Betahistine Appeal Letter.
To Whom it may concern;
I am writing this letter to support an appeal to cover an essential medication, betahistine. Betahistine is a
medication used throughout the world for treatment of vertigo due to Meniere’s disease and related
conditions. It combines reasonable efficacy with minimal side effects. (Benecke et al., 2010; Bradoo,
Nerurkar, Mhapankar, Patil, & Kute, 2000; Gananca, Caovilla, Gazzola, Gananca, & Gananca, 2011; Ihler
et al., 2012; Jeck-Thole & Wagner, 2006; Lacour, van de Heyning, Novotny, & Tighilet, 2007; Lezius,
Adrion, Mansmann, Jahn, & Strupp, 2011; Mira, 2001; Redon et al., 2011; Stambolieva & Angov, 2010;
Strupp et al., 2008)
This medication has been very effective in my patient, but recently coverage was denied.
The letter states that the change in coverage was being made to address safety concerns regarding an
outbreak of fungal meningitis. This makes no sense -- Contaminates in an injectable steroid have no
relationship at all to betahistine, which is simply a powder that is “compounded” by placing it into a gelatin
capsule.
There is also a statement that the FDA “does not verify the quality, safety and/or effectiveness of
compound medications made from bulk chemicals”. Of course, the FDA did review Betahistine in 1999,
and approved it ONLY for use in compounding pharmacies. The FDA minutes are available online.
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/pharmacycompounding/uc
m290733.pdf
The only active ingredient in betahistine capsules is the betahistine itself. We have seen some
suggestions that betahistine is not covered because it contains a “yellow dye”. This is illogical as most
medications contain a dye.
There are no reasonable substitutes for betahistine, as it has a unique mode of action. The alternatives
could harm my patient because they are sedating as well as have potential side effects of confusion and
urinary retention. These include antivert, benzodiazepines, and anticholinergic drugs.
Please cover my patient’s continued use of Betahistine
Sincerely,
[Type text]
References:
Benecke, H., Perez-Garrigues, H., Bin Sidek, D., Uloziene, I., D, K., Sondag, E., & Theeuwes, A. (2010).
Effects of betahistine on patient-reported outcomes in routine practice in patients with vestibular
vertigo and appraisal of tolerability: experience in the OSVaLD study. Int Tinnitus J, 16(1), 14-24.
Bradoo, R. A., Nerurkar, N. K., Mhapankar, J. B., Patil, S. F., & Kute, D. G. (2000). Management of acute
vertigo with betahistine. Indian J Otolaryngol Head Neck Surg, 52(2), 151-158. doi:
10.1007/BF03000335
Gananca, M. M., Caovilla, H. H., Gazzola, J. M., Gananca, C. F., & Gananca, F. F. (2011). Betahistine in
the treatment of tinnitus in patients with vestibular disorders. Braz J Otorhinolaryngol, 77(4), 499503.
Ihler, F., Bertlich, M., Sharaf, K., Strieth, S., Strupp, M., & Canis, M. (2012). Betahistine exerts a dosedependent effect on cochlear stria vascularis blood flow in guinea pigs in vivo. PLoS One, 7(6),
e39086. doi: 10.1371/journal.pone.0039086
Jeck-Thole, S., & Wagner, W. (2006). Betahistine: a retrospective synopsis of safety data. Drug Saf,
29(11), 1049-1059. doi: 29114 [pii]
Lacour, M., van de Heyning, P. H., Novotny, M., & Tighilet, B. (2007). Betahistine in the treatment of
Meniere's disease. Neuropsychiatr Dis Treat, 3(4), 441-453.
Lezius, F., Adrion, C., Mansmann, U., Jahn, K., & Strupp, M. (2011). High-dosage betahistine
dihydrochloride between 288 and 480 mg/day in patients with severe Meniere's disease: a case
series. Eur Arch Otorhinolaryngol, 268(8), 1237-1240. doi: 10.1007/s00405-011-1647-2
Mira, E. (2001). Betahistine in the treatment of vertigo. History and clinical implications of recent
pharmacological researches. Acta Otorhinolaryngol Ital, 21(3 Suppl 66), 1-7.
Redon, C., Lopez, C., Bernard-Demanze, L., Dumitrescu, M., Magnan, J., Lacour, M., & Borel, L. (2011).
Betahistine treatment improves the recovery of static symptoms in patients with unilateral vestibular
loss. J Clin Pharmacol, 51(4), 538-548. doi: 10.1177/0091270010369241
Stambolieva, K., & Angov, G. (2010). Effect of treatment with betahistine dihydrochloride on the postural
stability in patients with different duration of benign paroxysmal positional vertigo. Int Tinnitus J,
16(1), 32-36.
Strupp, M., Hupert, D., Frenzel, C., Wagner, J., Hahn, A., Jahn, K., . . . Brandt, T. (2008). Long-term
prophylactic treatment of attacks of vertigo in Meniere's disease--comparison of a high with a low
dosage of betahistine in an open trial. Acta Otolaryngol, 128(5), 520-524. doi: 790554273 [pii]
10.1080/00016480701724912
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