Dr Kirollos Hanna Talks Chemotherapy Shortage Challenges and Solutions

Kirollos S. Hanna, PharmD, BCPS, BCOP, FACCC, director of pharmacy services at Minnesota Oncology, spoke with The American Journal of Managed Care® (AJMC®) about chemotherapy shortages and what Minnesota Oncology does to work around the resulting challenges while identifying which patients need access to the drugs most.

Kirollos S. Hanna, PharmD, BCPS, BCOP, FACCC | Image credit: LinkedIn

AJMC: Can you provide some more insight into the specific challenges that treatment centers are facing due to the cisplatin shortage, and how is Minnesota Oncology dealing with these challenges?

Hanna: Drug shortages are things that we've been dealing with for decades and it really is, to me, a surprise that this far into everything that we have seen and the challenges that we have historically faced, that there hasn't really been a strong legislative push around drug shortages. I mean, we need to figure out a better way to do this. In the grand scheme of things, the generic market is not a strong business—it's not a lucrative business, there's not a lot of margin there—but, unfortunately, the bottom line is many of our generic drugs are the standard of care in treating patients. So we do have to do something around the generic market because immunotherapy, targeted therapy, etc., while it has impacted many disease states, it still hasn't displaced cytotoxic, generic chemotherapy in the grand scheme of things.

And when you look at drug shortages and how you navigate drug shortages, it's challenging. There is no good model in the United States that can help us predict what's to come. There is no good strategy. I mean, we can wake up one morning [and] a major manufacturing facility of a generic product that makes 50% of the United States allocation is all of a sudden having quality control issues, or it's under, or there's a hurricane or a storm, or whatever it may be. These are some challenges that I think we could do a much better job, whether that is more facilities, figuring out various ways [to address challenges], and again outsourcing to other countries.

One of the key challenges that we faced recently is the cisplatin shortage that has gotten a lot of media attention. Now, given the cisplatin shortage, what did we have to do? The FDA went out, they contracted with a company out in China, they brought in this resource, etc. But then again, we're now facing payer challenges and how we're billing all of that, etc. We can clearly implement or think of novel strategies to do things, and I think cisplatin because of how much it was talked about got a lot of media attention, but look where we are today. Vinblastine, a curative intent for Hodgkin's lymphoma, is on shortage; fluorouracil for colorectal cancer patients was on shortage; the cisplatin [shortage] lead to carboplatin shortages; we just recently had another Hodgkin's lymphoma drug on shortage besides vinblastine that's used in ABVD. There are just a lot of things that we're continuing to see, but it doesn't seem like there's been much improvement in the overall process.

Now, again, this is where pathways I think can be limited, and you do need to carve out areas within your institution where going to a different therapeutic approach isn't considered off-pathway. Now that's whether you have a payer relationship or whether you have certain incentives in your institution, because again, if your pathway is recommending cisplatin but you have to go carboplatin and that's not preferred on pathway or whatever it may be, your hands are tied behind your back in the grand scheme of things. One thing that we've done to alleviate some of these shortages within our institution is that we evaluated our quarterly utilization of the top 15 generic drugs. And we have started to build a much more healthy sort of par level, just bare minimum that kind of aligns with your quarterly utilization. Because quarter over quarter, your utilization is not likely to significantly change, but we started to do that, which has sort of helped us in the grand scheme of things.

AJMC: Some physicians have had to resort to alternative treatment strategies and even more expensive novel therapies as a result of the chemotherapy shortage. Is this happening at Minnesota Oncology as well, and you elaborate on the potential impact of these substitutions on patient care and outcomes?

Hanna: Drug shortages have definitely led us to adopt different approaches. In some cases, it's subtherapeutic approaches. The data may recommend one therapeutic modality because that is where the majority of the data is. But then again, from a pharmacology perspective and understanding how these drugs work, some may adopt alternatives that may be subtherapeutic. I'm not really familiar with many approaches within the drug shortage space that have led to a more expensive therapeutic alternative, although I'm sure there might be a handful of patients that could benefit from maybe a slightly higher therapeutic alternative depending on what carve out that looks like. But again, I think really the key thing is that we can't optimally treat our patients if we don't have the drugs that we need, and amidst shortages, depending on the severity of the shortage, we have historically identified subsets of patients that we're going to allocate the drug to—curative intent patients.

Going back to the cisplatin shortage again being one of the things that we recently faced, you look at bladder cancer patients in certain lines of their disease, [and] cisplatin has the best data and it leads to curative intent outcomes. You look at testicular cancer, very, very similar. These young patients have a very long time to live and again you look at like the BEP [bleomycin, etoposide, and cisplatin] regimen or the VIP [etoposide, ifosfamide, and cisplatin] regimen, and a lot of these regimens incorporate cisplatin for curative intent. There's not data around carboplatin; carboplatin has, in some cases, also been inferior.

I think when we go down that route, it's where you start to carve out certain subsets of patients where there is no therapeutic alternative, and that's kind of been the key area where we've had to either allocate per patient depending on the severity. So if we know Bob is coming in for 5 or 6 cycles of chemotherapy, we want to make sure that we have drug X for Bob to meet those number of cycles. Because we also don't want a patient to come in, be treated for 3 or 4 cycles, and then all of a sudden we never know where the trajectory is going to head in terms of a drug shortage and what we're going to be allocated on any weekly or given basis, so then ultimately we have to do it like that in terms of the curative intent natures, etc., where we're allocating to specific patients.

This interview has been lightly edited for clarity.