Simon Harris (Wicklow, Fine Gael)
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The HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

The HSE carefully considered the pricing and reimbursement of human alpha1-proteinase inhibitor (Respreeza). The manufacturer, CSL Behring, was notified in August 2017 that the HSE was unable to recommend reimbursement. The HSE concluded that there was not enough evidence to suggest that patients would derive a clinically meaningful benefit from this treatment and that the current price was not a cost effective use of resources.

A number of patients were on an access scheme for this product, operated by the manufacturer, for the treatment of Alpha-1 deficiency. This scheme was being run independently by the manufacturer without reference to the HSE.

Late last year the company decided to terminate the access scheme. Following interventions by the HSE, the company modified its decision and agreed to continue to supply the medication free of charge for the patients on the access scheme but stipulated that it would not cover the cost of administering the medicine.

Due to the critical and exceptional circumstances, the HSE decided to facilitate a transitional arrangement, under which it would fund the necessary nursing service to ensure that patients would continue to receive the medicine until a new clinical trial commences.

The terms of this transitional arrangement, under which the HSE has agreed to fund the administration of the drug, include a requirement that the lead clinician (who is the patients' treating consultant) ensures that appropriate alternative treatment regimes are put in place for those patients not proceeding onto the next trial.

This transitional arrangement for the 19 Alpha 1 clinical trial patients does not alter the reimbursement decision of the HSE in relation to Respreeza. The company is welcome to submit a new reimbursement application which will be assessed in line with the 2013 Act.

The HSE is continuing to liaise with the treating Consultant and the Pharmaceutical Company in relation to the long term care of this group of patients (19 Alpha 1 clinical trial patients) on the condition that the company would continue to supply the medicine into 2019.

The HSE has indicated that negotiations with the Company in respect of the 19 Alpha 1 clinical trial patients are in the final stages.