Gino Kenny (Dublin Mid West, People Before Profit Alliance)
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528. To ask the Minister for Health the reason epidiolex that is a cannabis-based medicine for the treatment of epilepsy and been approved by the EMA and FDA, has not be approved for reimbursement by the HSE; and if he will make a statement on the matter. [8389/20]

Simon Harris (Wicklow, Fine Gael)
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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 licenced 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 the health needs of the public, cost effectiveness, potential or actual budget impact and efficacy.

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).

I am advised by the HSE that it has received two applications for the reimbursement of Cannabidiol (Epidyolex®):

1. for use as adjunctive therapy of seizures associated with Lennox-Gastaut Syndrome in conjunction with clobazam, for patients two years of age and older.

In February 2020, the HSE commissioned the National Centre for Pharmacoeconomics to complete a rapid review on this medicine.  The NCPE recommended a full health technology assessment  to assess the clinical effectiveness and cost effectiveness of cannabidiol compared with the current standard of care. On 16 March 2020, the HSE commissioned a full pharmacoeconomic assessment for this indication.

2. for use as adjunctive therapy of seizures associated with Dravet Syndrome in conjunction with clobazam, for patients two years of age and older.

In February 2020, the HSE commissioned the NCPE to complete a rapid review.  The NCPE recommended a full HTA to assess the clinical effectiveness and cost effectiveness of cannabidiol compared with the current standard of care. In March 2020, a full pharmacoeconomic assessment was commissioned by the HSE.