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Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.
DESCRIPTIONThe intent of the Insomnia Agents generic first program is to encourage the use of cost-effective generic insomnia agents over the more expensive brand agents and to accommodate for use of brand nonbenzodiazepine hypnotics – (Lunesta) and the melatonin receptor agonist Rozeremwhen generic agents cannot be used due to documented intolerance, FDA labeled contraindication, or hypersensitivity. All dosage forms of the brand drugs listed will be included as targets in the program. If the patient cannot be treated with a controlled substance, Rozerem may be approved for use.
A quantity limit of 30 units per 30 days will be in place for the targeted medications.
POLICYBrand Insomnia Agents will be approved when ANY ONE of the following is met:
**If approved, BCBSMS will only reimburse for the same amount as generic zolpidem on prescriptions for Lunesta or Rozerem.
POLICY EXCEPTIONSInsomnia agent generic first program is not required for Federal Employee Program (FEP) and State Health Plan members.
POLICY GUIDELINESInvestigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
01/01/2014: New policy added.
07/30/2015: Code Reference section updated for ICD-10.
02/02/2016: Approved by Pharmacy & Therapeutics (P&T) Committee. Investigative definition updated in policy guidelines section.
SOURCE(S)1. Rozerem prescribing information. Takeda Pharmaceuticals America, Inc. November 2010.
2. Lunesta prescribing information. Sunovian Pharmaceuticals, Inc. October 2012.
3. Sonata prescribing information. King Pharmaceuticals, Inc. April 2012.
4. Ambien prescribing information. Sanofi-Aventis U.S. LLC. May 2012.
5. Ambien CR prescribing information. Sanofi-Aventis U.S. LLC. May 2012.
6. Wilson S, Nutt D, Alford C, et al. British Association for Psychopharmacology consensus statement on evidence based treatment of insomnia, parasomnias, and circadian rhythm disorders. J Psychopharmacology. 2010;0(0):1-25.
7. Silenor prescribing information. Somaxon Pharmaceuticals, Inc. March 2010.
8. Panossian L, Avidan A. Review of sleep disorders. Med Clin N Am. 2009;93:407-425.
9. Kraus, S.S., Rabin, L.A. Sleep America: Managing the crisis of adult chronic insomnia and associated conditions. J Affec. Disord. (2011), doi:10.1016/j.jad.2011.05.014.
10. FDA Drug Safety Communication: Risk of next-morning impairment after use of insomnia drugs; FDA requires lower recommended doses for certain drugs containing zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist). January 10, 2013. Accessed January 17, 2013 at: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM335007.pdf.
11. American Geriatrics Society 2012 Beers Criteria Update Expert Panel. American Geriatrics Society updated Beers criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2012. Available at: http://www.americangeriatrics.org/health_care_professionals/clinical_practice/clinical_guidelines_recommendations/2012. Accessed February 2013.
12. Glass J, Lanctot K, Herrmann N, Sproule B, Busto U. Sedative hypnotics in older people with insomnia: meta-analysis of risks and benefits. BMJ, doi:10.1136/bmj.38623.768588.47 (published November 11, 2005).
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.