Dáil debates

Thursday, 8 November 2018

Saincheisteanna Tráthúla - Topical Issue Debate

Medicinal Products Availability

3:35 pm

Photo of Caoimhghín Ó CaoláinCaoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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This is the second time in a relatively short period in which the Minister has not been present to answer a Deputy's questions. I protested strongly on the previous occasion, when the Minister of State, Deputy Finian McGrath, presented, and I now see the Minister of State, Deputy Catherine Byrne, will be replying. I respect the Minister of State greatly but this is simply not an acceptable practice. I had understood that there is an obligation on the primary Minister to present and answer a Deputy's Topical Issue when selected. I very much regret what is happening. It is most unacceptable. I am sure the Minister of State will convey my comments to the Minister, Deputy Harris.

I recently wrote to the Minister about Spinraza, or nusinersen, seeking a one-to-one meeting with him. Not only has he not been in attendance on the two occasions on which I sought to address this very important matter, he has also written to me declining my request to meet him to address it. That is most strange. Here I am again seeking to establish exactly matters things stand with respect to the need to approve the drug Spinraza - or nusinersen, to give it its formal name - for HSE reimbursement. This is absolutely a must and it should be done without further delay. I understand there have been direct talks with the manufacturing pharmaceutical giant, Biogen, which makes Spinraza. I also understand that Ireland has been offered the same arrangement as was negotiated by the BeNeLuxA group of states, namely, Belgium, Netherlands, Luxembourg and Austria. We have now joined the BeNeLuxA initiative.

It is my view, which I would have put directly to the Minister, that any negotiation such as that specific to Spinraza with Biogen in this instance, or in any other comparable negotiation, should seek to widen the scope of engagement to take into account all possible areas for address, including what other benefits could be secured in our collective interest as a people. I speak of exploring what other financial savings could be achieved by examining other product lines manufactured by Biogen. It would include biosimilars relating to other branded drugs that we currently have access to in this jurisdiction. The focus is on Spinraza but significant gains could be made by widening the scope of the engagement with Biogen. There is the potential for real and substantial savings to be made not only with the initial cost of Spinraza and the significant reduction that the BeNeLuxA negotiation has made available to us but also through other savings that could be made by replacing branded products that are currently available and that are prescribed by general practitioners. They could be replaced with biosimilars currently produced by Biogen.

I apologise as I had not realised the time allocation had elapsed. I am making the point that it is within the gift of the Minister, the Department and the HSE to ensure this exercise can bring a financial reward that could see us reach a position where there would be no additional cost to the public purse because of an imaginative and thoughtful approach to the project.

Photo of Catherine ByrneCatherine Byrne (Dublin South Central, Fine Gael)
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I apologise for the Minister not being here. The last time I saw him he was attending a committee meeting. He must be still there. I have been asked to take this Topical Issue on his behalf and I thank Deputy Ó Caoláin for raising it.

Nusinersen or Spinraza is indicated for the treatment of spinal muscular atrophy, SMA, a disorder characterised by progressive muscle atrophy and weakness. The Minister appreciates that this debilitating and progressive condition places enormous pressure on SMA sufferers and their families and carers and that access to potentially beneficial drug treatments is an extremely important issue for people with spinal muscular atrophy. As the Deputy is aware, the Oireachtas has put in place a robust legal framework in the Health (Pricing and Supply of Medical Goods) Act 2013, which gives full statutory powers to the HSE to assess and make decisions on the reimbursement of medicines, taking account of a range of objective factors and expert opinion as appropriate. The Act gives the criteria to be applied in the making of reimbursement decisions, which include the clinical and cost-effectiveness of the product, the opportunity cost and the impact on resources that are available to the HSE. In reaching its decision, the HSE will examine all relevant evidence and will take into account such expert opinions and recommendations that are appropriate, including from the National Centre for Pharmacoeconomics, NCPE.

The HSE received an application for the reimbursement of Spinraza in July 2017. The NCPE conducted a health technology assessment on Spinraza and did not recommend the reimbursement of Spinraza at the submitted price. The statutory assessment process involves a health technology assessment followed by detailed consideration by the HSE expert groups on new drug therapies, including the technology review group for rare diseases and the drugs committee. The assessment is particularly centred on reviewing the evidence of the clinical effectiveness of this new drug therapy, for example the benefits for patients undergoing clinical trials. The application is currently undergoing the final stages of assessment and the various reports are due to be considered shortly by the HSE leadership team, following which the final decision will be notified.

In July 2018, two members of the BeNeLuxA initiative on pharmaceutical policy, Belgium and the Netherlands, completed a joint negotiation for the reimbursement of Spinraza. However, this joint negotiation process commenced when Ireland had only opened negotiations with Belgium, the Netherlands, Austria and Luxembourg with a view to joining the existing collaboration between these four countries. As a candidate country, Ireland was not notified due to confidentiality arrangements that negotiations were occurring for the reimbursement of Spinraza and we were not party to the negotiations and proceedings that occurred. I understand the Deputy's frustration.

Photo of Caoimhghín Ó CaoláinCaoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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We are talking about 25 seriously ill children and double that number of adults who would benefit directly from access to Spinraza. I will speak to the BeNeLuxA initiative and the negotiation process available to Ireland for Spinraza.

It would mean that each vial, costing €83,000 each, would cost less than €50,000 as a result of the BeNeLuxA position that gives a significant saving of €33,000 per vial. In year one, six vials would be used and in each subsequent year it would be down to three vials per year in relation to those who would benefit directly from it.

While it is still a considerable sum, Biogen, like many of the other pharma giants, is a significant player in the production of many products, some branded and some biosimilar. We do not appear to have a biosimilar strategy in this State but I am asking the Minister of State to convey to the Minister for Health that from my examination of Biogen's range of products, there is the potential to engage seriously with it on biosimilars for other drugs that are currently costing us significant sums annually in tandem with the negotiation on Spinraza. A saving can be negotiated with Biogen that would eliminate the total cost of the introduction or approval of the reimbursement of Spinraza in this State. That would mean a lot for the children, families and parents in each of these cases.

I appeal to the Minister of State as a mother and a grandmother to impress on the Minister that the answer that I have received here today is not worth the paper it is written on. I have given more information than he has been willing to share in recent times and he has not yet presented in the House to address this issue. I appeal to the Minister of State to impress on him the importance of a decision in the favour and interest of these children.

3:45 pm

Photo of Catherine ByrneCatherine Byrne (Dublin South Central, Fine Gael)
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I reiterate that the HSE is the body that makes the decision on the reimbursement of medicine under the Health (Pricing and Supply of Medical Goods) Act 2013.

I understand the Deputy's concerns and his interest in this. I listened carefully to what he has said and I am a mother and a grandmother so I understand that when children are ill we must do our best and beyond our best to look after them. In many ways they are the jewel in all of our crowns as parents and grandparents. I will appeal on the Deputy's behalf and on a personal basis to the Minister to look at some of the recommendations and points that the Deputy has raised when I get a chance to talk to him this evening or tomorrow. I will appeal to him on the Deputy's behalf to meet with the Deputy at some stage to discuss further some of the points the Deputy has raised with me today. Unfortunately I do not have the same level of knowledge on this as the Deputy so I am reluctant to speak further on it.

Photo of Seán Ó FearghaílSeán Ó Fearghaíl (Ceann Comhairle; Kildare South, Ceann Comhairle)
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The matter will be brought to the attention of the Minister by the Minister of State.

The general issue that Deputy Ó Caoláin raised is of concern to me. We have been trying to arrive at a point where Ministers who have Topical Issues tabled to them would correspond with my office or with the Deputy concerned directly to let them know whether they will be available or not to take the Topical Issue, thereby giving the Deputy the opportunity to defer the Topical Issue to another stage. That is what we all want to see happening. It is important that we accept that Ministers have a lot of responsibilities and that they cannot be in two places at once, but equally they have to treat the Topical Issues debate here seriously.