John Brassil
Question:103. Deputy John Brassil asked the Minister for Health the progress that has been made on the provision of Respreeza; and if he will make a statement on the matter. [6406/18]
View answerThursday, 8 February 2018
Questions (103)
Written answers
The HSE has statutory responsibility for decisions on 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 were notified in August 2017 that the HSE was unable to recommend reimbursement as they 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 a Respreeza access scheme, operated by the manufacturer CSL Behring for the treatment of Alpha-1 deficiency. This scheme was being run independently by CSL Behring and without reference to the HSE, when the Company decided that the scheme would end on 30 September 2017. This decision left approximately 20 patients without access to medication.
Subsequently the company modified its decision and agreed to continue to supply the medication free of charge for the patients on the access scheme for a further period of six months, or until the next clinical trial commences in 2018, but not to cover the cost of administering the medicine from the end of October 2017.
Due to the critical and exceptional circumstances, the HSE decided to facilitate a transitional arrangement under which it would fund the provision of the necessary nursing service to ensure that patients could continue to receive the medicine until a new clinical trial commences in 2018.
The Company anticipates that approximately half of the current access group of patients will be recruited into the next clinical trial in 2018.
The terms of this transitional arrangement, under which the HSE has agreed to fund the administration of the drug, includes a requirement that the lead clinician concerned ensures that appropriate alternative treatment regimes are put in place in good time for those patients not proceeding onto the next trial.
This transitional arrangement 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.