Niall Collins (Limerick County, Fianna Fail) | Oireachtas source

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.