Oncotype Test Not Covered... worth it to pay out of pocket?
I was diagnosed May 30 and met with MO mid June. She has been trying to get the oncotype test approved to decide on treatment but when I met with her yesterday it still had not been approved. She would like me to decide about chemo without it and I am leaning towards not doing it. I feel like the oncotype test would be a bigness benefit but at $4k I'd like to know others thoughts before we go ahead and charges it
Comments
-
With er and pr positive I wouldn't do chemo but I would do hormone therapy. Not sure oncodx is that useful especially if you are going to take AI drugs.
0 -
Actually, I believe that BarredOwl posted on someone's thread that the Oncotype test ASSUMES that the person will be taking anti-hormonal treatment (as it is only used for ER+ bc). There may be a max out of pocket cost, if your insurance denies. Worth asking.
0 -
Yes it assumes tamoxifen use not AI drugs.
0 -
I was ER and PR positive, but had a score of 24. I'd want to know if it were me
0 -
JennD, the Oncotype is approved for your type of early stage ER+ cancer by virtually all major insurers. The info it provides is extremely important and the use of the Oncotype has been one of few major improvements in BC diagnostics, sparing thousands of women chemo if their particular results indicate that their cancer has little recurrence risk meaning that chemo will have little value for them. Call your insurance company yourself and see what the hold up is. It is very irresponsible of your doc to expect you to make this decision without this very crucial info, but I have unfortunately read many posts over the last couple of years about docs that have either not ordered test at all or been unhelpful in jogging the approval from the insurance co. In the very unlikely case that your insurance does not cover it and you are willing to pay out of pocket, if I were you I would get a Mammaprint test done. It costs about the same as the Oncotype but tests a larger array of genes and gives a high risk or low risk result (no intermediate category as in the Oncotype test.)
0 -
Thank you everyone for your responses! I'm in Canada so the cancer agency has very strict criteria for paying for it and my insurance plan doesn't cover it. We have sent an email to see what the cash out of pocket cost will be and I will check into the mammaprint. My MO didn't mention that when I asked about paying for tests out of pocket.
0 -
Jenn, where are you in Canada? Healthcare is provincial and every province has different rules about the Oncotype test.
What is the actual size of the invasive component of your cancer? And is your invasive cancer HER2+ or HER2- ? Those are the factors that might disqualify you from getting the test.
0 -
JennD, I think as of now it is covered in seven provinces. Not in mine, so I went out of pocket. I wasn't planning to do chemo, but had the recurrence score come back high risk or even high intermediate, I would have done it.
0 -
Yes assumes tamoxifen not AI treatment. A score of 24 is intermediate basically an unknown. I wouldn't want to pay 4k for it.
0 -
Bessie I'm in BC and am HER2-. My IDC tumor was .45 but they are trying to get it remeasured because if it is actually .5 then it is covered. Its also covered if you are 40 or younger but I'm 44.
Chemo feels like overkill for such a small tumor but if the oncotype testcame back that I have a high risk of recurrence wouldn't it be the best option?
0 -
Just FYI with mammaprint if you don't have insurance coverage Agendia will subsidize the out of pocket cost so it's not horrible. I got a letter stating that but then insurance picked up the cost. Don't know if they do it for Canadians though--but maybe look to see who provides the mammaprint in Canada, might be Agendia, don't know. If so I bet they would help.
0 -
I had the Oncotype test done. I had early stage IDC, Stage 1b, Grade 1 but I also had a micromet in the SN. That prompted my MO to order the test. It was pricey - like $5k but we have BC/BS and they agreed to cover it at least on the front end. Genomic Labs conducted the test. They told me BC oftentimes approves the test and then un-approves it - at least temporarily. They got it approved. Had they not they would have charged me based on a sliding income scale.
My score came back@11 so I was able to dodge chemo. I had 33 Rads treatments. Not a walk in the park but certainly better than chemo. I also took Tamoxifen.
My MO told me they had been overtreating women for years so the test was a huge aid in determining a treatment plan not to mention the $ the insurance companies save by not paying for chemo.
I am 6 years out next month.
Good luck.
Diane
0 -
Jenn, you probably already have a copy, but here is a link to the BC Cancer Agency cancer management guidelines for early stage breast cancer:
http://www.bccancer.bc.ca/health-professionals/pro...
The information about the Oncotype test criteria is about 1/2 way down the page. There are 4 factors that would have made you eligible for the test - grade 3, or age 40 or under, or tumor size of .5cm or greater, or micromets to the nodes - and you miss all of them (which isn't a bad thing since these are not favourable factors). What is important to note is that the BC Cancer Agency criteria for the Oncotype Test appear to be fully consistent with, and even more detailed than the NCCN Treatment Guidelines. The NCCN guidelines are pretty much the gold standard of treatment guidelines, used by most doctors in the U.S. and used as well by many doctors and jurisdictions in Canada.
What's also important to note in the NCCN Guidelines, and also in the BC Cancer Agency guidelines, is that with your diagnosis, chemo is not even mentioned as a consideration. Do you know the basis of your MO's recommendation that you consider chemo, or why she is asking you to decide about it?
Here is the what the BC Cancer Agency says about chemo:
3A. Criteria for Consideration of Chemotherapy
Chemotherapy may be indicated for some hormone receptor positive breast cancers in addition to hormone therapy and local management. The decision to recommend chemotherapy is based on a number of patient and tumor factors weighed together. In general, if the cancer exhibits any or several of the characteristics listed below, the benefits of chemotherapy should be considered:
- Tumor >2cm
- Lymphatic and/or vascular invasion present
- Grade 3
- Weak ER and PR expression (Allred score 3-5; ER 1+ by IHC)
- Node positive
None of these features alone or in combination mandates the use of chemotherapy. The decision making process is complex and involves balancing the potential benefits of adjuvant chemotherapy with the potential harms (side effects) and must be considered on a case by case basis. Other important factors in this decision making process include patient factors such as age, life-expectancy, and co-morbidities. Patient preference and willingness to accept chemotherapy side effects must also be considered. Cancers without any of the above features arising in very young women (35 and younger) may still warrant chemotherapy, as young age is an independent adverse prognostic factor.10 Clinicians must make individual recommendations based on clinical judgment and specialized knowledge of breast cancer management. Recurrence risk assessment tools such as Adjuvant Online can facilitate discussion with patients and illustrate the probable benefits of hormone therapy and chemotherapy in individual cases.
Do you know if your MO has used Adjuvant Online? Has she had any discussion with you about your estimated metastatic recurrence risk with and without chemo, assuming that you do proceed with endocrine therapy? It sounds as though even without the Oncotype test there is more information that your MO should be providing you with, if she is asking you to decide on chemo. And it's unclear, based on your diagnosis, why chemo is on the table, and that too should be explained.
0 - Tumor >2cm
-
If I only could pick one test, and it had to be out of pocket, I'd choose the mammaprint over the oncotype. 1) the Mammaprint doesnt' have an intermediate range so there's not gray area and 2) at least for me, the mammaprint test is only $500 out of pocket if insurance refuses to pay. Mammaprint has been validated by independent studies to show it is effective and prognostic.
0 -
Re: MammaPrint ("70-gene test") (Agendia Inc.)
Prior to ordering this test, consideration should be given to "Clinical Risk Classification" under MINDACT Trial Criteria, and to the possible outcomes in light of that categorization. The test results may be considered less informative in certain situations, and knowing this ahead of time may influence whether your Oncologist would recommend ordering this test or a different test, as well as whether you may or may not feel the results could be helpful to your decision making.
For example, for a person who is deemed "Clinical Low Risk" under MINDACT criteria, what were the pertinent MINDACT findings and what would the recommendation be regarding added chemotherapy if the genomic test result was (a) MammaPrint "High" risk; or (b) MammaPrint "Low" risk?
In this regard, below please find a link to a 2017 ASCO Biomarker Guideline Update in which ASCO provides revised guidance regarding the clinical utility of the MammaPrint test in various patient subgroups and in light of "Clinical Risk Category" (classified per specific MINDACT Trial categorization methods).
>> ASCO Guideline Update (2017): http://ascopubs.org/doi/full/10.1200/JCO.2017.74.0472
The ASCO review and update was prompted by the publication of the MINDACT trial results in August of 2016 by Cardoso et al. (links at bottom).
The 2017 ASCO Guideline Update uses very specific wording (emphasis added): "with high clinical risk PER MINDACT categorization" or "with low clinical risk PER MINDACT categorization," and refers to clinical risk "as determined by using a MODIFIED version of Adjuvant! Online per clinical trial criteria."
In this regard, Cardoso et al. (links below) indicates that they developed their own classification program or system by modifying an existing one (bold and capitalization added):
>> "In this randomized, phase 3 study, we enrolled 6693 women with early-stage breast cancer and determined their genomic risk (using the 70-gene signature) and their clinical risk (using a MODIFIED version of Adjuvant! Online)."
The paper further states:
>> "Details regarding clinical risk assessment according to the modified version of Adjuvant! Online are provided in Table S13 in the Supplementary Appendix."
I strongly recommend that anyone interested in this test (or who has received the test) discuss the MINDACT trial publication and Table S13 in the Supplementary Appendix with their Medical Oncologist and obtain accurate, case-specific professional medical advice regarding Clinical Risk category.
BarredOwl
______________________________________________________________________________
Cardoso (2016) (MINDACT TRIAL): "70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer"
Main Page: http://www.nejm.org/doi/full/10.1056/NEJMoa1602253
PDF version (Free): http://www.nejm.org/doi/pdf/10.1056/NEJMoa1602253
Supplementary Appendix (Free): http://www.nejm.org/doi/suppl/10.1056/NEJMoa1602253/suppl_file/nejmoa1602253_appendix.pdf
See also,
Hunter perspective (2016) (Free): http://www.nejm.org/doi/pdf/10.1056/NEJMp1608282
Hudis editorial (2016) (available for purchase): http://www.nejm.org/doi/pdf/10.1056/NEJMe1607947
[EDIT: Removed remark re paywall. As of this date, the ASCO Guideline Update (2017) above is available at no charge.]
0 -
Re: OncotypeDX for Invasive Breast Cancer ("21-gene test") (Genomic Health)
This test is used in certain cases of invasive disease that is (1) hormone receptor-positive; and (2) HER2-negative. This is because the test for invasive disease is designed (and validated) for use in patients who will receive endocrine therapy (i.e., who are hormone receptor-positive). It is used to help inform the decision between: (a) endocrine therapy plus chemotherapy; or (b) endocrine therapy alone.
The Oncotype Reports currently feature the results of early validation studies in which patients were assigned to receive either: (a) 5 years of Tamoxifen Alone; OR (b) Chemotherapy plus 5 years of Tamoxifen. Therefore, the information about recurrence risk in the current Reports reflects risk with a specific endocrine therapy (Tamoxifen). However, in light of other clinical evidence, in practice, patients receiving the test will receive a case-specific recommendation for endocrine therapy that is appropriate to their particular situation (e.g., Tamoxifen, an Aromatase Inhibitor).
Here is an example of a later Oncotype validation study conducted in patients who had received 5-years of the aromatase inhibitor Anastrozole. This study used samples and 9-yr recurrence rates from the tamoxifen arm and the anastrozole arms of the ATAC trial, in node-negative and node-positive postmenopausal women with localized breast cancer.
>> "Prediction of Risk of Distant Recurrence Using the 21-Gene Recurrence Score in Node-Negative and Node-Positive Postmenopausal Patients With Breast Cancer Treated With Anastrozole or Tamoxifen: A TransATAC Study"
>> Dowsett (2010): http://jco.ascopubs.org/content/28/11/1829.full.pdf
The prospective TAILORx trial, in node-negative (N0), hormone receptor-positive, HER2-negative disease, permits a variety of endocrine therapies. The 5-year results for those with Recurrence Scores of 0 to 10 assigned to receive endocrine therapy alone were reported here:
>> "Prospective Validation of a 21-Gene Expression Assay in Breast Cancer"
>> Sparano (2015): http://www.nejm.org/doi/full/10.1056/NEJMoa1510764#t=article
>>QUOTE: "In the low-risk cohort of 1626 patients, endocrine therapy included an aromatase inhibitor in 963 patients (59%), tamoxifen in 560 (34%), sequential tamoxifen followed by aromatase-inhibitor therapy in 13 (1%), ovarian-function suppression in 44 (3%), or other or unknown therapy in 46 (3%)."
Recurrence Score is determined by tumor biology and gene expression levels from 16 cancer-related genes and 5 control genes. It is a fixed value. Various validation trials have demonstrated a relationship between Recurrence Scores and certain types of recurrence risk in those receiving various endocrine therapies. The reports feature the results of earlier studies. However, our understanding of the implications of a particular Recurrence Score for recurrence risk may be improved or refined over time, as additional clinical trial data accumulates from more robustly designed trials, such a TAILORx (node-negative) and RxPONDER.
BarredOwl
0 -
For those who may need assistance, here is a link to the Genomic Health page with information about Insurance Coverage and Financial Assistance for Oncotype testing:
0 -
The problem now is you are probably right at the time frame to start chemo. Too much time has passed to get additional testing. It takes a couple weeks to get the information back.
0 -
If you can figure out the payment with all the helpful advice above, I'd get it. The oncotype gives some good information and makes you more sure about the decisions you make. It was probably one of the most definitive tests I had.
0 -
JennD:
Your Medical Oncologist is the person best suited to provide you with case-specific expert advice regarding the basis for any recommendation for chemotherapy (per Beesie's post), and whether and what type of further testing could provide value, as well as recommended time-frame for initiating any chemotherapy (if indicated and elected). As you received lumpectomy, a Radiation Oncologist can advise you regarding recommended timing for initiating radiation (a) with, or (b) without chemotherapy.
General Information re Time to Chemotherapy ("TTC") in the "Adjuvant" (Surgery-First) Setting:
There are various studies in this area. See for example:
Chavez-MacGregor (2016): "Delayed Initiation of Adjuvant Chemotherapy Among Patients With Breast Cancer"
http://jamanetwork.com/journals/jamaoncology/article-abstract/2474437
"Time to chemotherapy was defined as the number of days between surgery and the first dose of chemotherapy."
They concluded: "Given the results of our analysis, we would suggest that all breast cancer patients that are candidates for adjuvant chemotherapy should receive this treatment within 91 days of surgery or 120 days from diagnosis. Administration of chemotherapy within this time frame is feasible in clinical practice under most clinical scenarios, and as medical oncologists, we should make every effort not to delay the initiation of adjuvant chemotherapy."
I do not know how this guidance would be applied in the individual case, and expert advice should be obtained.
Most studies in this area are retrospective and have various limitations. In addition, the results of various studies in this area are not consistent with each other in all aspects, and there are some important differences between sub-groups (e.g., triple-negative patients). Thus, regarding time to chemotherapy, patients should always seek current, case-specific expert professional advice, to ensure the complete body of evidence, including the most recent and reliable data that is applicable to their particular situation and diagnosis, is considered.
Patients experiencing larger delays should not assume any window has closed and decline treatment, but should instead seek case-specific expert advice regarding initiation of treatment / the potential impact of delay.
BarredOwl
0 -
If you can figure out the payment with all the helpful advice above, I'd get it. The oncotype gives some good information and makes you more sure about the decisions you make. It was probably one of the most definitive tests I had.
0 -
Beesie and BarredOwl, wow. Thank you for all the useful information. Beesie, to answer your question. My MO stated that I am in the middle ground because I am close to 40, grade 2 and according to her at a 20% risk of recurrence which I am sure is before radiation although I can't remember if she told me what the risk is after radiation. She has never mentioned Adjuvant online but I will ask when I go back. The factors she stated to me don't feel like a convincing argument for me. I realize I am now in a time crunch because through her attempt to get the test paid for she neglected to follow up with pathology in a timely manner, therefore a test that should have taken 2 weeks still hasn't come back after a month. I am asking for a second opinion or at least someone who can more clearly communicate with me and as well I am bringing someone I know will ask all the right questions. My husband has been trying but he is generally the kind of person to do whatever the Dr says without questioning which does not work for me. I will also wade through the information you have all provided and see what else I can find.
Thank you for all the replies, it is really helping my anxiety knowing I have somewhere to reach out.
0 -
Jenn, Go over her head. Order your surgeon to send the tissue sample to Genomic Health and put a rush on it. I got my results in only 10 days. Genomic Health will pay all or part of the cost if your provincial health system refuses to cover it. Ironically, your pathology takes you out of the gray area due to the small size of the IDC tumor (DCIS doesn’t require chemo) and negative nodes. Here in the States, with pathology like yours if your doctor refuses to order OncotypeDX it would be because you are at clinical low risk and chemo is NOT indicated. Yes, you’re only 40. But that would be a consideration if your tumor were >1cm, grade 3 or you had a positive node—you’d be out of the “gray area” for the opposite reason. Age should not be the deciding factor if all other things point to low risk.
0 -
ChiSandy, I agree that her disclosed clinical and pathological results don't put her into a questionable grey area and many MOs in Canada would recommend no chemo without an Oncotype DX test. Going over her MO's head is not really viable within the context of a publicly funded healthcare system. You absolutely can be an advocate for yourself and completely direct your treatment, but you do so via diplomacy, persuasion and negotiation skills and within the protocols of the system. It's not a revenue driven customer service centered model and that makes a huge difference in how you get the care you desire. I have had firsthand experience with the US system when I regularly flew down with my son to a world renowned center in the US south for 3½ years and paid out of pocket. I chose to have my cancer treatment in Toronto, where I live, and orchestrated and received timely, outstanding care and results from skilled and compassionate docs, for which my only financial burden was to pay for parking. There's pluses and minuses to both systems. BC was the 5th province to pay for the Oncotype DX test in Canada and each province manages their own process, protocols and criteria for funding the test. If we wish to see a specialist in Canada (funded by the healthcare system), a referral must be made to the specialist from either your family physician/PCP or another specialist. Only if we choose to go to a private clinic (and there are lots of them in BC) or have cosmetic surgery or other non-funded services, can we call the specialist's office and book an appointment ourselves. Once we are a patient of a specialist, we can schedule our appointments directly with the specialist. We need to have seen that specialist within a year, or require another referral in order to have the healthcare system fund everything.
Jenn, since you are age 44 with a 0.45cm grade 2 tumour, 0 nodes, you do not meet the eligibility criteria for your province to pay for the test. Here's what BC requires:
PN0 or pNoi+ and 1) grade 3, 2) grades 1 or 2 and age 40 or younger, or 3) grade 2 and pT1b or larger
OR pN1mi any grade
Since you don't fall into any of these categories, the province will not approve any request for funding the test. The process is that your MO or internist completes a requisition. You have to sign consent to the lab holding your tissue to send samples to Genomic Health and this form will be reviewed by the relevant BC program area to ensure you meet the eligibility criteria and only then will the province fax consent to Genomic Health for your test and fund it. Genomic Health then requests your block or slides from lab that holds your tissue, the hospital sends these to Genomic Health, they complete the test and send the results back. Yes, there's an appeals process, but with your MO, that isn't going to go anywhere and regardless, weeks would spin by.
Personally, from what you describe, I would not have confidence in your MO and would request a referral from your surgeon to another MO. You are low risk, but depending on your mindset and how much reassurance you desire, you could investigate the suggestions above re compassionate funding of the test by Genomic Health and perhaps pay a portion out of pocket, if you choose to pursue this. Do report back if you do this, as I don't believe anyone has confirmed whether Genomic Health provides financial relief outside of the US. Good luck.
0 -
Jenn there are several online calculators available. Here's a review of them and a link.
https://www.nature.com/articles/npjbcancer201611
0 -
Jenn, the 20% risk of recurrence that your MO mentioned absolutely is not your risk of mets (i.e. distant recurrence), which is what chemo is given to address. 20% sounds more like a local recurrence risk, i.e. a recurrence that happens in the breast cancer (and which could still be early stage and very treatable). If 20% is in fact your local recurrence risk prior to rads, then after rads, it will be closer to 10%, and if you take Tamoxifen, you will be able to bring it down to something in the range of 6% - 7%. You should confirm this with your oncologist.
ChiSandy made a very important point when she said "Here in the States, with pathology like yours if your doctor refuses to order OncotypeDX it would be because you are at clinical low risk and chemo is NOT indicated." And that's what confuses me about your situation and the fact that your MO is asking you to decide about chemo. The reason you are not eligible for the Oncotype test in BC is because all your characteristics combined create a low risk profile, one for which chemo would normally not be recommended. And, as per the information I provided in my earlier post, in fact you not only do not meet the British Columbia criteria for the Oncotype test, you also do not meet their criteria for requiring chemo.
Your diagnosis is early stage with favourable characteristics, so the question is, what is your risk of mets? That's what you need to know to determine if chemo is warranted. I've put your info into both the CancerMath and Predict models, and here is what I've come up with. Note that for CancerMath, I couldn't put in the .44cm size of your tumor, so I put in 0.5cm one time and then ran the numbers again with a 0.4cm tumor size; the numbers I've got here are the average of the two.
As you can see, CancerMath appears to present a more favourable scenario - I've found that this is usually the case for most people. But both scenarios are quite positive, and both show little benefit to chemo. Of course this is not as precise or accurate for you as a individual patient as the Oncotype test results would be, but at least it gives you an idea as to your risk level. If your Oncotype results were to show something similar, the recommendation would be against chemo. For such a small benefit, the risks from the chemo itself could outweigh the benefit you get. Here are links to the models, so you can put the numbers in yourself:
http://www.lifemath.net/cancer/breastcancer/therap...
http://www.predict.nhs.uk/predict_v2.0.html
And again, you should run this by your oncologist and ask if she believes that your risk is in this range and that the benefit you'd get from chemo would be this low.
downdog, great explanation of the Canadian heatlhcare system.
One final comment. I was diagnosed just about 12 years ago. At that time, the Oncotype test had just come onto the market and was not in use very much either in Canada or the U.S.. The criteria used to decide on chemo were tumor size, hormone status, HER2 status, grade, lymph node status, age of patient. Based on those criteria, honestly, Jenn, you would not even have come close to being thought to require chemo. Of course the advantage of the Oncotype test is that it provides a more precise personalized risk assessment based on the genetic make-up of the cancer. As a result, a small number of women who might not have been prescribed chemo in the past now receive chemo because they have a high Oncotype score. But by far the bigger impact has been that many women who in the past would have been prescribed chemo (for example, grade 3 with a 1cm or larger tumor or 1 positive node) are told that they don't require it.
0 -
I don't know if this extends to Canada, but my understanding is the company that does the oncotype test, I believe they are Genomic Health, may provide a reduced out of pocket cost to those whose insurance does not cover the test. I am in the US with a good PPO, and my insurance did cover but when I was checking the company did tell me there were options to bring down the cost if they didn't.
My diagnosis was similar to yours -- *slightly* larger tumor, but Grade 1 -- and I was glad I did the test. Even though my surgeon and MO were fairly confident going in that I would not need chemo, having the added confirmation from the test was reassuring for me. As some have noted there is the "risk" that you might come back in a gray area and then face decision to do chemo or not. I think it comes down to knowing what kind of person/patient you are. For me, more info is preferred. Good luck with everything, and see if the company will offset any of your costs.
0 -
bosumblues, I am in BC in Canada and yes it is because of the size. No it doesn't make sense that treatment is paid but finding out if it's necessary isn't.
I contacted Genomic health and they are willing to do it at a slightly reduced rate of $3340. I will be finding out on Monday if the path review came back larger and the test will be paid for by my medical
0 -
If I am understanding the information provided by downdog correctly, then a revision from intermediate grade (Grade 2) to high grade (Grade 3) might also impact your eligibility under your provincial practice in BC. Hopefully, the pathology review also reviewed the grade determination, which has some elements of subjectivity.
BarredOwl
0 -
JennD, good work! That's $1000 less than I paid!
0
