Charlie McConalogue (Donegal, Fianna Fail)
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293. To ask the Minister for Health the status of the HSE's negotiations on the drug Respreeza; if the HSE plans to return to negotiations on the availability of this drug; if he and the HSE will ensure that accommodations are made for the 21 persons who participated in trials of the drug in order for them to continue to avail of same; and if he will make a statement on the matter. [40270/17]

Simon Harris (Wicklow, Fine Gael)
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The HSE has carefully considered the pricing and reimbursement of human alpha1-proteinase inhibitor (Respreeza) through its decision making processes which are aligned with the statutory criteria set out in the Health (Pricing and Supply of Medical Goods) Act 2013.

Following a detailed review process over the past 18 months, the HSE has written to CSL Behring, the manufacturers of human alpha1-proteinase inhibitor, advising them that the HSE will not support reimbursement at this time.

The HSE was unable to recommend reimbursement as they concluded that there is not enough evidence to suggest that patients will derive a clinically meaningful benefit from this treatment.

The HSE was also required to consider cost effectiveness and deemed that the current price was not a cost effective use of resources.

I am aware that there are a number of patients on a compassionate access scheme which is operated by CSL Behring and that the company is planning to terminate access to this treatment scheme.

I consider this action by the company as unethical and as I have stated previously, there should be no link between compassionate use schemes and reimbursement decisions and manufacturers should be frank with patients and clinicians on the operation of such schemes.

On my request, the HSE has sought assurances from the hospital that appropriate care arrangements are in place in the event that the access programme is discontinued, and that appropriate ethical guidelines have been and continue to be followed in relation to all aspects of the clinical trial and access programme.

It is the responsibility of both the company and the investigator (clinician) to ensure that they have considered and made arrangements for the patients, including in circumstances where the product is not reimbursed by the HSE. I would expect that the company would honour any commitments made to patients in this regard.