Drug companies must be especially cautious when interacting with patients and nonprofits. Such interactions must navigate a policy minefield designed to protect patients as well as ensure fair market conpetition.

One example of such policy is regulation that prohibit drug companies from enticing patients to take one drug instead of another. This is important from a medical ethics perspective. However, such policies complicate the process of assisting patients with affording expensive newer drugs like cancer targeted therapies and immunotherapy.

Most patients could not afford to take the expensive ($17K+ per month) FDA-approved drug — like crizotinib, the one that keeps me going as a ROS1 cancer patient — without insurance and copay assistance. This is especially problematic for Medicare patients, who must pay out of pocket to get through the prescription drug coverage “donut hole” every year. I’ll be there soon.

To be fair, and to comply with regulations, patient assistance programs should help all patients access any approved targeted therapy. But who should pay for that? If one drug maker supports such a program, must all makers of competing drugs do so? If only one or two drugmakers participate in the program, does that make it unethical? Does such a program support higher drug prices, or fuel innovation by allowing patients rapid access to new, more effective drugs?

I don’t have the brainpower to answer those questions. I just know that cancer targeted therapy has made a huge difference in my life for nearly seven years, and I want every patient to have the same opportunity to access an appropriate new therapy that matches their biomarker.

The article below explores some of the pitfalls awaiting those who try to help patients pay for expensive new drugs. Sorry it’s behind a paywalll.

Two patient charities settle allegations of helping drug makers pay Medicare kickbacks (STAT News)