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 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'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.
The HSE has advised that it has received 2 applications for pricing and reimbursement of Ocrelizumab in Multiple Sclerosis.
Application 1 is for use of Ocrelizumab for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features. Following a number of rounds of commercial negotiations, agreement has been reached in relation to the commercial terms which will apply to this indication when reimbursed. The HSE is currently working on putting in place the required administrative processes to support reimbursement of this specific indication.
Application 2 is for the use of Ocrelizumab for the treatment of adult patients with early primary progressive multiple sclerosis (PPMS) in terms of disease duration and level of disability, and with imaging features characteristic of inflammatory activity. The HSE and the manufacturer have had a number of rounds of commercial negotiations in relation to this indication (use). Commercial discussions have concluded, the medicine has been reviewed by the HSE Drugs Group and the HSE Senior Leadership Team have received the Drugs Group recommendation. The HSE's final decision on reimbursement will take into consideration the statutory criteria contained in the 2013 Health Act.