Mairéad Farrell (Galway West, Sinn Fein)
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121. To ask the Minister for Health if she has engaged with the HSE on the recent approval of Belimumab for the treatment of lupus; if funding will be given in budget 2026 towards this treatment; and if she will make a statement on the matter. [52239/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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I wish to thank the Deputy for her question.

Belimumab (Benlysta ®) is a monoclonal antibody used to treat certain forms of lupus, specifically Systemic lupus erythematosus (SLE) and Lupus nephritis (a kidney complication of lupus)

It works by blocking a protein called BLyS (B-lymphocyte stimulator), which helps B cells survive. In lupus, B cells are overactive and produce harmful autoantibodies. By inhibiting BLyS, belimumab reduces B cell activity, helping to control the autoimmune response and reduce symptoms.

Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines.

In terms of Belimumab (Benlysta®) the HSE received applications from GSK for pricing and reimbursement of belimumab (Benlysta®) for two indications: systemic lupus erythematosus (SLE) and lupus nephritis.

Following Rapid Reviews by the NCPE, full Health Technology Assessments (HTAs) were commissioned for both. The HSE Drugs Group reviewed the clinical and economic evidence, including commercial negotiations, and in January 2024 recommended against reimbursement under High Tech arrangements for both indications.

The HSE Senior Leadership Team supported these recommendations, citing resource constraints and prioritisation across services. Formal notice of the proposed decisions not to reimburse belimumab for either SLE or lupus nephritis has been issued to the applicant, who has the opportunity to make further representations. Final outcomes are pending completion of this process.

The application remains under consideration.