Chronic Insomnia Treatment and Medicare Part D: Implications for Managed Care Organizations

The elderly population is of particular concern with regard to insomnia and managed care. Early intervention and management of insomnia as a chronic disease are recommended. Increased awareness of the negative clinical and economic consequences associated with not treating insomnia may serve to raise the perceived importance of having effective formulary options for this disease area. Because the elderly population is now covered by Medicare Part D, health plans previously without a Medicare drug benefit must now select and reimburse for sedative-hypnotics for the elderly. A review of the major Medicare Part D plans’ formularies reveals they offer a limited number of sedative-hypnotic alternatives, but not all are available. Due to variable response, variation in comorbidities, drug and disease interactions, and individual patient needs, managed care organizations should cover a reasonable array of drugs. This is essential to optimally manage patients with chronic insomnia to reduce the long-term clinical morbidity and economic consequences.

(Am J Manag Care. 2007;13:S121-S124)

According to the National Institutes of Health State-of-the-Science Conference Statement, chronic insomnia is defined as “complaints of disturbed sleep in the presence of adequate opportunity and circumstance for sleep.”¹ About 30% of the general US population complains of sleep disruption,¹ and an estimated 10% to 20% suffer from chronic insomnia.² Similar rates of insomnia have been described in enrollees in managed care organizations (MCOs).^3,4 A population of particular concern with regard to insomnia and managed care is the elderly, who are at higher risk for insomnia, with up to 47% being affected.^4,5 Because this population is now covered by Medicare Part D Voluntary Prescription Drug Benefit Program, health plans previously without a Medicare drug benefit must now select and reimburse for sedative-hypnotics for the elderly.

The impact of chronic insomnia on managed care likely varies depending on if and how the disorder is managed. Intuitively, when compared with no treatment, overall costs should be reduced and quality of life should be improved with the use of individually selected pharmacologic and nonpharmacologic therapies shown to improve clinical outcomes. Research suggests that, if left untreated or not treated adequately, insomnia may develop into a chronic disease.⁴ Additionally, the disease is strongly correlated to other chronic diseases (eg, osteoarthritis, rheumatoid arthritis, coronary artery disease, endstage renal disease, gastroesophageal reflux disease) and may aggravate hypertension, heart failure, or dementia.⁴ Also, insomnia may be a precursor of certain psychiatric disorders, as it predates the emergence of disorders such as anxiety and depression, suggesting that early intervention may prevent psychiatric morbidity.^2,6 As a result of these correlations, many clinicians recommend early intervention and management of insomnia as a chronic disease when patients are first diagnosed. While it is unclear if insomnia is a cause, effect, or solely a correlate of the above-listed comorbidities,⁷ early treatment may be the most cost-effective approach⁸ compared with prolonging management, inadequate treatment, or no treatment at all. Given the potential for insomnia to develop into a disorder or to act as a correlate with other diseases, insomnia warrants the attention of MCOs, including those affected by Medicare Part D.

The total direct healthcare cost of insomnia has been estimated at $14 billion in 1995.⁵ Because insomnia can be a costly disorder (both for the patient and the payer), a closer look into the current state of Medicare Part D and insomnia is worthwhile. This article briefly describes the history of Medicare Part D, examines the current state of the larger managed care plans within Medicare Part D in regard to insomnia, and explores future considerations for Medicare Part D and the treatment of insomnia.

Medicare Part D: 2006 to Present

MCOs are increasingly more concerned about clinical outcomes and their total healthcare costs and less concerned about the CMS oversight of their formularies. Still, if MCOs deviate from the USP guidelines, plans must have clinically justifiable reasons. Increased awareness of the negative clinical and economic consequences associated with not treating insomnia may serve to raise the perceived importance of having effective formulary options for this disease area. Medicare Advantage Prescription Drug Plans and pharmacy drug plans may generally understand the need to individualize insomnia drug therapy; however, they may sacrifice treatment options to control costs. To assess how plans have incorporated the voluntary USP guidelines and to determine similarities among Medicare Part D programs, the largest, most popular individual plan formularies were reviewed.

A review of the published formularies of 5 large Medicare Part D programs revealed several similarities (Table). The 5 large Medicare Part D plans represented in the table supported multiple benefit designs, each with its own formulary and copayment structure. One typical benefit example was used to illustrate sedative-hypnotic drug coverage practices; neither the most strident nor the richest formulary was selected from each plan. Typically, in the Medicare Part D formulary format, tier-1 medications were generic, tier-2 medications were brand name, and tier-3 medications were specialty medications (both brand and generic). Some plans carried a 4-tier format, which translated into tier 1 for generic medications, tier 2 for preferred brandname medications, tier 3 for nonpreferred brandname medications, and tier 4 for specialty medications. Some plans provided specific dollar copay amounts for tiers 1 and 2, then converted the copay to a coinsurance in tier 3 or 4. The options were usually tiered, meaning patients willing to pay higher costs generally received greater therapy options, and lower costs offered more limited therapy alternatives or greater out-of-pocket costs. Plans usually offered 2 or more drug therapy options for chronic insomnia.

Most reviewed plans covered generic zolpidem on tier 1 and brand zolpidem IR on tier 2. Some plans covered chloral hydrate as a tier-1 option; however, it was unclear how commonly this was prescribed. None of the 5 large plans covered ramelteon or zolpidem CR, and few plans covered zaleplon. None of these medications required preauthorization nor was subject to step-edits. Plans typically had 2 drug options; only 1 plan offered 3 drug choices. In addition, while quantity limits of less than 30 units per month may conflict with the management of insomnia as a chronic disease, most plans reviewed imposed quantity limits (eg, 14 or 25 units per 25 days), possibly to minimize misuse or abuse. Interestingly, ramelteon–which has no abuse potential–is not covered by the reviewed plans. Some plans also limited availability of sedative- hypnotic medications via mail service due to limit constraints and shipping concerns. Although most plans offered at least 2 therapeutic choices, choosing a sedative-hypnotic other than chloral hydrate or generic zolpidem would lead to a higher copayment or could delay therapy through a stepedit or reduced supply (due to quantity or duration limits). All plans had a policy and procedure by which patients could request an exception to the formulary, and some plans even offered a 31-day “emergency supply†for a patient switching from another Medicare Part D prescription drug plan that did provide coverage. The assumption was that the patient would either switch medications to one that was covered or would apply for an exception. It was unclear how many medications were switched, how many exceptions were accepted, or how many beneficiaries ended up paying out of pocket.

Outlook and Future Considerations

- Will the lower tier status of generic sedativehypnotics result in greater use by patients

- Does patient variability in sedative-hypnotic response support a broad, inclusive formulary?

- What is the appropriate duration of use, and how do we measure drug therapy clinical outcomes of chronic insomnia?

- How can formularies be constructed that are responsible to the physiologic changes in the elderly?

Chronic insomnia occurs commonly in the elderly, alone or as a comorbid condition, and should be managed as a chronic disease. Patients with chronic insomnia require long-term management, and may have drug interactions and comorbid disease interactions that impact insomnia treatment choices. A review of the major Medicare Part D plans' formularies reveals that they offer a limited number of, but not all are available, sedative-hypnotic alternatives. Due to variable response, variation in comorbidities, drug and disease interactions, and individual patient needs, MCOs should cover a reasonable array of drugs. This is essential to optimally manage patients with chronic insomnia to reduce the long-term clinical morbidity and economic consequences.

Address correspondence to: Thomas J. Bramley, PhD, Senior Director, Xcenda, 1528 Preston Street, Salt Lake City, UT 84108. E-mail: tommy.bramley@xcenda.com.1. National Institutes of Health State of the Science Conference statement on Manifestations and Management of Chronic Insomnia in Adults, June 13-15, 2005. Sleep. 2005;28:1049-1057.

3. Hatoum HT, Kania CM, Kong SX, Wong JM, Mendelson WB. Prevalence of insomnia: a survey of the enrollees at five managed care organizations. Am J Manag Care. 1998;4:79-86.

5. Roth T, Roehrs T, Pies R. Insomnia: pathophysiology and implications for treatment. Sleep Med Rev. 2007;11:71-79.

7. Martin SA, Aikens JE, Chervin RD. Toward cost-effectiveness analysis in the diagnosis and treatment of insomnia. Sleep Med Rev. 2004;8:63-72.

9. Bach PB, McClellan MB. The first months of the prescription- drug benefit. A CMS update. N Engl J Med. 2006;354:2312-2314.

11. USP Model Guidelines Expert Committee; US Pharmacopeia. Narrative review: the US Pharmacopeia and model guidelines for Medicare Part D formularies. Ann Intern Med. 2006;145:448-453.

Attachment/7b35430a-44cb-48e4-ac3d-62fa1ce85929/oid6075.pdf. Accessed July 10, 2007.

14. Centers for Medicare & Medicaid Services (CMS) call letter 2008. http://www.cms.hhs.gov/PrescriptionDrugCovContra/Downloads/CallLetter.pdf. Accessed June 25, 2007.

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