Pádraig O'Sullivan (Cork North Central, Fianna Fail)
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1190. To ask the Minister for Health if consideration will be given to developing an ovarian-breast cancer specific strategy in view of a recent study titled “Comparator Report on Cancer in Ireland – Disease Burden, Cost and Access to Medicines”, which found that patient access to newer cancer medicines is limited and comes later in Ireland compared to other EU countries, and shows that Ireland’s survival rates for the disease continue to lag behind the best performers; and if he will make a statement on the matter. [55267/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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The National Cancer Strategy 2017-2026 provides the blueprint for the development of cancer services in Ireland over its lifetime. The goals of the Strategy are to reduce the cancer burden; to provide optimal care; to maximise patient involvement and quality of life; and to enable and assure change and maximise patient involvement.

The mortality rate for breast cancer in Ireland has steadily and significantly declined in Ireland over the period 1994-2018. This is due to a combination of factors, including screening (BreastCheck) and treatment improvements. This is also evident in the survival rates for breast cancer, which have increased from 69% in 1994-1999 to 88% for those diagnosed between 2014-2018.

The Strategy brought about an integrated cancer control and surveillance service for defined population subgroups with an inherited familial predisposition to cancer. Ovarian cancer risk may be higher in women who have a faulty BRCA gene mutation in their family. Screening or risk-reducing surgery will be offered if you are considered at increased risk.

The HSE's National Cancer Control Programme (NCCP), in conjunction with the National Clinical Effectiveness Committee, published a National Clinical Guideline on Ovarian Cancer in August 2019. The guideline is based on best research evidence, in conjunction with clinical expertise and patient preferences, and was developed using a clear evidence-based methodology that is used internationally.

The overall objectives of the National Clinical Guideline on Ovarian Cancer are:

- to improve the quality of clinical care, improving patient outcomes by reducing morbidity and mortality;

- to reduce variation in practice and improve consistency and standards of care by promoting interventions of proven benefit - and discouraging ineffective ones; and 

- to address areas of clinical care with new and emerging evidence.

The NCCP works to ensure strong focus on early detection, including through development and delivery of public awareness campaigns and educational initiatives for healthcare providers and community organisations.

The continued implementation of the recommendations from the National Cancer Strategy 2017-2026 will advance the main goal of the strategy, which is to prevent cancer across our population.

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 licenced 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.

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. In 2022 the Government allocated €35m extra funding, which included €20m for new development funding, and €15m for new cancer drugs.