David Spigel, MD: Options for Treatment and Reimbursement

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

I’m not saying it never happens but it’s unusual to not get a drug like afatinib for a patient who needs it. In this case, she qualifies for it. She’s got an activating mutation and she meets criteria for it.

The one obstacle for patients and doctors is going to be the co-pay, and so I always tell patients we’re going to submit a prescription to a specialty pharmacy that her insurance uses. Almost certainly it will be a specialty pharmacy they choose, and we’re going to find out what your out-of-pocket expense is. That might mean you get the bottle today and it’s no co-pay or a $5 co-pay, or it might mean that there’s a bigger co-pay and we’re not going to dispense the medication to you until we see if we can get assistance for you through a co-pay organization.

As you know, some patients just fall in this unusual gap where they make too much money to qualify for assistance and yet the co-pays are still quite high. That’s unfortunate. That’s not as common as maybe it used to be but it can still happen.

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