May 13, 2020
In the latest ASCO in Action Podcast, American Society of Clinical Oncology (ASCO) CEO Dr. Clifford A. Hudis is joined by Dr. Ray Page, Past Chair of ASCO’s Clinical Practice Committee and President of the Center for Cancer and Blood Disorders, to discuss the benefit of drug repository programs solely for oral medications that are maintained within a closed system.
These programs can play an important role in helping patients afford their treatment and can reduce the financial toll on the cancer care delivery system, provided that important guardrails are implemented to keep these programs safe.
Subscribe to the ASCO in Action podcast through iTunes and Google Play.
The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.
Welcome to this ASCO in Action podcast, brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content, and offering enriching insights into the world of cancer care. You can find all of the shows, including this one, at podcast.asco.org. The ASCO in Action podcast is an ASCO series where we explore the policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for-- people with cancer.
My name is Clifford Hudis, and I'm the CEO of ASCO, as well as the host of the ASCO in Action podcast series. For today's podcast, I am really pleased to join once again Dr. Ray Page. Dr. Page is a past chair of the American Society of Clinical Oncology's Clinical Practice Committee, he is the President of the Center for Cancer and Blood Disorders where he also serves as a medical oncologist and hematologist, and he's a great and good friend of ASCO's.
Earlier this year, ASCO released a position statement on state drug repository programs outlining the society's support for such programs solely for oral medications and provided that they are maintained within a closed system. ASCO's statement also makes recommendations to help ensure that these programs are implemented appropriately with sufficient patient protections in place.
Today, Dr. Page and I will discuss the important role that these programs can play in helping our patients afford their treatment while reducing the financial toll on the cancer care delivery system as a whole. We will discuss the important guardrails that are needed to keep these programs safe. And with that, I want to welcome you, Dr. Page, and thank you for joining me today.
Thank you very much, Cliff, for having me for this conversation today. And I just want to let you know that I have no disclosures for this conversation.
Thanks again for joining us today, it's a real pleasure to talk with you once more. And I want to get to today's subject. First and foremost, what are state drug repository programs? How do they work and what's the purpose?
In its simplest definition, a drug repository program is basically a legal process that allows unused drugs that have been prescribed to patients to be able to be donated and reused rather than thrown away or set aside if it's no longer needed. Its purpose is to offer a practical way to increase access of prescription drugs for patients. And often, this process can offer more timely access to drugs with a negligible financial impact for the patients. And this was a program that has managed at the state level, and it's subject to individual state laws and State Department of Pharmacy rules and procedures.
And these kind of programs are of exceptional importance to cancer patients who are constantly challenged today with getting affordable access to vital drug treatments for their disease, and these issues are described very well in ASCO's 2017 position statement on the affordability of cancer drugs. And this has all been on the radar of ASCO's State Affiliates Council in recent years where our state society presidents and their executive directors have shared model state legislation to advance these kinds of drug donation programs in their individual states.
So Ray, before we go any further, can you tell me, what does this actually mechanically in practical terms look like at the level of a practice or from the perspective of a patient or a pharmacy? What actually happens physically with product in the context of a repository?
It really varies from practice to practice and state to state, but Cliff, I can tell you that I see this in my own practice absolutely every day in my doctor-patient interaction. And this is really what's gotten me personally intensely interested in pursuing and establishing laws in Texas to allow for pill donation. Because ideally, we would like to have that transaction between the doctor and the patient of being able to get unused drug for those patients where the drug's not used anymore.
And so there's many reasons why in the office, these people don't need the drug anymore. They could have progression of disease that requires new drug, or alternatively, they could have completed their treatment regimens that may have resulted in a cure. But oftentimes there can be interval dosage adjustments due to side effects and toxicities where they just need a new prescription.
And lastly, I just have to mention a little bit about the negative impacts of the pharmacy benefit managers in this world, and I'll refer our listeners to our previous podcast that we did together a few months ago just understanding the global concerns of the PBMs, but however, I'll just say that their drug distribution process oftentimes contributes to the tremendous cancer drug wastage that we have in the United States.
Well, I mean, picking up on that, if readers take a look at ASCO's position statement, they'll see that we identify there the fact that appropriately-implemented drug repository programs can help address some of the cancer drug waste, And if I remember correctly, this was quantified by researchers in New York at Memorial Sloan Kettering Cancer Center. I think they found an estimate of about $3 billion annually.
The question is, exactly what causes this waste? And you alluded to the fact that you see this in your practice as well, but I just want to be really clear and in a practical sense, this waste is that a patient is dispensed-- I'll say, for argument's sake, 60 pills, and has progression of disease or a toxicity-based dosage adjustment and comes back for a routine office visit and still has, for argument's sake, 20 of the pills leftover. And the goal here is to essentially recycle those pills back into the supply, is that right?
That is correct. And so that's the basic mechanism. And as practicing physicians we see this issue all the time, where for the reasons that I explained, there's always unused pills that we don't need anymore. And if there is a mechanism by which we can safely transfer that drug to somebody that can actually use it and need it, there can be substantial positive impact with that for our patients.
And is it only a financial benefit, Ray? Or are there non-financial benefits as well that this repository programs can somewhat mitigate?
Yeah. Well the financial impact of this is huge. The Americans are paying over $61 billion a year in out-of-pocket expenditures for drugs, and drug abandonment can have serious effects on a patient's health leading to hospitalizations, extensive health care cost, and even death. And the British Medical Journal reported an estimated $3 billion in leftover cancer drugs are discarded in the United States every year, and that's truly a tragic impact on our society.
But also, outside of financial, in 2015 the Environmental Protection Agency estimated that about 740 tons of drugs are wasted just by nursing homes every year, and obviously this can't be good for our environment, and we've all heard reports about many of these discarded drugs ending up in our water systems. So redistribution and enabling access to these unused drugs can help alleviate some of these problems that go outside the finances.
Well thank you for that. I mean, high out-of-pocket expenses have been for a long time a serious concern for us at ASCO, and you've I think touched on how this can help reduce them. My question is, are there any pushbacks from patients or providers with regard to these programs? I mean, I can imagine that there might be some bureaucratic overhead that might represent a challenge for small practices or maybe there's some risk associated with it, but I'm just guessing. Is there any clear objection to these that we should be thinking about and possibly working to mitigate?
In general, in my interactions with my patients, most everyone has negligible concern about getting a donated drug for immediate use. There should be informed consent and disclosure, obviously, but the patients generally trust their physicians recommendations and are truly interested in just getting the opportunity to get access to the drugs. From a patient's perspective, I generally think that their greatest concern are just getting quick access to the oral drugs so they can get started on their cancer therapy as soon as possible, often to alleviate active symptoms that they're having, and to alleviate some of the fear of just not getting access to beneficial drugs.
And the physicians I think share that same sentiment of the patients, but in addition, physicians have concern and desires and assurances that these donated drugs are indeed safe for re-distribution.
And Ray, is that what the informed consent would allude to? I was sort of wondering when you said informed consent. In a sense, is there anything different in the informed consent versus what would but with any other cytotoxic prescription, for example? I mean, is there really a way to describe the potential risk or the changes in the risk that there might be some loss of purity in a substance or substitutes? Or-- I'm just trying to figure out what the consent really ultimately conveys.
At least through some of the mechanisms that I'm familiar with that we've developed in Texas is basically there's just a disclosure form that the drug that was in possession of the patient, that they just sign a disclosure that they haven't tampered with it, messed with it, they're stored properly, those kind of things to create those assurances. And then the patient's just given a basically informed consent that they're aware that this transaction has been through a patient and outside the pharmacy.
I see. OK. I mean-- so it sounds to me like we're just, in a sense at a societal level, trying to basically make it clear that there's a theoretical risk of some loss of control, but it's, from a practical point of view, not particularly high, right?
Yes. And I think many oncologists across the United States have just had those experiences with patients in the office that maybe don't have the financial resources, they're looking just for access to drugs. And if there's drug that's available that's been donated, a lot of patients seem to have no problem accepting the drug. And again, I mentioned that a lot of the patients generally trust their physicians' recommendations in that transaction.
Well, I just have to say, I'm as you're talking, I'm reflecting on my own practice experience over the decades. And even for old and inexpensive drugs, it always bothered a lot of my patients that they couldn't simply give their inexpensive tamoxifen, for example, or aromatase inhibitors-- generic drugs, for that matter-- to somebody else in need when they no longer could use it. I think they just were offended by the waste. And even apart from the financial aspects that you've so clearly described, there is, I think, a real altruistic desire to use these drugs and not discard them wastefully, and it's nice to see that there may be the opportunity for patients to satisfy that need.
I agree with you, Cliff. I think there is a strong sense of altruism with our patients. Without a doubt, I think patients have extreme difficulty taking a drug that they know that they-- that the cost of that-- monthly cost of that drug was, say, $12,000 or $16,000, and that they're forced to discard it or flush it in the toilet or turn it in without it being potentially used by somebody else that may be in need, because they've certainly been in those shoes and experienced that themselves.
As you know, ASCO strongly supports repository programs, but we're very focused on oral medications, and we make the assumption that they will be maintained within a closed system. For our listeners, can you describe the difference between a closed system and open system and why we would be favoring a closed system? What makes it safer?
So Cliff, to define a closed system versus an open system, a closed system is a way to have the spirit of having an overabundance of precaution to assure patient safety. And basically, that allows for drugs that are prescribed to a patient and they bring back in that they have appropriate disclosure and supervision, and those drugs are reviewed by a pharmacist and assured that they're safe and able to be recycled according to state laws and pharmacy board rules.
And that's as opposed to an open system where, say, you have a patient that comes into the office and they got a bottle of pills that are unused and they give them to the physician, and then the physician turns around and redistributes those drugs to the next patient who's in need.
I think for many listeners, and probably for even more of our patients nowadays, when they think of cancer treatment, many people are used to thinking about perennial therapies, infusions and the like. But this is really focused obviously on oral medications. What are some of the oral treatments that have been made available? You indirectly alluded to some in terms of price, but what are some of the specific ones that have been successfully made available to patients through drug repository programs so far?
Great question, Cliff. I'll just emphasize it today. Over 40% of cancer therapies that oncologists prescribed are oral drugs, and we have several hundred experimental oral cancer drug that are in clinical trials. So it's anticipated that as time goes on in the future, we're going to be prescribing more and more oral cancer therapies rather than patients spending all day in a chemo chair getting IV infusions. And that's a great thing for our patients.
But currently, I estimate that there's probably over 100 oral anti-cancer drugs and supportive care drugs that are being prescribed to our patients, and these encompass a wide range of treatments, including your classic cytotoxic chemotherapy pills, hormonal agents, molecularly-targeted drugs, and symptom management drugs. And so each state has a drug repository program, has its own pharmacy rules for that redistribution. And in general, most of these drugs, in order to be available, must be in untampered and in secure packaging such as blister packs.
And so most states require inspection by a pharmacist, and therefore, there's a number of great drugs that may not be readily available for redistribution based on state laws and pharmacy rules that are designed to protect patient safety.
Are there other safeguards or any other provisions you think that state drug repository programs could take advantage of to improve their ability to serve patients? Is there anything else we should be doing, you think, as we gain experience with these programs?
You know, Cliff, I'm very pleased that ASCO came out with this position statement in support of the drug depository program that are being developed by each state. And ASCO has provided a few guiding principles for states to consider in their programs, and I think the ASCO recommendations for redistribution in a closed system is in the spirit of an abundance of precaution to assure patient safety.
However, like I said, this can potentially reduce the availability, but ASCO has made some recommendations to the states to where they want to assure that if they're not in a closed system, that the state and federal legislative address the concerns of drug related redistribution that are not in a closed system, that the surplus medications are administered in a safe, effective, and private manner in accordance with the prescribing clinician's guidance.
And the state should have a liability protection in accordance with their state health regulatory authority, and that includes such things as the informed consent and disclosures that we talked about. And then ASCO and other professional medical organizations should continue to make efforts to educate physicians about the existence and the value of these programs, and then ASCO also suggests that this drug repository program should be implemented and no additional cost, or at least as a negligible cost to the patient.
Ray, I think that's great, and I actually, personally and on behalf of the membership and our whole community, applaud you for your activism in this area. Is there anything else that you haven't said that you would want our listeners to know about or have we pretty much covered it all?
Yeah, Cliff, I think there is just a couple of closing thoughts that I want to convey to you. So first, most states allow the redistribution of pills and blister packs, but not pills that are partially used in bottles as we've discussed. But during the last couple of years and again today, I want to implore to the pharmaceutical manufacturers to package their new, often very expensive anticancer drugs in blister packs.
So studies have shown that packaging in this way usually results in improved patient safety and compliance with taking their pills, but most importantly, if for whatever reason those pills are not needed anymore by the patient, the patient or the prescribing institution can donate those pills for redistribution to a fellow patient with a similar cancer. So it's the right thing to do.
And lastly, most states have some form of drug repository program already in their laws; however, unfortunately, most states do not have the program properly turned on. A few states, such as Iowa and Wyoming and Oklahoma, have successful programs working for the patients, but some states have rudimentary programs that need expansion. And then many states need to update their laws and get their programs working again, and this is not an easy process by any means.
I've been working for many years to get a meaningful Texas law passed, which although not perfect, we got a law passed in 2017. And in Texas in the last couple of years, we have been working on the rules and the forms and the processes, and I'm proud to say that my cancer center in Fort Worth is the first registered provider in the state of Texas, and we are currently working with the University of North Texas Health Science Center School of Pharmacy on this, and we've been collecting donated drugs, and we hope that very soon we'll be the first provider in Texas to re-distribute cancer drugs in the state of Texas.
So again, this is not an easy process, but I encourage all states to dust off and modernize their laws to allow cancer patients the ability to get affordable access to drugs through such opportunities as the drug repository program.
Ray, again, I just have to emphasize how deeply grateful I am and I'm so happy to see that you've taken this on and with so much passion. It is hard to understand an argument against this, and that doesn't make it easy, but it's good to be right and it's good to see the effort that you've put into this and to start to see this success. It really does matter to patients as we have been discussing.
So for those of you who want to read more about this, I encourage you to open up ASCO's position statement on drug repository programs. Also there you can find breaking cancer policy news and more, all of that at ASCO in Action. That's on the website at asco.org/ascoaction, remembering that ascoaction is written here as one word.
And until next time, I want to thank everyone for listening to this ASCO in Action podcast. I want to remind you that if you enjoyed what you heard today, we'd love it if you'd give us a rating or a review on Apple Podcasts or wherever you listen. And while you're there, be sure to subscribe so you never miss another episode. The ASCO in Action podcast is just one of ASCO's as many podcasts. You can find all of the programs at podcast.asco.org.