Dáil Éireann Debate, Tuesday - 2 July 2024
451. Deputy Sean Sherlock asked the Minister for Health the reason no pathfinder programmes, such as the one recently announced for the RSV vaccine, have been implemented for cancer patients in need of newly licenced oncology medicines; and if he will make a statement on the matter. [28069/24]
Amharc ar fhreagraThe State is committed to providing timely access to new and innovative medicines to all patients. Budgets 2021 to 2023 saw almost €100 million allocated for the reimbursement of new drugs, enabling the HSE to approve 148 new medicines. This included 61 oncology medicines.
Budget 2024 made €30 million available for new drugs. €20 million of this will be invested directly by the Government and a further €10 million will come from efficiencies to be identified by the HSE. Efficiencies were identified as a priority for 2024 by the Minister, with a joint HSE-Department of Health Taskforce established to address medicine expenditure.
The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the 2013 Act. Reimbursement is for licenced indications which have been granted market authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority. In line with the 2013 Act, and the national framework agreed with industry, a company must first submit an application to the HSE to have a new medicine added to the reimbursement list.
The timing of company applications for reimbursement in different countries can vary for a number of reasons, not least the available market share in each country. Once a company responsible for the commercialisation of a new medicine receives market authorisation, it can apply for reimbursement in the country (or countries) of its choice.
In assessing the application, the HSE is required by statute to consider a range of criteria including the magnitude of the clinical effect, cost effectiveness, budget impact, opportunity cost and unmet need.
In 2024, there will be significant investment in additional staff resources to enhance the HSE’s medicines pricing and reimbursement process.
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. This recruitment process has commenced and is ongoing.
Investing in this capacity will support agencies to operate to the fullest of their ability, providing timely and efficient evaluation of cancer medicines for reimbursement.
