Abstract
Background
Because of insufficient data about their benefit–risk ratio in real life, drugs used for Alzheimer’s disease (AD; cholinesterase inhibitors and memantine) were withdrawn from the list of reimbursable drugs in France on 1 August 2018.
Objectives
In this context, this study aimed to investigate the effects of the removal of AD drugs from the list of reimbursed drugs among patients followed in memory centres in France, in terms of prevalence and factors associated with drug discontinuation and evolution of disease management and cognition after drug discontinuation.
Methods
This is an observational study based on data from the National Alzheimer Data Bank (‘Banque Nationale Alzheimer’ [BNA]), which centralizes information about patients consulting in memory centres. The drug discontinuation rate was estimated among patients receiving AD drugs at the last visit before the end of reimbursement. Factors associated with drug discontinuation were investigated among sociodemographic and disease characteristics, as well as among the use of healthcare resources before the end of reimbursement. We compared the evolution of disease management (psychotropic drugs and non-pharmacological interventions) and Mini-Mental State Examination (MMSE) score during the year following the end of reimbursement among patients with a diagnosis of AD.
Results
Among the 19,380 patients of the study sample (62.5% females, mean age 81 years, 86.8% with a diagnosis of AD), 19.5% discontinued their treatment after the end of reimbursement. The main factors associated with drug discontinuation were the type of dementia and lower MMSE level. Compared with patients with a diagnosis of AD, those with vascular dementia were more likely to stop their treatment, whereas those with dementia with Lewy bodies were less likely to discontinue. Among patients with a diagnosis of AD, drug discontinuation was associated with increased use of psychotropic medications, especially antidepressants, and non-pharmacological interventions afterwards, but there was no difference regarding the evolution of MMSE score.
Conclusion
This study provides real-life information about the use of AD drugs after they were withdrawn from reimbursement in France and shows that drug discontinuation was limited among patients followed in memory centres and accompanied by increased use of other healthcare resources.
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Acknowledgements
The authors thank the members of the scientific committee of the BNA who examined and authorized this project, as well as all the memory centres that contribute to the BNA.
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Funding
No funding other than the statutory salary of the investigators (Université Versailles Saint-Quentin-en-Yvelines and AP-HP, Université Paris-Saclay).
Conflict of interest
Marie Herr, Joël Ankri, Capucine Diard, and Anne Hiance-Delahaye have no disclosures to declare.
Ethics approval
The study protocol was approved by the Scientific Committee of the BNA on 18 October 2019 and received authorization from the National Commission for Data Protection on 31 December 2019.
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Availability of data and material
The data from the current study are not publicly available because data are only accessible to investigators after their project has been authorized by the Scientific Committee of the BNA.
Code availability
The code used in the current study is available from the corresponding author upon reasonable request.
Author contributions
MH, JA and AHD designed the study protocol; MH performed the analyses and wrote the first version of the manuscript; and MH, JA, CD, and AHD interpreted the results and approved the final version of the manuscript.
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Herr, M., Ankri, J., Diard, C. et al. Removal of Drugs for Alzheimer’s Disease from the List of Reimbursable Drugs in France: Analysis of Change in Drug Use, Disease Management and Cognition Using the National Alzheimer Data Bank (BNA). Drugs Aging 38, 63–74 (2021). https://doi.org/10.1007/s40266-020-00817-3
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DOI: https://doi.org/10.1007/s40266-020-00817-3