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

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.

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!

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.

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.

Hi Krista,
These are tough situations with patients receiving adjuvant treatment. Just a few questions, has treatment been with held at all to allow time for resolution? What is the patients level of motivation to continue in light of this persistent irAE which is impacting QOL? Was Sjogren’s considered or investigated with labs?

So taking inventory that:
This irAE being one of the less common one but it is no less impactful that other irAE’s & we don’t know potential long term issues ( ie dental issues)
It can be difficult to treat and and have prolonged resolution
The pt is almost half finished with therapy

My thoughts are; this is adjuvant I would hold treatment allow all toxicity to resolve, let the patient regain the lost weight if appropriate and see if patient can be restarted on therapy to complete a 12 month course of therapy successfully.

Thanks for bringing this challenging case for discussion, Looking forward to your reply!

-Kathy

We have utilized both approaches, by using 1 syringe and changing the safety needle between injections and we have used several prefilled syringes for multiple tumors.Either approach is acceptable, it’s a matter of preference.