Oncotype Test Not Covered... worth it to pay out of pocket?
Comments
-
You really should call mammaprint as well (Agendia). They are subsidizing the test for much more than Genomic health.
0 -
Hi Lisey:
Have you read this recent 2017 ASCO Guideline Update regarding MammaPrint (70-gene test)?
>> 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.
Prior to ordering this test, Medical Oncologists should give some consideration to the patient's "Clinical Risk Classification" under MINDACT Trial Criteria, and to the possible outcomes in light of that categorization. (This is a determination according to the criteria used in the trial, and not some layperson's understanding of clinical risk.) The MammaPrint test results may be considered less informative in certain situations. Knowing this ahead of time may influence whether one's Oncologist would recommend ordering this test or a different test, as well as whether one may or may not feel the results could be helpful to their decision making.
For more, see my more detailed post on the first page of this thread:
https://community.breastcancer.org/forum/147/topics/857327?page=1#post_5013670
BarredOwl
0 -
HI Barred, Let me understand what this is saying, and ask you a question. It's saying low clinical risk (by the standard definiition of size, nodes, grade) do not benefit from Chemo, so mammaprint is unnecessary since even if it came back high risk they wouldn't benefit? That doesn't make sense to me. People classified as low risk cliniically but high risk via mammaprint should have chemo, right? Therefore if they don't get the mammaprint - they wouldn't know.
What about someone like me, classified low risk, but got an intermediate oncotype... Mammaprint I was low risk, but another poster with my identical stats (low risk clinicially, intermediate oncotype) had the mammaprint and was high risk, so did chemo.
I trust the genomic testing more than classical staging.. so I'm not sure why they are saying not to do testing if you are appearing low risk.
0 -
My insurance said they would not cover the Oncotype test but I asked the Path Lab to send my specimen anyway. Genomic did call me personally and asked about how I was going to pay. I told them I could not afford the $4700 they were asking and then they asked me a series of questions about my bills and finances. The person on the phone told me I fit into some category and that they would most likely do it for free....they would call me back.
Meanwhile while waiting for their call , I called my insurance daily and pleaded with them how paying for the test could actually save them money due to the possibility of not paying for chemo, how my employer would benefit by me not taking numerous sick days, and how I would benefit from the possibility of not having to endure the side effects of chemo.
Well one week later my results got released to my MO, but no one had called me about payment. Totally thrilled, yet confused, I went to my insurance portal and saw that my insurance had a pre auth approved for payment to Genomic Labs. Yay!
My result came back 12!
Hugs to all waiting on results
0 -
Hi Lisey:
As you know, I am a layperson with no medical training, did not receive the MammaPrint test, and never received medical advice regarding the test.
Guidelines do not mandate individual management, and there may be appropriate exceptions or more specialized situations. Thus, patients interested in the test should always seek current, case-specific expert professional medical advice from a Medical Oncologist regarding their clinical risk categorization per MINDACT criteria, and whether in light of same (and all other relevant information), the MammaPrint test may be informative in their particular case.
Re: "It's saying low clinical risk (by the standard definiition of size, nodes, grade) . . "
My layperson understanding is that while certain standard pathologic criteria of ER status, HER2 status, Grade, Nodal status and Tumor Size were used to categorize risk in the MINDACT trial, they used a specific methodology to weigh these factors (i.e., a MODIFIED version of Adjuvant! Online) for the purpose of assigning clinical risk category. The same categorization methodology must be used when considering the potential utility of the test before ordering it, as well as to properly apply the MINDACT findings in the individual case in those who received it. Thus, patients cannot "intuit" their clinical risk category from their layperson understanding of clinical risk.
Re: "I trust the genomic testing more than classical staging"
It is not a question of trust, but a question of clinical validation and demonstrated clinical utility. Evidence of superior performance over standard pathologic criteria is required. A gene signature is only as good as the quality and scope of clinical validation available to demonstrate its prognostic and/or predictive abilities in specific patient subgroups.
Please note that the Guideline Update addresses different subgroups separately, providing separate recommendations for various types of node-negative and node-positive disease, because the specific findings and quality of the data available differs for these subgroups. The exact language of the guideline should be consulted.
Re: "People classified as low risk cliniically but high risk via mammaprint should have chemo, right?"
What might seem intuitive was not what was actually found in the MINDACT trial for certain sub-groups. For this "discordant" group ("MINDACT Clinical Risk Low" and "MammaPrint Genomic Risk High"), Cardoso et al reported [parentheticals added by me]:
"Among patients at low clinical risk [per specific MINDACT trial categorization methods] and high genomic risk, those who underwent randomization on the basis of genomic risk (and therefore received chemotherapy) had a 5-year rate of survival without distant metastasis of 95.8% (95% CI, 92.9 to 97.6), as compared with a rate of 95.0% (95% CI, 91.8 to 97.0%) among those who underwent randomization on the basis of clinical risk (and therefore received no chemotherapy) (adjusted hazard ratio for distant metastasis or death with chemotherapy vs. no chemotherapy, 1.17; 95% CI, 0.59 to 2.28; P = 0.66) (Fig. 2B). This finding does not show any advantage of directing therapy on the basis of genomic risk among patients at low clinical risk but high genomic risk, since these patients had no [apparent statistically significant] benefit from the use of adjuvant chemotherapy."
This was a secondary endpoint and there are caveats. For example, an accompanying commentary stated, "Similarly underpowered was an analysis that showed no advantage of directing therapy on the basis of genomic risk among patients at low clinical risk." Would the result have been different if the study had been more highly powered? There is no way to know one way or the other. Also, the "low clinical risk" group was relatively diverse, so while it was not possible to show improvement in outcomes among the group as a whole, it seems conceivable that there might be specific patients or sub-group(s) (as yet to be identified) who could benefit from added chemotherapy.
That said, for those who have already received the test, there may be other useful information to be gleaned from Cardoso et al. and its appendix.
Re: "What about someone like me, classified low risk, but got an intermediate oncotype... Mammaprint I was low risk, but another poster with my identical stats (low risk clinicially, intermediate oncotype) had the mammaprint and was high risk, so did chemo."
Without the actual statistics for the other person, I have no idea whether the other person would be considered "clinical low risk" per MINDACT criteria. An "intermediate" Recurrence Score (18-30) includes a relatively broad range of distant recurrence risks. Also, the advice you each received would have incorporated additional considerations (e.g., LVI, age, co-morbidities).
On the one hand, you received these tests and related medical advice prior to publication of the MINDACT trial results or the 2017 ASCO Guideline Update. On the other hand, the MINDACT trial did not address this specific situation: No Recurrence Score information was available. At least one other study assessed the use of both tests, but I do not believe that clinical outcomes are available.
Since you have no pending treatment decision, I am willing to agree with you that you would be considered "clinical low risk" under MINDACT criteria, but you should confirm it with your MO. In addition, having already received the test, I recommend that prior to your next follow-up appointment, you let your MO know in advance that you would like to know your "Clinical Risk Category" per MINDACT trial criteria, and to discuss the findings of Cardoso and its Appendices as they apply to your case.
BarredOwl
[Edited to correct typo and inserted "interested in the test"]
0 -
My insurance also wouldn't cover the Oncotype but Genomics did pick up the tab. I was very glad they did because my score came back low and I was able to avoid chemo in spite of one positive lymph node.
0 -
Barred, those are interesting findings. thanks for dissecting it. I wonder if the same clinical low risk / high oncotype score has had similiar results.
0 -
Here’s an article I came across yesterday:
http://www.clinicaloncology.com/Breast-Cancer/Arti...
Basically, for certain rarer and usually more “indolent” types of invasive bc (tubular, pure mucinous, encapsulated papillary, etc.), the authors posit a 0-3 (1 point per biological risk factor, lower is better) simple risk scale as a reliable clinical staging system that might obviate the need for genomic testing. 1 point each is given for Grade 3 and ER-.The only thing I find weird is that HER2- status is worth a point, but HER2+ isn’t. Had been under the impression that triple-positive is more aggressive than ER+/HER2-. The full “scale” is available at a paid-subscriber-only site, if I’m not mistaken.
This isn’t really relevant for most of us, who have DCIS, "garden-variety" IDC or ILC, but interesting nonetheless. Barred Owl, impressions?
0 -
Hi ChiSandy:
I found this article in The Oncologist from June 7, 2017 and the named institutions. However, the article does not seem to focus on "indolent" disease or mention the less common invasive subtypes (based on word searching the pdf). It seems designed to be more broadly applicable and relates to breast cancer staging in general.
Chavez-MacGregor (2017): http://theoncologist.alphamedpress.org/content/early/2017/06/05/theoncologist.2017-0116.abstract
A pdf version of the article can be obtained at no cost with free registration.
The 7th Edition of the AJCC Staging Manual is currently used for staging. The 8th Edition is currently slated for implementation in the clinic in 2018. The authors explain:
>> "The eighth edition of the AJCC recommends the use of a "prognostic stage" based on data from the group of Dr. D. Winchester. . . [This] new proposed staging system, while providing an improvement in grouping patients with similar prognoses, is complex, and its incorporation into clinical practice may require special software or electronic tools [21]."
Regarding the advantages of their own approach:
>> "Our proposed risk-score point-based system provides refinement and builds on the anatomic AJCC system. This score system has several advantages over the "prognostic staging" described in the eighth edition of the AJCC staging manual. It is simple and easy to calculate; in addition, the information needed to calculate it is available in most pathology reports. This risk score modification will be easy to incorporate into routine clinical practice and reflects the current use of endocrine and HER2-targeted therapies. Furthermore, because this risk score does not change the current TNM system, it will still provide a common language with which to communicate with colleagues when biological data is not available, or to compare outcomes from retrospective cohorts."
They invite adoption of their system in the future:
>> "In order for our staging systems to remain current and useful, we must make efforts to incorporate clinically relevant biological information in a simple form that is easy to use in daily practice. Our risk score incorporating ER and HER2 should be considered as a simpler alternative to the proposed eighth edition AJCC "prognostic stage" in upcoming revisions."
I guess only time will tell.
BarredOwl
0 -
Hello,
There has been so much useful information to go through and I needed some time to process everything. Meanwhile I received a verbal review of my pathology and it was a bit of a surprise to me.
It appears that my original pathology was slightly incorrect and my IDC tumor which was originally measured at .45 cm is actually .6cm. This will allow the test to be paid for but does raise some other questions about my original report. For example, the tumor size wasn't measured correctly according to a review by the cancer agency, and I have concerns about the clean margin reported because I was re-excised and found to have more DCIS. I also found out that my original MO, whom I have asked to be switched from, did not order the pathology review until just over a week ago when I was told it was ordered close to a month ago. Feeling really anxious about trusting anything at this point. This means that my window for having chemo is closing and I still haven't gotten the oncotype test. But given everything that I have read in this thread, it appears that the test won't be a huge benefit to helping me make that decision anyway. Sadly, my appointment for a second opinion isn't until Sept. 5th.
But with or without the second opinion I am feeling like I should be starting some kind of treatment soon. I spoke with the RO and he will be starting the mapping for radiation the week after next, then I start RADs the second week of Sept. Radiation wasn't my first choice because I have lung cancer in my family but the waitlist for mastectomy with immediate reconstruction is insane here. So I will continue to pursue that while I start my treatment because I don't know what else to do.
I'm anxious about starting tamoxifen because I don't tolerate meds well usually and I have had to be scheduled for a hysterectomy in January due to spotting every other month. I keep thinking that if I think positive, I won't have any issues with the meds but thinking positive is difficult some days. I realize my prognosis is good but all the issues with the first MO pushing me to make decisions without the information she told me would be helpful to me in making the decision has really raised my anxiety. Now the changes to the pathology have me upset again.
Sorry for the long post but I needed to get it all out...
0 -
Thanks, BarredOwl. “Indolent” was my descriptor, because the Clinical Oncology News abstract named those lower-risk types of breast cancer which are typically much less aggressive. Incidentally, David Winchester is my surgeon’s partner.
0 -
Lisey, I see that you had the BluePrint test in addition to the MammoPrint. I'm very interested in getting that one. Did insurance cover it and/or did Genetech offer a subsidy?
0 -
Hi Fleur, Yes, they do the mammaprint and blueprint as a suite standard now. We only asked for mammaprint, but the blueprint came with - which is important for subtyping. As far as cost, my insurance refused to cover it and I've been told my Mammaprint the most I would pay is $500 total. I have yet to get a bill from them 1 year out. Agendia is the lab, not Genetech. The agendia customer service number is incredibly helpful to navigate all this. I suggest calling them in California.
0 -
Lisey, thanks for the info!
0 -
To all, this has been such an informative thread. Thank you Jenn! I have been reading about oncontype testing and just assumed it was expected. I am in the US and just emailed my breast sergen to find out what my results were. I am schedulaed to meet a oncon and radiologyst oncon on the 20/21st. Do they actually request this test and not when I had a masectomy 4 weeks ago?
0 -
They usually wait to order it until they can discuss your surgical path results with you, as not all insurers cover it. And if your tumor falls outside the “gray area” where it’s not certain if chemo would work, much less be worth it, it’s not done because it’s pretty obvious that your tumor would score either very low (no chemo) or high (chemo necessary). Had my tumor been either smaller than 1cm or grade 1 rather than 2, they wouldn’t have ordered Oncotype DX. I still scored low-risk, though not super-low. Based on that, chemo was not recommended.
0 -
What an interesting post. Sort of like Oncotype 101, 201 and 301. BarredOwl, seriously, you need to start charging! Luckily for me, treatment was a no-brainer, and I was happy to have the kitchen sink thrown at the whole disaster.
JennD, I hope your second opinion went well for you. All this waiting must be frustrating.
0
