Dáil Éireann Debate, Wednesday - 21 June 2023
199. Deputy David Cullinane asked the Minister for Health if he has explored the possibility of recognising a product (details supplied) as medical treatment under the drugs payment scheme, instead of a food supplement; and if he will make a statement on the matter. [29969/23]
View answerThe 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 (HPRA).
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 Medical Cannabis Access Programme (MCAP), a 5-year pilot programme, 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
Prospective suppliers of products to the MCAP can apply to the HPRA to have a cannabis product considered for inclusion. 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.
The HSE Executive Management Team (EMT) have supported reimbursement of Delta-9-tetrahydrocannabinol (THC) / Cannabidiol (CBD) (Sativex®) for the following indications:
• as treatment for symptom improvement in adult patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and
• who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy, subject to a managed access protocol being implemented.
As a condition of reimbursement, an individual patient approval system will be put in place by the HSE, to enable reimbursement for patients who meet the pre-defined criteria of a HSE devised managed access protocol (MAP).
