Sir, – Epilepsy is a group of brain disorders characterised by the occurrence of recurrent unprovoked seizures, and in one-third of individuals with epilepsy, seizures may be difficult to control. Some have very severe epilepsy, often due an underlying genetic abnormality, and have frequent life-threatening seizures with devastating effects on quality of life, and that of the wider family.
There is long historical interest in the use of marijuana in the management of epilepsy. In recent years, controlled trials published in top medical journals of a non-psychoactive cannabis constituent, cannabidiol (CBD), have demonstrated positive benefits in some individuals with particular types of severe epilepsy. Pharmaceutical grade CBD (Epidyolex) is the only European Medicines Agency (EMA) cannabinoid approved for the treatment of selected patients with some forms of complex difficult epilepsy. Despite it being the only medical cannabis product approved by the EMA, it is still not approved for reimbursement by the Health Services Executive (HSE) in Ireland. This process is ongoing with no definite end in sight to the conclusion of the reimbursement decision.
So, I could now prescribe Epidyolex for my patients who I think might benefit from it, but it is prohibitively expensive at around €2,000 per month.
Meanwhile, and separately, the then-minister for health Simon Harris announced in June 2019 the establishment of a “Medical Cannabis Access Programme (MCAP)” to provide cannabis-based products in a number of situations, including for individuals with certain complex epilepsies. This programme is still not satisfactorily operational, consists of cannabis-based products with tetrahydrocannabinol (THC), a psychoactive compound, for which no clinical trial data exists on its efficacy in complex epilepsy (despite anecdotal reports of positive benefits in some), does not contain CBD-only containing preparations, including the only licensed EMA product, and from an administrative point of view, the programme is highly time consuming and demanding for clinicians.
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The saga of the appropriate availability of medical cannabis for complex epilepsy has been going on for a number of years now in Ireland, and neurologists, patients and families are deeply frustrated with the lack of joined-up thinking at department and HSE levels. On behalf of the neurological community, and patients with severe epilepsy and their families, I am pleading that the only EMA-licensed product for the treatment of some of the most severe life-threatening forms of epilepsy be made available to appropriate patients. If this were to happen, the MCAP would become largely redundant. – Yours, etc,
Prof NORMAN DELANTY,
Consultant Neurologist,
Beaumont Hospital,
School of Pharmacy
and Biomolecular Sciences,
and FutureNeuro
Research Centre,
Royal College of Surgeons
in Ireland,
Dublin 2.