cancer treatment denied in B.C.

With the Annual Cancer Conference taking place in Vancouver my question is why a certain group of Her2 positive breast cancer patients aren't getting Herceptin.

They are being told it is because there is no clinical evidence showing that there would be any advantage to them receiving it,but, there is no clinical evidence showing that there wouldn't be any advantage to them either.

In fact these are a small group of women that are in a catch 22 situation because they are not being studied,so there will never be evidence for them receiving Herceptin one way or another.

This puts them in the ghastly position of waiting for a recurrence or metastasis with no adjuvant therapy available.

The other point I'm trying to make in my letter is that the Herceptin treatment that the Cancer Agency is approving is based on empathetic reasoning ( by extending treatment to 1 year post adjuvant therapy) instead of scientific reasoning (Herceptin used within 7 weeks of adjuvant therapy ). How can patients be denied treatment supposedly for scientific reasons when the cancer agency is not using scientific reasons to grant therapy???

An open letter to the Federal Health Minister and Provincial Health Ministers
Women diagnosed with Her2 Positive Breast Cancer
CANCER TREATMENT DENIED

The Lost Women of Herceptin

I would like to express how incredible the development of Herceptin has been and what an amazing contribution Genentech, Roche and all researchers involved have made in implementing Herceptin use as a drug to prevent recurrence in early stage Her 2 positive breast cancer patients.

Overexpression of the Her2 gene is a negative prognostic indicator which leads to an aggressive form of breast cancer effecting approximately 20-30 % of all newly diagnosed patients. Herceptin, a therapy developed to target Her2 overexpressed cancer, has shown efficacy for advanced breast cancer in past clinical trials. Earlier this year results from clinical trials addressing the effectiveness of adjuvant (treatment to prevent recurrence) Herceptin in combination with chemotherapy or after the completion of all other adjuvant therapy in early stage breast cancers have shown unexpectedly large positive results. The drug is well tolerated with few side effects, of concern is a risk of cardiotoxicity of up to 4 %, this can be managed with diligent monitoring. Evidence from these recent clinical trials has demonstrated an approximate 50% reduction of recurrence for those patients treated with Herceptin vs. those that did not receive Herceptin. This group of mostly young (pre-menopausal) women at a high risk of recurrence of breast cancer has been given the hope of a cure for their disease where there was no hope before.
Miraculous results, to say the least.
Unfortunately, with so much good news a small group of women have been overlooked in the medical and media excitement…. they have not been given an equal opportunity to benefit from Herceptin treatment. Although they are Her2 positive as well, and at high risk of recurrence, the BC Cancer Agency has chosen to deny them treatment. This decision is arbitrary rather than scientifically based. I consider these people The Lost Women of Herceptin.
As of July 2005, a provincially funded adjuvant Herceptin program began in this province. Patients that had completed chemotherapy after July 1st 2004 and met treatment criteria for Herceptin use were considered eligible. This allowed for up to a one year delay from the completion of chemotherapy in starting Herceptin treatment.
Although the scientific data only addressed Herceptin use within seven weeks of the completion of all other adjuvant treatments; for empathetic reasons the BC Cancer agency extended it's eligibility (read paid for by the province) for Herceptin to one year. This was an extremely generous move on the part of the BC Cancer Agency. However, in doing so an arbitrary line in the sand has been drawn for provincially funded Herceptin which excludes all Her2 positive women whom completed therapy before the date of July 1st 2004; The Lost Women of Herceptin.
This is a small group of women since testing breast cancers for her2 at the time of diagnosis was not mandated in the past and many of these women will have relapsed, approximately 33% within four years of diagnosis. The remaining patients in this small category are being denied treatment on the grounds that there is no evidence they will benefit from delayed Herceptin treatment, although conversely there is no evidence to show they won't benefit. Although Herceptin has soundly proven its merit as a preventative of recurrence in early breast cancer and in delaying disease progression in metastatic disease, the effectiveness of delayed adjuvant Herceptin treatment will never be studied. One would think, common sense should dictate that in this grey area these high risk patients be given the same hope for a cure as the other patients have been given….thanks to Herceptin.
Researchers, clinicians, pharmacologists, cardiologists and oncologists are unable to deny the possibility of benefit, and indeed when consulted admit that if it were their wife, mother, sister or themselves in this position they would opt for treatment providing they were financially capable. This leaves The Lost Women of Herceptin in the position of trying to raise approximately $ 50,000 each, for Herceptin. On a purely financial level there will be less cost to the medical system if these patients are treated sooner rather than in a palliative situation, not to mention the emotional cost to patients and their families.
The cruelest cut of all is that the patients that cannot afford the Herceptin as a curative treatment have no choice but to wait for a recurrence and potential metastatic progression of their disease. Ironically, at that time they will receive fully funded Herceptin treatments, though at this point there is no chance of a cure.
I am hoping that good judgment and empathy prevails for these Lost Women. Time is of the essence. I implore the Patients themselves, their families and friends, their physicians and care givers to contact their local, provincial, and federal representatives and ask for fair treatment for them.

Sincerely, Elizabeth E. Kinar
ruher2positive@yahoo.ca

[AlaskaAngel]

When I was diagnosed and treated in 2002 for Stage 1 breast cancer that is strongly HER2-positive, I was excluded from the clinical trials offering Herceptin. I am among those whose tumors measured less than 2 cm and am node-negative. The same scientific community that said I was not at enough risk to qualify for the Herceptin clinical trial simultaneously decided that I was at enough risk that I should go through all the trauma and expense of chemotherapy. I am among those whose tumors measured over 1 cm and am node-negative. By national standards outlined by the scientific community, the standard chemotherapy that was recommended to me included the possibility of serious damage to the heart based on scientific research. The same research could not say definitively that the chemotherapy offered would protect me from recurrence or metastasis.

When the first major results of the Herceptin trials were announced earlier this year, as a breast cancer patient who tested strongly positive for HER2 I was watching and listening to each public announcement. The announcements indicated broadly that Stage 1 breast cancer patients would be able to receive and benefit from Herceptin – but only those who were part of the clinical trial or who had recently completed treatment were recommended to receive Herceptin. Those breast cancer patients who tested strongly HER2-positive and who were excluded from the clinical trial or who completed chemotherapy much earlier have been refused the opportunity to scientifically verify that they will benefit from receiving Herceptin now.

If I were newly diagnosed this year with the same exact cancer characteristics, I would be eligible to receive Herceptin, even if I also completed the same chemotherapy and radiation that I completed in 2002. Please take the time to be sure you comprehend that last sentence.

Many of these women were never even tested to find out whether their tumors were HER2 positive or negative. Many who were tested were never told the results, and many never were told the results could be important. In my case my doctors never gave me the results. I had to request my medical record myself to find out.

Herceptin therapy, much like the standard chemotherapy already received, includes the possibility of serious damage to the heart based on scientific research. Chemotherapy includes other risks that Herceptin does not. Patients on Herceptin are to be carefully monitored for possible heart damage, and often it is reversible. The risk of heart damage is not a reason not to offer Herceptin to those who have the exact same diagnosis as I do and who have more recently completed the chemotherapy I have completed.

Because testing for HER2 has not been standard until now and thus there are no reliable long-term statistics about survival or recurrence rates for women in this group, we are advised that no one truly knows exactly how much greater our risk is than the wider population of all breast cancer patients. Obviously, if the scientific community is now recommending that women with the same exact cancer characteristics at diagnosis who have completed treatment should have Herceptin, then there is reason for us to believe that we should be eligible to receive Herceptin also.

The scientific community that set the parameters for the clinical trials has not stepped forward to accept responsibility for the lives of this group of women. Perhaps they will have the intelligence and integrity to do so at the Annual Cancer Conference in Vancouver, as well as at the annual San Antonio oncology conference in December. If not, those who provide funding for scientific investigation should bring those responsible in the scientific community forward to address this problem in a meaningful way now.


AlaskaAngel

[CLTann]

The two eloquently written comments on the non-eligibility of the early breast cancer HER2++ patients clearly addressed the need of the "forgotten" group. The rationale that this group of patients are not seriously sick therefore they don't deserve Herceptin is ludicrous. The government authorities don't want to extinguish a smolder at the early stage, but would rather wait for a full flare-up. Not only they are playing with patients' life, but also contradict the very purpose of cancer treatment-- to eradicate the cancer cells totally. How many unnecessary lives must be sacrificed before they realize how immoral, arbitrary, unscientic and cruel their beaurecratic edict is hurting those who need the drug most at the very early stage. I am in this group but luckily I live in USA and I have been told that the insurance will cover the Herceptin treatment. I just want to express my outrage in the unfair and wrong rule in Canada.

[BCHusband]

CLTann,

My wife had a lumpectomy in July05 for Stage 2 (Lymphnode Negative HER2+++) that was followed by 4 treatments of AC. ONC is recommending Taxall w/ Herceptin for 12 weeks followed by 40 more weeks of Herceptin (about $80k), but we're not sure our insurance will cover the Herceptin. Right now, our insurance provider (the largest in D.C. area and what we thought was a premium PPO Individual Plan for the self-employed) is reviewing my wife's case and will hopefully let us know before the Herceptin begins in two weeks. We're not optimistic, however, as our ONC tells us that our insurance company has recently denied coverage of Herceptin for other early stage patients with characteristics similar to those of my wife. We don't know what we'll do if Insurance is denied-- we're thinking about waiting a few months as we keep hearing Genentech is working to get Herceptin approved by FDA for early stage indications.

Did you or your ONC have to do anything special to get U.S. Insurance Provider to cover the cost of Herceptin for early stage?

[CLTann]

My onc and his nurse said that there are already two patients of his getting the same treatment; the insurance paid for the treatment. Therefore, they don't think there will be a problem. We are in N.C.

I don't know what else I can help. I would be more than happy to ask my onc for additional questions. But the doctors here are not very responsive to patients. Very frustrating.

Ann.

[wendywidder]

I have been taking Herceptin since August (every 3 weeks) after chemo and mastec but also don't know if insurance will pay. What else can I do? Who knows when they will "decide" yes or no? I just keep taking it!

Wendy from Missouri

[lu ann]

I had to go ahead and have procedures done before I got pre-certification from the insurance company. Cancer cells don't stop growing while you wait for approval. I think if you pay something toward your medical bills they cannot garnesh your wages or take away your home.

We just have to keep fighting like we did for mamograms. I had my first mamogram in 1987 at age 31. I decided to have it because my mother had pre-menapausal breast cancer and later died from a recurrance. Mamograms were not automatically covered by women under 40 years old at that time. I was dx. with fibrocystic breasts so it was covered. Four years later I was dx. with stage 1 BC.

We are the fortunate ones who have insurance. I am grateful, but every year our premiums go up and our benefits go down. Not fair.

All we can do is try to vote the right people into our government who truly want to work for the people and not just collect their big pay checks.

Love and Blessings, Lu ann.

[BCHusband]

I'm posting in case this helps someone else in similar situation and to get feedback to improve letter. I deleted personal information for privacy.

To:
Carefirst BlueCross BlueShield - Member Services
Attn: Manager in Member Services
PO Box 644
Owings Mills, MD 21117-9998


Subject: Is the treatment recommended for my wife covered under our
Carefirst policy?

Patient: (my spouse)

Member: (me)

Diagnosis: Breast Cancer, Code 174.8
Recommended Treatment: Herceptin, Code J9355
Infusion Procedures: Codes 964.12 and 964.10
Treatment Schedule: to begin 23.November.2005

Doctor: (our ONC in Virginia)

Member Services Manager,

I’m writing this letter as a follow-up to our conversation from earlier
this afternoon to find out if my Carefirst Policy covers the treatment
recommended for my wife. Time is of the essence for Carefirst to provide
a definitive and clear response to the subject question as my wife’s
health is at risk and as the treatment is scheduled to begin in three
weeks. It is critical for us to know as soon as possible if the
recommended treatment is covered by our Carefirst policy as we cannot
afford to pay for the treatment otherwise. Further, if our policy does
not cover the recommended treatment for my wife’s diagnosis, we will
then need as much time as possible to explore alternative treatments
that are more affordable yet equally effective.

As you’re aware, I was on the phone today for over an hour either
talking with a Carefirst Member Services representative or waiting on
hold while a Carefirst representative was transferring me to other
departments or gathering information. Notwithstanding the fact that I
provided both the diagnosis and treatment codes, I was not provided a
straightforward answer to the subject question. Rather, I was told by
Carefirst representative's that there is no way for us to know for sure
if our policy covers the recommended treatment until after the treatment
starts and our doctor’s bills are processed through Carefirst’s system.

Given the estimated cost per treatment, the weekly treatment schedule
and the amount of time that typically elapses between the Date of
Service and our receipt of an Explanation of Benefits, we could easily
end up being personally responsible for tens of thousands of dollars in
bills before we, as the insured, our informed by Carefirst if our policy
even covers the treatment. We just simply cannot believe that Carefirst
requires us to assume such a financial risk and personal liability when
Carefirst has access to the diagnosis and recommended treatment weeks in
advance before the first cost is incurred. Is it unreasonable to want to
know in advance if our policy covers the treatment for my wife’s
specific diagnosis?

About five years ago, I selected Carefirst for my family’s medical
insurance based largely on your company’s reputation for quality of
service. I’m now requesting that Carefirst live up to its reputation and
let us know if my wife’s treatment will be covered in advance of the
treatment being administered. Please relieve my family of the undue
hardship and burden of being asked to begin treatment before we even
know if the treatment is covered under our insurance policy.

Please contact me at the number above should you have questions or need
additional information. Also note that our doctor’s office number and
POCs are listed above should you have questions of them.

Sincerely,
BCHusband

Copies:
-ONC
-Virginia’s Bureau of Insurance

[janet/FL]

Genentech has a program for reimbursing the infusion center for the Herceptin. Single point of contact--I think it is called. I think Lolly just posted on another place to go for help. I was prepared to go this route if Blue Cross denied. I just went ahead and got the Hercptin and worried and worried about it. Did ask them first as didn't want to be turned down. :-)

But it went through. There are so many insurance worries. One thing you can do is make sure that your group is participating Blue cross providers. My first onc wasn't and it would have cost me a fortune. He expected me to pay for everything up front and if BC reimbursed me then that was fine for me, but he didn't care--he had his money!
Make sure you do this with every place you go. I get thousands of dollars of bills. Most are remedied, some I pay. Some places tell you up front you will have to pay, others seem to try to avoid answering. So far, I have found this stress about eqaul to the treatments! However, I am doing out of state BC and this makes for more problems.
Is there a reason your doctor is going Taxol not Taxotere? Taxotere seems to have the best track record.
Good luck
Janet

[BCHusband]

We received a telephone call from Carefirst today and were notified that the insurer plans to cover my wife's Herceptin treatments (for early stage as noted above). What a relief!!! We can now proceed with her treatment without worring about the financial ramifications.

[AlaskaAngel]

Glad to hear it, and appreciate you letting others know. I wonder what the differences were between her case and the others her onc spoke of -- but am happy you have heard good news.

AlaskaAngel