Seanad debates

Wednesday, 10 July 2019

Nithe i dtosach suíonna - Commencement Matters

Medicinal Products Availability

10:30 am

Photo of Rose Conway WalshRose Conway Walsh (Sinn Fein)
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I thank the Minister of State at the Department of Health, Deputy Catherine Byrne, for coming to the House to respond to my Commencement matter on the status of the levodopa-carbidopa intestinal gel, LCIG, known as Duodopa. The medicine is used to treat advanced Parkinson's disease, a neurodegenerative disorder that affects 12,000 people in Ireland. The uncertainty around the availability of this treatment option for people with advanced Parkinson's first arose in June 2018. At that time, there was an expectation that certainty of supply would be achieved within three to four months. In cases where patients were in critical need of this medicine it was made available through an access programme provided by AbbVie, the company that manufactures the medicine. However, as of 30 April of this year, this route is no longer available to patients or treating consultant neurologists. I understand that 81 patients were treated under this programme. The 82nd patient and subsequent patients will be denied access to the treatment. One such patient is a man from Cork who was diagnosed with Parkinson's disease at the age of 30. He is now married with young children and is still in his 30s. He is significantly affected by his condition and urgently needs to be treated with Duodopa now, not in one month or two months, to ensure he does not miss the window of opportunity during which the treatment can have its maximum benefit for him, as a patient who is suffering unnecessarily.

Last week, the National Centre for Pharmacoeconomics, NCPE, stated on its website that the health technology assessment, HTA, for Duodopa had been completed, which is one year after the reimbursement ceased. The issue needs immediate attention. I ask the Minister of State and her ministerial colleagues to lend their support to ensuring this matter is expedited to ensure reimbursement for this medicine and equitable access to it. People should not have to travel to the UK and beyond to access the deep brain stimulation, DBS, services as some people have been forced to do. The Minister of State knows that Duodopa is a proven and tested product. The positive impact it can have on patients and their carers is immeasurable. Combining a specialist nurse service with this treatment will keep patients out of hospital and, therefore, money is saved and space in hospitals is freed up.

The costs of every other medicine for Parkinson's disease are covered. Why is Duodopa not covered? Patients do not opt for the treatment without first giving it great consideration and when it is not critically needed. However, when it becomes necessary for patients to access this treatment, they must be able to do so. The Minister of State will be aware of the procedure involved in taking this medicine. The treatment requires the medicine to be administered through a patient's intestine and is unpleasant. When there is no other option, however, this treatment becomes necessary. We urgently need a timeline or date for when we can expect to see a long overdue decision on Duodopa. There are a number of patients for whom this medicine provides a lifeline and constitutes their only sense of hope. The matter is, therefore, urgent.

Photo of Catherine ByrneCatherine Byrne (Dublin South Central, Fine Gael)
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I thank the Senator for raising this Commencement matter today. Unfortunately, the Minister for Health cannot be here, so I will take this opportunity to clarify his position on the availability of levodopa-carbidopa intestinal gel, LCIG, for patients with advanced Parkinson’s disease. As the Senator may know, the HSE has been given statutory responsibility for medicine pricing and reimbursement decisions by the Oireachtas, under the Health (Pricing and Supply of Medical Goods) Act 2013. That Act specifies criteria for decisions on whether the State will reimburse medicines, a statutory process in which the Minister for Health has no role. The HSE's decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, including on the advice of the National Centre for Pharmacoeconomics, NCPE. The NCPE conducts health technology assessments, HTAs, for the HSE, and then makes recommendations on reimbursement to assist HSE decisions. The NCPE uses a decision framework to systematically assess a drug’s clinical and cost effectiveness as a health intervention. The HSE strives to reach a decision in as timely a manner as possible. However, because of the significant moneys involved, it must ensure the best price is achieved, as these commitments are often multi-million euro ongoing investments. This can lead to a protracted deliberation process.

On 14 June 2019, the NCPE completed an HTA on LCIG for patients with advanced Parkinson’s disease. The NCPE recommended that LCIG should not be considered for reimbursement, unless cost-effectiveness can be improved relative to existing treatments. That recommendation is available on the NCPE website. The HSE’s final decision on reimbursement will take the statutory criteria in the 2013 Health (Pricing and Supply of Medical Goods) Act into consideration. Under an interim agreement between the HSE and the manufacturer, dating back to 2014, the HSE has agreed to fund this drug for up to 81 patients. The manufacturer agreed to fund the treatment of any new patients above that cap through a medical access programme. This interim agreement was dependent on the manufacturer delivering two things, namely, additional clinical evidence and a new HTA dossier to enable the NCPE to complete a full HTA on this product. However, the HSE has informed the Department that the manufacturer has unilaterally set aside this agreement. Furthermore, the company announced that it would not be enrolling any new patients in the free of charge access programme after 30 April 2019, which the Senator has already mentioned. The manufacturer stated that it would continue to provide the drug free of charge to patients already on the access programme, which is a total of 24 patients. I want to make it clear to the Senator that the HSE has yet to make a final decision on this reimbursement application and the statutory process is still ongoing.

Photo of Rose Conway WalshRose Conway Walsh (Sinn Fein)
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I thank the Minister of State for her response. I ask her to ask the Minister, or the HSE directly, to sit down with the manufacturer and negotiate on the price of the drug. I understand the processes involved, the limited resources and everything else around it. However, can the Minister of State imagine what it must be like to be patient No. 82 in this situation? I cited the example of the 30 year old patient earlier. We are not playing with numbers here, but with people's lives. If the HSE sits down with the manufacturer and works out a price, then it can be agreed, as has happened in many other cases.

The effectiveness of the drug treatment is borne out by the fact that it is approved in other countries. It cannot be different for an Irish person living in London or somewhere else in the UK than it is for someone living here. We cannot force patients to go abroad. I am no friend of drug manufacturers, and they need to decrease their prices, but we cannot expect them to continue providing treatment free of charge indefinitely either. There has to be some fairness there. I ask the HSE to sit down with the drug company at the earliest possible moment and negotiate the price, within weeks rather than months. I am concerned that we are now going into the holiday period. Is there is any way this could be done before the end of July, so that the uncertainty will be removed for these patients going into August and September?

Photo of Catherine ByrneCatherine Byrne (Dublin South Central, Fine Gael)
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The Parkinson's Association of Ireland, among other groups, has been in contact with the Minister. He appreciates that Parkinson's disease is a debilitating condition and that it is a worrying time for patients, families and carers. While the Minister hopes this application will shortly come to a satisfactory conclusion for all concerned, it is important to note that the HSE is the decision-making body on the reimbursement of medicines, under the Health (Pricing and Supply of Medical Goods) Act 2013. Accordingly, the HSE alone will make the final decision on whether LCIG will be reimbursed. However, I will bring Senator Conway-Walsh's question back to the Minister and will ask him to contact the HSE to see if the decision on this vital medication, that so many people badly need, can be made sooner rather than later. I will bring that back to him.

Photo of Rose Conway WalshRose Conway Walsh (Sinn Fein)
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I very much appreciate that. Could the Minister of State ask the Minister if it could be included in the July meeting, if at all possible?

Photo of Catherine ByrneCatherine Byrne (Dublin South Central, Fine Gael)
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I will.

Sitting suspended at 11.27 a.m. and resumed at 11.30 a.m.