Martin Daly raises access issue over romosozumab for men
Martin Daly raised a parliamentary question about access to romosozumab for a male patient with a rare form of osteoporosis who is now disabled and cannot access the drug because reimbursement covers only postmenopausal women. He asked the minister to check the licensing position and whether a licence application for use in men could be pursued.
He said he had representation from a young middle-aged man with a rare form of osteoporosis who is disabled with multiple non-traumatic fractures and does not have access to romosozumab by virtue of being male.
The minister replied that the European Medicines Agency (EMA) originally assessed romosozumab for use in both women and men, but the company withdrew the male indication during the assessment after concerns about the benefit-risk profile.
Romosozumab has been added to the HSE reimbursement list for postmenopausal women at high risk of fracture, and there is no licence for its use in men. Prescribing it for men would therefore be off-label, and the HSE does not extend reimbursement to male patients for that reason.
The minister said the company marketing the medicine withdrew the licence application for male use and that there was nothing the minister could do to change that. Deputy Dilley thanked the minister for the answer and said the case would have to be taken up with the company.
Issue raised
He said he had representation from a young middle-aged man with a rare form of osteoporosis who is disabled with multiple non-traumatic fractures and does not have access to romosozumab by virtue of being male.
Regulatory background
The minister replied that the European Medicines Agency (EMA) originally assessed romosozumab for use in both women and men, but the company withdrew the male indication during the assessment after concerns about the benefit-risk profile.
Reimbursement position
Romosozumab has been added to the HSE reimbursement list for postmenopausal women at high risk of fracture, and there is no licence for its use in men. Prescribing it for men would therefore be off-label, and the HSE does not extend reimbursement to male patients for that reason.
Response and next steps
The minister said the company marketing the medicine withdrew the licence application for male use and that there was nothing the minister could do to change that. Deputy Dilley thanked the minister for the answer and said the case would have to be taken up with the company.
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Transcript
Thanks, Sass Concordia, and I want to apologise to the Minister in advance of this question. There was incorrect information in the question I did contact your team. So I'll ask the question and you may be able to get back to me because I gave you short notice in respect of this. It's in relation to Romosiosumab, which is a licensed treatment for postmenopausal women who have advanced osteoporosis, which is refractive to all other therapies. I have representation from a young middle-aged man who has had a rare form of osteoporosis, which has rendered him disabled and doesn't have access to the drug by virtue of being a male. Minister. Thank you for raising this case. You're right, it is reimbursed for women who have postmenopausal women with osteoporosis. As I understand it, and I'd like to just have the opportunity to check it, the EMA originally assessed the drug for use both in women and men, but the company withdrew the male indication during the process after concern of a benefit-risk profile. So it has been added to the HS reimbursement list for postmenopausal women at high risk of fracture, but it's not licensed for use in men for that reason. Prescribing it for men would be off-label, and so the HSE doesn't extend reimbursement to male patients for that reason. However, there is no license for it to treat osteoporosis in men. So it is impossible. The company marketing the medicine withdrew the license application for the treatment, and there isn't anything that I can do about that. I'm sorry, Deputy. Deputy Dilley. Can I say I appreciate the Minister's answer to that, and it was at short notice. No, no, it's fine. I'm glad that I raised it on the floor. I suppose the difficulty for this young man who was a self-employed businessman, who is now disabled with multiple fractures, non-traumatic fractures, and his ask was the possibility if there was an application for license. But that's down to the company, as you've said, Minister, and I accept that completely, and I think we'll have to revert to the company. Thank you for your answer. I appreciate it. Thank you, Deputy.