Addressing the Importance of Safety When Considering Medications for the Treatment of Insomnia in Older Adult Patients - A Q&A With Derek van Amerongen, MD, MS

AJMC^®: How do you use the American Geriatrics Society Beers Criteria and other types of recommended therapy lists to manage covered therapies for populations of older adult patients?

Editors from The American Journal of Managed Care^® (AJMC^®) spoke with Derek van Amerongen, MD, MS, to discuss coverage of treatments for the older adults with insomnia. He is vice president and medical officer, Humana Health Plans of Ohio; associate professor, Department of Obstetrics and Gynecology, University of Cincinnati School of Medicine; and adjunct professor, Xavier University Graduate School of Healthcare Administration, all in Cincinnati, Ohio.

van Amerongen: When considering medications for any patient population, an understanding of their safety is important, [and that’s] particularly [true] in Medicare members for a variety of reasons. First, as we age, our sensitivities to medications change.^1-4 Second, the population of patients who are on Medicare are much more likely to be on more than 1 medication, and so interactions among various medications must be considered.⁵ Much work has been done to evaluate medication safety in older adults, and resources such as the Beers Criteria⁶ are very helpful for practitioners as well as for Medicare members because [information on medication safety] is compiled into a manageable list of medications that is available to anyone via the internet. Healthcare practitioners should always consult the Beers Criteria before they prescribe medication to their older adult patients with [an eye to] the context of what medications have already been prescribed to the patient. Pharmacists also use the Beers Criteria when performing medication therapy management (MTM). At Humana, because we are focused on helping members understand how they can access information that is relevant to their health and use it in a constructive way to have a better relationship with their healthcare professional, we also help our members access the Beers Criteria. They can look up their own medications to learn how they are scored in terms of safety. Patients can then use this information to engage in discussions with their healthcare professionals about the best medication choices for them. I think it has been a great tool and one of the reasons that we have such strong patient and member satisfaction [at Humana].

AJMC^®: Recently published changes to the Medicare formulary for Humana indicate that zolpidem now requires prior authorization before use, and zolpidem extended-release is now listed as a not-covered medication as well as one to avoid in older adult patients.⁷ The preferred alternatives listed include trazodone and suvorexant (Belsomra; Merck). Can you explain the rationale behind this decision?

van Amerongen: When preparing a drug formulary, consideration of a drug’s clinical efficacy and its safety go hand-in-hand. Medications for the treatment of insomnia in older adult patients specifically mentioned in the Beers Criteria include the nonbenzodiazepine, benzodiazepine receptor agonist hypnotics (Z drugs)—zolpidem, eszopiclone, and zaleplon. These are all listed in red in the patient version of the Beers Criteria, which means they are associated with significant issues, such as memory impairment, delirium, etc, when used in older adult patients. These types of red flags need to be considered. The decision of where to place a drug on formulary is based on medication safety and on evidence from recommended therapy lists like the Beers Criteria, as well as on information from the FDA. [In the case of drugs with safety issues in a certain population,] ideally more than 1 [safer] alternative medication would be listed on the formulary.

Ultimately, the safety of a medication is a critical part of the counseling every member should receive from their healthcare professional. In addition, safety needs to be considered when deciding on a particular clinical scenario for a particular member based on their comorbidities, other medications they may be taking, etc. As an insurer, we need to pay attention to information—well substantiated in the literature—indicating that these drugs need to be very thoughtfully managed.

At the same time, new medications with safety profiles that are as good or better than currently recommended medications and phase 4 data or real-world evidence on existing medications can impact where medications fall on the formulary.

AJMC^®: Was it important that the preferred alternatives in this case had evidence showing safety in the older adult population?

van Amerongen: Safety of our members is always a paramount concern when we are building our formulary. Clinical efficacy is critical, but medication safety must also be validated. In older adult members, especially those who have comorbidities and may well be on other medications, we have to make thorough evaluations to ensure that an effective treatment will not lead to unexpected adverse events. We are then confident that the preferred medications on the formulary offer physicians and our members appropriate choices. Of course, it is always important for the prescribing clinician to carefully assess the member’s situation to be sure a medication is right for that individual, and that the member is fully educated on the risks and benefits of that option.

AJMC^®: Is this type of safety policy specific for Medicare patients?

van Amerongen: Not at all, but there is certainly a heightened awareness of safety in older Medicare patients, particularly when thinking about MTM. [Patients in this population] typically are taking multiple drugs (the industry definition of “polypharmacy” is 5 or more agents) and have multiple comorbidities. There may have been an urgent care visit related to medications they are taking that created a red flag. As people age, chronic conditions emerge. However, among the things we do at Humana is ensure that we are not being hindered by preconceived barriers. In other words, [when making decisions regarding medication coverage,] we do not say, “Let’s not look at people under 65,” or “Let’s not worry about patients who have at least 3 chronic conditions.” Because certainly in some cases, a patient may be younger [than 65 years] and have only 1 condition, but that condition is significant enough that [one of our pharmacists] needs to reach out to the patient and talk about how we can assist with their polypharmacy and do a better job working with their healthcare team. Any patient with Humana who is on a specialty drug will receive a monthly call from a pharmacist to check in, to make sure things are going well, and to ask if their medical status has changed or has had any updates.

AJMC^®: Have you done this type of step-through therapy in any other areas?

van Amerongen: A big focus right now has been around pain management and helping our members understand the most appropriate way to step through various medications to deal with both acute and chronic pain. [Humana] has completed substantial data analyses to understand the challenges our members face regarding pain management. As a result, we have been able to dramatically reduce, for example, the opioid use rate among our members. Over the past 4 years we have seen a reduction of more than 30% in the prescribing rate for opioids. That does not mean we are informing patients that they cannot have anything for pain, but rather we are working to identify more effective and safer alternatives. We are also working to help our members and healthcare providers understand that pain management requires a multifactorial approach that is more complex than just writing a script. By addressing pain management in a more holistic way, patient outcomes are improved and we can have a major impact on the rate of opioid prescription.

AJMC^®: Does Humana have a plan to holistically look at the whole patient in terms of sleep?

van Amerongen: Sleep is a health area, like pain, in which we really try to understand the facets of therapy from a holistic perspective. We then can create a path for both members and healthcare providers that reduces the challenges while still being respectful of the interaction between them.

Good sleep is restorative, restoring and repairing our cells and improving our memory and neurological functioning. At Humana, we have a program called Go365, the largest program [of its kind] in the United States; it has about 4 million members. A large component of Go365 which has been developed over the past few years is a time module on sleep that helps members understand what good sleep is and ways to monitor it.

In the last few years, I personally have really become a huge advocate for focusing on sleep. It’s [an] interesting [development for me] because I learned nothing about sleep when I was in medical school—other than I didn’t get enough of it. In the past 3 to 5 years, though, more research studies are being done about the impact of sleep on patient health, and now, it’s so obvious that if we are not understanding how to ensure that patients are getting good, restful, restorative sleep, within the context of everything else we are encouraging patients to do for themselves—good nutrition, physical activity, avoiding smoking, and managing stress—then we are missing a huge piece of the patient’s health.

We are seeing a societal shift to holding our sleep habits sacred and ensuring good sleep hygiene, which entails having a regular bedtime; sleeping in a quiet, dark room with no screens or light; and maybe having some soft music or white noise to encourage a restful mood. Research has now shown that people with poor sleep hygiene are at a higher risk for heart disease, cancer, diabetes, and even Alzheimer disease (AD).⁸ One of the very early signs of minimal cognitive impairment that ultimately progresses to AD is sleep disturbances. And, the sleep patterns of patients who have moderate-to-severe AD are totally disruptive; some wake up at 2 o’clock in the morning and fall asleep at 1 o’clock in the afternoon.⁸

I wish that every medical student and health professional student in the country would have an entire course on sleep because it’s so incredibly important.

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2. Newman AB, Enright PL, Manolio TA, Haponik EF, Wahl PW. Sleep disturbance, psychosocial correlates, and cardiovascular disease in 5201 older adults: the Cardiovascular Health Study. J Am Geriatr Soc. 1997;45(1):1-7. doi: 10.1111/j.1532-5415.1997.tb00970.x.
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6. 2019 American Geriatrics Society Beers Criteria Update Expert Panel. American Geriatrics Society 2019 updated AGS Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2019;67(4):674-694. doi.org/10.1111/jgs.15767.
7. Formulary changes. Humana website. humana.com/provider/news/pharmacy-news/formulary-changes. Published 2019. Accessed October 11, 2019.
8. Lim AS, Kowgier M, Yu L, Buchman AS, Bennett DA. Sleep fragmentation and the risk of incident Alzheimer’s disease and cognitive decline in older persons. Sleep. 2013;36(7):1027-1032. doi: 10.5665/sleep.2802.

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