Marian Harkin (Sligo-Leitrim, Independent)
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When will Duodopa, which was approved for reimbursement in February 2020, be sanctioned for use by patients who urgently need it? Duodopa is manufactured by AbbVie, which has a number of manufacturing plants along the west coast. It seems we are very good in this country at manufacturing new medicines but we lag behind when it comes to making those medicines available to people living here. This medicine has taken 26 months to go through the reimbursement approval process. The HSE's drugs group approved it for reimbursement in February but, eight months later, we are still waiting for it to be sanctioned.

There was a big announcement in the budget of an allocation of €50 million for new medicines. In fact, the Minister for Health, Deputy Stephen Donnelly, singled out Parkinson's disease when speaking about that allocation. Duodopa is used to treat advanced Parkinson's disease when no other medicines have worked. I am aware of a person who has been in hospital for more than a month awaiting the go-ahead to be treated with the drug. I will not name the hospital in question in case it might identify the patient. This person cannot leave the hospital and every day must be like a week and every week like a month as progress is awaited. I really hope the Minister of State can offer me good news by giving a date for the sanctioning of Duodopa under the reimbursement scheme.

Anne Rabbitte (Galway East, Fianna Fail)
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I thank the Deputy for raising this important issue and for giving me the opportunity, on behalf of the Minister, to provide as much clarity as possible on the availability and reimbursement of Duodopa for patients with advanced Parkinson's disease.

As the Deputy may know, the HSE was 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 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 making a decision. The HSE strives to reach a decision on drug reimbursement in as timely a manner as possible. However, because of the significant moneys involved, it must ensure that the best price is achieved, often leading to a protracted deliberative process.

On 14 June 2019, the NCPE completed an assessment of the drug for patients with advanced Parkinson's disease and recommended that it should not be considered for reimbursement unless its cost-effectiveness could be improved compared to other existing treatments. This recommendation is available to view on the NCPE website. Following this recommendation, the HSE entered into lengthy pricing negotiations with the manufacturer. When these concluded, the reimbursement was formally considered by the HSE drugs group over two meetings, the second of which was held in February, as the Deputy indicated.

The Minister wishes to make it clear to the Deputy that Duodopa was not approved for reimbursement in February. Instead, it was at that time that the drugs group made a positive recommendation to the HSE executive management team. This was in the context of the recognised unmet need, the clinical evidence, and its cost-effectiveness. The drug is one of a number of medicines with a significant budget impact awaiting a decision by the HSE executive management team.

The HSE has yet to make a final decision on this specific reimbursement application and the statutory process is still ongoing. However, the House will be aware that an additional €50 million, which Deputy Harkin mentioned, was allocated to the HSE in budget 2021 to enable the approval of new medicines. The Minister understands that the reimbursement of Duodopa will be considered in that context.

Marian Harkin (Sligo-Leitrim, Independent)
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I thank the Minister of State. Unfortunately, she did not give me a timeline or a date. It was very clear from my question and from what I have said that this is what the family are waiting for. This is a 26-month process. The Minister of State has quite rightly pointed out that it was the drugs group that made a positive recommendation last February. What has been the hold-up since then, especially since the Minister made all of this extra money available for new drugs and specifically spoke about drugs for Parkinson's disease? This family sees other families able to access this drug. They know it works and that it is the only thing that will work for their loved one. They are glad to see others receiving it but they are still waiting. The Parkinson's groups in the north west and in Mayo are waiting to hear what the Minister of State has to say on this because there is no other drug that will fit the bill. I ask the Minister of State to make her very best effort, as I know she will, to speed this process up as much as possible. I am disappointed, not for me, but for the person I know who is waiting and who is listening to this debate. I honestly thought I might have heard some positive news. I will leave it with the Minister of State. I would appreciate it if she would come back to me as soon as she can.

Anne Rabbitte (Galway East, Fianna Fail)
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I will take on board what Deputy Harkin has said and will talk to the Minister about it. I compliment the wonderful work of the Parkinson's groups. The Deputy has mentioned those is Mayo and the north west. It would be remiss of me not to mention the Parkinson's group in Galway as well. In his note to me, the Minister stated that he hopes that the final decision on this reimbursement application concludes shortly for all concerned. This comes from his note. I will follow up with him on foot of what we have discussed. The Deputy might let the family know that.