QUESTION NO: 380
DÁIL QUESTION addressed to the Minister for Health (Simon Harris T.D.)
by Deputy Darragh O'Brien
for WRITTEN ANSWER on 11/07/2017
* To ask the Minister for Health the status of the reimbursement of the drug respreeza/zemaira; and if he will make a statement on the matter.
Darragh O'Brien T.D.
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 has considered the issue of reimbursement of Respreeza for maintenance treatment of emphysema in adults with documented severe alpha1-proteinase inhibitor deficiency. Following this process, it has decided not to support reimbursement of the medicine.
The HSE, in such instances, is required under the Health (Pricing and Supply of Medical Goods) Act 2013 to issue a notice of proposal to the applicant, setting out that it does not intend to reimburse this medicine and the reasons why.
The company is entitled to make written representations and is given at least 28 days in which to do so. The HSE is required to consider carefully any written representations it receives from the applicant.
The notice period for applicant company representations recently ended. The HSE is now considering the representations received from the applicant and has also met with the company.
A final decision by the HSE can only be made after the representations received under the 2013 Health Act processes have been carefully considered.