Brendan Griffin (Kerry, Fine Gael)
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I thank the Leas-Cheann Comhairle for selecting this matter. I have tried to raise it on Topical Issues for three weeks, so I am very grateful to be able to speak.

I want to raise the cases of cystic fibrosis sufferers who hope to be able to avail of the drugs Kalydeco and Orkambi. These are important and groundbreaking drugs for cystic fibrosis sufferers and we need to ensure they are available to them in order to improve their quality of life and change their lives.

I understand that negotiations are ongoing between the HSE and the manufacturer. I want both parties to put the people who are in the middle first and ensure that everything possible will be done to ensure that these vitally important drugs will be made available to those who need them as soon as possible. Every day that goes by without these drugs being available to those who need them most, is a day too long. I have been contacted by many people living in Kerry, including parents and grandparents of children with cystic fibrosis. My colleague, Deputy Neville, whom I know cannot contribute to this debate, has informed me of the number of people in Limerick who are in the same situation.

We know the drugs are expensive and a lot of money is involved, but the results and prize are far too important. We need to pursue this issue. I want to know that everything that can possibly be done on behalf of these people is being done by the Department so that the drugs will be made available to them as soon as possible.

I ask the Minister of State to update us on the negotiations. We would be very grateful. Again, I cannot stress the urgency of the situation enough. It is vitally important.

Anne Rabbitte (Galway East, Fianna Fail)
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I thank Deputy Griffin for sharing time. Like Deputies Griffin and Neville, many people in Cork have contacted Deputy Moynihan. Deputy Griffin has set the backdrop and I will now read a letter from a dad who wrote to me. He is a representative of the newly formed parents group of Kalydeco. It was established to try to obtain reimbursement for the cystic fibrosis drug Kalydeco for children aged between two and five years. The drug is already reimbursed for children aged over six. The group represents 18 families that have children in the age group which will benefit from Kalydeco. The letter to which I refer states:

As you will be aware the NCPE recently recommended against the reimbursement of the cystic fibrosis drug Kalydeco for 2 to 5 year olds. at the submitted price. As a father of 3 year old with cystic fibrosis and who has the form of cystic fibrosis that Kalydeco treats, I was astonished, disappointed and saddened at the decision of the NCPE. The NCPE decision was made on the 12th of October of this year. To make matters worse, the NCPE took seven months to make the decision. My feelings of disappointment were worsened largely by the fact that the Government is already reimbursing this drug in six year olds and over and has been doing so sometime since early 2013. So why then has this extension not been made available to 2 to 5 year olds? The drug is safe and more effective in children in 2 to 5 years of age in range than in children and adults over 6. The fact that the Government has not reimbursed the drug amounts to age discrimination. It is not reasonable to say that the drug is not good enough in one age group and not in another.

I am speaking on behalf of 18 families, but cystic fibrosis affects people in every county. When 18 families feel they have been totally and utterly sidelined, they deserve a response. I look forward to hearing from the Minister of State.

Marcella Corcoran Kennedy (Offaly, Fine Gael)
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I thank Deputies Griffin and Rabbitte for raising this issue. The Minister for Health, Deputy Harris, has asked me to extend his apologies for not being available to be here.

I am very aware, as we all are, that access to potentially beneficial drug treatment is an important issue for people with cystic fibrosis and that cystic fibrosis sufferers and their families face enormous day-to-day challenges in dealing with this progressive and debilitating condition. It is important to point out, however, that it is the HSE which has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the community drug scheme, in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013, as Deputies are probably aware.

Decisions on which medicines are licensed for use in Ireland and which are reimbursed by taxpayer are made on objective, scientific and economic grounds by the HSE on the advice of the National Centre for Pharmacoeconomics, NCPE. It is a team of clinicians, pharmacists, pharmacologists and statisticians that evaluates the benefits and costs of medical technologies and provides advice to the HSE.

It conducts health technology assessments of pharmaceutical products for the HSE and can make recommendations on reimbursement to assist the HSE in its decision-making process. Since July of this year, a revised and more transparent assessment process for the reimbursement of new medicines by the HSE has been in place. Importantly, this process includes consideration of the budget impact of individual new medicines, the opportunity cost of the treatment and resources available to the HSE. I understand how patients and their families must feel in the circumstances, as they await decisions from the HSE on reimbursement. However, as with all new drugs developed, the HSE must follow a process.

Orkambi is indicated for the treatment of cystic fibrosis in patients aged 12 years and older who have a particular mutation in the CFTR gene. Following a request from the HSE, the NCPE completed a health technology assessment for Orkambi and submitted to the HSE in June 2016. The NCPE determined that the manufacturer failed to demonstrate cost-effectiveness or value for money from using the drug. The NCPE has confirmed that all relevant costs were included in the analysis.

The five-year gross budget impact of reimbursing Orkambi is estimated at more than €390 million and the NCPE noted the significant opportunity costs associated with reimbursing the drug. The biggest barrier to access of such medicines is the price being charged by companies. The HSE has since had further engagements with the manufacturer in an effort to secure significant price reductions for Orkambi. The HSE is considering the outcome of these engagements, together with the NCPE recommendation and other expert advice, in making a final decision on reimbursement. The HSE has advised that the decision will be made on objective, scientific and economic grounds, in line with the 2013 Act.

In regard to Kalydeco, I am informed that, following a request from the HSE, the NCPE carried out an assessment of the manufacturer's economic dossier of ivacaftor, the brand name for which is Kalydeco, for the treatment of cystic fibrosis patients aged two years and older weighing less than 25 kg. In October of this year, the NCPE recommended that Kalydeco should not be reimbursed by the HSE. The five-year gross budget impact of reimbursing Kalydeco is estimated at more than €21 million and the NCPE noted the significant opportunity cost associated with reimbursing the drug.

The HSE will enter into negotiations with the manufacturer in an effort to secure significant price reductions for Kalydeco. The HSE will consider the outcome of these engagements, together with the NCPE recommendation and other expert advice, in making a final decision on reimbursement. As already stated, the HSE has advised that it will make this decision on objective, scientific and economic grounds.

It is appropriate that these should not be political decisions and that a scientific and evidence-based approach is taken in determining the extent to which patients would benefit from treatment with expensive new drugs, the opportunity cost of such decisions on the public service and whether this represents cost-effectiveness for the health service and taxpayer.

It is essential that the HSE has everyone's support in getting the best results for patients.

Brendan Griffin (Kerry, Fine Gael)
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For the record of the House, I wish to pay tribute to Marisa Reidy, a campaigner in County Kerry who has gone public about her situation in terms of Orkambi and her daughter. I pay tribute to her bravery and her persistence in pursuing what everyone feels needs to be done.

On Kalydeco, I wish to read a particular item of correspondence I received from another Kerry family:

A few days short of our daughter's fourth birthday, when she was due to start Kalydeco, we were given the news that she would not be offered the drug on the grounds of cost effectiveness. This was the cause of much heartbreak and many tears in our household. We want to know why Kalydeco cannot be given to two to five year olds at the same agreed price as six years and over.

We know a price for Kalydeco in the six years and over category has been agreed by Vertex and the HSE in 2013. We also know that it only rightly took the bones of a week to agree said price. We would hope and pray that it would be found in the hearts of all involved to resolve this very serious matter as quickly as you did in 2013. Surely the quality of our children's lives deserves the same urgency as the original decision in 2013.

Our daughter's diagnosis was the most heartbreaking day of our lives and one that will never be forgotten, but the beautiful staff of the Butterfly unit in University Hospital Limerick helped us cope and taught us to have our cry, get it out of the way, and promised us only positivity after that. We have lived successfully under this very wise philosophy for four years until we had our hearts and the hearts of every doctor, consultant, nurse, parent and sufferer of CF broken by this mind-blowing decision. We had a carrot dangled in front of us - the closest thing to a cure there is for our beautiful child - and with no warning it was snatched away from us and so has remained gone.

Is there anything you can do to help us in our quest to get this drug available to improve our daugher's life?

I think that says it all.

Pat Gallagher (Donegal, Fianna Fail)
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I have given the Deputy an extra minute.

Brendan Griffin (Kerry, Fine Gael)
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I thank the Leas-Cheann Comhairle. This is urgent. I note from the Minister of State's reply that the HSE will enter into negotiations in respect of Kalydeco. It needs to happen today. It needs to happen now.

Pat Gallagher (Donegal, Fianna Fail)
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I call Deputy Anne Rabbite. The Deputy cannot deprive other Members.

Brendan Griffin (Kerry, Fine Gael)
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There is an urgency here and this needs to be accelerated rapidly.

Pat Gallagher (Donegal, Fianna Fail)
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I know how heart-rending it is, which is why I gave the Deputy extra time. I call Deputy Anne Rabbitte.

Anne Rabbitte (Galway East, Fianna Fail)
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Deputy Griffin need not worry. I will carry on from where he left off. What we are asking is how can we put a price on a child's life. How will we get the HSE to engage? What is the timeframe? Those are the questions. What gives us, as a political establishment, the right to put a price on a child's life? I know we have to mind the purse strings of Government and everything else in the national interest but at the end of the day we are speaking about parents, their children and their lives.

The other issue I would like to pick up on is that this depends on the weight of a child. The limit is 25 kg. The price and the weight matter. In light of what Deputy Griffin has stated, and given the HSE could make the decision for those six years old and over, the HSE needs to go back and review the situation and engage on the issue. If we can do it for six year olds, we can do it for those who are younger.

Marcella Corcoran Kennedy (Offaly, Fine Gael)
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Based on the information received from the HSE, it has advised that it is considering the outcome of the negotiations with the manufacturer of Orkambi and is entering into negotiations on Kalydeco. Having heard the Deputies' contributions, I will convey the urgency of those negotiations. No one could argue with the sentiments of those affected such as the family referred to by Deputy Griffin and Marisa Reidy and her daughter. I will convey that to the HSE.