Robert Troy (Longford-Westmeath, Fianna Fail)
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164. To ask the Minister for Health if he will provide an update on the implementation of drug reimbursement recommendations contained within a report published in March 2023 (details supplied); the reason the recommendations contained have not been implemented to date, resulting in substantial financial pressure being placed on families, in particular the sanctioning of fenfluramine for the treatment of Dravet syndrome as per this report. [24159/24]

Robert Troy (Longford-Westmeath, Fianna Fail)
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166. To ask the Minister for Health if he will urgently expedite the approval of fenfluramine for the treatment of Dravet syndrome (details supplied). [24161/24]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 164 and 166 together.

In February 2023, I published the Mazars Review which examined the governance arrangements around the HSE’s Drug Pricing and Reimbursement Process. The Report found that the reimbursement process is operating in line with the legislation and that it is delivering results in line with international norms. I fully support the recommendations contained in the Mazars report around improving the process, increasing transparency, providing easier access, and supporting value for money.

The Group has conducted two rounds of targeted stakeholder consultation. The insights gained from stakeholders have been considered by the Group as it continues its work on progressing the various recommendations of the Review. The Group’s work is now nearing completion and a report on this will be submitted to me in the coming weeks.

In 2024, there will be significant investment in additional staff resources to enhance the HSE’s medicines pricing and reimbursement process. This is a recommendation of the working group established following the publication of the Mazars Review in February 2023.

Funding has been allocated for an additional 34 WTE for the agencies involved in the HSE’s medicines pricing and reimbursement system has been granted. This will enable them to conduct timely and efficient evaluations of medicines for reimbursement. It will also maximise the use of this substantial public investment to support access to more medicines for more people. Funding has also been approved for an online tracker which will allow patients and industry to follow the progress of an application through the assessment process. This will enhance transparency for all stakeholders.

The HSE have advised the following in terms of the specific details of the application for pricing and reimbursement of Fenfluramine (Fintepla®):

Dravet Syndrome

The HSE received an application for pricing and reimbursement of Fenfluramine (Fintepla®) on the 28^th July 2023 from UCB Pharma (the applicant) for the treatment of seizures associated with Dravet syndrome as an add-on therapy to other anti-epileptic medicines for patients two years of age and older.

The first step in the process is the submission of a Rapid Review dossier (a clinical and economic dossier) to the National Centre for Pharmacoeconomics (NCPE) for assessment. The HSE commissioned the Rapid Review process on the 31^st July 2023.

The NCPE Rapid Review assessment report was received by the HSE on the 7^th September 2023. A full health technology assessment (HTA) was recommended to assess the clinical effectiveness and cost effectiveness of Fenfluramine (Fintepla®) compared with the current standard of care.

The HSE commissioned a full Health Technology Assessment (HTA) on the 29^th September 2023 as per agreed processes.

A full submission was received from the applicant on the 16^th May 2024.

A preliminary review was sent to the applicant on the 20^th May 2024.

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 Fenfluramine (Fintepla®) for Dravet Syndrome are available at: www.ncpe.ie/fenfluramine-fintepla-for-dravet-syndrome-hta-id-23048/.

The HSE Corporate Pharmaceutical Unit (CPU) is the interface between the HSE and the Pharmaceutical Industry in relation to medicine pricing and reimbursement applications.

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 pharmacoeconomic report will be reviewed by the HSE Drugs Group along with the outputs of any commercial negotiations, and any patient group submission(s) received. The HSE Drugs Group will consider all of the evidence and make a recommendation to the HSE Executive Management Team.

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 use 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 application remains under consideration with the HSE. The HSE cannot make any comment on possible outcomes from the ongoing process.