Oncologists, Hematologists Welcome CDC Clarification on Opioid Therapy for Chronic Pain

Oncologists and hematologists are welcoming a clarification from the CDC about the use of opioid pain relief for patients with cancer, past cancer, or sickle cell disease, and they are hopeful that payers see the update so that patients in pain are not denied or delayed relief.

In 2018, 2 years after the CDC issued voluntary guidelines meant for primary care physicians prescribing opioids for acute pain, physicians across the country started reporting that payers had adopted the guidelines as gospel and were denying opioid prescriptions, or increasing the use of prior authorizations, for patients suffering from pain stemming from cancer treatment, end-of-life care, and other conditions.

The issue picked up steam as organizations like the American Medical Association stepped in; in addition, a viewpoint published in JAMA Oncology said that inconsistency in and lack of evidence were putting patients at risk of inadequate pain relief.

In November, representatives of the National Comprehensive Cancer Network, the American Society of Clinical Oncology (ASCO), and the American Society of Hematology met with the CDC to discuss the complex issue, as clinicians have to decide how to prescribe opioids safely while also being mindful of the potential for dependence and abuse, either by the patient or possibly by those taking care of the patient who might have access to the medication.

Scott Gottlieb, MD, who departed the FDA as commissioner last week, gave a presentation in the beginning, said Judith A. Paice, PhD, RN, who directs the cancer pain program in hematology-oncology at Northwestern University’s Feinberg School of Medicine, in an interview with The American Journal of Managed Care^® (AJMC^®). Stakeholders at the meeting discussed how multiple guidelines for opioid prescribing had the unintended consequence of changing both practice and reimbursement by payers.

In mid-February, the organizations followed up with a letter to Deborah Dowell, MD, MPH, the chief medical officer for the opioid response coordinating unit at the CDC, asking the CDC to release an immediate clarification that the 2016 guidelines were not intended to apply to patients in active cancer treatment.

“Although the CDC guideline clearly states that the guideline is not intended to apply to this population, many payers are still inaccurately applying the CDC guidelines to patients in active treatment for coverage determinations relating to opioids,” the February letter said.

In addition, while the CDC guidelines on pain management are intended to apply to cancer survivors, the organizations said that at their meeting they discussed that for some groups of cancer survivors “the relationship of benefits to risk in the use of opioids is unique and distinct from the needs of other patients with chronic pain. These survivors may have persistent pain due to either past cancer or past cancer treatment.”

On Tuesday, the organizations released a February 28 letter from the CDC that they hope will gain the attention of payers. “The Guideline is not intended to deny any patients who suffer with chronic pain from opioid therapy as an option for pain management,” the letter states.

The guidelines were written in response to rising drug overdose deaths, starting first with increased prescribing of opioids, followed by increases in overdose deaths from heroin and now from illicitly manufactured fentanyl (as opposed to prescription fentanyl, which comes as a patch or lozenge, usually for advanced cancer pain).

The CDC has said that on average 130 Americans die every day from an overdose of opioids, although in 2017 synthetic opioids, or illicit opioids, drove most of the 47,600 opioid-related deaths.

However, Paice said that in her opinion, the clarification does not go far enough.

“I think the guidelines are written in such a way that they exclude cancer patients in active treatment and people at the end of life but that exclude such a wide swath of people,” she said. “What is active treatment?” she added, noting that “some people are on maintenance chemotherapy for years and years and years.” These may include oral chemotherapies or infusions, or women may be on aromatase inhibitors for a decade following breast cancer.

“There are too many gray areas,” said Paice, who was the lead author on ASCO’s 2016 guideline for managing pain in adult survivors of cancer.

It states that chronic pain can be a serious negative consequence for people surviving cancer. Thanks to improvements in treatments, two-thirds of patients with cancer live 5 or more years after a diagnosis. The prevalence of pain in cancer survivors is estimated to be about 40%.

The ASCO guidelines say that “Clinicians may prescribe a trial of opioids in carefully selected cancer survivors with chronic pain who do not respond to more conservative management and who continue to experience pain-related distress or functional impairment.”

The guidelines also note that patients with cancer are not exempt from universal precautions to make sure that opioids are not being prescribed in a situation where there is a high chance that they will be diverted, and they recommend steps to take if someone with a history of current or past substance use who also happens to have cancer needs pain relief; providers should still use risk stratification and adherence monitoring.

The CDC guidelines have also affected patients with sickle cell disease, which begins causing severe pain in childhood and can include both acute and chronic pain simultaneously in adulthood.

In an interview with AJMC^®, Deepika Dabari, MD, a pediatric hematologist in Washington, DC, recalled a young patient in crisis who did not respond to nonopioid or oral opioid therapy at home. As part of the next step, the patient was sent to the emergency department for intravenous opioid therapy there, as well as other medication. When that didn’t work, Darbari sought to have the patient admitted to the hospital for intravenous opioids.

The insurance company denied the first day of care, saying the patient had to try nonopioid treatment first. When Dabari sought a “peer-to-peer” discussion with the physician for the payer on the phone, he refused to budge, saying those were the guidelines.

“Doing a peer to peer takes significant time,” she said. These types of denials are new to her and did not occur before 2016 or 2017, she said. There are multiple reasons why patients with sickle cell may have pain, both acute and chronic, due to pain in the bones, abdomen, chest, spleen, joints, and leg ulcers.

“I think we will have to see if it helps,” Darbari said of the CDC letter. “It gives me something kind of to take back to the insurance company.”

She said she is hoping the clarification will make a difference, noting the burden that prior authorizations and phone discussions have on providers.

Like Darbari, Chad Kollas, MD, a palliative care doctor in Florida, said he too is hopeful that the CDC letter will make a difference. “Much of its impact will depend on the reaction to its release,” he said in an email to AJMC^®.

He agreed with Paice that the CDC clarification is “not strong enough with regard to supporting treatment of cancer pain syndrome in survivors,” but he said he is grateful there is an acknowledgment that opioids may be useful.

The CDC not not immediately return a call or email looking for comment.