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Medicinal Products Prices

Dáil Éireann Debate, Tuesday - 27 March 2018

Tuesday, 27 March 2018

Ceisteanna (399)

Billy Kelleher

Ceist:

399. Deputy Billy Kelleher asked the Minister for Health if the HSE has followed his request to re-engage with a company (details supplied) in relation to the provision of Respreeza; if not, the reason for same; and if he will make a statement on the matter. [13913/18]

Amharc ar fhreagra

Freagraí scríofa

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 for a further six months, or until the next clinical trial commences in mid 2018, 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 in 2018. 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 in good time for those patients not proceeding onto the next trial.

The HSE is liaising with the treating consultant and the pharmaceutical company in relation to the longer term care of this group of patients and in order to ensure that appropriate care arrangements are in place for each patient in advance of an anticipated further clinical trial which is expected to begin later in 2018.

The HSE has asked that the plan for the longer term care of this group of patients would be finalised without delay.

This transitional arrangement does not alter the reimbursement decision of the HSE in relation to Respreeza.

The HSE has advised the company that it is willing to undertake a timely review of any new application for reimbursement.

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