Insurance refusing to approve my taking of Avistan.

I am fighting them too.
Carla, My doctor wanted to give me Gemzar and Avastin. Insurance wouldn't approve of both of them. So my doctor put me on the Avastin and it is working for me. My doctor's office did have it approved before I started on it. I saw the news the other night where they are not going to approve Avastin for breast cancer. This is so scary.

In the meantime, I have had about 7 treatments. The insurance company paid for the first 3 treatments and are balking at the rest. The Avastin alone costs $15,000 every treatment and I go every 3 weeks. It has had me so upset. I got the the shingles when they wouldn't approve the Gemazar and Avastin. Now they probably want to do the same with Avastin. My doctor's office told me not to worry that they would fight it and get it covered. I hope so. I sure don't want to break out in the shingles again because of all the stress.

I would love to walk up to the CEO of the insurance company and tell him that his wife or someone in his family that needed the drug, couldn't have it (even though it is working for them.) I just wonder what would happen.

I hope you get it approved Carla. Keep me posted on how it goes.

Linda

clamryn said:

I am fighting them too.
Carla, My doctor wanted to give me Gemzar and Avastin. Insurance wouldn't approve of both of them. So my doctor put me on the Avastin and it is working for me. My doctor's office did have it approved before I started on it. I saw the news the other night where they are not going to approve Avastin for breast cancer. This is so scary.

In the meantime, I have had about 7 treatments. The insurance company paid for the first 3 treatments and are balking at the rest. The Avastin alone costs $15,000 every treatment and I go every 3 weeks. It has had me so upset. I got the the shingles when they wouldn't approve the Gemazar and Avastin. Now they probably want to do the same with Avastin. My doctor's office told me not to worry that they would fight it and get it covered. I hope so. I sure don't want to break out in the shingles again because of all the stress.

I would love to walk up to the CEO of the insurance company and tell him that his wife or someone in his family that needed the drug, couldn't have it (even though it is working for them.) I just wonder what would happen.

I hope you get it approved Carla. Keep me posted on how it goes.

Linda

FDA guidelines for Avastin use
I was looking for info on Avastin and found this:

*********************************************************************************************
Avastin is approved, in combination with intravenous 5-fluorouracil-based (5-FU) chemotherapy, for first- or second-line treatment of patients with metastatic carcinoma of the colon or rectum; in combination with carboplatin and paclitaxel for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC); and for the treatment of metastatic renal cell carcinoma in combination with interferon alfa.
**********************************************************************************************

So that is probably how the insurance companies are able to refuse to pay for the treatment since the FDA doesn't list ovarian cancer as an approved indication for Avastin use. So that means using Avastin for ovarian cancer is not the "standard of care" even if it helps extend survival.

My insurance won't pay for the IV vitamin C treatments that I've been doing because it isn't considered the standard of care for ovarian cancer either. Do I let myself get upset about that? Nope. I can heal from cancer best when I am calm & staying as calm as possible is my full-time job. I feel that is my best option for survival.

Carolen

carolenk said:

FDA guidelines for Avastin use
I was looking for info on Avastin and found this:

*********************************************************************************************
Avastin is approved, in combination with intravenous 5-fluorouracil-based (5-FU) chemotherapy, for first- or second-line treatment of patients with metastatic carcinoma of the colon or rectum; in combination with carboplatin and paclitaxel for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC); and for the treatment of metastatic renal cell carcinoma in combination with interferon alfa.
**********************************************************************************************

So that is probably how the insurance companies are able to refuse to pay for the treatment since the FDA doesn't list ovarian cancer as an approved indication for Avastin use. So that means using Avastin for ovarian cancer is not the "standard of care" even if it helps extend survival.

My insurance won't pay for the IV vitamin C treatments that I've been doing because it isn't considered the standard of care for ovarian cancer either. Do I let myself get upset about that? Nope. I can heal from cancer best when I am calm & staying as calm as possible is my full-time job. I feel that is my best option for survival.

Carolen

Latest Results
ASCO 2011: Bevacizumab ICON7 and OCEANS Trial Results
By Anna Azvolinsky, PhD | June 21, 2011
________________________________________
Two large-scale Phase 3 trials that add bevacizumab(Drug information on bevacizumab) to standard chemotherapy regimens in advanced ovarian cancer reported results at ASCO this year. The ICON7 trial adds bevacizumab (Avastin) to a standard chemotherapy regimen for newly diagnosed ovarian cancer patients. The OCEANS trial tests the therapeutic benefit of bevacizumab in conjunction with chemotherapy followed by maintenance dosing of bevacizumab in previously-treated ovarian cancer patients. The OCEANS trial reported a 52% risk reduction in disease progression for women in the bevacizumab arm, while the ICON7 trial found that treatment-naive ovarian cancer patients had a 36% reduced risk of death among those patients that are high-risk.
The OCEANS Trial Results
• "The OCEANS study is a positive study," said the presenter and lead investigator, Carol Aghajanian, MD during a press briefing. Dr. Aghajanian is a medical oncologist and the head of Memorial Sloan Kettering Cancer Center's chemotherapy program. The combination of bevacizumab and chemotherapy "provides a clinically meaningful benefit in recurrent ovarian cancer." This is the first advanced stage trial of an antiangiogenic agent that has demonstrated
The data showed that adding bevacizumab to platinum-based chemotherapy reduced the risk of progression in women with recurrent platinum-sensitive ovarian, peritoneal, or fallopian tube cancer by one-half (p<0.0001). Women with added bevacizumab during their chemotherapy regimen and following chemotherapy treatment as a maintenance therapy were 52% less likely to progress than those women who were given a placebo. The median progression-free survival (PFS) was 12.4 months compared to 8.4 months for the placebo group. The PFS finding was consistently better for the bevacizumab group regardless of patient factors such as age and cytoreductive surgery for recurrence.
The objective response rate was statistically significantly higher in the combination group: 78.5% compared to 57.4% in the chemotherapy-alone group (p<0.0001). The median number of chemotherapy cycles, bevacizumab, and placebo cycles completed for each study arm were 6,12, and 10, respectively. So far, interim overall survival (OS) results favor the use of bevacizumb, with a median OS of 35.5 months for the combination compared with 29.9 months for the chemotherapy-alone arm. The OS results are not yet mature however.
Dr. Aghjanian stated that "the safety data were reassuring and consistent with the known bevacizumab side effect profile."
The OCEANS Trial Design
The OCEANS trial is a Phase 3, randomized, blinded and placebo-controlled trial that compares the use of carboplatin(Drug information on carboplatin) and gemcitabine(Drug information on gemcitabine) (C/G) chemotherapy with C/G plus bevacizumab in women with platinum-sensitive recurrent ovarian cancer who had not previously received chemotherapy for their recurrence.. The trial was started in 2007 and 487 patients were randomized to two arms consisting of chemo every 3 weeks for 6 cycles with either bevacizumab (15 mg/kg) or placebo every 3 weeks for 6 cycles followed by maintenance with bevacizumab or placebo until disease progression. The primary outcome of the trial was PFS. According to the abstract presenter, the 15 mg/kg dose was chosen based on a previous Phase II trial that compared this dose to several lower doses in ovarian cancer patients.
The ICON7 Trial Results
Mature PFS data for this study showed a 15% improvement in PFS at 12 months for patients taking bevacizumab compared with placebo (p=0.0041). The overall survival interim analysis showed that at a median followup of 28 months, the risk of death was reduced by a significant 36% among high-risk patients. "Bevacizumab is the first new active agent for the front-line treatment of ovarian cancer in more than 15 years, according to the presenter and lead investigator of the study, Dr. Gunnar Kristensen. According to Dr. Kristensen, " we see there is an overall trend for improvement of overall survival with bevacizumab." "The treatment effect is greater in high-risk patients, which may be of clinical relevance." The final overall survival results are expected in 2013.
"This treatment was tolerated well, without a substantial increase in side effects. The side effects were mild and manageable." according to Dr. Kristensen.
The ICON7 Trial Design
ICON7 is a randomized two-arm global trial that is assessing the benefits of adding bevacizumab to a standard chemotherapy regimen of carboplatin and paclitaxel(Drug information on paclitaxel) in newly diagnosed ovarian, epithelial, and fallopian tube cancer. The large-scale study started in 2006 and has since enrolled more than 1500 patients. The primary endpoint is comparing the progression-free survival of the standard chemo regimen to chemotherapy with additional bevacizumab. Patients receive paclitaxel and carboplatin (P/C) via IV every 3 weeks for 6 courses or P/C plus concurrent bevacizumab (7.5mg/kg) as an infusion.
Future of Bevacizumab in Ovarian Cancer
Although these trials are positive, adding bevacizumab to chemotherapy regimens is still being debated by oncologists because of the incremental increase in PFS. Active ovarian oncologists and researchers are split as to whether PFS is a good enough measure and whether studies should always have overall survival as a primary endpoint. The FDA has been requiring more overall survival data, partly as a result of the increased cost of oncology drugs. Researchers acknowledge that cost plays a role in consideration of treatment options. Dr. Kristensen, for example, stated that the cost of bevacizumab and a lack of substantial survival benefit in ovarian cancer patients may result in only high-risk patients being prescribed a bevacizumab regimen. Additionally, tt is not know how much of a benefit is added with a maintenance dose of bevacizumab.
How bevacizumab will be utilized by oncologists remains to be seen, but for now, there is a consistent trend of a benefit in the utilization of bevacizumab in combination with chemotherapy as well as a documented benefit as a monotherapy in ovarian cancer.

Tethys41 said:

Latest Results
ASCO 2011: Bevacizumab ICON7 and OCEANS Trial Results
By Anna Azvolinsky, PhD | June 21, 2011
________________________________________
Two large-scale Phase 3 trials that add bevacizumab(Drug information on bevacizumab) to standard chemotherapy regimens in advanced ovarian cancer reported results at ASCO this year. The ICON7 trial adds bevacizumab (Avastin) to a standard chemotherapy regimen for newly diagnosed ovarian cancer patients. The OCEANS trial tests the therapeutic benefit of bevacizumab in conjunction with chemotherapy followed by maintenance dosing of bevacizumab in previously-treated ovarian cancer patients. The OCEANS trial reported a 52% risk reduction in disease progression for women in the bevacizumab arm, while the ICON7 trial found that treatment-naive ovarian cancer patients had a 36% reduced risk of death among those patients that are high-risk.
The OCEANS Trial Results
• "The OCEANS study is a positive study," said the presenter and lead investigator, Carol Aghajanian, MD during a press briefing. Dr. Aghajanian is a medical oncologist and the head of Memorial Sloan Kettering Cancer Center's chemotherapy program. The combination of bevacizumab and chemotherapy "provides a clinically meaningful benefit in recurrent ovarian cancer." This is the first advanced stage trial of an antiangiogenic agent that has demonstrated
The data showed that adding bevacizumab to platinum-based chemotherapy reduced the risk of progression in women with recurrent platinum-sensitive ovarian, peritoneal, or fallopian tube cancer by one-half (p<0.0001). Women with added bevacizumab during their chemotherapy regimen and following chemotherapy treatment as a maintenance therapy were 52% less likely to progress than those women who were given a placebo. The median progression-free survival (PFS) was 12.4 months compared to 8.4 months for the placebo group. The PFS finding was consistently better for the bevacizumab group regardless of patient factors such as age and cytoreductive surgery for recurrence.
The objective response rate was statistically significantly higher in the combination group: 78.5% compared to 57.4% in the chemotherapy-alone group (p<0.0001). The median number of chemotherapy cycles, bevacizumab, and placebo cycles completed for each study arm were 6,12, and 10, respectively. So far, interim overall survival (OS) results favor the use of bevacizumb, with a median OS of 35.5 months for the combination compared with 29.9 months for the chemotherapy-alone arm. The OS results are not yet mature however.
Dr. Aghjanian stated that "the safety data were reassuring and consistent with the known bevacizumab side effect profile."
The OCEANS Trial Design
The OCEANS trial is a Phase 3, randomized, blinded and placebo-controlled trial that compares the use of carboplatin(Drug information on carboplatin) and gemcitabine(Drug information on gemcitabine) (C/G) chemotherapy with C/G plus bevacizumab in women with platinum-sensitive recurrent ovarian cancer who had not previously received chemotherapy for their recurrence.. The trial was started in 2007 and 487 patients were randomized to two arms consisting of chemo every 3 weeks for 6 cycles with either bevacizumab (15 mg/kg) or placebo every 3 weeks for 6 cycles followed by maintenance with bevacizumab or placebo until disease progression. The primary outcome of the trial was PFS. According to the abstract presenter, the 15 mg/kg dose was chosen based on a previous Phase II trial that compared this dose to several lower doses in ovarian cancer patients.
The ICON7 Trial Results
Mature PFS data for this study showed a 15% improvement in PFS at 12 months for patients taking bevacizumab compared with placebo (p=0.0041). The overall survival interim analysis showed that at a median followup of 28 months, the risk of death was reduced by a significant 36% among high-risk patients. "Bevacizumab is the first new active agent for the front-line treatment of ovarian cancer in more than 15 years, according to the presenter and lead investigator of the study, Dr. Gunnar Kristensen. According to Dr. Kristensen, " we see there is an overall trend for improvement of overall survival with bevacizumab." "The treatment effect is greater in high-risk patients, which may be of clinical relevance." The final overall survival results are expected in 2013.
"This treatment was tolerated well, without a substantial increase in side effects. The side effects were mild and manageable." according to Dr. Kristensen.
The ICON7 Trial Design
ICON7 is a randomized two-arm global trial that is assessing the benefits of adding bevacizumab to a standard chemotherapy regimen of carboplatin and paclitaxel(Drug information on paclitaxel) in newly diagnosed ovarian, epithelial, and fallopian tube cancer. The large-scale study started in 2006 and has since enrolled more than 1500 patients. The primary endpoint is comparing the progression-free survival of the standard chemo regimen to chemotherapy with additional bevacizumab. Patients receive paclitaxel and carboplatin (P/C) via IV every 3 weeks for 6 courses or P/C plus concurrent bevacizumab (7.5mg/kg) as an infusion.
Future of Bevacizumab in Ovarian Cancer
Although these trials are positive, adding bevacizumab to chemotherapy regimens is still being debated by oncologists because of the incremental increase in PFS. Active ovarian oncologists and researchers are split as to whether PFS is a good enough measure and whether studies should always have overall survival as a primary endpoint. The FDA has been requiring more overall survival data, partly as a result of the increased cost of oncology drugs. Researchers acknowledge that cost plays a role in consideration of treatment options. Dr. Kristensen, for example, stated that the cost of bevacizumab and a lack of substantial survival benefit in ovarian cancer patients may result in only high-risk patients being prescribed a bevacizumab regimen. Additionally, tt is not know how much of a benefit is added with a maintenance dose of bevacizumab.
How bevacizumab will be utilized by oncologists remains to be seen, but for now, there is a consistent trend of a benefit in the utilization of bevacizumab in combination with chemotherapy as well as a documented benefit as a monotherapy in ovarian cancer.</p>

Avastin as "monotherapy"?
"How bevacizumab will be utilized by oncologists remains to be seen, but for now, there is a consistent trend of a benefit in the utilization of bevacizumab in combination with chemotherapy as well as a documented benefit as a monotherapy in ovarian cancer."
**********************************************************************************************

Where is the "documented benefit" with Avastin used as "monotherapy" in OVCA? I think it is very difficult to even conduct a clinical trial that does not include the "standard of care" for first-line therapy for OVCA. They must be talking about using Avastin for maintenance.

The biggest problem with Avastin is the risk of stroke/blood clots. If everyone on Avastin followed an anti-inflammatory diet as you did (Tethys41), that risk would be negligible. That could be the problem with "overall survival" -- they are not exactly saying it but it is possible that some of the patients are not dying from the cancer but from strokes/heart attacks/pulmonary embolisms from the Avastin. That's why the FDA is looking into "overall survival" before making their recommendation on Avastin.

A second problem with Avastin is that there has found to be a re-bound effect with other factors that promote angiogenesis over-riding the benefits of Avastin (that research is posted on the board already). Avastin only blocks one of several factors that promote angiogenesis. So anyone who does well after using Avastin probably has their own immune system to thank for their "prolonged remission"--chemo and Avastin just bought them a little more time. Unfortunately, not everyone's immune system can survive chemo.

People are still looking for the "magic bullet" that will eliminate the need to change their life after a cancer diagnosis or after being declared NED--the magic bullet doesn't exist and I don't think it EVER will exisit.

No matter how many people are "racing for the cure," I don't think the cure for OVCA is gonna be found by a pharmaceutical company (with the exception of whomever is working on the vaccine). Why would Big Pharma want to cure us anyway? There is big money to be made in the treatment.

Just as antibiotics are never the sole reason why someone recovers from a bacterial/fungal infection, I think it is the same with cancer. The antibiotics buy the person TIME for their immune system to fight their infection. If antibiotics were all that was needed to fight infections, then no one would have ever died from AIDS.

Chemo and all the drugs used for cancer therapy are life saving to be sure, but what we are not being told is that any hope of prolonged survival must come from the individual & their own immune system. That is why cancer survival is not 100% accurately predictable for anyone.

I guess I am just jacked up about this issue because I am reading the newly-published "Defeat Cancer" book with 15 different integrative cancer doctors featured in the book who are all saying the same thing about cancer but in slightly different ways: cancer is a chronic life-long condition that can be managed if there is enough of an immune system to work with.

Tethys41: You probably shouldn't get that book, it'll drive you crazy with options! Hahahahaha! But I know that you will LOVE it anyways!

LQ (I'll go back to cleaning my house now)

Tethys41 said:

Trials
The use of Avastin for treatment of ovarian cancer is still somewhat in the trial stage. I know when I was diagnosed in 2009, they had just completed a trial with Carboplatin, Taxol, and Avastin. I was stuck in the limbo of the end of trial, but the incomplete data phase, so it appeared I would not be eligible to receive it because the data would not be in for 6 months. My doctor requested it, however, and my insurance approved it. Just after the very end of my chemo treatments, the data was in for long term use of Avastin, following chemo treatments, and the data was positive, so I continued on it for another 11 rounds. I was fortunate in that I did not suffer any of the common side effects, like elevated blood pressure.

Understand that these drugs are expensive, but not as expensive as what the insurance company pays. I saw the bill for my Avastin treatments and it was $20,000 per dose. The cost to the provider, however, is about half that. Yes, there is money to be made by prescribing chemo. My husband and I calculated to cost and determined that it was costing $15 per drop of IV. That's some really fine wine.

Today...
I'll opt for the Fine Wine.

At least I will enjoy the wine and know what I'm getting.

Love ya'

tjpt16 said:

Avastin
I have stage 4 clear cell ovca since Nov. 2009. Had chemo, surgery, and radiation at MD Anderson, and ten more months of chemo in Japan where I live. In mid-June I arrived at the Cancer Treatment Center of America in Tulsa. New chemo is gemzar and carboplatin every two weeks. Avastin has been approved by my insurance and will be added my second chemo. So far I'm liking this center. Holistic treatment.....oncologist, nutritionist, naturopath, mind body, physical therapy, all working together on my team. loving my new power port. have challenges with lymphedema in my Robyn leg and low platelets. otherwise I'm dandy and hopeful for the future.

Teresa

If there's any comfort in this: Avastin didn't work for me.
My insurance approved Avastin for me, which I took in combination with oral Cytoxin (used as a catalyst since apparently Avastin works better in combo with other drugs) for 4 months. I loved how I felt on this combination, almost like not being on chemo at all! Unfortunately, my cancer cells felt the same way (just like no chemo at all!) and I had significant disease progression during those 4 months on this, even though initially it caused a drop in my CA125. So maybe you leave this one "to the fates". Avastin isn't the 'be all / end all' for everyone, and maybe if your insurance continues to deny coverage for it, you can be phylisophical that this wasn't "meant to be" or that the prevention of getting that drug is in reality some kind of hard-to-recognize "answered prayer".

I know that Avastin/Cytoxin also didn't work for Nancy, as we took it during relatively the same time. Poor Nancy. I still can't believe she's gone.

LaundryQueen said:

Avastin as "monotherapy"?
"How bevacizumab will be utilized by oncologists remains to be seen, but for now, there is a consistent trend of a benefit in the utilization of bevacizumab in combination with chemotherapy as well as a documented benefit as a monotherapy in ovarian cancer."
**********************************************************************************************

Where is the "documented benefit" with Avastin used as "monotherapy" in OVCA? I think it is very difficult to even conduct a clinical trial that does not include the "standard of care" for first-line therapy for OVCA. They must be talking about using Avastin for maintenance.

The biggest problem with Avastin is the risk of stroke/blood clots. If everyone on Avastin followed an anti-inflammatory diet as you did (Tethys41), that risk would be negligible. That could be the problem with "overall survival" -- they are not exactly saying it but it is possible that some of the patients are not dying from the cancer but from strokes/heart attacks/pulmonary embolisms from the Avastin. That's why the FDA is looking into "overall survival" before making their recommendation on Avastin.

A second problem with Avastin is that there has found to be a re-bound effect with other factors that promote angiogenesis over-riding the benefits of Avastin (that research is posted on the board already). Avastin only blocks one of several factors that promote angiogenesis. So anyone who does well after using Avastin probably has their own immune system to thank for their "prolonged remission"--chemo and Avastin just bought them a little more time. Unfortunately, not everyone's immune system can survive chemo.

People are still looking for the "magic bullet" that will eliminate the need to change their life after a cancer diagnosis or after being declared NED--the magic bullet doesn't exist and I don't think it EVER will exisit.

No matter how many people are "racing for the cure," I don't think the cure for OVCA is gonna be found by a pharmaceutical company (with the exception of whomever is working on the vaccine). Why would Big Pharma want to cure us anyway? There is big money to be made in the treatment.

Just as antibiotics are never the sole reason why someone recovers from a bacterial/fungal infection, I think it is the same with cancer. The antibiotics buy the person TIME for their immune system to fight their infection. If antibiotics were all that was needed to fight infections, then no one would have ever died from AIDS.

Chemo and all the drugs used for cancer therapy are life saving to be sure, but what we are not being told is that any hope of prolonged survival must come from the individual & their own immune system. That is why cancer survival is not 100% accurately predictable for anyone.

I guess I am just jacked up about this issue because I am reading the newly-published "Defeat Cancer" book with 15 different integrative cancer doctors featured in the book who are all saying the same thing about cancer but in slightly different ways: cancer is a chronic life-long condition that can be managed if there is enough of an immune system to work with.

Tethys41: You probably shouldn't get that book, it'll drive you crazy with options! Hahahahaha! But I know that you will LOVE it anyways!

LQ (I'll go back to cleaning my house now)

LQ... Dr Sabbatini agrees
LQ... Dr Sabbatini agrees with you, at least in part. We talked about this last week - how unreliabel OVCA is, with regard to treatment, etc. It's just a rogue kind of disease and virtually impossible to totally eradicate, once it reaches stage III.

Dr S believes the only answer is in vaccine research. Not vaccine as we typically think of it (preventative), but a vaccine that will effectively prevent recurrence via antibodies.

The physican/lab, etc that achieves this will reap huge rewards, both monetary and otherwise.

I've been tempted if someone close to him died from OVCA, because Dr S truly seems to have a personal vendetta against the beast.

Carlene