DESK REVIEWS | 07.05.01. Are any antidementia medications approved by National Medicines Regulatory Authority?

DESK REVIEW | 07.05.01. Are any antidementia medications approved by National Medicines Regulatory Authority?

Yes. These are: donepezil, galantamine, rivastigmine, and memantine.

Clinical Practice Guidelines (CPGs) for management of dementia published by the Indian Psychiatric Society (Shaji. et al., 2018) lists the following approved anti-dementia drugs (Cholinesterase Inhibitors):

  • Donepezil
  • Rivastigmine
  • Galantamine
  • Rivastigmine Transdermal Patch
  • Donepezil Extended Release
  • NMDA Antagonist Memantine.
References:

Shaji, K.S., Sivakumar, P.T., Rao, G.P., Paul, N., (2018). Clinical Practice Guidelines for Management of Dementia. Indian J. Psychiatry 60, S312–S328. https://doi.org/10.4103/0019-5545.224472

There is coverage for dementia medications according to the National Formulary 2015 (there are amendments in 2017, 2018 but not affecting Alzheimer’s drugs). Covering is only available for donepezil (classified as anticholinesterase). It can only be obtained at health facilities at level 3 (tertiary hospitals/type A hospitals according to BPJS) and can only be prescribed for mild to moderate Alzheimer’s. Coverage is 30 tablets per month for both film-coated tablets 5mg and for dispersible tablets 10mg.

Most drugs are approved by the National Medicines Regulatory Authority but not included on the essential drug list of drugs in Kenya (Ministry of Health, 2016a) and are unavailable in public facilities. For instance, Donepezil is mostly available in private facilities (Mokaya et al., 2016).

References:

Ministry of Health. (2016a). Kenya Essential Medical Supplies List 2016. Nairobi, Kenya. http://publications.universalhealth2030.org/uploads/KEMSL-2016Final-1.pdf

Mokaya, J., Dotchin, C. L., Gray, W. K., Hooker, J., & Walker, R. W. (2016). The accessibility of Parkinson’s disease medication in Kenya: results of a national survey. Movement Disorders Clinical Practice, 3(4), 376–381. https://doi.org/10.1002/mdc3.12294

 

According to the Clinical Guidance[1] for Cognitive Impairment, the recommended medicines are cholinesterase inhibitors for management of dementia and antipsychotic medications for the management of challenging behaviours (CENETEC, 2017).

[1] Diagnóstico y Tratamiento de la Demencia Alzheimer. http://www.cenetec.salud.gob.mx/descargas/gpc/CatalogoMaestro/393_IMSS_10_Demencia_Alzheimer/EyR_IMSS_393_10.pdf

References:

CENETEC. (2017). Diagnóstico y Tratamiento de la Enfermedad de Alzheimer. Guía de Evidencias y Recomendaciones: Guía de Práctica Clínica. Guia de Practica Clinica. http://www.cenetec-difusion.com/CMGPC/IMSS-393-10/RR.pdf

No medications can be sold or prescribed in South Africa without the South African Health Products Regulatory Authority’s (SAHPRA) approval. Anti-dementia medications are available in South Africa, for example:

Acetylcholinesterase inhibitors:

  1. Donepezil (Aricept)
  2. Rivastigmine (Exelon)
  3. Galantamine (Reminyl)
  4. Memantine (Ebixa)

Anti-depressants:

  1. Citalopram
  2. Sertraline
  3. Mirtazapine
  4. Agomelatine
  5. Escitalopram
  6. Venlafaxine

These medications are prescribed as treatment guidelines by the South African Society of Psychiatrists (SASOP) (Emsley et al., 2013) that primarily guides the private sector in psychiatric practice. It is unclear to what extent these are adopted by the public sector, especially considering the health care system’s challenges in maintaining medicinal stocks and supplies at health care facilities.

Anti-dementia medications are expensive and not all medical insurance schemes will pay for these (Truter, 2013). Dementia is not listed as a chronic condition and, therefore, do not cover full costs of anti-dementia drugs as chronic medication.

References:

Emsley, R., Seedat, S., & Van Staden, W. (2013). South African Journal of Psychiatry PART 2 The South African Society of Psychiatrists (SASOP) Treatment Guidelines for Psychiatric Disorders Head of Publishing The South African Society of Psychiatrists (SASOP) Treatment Guidelines. South African Journal of Family Practice, 19(No. 3), 196. https://doi.org/DOI:10.7196/SAJP.474

Truter, I. (2013). Antipsychotic drug prescribing to patients with dementia in a South African patient population. African Journal of Pharmacy and Pharmacology, 7(41), 2755–2762. https://doi.org/10.5897/ajpp2013.3893