David Stanton (Cork East, Fine Gael)
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1339. To ask the Minister for Health if an application has been submitted to the HSE to have sativex oromucosal spray added to the drug payment scheme reimbursement list; if he is aware of any report by the HSE drugs group following any such application; if a decision has been made or is expected to be made on the issue; and if he will make a statement on the matter. [13024/23]

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 drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

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). There are formal processes which govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded and/or reimbursed.

In terms of the specific details of the application for pricing and reimbursement of Delta-9-tetrahydrocannabinol (THC) / Cannabidiol (CBD) (Sativex®):

In 2014, the HSE notified Almirall (the applicant) that there was significant uncertainty around the cost-effectiveness of Sativex® (on the basis of the then application: www.ncpe.ie/wp-content/uploads/2013/01/Summary-v1.pdf) and as a consequence did not support reimbursement of Sativex® (at that time).

The HSE received a revised application from Almirall for pricing / reimbursement of Sativex® on 9 February 2018.

- The first step in the process is the submission of a Rapid Review dossier (a clinical and economic dossier) to the National Centre for Phamacoeconomics (NCPE) for assessment. The HSE commissioned the Rapid Review process on 12 February 2018.

- The NCPE Rapid Review assessment report was received by the HSE on 3 April 2018. The NCPE advised the HSE that a full HTA was recommended to assess the clinical effectiveness and cost effectiveness of delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) (Sativex®) compared with the current standard of care.

- The HSE commissioned a full Health Technology Assessment (HTA) on 19 April 2018 as per agreed processes.

- The NCPE publishes details of medicines where the HSE has commissioned a Rapid Review assessment and-or a full health technology assessment on their website. The website is updated at regular intervals and includes assessment outcomes and updates on reimbursement for each individual medicine and indication listed. Details of the assessment(s) of delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) (Sativex®) is available at

- The NCPE Health Technology Assessment was received by the HSE on 15 July 2021. The NCPE recommended that delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) (Sativex®) 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 not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments.

- The HSE Corporate Pharmaceutical Unit (CPU) is the interface between the HSE and the Pharmaceutical Industry in relation to medicine pricing and reimbursement applications. CPU engaged in commercial negotiations with the applicant (Almirall) in relation to their application.

- The Drugs Group is the national committee which the HSE has in place to make recommendations on the pricing and reimbursement of medicines. The membership of the HSE Drugs Group includes public interest members. The totality of clinical and economic evidence for delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) (Sativex®) was comprehensively and extensively reviewed by the Drugs Group at the November 2022 meeting. The Group recommended in favour of reimbursement of delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) (Sativex®) subject to the establishment of a HSE Medicines Management Programme-led managed access protocol.

- The decision making authority in the HSE is the HSE Executive Management Team. The HSE Executive Management Team decides on the basis of all the demands it is faced with (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 Health (Pricing and Supply of Medical Goods) Act 2013. The HSE EMT supported reimbursement of delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) (Sativex®) 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 as per a Medicines Management Programme (MMP) devised managed access protocol. The processes necessary to implement this required managed access protocol (MAP) are currently being developed by the HSE MMP.

The HSE cannot comment on the specific timeline for the HSE approval to be formalised while the processes required to implement the managed access protocol are ongoing.