Joe O'Reilly (Fine Gael)
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I welcome the Minister of State, Deputy Niall Collins, to the House and thank him for taking this matter. Like most people, I am not quite sure how to pronounce the name of this drug, Duodopa, but this is my best shot. It is the only flippant remark I can make about this, as it is otherwise a very serious matter.

Duodopa is a pump-based system that infuses a liquid form of Parkinson's disease medication, levodopa, to provide more consistent relief of symptoms on a minute-by-minute basis. It is very effective and there are approximately 100 patients in Ireland who would benefit from it. Patients would typically claw back three to four hours per day of normal function that would previously have been lost to immobility. There is no question as to its clinical benefit and it is generally used in patients with the most significant disability and who therefore have most to gain from its use. It is worth noting that without it, people may be housebound and reliant on carers, presenting both the people in question and the State with a cost that must be factored into assessments.

This issue relates to 100 patients from 10,000 sufferers of Parkinson's disease, or 1% of the total, but for those 100 people it is the difference between having some sort of quality of life and none. The drug is everything to them. It is like winning the lottery because it provides quality of life for them and their families, loved ones and carers. It is critical to those 100 cases. We are talking about 100 individuals rather than any type of statistic. The National Centre for Pharmacoeconomics found it cost-effective at a cost of €30,000 per year. It would be transformative for those who get it.

A separate but related matter is the development of the national deep brain stimulation service in the Mater and Beaumont hospitals. Deep brain stimulation is a surgical treatment for Parkinson's disease that is an alternative to Duodopa and is relevant for approximately 5% of patients, or 500 people. People have traditionally gone to the UK for this treatment.That is hardly satisfactory in a Covid context or in any other context. Professor Tim Lynch of the Mater hospital, Dr. Richard Walsh of Beaumont Hospital and Ms Catherine Moran of Mater and Beaumont hospitals, as well as a very nice and helpful nurse named Katrina with whom I had a conversation - I apologise that I do not have her surname before me - and who is extraordinarily helpful and committed to this cause, are all working on this issue. There are approximately 50 patients waiting for surgery and they hope to perform the first deep brain stimulation in Beaumont hospital this year. A business case for funding for this initiative has gone to the HSE. The Minister for Health, Deputy Donnelly, allocated €50 million for new therapies in the budget and he specifically mentioned Parkinson's disease in his remarks. Duodopa and deep brain stimulation are central to all of this. I look forward to the reply of the Minister of State.

Niall Collins (Limerick County, Fianna Fail)
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I thank the Senator for raising this issue and for giving me, on behalf of the Minister for Health, the opportunity to clarify the position on the availability of levodopa-carbidopa intestinal gel, known as Duodopa, 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 under the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies certain criteria for decisions on whether the State will reimburse medicines. The Minister for Health has no role in this statutory process. HSE 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 assessments on behalf of the HSE and then makes recommendations on reimbursement to assist the HSE in its decision-making.

The HSE strives to reach a decision on drug reimbursement in as timely a manner as possible. Due to the significant moneys involved, however, it must ensure that the best price is achieved, often leading to a protracted deliberative process. Under an interim agreement between the HSE and the manufacturer dating back to 2014, the HSE agreed to fund this drug for up to 81 patients. The manufacturer agreed to fund the treatment of any new patients above the cap of 81 patients through a medical access programme. However, the HSE was informed in 2019 that the manufacturer had unilaterally set aside this agreement. The manufacturer agreed that it would continue to provide the drug free of charge to patients already on the access programme but stated that it would not be enrolling any new patients in the free of charge access programme after 30 April 2019.

On 14 June 2019, the NCPE completed an assessment of Duodopa for patients with advanced Parkinson's disease and recommended that it should not be considered for reimbursement unless its cost-effectiveness compared with other existing treatments could be improved. This recommendation is available to view on he NCPE website. Following this recommendation, the HSE entered into lengthy pricing negotiations with the manufacturer. When these concluded, the reimbursement of Duodopa was formally considered by the HSE drugs group over two meetings, the second of which was held in February 2020. At that time the drugs group made a positive recommendation for reimbursement to the HSE executive management team. This was in the context of the recognised unmet need, the clinical evidence, the cost-effectiveness evidence and the resources available to the HSE.

It is important to note that Duodopa is only one of the medicines with a significant budget impact awaiting decision by the HSE executive management team.The HSE has yet to make a final decision on the specific reimbursement application and the statutory process is ongoing. I am happy to report to the House, however, that €50 million has been allocated to the HSE in budget 2021 to enable the approval of new medicines.

Joe O'Reilly (Fine Gael)
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I am encouraged by this paragraph in the Minister of State's reply:

At that time the drugs group made a positive recommendation for reimbursement to the HSE executive management team. This was in the context of the recognised unmet need, the clinical evidence, the cost-effectiveness evidence and the resources available to the HSE.

That was in February 2020. I ask the Minister of State if he could arrange, through the Department, for me to get a note specific to this recommendation regarding when it will be implemented and when Duodopa will be available to patients. In the same context, I also ask the Minister of State to get me a brief on deep brain stimulation as a parallel treatment for another 5% of people. I look forward to the Minister of State's response.

Niall Collins (Limerick County, Fianna Fail)
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I will ask the Department and the HSE to follow up on the Senator's requests. We appreciate that Parkinson's disease is a debilitating condition and fully acknowledge that it is a worrying time for patients, families and carers, as Senator O'Reilly outlined in his remarks. I hope for all concerned that a final decision on this reimbursement application is reached shortly. It is important to note, however, that the HSE is the decision-making body for the reimbursement of the costs of medicines under the Health (Supply and Pricing of Medical Goods) Act 2013. The Senator will be aware that the Government has provided €50 million for new medicines in 2021 and it is anticipated this new funding will enable the HSE to approve a significant number of new medicines this year.

Pauline O'Reilly (Green Party)
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I thank the Minister of State and Senator O'Reilly. I believe there will be follow up on that issue.