Dáil Éireann Debate, Tuesday - 8 November 2022
997. Deputy Colm Burke asked the Minister for Health if his Department will put in place a strategy which will help to improve the time period where patients can get access to newly approved cancer medicines in Ireland, given that the average time period to the reimbursement decision following European Medicines Agency approval is in excess of two years, which is double the time for the EU-15 average; and if he will make a statement on the matter. [54531/22]
View answer999. Deputy Colm Burke asked the Minister for Health the strategy that his Department intends to put in place to improve the reimbursement timelines for new cancer medicines, in view of patient access to newer cancer medicines being lower and taking a longer time period in Ireland in comparison to other EU15 countries, and also taking into account that the provision of access to new, more effective treatments, whilst operating on constrained budgets, is shared by all countries; and if he will make a statement on the matter. [54533/22]
View answer1000. Deputy Colm Burke asked the Minister for Health if consideration will be given to reviewing the rigorous statutory assessment arrangements in Ireland, regarding the reimbursement process for new cancer medicines, given the five-year net survival rate for all invasive cancers averaged 65% for cancer patients diagnosed between 2014 and 2018, which is in the middle and lower end of survival rates across all invasive cancers in the EU15 countries during the same time period, to improve survival rates and save additional lives of cancer patients going forward; and if he will make a statement on the matter. [54534/22]
View answerI propose to take Questions Nos. 997, 999 and 1000 together.
The Health (Pricing and Supply of Medical Goods) Act 2013 provides a rigorous process for the assessment of new medicines for reimbursement. This allows taxpayers to be confident both that the right medicines are chosen, and that those medicines are approved at a price that can sustainably be afforded in a budget-limited health service. Economic assessment is valuable to stretch the funds granted to the HSE as far as possible, allowing them to provide a range of services as well as innovative medicines for all citizens.
The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority. In line with the 2013 Act, and the national framework agreed with industry, a company must first submit an application to the HSE to have a new medicine added to the reimbursement list.
The timing of company applications for reimbursement in different countries can vary for a number of reasons, not least the available market share in each country. Once a company responsible for the commercialisation of a new medicine receives market authorisation, it can apply for reimbursement in the country (or countries) of its choice. Ireland, by virtue of its size and market share, may not always be prioritised by a company in the first stages of marketing a new product. Describing timelines for reimbursement from EMA approval to HSE reimbursement approval does not consider this important factor and misrepresents the process, as statutorily the HSE would not be able to approve or assess a drug until an application for reimbursement was received.
When an application is made to have a product added to the reimbursement list in Ireland, the HSE is required, under the 2013 Act, to decide within 180 days of receiving the application, to either add the medicine to the reimbursement list or refuse to reimburse the medicine. In assessing the application, the HSE is required to consider a range of criteria including the magnitude of the clinical effect, cost effectiveness, budget impact, opportunity cost and unmet need.
The principal factors in determining the speed of reimbursement are the price at which a manufacturer applies for the reimbursement of a product and the outcome of the HSE’s rigorous assessment process as to its clinical and cost-effectiveness.
In terms of the time taken from application to a decision on reimbursement, the HSE advise that the biggest impediments to achieving the 180-day timeline is often the failure of companies to provide sufficient evidence to support the efficacy of some medicines, and the need for the HSE to get involved in protracted negotiations in seeking to achieve better prices for the State.
The State is committed to providing timely access to new and innovative medicines to all patients. Budget 2021 allocated €50 million for the reimbursement of new drugs, enabling the HSE to approve fifty-two new medicines. This included twenty-seven oncology medicines and nineteen medicines for the treatment of rare diseases.
Budget 2022 has allocated a further €30 million for the reimbursement of new medicines and as of 7 November the HSE has approved reimbursement for 47 new drugs, 14 of which were for oncological use. Further dedicated funding has also been announced for new drugs in Budget 2023.
