Nerlynx Approved by FDA to Treat Early-Stage, HER2-Positive BC
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I met with my MO earlier in the week to discuss Nerlynx. He recognized the reports are showing a benefit but was little skeptical of its long-term benefit as the published results don't go out to 5- or 10-year histories. He also talked about the side effects, of course. And the price, which is around $10,000/month similar to what i saw for individual doses of Herceptin or Perjeta.
Given my history, we decided he would submit it to my insurance and see if they'll cover it.
One thing he mentioned that I didn't recall hearing before is that this is in pill form but you take 6 pills a day? He wasn't specific if they have to be spread out every so often, or you gulp a big pile o' pills at a time?
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You take the 6 pills at the same time but they are very small.
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thanks, wellshoot. How has it been going for you with the Nerlynx treatment?
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Just out of curiosity, I checked on my insurer's website. My cost would be $500 per month! Of course - that's nowhere near the $9,000+ they would be paying, but still ...
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This past year, I max'ed out my insurance cap on co-pays/deductibles in January lol - courtesy of the big bill for a Herceptin treatment and some smaller things thrown in for fun.
I'm pretty much resigned one way or another that may happen again in 2018, and budgeting for it. Would like to be wrong.
If Nerlynx gets approved, assuming I'll have another quick buyoff on the max copays to cope with in early 2018. Or maybe a "free' round if the first doses get charged this month when I'm long since over the 2017 cap.
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My max out of pocket is just under $7,000 - so an awful lot for my family.
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I have done fairly well on the drug. I am on my fourth month and I may have had four or five “bad” days. I take an Imodium and then I’m fine. My insurance has covered it but I think the drug company has a coupon program to reduce the cost dramatically.
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I just started Nerlynx, took my first dose today along with recommended Immodium 3x daily to prevent D before it starts. My Onc said she'd add additional meds if needed. I'm concerned taking all that Immodium will cause sudden problems with constipation. I had that happen while on chemo & that was worse than any diarrhea I had! Today was ok, will see what happens in the next week or so.
Regarding hig cost & coverage:. My Onc clinic has a pharmacy & they worked with my insurance company to get it covered. They did more than one appeal as it was denied at least twice, finally was approved but with a huge copay that I couldn't afford. Nerlynx is being supplied through a specialty pharmacy & they applied for a grant that covered the copay completely. If that hadn't worked they said they would go to the manufacturer & get them to cover it. Anyway there are ways to get large copays covered, and my oncologist & her staff, & the specialty pharmacy, worked to make that happen. They said they'd do it again for reauth when needed. My Onc & her staff have been amazing in the work they did to get this covered for me.
Just wanted to let others on this thread know there are ways to get this covered with the help of your oncology clinic.
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No big problems with my insurance but a little back and forth on paperwork before I got the Rx shipment yesterday. Debated waiting for an appt with my MO first, but they were hard to schedule with given the holidays. Decided to bite the bullet and take the first dose today so I''ll have a week to see how any SEs develop before I'm due back on a full work schedule the Monday after New Year's.
From the instructions, it seemed that it could be 8 days before significant D reactions occur? Would be interested what anyone else's experience has been taking this together with the Imodium precautions. I'm hoping it's not too bad or will settle down in a few weeks as I have travel plans toward end of January.
Someone I know was diagnosed HER2+ shortly before I was, and we've been tracking through roughly similar treatment plans. Her doctor strongly recommended she do the Nerlynx but she hasn't started yet.
I saw just recently some 5-year results being discussed, which seem to hold up reasonably well (?) for the idea to take this drug. When I saw my MO, he'd raised concern with just 2 years or less of data that longer-term the benefits might fizzle out. I don't get that impression reading the study summary.
http://www.onclive.com/web-exclusives/longterm-data-published-for-neratinib-in-her2-breast-cancer
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I started this drug 5 weeks ago. It was about a week before the big D hit. I am taking it as part of a trial and was taking it with Colestipol daily for one month with Imodium as needed. I didn’t bother with the Imodium as the D was quite predictable and I was on leave from work and it was mostly manageable with diet. It settled down a lot about a week ago when the Colestipol finished.
The article you linked to refers to the overall study data. The reports I have seen have quite varying results for the different sub-group analyses with better results for hormone positive patients and marginal improvements for hormone negative and node negative patients. I know for my sub-group being hormone negative with lots of nodes it looked like the two year benefits were not sustained over the five years. My thoughts were that the drug was worth trying but not persevering with if the side effects were excessive and unmanageable.
Fortunately for me so far this has been by far the easiest treatment I have had and I hope it stays that way. Other patients do not seem to have been that lucky and have had significant unmanageable problems.0 -
Thanks - I was reading something about the different sub-groups, wasn't sure how to interpret it where any of us may cross into more than one of the groups. The hormone positive group seemed to fare relatively well, the node-negative results not as great and I fit into both categories ...
I'm thinking I will plug away at this unless the SEs become too severe, as I've been treated BC twice now (DCIS back in 2008 and HER2+ IDC found in 2016). Not at all keen to push my luck with a third incidence.
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Hi everybody, according to the promising results of the above trial my daughter being early stage HER2+++ and HR +, I wonder if this would be an additional option for her.
Do you ladies know if there is a certain time limit between the last Herceptin infusion and the start of the Nerlynx drug?
After dx in August 2015 she had TCHP plus 12x Herceptin.
Thank you in advance. Gudrun
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I am very interested in reading all of the information that you all have written. My doctor wants me to take this when I am done with Herceptin.
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Gudrun - In the study the average start time after finishing herceptin was something like 4.5 months but went up to two years. I thought better results were seen in the less than 12 months sub-group.
As to whether there is a certain time limit it would depend on what country you are in and how you were funding it. I think in the US it is up to two years after herceptin. I’m sure some local US people could advise. In Australia where I am it is not funded and is only available in clinical trials so you need to meet the trial conditions.0 -
From the small mountain of literature attached with my package, it did seem to suggest highest benefit if you start Nerlynx within a year after finishing Herceptin, and with a significant wait the effect (on average) can be considerably lessened. How statistically meaningful the latter data is, I'm not sure as the sample size was much smaller for the >1 year group. Always best to ask your medical team. Now that it is becoming better known, I'd guess that starting it not long after Herceptin finishes will become fairly common?
This was another article I found today. I assume since it's from the manufacturer's data it's not as verified as the clinical trial but some stats on taking Imodium upfront in the process. It looks encouraging if you take the preventives, and can stick the treatment out over the first month, it gets a lot better from there. Hope so, anyway.
https://www.fiercepharma.com/pharma/puma-s-neratin...
All my admiration and appreciation to those who took this in the clinical trial phase without any mitigating treatment -- it must have been rough.
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Thank you ladies for your input whlch inspired me to do some extra research. I found this on a recent article I'll add in my next post. (because it hadn't worked, post always deleted automatically. Sigh )
There a Mr Steven Vogel comments on the question if we should recommend Extended Adjuvant Neratinib"
"No!" is the short answer. We lack evidence of a substantial benefit for the true endpoint (overall survival) or the best surrogate endpoint (distant disease–free survival) for a tolerable schedule. The 1.7% improvement in distant disease–free survival at 5 years in the entire population is not statistically significant. Further, the monetary cost to society is exorbitant, and the subjective tolerability of a year of neratinib therapy using prophylactic loperamide is not clearly established in a large, defined population."
For my daughter that means she won't meet the conditions although being strongly ER and PR positive with residual disease after neoadjuvant chemo but - fortunately - with no positive nodes !?
What do you think?
P.S. Excuse my "stiff" English. I learnt it at school but have never spoken it. My mother tongue is German.
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Thank you ladies for your helpful input whlch inspired me to do more research. See recent article above.
The question is who is recommended the drug?
Quote:
"Should one ever consider extended adjuvant neratinib therapy? In the very high-risk situation of a locally advanced HER2-positive, estrogen receptor–positive breast cancer with many positive nodes and involved margins of resection, with residual disease after neoadjuvant chemoimmunotherapy including pertuzumab, I personally would discuss extended adjuvant neratinib with the patient."
Accordingly, my daughter would not meet the conditions although being strongly ER and PR positive with residual disease after neoadjuvant chemo but - fortunately - with no positive nodes !?
How do you see it?
P.S. Excuse my "stiff" English. I learnt it at school but have never spoken it. My mother tongue is German.
Best wishes for a good New Year to everyone
Gudrun
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In practice it seems to be those with multiple positive nodes who are her2 positive and finished herceptin within the last 12 months that are being recommended it. The hormone positive or negative doesn’t seem to be that relevant.0
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I think that residual disease after NAC with Herceptin puts you in the group with the most benefit of taking Nerlynx.
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Thank you Brave for telling me your thoughts. I think we'll contact our breast centre. Bevorehand, I'll have to discuss that with my daughter. Wishes to you.
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Hi all. Thank you for keeping this conversation going. I am supposed to start at the end of February. I appreciate all the feedback. Please keep it coming.
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Suburbs, me too! Hope we fare well.
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KimCee, let's pinky swear on that. We WILL fare well. Yes, indeed! Coincidentally, I just opened the mai and received the official approval from my insurance company. Perfect timing.
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Please do let us know how this new treatment goes.
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I am 8 days into my Nerlynx treatment. First in my oncologist's practice to take it. He said he offered after I started it to others with worse "stats" than mine, particularly larger tumors, and positive nodes, but they declined due to the SEs. I made a vow to do everything I was offered to reduce my recurrence risk, so here I am. Happy to have something that is able to cross the blood/brain border. CNS mets are a real possibility for us HER2+ gals. Also, even though my tumor was small and I have no +nodes, the benefit for er/pr+ excites me. I am strongly er/pr+.
The diarrhea is no joke if it hits hard, lol. I had 2 days that were like a colonoscopy prep! However, ....and I am knocking on wood as I type...I have had no episodes in about 36 hours. Fingers crossed! My Onc and I are in almost daily contact via email about my symptoms and adjusting the meds to counteract them. I'm the guinea pig for that oncologist office, I guess. I pray we got the balance right at last.
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my oncologist says he will be putting me on this when I'm done with my 17 herceptin treatments. He was first looking at perjeta but because my nodes were clean he said showed better results.
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I only have 3 more Herceptin treatments to go. Then my doctor wants to put me on this. I asked him if there was financial help with this and he said yes. I don't always know if the doctor knows about all the financial help or if I need to talk to the financial person in his office.
BarbD- My nodes were clean but I had Herceptin and perjeta. Maybe some other reason why I had it.
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My MO hasn't mentioned it to me. Perhaps that's because I had NAC chemo and all cancer was gone at the time of surgery? Or maybe because I'm sick of taking meds and want a break? I quit the Tamoxifen because of so many problems I was having. I decided that I needed to see how I felt without any meds.
As far as cost - check with your insurance but also check out the manufacturer's website. Many expensive drugs with high copays have assistance programs for those with insurance. I was able to get my Neupogen shots almost completely covered with a special program card through the maker.
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I'm closing in on a month with this drug, and so far not too bad. I've had days intermittently with D but just in the mornings without impacting the rest of my day. Similar to with Perjeta when I was on TCHP chemo. I've been trying to follow the Imodium recommendation but haven't been able to sustain the full dose without it driving me toward constipation.
I've been feeling more tired than I was before, but that's a matter of degree, not a new issue. Through chemo, radiation, and surgeries I've never gotten past crashing out a lot more than I did before all this started up. Hoping more exercise will help.
The co-pay quoted with my insurance wasn't terrible, but my clinic gave me a manufacturer co-pay assistance link that can work with commercial insurance. It reduced my co-pay to $10 when I reordered for the second month's supply.
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