By now there should be little doubt that opioid abuse is a significant problem in the U.S. Over the last two decades, drug overdose has overtaken automobile accidents as the leading cause of accidental death in the U.S.1 The Centers for Disease Control (CDC) now estimates that there were 65,000 deaths due to drug overdose in 2017.2
It is fairly common to use the word “exponential” in ordinary conversation when we want to characterize something as growing very fast. But while exponential, or geometric, growth might be nice to see in your retirement account, it can actually be pretty frightening when the thing that is growing is a dangerous problem.
In the Spring of 2017, public health statisticians at the University of Pittsburgh published a paper examining the epidemic of drug overdose deaths in the U.S.3 Using a slightly different methodology than the CDC (accounting for the differing totals), they found that annual drug overdose deaths have increased “on a nearly perfect exponential curve for at least the last 37 years.” 3 Here is what that looks like:
As the red circle indicates, an exponential pattern that persists for nearly 40 years leads naturally to the prediction that the pattern will continue into the near future. By extrapolation, these analysts forecast that in the next five years approximately 300,000 new drug overdose deaths can be expected in the U.S. if the curve is not deflected.3
Fortunately, this outcome is not preordained. We can take action today that can deflect the curve and prevent needless addiction and death.
Unfortunately, there are no simple solutions to such a large, multi-faceted problem. Public health experts agree that only a multi-pronged approach is sufficient to address the prescription opioid epidemic.1
Ordinary Pharmacy Benefit Manager (PBM) utilization management programs that focus on drugs of abuse are not sufficient to combat a problem on such a gigantic scale. Nor can we afford to wait for people to progress from opioid misuse, to abuse, and addiction before we intervene. The problem is accelerating much too fast for this.
At OptumRx, we recognize that attacking such a complex, deeply embedded problem will require a comprehensive approach. Therefore, we are deploying five interrelated strategies we call OptumRx Opioid Risk Management.
OptumRx Opioid Risk Management addresses the opioid epidemic through tightly linked, multi-dimensional efforts that include clinical programs, multiple outreach channels, and multiple member touch points. All of these are needed if we intend to get out in front of misuse, abuse, dependence, and illegal medication sharing before they start, while providing support and treatment for those in need.
Our high-touch, five-prong strategy focuses not only treatment, but also prevention, education, and safe prescribing. To treat at risk and higher-risk populations, we add provider surveillance, high risk identification and intervention, as well as support for those who fall into abuse. Ultimately, our goal is for improved health outcomes and reduced overall health care costs.
The OptumRx Opioid Risk Management engagement strategy addresses opioid-related clinical opportunities across the entire care continuum, as we work to stop the progression from misuse to abuse.
Our clinical rigor, advanced analytics and ongoing monitoring closer to the point of care form the foundation of this program. Our intelligent system automatically flags and identifies members and their prescribers for tailored outreach and interventions.
For a full discussion of all five strategies, please call your consultant or OptumRx representative. In this article we want to focus on just two of the strategies, 1) Prevention and Education, and 2) Minimizing Early Exposure.
Prevention is the key
Given the scale of the problem, there is an urgent need to stop opioid abuse before it starts. These two steps are vital to slowing the exponential rate of increase, and ultimately reducing the number of people who are at-risk.
Looking at the three intervention categories below we find first, all those who use opioids. Next there are those who are new to therapy, followed by those who are beyond their first opioid treatment experience. Among OptumRx members, approximately 65% of those who are prescribed a short acting opioid are considered new to therapy. Of these, 46% are not in compliance with CDC prescribing guidelines.
This image illustrates how we use different data elements and rules algorithms help us target the right people for support:
The 2016 Surgeon General’s report on addressing addiction in the U.S. observes that early intervention is critical to prevent substance misuse from starting.4 And the situation with respect to opioids is especially urgent, as indicated by a recent CDC study showing that people can become dependent upon opioid drugs in as few as 3-5 days.5
Evidence-based prevention interventions, carried out before the need for treatment, are critical because they can delay early use and stop the progression from use to problematic use or to a substance use disorder. The good news is that there is strong scientific evidence that prevention can markedly reduce the costly individual, social, and public health consequences associated with substance misuse.4
It is vital that we focus on preventing new cases of opioid misuse, abuse, or dependency, or we will never be able to get ahead of the epidemic. Consider: An estimated 3,600 people in the U.S. started misusing an opioid pain medication for the first time today.6 Federal statistics show that 12.5 million Americans reported abusing prescription opioids in a single year, while 4.5 million people currently meet the clinical definition of a substance use disorder with prescription pain killers.7,8
Treatment is not enough
For our clients, opioid abuse treatment costs are certainly the key dollar component of the crisis. In the article just linked to, we note the vastly different amounts paid by insurance companies for ordinary (non-opioid-abusing) patients ($3,435) compared to the average $19,333 for patients with an opioid abuse or dependence diagnosis. Overall treatment costs range from over $78 billion to over $100 billion per year, depending on exactly how many we assume may need treatment.9
It appears that treatment is probably top-of-mind for many people when it comes to the opioid problem, not prevention. For example, if we search online for “stopping the opioid epidemic,” the websites for the American Society of Addiction Medicine (ASAM) and their associated coalition are the top non-news media results.10
Looking at the messaging on the ASAM site, we can see that their emphasis is on treatment – not prevention. That’s not terribly surprising, because they represent treatment professionals.
The problem is, the math simply doesn’t support emphasizing treatment over prevention for opioid abuse. There aren’t enough doctors, clinics or dollars in the world to treat everyone who needs it.
We need to remember that prescription opioid pain medications, like hydrocodone and oxycodone, are chemically similar to heroin and have a similar effect on our minds and bodies. The National Safety Council stresses that Opioid Use Disorder (OUD) is a brain disease and a serious chronic health condition, like heart disease or diabetes.6
Access to treatment is key to helping those who have progressed to a substance use disorder such as OUD. And like these conditions, medication and support to make lifestyle changes may be required to effectively treat these patients.6
However, there is nowhere near the treatment capacity to address even the current rates of opioid abuse or dependence. There are shortages of both treatment clinics and of doctors who are certified to administer addiction-fighting drugs (such as methadone or buprenorphine). Clinics in every state are running at or near capacity.6
Clinical capacity aside, about half of all OUD cases are treated in a physician’s office (with buprenorphine).7 But federal law caps the number of patients addiction specialist physicians can treat during their first year of certification. And in any case they are prohibited from treating more than 100 patients at a time.1
The upshot is that even if we assume that all qualified physicians were to provide medication assisted treatment at the maximum level, fewer than half of the currently addicted people could receive treatment.6
In other words, while treating those with OUD is certainly important, in no way does it constitute a complete solution. We can never treat our way out of this crisis.
Beyond the basics
With this thought in mind, we can now turn to examine the role that Pharmacy Benefit Managers (PBMs) can play to reduce prescription drug abuse and diversion. Many PBMs (and insurers with pharmacy services) offer basic controlled substances utilization management programs such as prior authorization and maximum quantity limits per prescription. They may also perform prescription claims reviews to identify individuals, pharmacies and prescribers that may be fraudulently using or dispensing controlled substances.1
The problem with the basic PBM approach is that it is not enough to simply reduce the number of prescriptions filled, although that is important. Nor is it sufficient to look backward in time to identify troubling patterns of behavior, although that is also important.
OptumRx believes that prevention begins with a high-touch engagement strategy that focuses on safe prescribing, opioid awareness, and limiting the supply chain. Together, these strategies will give us a realistic chance to get out in front of epidemic – before it starts.
Let’s take a closer look.
- Prevention & education
The Prevention and Education arm of the OptumRx Opioid Risk Management solution begins with robust member education. Greater awareness helps promote safety as well as prevention. Education includes helping people understand risks, side-effects and alternatives. But it also includes knowing how to control these drugs once they enter our homes. This entails keeping them secure, and disposing of them if left unused.
Our intelligent systems help us to identify the right members closer to the point of dispensing who may need additional education. So we can provide first-fill patient educational mailings for those patients who do end up needing an initial first fill of opioid drugs.
These mailings help to alert patients to the danger of opioids, and provide clearly written guidance for how and when they are to be used, including how to store them, avoiding sharing them, which is called “diversion.” Diversion of opioids is a serious issue: We know that 60% of Americans have leftover opioid painkillers stored at home and 70% of misused/abused opioid prescriptions come from a friend or a relative.1
In addition to the first-fill letter mentioned above, OptumRx also provides access to a member-directed information sheet called Opioid Pain Medications: What you need to know. This informative piece offers clear, readable information on the safe use of opioids, their dangers and safe disposal.
This last point is very important. Members need to educate themselves on how to dispose properly of unused medications at home. In a recent study reported to the 2017 scientific meeting of the American Pain Society (APS), just 16% of post-surgical patients surveyed reported knowing how to properly store their medications. Furthermore, only 11% stored the drugs securely, 22% knew how to dispose of the drugs, and only 4% actually disposed of their drugs.11
In general, member education helps patients and family members realize that changing the use of opioids will require changing their own sense of what is right and appropriate. For far too long, as a society, our mindset regarding demand, consumption, sharing, proper storage and disposal of opioid drugs has been much too apathetic. We need a change in attitude as quickly as possible, as doctors worry that patients have learned to associate the liberal use of pain killing medication with quality of care.12
- Minimizing early exposure
Minimizing early exposure to opioids is another part of our prevention strategy. As a PBM, we can make an immediate and substantial impact by capitalizing on our line-of-sight into prescriptions claims activity in near-real-time. This data is combined with our clinical utilization management (UM) criteria to drive safe prescribing and dispensing.
We now know that a major driving factor of this crisis has been the gross over-promotion and overprescribing of prescription opioid drugs. This includes our nation’s pharmaceutical manufacturers and our prescribing physicians.
Plan sponsors and other payers can no longer sit idly by in hopes that these practices will suddenly change on their own. Rather, the payer community must be open to adopt a more aggressive stance in benefit design and utilization management programs that guarantee compliance with latest best practice safety standards in order to protect their members.
This starts with keeping a tight rein on how many individual pills any one person can obtain, particularly at the outset of opioid treatment, as well as keeping their potency to the absolute minimum. In this respect, stopping opioid abuse before it starts means we need to reduce the sheer number of opioid pills in circulation.
The new clinical standard holds that opioid use is almost always inappropriate, except for cases of active cancer, palliative care, and end-of-life care.13 The most recent CDC guidelines for opioid use state that opioids are not first line therapy. Instead, doctors should prescribe non-drug therapy and non-opioid drug therapy for chronic pain.12 In fact, the latest evidence has convincingly shown worse surgical outcomes for people who do use opioids compared to those who do not.14
Here are just a few of the disadvantages of opioid use – above and beyond the danger of dependence:
- Opioids show increased risk of side effects, including nausea, vomiting, gastrointestinal bleeding, cognitive impairment, and respiratory depression.15
- Opioids impair recovery from injury or surgery. It was commonly believed that by reducing pain in patients, they could resume activity more quickly, and their rehabilitation would be more effective. However, we now know that this is not true. The research shows that administering opioids following an injury actually delays recovery and increases the risk of permanent disability.15
- Opioids offer no added pain relief versus non-opioid alternatives. Many people assume that opioids are the strongest pain medications, and should be used for more severe pain. But the scientific literature does not support that assumption. There are many other treatments that should be utilized for treating pain. Studies have shown that common nonsteroidal anti-inflammatory drugs (NSAIDs)like naproxen or ibuprofen are just as strong as the opioids.16
There are new laws now in place in several US states that limit opioid dispensed quantities to seven day’s supply.1 These are a first step, but are not nearly strict enough. Consider that, in just seven days, a standard dosing regimen calling for 1 to 2 tablets every 3-4 hours for a drug like hydrocodone (Vicodin®) would allow dispensing up to 112 tablets – more than enough to share, sell or even overdose in a patient naïve to such therapy.
This is why our utilization management edits are tightly aligned with CDC treatment guidelines. These new, tighter utilization edits can help slow the growth of opioid use. Here, managing quantity limits on all prescriptions, particularly first-fills, is key.
As such, we need to start thinking of reducing prescribing volume, so we can limit patient exposure to these drugs. We focus in particular on patients who are new to opioid therapy, because the risk of long-term opioid use increases in as few as five days after opioids have been prescribed, while a second opioid prescription doubles the risk that someone will still be using opioids up to a year later.5
In addition, we need to start thinking in terms of units of pain relief, rather than the traditional “X number of days” supply. The new CDC guidelines approach this by promoting what are called “morphine-milligram” dosing equivalents (MMEs).6 This is a numerical standard which allows us to compare the relative potency of different opioid drugs, which in turn makes it easier to evaluate how much risk each patient faces.6
Just to illustrate the impact of the MME standard, we know that the risk of chronic opioid use increases with each additional day of medication supplied, starting with the third day. The sharpest increases in chronic opioid use are noticed with an initial 10 or 30 day supply.5
As described above, nearly half (46%) of all prescriptions for OptumRx members who were new to opioid therapy are not in compliance with CDC 1st-fill guidelines. Further bearing this out, in the same 2017 APS survey cited above, one in four patients had at least 200 unused morphine equivalents left over at 1 month post-surgery.11
These leftover units of opioid drugs can be extremely dangerous. This graph shows that patients who receive high-dose opioid prescriptions face a risk of overdose that is nine times higher than low-dose patients:
At OptumRx, we are programming these new MME dosing equivalents into our Utilization Management edit logic. We have created sophisticated algorithms that calculate, at point of claims processing, the exact MME for every opioid drug on the market today, down to the individual drug, strength, and formulation level. These algorithms will now ensure that a patient newly initiated on an opioid therapy is limited to less than or equal to a seven-day supply of medication based upon CDC dosing guidelines.
Additionally, these edits will monitor patients using these products chronically. The amount of individual drug dispensed is automatically limited to dosage units that are also limited to CDC safety recommendations. These steps will vastly reduce patient exposure to excessive doses from the very first fill that may put them at higher risk of overdose.
In addition, we need to look more closely at those patients who do require opioids immediately after certain procedures.17 There are multiple, critical questions here:
- Do they need to be initiated on an opioid drug at all?
- What quantity and dosing regimen of opioid drug should they be given?
- Do they need to stay on opioids?
- Should they ever be initiated on a long-acting opioid drug?
- If so, for how long? After the first refill? What about after the second refill?
In the past, too often these kinds of patients routinely receive extended regimens of long-lasting narcotics, which is a strong predictor for potential misuse.5 Rigorously adhering to the new CDC Guidelines will help reduce these risks.
Be sure to look for the next installment of our series on the OptumRx Opioid risk Management program, where we will look more closely at how we are using the new CDC Guidelines to execute on the third strategy: Reducing Inappropriate Supply.
While slowing and ultimately ending the opioid abuse problem is a huge challenge, there is reason for some optimism. For instance, we can look at the slow, but steady success we have seen in lowering the death rate from drunk driving: Since the early 1980s, alcohol-related traffic deaths in the United States have been cut by more than half:
In a fascinating coincidence, it has been estimated that reductions in driving after drinking prevented more than 300,000 deaths during this time period – which is exactly the number of additional deaths predicted by a simple extrapolation of the drug-death overdose rate of the last 37 years.3
There hasn’t been any one approach that has resulted in reduced rates of drinking and driving and related deaths. Rather, we have seen multiple policies and enforcement approaches working together that have created awareness of the consequences of drinking and driving. Cumulatively, these comprise well-documented, scientific evidence on the effectiveness of these policies for reducing alcohol misuse and related harms.4
There is no reason to think that we cannot achieve similar improvements in the opioid abuse epidemic. By leading with a robust member education effort coupled with a strong prevention focus on effective utilization management, we can help stop abuse before it starts.
Additional articles will look at OptumRx efforts beyond prevention. We also address the needs of those who have run into trouble using opioids. While OptumRx does not directly treat opioid dependency, we can serve as a critical link in the care delivery system through provider surveillance, high risk identification and intervention. We can even deliver important operational and plan design features that help support and manage those who are afflicted.
These five strategies are designed to work together; not only to control the spread of opioid abuse, but ultimately, to deliver improved health outcomes and lower overall health care costs. Please contact your representative to learn more about how OptumRx is providing the critical leverage to execute the massive structural and behavioral shifts required to end the opioid epidemic.