shouldn’t be one of them. I am so happy you are helping Janet Lee and Don.
Holly -
- March 14, 2013 at 3:11 pm
We all have our obstacles to over come in dealing with this disease, fighting with your insurance carrier shouldn’t be one of them. I am so happy you are helping Janet Lee and Don.
Holly -
- March 15, 2013 at 2:45 pm
My Medicare Drug Rx Plan helped pay for the Z but i was able to get help from the Chronic Disease Fund in Plano, Texas. I was very fortuanate to have received help from the Fund plus i was in the Catastrophic category in my drug plan in a month. Good luck!
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- March 15, 2013 at 2:45 pm
My Medicare Drug Rx Plan helped pay for the Z but i was able to get help from the Chronic Disease Fund in Plano, Texas. I was very fortuanate to have received help from the Fund plus i was in the Catastrophic category in my drug plan in a month. Good luck!
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- March 15, 2013 at 3:09 pm
Thanks, BigB. Your response is very helpful. Thank you for responding!
I am trying to get some guidance not for myself, but for other melanoma patients who may have trouble getting coverage if they have a non-V600E mutation, so please be patient with my questions.
1. Are you saying that your Medicare presciption drug plan did pay for Zelboraf? Which prescription drug plan was that?
2. Did Medicare just cover it or did you need to provide them with some proof that Zelboraf works on non-V600E mutations? Which BRAF mutation do you have?
3. I assume that the Chronic Disease Fund helped to cover your Medicare co-pay, is that correct? How did you locate such a fund?
4. Are you saying that once you (and the Chronic Disease Fund) got through the prescription drug "donut hole", Medicare took over the entire cost of your Zelboraf?
I'm certain that your research and your responses will be very helpful to others in the future.
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- March 15, 2013 at 3:09 pm
Thanks, BigB. Your response is very helpful. Thank you for responding!
I am trying to get some guidance not for myself, but for other melanoma patients who may have trouble getting coverage if they have a non-V600E mutation, so please be patient with my questions.
1. Are you saying that your Medicare presciption drug plan did pay for Zelboraf? Which prescription drug plan was that?
2. Did Medicare just cover it or did you need to provide them with some proof that Zelboraf works on non-V600E mutations? Which BRAF mutation do you have?
3. I assume that the Chronic Disease Fund helped to cover your Medicare co-pay, is that correct? How did you locate such a fund?
4. Are you saying that once you (and the Chronic Disease Fund) got through the prescription drug "donut hole", Medicare took over the entire cost of your Zelboraf?
I'm certain that your research and your responses will be very helpful to others in the future.
-
- March 15, 2013 at 3:09 pm
Thanks, BigB. Your response is very helpful. Thank you for responding!
I am trying to get some guidance not for myself, but for other melanoma patients who may have trouble getting coverage if they have a non-V600E mutation, so please be patient with my questions.
1. Are you saying that your Medicare presciption drug plan did pay for Zelboraf? Which prescription drug plan was that?
2. Did Medicare just cover it or did you need to provide them with some proof that Zelboraf works on non-V600E mutations? Which BRAF mutation do you have?
3. I assume that the Chronic Disease Fund helped to cover your Medicare co-pay, is that correct? How did you locate such a fund?
4. Are you saying that once you (and the Chronic Disease Fund) got through the prescription drug "donut hole", Medicare took over the entire cost of your Zelboraf?
I'm certain that your research and your responses will be very helpful to others in the future.
-
- March 15, 2013 at 2:45 pm
My Medicare Drug Rx Plan helped pay for the Z but i was able to get help from the Chronic Disease Fund in Plano, Texas. I was very fortuanate to have received help from the Fund plus i was in the Catastrophic category in my drug plan in a month. Good luck!
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- March 17, 2013 at 3:42 am
Good evening all. First, thank you so much to POW for her help in this nightmare of trying to get Zelboraf covered by our insurance company. I can understand the FDA originally approving Zelboraf for the BRAF V600E — after all, the vast majority of BRAF murtations are V600E and it makes sense to concentrate on that group. However, 19 months after the inital approval, shouldn't there be something more to offer for the BRAF mutations OTHER than V600E?
We have appealed three times to our insurance company; the last appeal was even supported by our Congressman from central Massachusetts, Jim McGovern. Even that was denied — as "not being medically necessary." At their request, we are sending more information to the Office of Personnel Management in Washington, DC to prove that Don is BRAF positive and is being treated for metastic melanoma. In al honesty, I do believe we are dealing with idiots.
In the meantime, mainly through the efforts of Dana Farber, Genentech has agreed to provide Zelboraf to my husband, Don, and he took his first dose at 11:55 a.m. yesterday. Interestingly, even Genentech has in essence tied its own hands and is subject to strict overisght by the FDA in what it does with Zelboraf, and theyn were not "free" to simply give it to a patient that did NOT have the V600E BRAF mutation. Dana Farber supplied an enormous amount of information to Genentech for them to even consdier giving the drug to Don, including the "Australian" paper from December of 2012 citing exciting positive results for V600R patients.
The other side of the story with Genentech is that Don and I had to "prove" that we were beneath a certain income threshhold. It seems that, if your combined household income is above $100,000 per year, you are not worth helping. If your household income is $99,000 or less, it seems that your life is worthy of help. With Don's illness, he has been unable to work since Christmas; I am not working so that I can help take care of him. So I had to provide "proof" that our income would be below $100,000 in 2013. That may sound like a lot of money to many people, but we are two professionals who have worked for over 40 years to reach this level and have planned for a contented retirement together.
We are continuing our fight with the BC/BS Federal Employee Plan. I honestly believe that the mission of insurance companies is to figure out a way to NOT pay your claim. I believe the bureaucrats put on their blinders and see "V600E" and nothing else.
Don's disease is quite advanced, and I know that waiting these past 6 weeks for a systemic treatment has been detrimental to his overall status. We pray that the Zelboraf will give him some relief from his pain and give us some quality time together.
Until Genentech came through this week with the Zelboraf for Don, Tim Turnham of MRF was unbelievable in his help in getting us into the pipeline for a Glaxo Smith Kline compassionate care use of Dabrafenib. According to Tim, GSK actually wants to use the Dabrafenib on rare BRAF mutations. Because of Dons advanced disease, we really had no choice but to start the Zelboraf rather than wait even a few more days or weeks for the Dabraneib.
I know this post is long, but I have not really had the time to post recently. Don had to have his brain met surgically removed (cyberknife was ineffective — and his brain met brew larger and was affecting him dramatically) and he is now in rehab. We believe tumors are now impinging on his lower spinal column, so the Zelboraf is desperately needed.
Thanks again to you all, who give me hope and support!
Janet Lee
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- March 17, 2013 at 3:42 am
Good evening all. First, thank you so much to POW for her help in this nightmare of trying to get Zelboraf covered by our insurance company. I can understand the FDA originally approving Zelboraf for the BRAF V600E — after all, the vast majority of BRAF murtations are V600E and it makes sense to concentrate on that group. However, 19 months after the inital approval, shouldn't there be something more to offer for the BRAF mutations OTHER than V600E?
We have appealed three times to our insurance company; the last appeal was even supported by our Congressman from central Massachusetts, Jim McGovern. Even that was denied — as "not being medically necessary." At their request, we are sending more information to the Office of Personnel Management in Washington, DC to prove that Don is BRAF positive and is being treated for metastic melanoma. In al honesty, I do believe we are dealing with idiots.
In the meantime, mainly through the efforts of Dana Farber, Genentech has agreed to provide Zelboraf to my husband, Don, and he took his first dose at 11:55 a.m. yesterday. Interestingly, even Genentech has in essence tied its own hands and is subject to strict overisght by the FDA in what it does with Zelboraf, and theyn were not "free" to simply give it to a patient that did NOT have the V600E BRAF mutation. Dana Farber supplied an enormous amount of information to Genentech for them to even consdier giving the drug to Don, including the "Australian" paper from December of 2012 citing exciting positive results for V600R patients.
The other side of the story with Genentech is that Don and I had to "prove" that we were beneath a certain income threshhold. It seems that, if your combined household income is above $100,000 per year, you are not worth helping. If your household income is $99,000 or less, it seems that your life is worthy of help. With Don's illness, he has been unable to work since Christmas; I am not working so that I can help take care of him. So I had to provide "proof" that our income would be below $100,000 in 2013. That may sound like a lot of money to many people, but we are two professionals who have worked for over 40 years to reach this level and have planned for a contented retirement together.
We are continuing our fight with the BC/BS Federal Employee Plan. I honestly believe that the mission of insurance companies is to figure out a way to NOT pay your claim. I believe the bureaucrats put on their blinders and see "V600E" and nothing else.
Don's disease is quite advanced, and I know that waiting these past 6 weeks for a systemic treatment has been detrimental to his overall status. We pray that the Zelboraf will give him some relief from his pain and give us some quality time together.
Until Genentech came through this week with the Zelboraf for Don, Tim Turnham of MRF was unbelievable in his help in getting us into the pipeline for a Glaxo Smith Kline compassionate care use of Dabrafenib. According to Tim, GSK actually wants to use the Dabrafenib on rare BRAF mutations. Because of Dons advanced disease, we really had no choice but to start the Zelboraf rather than wait even a few more days or weeks for the Dabraneib.
I know this post is long, but I have not really had the time to post recently. Don had to have his brain met surgically removed (cyberknife was ineffective — and his brain met brew larger and was affecting him dramatically) and he is now in rehab. We believe tumors are now impinging on his lower spinal column, so the Zelboraf is desperately needed.
Thanks again to you all, who give me hope and support!
Janet Lee
-
- March 17, 2013 at 3:42 am
Good evening all. First, thank you so much to POW for her help in this nightmare of trying to get Zelboraf covered by our insurance company. I can understand the FDA originally approving Zelboraf for the BRAF V600E — after all, the vast majority of BRAF murtations are V600E and it makes sense to concentrate on that group. However, 19 months after the inital approval, shouldn't there be something more to offer for the BRAF mutations OTHER than V600E?
We have appealed three times to our insurance company; the last appeal was even supported by our Congressman from central Massachusetts, Jim McGovern. Even that was denied — as "not being medically necessary." At their request, we are sending more information to the Office of Personnel Management in Washington, DC to prove that Don is BRAF positive and is being treated for metastic melanoma. In al honesty, I do believe we are dealing with idiots.
In the meantime, mainly through the efforts of Dana Farber, Genentech has agreed to provide Zelboraf to my husband, Don, and he took his first dose at 11:55 a.m. yesterday. Interestingly, even Genentech has in essence tied its own hands and is subject to strict overisght by the FDA in what it does with Zelboraf, and theyn were not "free" to simply give it to a patient that did NOT have the V600E BRAF mutation. Dana Farber supplied an enormous amount of information to Genentech for them to even consdier giving the drug to Don, including the "Australian" paper from December of 2012 citing exciting positive results for V600R patients.
The other side of the story with Genentech is that Don and I had to "prove" that we were beneath a certain income threshhold. It seems that, if your combined household income is above $100,000 per year, you are not worth helping. If your household income is $99,000 or less, it seems that your life is worthy of help. With Don's illness, he has been unable to work since Christmas; I am not working so that I can help take care of him. So I had to provide "proof" that our income would be below $100,000 in 2013. That may sound like a lot of money to many people, but we are two professionals who have worked for over 40 years to reach this level and have planned for a contented retirement together.
We are continuing our fight with the BC/BS Federal Employee Plan. I honestly believe that the mission of insurance companies is to figure out a way to NOT pay your claim. I believe the bureaucrats put on their blinders and see "V600E" and nothing else.
Don's disease is quite advanced, and I know that waiting these past 6 weeks for a systemic treatment has been detrimental to his overall status. We pray that the Zelboraf will give him some relief from his pain and give us some quality time together.
Until Genentech came through this week with the Zelboraf for Don, Tim Turnham of MRF was unbelievable in his help in getting us into the pipeline for a Glaxo Smith Kline compassionate care use of Dabrafenib. According to Tim, GSK actually wants to use the Dabrafenib on rare BRAF mutations. Because of Dons advanced disease, we really had no choice but to start the Zelboraf rather than wait even a few more days or weeks for the Dabraneib.
I know this post is long, but I have not really had the time to post recently. Don had to have his brain met surgically removed (cyberknife was ineffective — and his brain met brew larger and was affecting him dramatically) and he is now in rehab. We believe tumors are now impinging on his lower spinal column, so the Zelboraf is desperately needed.
Thanks again to you all, who give me hope and support!
Janet Lee
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