Anne Rabbitte (Galway East, Fianna Fail) | Oireachtas source

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.

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