Léim ar aghaidh chuig an bpríomhábhar
Gnáthamharc

Medicinal Products Reimbursement

Dáil Éireann Debate, Thursday - 21 September 2017

Thursday, 21 September 2017

Ceisteanna (150)

Darragh O'Brien

Ceist:

150. Deputy Darragh O'Brien asked the Minister for Health the status of the reimbursement of the drug Respreeza/Zemaira; and if he will make a statement on the matter. [39975/17]

Amharc ar fhreagra

Freagraí scríofa

The HSE has carefully considered the pricing and reimbursement of human alpha1-proteinase inhibitor (Respreeza) through its decision making processes which were aligned with the statutory criteria set out in the Health (Pricing and Supply of Medical Goods) Act 2013. It should be noted that human aplha1-proteinase inhibitor does not strictly speaking come within the scope of the above act as it is not intended for this drug to be included on the HSE's reimbursement list as defined in section 17 of the Act.

The HSE Drugs Group considered the clinical information in relation to Respreeza. 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. Following a number of media reports, it appears that the company may be planning to terminate access to this treatment scheme.

The HSE has not received any formal notification from the manufacturer of its intention to terminate access to this 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. I would expect that the company would honour any commitments made to patients in this regard.

Barr
Roinn