Pain-management experts say a new program by pharmacy-benefits manager (PBM) Express Scripts to curb promiscuous opioid prescribing means well, but usurps the clinical judgment of physicians about individual patients.
Under the Express Scripts program, dispensing pharmacies will, among other things, limit patients new to opioid therapy to a 7-day supply for their first prescription no matter whether their pain is acute or chronic and regardless of what the physician’s prescription says.
Also, the default prescription will be for short-acting opioids. To obtain long-acting opioids for a first-time user, a physician needs prior authorization. Getting such permission also will be necessary for continuing opioid therapy beyond the initial 7 days.
“While the intent may be to help, I think the policy is somewhat misguided in its mandatory nature,” said Charles Argoff, MD, a professor of neurology at Albany Medical College, New York, in an interview with Medscape Medical News. “The point is, they’re practicing medicine.”
Patrice Harris, MD, who chairs the opioid task force for the American Medical Association (AMA), told the Associated Press that the program was “a one-size-fits-all approach.”
“The AMA’s take has always been that the decision about a specific treatment alternative is best left to the physician and the patient,” said Dr Harris, a member of the AMA’s board of trustees.
Express Scripts counters that the opioid abuse epidemic demands a new strategy.
“We actually agree the doctor-patient relationship is critical, but we had 33,000 deaths from opioids in 2015,” said Steve Miller, MD, the company’s chief medical officer, in an interview with CBS Radio. “The approach that’s been taken is not working.”
The Express Scripts program is especially making waves because the company is the nation’s largest PBM, managing the pharmacy benefits of some 83 million Americans in a variety of health plans. Its response to the opioid abuse epidemic comes on top of a similar program already underway at CVS Caremark, the second-leading PBM.
In addition to limiting the initial supply of opioid analgesics in its new program, Express Scripts sets the daily dosage at no more than 200 mg morphine-equivalent dose (MED) per day. Daily MED equals the morphine-milligram equivalent (MME) of all opioids someone’s likely to take within 24 hours.
The dosage rule comes into play when a physician is prescribing opioids for someone already using such medications. When a patient exceeds 200 mg MED per day, Express Scripts will send a safety alert to the physician, who may not know the patient’s opioid level, the company says. The physician may decide that for safety’s sake, the patient shouldn’t have any more opioids. But if the physician believes the additional medication is necessary, he or she can submit a prior authorization request.
Physicians also will receive point-of-care electronic messages alerting them to a patient’s misuse and abuse of opioid analgesics, as well as visits to multiple prescribers or pharmacies.
CDC Guidelines Were a “Strong Foundation”
The company is rolling out its so-called Advanced Opioid Management program on September 1, but only for beneficiaries whose health plans have enrolled in it so far. Medscape Medical News asked Express Scripts how many of its members would be in the program, but did not receive an answer. The program does not include cancer patients or patients receiving hospice or palliative care.
Express Scripts spokesperson Jennifer Luddy told Medscape Medical News that the company tested its new approach in an in-house pilot study of more than 100,000 patients who had never taken opioid painkillers before. “We observed a 38% reduction in hospitalizations and 40% reduction in emergency room visits in the intervention group vs control group in 6 months of follow-up,” Luddy said.
The new program isn’t identical to the pilot study. According to a company news, “Express Scripts added novel opioid management features addressing other points of the care continuum, from safe disposal, to tools for physicians at the point of care and safety checks for dispensing pharmacies.”
Opioid prescribing guidelines issued by the Centers for Disease Control and Prevention (CDC) for primary-care physicians in 2016 constituted a “strong foundation” for its new program, according to Luddy. Among other things, the CDC recommended that for patients with acute pain who are starting opioid therapy, clinicians should match the pill supply to the expected duration of pain, which should rarely exceed 7 days. Patients with acute pain should receive short-acting opioids, as should those with chronic pain, at least initially. With either kind of patient, clinicians should start with the lowest effective dosage and think twice about increasing it to 90 mg MME or above.
Company’s Pilot Study Never Published
With its prior authorization process, Express Scripts doesn’t close the door to physician discretion. However, physicians interviewed by Medscape Medical News complain that prior authorization not only poses an administrative burden but also can delay patient care by as much as 2 or 3 days.
“It can limit the physician’s ability to manage the patient,” said Steven Stanos, DO, president of the American Academy of Pain Medicine (AAPM), in an interview with Medscape Medical News. Dr Stanos noted that prior authorization requirements are piling up on specialists in his field.
For its part, Express Scripts has invested millions of dollars to computerize and streamline this permission process for physician and patient alike, according to company spokesperson Jennifer Luddy. The Express Scripts portal for prior authorization syncs with the physician’s electronic health record system “for improved workflow,” she said. There’s also a browser-based portal for those who want that option.
Dr Argoff at Albany Medical College also worries about administrative hassles that the Express Scripts program may create, but he has an even bigger objection to the initiative. “Their policy isn’t evidence-based,” he said.
Dr Argoff is skeptical, for one thing, about the evidence ungirding the CDC guidelines that inspired the Express Scripts program, calling it a mixture of weak and strong. He also questions the value of the Express Scripts pilot study that the company touts. The description of the study on the Express Scripts website is sketchy, he said.
“We don’t know about the population of patients that were studied,” said Dr Argoff, the director of the Comprehensive Pain Management Center at Albany Medical College. “We don’t know if these people had other substance-issue risk factors — alcoholism, cocaine, marijuana. We don’t know anything about this group.”
Such details would appear in an article in a peer-reviewed journal. However, the Express Scripts pilot study was never published, according to Luddy.
It’s also not clear what the intervention group in the study experienced that the control group didn’t. Express Scripts said the intervention group received an educational letter, and a subset of these patients who had high-risk patterns of opioid use also received a telephone call from a pharmacist. There’s no mention of opioid-naive patients receiving an initial 7-day supply. Medscape Medical News asked Express Scripts whether the pilot study restricted the first opioid prescription for the intervention group in this way, but did not receive an answer.
Preaching to the Pain-Medicine Choir?
For Edward Michna, MD, a board member of the American Pain Society, the Express Scripts program provokes professional chagrin about his profession’s track record in opioid prescribing.
“The bottom line is, if doctors did the right thing, we wouldn’t need all these third parties practicing medicine,” said Dr Michna in an interview with Medscape Medical News.
His comment echoes what former CDC Director Tom Frieden, MD, MPH, pronounced in 2016 when the agency introduced its opioid guidelines: “The prescription overdose epidemic is doctor-driven.”
That said, Dr Michna believes that physicians are becoming better educated about opioids. The AMA’s Dr Harris also said physicians are turning the corner. “Physicians continue to make strides in making more judicious prescribing decisions — evidenced by a 17% nationwide decrease in opioid prescriptions since 2012,” she said in a statement emailed to Medscape Medical News.
Dr Harris noted that more people are now fatally overdosing on heroin and illicit fentanyl than prescription opioids, a point made by some physicians who feel blamed for the opioid-abuse epidemic.
Express Scripts is preaching to the choir when it comes to pain-management specialists, who account for only 3% of opioid prescriptions. They agree that when these drugs are indicated — and there are plenty of alternatives for treating pain — clinicians generally should prescribe the lowest effective dose for the shortest possible duration, as opposed to a month’s supply for a backache that clears up in a few days.
“The problem with excessive amounts of opioids is that patients don’t use all the pills, and they end up in the medicine cabinet,” said the AAPM’s Dr Stanos. “Then someone abuses them or diverts them to the street.”
The recurrent complaint among physicians is that CDC guidelines have essentially become hard-and-fast rules in the Express Scripts program. Physicians may have reasons for departing from the rules on prescription duration and dosage and the requirement for short-acting opioids.
“It’s all about individualized care,” said Dr Michna. “An educated physician dealing with a properly educated patient — they should be making these decisions.”
Follow Robert Lowes on Twitter @LowesRobert
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