The HSE has statutory responsibility for medicine pricing and reimbursement decisions, under the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies criteria for decisions on the reimbursement of medicines. As Minister, I have no role in this statutory process.
HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, including 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's clinical and cost effectiveness as a health intervention.
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, ongoing investments. This can lead to a protracted deliberation process.
I wish to advise you that the NCPE completed a health technology assessment in October 2018 on ocrelizumab for adult patients with early primary progressive multiple sclerosis. The NCPE did not recommend that it be reimbursed for this indication. However, the HSE has advised that there has since been considerable commercial engagement with the applicant.
The HSE's final decsion on reimbursement will take into consideration the statutory criteria contained in the 2013 Health Act.