[Kathleen Madden]

What are some of the barriers that you have encountered with creating these required survivorship care plans? How have you addressed these barriers?

I know in my practice, time is a number one barrier is time both meeting with patients and then entering the required information is the greatest issue. We try to identify patients before they come in for their appointment and will often mail them thier completed care plan.
Additionally, we are working with our IT team to upgrade some of the integration features in our EMR to help make the templating process more fluid, currently the most applicable information is input by hand.

Patients often greet this with appreciation but I often question how helpful this actually is for our patients in the current context to their care and how can we make this more meaningful for them? A work in progress…

[Kathleen Madden]

NEW DOSING OF OPDIVO APPROVED 3/6/18
Opdivo (nivolumab) PI was updated for melanoma to reflect

UNRESECTABLE OR METASTATIC:

-Opdivo 240mg q 2 weeks or 480mg q 4 weeks
– Yervoy+ Opdivo 1mg/kg q 3 weeks x 4 infusions, followed by either 240mg q 2w or 480mg q 4w- maintenance

ADJUVANT:

-240mg q 2 w or 480mg q 4

INFUSION TIMES:
all are approved for Opdivo over 30min

[Kathleen Madden]

No, Krista, we have been fortunate enough that even our most severe cases of pneumonitis have responded to high dose steroids, but I could see how the thought consideration could come up.
I suppose that we may in that instance consider temsirolimus or another anti-rejection med, which would be utilized with a patient who had a lung transplant- like we do with mycophenalate & irAE related hepatitis.

-Kathy

[Kathleen Madden]

Well said ladies, I certainly echo your points on the clinical decsision making. It is going to be great to have another option to enable continuation of therapy. Somtimes this can be confusing for patients, in justifying a switch of therapy, I usually use the analogy of changing blood pressure medications such as a betablocker, within the same category, that usually helps as that analaogy tends to be relatable.

Additionally, I think the role of pt support programs can play a role of initial choice of therapy.

[Kathleen Madden]

We too have been following approval indications, and have been fielding questions from patients. This patient population we have typically been promoting clinical trial options, typically adjuvant vaccines, however some of the adjuvant ICI trials are starting to expanding to include early stage III patients.

On another note, I know that serum marker research is well into development but not ready for release yet. My hope is that advancement with lab markers will assist in evaluating risk for recurrence and help with questions such as this in weighing risks / benefits and lead to other immunologic tests evaluating potentential for irAE’s for all pts but especially early stage adjuvant patients.

[Kathleen Madden]

HI Lisa,
Despite the rampid impact of flu among staff, patients and community we have only had a modest inquiry from patients on ICI’s regarding taking prophylatic tamiflu. Our approach is congruent with that of yours, if at high risk, in a high risk situation (direct care provider for an flu + ill person), or demonstrating early onset sx then we typically are not recommending tamiflu.

Homeopathic approach:
Oscillococinium, 1 vial weekly during flu season, may serve as a respiratory protectant against respiratory aquired illnesses. This can be used in addition to regular good sleep, eating, hydration & stress management habits.
This is not a guarantee just as tamiflu is not a guarantee of not acquiring the flu, but it may reduce risk and will not interfere with other medications.
Oscillo can be found OTC at most pharmacies where homeopathic medications are available.

[Kathleen Madden]

HI Yael,
ICI related hepatotoxicity can be challenging, factors that make it difficult to treat can be an activation of a hepatitis viral infection, a high burden of liver metastases and insuring that there are no obstructions. The liver biopsy that your patient had may be helpful to determine how her liver cells are behaving, especially if therapeutic interventions are not demonstrating effectiveness.
Early on in clinical trials and with challenging cases such as yours, the biopsies often resulted in proliferative lymphocytic activity. Mycophenolate can be useful given by intravenous vs orally concomitantly with continued high dose steroids 2mg/kg. If a patient seems to not be as responsive to methyprednisolone IV, considering a switch to dexamethasone IV ( if not already on dex). These cases can be very tough, most of my patients recovered, but it was a slow and long process that can take up to 8 + weeks.

I am confident that my other colleagues here will have some additional advice or pearls to offer.
The very best to your patient, and if you have any additional inquiries or discussion points, we welcome the continued conversation.

Regards,
Kathy

[Kathleen Madden]

Baseline before or onset of therapy EKG & echo (if pt had a recent one with in several months- will obtain that info) if no echo on file- will send pt for baseline echo, but would not delay start of therapy
2 weeks after start of therapy- EKG
1 month after start of therapy- EKG
2 months after start of therapy- Ekg & Echo if any susupicous sx, prior EKG changes or extensive cardiac history
Typically if a patient is doing well we will then perform an EKG every 12 weeks in cadence with scans
Echo q 6- 12 months

[Kathleen Madden]

November we had 2 new patients revieving TVEC, we had our TVEC reps come in and inservice our housekeeping team as the handling guidelines were updated to reflect a less toxic, less expensive alcohol based cleaner for pharmacy prep & administration room cleaning.
We do still isolate a room and close it until it is cleaned & we do have disposable curtains in that room to stream line the process- we keep one room on our exam room floor prepared with the disposable curtain for any infectiuos issues or for these treatment patients.
PPE: we still gown, glove and wear mask with protective eye shield. All potentially soiled materials are disposed of in red bag waste.
The visit & education session was very helpful from our local rep.

[Kathleen Madden]

Ipi 3mg/kg is still approved for 90 min infusion, however, the FDA just recently approved the nivo in the metastatic setting to be admin over 30 min.

Is anyone using flip dose ipi/nivo?

[Kathleen Madden]

We had a 2 problems this past week (Jan- Feb) achieving a stream line auth for infliximab for 2 pts with grade 4 colitis, steroid refractory. One of our MD’s meet with our financial team & administration.
What emerged from that meeting was the following update & practice suggestion:

The LCD for Medicare was updated 11/1/17 to reflect approval for infliximab
-using the ICD-10 code “K52.1-Toxic Gastroenteritis and Colitis”

. For those patients who do not respond promptly (within 72-96 hours) to therapy with high-dose corticosteroids, Infliximab 5mg/kg may be utilized according to NCCN and ESMO guidelines, and soon ASCO guidelines. It has been included in the BMS algorithms for a decade.
To overcome issues with getting infliximab approved urgently for patients with ICI related diarrhea/ colitis and ensure that the financial team has all appropriate clinical information to obtain insurance authorization, the following is suggested

Clearly document a diagnosis of ICD-10 Code “K52.1-Toxic Gastroenteritis and Colitis” in the following places:

· Progress note for the related encounter
· Problem List
· Diagnosis used for professional billing when you close the encounter

I hope this update will be helpful to all & we will keep you posted with any barriers that we encounter- if any!

[Kathleen Madden]

Thank you so much Krista for the expert GI MD weigh on this topic. I am usually cautious about recommeding adding probiotics when some one is in full grade 4 liquid diarreha. Our rationale is that with the acute inflammation, there are many microscopic openings placing a patient at risk for infection & coupled with the lack of being able to absorb and process medications normally in the gut. Tytpically if our practice adds a probiotic will be when the stools are soft and leaning more toward some form, bland proteins are being better tolerated while on a steroid taper. A slow recovery can also be aided by cholystyramine ( Questran) powder 1-3 x daily to help bulk the stool.

[Kathleen Madden]

Hi Krista,
This has been an ongoing issue for quite some time now. In my experience the greatest chances of success are coding the ICI related diarrhea as ulcerative colitis ( K51.00-51.8- these codes encompass variations on UC + complications), clinical documentation has to reflect the accompanying diagnosis code.
The greatest issue that we encounter are the delays in approval, that a PA may take several days, so if we suspect that a diarrhea situation may be headed toward needing infliximab, we start the auth process in the out pt setting. Sometimes the coding can be an issue and complicate the process if a coder submits the wrong code, based on their interpretation of the clinical information.
If a patient is referred to our ER for immunotherapy induced diarrhea that is refractory to steroids, we have been successful in patients receiving infliximab in the ER.
In patient, we have not experienced the third party payer issues in quite some time, as the patients are correctly diagnosed and coded upon being admitted for ulcerative colitis.

[Kathleen Madden]

I agree with the aforementioned possibilities & considerations. Although, it is a little early for radiation necrosis onset, which usually presents 6-12 months post radiation- but it should still be part of the differential considerations.
Additionally, if a brain MRI reveals no new masses, these symptoms could be related to an early paraneoplastic leptomeningeal disease presentation. While this is uncommon, it often presents with persistent symptoms despite clean imaging. Dexamethasone to manage the symptoms & as long as the patient symptoms are under control, continuation of ICI therapy could be an appropriate course of management. These can be such tough cases, good luck with your patient and thank you for sharing. Looking forward to an update on how he is doing.

[Kathleen Madden]

HI Ladies,

Indeed a very interesting question and conversation. We’ve have had a small number of patients on adjuvant ipi, dependieng upon where patients were at with their therapy determined how we then proceeded. Most completed their 4 induction phases with ipilimumab followed by a year on maintenance and the few who remain more recently have been transitioned to nivo for maintenance. Most new adjuvant patients who don’t either qualify for or want to participate in a clincial trial consider adjuvant therapy with nivolumab.

Just as an aside note, so many changes are occurring so rapidly with dosing and administration that checking the manufacturers website for update PI/ admin info can be helpful.

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