Jack West, MD: Options for Treatment and Reimbursement

What are the options for treatment access and reimbursement in this patient?

A corollary of having a remarkably effective therapy like an EGFR TKI in patients with anEGFRactivating mutation is that it becomes important to   get the patient a treatment that is helpful for a long [time]. Fortunately, I have really not seen any difficulty in getting patients a prescribed EGFR inhibitor through various mechanisms. There are some patient assistance programs on various levels, our hospital has one, there are some that are statewide and many of the companies  manufacturing and marketing the EGFR TKIs are committed to getting the patients the drugs;  this can even include patient co-pay assistance or free drugs for a pretty high threshold of household income.

Practically speaking, it generally involves me writing a prescription and working with my pharmacy, and typically a central pharmacy, that handles the distribution. It often will be mailed to the patient’s home directly and mailed again every month. Between my pharmacy and the support staff, as well as the company’s staff, it’s possible to make a pretty straightforward process so that we can almost always get patients the drugs they need within a week or so. It’s never been a big problem.

CASE 2: mNSCLC

Sarah W. is a 58-year old physical therapist from Brooklyn, New York who is also active in a community theater group; her prior medical history is notable for mild GERD controlled with diet and proton pump inhibitor, and hyperlipidemia, controlled with atorvastatin.

She has a 12-pack-year smoking history but quit about 20 years ago after developing a severe respiratory infection. After showing chest x-ray abnormalities on a routine visit to her PCP, she is referred for further evaluation.

Her initial CT scan shows multiple bilateral lung nodules, a large 8-cm mass in the left upper lobe (LUL), suspicious for malignant pleural effusion, and several hepatic nodules

Transbronchial biopsy of the LUL mass shows adenocarcinoma T3 (based on size); biopsy of the hepatic nodules was consistent with metastatic disease, and she was deemed unresectable on surgical consult

Mutational status was reported asEGFRexon 21 (L858R) substitution; no other actionable mutations detected

At the time of diagnosis the patients performance status is 0

Sarah wishes to continue with her normal work schedule and rehearsals for an upcoming community theater production. Her oncologist initiates her on afatinib 40 mg/day.

At her 2-week follow-up, she shows symptoms of increasing diarrhea (≥6 stools/day), which has not improved with antidiarrheals, and a papular rash on her upper arms

Rash is not very itchy or bothersome, however, diarrhea interferes with both her work schedule and rehearsals

Diet modifications and loperamide are recommended for diarrhea, and topical corticosteroids for her rash; she continues therapy at 40 mg/day

At 3 months, while other symptoms have begun to improve, she shows symptoms of gingival stomatitis, and the nursing team recommends diet modifications and a mouth rinse as needed; she continues therapy at 40 mg/day

At her next follow-up, CT scan shows stable disease, with shrinkage in the primary mass and no new hepatic nodules.

Her diarrhea has improved to grade 1 with loperamide and diet; stomatitis and rash have been effectively managed with prior recommendations