Dr Ray Page Outlines Policy Priorities to Improve Access to Cancer Treatments
Ray Page, DO, PhD, president and director of research at The Center for Cancer and Blood Disorders and chair-elect of the American Society of Clinical Oncology’s (ASCO) Clinical Practice Committee, provides a look at legislation to improve patient access to treatments and address drug pricing in cancer care.
The American Journal of Managed Care® (AJMC®): ASCO has opposed recent right-to-try legislation in Congress—what is the fundamental issue that this legislation wasn’t addressing? Ray Page, DO, PhD (RP): Well, ASCO, they support the use of investigational drugs, but they prefer that it typically be in clinical trials, where you can have good patient oversight, and patient safety. But ASCO also supports the use of investigational drugs outside of clinical trials, but they want to make sure that there is patient safety involved with that.
So, when we look at the legislation that’s out there for right-to-try, ASCO disagrees with the legislation because there’s not enough good patient safety measures there, so it puts the patient at risk of having potential problems. So, part of that involves safety with taking the drugs themselves, because these are experimental drugs—they’re drugs that typically kill cancer, but they also have significant side effects and toxicities that may not be able to be appropriately identified or managed properly. So, the patients risk that if there’s not a good mechanism of oversight, of monitoring adverse events and safety measures, the patients can actually have some adverse physical outcomes.
Also, there’s potential concerns that if they get access to a drug that they’re taking and they’re potentially doing well that they may not necessarily be able to continue to take that drug and get access to that drug in perpetuity as time goes on because there could be dynamics that change with their ability to get access to that drug that’s being offered up as a right-to-try.
Then, the last thing is, if the legislation doesn’t really provide good mechanisms to where somebody is taking an experimental drug through right-to-try and they do run into health-related issues and problems and they have hospitalizations and end up having a lot of diagnostic tests and those kinds of things, whether or not the insurers or payers will be obligated to pay for that as a result of taking those therapies.
So, I think ASCO would like to see stronger legislation that helps protect the patient in the realm of trying these drugs, but also that they have physical safety as well as financial safety.
AJMC®: What’s a better solution that you believe will improve patient access to drugs? RP: The FDA offers access to investigational drugs outside of clinical trials primarily through an expanded access program, and this is often available for people with terminal disease and terminal illness. The FDA has recently streamlined its expanded access program, to where usually better than 99% of patients in that category can get access to drugs and usually it’s within a 4-day period, on average, if it’s not an emergent case. ASCO further supports improvements that exist through the 21st Century Cures Act, and there’s provisions within that act that will help simplify some of the opportunities to be able to get access to some of these drugs.
New policy initiatives should focus on increasing transparency among the pharmaceutical manufacturers, and their expanded access policies. And I think that will ultimately allow better efficiencies between the doctor and patient, being able to get expanded access to drugs that are available out there.
AJMC®: How can Congress help address the increasing unaffordability of cancer drugs, especially as more innovative, highly effective treatments like the CAR T cells continue to come to market? RP: You know, that’s such a difficult question to answer because we’re all experiencing the ramifications of really just high prices of drugs and CAR T cells is one of those examples where you have an effective therapy, but it has tremendous expense associated with it. And it’s difficult because we don’t want to classify therapies to where they’re a luxury treatment, you want to try to be able to have the opportunity to get access to get the right drug to the right patient at the right time. And there’s going to be periods of time when we have drugs and therapies that are very expensive that that’s the right drug for the patient at that time that they should be able to get access to. But then there’s other times when there are cheaper generics and other therapies that do just as well that we can do. But, it’s extremely difficult to try to put an impact on the price curve of the drugs, because they’re just rising exponentially.
But one thing that I can tell you for sure is that the physician, the medical oncologist is not responsible for the rising cost of those drugs. It’s much more of a societal problem and there’s many, many market dynamics there are out there that are contributing to that. So, it’s not just a very easy problem to fix. So, you can’t just say, “Well, we’re going to put the thumb on prescribers and doctors and tell them what they can and can’t prescribe and limit access to certain expensive therapies to cancer patients, and those kinds of things, and that should lower the price of drugs.” Well, that’s not going to happen. Because that’s not the problem.
So, it’s a difficult problem that you’re going to have to get all the stakeholders together to establish meaningful solutions. And the current administration and Congress and pharmaceutical companies and patient advocacy groups, they’re all trying to come together with ways to make an impact on the drug cost problem. But it is not an easy solution.