Catherine Byrne (Dublin South Central, Fine Gael) | Oireachtas source

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.