Dr. Mitch Freeman, Pharm.D.
Chief Clinical Officer
We will all remember 2020 for its startling impact on everyday life, from new work norms to how we receive medical care. The workers’ compensation and auto casualty industries have grappled with work-from-home requirements, increased unemployment, telehealth adoption and additional challenges with patient care and recovery. When it comes to pharmacy care, the pandemic has brought forth some issues while placing others on the backburner. This review will examine how the COVID-19 pandemic has affected the industry from a pharmacy perspective and what trends we expect to influence 2021.
Download the Mitchell ScriptAdvisor 2020 Clinical Review.
COVID-19 and Pharmacy Programs: Examining the Impact
COVID-19 reshaped healthcare quickly and significantly. The pandemic continues to rapidly evolve and is constantly reshaping the data we used in this review. Therefore, we will provide a quick overview of how certain changes during the pandemic may affect the industry in the coming year along with links to dive deeper into specific trends. For the workers’ compensation and auto industries, challenges arose in the form of unemployment and decreased driving rates. For pharmacy programs, the beginning of the pandemic sparked initial concerns about access to pharmacies, though that was assuaged when pharmacies were deemed essential businesses. To date, overall impacts on pharmacy programs have been less dramatic than first feared, but have sparked some major shifts, including a review of presumption laws, changing case rates, patients turning to mail order and potential treatments for COVID-19.
Presumption Laws
Many states passed rebuttable presumption laws near the beginning of the pandemic, which stated that those who contracted COVID-19 in a range of essential jobs were presumed to have gotten ill from work. Initially, these presumption laws were concerning to the industry, but recent data has suggested that costs associated with COVID-19 illnesses can be relatively minor. Learn more about presumption laws and COVID-19.
Mail Order
For those in high-risk groups, a physical pharmacy visit may be a risk not worth taking. Just like ordering groceries online, shifting to receiving prescriptions through mail order provided a safer option for many patients throughout the pandemic.
Potential Treatments
Countless treatments have been studied (and are still being studied) to determine if there is an effective treatment for COVID-19. While studies and vaccines are still in progress, some drugs are showing initial promise. Learn more about these drugs.
Ongoing COVID-19 Impact
From “long-haulers” who experience symptoms months after contracting COVID-19 to the potentially expanding list of those covered under a presumption law, the COVID-19 pandemic will likely leave an enduring mark on our industry. Listen to our experts’ predictions on how COVID-19 is changing our world in this webinar.
Looking Beyond COVID: Pharmacy Trends for 2021
Some of the issues, challenges and controversies of our industry may have not been center stage in 2020, but they still exist and have been affected by the pandemic. Let’s look at the current data and potential future trends for opioids, medical marijuana, topical medications and therapeutic alternatives.
Opioids
Is the opioid crisis over? In July, the American Medical Association (AMA) asked the Centers for Disease Control (CDC) to revise their guidelines for opioid prescribing because, as the AMA claimed, the prescription opioid epidemic has ended. For those who have been studying the epidemic over the years, the AMA’s comment seems to fall in line with the trends we have seen in prescribing rates. According to the AMA, opioid prescriptions dropped by 90 million from 2013 to 2019, which is more than a 37% decrease. Prescription opioid overdoses, according to the CDC, have decreased over the years as well. However, two major issues have signaled that the opioid crisis is far from over, despite the progress made. First, the increasing use of more dangerous synthetic opioids, such as fentanyl, are leading to rises in overdose deaths. According to the CDC, between 2015 and 2019, overdoses from synthetic opioids rapidly overtook overdoses from other types of opioids and accounted for more than 30,000 deaths by the end of 2019. Secondly, the pandemic has accelerated issues related to drug use and abuse. According to ODMap from the University of Baltimore, suspected drug overdoses have increased 18% since the beginning of stay-at-home orders compared to the same period pre-stay-at-home. An analysis from the White House drug policy office reported that drug fatalities increased more than 11% in the first four months of 2020 compared to the year previous. Stress and anxiety are often catalysts for increased drug and alcohol use, and the pandemic and subsequent lockdowns have caused increases in anxiety, stress and difficulties managing mental health. Although many of these studies look at the beginning of the pandemic, we expect the numbers to increase as the pandemic stretches on. In April, the DEA allowed for prescribing opioids via telehealth without an in-person visit. It is yet to be determined if this has had any effect on prescribing rates, but it is certainly something to continue monitoring. For the industry, although overdoses are not directly related to prescriptions someone may receive in the course of treatment, there is still cause for concern. According to a study by the National Institute on Drug Abuse, “an estimated 4 to 6 percent who misuse prescription opioids switch to heroin and about 80 percent of people who used heroin first misused prescription opioids.” In this regard, the industry still needs to be vigilant about new prescriptions and continue to monitor those claimants who are long-term opioid users. As for prescribing opioids, the industry needs to be aware of stakeholders who may prescribe at higher rates. A study published in the National Institutes of Health found that orthopedists were the most likely of any specialty to prescribe opioids, regardless of the chronic pain diagnosis.
Source: National Institutes of Health
A similar study found that surgeons were among the highest prescribers, with the highest-prescribing five percent of surgeons prescribing 40 to 70 pills per patient on average. The study found that this was largely due to defaults in outdated computer systems and, once those defaults were lowered, the number of pills prescribed also decreased. These trends are important to note as we continue to monitor opioid prescriptions on new claims and determine medical necessity. We expect that the fallout from the pandemic in relation to general drug abuse, and specifically opioid abuse, will continue to ripple throughout the upcoming years. Continue to monitor your pharmacy program with your PBM to identify early opioid use, identify physicians who may be unintentionally overprescribing, monitor claim MED escalation and evaluate any out-of-network dispensing. Also, make sure to check in on long-term opioid patients dealing with stress and isolation, as these can be catalysts for increased drug use and abuse. Case management may be a helpful strategy for those who need additional support.
Medical Marijuana
This year has fueled renewed interest in medical marijuana legalization, from both a legislator standpoint and a constituent standpoint. The pandemic spurred increased sales of marijuana, as many states deemed dispensaries essential businesses and people turned to the drug as a coping mechanism. As states have grappled with budget strains due to the pandemic, marijuana has offered an interesting option for additional tax revenue.
Public acceptance over the years has also grown, with a May 2020 Gallup poll revealing that 70% of surveyed Americans find smoking marijuana morally acceptable, just slightly shy of those who find gambling morally acceptable and ahead of those who find the death penalty morally acceptable.
Legalization efforts have continued throughout 2020, with several states considering or passing new legislation related to legalizing, decriminalizing, expanding qualifying conditions or allowing for temporary prescribing through telehealth. Several ballot initiatives have also been created across the U.S., with activists taking their case to voters. With all this renewed interest, what will the future look like? Despite the continued push for legalization, there are still limited studies on the drug’s efficacy. Here are some findings from recent studies:
Concerns With Marijuana’s Effect on Health and Wellness
One study published in JAMA found that high-potency weed users were more likely to develop generalized anxiety disorder, more likely to use weed at least once per week, twice as likely to have used illicit drugs in the past twelve months and three times as likely to be tobacco smokers. A memo released by the American Heart Association (AHA) warned of potential danger to heart health for users of THC products. According to the AHA, these products could trigger heart attacks, strokes or heart failure. The memo noted that CBD does not appear to cause harm to the heart.
Some Evidence of Pain Relief
A recent analysis of state registry data of 20 states found that nearly 65% of those who received medical marijuana cited pain as their qualifying condition. More than 85% had either substantial or conclusive evidence of therapeutic efficacy. A screening of 1,975 citations, including 72 systematic reviews, found that pain was the most common condition for those using medical marijuana. A small number of studies found that marijuana showed benefit for reducing pain, but overall they were generally inconclusive.
Might Help Reduce Opioid Use
One study published in the National Library of Medicine found a moderately lower rate of opioid use in states that have legalized marijuana. A survey of 9,000 people found that 41% reported a decrease or cessation in opioid use due to marijuana use. About 8% reported an increase in opioid use. 46% reported no change in opioid use. In states with legalized marijuana, one study found that opioid overdoses were decreased. However, a later study found that overdoses actually increased by 23% in states with legalized marijuana. That study concluded that there was no evidence that broad or restrictive cannabis laws were associated with changes in opioid overdose mortality.
Potential Use for Opioid Withdrawal
A 2020 study found that nearly 63% of participants had used cannabis to treat opioid withdrawal symptoms. They reported that the use of marijuana helped to improve anxiety, tremors and trouble sleeping. A small percentage of the group indicated that marijuana actually worsened their withdrawal symptoms.
Auto Accidents Increase in States With Legalized Marijuana
A study found that in states with legalized marijuana, crashes increased by 5.2–6% in comparison to neighboring states without legalized marijuana. Another study found that accident-causing drivers were 3–7 times more likely to have THC in their blood. Those with THC in their blood were twice as likely to be responsible for a fatal crash. Some studies, however, have not found a significant correlation between marijuana use and auto accidents. What most of these studies underline is the fact that little is known about the true effects of marijuana. More wide-range, controlled studies need to be conducted to learn the true benefits or side effects of the drug. Moving forward, we expect legalization efforts to continue. On the federal level, several bills are being considered to de-schedule marijuana or regulate it like alcohol. If these pass, they could open up the ability to study the drug further, which would then allow for better control and regulation of the drug. For your claims, continue to monitor the laws in each state, including court cases, to guide your decisions on the drug. Visit our state-by-state map to learn more about the regulations across the U.S.
Topicals
Topical medications are another area to watch. Although the pandemic likely did not have a large effect on the trend, the increasing utilization of topicals may be exacerbated by physician’s financial strain during the pandemic. Topical medications are particularly concerning in the workers’ compensation and auto casualty industries for their price inflation. A study published in the National Library of Medicine found that, between 2005 and 2016, the AWP of generic topicals increased an average of 273% and the AWP for brand name topicals increased an average of 379%. The largest price increase for a topical within the top 20 topical medications was for a combination cream of nystatin and triamcinolone, which increased 2,529% over the 11-year span. As you monitor prescriptions, it is important to note these key points about topicals:
- Many topicals are available as over-the-counter options with a slight decrease in concentration. These OTC medications can cost as little as one-tenth of the brand name topical while still providing nearly the same efficacy to the patient.
- A slight change in formulary can decrease costs. An example of this would be brand name NuLido Gel versus a generic lidocaine cream with nearly identical ingredients and concentrations. Again, the price of the generic is less than one-tenth of the price of the brand.
- Profit motives often drive increased utilization of brand-name topical medications, not clinical efficacy. Keep an eye out for increased physician dispensing of topicals as well.
It is likely that we will continue to see the growth of topical utilization in the coming year. We recommend that you continue to monitor your program and employ these management strategies:
- Be aware of generic availability and opt for generics when possible.
- Look at the mix of ingredients in expensive topical medications and see if there are more cost-effective options with the same efficacy.
For a deeper dive and more examples of topical medications, visit our latest quarterly drug review on topicals.
Therapeutic Alternatives
High-cost brand products with potential therapeutic alternatives are the last trend to watch as we head into 2021. Therapeutic alternatives are typically generic drugs that have different chemicals than the brand drug but are expected to have a similar clinical effect and safety profile. These expensive brand drugs can show up in the form of multi-ingredient drugs, special dosage forms, compounding kits, varying strengths and extended-release formulations. A classic example of a multi-ingredient drug is Duexis, which is made of the same ingredients as ibuprofen and famotidine. Duexis costs nearly $3,000 per month, whereas ibuprofen and famotidine together cost a little over $30. While Duexis may allow a patient to take fewer pills, the cost is significantly higher for the same clinical efficacy. Extended-release formulations are also particularly costly. A study looking at Medicare and Medicaid spending found that, between 2012 and 2017, prescriptions for extended-release drugs cost the healthcare system nearly $14 billion more than equivalent twice-a-day medications would have cost. Amrix is a good example of an extended release formulation, which is more than $1,000 per month. The generic, regular release cyclobenzaprine costs less than $10. Although the patient may have to take more doses throughout the day, the clinical efficacy is the same and the cost is significantly lower. The pandemic likely had little impact on this particular trend, and we expect it to continue through to 2021 and beyond. Continue to monitor your pharmacy program and watch for these issues:
- Similar ingredients with unique strengths.
- Ingredients in long-acting form (ER, XL, CR).
- Combinations of ingredients that are available separately as generics.
Dive deeper into therapeutic alternatives and see more examples in our recent quarterly drug update.
Direction of Care
All of these clinical trends can be managed in several different ways. One very effective method is using direction of care in states that allow it. By directing care to pharmacies in-network, you can control the dispensing of off-formulary, expensive or dangerous medications. Alternatively, by directing care to in-network physicians, you can help promote the providers treating your claimants are producing the best outcomes and not prescribing dangerous or overly costly medications. Direction of care produces better outcomes for all those involved. This method promotes safety for the injured worker by providing safety checks from the PBM and standardizing safety requirements across all in-network pharmacies. Direction of care also helps insurers control high-cost medications where appropriate. A lack of direction of care can harm local pharmacies as well, by driving care toward out-of-network and out-of-state mail order pharmacies. Read more about the benefits of directed care here.
Practical Guidance for Your Program
As we move into 2021, there are a few key strategies to keep your pharmacy program operating at its best:
- Continue to monitor these trends in your claims with your PBM and identify where key issues are affecting your program.
- Employ strategies with your PBM to control inappropriate prescribing and utilization by leveraging state regulations such as formularies, initiating prescriber intervention and directing care to in-network pharmacies when possible.
- Address out-of-network and out-of-state mail-order pharmacies.
- Communicate with physicians to encourage filling prescriptions at in-network pharmacies.
Post-COVID
Much has changed due to the COVID-19 pandemic, while many trends have not. The pandemic has accelerated some trends, such as opioid abuse and marijuana legislation, while it has likely not influenced the rate of topical or high-cost brand drug prescribing. Overall, the pandemic has led to innovation and rapid adoption of new ways to manage claims, provide care, keep people safe and help people get to their optimal health. What has not changed, however, is our focus on caring for individuals and providing the best treatments for their injuries. We expect the process of doing so will continue to improve in the coming years. To learn more about various trends related to COVID-19 and the industry, such as telehealth, work-from-home and more, visit our mPower site.