The startling increase in the use of opioids has many causes. Two decades ago, health providers perceived that pain was under-treated, and in 1998 the Joint Commission formally recognized pain as the fifth vital sign. At the same time, drug companies developed and promoted a new generation of synthetic opioids, and added extended release as well as abuse deterrence formulations. Doctors prescribed, and patients consumed, these drugs in ever increasing quantities. At the same time, illicit forms of opioids became more widely available and abused. Now, with the harrowing increase in mortality attributed to opioid abuse, it is time to look for new solutions.
As the adverse consequences resulting from opioid misuse became apparent, employers sought the help of pharmacy benefit managers which responded by developing prospective (i.e., pre-dispensing) and retrospective utilization review programs to detect and intervene in unsafe prescribing of these addictive medications. Patients and prescribers who were engaged in unsafe behavior were identified and educated. Other interventions, in the form of member-specific drug limits, dispensing restricted to a single pharmacy, and prior authorization to ensure use for an appropriate diagnosis, were implemented – all programs shown to reduce opioid abuse. These programs had positive effects, but the magnitude of the opioid epidemic continued to increase.
Pharmacy benefit management companies have still more aggressive utilization management techniques to guide physician prescribing, including such tools as quantity limits, step therapy to emphasize generics and restricted formularies. We believe these can be used to bring about more appropriate use of opiates for pain management. However, some prescribers may resist embracing recommended guidelines to address this epidemic at the broad population-level. The American Medical Association (AMA) for example has criticized such programs as heavy-handed, cookie-cutter approaches, and has counseled that providers should be making these decisions on behalf of patients, taking into account individual patient needs. To be sure, prescriber autonomy and respect for the physician-patient relationship are of paramount importance. However, there is little evidence to show that past opioid prescribing habits are necessary or appropriate, and there is a great deal of evidence that they have produced significant harm.
With widespread recognition that more aggressive control was called for, the Centers for Disease Control and Prevention (CDC) assumed the lead, announcing a Guideline for Prescribing Opioids for Chronic Pain in 2016. The CDC Guideline was based on three principles: opioids should be used only when necessary; only at the lowest dose and for the briefest duration needed; and when used, caution should be exercised and patients monitored closely. The Guideline made specific recommendations such as implementing step therapy requiring the use of immediate release formulations before extended release drugs when initiating treatment for chronic pain, avoiding doses greater than 90 Morphine Milligram Equivalents per day, and limiting prescriptions for acute pain to seven days or less. All of these recommendations can be integrated in standard utilization management.
How would implementing such recommendations affect patients and their employers? We have used commercial insurance data to estimate the impact that imposing limits on daily dosing and length of therapy as outlined by the CDC could have on opiate addiction. The evidence suggests that in a given year, at a company with 100,000 employees, 61 employees would avoid addiction if prescriptions were reduced to align with the doses and duration of use consistent with the CDC Guideline. For employers, this translates into substantial health care cost savings, as a person struggling with addiction would have more than $15,000 in additional health care costs a year as compared to a person who is not dealing with substance abuse. Perhaps more important is the incalculable avoidance of human suffering—as certainly any employer would want to prevent the pain and suffering experienced by employees and family members who have lost loved ones to the consequences of addiction.
Pharmacy Benefit Managers’ Role
In the face of such a crisis however, we believe it is time to give greater weight to the CDC Guideline — based on patient care and safety. The CDC Guideline should become the default approach to prescribing opiates, a scenario in which physicians would have to seek exceptions for those patients who need more medication or longer duration of therapy. What is more, pharmacy benefit managers are better placed than others in the pharmacy supply chain to put this approach to the CDC Guideline into practice. Wholesalers have no real contact with patients or payers. Retail pharmacists have opportunities to provide patient counseling about opiates, and are required by the Controlled Substance Act to exercise a “corresponding responsibility” as to whether a prescription was issued for legitimate medical purpose. But when faced with a valid prescription written by a medical professional, it is difficult, and often not appropriate, for retail pharmacists to take it upon themselves to limit prescribing.
PBMs have experience with implementing and enforcing such efforts. Their adjudication systems can enforce quantity limits (both strength and duration) as well as ensure implementation of appropriate step therapy of immediate release formulations before more dangerous extended release opioids are used. Currently, the major PBMs all offer such programs to employers or insurers who “opt in” to the program. Greater gains are possible if PBMs make such programs automatic or “opt out.” In this situation, clients would automatically have the limits built into their plan, unless they did not want them, and in standard PBM practice, few clients tend to opt out.
In the end though, preventing opiate addictions and deaths are one of the core health benefits that payers, employers and insurers, should provide to employees and members. In light of the human suffering and financial costs caused by the current epidemic, a thoughtful, responsible, evidence-based treatment of pain is a service we must provide to our patients. Employing principles sanctioned by the CDC is clearly necessary and prudent.
I personally object to this as another means to give prescribers more work to do which they are not paid for. It’s burdensome, unnecessary and harmful. The CDC published guidelines. Medical boards are following those guidelines for physicians who over-prescribe. Prescribers databases are kept and reviewed. Over-prescribers are identified and asked by medical boards to justify their actions. Inappropriate actions lead to mandated education. Continued inappropriate actions lead to licensure restriction or loss. Why punish the vast majority of good prescribers because of a few inadequate prescribers? Simple. More power to the PBM’s to position themselves between prescriber and patient! It’s unnecessary. PBM’s do NOT examine patients, do not review medical history, do not respond to after-hours calls and are not licensed to practice medicine.
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