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ASCO in Action Podcast

May 14, 2019

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Welcome to this ASCO in Action podcast. This is ASCO's podcast series where we explore policy and practice issues that impact oncologists, the entire cancer care delivery team, and most importantly, the patients we care for, people with cancer. My name is Cliff Hudis. And I'm the CEO of ASCO, as well as the host of this ASCO in Action podcast series.

For today's podcast, we're going to do something a little different. We don't have a guest today. Instead, we're going to spend some time going over a quick update on an important clarification issued recently by the CDC, the Center for Disease Control and Prevention, and specifically, their guidelines for prescribing opioids for chronic pain, a very topical issue.

The clarification they issued was the form of a letter from the agency to ASCO, as well as to ASH and the NCCN. And in this letter, the clarification affirmed that the CDC guideline was never intended to deny access to clinically appropriate opioid therapy for patients suffering with acute or chronic pain from conditions like cancer and sickle cell disease.

But I want to explain first why it was important that they issue this clarification and then talk about what we have to do next. Opioid abuse in the United States is clearly a very serious issue. And the tremendous toll that it's been extracting on individuals and families across the nation is well-reported. Indeed, it was one of the reasons originally given for the passage of the 21st Century Cures Act. In fact, one of the motivations had to do with addressing some parts of the opioid crisis.

And so this just makes the point that finding a solution to the problem is among the very highest priorities that government and really the general public, as well as professional societies and advocacy groups and all stakeholders, have to be working towards.
However, we do have to, at the same time, be careful that we don't overreach and cause additional harm, especially to vulnerable populations, as we take steps to reduce opioid abuse. What happened before was that there was a misinterpretation of the opioid prescribing recommendations that had been issued by the CDC.

And this resulted in part in new laws and regulations, as well as third-party payment policies that severely limited essential pain medications from patients with cancer and sickle cell disease. The consequence for them was suffering and even more prolonged hospitalizations and health care expenses.

So the challenge here was to fix this mistake. As we talk about how this happened, I want to take a moment and provide a little bit of background on this. Last spring, about a year ago I think, there were papers published, at least one in particular, that highlighted seeming discrepancies-- and I emphasize the word seeming-- between opioid use guidelines that had been issued by the CDC, the NCCN, ASCO, and others.

To their credit, the NCCN, led by Bob Carlson, responded to this by reaching out to us at ASCO and asking if we would be willing to collaborate on a meeting of the minds to identify what was true and not true in terms of those supposedly conflicting guidelines and then issue some sort of a unified statement to help address the situation.

In November of 2018, hosted here at ASCO headquarters, representatives from ASCO, the National Comprehensive Cancer Network or NCCN, the American Society of Hematology, ASH, and the CDC met to discuss the similarities, as well as the differences, among our various published respective guidelines in the area of managing chronic pain. We also discussed how to more clearly communicate to all of our respective memberships how and when practice guidelines should be applied in patient care.

While discussing the CDC guideline, it became very clear to all of us that it was necessary to issue at some point a clarification on the question of where the CDC guideline applied to patients with cancer and sickle cell. And indeed, the first action item we took after this November meeting was that ASCO, ASH, and the NCCN sent a letter to the CDC asking for clarification.

We're really happy, again, to report that this collaboration worked. Very soon after they received this letter from us, the CDC responded favorably. And in their response letter, they noted that their guideline, that is, the CDC's guideline, was initially developed to provide recommendations for primary care clinicians who prescribe opioids for patients with chronic pain outside of active cancer treatment, outside of palliative care, and outside of end of life care.

So I want to pause for just a second and make very clear the aim of their original publication was primary care docs, not oncologists or hematologists, and the patients they were talking about were by and large not the patients who are seen and cared for in oncologists' offices. So the letter really did clarify that the CDC's guideline was never intended to deny clinically appropriate opioid therapy to any patients with acute or chronic pain from conditions like cancer and sickle cell disease.

But instead, it was intended to ensure that physicians and patients consider all safe and effective treatment options for all patients with pain. And underneath all this remained the shared goal of reducing inappropriate use. Beyond this, the CDC also noted that the treatment guidelines from disease-specific experts-- and that means ASCO, NCCN, and ASH-- should be the guide to treatment and reimbursement decisions in the specific circumstances they cover.

So let's just spend another 30 seconds on this idea. They did issue a guideline. It does apply to the general population. They never intended for it to apply to cancer patients or sickle cell patients. And they further called out in a sense the primacy of the disease special list in terms of the guideline priority.

So it's great that we got this clarification. It's wonderful news. But I would submit to you that it's really just the first step towards ensuring that our patients don't suffer needlessly. So with this clarification in hand, we can and I would say we must act swiftly to correct existing policies that have already resulted in some areas in blanket restrictions on opioid prescribing, again, based on a misinterpretation over application of the CDC guideline. Every single day that goes by, there are Americans who are experiencing debilitating pain that could be avoided with appropriate treatment. We have some evidence for this. In 2018, as you may know, the American Cancer Society Cancer Action Network, that's ACS CAN, reported that 30% of cancer patients and survivors said that they were unable to obtain their prescribed opioid medication because of insurance denials. And that was a significant increase almost threefold from the 11% reported in 2016.

So if you remember what we were talking about a moment ago, here's a set of guidelines that come out. They're not meant to be applied to cancer patients. And yet, we saw that as they were being misinterpreted and misapplied, there was a tripling in the number of patients reporting trouble getting indicated medications, and I mean cancer patients.

Furthermore, 48% of individuals with cancer reported that their options for pain management were being limited by laws, guidelines, or insurance coverage denials. So this was, again, an external hand influencing their care coming from outside of their doctor's office.

And even in states that exempt patients undergoing cancer treatment, there are significant administrative hurdles that are delaying access to much needed pain relief, not to mention that such exemptions often excluded cancer survivors. And survivors can have chronic pain for years sometimes from the disease or treatment. And without that exemption, they would, in fact, be suffering in a way that should be avoided.

So it goes without saying, but I'll say it, that we really appreciate the CDC's leadership on this complex crisis. The agency has rightly noted that the opioid epidemic will continue to need ongoing collaboration and leadership. And we all need this as we work towards resolving the crisis. But they also acknowledge the importance of making sure that cancer patients and patients with sickle cell disease get the care and caring that they need and they deserve.

I'll also point out that the US Food and Drug Administration plays an important role in advancing the use of evidence-based prescribing guidelines so that they are able to more accurately and appropriately direct the prescription of opioids. Former FDA commissioner Dr. Scott Gottlieb recognized this. And we look forward to continuing this important partnership with acting FDA commissioner Dr. Ned Sharpless.

I think it's fair to say that the opioid crisis requires a response that protects the public, limits abuse, and ensures access for individuals who live with severe chronic pain. That's a vulnerable group. Clinicians, legislators, regulators, insurers, guideline developers, and patients have to join forces to make sure that we establish sensible, evidence-based approaches that confront opioid abuse but do not add a new group that suffers unnecessarily. We don't want to have one national crisis become two.

So I want to close by extending my deepest appreciation to NCCN and ASH for collaborating with us to address this critically important issue and to ensure that our respective members are able to provide the highest quality care that their patients expect and deserve.

If you want more information on our efforts to ensure access to appropriate pain control for patients with cancer and our other policy priorities, please visit ASCO in Action on our website at all one word. And until next time, I thank you for listening to this ASCO in Action podcast.