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Reimbursement vs. Indication: Are They Clashing in Alzheimer's Disease?

17. 5. 2020

Data from clinical trials and recommended procedures do not always align with insurance reimbursement criteria. Is this the case with Alzheimer's disease treatment?

The primary drugs used in the therapy of Alzheimer's dementia include memantine and acetylcholinesterase inhibitors. Acetylcholinesterase inhibitors are most effective in the early stages of the disease, but these patients were not reimbursed by public health insurance for a long time. Does this problem exist with memantine as well?

Mechanism of Action

Memantine is a non-competitive antagonist of glutamate N-methyl-D-aspartate (NMDA) receptors. It blocks their chronic hyperactivation, thus preventing the increased calcium influx into neurons that induces apoptosis, considered one of the pathogenic mechanisms in Alzheimer's disease. Clinical trials have shown memantine to be effective in treating Alzheimer's and vascular dementia and in slowing their progression. It enhances cognitive functions, vigilance, daily activities, and by increasing patient autonomy, it reduces the need for caregiver assistance. Memantine is well-tolerated.

Efficacy and Reimbursement Conditions

The efficacy and safety of memantine have been demonstrated in moderate to severe stages of Alzheimer's disease. Placebo-controlled, double-blind, multicenter studies showed effectiveness both in monotherapy (at a dose of 20 mg/day; Mini Mental State Exam – MMSE score 3–14) and in combination with acetylcholinesterase inhibitors (memantine at a dose of 20 mg/day, MMSE score 5–14).

Memantine is reimbursed for patients with a confirmed diagnosis of Alzheimer's dementia with impairment levels expressed according to the MMSE scale ranging from 6–19 points. Treatment with memantine is not reimbursed for patients who do not show objectively demonstrable therapeutic effect (i.e., halting progression or a decrease of less than 2 MMSE points compared to the previous state) after 6, 9, etc., months from the start of treatment. Additionally, it is not reimbursed for MMSE scores < 6 points. For MMSE scores of 18–19 points, memantine is only reimbursed for patients who do not tolerate acetylcholinesterase inhibitors.

Brighter Future

Compared to the past, current reimbursement criteria are much more favorable. In line with recommended practices, it is now possible to use acetylcholinesterase inhibitors in the early stages of the disease and to introduce/add memantine to the medication regimen for patients with moderate to severe Alzheimer's disease.

(dos)

Sources:
1. SÚKL. Memantine Accord. Prices and Reimbursements. Available at: www.sukl.cz/modules/medication/detail.php?code=0194624&tab=prices
2. Sheard K., Hort J., Rusina R. Recommended practices for the treatment of Alzheimer's disease and other diseases associated with dementia. Cognitive Neurology Section of the Czech Neurological Society ČLS JEP, 2018. Available at: www.czech-neuro.cz/content/uploads/2018/03/sheardova-2.pdf



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