Michael Healy-Rae (Kerry, Independent)
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444. To ask the Minister for Health if sativex will be covered under the medical card scheme; and if he will make a statement on the matter. [42785/20]

Stephen Donnelly (Wicklow, Fianna Fail)
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The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drug schemes, in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013.

In line with the 2013 Health 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 efficacy, the health needs of the public, cost effectiveness  and potential or actual budget impact. 

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 NCPE conducts health technology assessments (HTAs) for the HSE and makes recommendations on reimbursement to assist HSE decisions.

The HSE has advised that, in 2014, it notified the manufacturer of Delta-9-tetrahydrocannabinol/Cannabidiol, THC/CBD (Sativex®) that there was significant uncertainty around the cost-effectiveness of the medicine and as a consequence it did not support reimbursement of Sativex at that time.

In February 2018, the HSE received a revised application from the manufacturer for pricing / reimbursement of Sativex indicated as treatment for symptom improvement in adult patients with moderate to severe spasticity due to multiple sclerosis 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.

In April 2018, the HSE commissioned a full HTA with respect to this indication. On 12 August 2019, the NCPE received the applicant's submission. The Health technology assessment  is currently ongoing at the NCPE. The output of this HTA will be an important input into the decision-making processes of the HSE.

The application for Sativex remains under consideration with the HSE and is being assessed in line with the 2013 Health Act.