Mairéad Farrell (Galway West, Sinn Fein)
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93. To ask the Minister for Health if the decision not to reimburse for belimumab will be reviewed; and if she will make a statement on the matter. [64337/25]

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.

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.

The HSE has received applications from GSK, the marketing authorisation holder, for pricing and reimbursement of belimumab (Benlysta®) for two indications: systemic lupus erythematosus (SLE) and lupus nephritis (a kidney complication of lupus).

In line with the process set out in the 2013 Act the HSE’s Senior Leadership Team decided against reimbursement under High Tech arrangements for both indications in January 2024. This followed a robust Pharmacoeconomic assessment by the National Centre for Pharmacoeconomics, commercial negotiations and reviews of the clinical evidence.

The HSE Senior Leadership Team cited resource constraints and prioritisation across services as reasons for not reimbursing this medicines. In accordance with the 2013 Act, the HSE must robustly assess applications for pricing and reimbursement to make sure that it can stretch available resources as far as possible and to deliver the best value in relation to each medicine and ultimately more medicines to patients in Ireland.

Formal notice of the proposed decisions not to reimburse belimumab were issued to the applicant, who had the opportunity to make further representations.

As part of their representations, the applicant, GSK, have now submitted a revised commercial proposal in relation to the two separate pricing and reimbursement applications for belimumab (Benlysta®) for Lupus nephritis (LN) and Systemic lupus erythematosus (SLE) for further consideration by the HSE.

This new proposal is currently under consideration with the HSE.