Kevin O'Keeffe (Cork East, Fianna Fail)
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981. To ask the Minister for Health the progress made by the HSE following representations by the applicant company to provide a drug (details supplied). [37486/17]

John Curran (Dublin Mid West, Fianna Fail)
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1178. To ask the Minister for Health the position regarding persons who have been using Respreeza for many years; if this drug will continue to be available to these persons; the position with regard to persons who also might benefit from using this drug; and if he will make a statement on the matter. [38218/17]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 981 and 1178 together.

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.

The HSE has decided not to support reimbursement of the medicine at the price sought by the applicant indicating that it did not consider the evidence for its clinical benefit to be sufficiently strong, in the context of the proposed cost and budget impact. I instructed the HSE to engage with patient groups directly in relation to this decision .

In relation to the access scheme, the operation of such schemes is at the discretion of manufacturers. As Minister for Health, I have no role in the operation of these schemes. There is no provision in Irish legislation for the approval of patient access programmes for specific groups of patients with an unmet medical need.

I have previously said that any attempts by manufacturers to link continued access for patients already being treated with a new medicine with decisions under the statutory reimbursement process is both inappropriate and unethical. Manufacturers should operate such schemes in a compassionate and not a commercially-motivated manner. There should be no link between patient access schemes and reimbursement decisions and manufacturers should be open with patients and clinicians from the outset.