Medicinal Products

Thursday, 20 November 2025

Questions (85)

Martin Daly

Question:

85. Deputy Martin Daly asked the Minister for Health the reason the osteoporosis drug Prolia, denosumab, is not routinely available free of charge to men with confirmed debilitating osteoporosis in Ireland in the same manner as it is available to women in equivalent clinical circumstances; and the steps her Department is taking to ensure equitable access for male patients in the Roscommon–Galway constituency who could benefit from this treatment but currently face significant financial or access barriers. [64522/25]

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Oral answers (3 contributions)

Deputy Martin Daly

I apologise to the Minister as this question contains incorrect information. I contacted her team to convey that message. I will ask the question and she might get back to me on it. I gave her short notice in respect of it. Romosozumab is a licensed treatment for postmenopausal women with advanced osteoporosis that does not respond to all other therapies. I have had a representation from a young middle-aged man who has a rare form of osteoporosis that has rendered him disabled. He does not have access to this drug by virtue of being a male.

Deputy Jennifer Carroll MacNeill

I thank the Deputy for raising this case. He is right that this drug is reimbursed for postmenopausal women with osteoporosis. I would like an opportunity to check this but, as I understand it, the European Medicines Agency, EMA, originally assessed the drug for use in both women and men. However, the company withdrew the male indication during the process following concern over the benefit-risk profile. It has been added to the HSE reimbursement list for postmenopausal women at high risk of fracture but it is not licensed for use in men for that reason. As prescribing it for men would be off-label, the HSE does not extend reimbursement to male patients. There is no licence to use it to treat osteoporosis in men. The company marketing the medicine withdrew the licence application for that use. I am sorry to tell the Deputy there is nothing I can do about that.

Deputy Martin Daly

I appreciate the Minister's answer, which is given at short notice. I am glad I raised the question on the floor of the House. The young man I mentioned is in difficulty. He is a self-employed businessman and is now disabled with multiple non-traumatic fractures. He asked whether there was a possibility he might be reimbursed for this medicine. However, it is down to the company to apply for a licence, as the Minister said. I accept that completely. We will have to revert to the company. I appreciate her reply.