CFI welcomes the invitation from the Minister for Health, Stephen Donnelly TD to meet with CFI later this month. A parent representative will be part of the meeting and we will of course report back on the main outcomes from this meeting. CFI also understands that we be receiving an invitation to meet the Chairperson of the Joint Oireachtas Commitee on Health, Sean Crowe TD and again a parent representative will be at this meeting with CFI. One of the further outcomes from the protest on the 14th of September are a number of parliamentary questions. Of particular interest is the question from Senator Senator Sharon Keogan and the reply from the Minister for State for Health, Frankie Feighan TD :
"I welcome the Minister of State to the Chamber. I am disappointed not to see the Minister, Deputy Stephen Donnelly, this afternoon. At this stage, no one needs the background to this debacle which has been ongoing since the start of the year and has been raised multiple times in both Houses. I spoke on it on the Order of Business in June and again in September when we realised that the HSE's corporate pharmaceutical unit had held no meetings with Vertex Pharmaceuticals over the summer recess, with the last meeting held on 4 July.
The two parties met again on Friday, 16 September, and a spokesperson for Vertex informed me that the HSE has made no explicit movement away from its current position that Vertex will need to submit a full health technology assessment, HTA, dossier to the National Centre for Pharmacoeconomics for this patient population.
Campaigners for these children have repeatedly called for the red tape not to be wrapped around Kaftrio because this is guaranteed to lead to decisions being postponed and access delayed to this life-saving and life-changing drug therapy. Why is the HSE's corporate pharmaceutical unit, CPU, insisting that Kaftrio, which is already being administered to children and adults alike in Ireland - and to children in other countries with the specific gene mutation found in these 35 children - undergo a full HTA prior to reaching a pricing agreement? Vertex maintains that it has put forward several solutions that would allow rapid access for the 35 children. The HSE remains set on the submission of a HTA while Vertex remains committed to finding a quick solution for access for the 35 children currently impacted.
All of this is from Vertex's side, but only because we have heard so little from the HSE, which is not unusual. We have heard so little from it that I had to submit a freedom of information request to try to see what was being said. I was told it would cost at least €700 to fill it. I am still trying to see what information we can get, if any.
Would the Minister of State care to update the House but, most importantly, the families of the 35 children, as to what progress the HSE is seeking to make in its negotiations with Vertex, beyond "Do what we say". To my knowledge, to date neither the Minister nor the representatives of the HSE's CPU, have met with Cystic Fibrosis Ireland, which is leading the campaign to secure this medication. Vertex, however, met with it at the European cystic fibrosis conference in Rotterdam on 10 June. From where we stand, the efforts to resolve this pricing dispute seem very one sided. Perhaps there is something in the Minister of State's speech that can set the record straight. I look forward to hearing from him what the Minister for Health has got to say."
Minister of State at the Department of Health (Deputy Frankie Feighan)
"I thank Senator Keogan for raising this issue. Cystic fibrosis is a devastating disease for patients and their families. With Ireland having one of the highest per capita rates of cystic fibrosis in the world, many of us will have been affected by the sadness it can cause for families. Access to effective treatments offers hope to those suffering from this disease, and I aim to make this possible for every patient who needs it.
Kaftrio has been a life-changing drug for cystic fibrosis sufferers. Access to drugs like this was what we expected when the HSE signed the agreement with its manufacturer, Vertex, in 2017. The deal stipulated that our patients would have access to Vertex's entire portfolio of cystic fibrosis drugs for a capped yearly cost. We made a ten-year commitment that has already seen us pay hundreds of millions of euro to Vertex. We entered this agreement in good faith, expecting that as new licences were approved for its medicines, the HSE would receive access at no additional cost. This has been the case previously when new indications were licensed. The agreement was amended in 2019 and 2020 to include these patient groups at no additional cost. However, for this particular subtype, affecting a small group of children, Vertex is requesting additional funds to provide access.
The HSE has statutory responsibility for the community drug schemes. It has structures in place to ensure that our health service is able to provide the right care sustainably. Its CPU has engaged extensively with Vertex - holding ten meetings - to try to see this patient group included in our pre-existing agreement. Considering the significant budgetary impact of the additional resources Vertex is requesting, it must engage with the pricing and reimbursement process that all other medicines are required to undergo.
The HSE continues to engage proactively with Vertex, having met as recently as 16 September, hoping to better understand why the company has chosen to take this position.
The Government is committed to providing access to innovative new medicines for patients, and budgets 2021 and 2022 saw €80 million in funding dedicated to new medicines. A total of 90 new medicines, or the expanded use of existing medicines, were made available by this funding, 21 of which related to the treatment of rare diseases.
I thank Cystic Fibrosis Ireland for its efforts in bringing attention to this matter. The event it held outside Leinster House last month helped raise awareness among the public and my colleagues in the Oireachtas. The dedication of the organisation's members is admirable. We share the common goal of making this drug available to the children who need it, and the Minister is eager to gain their insight on possible routes to a solution. To that end, his office has been in contact with them to arrange a meeting in the coming weeks and he looks forward to hearing their ideas and making progress on this issue.
As Senator Keoghan outlined, access for these 35 children and their families has been denied. I hope that through all the various stakeholders, the Minister's office, Cystic Fibrosis Ireland, the pharmaceutical companies and perhaps even the Senator, we can get a resolution to this difficult and complex issue."