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Yes! It’s certainly something that needs more advocacy, particularly as more and more young patients are diagnosed with cancer and hopefully cured from cancer. Not to mention the fact that more women are delaying childbearing, so the odds that a woman will be diagnosed with cancer before having children increases with that in mind.
I know that when we’ve referred patients to fertility clinics, they do expedite getting these patients in for consultation. However, it’s one more piece of the puzzle to make the circumstances even more complicated and overwhelming, not to mention being cost prohibitive for many.
And, the fact that so few fertility specialists actually specialize in the Oncology patient creates another barrier. We know that many ancillary providers are not familiar with newer oncolytics (IO, for example), so it’s possible that many fertility experts are not either. It’s scary to think about that, especially with an IO patient who has completed therapy in the adjuvant setting, for example. Just what could the long-term ramifications on carrying a pregnancy be? We all have a lot to learn.
We haven’t switched anyone yet, but our thinking is in line with yours…..we’ll switch the long-term responders who are reliable about reporting changes first and see how that goes before switching the others.
Yes – we, too, have a template. It does save some time, but some of the info can be a little boilerplate. But, at least it’s helpful when trying to complete these plans on top of everything else. It’s sad, though, because these are supposed to help the patients but in all honesty are one more requirement actually taking time away from patients as we hustle to complete these.
Krista,
Insurance coverage for IVF and fertility treatment in general varies by state and by insurance plans. There are certain states that are “baby states,” and fertility coverage is mandated. These include Mass and IL (that I know of). I know that some larger West Coast companies that are progressive are providing fertility coverage for employees as well. Unfortunately, insurance plans usually don’t differentiate between needing fertility preservation for cancer or for general infertility – a plan has fertility benefits, or it doesn’t. It’s sad, as an egg retrieval for egg harvesting is tens of thousands of dollars (usually $20K plus). The meds alone are $5K plus. Sperm banking, on the other hand, is relatively cheap….several hundred dollars plus storage fees that are probably around several hundred per year. Another caveat is that a patient (female) has to have enough time before treatment to go through the stimulation/egg harvesting process. It’s easier for males, as sperm banking is usually a one-day affair.
There is an OncoFertility Consortium that I believe is run out of Northwestern. One reproductive endocrinologist that I know of that specializes in treating cancer patients/fertility preservation is Dr. Laxmi Kondapalli at Colorado Center for Reproductive Medicine. There might be a few others across the country, but it is a very small group, for sure. There is a definite need for more of them as we diagnose and treat (and hopefully cure) patients that are younger and younger.
As for the responsibility of pharma…..I don’t know, but I would think that they are required to report any relevant info in the post-marketing setting.
TIME, TIME, TIME is the greatest barrier. In our practice, it has fallen to the NPs to complete these. I will say, too, that it is rather awkward when a patient has been a “survivor’ for quite some time and we’re now presenting them with a plan. We do have a team of navigators identifying patients before the appointments. However, I have heard of some places that have a team that does only Survivorship – in other words, a NP designated to this alone.
Wow – I had not heard about Medicare reimbursement. We have not yet started the 480 mg monthly dosing, but if reimbursement is an issue, our practice will probably delay doing that. As far as seeing the patients monthly, I think that will vary on physician preference. For a very busy practice, I could certainly see some physicians liking the once monthly visits/treatments, but on the other hand, this might not be good for the patient that likes/wants to be seen frequently or is possibly not one to report AEs unless at a visit.
I work at a practice that has adopted OCM guidelines and therefore, we, too, are required to complete survivorship plans. As mentioned above, Stage IV patients are exempt. This is certainly a reflection on the fact that we historically have had few durable responses in patients with Stage IV cancer (melanoma among other tumor types), but as we know, IO has changed the face of melanoma and other cancers. That being said, we are completing survivorship plans for patients with other stages. I do believe that we are going to see more a more late immune-mediated adverse events that occur as we follow these patients longer and longer. Also, as previously mentioned in another post, fertility issues/safe childbearing, etc. is going to be another major topic in survivorship with our young patients, as we really have no data about how these drugs could impact a pregnancy after the mother has completed therapy and drug is presumably washed out. We know, from experience, that the immune system can continue to be upregulated for a durable amount of time.
I think it will certainly decrease volumes in the clinic. I also think that it could impact which treatment providers choose – pembrolizumab vs. nivolumab. I know that certain providers chose pembro based on the fact that dosing is less frequent while others who like to see patients more frequently chose nivo. I do know that my nivo patients will be thrilled with the once monthly dosing!
We tend to be creatures of habit as well and really only look to switch to other BRAF-MEK combos if there might be decreased incidence of side effects. For example, if someone has horrid fevers from Taf-Mek, we’ve tried Vem-cobi. I do believe that this newer (third) combo coming to market has a lower incidence of certain AEs with similar efficacy, so it can likely find its place and be utilized. And I hope that competition will help control costs -always an issue and one we deal with so commonly with oral meds.
This is certainly an interesting approval given that IIIA patients weren’t included in the trial. While we have yet to encroach this in practice, I think that this will be decided on a case-by-case basis. For example, I think that if you see a younger, healthier patient, oncologists are going to want to be more aggressive in the adjuvant setting. As with everything, it will end up being about weighing risks and benefits. I am happy that more patients than just those eligible for the trial can potentially benefit from this, but it certainly creates some gray areas!
I agree with your statement, Krista…..there is certainly no one-size-fits-all approach to managing IMAEs. Some AEs definitely warrant longer courses of steroids than others. For example, rashes usually respond very quickly to steroids, and in my experience, wouldn’t warrant 6 weeks of steroids. And, you’re right on par with the endocrinopathies that don’t warrant interruption at all.
I can recall one similar case – patient didn’t respond to steroids or Cellcept. Viral work-up negative. All other hepatotoxic drugs discontinued (statins, acetaminophen, etc). It unfortunately wasn’t a happy ending for this patient – dealing with it went on for a year. We even referred to a hepatologist. However, this is the ONLY case that I can recall. It’s a reminder that these drugs, though seemingly benign, can still be very toxic and detrimental in a few select cases. Sending him for a biopsy was very appropriate – keep us posted on the outcome.
True – the side effects are a separate issue. It will be interesting to see which oncologists prefer in the BRAF mutant population. The good news is that we at least have options beyond interferon!!
This is such a challenging issue. We had a patient on adjuvant ipi who developed hypophysitis. She has been off treatment for almost a year, and she would now like to conceive. This is definitely unchartered territory for us, her OB and her Reproductive Endocrinologist. Beyond the hypophysitis, we know that the immune system plays a pivotal role in pregnancy and that there are checkpoints involved (PD-1/PDL-1 being one of them) to prevent the mom’s immune system from attacking the fetus. If a patient is having a durable response to immunotherapy, is the mom’s immune system, in that case, going to be too upregulated to sustain a pregnancy?…….There are certainly lots of unknowns in this realm.
On that note, I will say that if you use mycophenolate (CellCept), it can take several days to get a PA since it is an oral therapy. We have run into some occasional issues with this.
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