Dáil Éireann Debate, Wednesday - 3 February 2021
707. Deputy Róisín Shortall asked the Minister for Health his plans to raise awareness of the risk of ovarian cancer to women who might have undiagnosed cancer; the availability of zejula and niraparib as a treatment for ovarian cancer here; and if he will make a statement on the matter. [5338/21]
View answerThe HSE's National Cancer Control Programme, 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 HSE's National Cancer Control Programme (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.
With regard to the use of Niraparib (Zejula®) as a treatment for ovarian cancer, the HSE has a standard assessment process in place for the approval of the reimbursement of new drugs, and new indications for existing drugs. This process is intended to arrive at decisions on the funding of drugs that are clinically appropriate, fair, consistent and sustainable. The reimbursement process is underpinned by the Framework Agreement on the Supply and Pricing of Medicines (2016), and the Health (Pricing and Supply of Medical Goods) Act 2013.
Before a medicine is licensed for use in the European Union, and before it can be marketed for sale in the EU, it must receive a market authorisation from the European Medicines Agency (EMA). Once drugs are licensed, the company may apply for HSE reimbursement approval using the standard process outlined above.
Niraparib (Zejula®) is a Poly polymerase inhibitor (PARPi). These are a novel class of anti-cancer therapies. Niraparib (Zejula®) is currently being considered in line with the HSE reimbursement process. Ahead of the conclusion of this process, the reimbursement of Niraparib is not approved for reimbursement by the HSE.
