Dáil Éireann Debate, Thursday - 10 March 2022
382. Deputy Brendan Griffin asked the Minister for Health if the CBD oil licensed for the treatment of epilepsy will be covered under the medical card and long-term illness schemes; and if he will make a statement on the matter. [13644/22]
Amharc ar fhreagraThe Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. Reimbursement for medicines under the community drugs schemes is for licensed indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.
In making a relevant reimbursement decision, the HSE is required under the Act to have regard to a number of criteria including efficacy, the health needs of the public, cost effectiveness and potential or actual budget impact. The Minister for Health has no role in these decisions.
The Medical Cannabis Access Programme (MCAP) is a 5-year pilot programme that allows medical consultants to prescribe specified cannabis-based products for patients with certain medical conditions who have exhausted all other available medical treatment options. Those conditions are:
- Spasticity associated with multiple sclerosis
- Intractable nausea and vomiting associated with chemotherapy
- Severe, refractory (treatment-resistant) epilepsy
The MCAP is now open for medical consultants to make an application for themselves and their patients to be registered on the Cannabis for Medical Use Register, operated by the HSE.
Prospective suppliers of products to the MCAP can apply to the Health Products Regulatory Authority (HPRA), acting on behalf of the Minister for Health, to have a cannabis product considered for inclusion in the schedule to the Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations 2019. The onus is on prospective suppliers to submit applications to the HPRA.
For medical indications not included in the MCAP, doctors may continue to utilise the Ministerial licensing route to prescribe medical cannabis for their patients. In line with the Chief Medical Officer's advice, the granting of a licence for cannabis for medical purposes must be premised on an appropriate application being submitted to the Department of Health, which is endorsed by a consultant who is responsible for the management of the patient and who is prepared to monitor the effects of the treatment over time.
From 1st December 2021, the HSE approved reimbursement of Cannabidiol (Epidyolex®)100 mg/ml oral solution via the High Tech Drug Arrangements for the following indications:
- use as adjunctive therapy of seizures associated with Lennox-Gastaut Syndrome (LGS) in conjunction with Clobazam, for patients 2 years of age and older,
- use as adjunctive therapy of seizures associated with Dravet Syndrome (DS) in conjunction with Clobazam, for patients 2 years of age and older, and
- use as adjunctive therapy of seizures associated with tuberous sclerosis complex (TSC) for patients 2 years of age and older.
Approved prescribers will be required to provide confirmation that Cannabidiol (Epidyolex®) 100 mg/ml oral solution is being prescribed in accordance with the licensed indications and in line with the terms of reimbursement approval given by the HSE.
Finally, it is important to note that the medical decision to prescribe or not prescribe any treatment, including cannabis treatment, for an individual patient is strictly a decision for the treating clinician, in consultation with their patient. The Minister for Health has no role in this clinical decision-making process.
