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Medicinal Products

Dáil Éireann Debate, Tuesday - 30 November 2021

Tuesday, 30 November 2021

Ceisteanna (525)

Peadar Tóibín

Ceist:

525. Deputy Peadar Tóibín asked the Minister for Health when Epidyolex will be available to patients. [58376/21]

Amharc ar fhreagra

Freagraí scríofa

The 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.

In line with the 2013 Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list.

Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.

HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE).

The HSE advises that it received three applications for the reimbursement of Cannabidiol (Epidyolex):

- for use as adjunctive therapy of seizures associated with Lennox-Gastaut Syndrome in conjunction with clobazam, for patients two years of age and older (received 5 February 2020);

- for use as adjunctive therapy of seizures associated with Dravet Syndrome in conjunction with clobazam, for patients two years of age and older (received 5 February 2020);

- for use as an adjunctive therapy of seizures associated with tuberous sclerosis complex (TSC) for patients 2 years of age and older (received 9 June 2021).

The final decision-making authority in the HSE is the HSE Executive Management Team (EMT). The HSE EMT decides on the basis of all the demands with which it is faced (across all services) whether it can fund a new medicine, or new uses of an existing medicine, from the resources that have been provided to it in line with the 2013 Health Act.

The HSE has advised that reimbursement has been approved for Epidyolex 100 mg/ml oral solution via the High Tech Drug Arrangements for the three above indications.

From December 1st 2021 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.

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