The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. As Minister for Health I do not have any statutory power or function in relation to the reimbursement of medicines. The Act specifies the criteria for decisions on the reimbursement of medicines.
In line with the 2013 Act, if a company would like a medicine to be reimbursed by the HSE they must first submit an application to have it added to the reimbursement list.
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 the additional benefit of the applicant medicine compared to existing treatments available and the additional cost compared to the cost of existing treatments in their recommendation.
On behalf of the people of Ireland, 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. Where a manufacturer has failed to meet the requirements as set out in the 2013 Health Act, it can lead to a negotiation process. The purpose of those negotiations is to assist the applicant manufacturer in meeting the statutory requirements in as swift a timeframe as possible.
The HSE commissioned a HTA on Pembrolizumab as monotherapy for the adjuvant treatment of adults with Stage III melanoma and lymph node involvement in December 2018. The NCPE received the HTA submission from the manufacturer on 16 July 2019.
I am advised that the assessment is currently in process.