May 15, 2019
|Clifford A. Hudis, MD, FACP, FASCO
Chief Executive Officer, American Society of Clinical Oncology (ASCO)
|Robert W. Carlson, MD
Chief Executive Officer, National Comprehensive Cancer Network (NCCN)
|Roy Silverstein, MD
President, American Society of Hematology (ASH)
The human tragedy and loss caused by the opioid crisis in America compels bold responses. Policymakers and insurers have introduced measures that aim to reduce inappropriate opioid prescribing and support appropriate use. While we applaud their intentions, we must be careful to not create a new crisis through misguided application of well-intentioned clinical guidelines.
Here’s the problem: based on misinterpretation of opioid prescribing recommendations issued by the Centers for Disease Control and Prevention (CDC), new laws, regulations, and payment policies have been imposed that now deny essential pain medications to patients with cancer and sickle cell disease, who often experience chronic, debilitating and even life-long pain. For example, patients with sickle cell disease six months old through adulthood often suffer from recurrent bouts of severe pain—on top of chronic daily pain—from blocked blood flow, death of bone tissue, leg ulcers, and many other consequences of this life-long disease.
We recently learned of one heartbreaking situation in which a teenage girl with this disease was admitted to a hospital in severe pain only to have her insurance company deny her doctor’s request to administer intravenous opioid medication, the appropriate treatment given her condition. Decisions such as this result in worsening of pain and lengthy in-patient stays, extreme flare up of other symptoms, and undue hardship for patients and their families.
Laws and policies that restrict access to opioid medications by patients with severe pain and life-threatening disorders have clearly resulted in direct harm to vulnerable patients. According to a 2018 survey by the American Cancer Society Cancer Action Network, 30% of cancer patients and survivors reported they were unable to obtain their opioid prescription medication due to insurance denials, up from 11% in 2016. Additionally, 48% of individuals with cancer reported learning from their physician that their options for pain management were limited by laws, guidelines, or insurance coverage denials. Even in states that exempt patients undergoing cancer treatment, significant administrative hurdles are delaying access to much-needed pain relief. Furthermore, such exemptions often do not include cancer survivors and patients with sickle cell disease, who are left to suffer severe pain that could be avoided.
Thankfully, the CDC recently clarified that its opioid prescribing recommendations were not intended for individuals with cancer and sickle cell disease. Rather, the CDC guidelines are meant to guide primary care physicians as they determine the risks and benefits associated with opioid prescribing. Further, CDC has noted that recommendations or guidance from disease-specific experts—such as those developed by NCCN, ASCO, and ASH—should guide treatment and reimbursement decisions in specific circumstances.
With this clarification in hand we can—and must—act swiftly to correct policies that have resulted in blanket restrictions on opioid prescribing based on misinterpretation of the CDC guidelines. Every day that goes by, some Americans experience debilitating pain that is avoidable with appropriate treatment.
We appreciate the CDC’s leadership on this complex crisis. The agency has rightly noted the opioid epidemic will require ongoing collaboration and mentorship as we work toward resolving this crisis while also ensuring our patients get the care they need and deserve.
The U.S. Food and Drug Administration also has an important role in advancing the use of evidence-based prescribing guidelines to more accurately direct prescribing opioids. Former FDA Commissioner Scott Gottlieb, MD, recognized this and we look forward to continuing this effort in partnership with acting FDA Commissioner Ned Sharpless, MD.
The opioid epidemic requires a response that protects the public, limits abuse, and ensures access for individuals who live with severe chronic pain. Clinicians, legislators, regulators, insurers, guidelines developers, and patients must join forces to establish a sensible, evidence-based approach to make sure that one national crisis doesn’t become two.