Seanad debates

Wednesday, 17 October 2018

Commencement Matters

Medicinal Products Availability

10:30 am

Photo of Keith SwanickKeith Swanick (Fianna Fail)
Link to this: Individually | In context | Oireachtas source

I asked that the Minister come to the House so that I could echo my colleagues, Deputies Calleary and Lisa Chambers, and my Seanad colleague, Senator Conway-Walsh, in calling for the drug Spinraza to be made immediately available. Spinal muscular atrophy, SMA, is a group of inherited diseases of the motor nerves that cause very debilitating muscle weaknesses and wasting. It is life threatening, rare and the leading cause of death in infants and toddlers. There are 25 children in this country with this condition. It presents them with several burdens. They are wheelchair bound, suffer muscle recession and considerable pain and the day-to-day exercise of their lives is virtually impossible in things such as handwriting and other small things. I have met some of their family members. All they want is to give their children the best life they can.

Hope for these children comes in the form of Spinraza, the first treatment of its kind in the world. There is significant evidence from countries across the world, and from clinical trials, that Spinraza is changing children's lives significantly, slowing down muscle wastage and, in many cases, allowing muscle strengthening to occur which allows them to live a much more active, healthy life. Grace O'Malley from Robeen near Ballinrobe in County Mayo, along with her parents Paul and Lorraine, and other family members of those suffering from SMA are begging for access to this drug. They know it will not cure Grace but they also know from the CHERISH trial results, which outline the effectiveness of Spinraza, that these are the children who are most at risk of losing the muscle function which Spinraza has the potential to greatly manage and to improve Grace's condition and afford her some level of independence.

Earlier this year, Ireland entered an international alliance with the Benelux countries which was said would strengthen Ireland's hand in negotiations with big pharmaceutical companies. The Minister, Deputy Harris, hailed it as an agreement that would improve Irish patients' access to new and innovative drugs. I, like many others, am waiting to see the fruits of this arrangement. The Minister's repeated reference to the Netherlands and Belgium negotiating for Spinraza prior to Ireland joining the Benelux countries' initiative is misleading and confusing, considering the statement from Biogen on 20 September which said that in July 2018, Ireland was offered the same terms as other countries, regardless of the time of joining the initiative.

The latest information received by the families is that Spinraza has been referred to the rare diseases technical review committee. They have questions to which I would like answers. Who forms this committee? How does it differ from the National Centre for Pharmacoeconomics, NCPE, assessment? I understand that Professor Michael Barry is the head of the NCPE and the rare disease review committee, which raises a question about the impartiality of this whole process. As there is no new medical information to consider since the original dossier was presented to the NCPE, what exactly will it consider? The evidence will be the same as will the people. Will this review group engage with the patients? Has a timeframe been put on the assessments given the very serious nature of the disease?

Photo of Jim DalyJim Daly (Cork South West, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I thank Senator Swanick for raising this matter.

Spinraza is indicated for the treatment of 5q spinal muscular atrophy, SMA, a disorder characterised by progressive muscle atrophy and weakness. I am mindful of the fact that access to potentially beneficial drug treatments is an important issue for all people with serious illnesses. I fully appreciate that SMA sufferers and their families face enormous day-to-day challenges in dealing with this progressive and debilitating condition.

Securing access to new and innovative medicines in a timely manner is a key objective of the Irish health service. The challenge is to deliver on this objective in an affordable and sustainable way. 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 specifies the criteria to be applied in making a reimbursement decision, 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 the relevant evidence and take into account such expert opinions and recommendations that are appropriate, including from the National Centre for Pharmacoeconomics, NCPE. This ensures that each reimbursement decision is made on objective, scientific and economic grounds.

The HSE received an application for the reimbursement of Spinraza in July 2017 and referred it to the NCPE for advice. The NCPE conducted a health technology assessment on Spinraza and did not recommend reimbursement at the price sought by the applicant. The application for the reimbursement of Spinraza is currently being considered by the technology review committee on rare diseases and the HSE drugs group. These expert bodies are carefully reviewing the clinical effectiveness and cost effectiveness of the product in light of the prices being charged by the company which make it a very high cost treatment.

Photo of Keith SwanickKeith Swanick (Fianna Fail)
Link to this: Individually | In context | Oireachtas source

This is nothing personal but I am disappointed with the Minister of State's answer, which is pretty generic. What will the rare disease committee review? The information is exactly the same as that already received by the NCPE. The dossier is exactly the same, as are the patients and the medical evidence. That is not an adequate answer for people such as Grace and her parents. I have put four or five questions to the Minister of State and have listed them on a piece of paper that I will give to him because I sought specific answers to them. Why is this process being delayed? Why have the families heard nothing? When will a decision be made? Will the families be engaged with in this process because currently there is no engagement. I remind the Minister of State that a petition has been signed by more than 40,000 people. This may be an orphan drug, used in rare conditions by a small number of people in this country, but there is a far greater movement of people behind them who understand that price should never be an issue when it comes to children's lives.

Why has the process has been delayed? Why are the families hearing nothing about it and will they be engaged with? I remind the Minister of State that this drug is being reimbursed in countries such as Romania, Slovenia, Slovakia, Cyprus, Lithuania and Croatia. It is time we showed some respect to this cohort of patients and reimburse this drug as a priority.

Photo of Jim DalyJim Daly (Cork South West, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I think Senator Swanick understands better than most that it is not a decision for politicians. The House made that decision in 2013 when the Health (Pricing and Supply of Medical Goods) Act was passed by both Houses. It was agreed that politicians would not decide what drugs would be reimbursed and what prices would be paid to drug companies. I agree with that.I do not think politicians should make those decisions. The Senator has a number of questions. I respectfully suggest that he refers to the Health (Pricing and Supply of Medical Goods) Act 2013, which will answer each of his five questions, or at least four of them. If there are any specific questions, it would be more appropriate to direct them to the HSE because neither I nor the Minister have any role or function in this process. That has been a decision taken by the House. The Senator said price should never be a barrier when it comes to the health of children. The State is not going to approach drug companies, which are part of a multi-billion euro industry, with that mantra and suggest that price will never a barrier to approving any drug. That would be reckless, irresponsible and dangerous in the extreme. As these are powerful multinational companies - multi-billion euro companies - that have a lot to gain, there is a healthy tension there that demands time and necessitates things being done properly and a process that is held up to scrutiny, transparency, clinical effectiveness and cost effectiveness because, as the Senator and all of us here are aware, there are many competing demands on the limited resources that are available to the HSE on an annual basis for the delivery of services.

Photo of Keith SwanickKeith Swanick (Fianna Fail)
Link to this: Individually | In context | Oireachtas source

This cohort of patients is very small. As Biogen has offered the drug for the same price as that in the Benelux countries, we would not be paying any excess.