Tuesday, 27 February 2018

Questions (485)

Clare Daly


485. Deputy Clare Daly asked the Minister for Health if he has issued instructions to the HSE to meet a company (details supplied) in order to restart negotiations on the HSE reimbursement of a drug. [9934/18]

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Written answers (Question to Health)

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, 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 six months, or until the next clinical trial commences in 2018, but from October 2017 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 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 ensures that appropriate alternative treatment regimes are put in place in good time for those patients not proceeding onto the next trial.

The HSE has written to the consultant for assurance that these conditions are being complied with.

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.