Alan Dillon (Mayo, Fine Gael)
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498. To ask the Minister for Health if he will provide clarification in relation to the ground-breaking treatments, such as Sotatercept, which show potential in revolutionising the care for conditions like pulmonary hypertension; if this drug will be funded through budget 2024; and if he will make a statement on the matter. [46072/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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A record almost €3 billion, nearly €1 in every 8 spent by the State on health, will be spent this year on medicines. This is an unprecedented level of investment in supporting patients through the availability of the latest and wide range of medicines.

It is important that medicines expenditure is sustainable for the State and that we strive to maximise the available investment. This will enable us to provide as many people as possible with access to the necessary medicines.

Over the last 3 years the State has invested €98 million in new medicines funding to provide 127 new medicines or extended uses for medicines.

Going into 2024, I will ensure that my Department, the HSE and all relevant agencies and stakeholders place a priority focus on achieving the most efficient and effective use of available resources. This will require opportunities for savings to be identified and implemented. While dedicated funding for new medicines has not been allocated in Budget 2024, this does not mean that no new medicines will be approved for reimbursement in 2024. Any savings generated from identified initiatives will be immediately reinvested into new medicines for 2024.

In relation to sotatercept, the Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines and medical items, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

The HSE must comply with the relevant legislation when considering investment decisions around new medicines. Pharmaceutical companies are required to submit formal applications to the HSE if they wish their medicines to be added to the list of reimbursable items / funded via hospitals. In order to submit a formal application the medicine must hold a marketing authorisation.

The European Medicines Agency (EMA) is a centralised agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU. The EMA plays an integral role in the authorisation of medicines in the EU.

To date, the EMA has not granted a marketing authorisation for sotatercept for the treatment of pulmonary hypertension. As outlined above, the national assessment and decision process cannot commence in the absence of a marketing authorisation.