Dr Janice Mehnert on Treatment Developments, Payer Coverage for Immunotherapy

I think we’re in a bit of a lull for exciting new therapy developments, likely because the development of the checkpoint inhibitors has just been so extraordinary revolutionary, explained Janice Mehnert, MD, Head of the Phase I Developmental Therapeutics Program at Rutgers Cancer Institute of New Jersey, and the Head of the Melanoma Research Team.

From your vantage point leading phase I studies, what treatment developments excite you the most? 
I think we’re in a bit of a lull for therapies that I’m enormously excited about, and that’s an honest answer. But maybe that’s because the development of the checkpoint inhibitors has just been so extraordinary revolutionary. We are now in an era where we’re trying to figure out resistance. Especially PD-1 resistance—we have a lot of trials open for patients who are resistant PD-1 inhibition. But I don’t know that we have the right strategy to do that as of yet.
Watching some for these inject agents is interesting, weve really  got to pay attention to the endpoints that we’re choosing as we write those tirals. … Otherwise we could end up in a place where we’ve got a lot of promising Phase I agents that look good in small studies but then we get to a larger study and that benefit doesn’t pan out.

We’ve got to be very smart about selecting which strategies we move forward. We have to be very rigorous in how we design and how we test those strategies. And we have to be true to ourselves with the patients we select. It has always been a challenge to enroll patients in clinical trials who will be representative of the patients that will be treated ultimately in the real world. And there’s a number of reasons for that—safety being first and foremost. Nonetheless, as you get more comfortable with new agents, it’s time to be more inclusive with the population that you treat. That’s something we’re going to need to do as we move new agents into development.

How have you seen payer coverage evolve during the time you have treated patients with immunotherapy?
I will say payer coverage for patients where the label may not be 100 percent approved, has been more generous than what I have seen in the past. And I believe that is somewhat encouraging. There’s nothing worse than having a drug that you know is going to be approved any minute, that could really make a difference in a patient’s life, and not be able to get that drug to the patient because the paperwork just isn’t done yet. And we were in that situation with pembrolizumab. We did an expanded access protocol … and even in that window before that [protocol] opened, we were seeing patients that really could have benefited.

But when it’s too frequently available off label, it means patients aren’t enrolled in trials and we don’t get rigorous data. So, there’s a sweet spot in there we need to hit. … I do think it’s been fairly generous; however, I still say it’s very difficult to give patients financial advice about treatment because there’s no way to be able to tell people what their cost of care is going to be up front. A lot of it is very vague. And that is very, very challenging to people who are just trying to hold it all together.

When you think about how life changing a diagnosis of cancer is and how it is just so stressful just to be able to maintain any sense of normalcy. People want to work. They want to be able to do things and maintain a normal life. And yet a lot of times, the financial piece is just as devastating as the clinical piece of this.  
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