2005
Primary Health Care Policy Fellowship
Stacy Barnes, MGS
National Association of Geriatric Education Centers
Renee Crichlow,
MD, FAAFP
National Rural Health Association
Daniel Swagerty,
MD, MPH
American Geriatrics Society
Benzodiazepine is a class of medications frequently prescribed for the management of anxiety, panic attacks, seizure disorders, and muscle spasms. Medicare Part D, which begins January 2006, will exclude coverage for benzodiazepines. This is of particular concern for the population eligible for both Medicare and Medicaid (dual eligibles) who currently receive prescription coverage through Medicaid. Potential adverse consequences of excluding this class of medications from reimbursement include: potentially unsafe and riskier alternative drugs, higher costs, and increased morbidity and mortality. Quality care and cost savings can be attained through a specific modification in Medicare Part D.
We recommend that CMS support modification of Medicare Part D in order to continue coverage of benzodiazepines for appropriate clinical indications as specified under current CMS guidelines.
Rationale
CMS has had guidelines in place for the appropriate use of
benzodiazepines since the early 1980’s. The guidelines recognize safe and
appropriate use of these low-cost medications, including management of anxiety,
panic attacks, seizure disorders, and muscle spasms. Common examples of
benzodiazepines are lorazepam (Ativan), and temazepam (Restoril).
It is estimated that 10-12% of nursing home residents and 27% of all dual eligible individuals receive anxiolytics, most commonly benziodiazepines. Exclusion of benziodiazepines from reimbursement would affect more than 200,000 nursing home residents and at least 1.7 million of the 6.4 million dually eligible older adults.1
While Medicaid currently pays for benzodiazepines, Medicare Part D excludes this class of medication from coverage due to concerns regarding safety in older adults.2 Geriatricians, medical experts in the treatment of older adults, assert that benzodiazepines must be made available to appropriately treat the dually eligible population in a timely fashion. CMS has noted that patients may acquire these excluded medications through the exceptions and appeals process which allows authorized representatives or prescribing physicians to request coverage. However, the timeframe for this process is not realistic, especially for nursing home residents who may need the medication faster than the appeals process permits. The cost of excluding benzodiazepines from Medicare Part D reimbursement for the dually eligibles living in nursing homes would be twice what it would be to provide coverage for them.1 When the larger population of dually eligibles is taken into consideration, the costs would be even greater.
Additionally, abrupt discontinuation of benzodiazepines could result in relapse of the condition (63-81% occurrence rate), withdrawal symptoms, and/or death.1,3 Dosages of these medications must be tapered over several months with close supervision. Abrupt discontinuation can also lead to higher costs due to increases in hospitalizations, emergency department visits, and physician visits.
Whereas benzodiazepines are available as low-cost generic formulations, most of these alterative drugs are available only as high cost brand names. If benzodiazepines were excluded from coverage, other higher cost and potentially riskier alternative drugs would be prescribed. The problems with these alternatives are follows:
· Higher cost
Atypical anti-psychotics cost $100-150 compared to $10-15 for benzodiazepines for a 30-day supply to treat anxiety. This may result in a cost difference of $325 million per year.1,5
Anti-depressants, including drugs such as sertraline (Zoloft),
venlafaxine (Effexor), and buspirone (Buspar) cost $30-90 compared to $8-15 for
benzodiazepines for a 30-day supply. Despite higher costs, these alternative
drugs are safer for this population. However, these drugs take 4-8 weeks to
see maximum benefit and patients often need to take benzodiazepines for a
short-term transitional period.4
Sleep medications such as zolpidem (Ambien) cost $70 compared to $10 for temazepam for a 30-day supply to treat sleep disorders. This could result in an increased expenditure of $ 20 million per year.1,4
· Increased mortality
Older adults with dementia experience a two-fold increase in mortality rate while taking atypical anti-psychotics compared to those taking a placebo. The FDA is requesting that drug companies add a black box warning to the labeling of these drugs describing the risks and noting that these drugs are not approved for use in older adults with dementia.5
· Increased morbidity
Older adults with dementia experience a three-fold increase in stroke risk while taking atypical anti-psychotics.6
· Potentially unsafe alternatives
Atypical antipsychotics are not FDA approved for anxiety.
· High-risk alternatives
Drugs such as hydroxyzine (not approved for use by CMS due to serious
side effects in older adults) or herbals such as Kava Kava (associated with
hepatotoxicity) may be prescribed in lieu of benzodiazepines.7
Diphenhydramine and hydroxyzine prescribed for sleep in older adults will lead to increased risk for adverse effects such as falls and confusion.8
Conclusion
Coverage of benzodiazepines under Medicare Part D must be maintained to achieve quality care and cost savings for older adults.
References
1. Stefanacci RG. The cost of being excluded: Impact of excluded medications under Medicare Part D on Dually Eligible Nursing Home Residents. February 16, 2005. University of the Sciences in Philadelphia.
2. Fick DM, Cooper JW, Wade WE, et al. Updating the beers criteria for potentially inappropriate medication use in older adults. Arch Intern Med 2003;163:2716-2724.
3. Noyes R, Clancy J, Coryell BL, et al. Benzodiazepine withdrawal: a review of the evidence. J Clin Psych 1988;49;382-389.
4. http://www.drugstore.com
5. Kuehn BM. FDA warns antipsychotic drugs may be risky for elderly. JAMA 2005;293:2462.
6. Bullock R. Treatment of behavioral and psychiatric symptoms in dementia: implications of recent safety warnings. Curr Med Res Opin. 2005;21:1-10.
7. Clouatre DL. Toxicol Lett. 2004;150:85-96.
8. Fick DM, Cooper JW, Wade WE, et al. Updating the Beers criteria for potentially inappropriate medication use in older adults. Results of a US consensus panel of experts. Arch Intern Med 2003;163:2716-2724.