Eszopiclone Cost Effective in Long-Term Treatment of Insomnia
May 17, 2005, 19:26, Reviewed by: Dr.
|"Results may vary for different plans, but this study demonstrated that using LUNESTA for the treatment of insomnia may reduce health care costs."
Sepracor Inc. (Nasdaq: SEPR - News) announces the presentation of results from two analyses designed to assess potential pharmacoeconomic benefits associated with the use of LUNESTA(TM) brand eszopiclone in the long-term treatment of insomnia.
LUNESTA is the first and only sleep aid approved by the U.S. Food and Drug Administration (FDA) for long-term use. These data were presented yesterday at the 10th Annual International Society for Pharmacoeconomics and Outcomes Research Meeting (ISPOR) held in Washington, DC.
Forecasting the Impact of Adding a New Drug on Formulary Using Medical Claims Data and Clinical Literature: A Case Study of Insomnia Treatment
Using medical claims and clinical trial data, a budget impact model was developed to help health plans estimate the cost of adding new drugs to their formularies. The utility of the model was illustrated by considering LUNESTA.
Analyses of medical claims and clinical trial data for over 85,000 patients who used several insomnia medications showed that patient costs depend upon drug efficacy. Therefore, total costs for LUNESTA were illustrated by focusing on the drug's efficacy. Total sleep time was the primary efficacy measure considered by this illustration, but it included five other sleep efficacy endpoints that could also be considered by this model, including patient-reported time to sleep onset and number of nighttime awakenings, objective measures of time to sleep onset, sleep efficiency and wake time after sleep onset (WASO; a sleep maintenance measurement of the amount of time spent awake after initially falling asleep).
When using the primary efficacy measure of total sleep time, the model showed that, for a health plan with 100,000 members, introduction of LUNESTA to the health plan's formulary for the treatment of insomnia would decrease total annual expenditures for insomnia patients by approximately $587,881. Health plans may tailor the results of this model to reflect their unique populations by changing the model's assumptions about the proportion of patients between the ages of 18 and 64, the proportion of patients having insomnia and the proportion of patients using other medications. Due to this flexibility, different assumptions could yield different results.
"Results may vary for different plans, but this study demonstrated that using LUNESTA for the treatment of insomnia may reduce health care costs," said Ronald J. Ozminkowski, Ph.D., Director of Health and Productivity Research at Thomson Medstat of Ann Arbor, MI and principal researcher of this study.
Cost Effectiveness of Longer-Term Treatment With Eszopiclone 3 mg in Adults With Primary Insomnia
The second presentation at ISPOR was a decision analytical model that was developed based on the six-month, placebo-controlled trial that assessed the effect of LUNESTA 3 mg versus placebo on various sleep and daytime-function parameters.(1)
The findings from this six-month study were combined with quality of life and cost data from published literature and claims databases. For the purposes of this analysis, patients were classified over time as either "recovered" or "non-recovered" from insomnia based upon a composite index of eight sleep and daytime-function measures recorded during the six- month study.
This model is based on certain assumptions, including the reasonable assumption that the beneficial cost impact of restoring normal sleep is immediate; other assumptions may yield different results.
The results of this model demonstrated that the cost effectiveness associated with use of LUNESTA was comparable to, or better than, the cost effectiveness of broadly accepted treatments for other conditions, such as benign prostatic hyperplasia (BPH), menopausal symptoms, migraine, overactive bladder, irritable bowel syndrome and adult herpes infections.
"For years, sleep medicine experts have argued that chronic primary insomnia is a costly condition and that treating it with pharmacotherapy could be cost effective. This analysis provides, for the first time, some preliminary evidence that this may be true. Long-term treatment with LUNESTA may not only help reduce the symptoms of insomnia but has the potential to do it cost effectively by reducing its direct and indirect economic burden and improving the health-related quality of life of insomnia patients," said Marc Botteman, MSc, Managing Partner, Pharmerit North America and formerly Executive Director of Abt Associates, Inc., both of Bethesda, MD, and lead author of this study.
LUNESTA 1 mg, 2 mg and 3 mg tablets are available by prescription in pharmacies nationwide. LUNESTA is indicated for the treatment of insomnia in patients who experience difficulty falling asleep as well as for the treatment of patients who are unable to sleep through the night (sleep maintenance difficulty).
Data from a landmark, long-term (six-month), double-blind, placebo- controlled safety and efficacy study in 788 patients served as a basis for the FDA's decision to approve LUNESTA for long-term use. Sepracor's six-month study of LUNESTA was the first of its kind for a prescription non- benzodiazepine for the treatment of insomnia.
An estimated 100 million adult Americans suffer from either chronic or occasional insomnia.(2) Symptoms of insomnia include difficulty falling asleep, awakening frequently during the night, waking up too early, an inability to fall back to sleep or awakening feeling unrefreshed.
Important Safety Information
LUNESTA works quickly and should only be taken immediately before bedtime. Be sure you have at least eight hours to devote to sleep before becoming active. You should not engage in any activity after taking LUNESTA that requires complete alertness, such as driving a car or operating machinery. You should use extreme care when engaging in these activities the morning after taking LUNESTA. Do not use alcohol while taking any sleep medicine. All sleep medicines carry some risk of dependency. Do not use sleep medicines for extended periods without first talking to your doctor. Side effects may include unpleasant taste, headache, drowsiness and dizziness.
- Forecasting the Impact of Adding a New Drug on Formulary Using Medical Claims Data and Clinical Literature: A Case Study of Insomnia Treatment
Please visit http://www.sepracor.com or http://www.lunesta.com to access the FDA-approved labeling text for LUNESTA.
Sepracor Inc. is a research-based pharmaceutical company dedicated to treating and preventing human disease through the discovery, development and commercialization of innovative pharmaceutical products that are directed toward serving unmet medical needs. Sepracor's drug development program has yielded an extensive portfolio of pharmaceutical compound candidates with a focus on respiratory and central nervous system disorders. The company's commercialization efforts are carried out by its U.S.-based, 1,250-person, primary care and specialty-oriented sales force. Sepracor's corporate headquarters are located in Marlborough, Massachusetts.
This news release contains forward-looking statements that involve risks and uncertainties, including statements with respect to the safety, efficacy and pharmacoeconomic and other potential benefits of LUNESTA. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: unexpected interruptions in commercial distribution of LUNESTA; the accuracy and reasonableness of the pharmacoeconomic model assumptions; Sepracor's ability to fund, and the results of, further clinical trials; the timing and success of submission, acceptance and approval of additional regulatory filings; the scope of Sepracor's patents and the patents of others; the commercial success of LUNESTA; the ability of the company to attract and retain qualified personnel; and certain other factors that are detailed in the company's annual report on Form 10-K for the year ended December 31, 2004 filed with the Securities and Exchange Commission.
In addition, the statements in this press release represent Sepracor's expectations and beliefs as of the date of this press release. Sepracor anticipates that subsequent events and developments may cause these expectations and beliefs to change. However, while Sepracor may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Sepracor's expectations or beliefs as of any date subsequent to the date of this press release.
LUNESTA is a trademark of Sepracor Inc.
(1) Krystal AD, Walsh JK, Laska E, et al. Sustained efficacy of eszopiclone over 6 months of nightly treatment: results of a randomized, double-blind, placebo-controlled study in adults with chronic insomnia. SLEEP. 2003:26:793-799
(2) Extrapolated to current population from 2000 census based on Ancoli- Israel et al. SLEEP. 1999;22 (suppl 2):S347-S353
To receive a copy of this release or any recent release via fax, call Sepracor's automated news fax line at 1-800-758-5804 ext. 780960 or visit the web site at http://www.sepracor.com.
David P. Southwell
Executive Vice President
Chief Financial Officer
Jonae R. Barnes
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