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I spoke with our BMS reimbursement liaison earlier today and per the company July 1 the reimbursement should have gone through for Medicare.
We were so excited to hear about the approval! We have had several patients who have been waiting for the approval due to intolerability with Dabrafenib and Tramatenib. We just now need to wait for insurance to update their system to be able to get access to these drugs. The main issue is going to be the same as we see with the other targeted therapies which is high copays for our patients with Medicare part D. Finding sources or assistance programs to help with patients donut holes is always difficult.
We were just discussing this last week. After years of ASCO having huge announcements of positive very influential findings things have slowed down. With the discovery of Ipilimumab and Nivolumab and the BRAF/MEK inhibitors we are almost at a plateau when it comes to new innovations. I am sure there are many more to come but at the moment especially front line clinical trials seems to be limited.
Tissue availability is a large barrier for BRAF testing especially in patients with microscopic foci in a single lymph node. Often times there isn’t enough tissue to test. In these patients we often have to wait and see and if they end up with progressio. Of disease, they have to undergo procedure to procure more tissue. Patient often find distress in this process for they just have found out they have recurrent disease and now have to undergo a procedure for tissue for BRAF testing. If we can we try to at least do a IHC on tissue to see if we can get BRAF results.
I think we are more likely to give immunotherapy adjuvantly. The side affects of dabrafenib especially the pyrexia are very difficult for patients to maintain their normal lifestyle. I think that dabrafenib and tramatenib do have a place adjuvantly with patients who can’t recieve immunotherapy such as those with precious history of colitis or other autoimmune conditions or organ transplant patients.
I agree that the MSLT-2 trial is going to change who gets completion lymph node dissections, this may influence the use of Adjuvant Nivolumab in high risk IIIA that don’t undergo a completion lymph node dissection. Will be interesting to see how these decisions are made in these patients and of surgeons will have more of influence on the decision.
We have had this issue over the last several years. Medicare changed their policy to allow only 4 PETCT scans for a lifetime for a diagnosis. Many of the private payers have followed and only are allowing PETCT scans at initial diagnosis and/or if something it seen with what they determine as conventional imaging. We have found this most difficult in our patients who have subcutaneous or intransit disease for standard imaging doesn’t give us a good representation of their disease status.
Has anyone heard an update on when the FDA will be approving these medications? We have a few patients whose Pyrexia on danrafenib and tramatenib is really signicant and even with various interventions we are not able to keep them consistently on drugs.
We are currently moving most of our patients on both adjuvant and maintained Nivolumab to 4 weeks. It is easier on the patient from a time and financial perspective. They don’t have to take time off of work, find childcare, or have to pay Travel expenses as often. We are keeping patients on he 2 week schedule only if they are complicated or may need a little more frequent visits/monitoring.
We are now required under the OCM rules to meet a certain percentage of survivorship care plans per year. What I find interesting is that Medicare does not recognize stage IV patients as part of the OCM bundle for survivorship.
There is minimal information currently available about immunotherapy survivors in any of the cancers. Studies are needed to look at the finciancial, psychological, spirtitual and emotional long term side effects immunotherapy patients face along with residual physiological side effects.
We really haven’t used it in the adjuvant setting as of yet. We are treating patients mainly either in a adjuvant clinical trial or with Nivolumab. What I found intersting in the adjuvant BRAF study is was there was a higher incidence of pyrexia compared to the metastatic studies. The Pyrexia can really affect patients quality of life which makes it difficult to justify in the adjuvant setting.
I agree that a generalized way of treating patients based on grading alone is not the best method. Patients irAEs can be so individualized. Colitis may not always be diarrhea, it may abdominal pain and constipation. We have also had patients with grade 3 pancreatitis that are asymptomatic and only were diagnosed due to mandatory study labs that didn’t need the high dose steroids recommended by these guidelines.
Currently Nivolumab is approved for 30 min infusion for all melanoma metastic indications as single agent or in combination with Ipilimumab. However, the adjuvant Nivolumab was approved after the 30 min Nivolumab had been submitted to the FDA. Therefore for adjuvant Nivolumab the label states that it should be given over 60 min. There should be an update to the label soon, and adjuvant Nivolumab will be approved for 30 min infusion. There are several studies to support it’s safety in infusing it over 30 min.
LCDs can vary state by state. As Kathy mentioned the New York LCD for Medicare was recently changed. However other states may have different icd 10 codes approved for infliximab. Therefore you should check your states LCD to determine the icd 10 codes that are covered. These are available on the internet if you google the drug name and LCD alone with state you are located in.
The flipped dose clinical trials allow for the Ipillimumab 1mg/kg to be given over 60 min. We have started to do more flipped dozing of Nivolumab 3mg/kg and Ipi 1mg/kg which we are seeing less toxicity with but what appears to be the same response rates to the FDA approved dosing.
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