Dáil Éireann Debate, Wednesday - 15 September 2021
647. Deputy Alan Dillon asked the Minister for Health when the required managed access programme being developed by the HSE medicines management programme will be completed; if a drug will be included (details supplied); and if he will make a statement on the matter. [43498/21]
View answerThe 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 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 licensed 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 HSE has advised that it received an application on 25 September 2018 for the reimbursement of Rivaroxaban (Xarelto) 2.5mg co-administered with acetylsalicylic acid for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) orsymptomatic peripheral artery disease (PAD) at high risk of ischaemic events.
On 17 October 2018, following the completion by the NCPE of a rapid review, the HSE commissioned a full pharmacoeconomic assessment with respect to this indication, as per agreed processes.
On 14 January 2019, the NCPE received the applicant’s submission for this assessment. On 18 June 2019, the NCPE completed its assessment and recommended that this application not be considered for reimbursement unless cost-effectiveness could be improved relative to existing treatments.
In February 2021, having considered all of the evidence, the HSE Drugs Group made a positive recommendation to support reimbursement of Rivaroxaban for this indication, subject to the establishment of a managed access programme (MAP). The minutes of this Drugs Group meeting are publicly available online: www.hse.ie/eng/about/who/cpu/drugs-group-minutes/hse-drugs-group-minutes-february-2021.pdf
The HSE Executive Management Team (EMT) is the decision-making body for the reimbursement of medicines under the Health Act 2013. The HSE EMT considered the recommendation of the Drugs Group and subsequently supported reimbursement of Rivaroxaban 2.5mg subject to the implementation of the recommended MAP.
The processes necessary to implement the required MAP are currently being developed by the HSE Medicines Management Programme (HSE-MMP) along with relevant internal stakeholders. The timelines involved will vary depending on the requirements for the MAP. While such processes are ongoing the HSE is unable to give a definitive date for conclusion.
