Nivolumab dosing and Medicare

[Anonymous]

Hi Everybody,

As most of us know we received word from the FDA last week that nivolumab dosing is now approved for 480mg/q 4 week dosing for both metastatic and adjuvant therapy in melanoma. While this is exciting, there apparently is one snag that came to light this week.

Currently the maximum mg. dose reimbursable under Medicare guidelines is 440 mg. Unfortunately it does not look like this will be resolved until at least July when a new J code is assigned to the Q 4 week dosing. It also appears that Medicare patients will still not be able to enroll in the BMS assistance program. Wondering if other practices have heard of this and your thoughts- other then to continue the 240 dosing for Medicare patients?

Also are folks experiencing push back from their institution regarding the 480 mg dosing, similar to the 30 minute infusion times?

Thanks,
Lisa

[Anonymous]

Wow- Lisa- thanks for posting this Very important information.
Our group has not yet decided what we are going to do as there are a couple of issues we are planning to discuss as a group. The information you provide Lisa, will need to factor into this as well.

The issues our team felt needed to discussed include:
–> our group has some concern about going 4 weeks between visits. While the schedule is more convenient for patients, it minimizes the chances of “early intervention” which we know is so very important when screening for toxicity.

–> anecdotal experience suggests there may be a higher incidence of infusion reaction at this dose. I have inquired with BMS regarding formal data in his regard. So- PLEASE NOTE- this is ANECDOTAL. But, if indeed true, if is important to consider

Thanks again Lisa- for sharing this info!!

[Anonymous]

Hi Lisa,
Thanks for letting us know about the Medicare restrictions on dose of nivo. I was unaware of that. We just started our first patients on 480 mg this week – all went well.

Krista, excellent point about not seeing patients for 4 weeks. We had been seeing nivo patients in clinic every 4 weeks after 2-3 cycles of every two weeks if things were going well. They would come in for the nivo infusion with a treatment nurse at the 2 week point, but no formal appt. with an MD or NP. If any AE issues were noted by our nurses, then the patient would be seen by an MD/NP. The new schedule takes away that interim 2 week appt. so we will have to reassess our communication practices. Maybe a phone call to those patients at the two week time point should be instituted.

Let us know your experiences with this practice change.

Virginia

[Anonymous]

Krista,
I spoke with our BMS rep about the potential higher incidence of infusion reactions at the 480 mg dose and was told it was not felt to be an issue. It will be interesting to see what the formal data shows as well.

[Anonymous]

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.

[Mandi Murph]

Thank you, Lisa for sharing the issue with medicare & the 480mg dosing of Opdivo. I will need to bring this to the attention of my financial folks as they have been clearing a bunch of our patients during the past week-mostly medicare pts.

Regarding the time extension, for the majority of our pateints, they were prepared & looking forward to the change in schedule. During trials we did not (are not seeing) any more appreciable side effects (anecdotal).
We really push alot of education up front with the empahasis on pts “calling at the onset of any changes”.
We empahsize that this is the most important job that they are responsible for and we are in the best position to help when we are aprised of any symptomatic changes.
I think this topical issue directly relates to health literacy (current hot topic), and our assessement of each individual patients understanding and potential needs. Our own health literacy proficiency as nurses comes into play with identifying the patient who may not be as adherent vs the one who may be very nervous and need more support have different needs and we as nurses are pretty great at identifying the pt who may need that interim follow up.

[Anonymous]

I was not aware of the medicare issues with reimbursement. Thank you for sharing!

[Anonymous]

Just an update! I’m sure most of us got the memo, but 480 mg dosing is now approved for medicare. I do belive there is a 28 day stipulation on there, so may need to be a little more careful with scheduling.
Best,
Lisa

[Samantha Guild]

I spoke with our BMS reimbursement liaison earlier today and per the company July 1 the reimbursement should have gone through for Medicare.

[Author]

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