Speech by Minister Simon Harris TD on Topical Issue Debate on Orkambi

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I wish to thank the Deputies for raising this issue and allowing me the opportunity to provide an update in the Dáil.

I am pleased to inform the House, but most particularly CF patients, their families and friends, that the HSE and Vertex have today confirmed that an agreement has been reached in principle on the commercial terms for the supply to Irish patients of Orkambi (for patients aged 12 years and older) and for Kalydeco (for patients aged 2-5) from next month and for other treatments and age cohorts following market authorisation in Europe.

I wish to provide this update to the House today to offer reassurance to patients on this important matter and to inform them that the HSE and Vertex expect the medicines to be available from the 1st of May.  I also wish to inform the Dail that both parties are now working to finalise the contractual arrangements and complete approval processes in advance of the 1st of May.

I want to recognise the work the HSE has put into these negotiations over a long period and I thank them for that.

I want to also especially acknowledge that this has been an extraordinarily difficult time for CF patients, their families and friends as they have been waiting for this process to conclude.

However, I am sure that the Deputies will accept that, given the scale of the investment, the potential benefits for Irish patients and the impact of this decision on the health service overall, it is appropriate to allow the statutory process we have in this State to be appropriately concluded, so as to bring certainty to matters.

The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines in the community drug schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

In reaching a reimbursement decision, the HSE examines all the evidence which may be relevant in its view, including the dossier submitted by the company.

The HSE takes into account such expert opinions and recommendations which it may have been sought at its sole discretion, for example, from the National Centre for Pharmacoeconomics – the NCPE.

Under Section 19 (4) of the 2013 Act, the HSE is prohibited from making a decision to reimburse a medicine “except in accordance with the criteria specified in Schedule 3” of that 2013 Act. In the interest of time, I will not read out the statutory criteria.

With regard to Orkambi for the treatment of cystic fibrosis patients aged 12 and older, following an application by the company, the treatment was assessed in line with the statutory process, following which the HSE called on Vertex to re-enter negotiations.

Further meetings were held with the manufacturer in December and early January. The discussions with the company broadened to include Kalydeco and further treatments for CF patients.

Following a detailed consideration by the HSE Directorate, its legal representative and officials in the Department of Health, further negotiations took place last week and these discussions have continued into this week.

I am pleased that we are now in a position to reassure people we are now in the concluding stages of an agreement as I outlined earlier and expect the further work in the coming days will bring this matter to finality.