Dáil Éireann Debate, Thursday - 15 November 2018
107. Deputy Donnchadh Ó Laoghaire asked the Minister for Health the status of plans being made by the Health Products Regulatory Authority and-or the Health Service Executive to license and make available for reimbursement the drug Ocrevus; and if he will make a statement on the matter. [47456/18]
View answerThe HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies the criteria for decisions on the reimbursement of medicines.
HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE). The NCPE conducts health technology assessments (HTAs) for the HSE and makes recommendations on reimbursement to assist HSE decisions. The NCPE uses a decision framework to systematically assess whether a drug is cost-effective as a health intervention.
The HSE strives to reach a decision in as timely a manner as possible. However, because of the significant monies involved, it must ensure that the best price is achieved, as these commitments are often multi-million euro investments on an on-going basis. This can lead to a protracted deliberation process.
The European Medicines Agency provided Ocrelizumab (Ocrevus) with market authorisation in January 2018.
The NCPE completed a health technology assessment on 29 August 2018 for Ocrelizumab (Ocrevus) for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS). They recommended that Ocrelizumab (Ocrevus) not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments.
On 4 October 2018 the NCPE completed a health technology assessment for Ocrelizumab (Ocrevus) indicated for the treatment of adult patients with early primary progressive multiple sclerosis (PPMS). They did not recommend that Ocrelizumab (Ocrevus) be reimbursed for this indication.
The HSE is the statutory decision-making body for medicine reimbursement. It will make the final decision on whether Ocrelizumab (Ocrevus) will be reimbursed, taking into consideration the statutory criteria in the 2013 Health Act.
