The 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. As Minister for Health, I do not have any statutory power or function in relation to the reimbursement of medicines. In addition, Section 6 of the HSE Governance Act 2013 precludes me from directing the HSE to provide a treatment or a personal service to any individual or to confer eligibility on any individual.
In line with the 2013 Act, if a company would like a medicine to be reimbursed by the HSE pursuant to the community drugs schemes, the company must first submit an application to the HSE to have the new medicine added to the reimbursement list.
As outlined in the Framework Agreement on the Supply and Pricing of Medicines, and in line with the 2013 Act, the HSE will decide, within 180 days of receiving the application (or a longer period if further information is sought from the company), to either add the medicine to the reimbursement list or agree to reimburse it as a hospital medicine, or refuse to reimburse the medicine.
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.
I have been informed that the NCPE completed a rapid review on Niraparib (Zejula) on 21 June 2018. They recommended that a full HTA be conducted to assess the clinical effectiveness and cost effectiveness of niraparib compared with the current standard of care. The HSE commissioned the HTA on 27 June 2018.