How Will the Chemotherapy Shortage Affect Health Policy in the US?

Alyssa Schatz, MSW, Senior Director of Policy and Advocacy, NCCN, speaks with the Journal of Clinical Pathways about the current chemotherapy shortage affecting cancer treatment in the US and gives her perspective on how policy makers can make an impact.

Transcript:

Alyssa Schatz: My name is Alyssa Schatz. I'm the Senior Director of Policy and Advocacy at the National Comprehensive Cancer Network, or NCCN.

How will the chemotherapy shortage affect current and or future health policies?

Alyssa Schatz: I think the challenge our policy makers are faced with is how to ensure drugs are affordable, but also safe and effective. We often hear about how the United States overpays for drugs, but that conversation was really related to the brand name market, and generics manufacturers are operating on a razor-thin margin, which can lead to quality and supply issues. And when there are quality issues and a plant shuts down, there isn't capacity within the system to quickly ramp up that production.

So in the long term, I think the issue that policy makers need to grapple with is how to create a market that supports the manufacturing of high quality generics. We also need better information systems so that we understand and can prepare appropriately when there's a threat or a risk of a drug shortage. And finally, when a shortage does occur, there must be infrastructure in place to respond appropriately and ensure timeliness of care. And that may include things like guidance around labor, of prior authorization for appropriate and effective alternative therapies.

What are the current considerations around drug regulations and/or approval requirements that might be reconsidered or reevaluated because of the shortage?

Alyssa Schatz: So in the short term, we know that the FDA is importing these drugs in this urgent crisis, and they are appropriately conducting heightened quality checks and certifications on those drugs. In the long run, this is really an economic issue that policymakers will need to grapple with. But again, that's on sort of the drug regulation side and also the economic side, but we also know that payers have a significant role to play here in supporting their members and easing the pain caused by this crisis.

So when patients in cancer treatment are dealing with a shortage and they need to switch to an alternative regimen, currently providers are still going through a prior authorization process as they're trying to switch to that treatment alternative, which can add unnecessary delays in care. And our survey at NCCN actually found that of those providers that had been going through prior authorization, all of those prior auths were ultimately approved. So we know that they are applying for prior authorization that is appropriate, but it just adds an additional paperwork burden and additional delays in care. So clear guidance from payers around how to handle those alternative treatment plans would be very helpful, I think, right now in improving timeliness of patient care.

How might the shortage impact the ongoing research and development of future oncology treatments?

Alyssa Schatz: If there are currently clinical trials ongoing that use cisplatin or carboplatin in combination with an experimental treatment, drug shortage is certainly concerning in terms of its potential impact on those trials. I will say that I know cancer centers will be doing everything that they can to prevent any interruption to a trial protocol, but we really need to come together to support them in those efforts and to prevent future shortages and the disruption that they can cause in both their care systems and also our research systems.

What, in your opinion, can be done to prevent future drug shortages?

Alyssa Schatz: I think there are a number of ideas that have been floated out there and solutions that different stakeholders are coming forward with to prevent drug shortages. And I think the first and most important thing to remember is that drug shortages are not inevitable. We can come together in partnership to ensure that drug shortages do not occur in the future, but I think it will require solutions that come from multiple stakeholders and are multifaceted solutions.

So solutions that have been floated include having a national stockpile of cancer drugs, critical cancer drugs, for when these shortages may be at risk of happening. Other solutions are around improving our information systems so that we know when a drug shortage might occur. And then there are also economic solutions. People have purport to better support the generic market and their ability to manufacture high quality generics with a robust capacity within the system.

But I think, again, what's really required is for all different stake builders to come together to put forth their ideas on this issue. And it would be ideal for HHS to convene a task force that includes payers and includes healthcare professionals, physicians, pharmacists, includes manufacturers of generics, and includes patients and caregivers so that we can come to the best possible solution.