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. The Minister for Health has no role in this statutory process.
The NCPE completed a health technology assessment on 29 August 2018 for Ocrelizumab (Ocrevus) for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS). They recommended that Ocrelizumab (Ocrevus) not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments.
On 4 October 2018 the NCPE completed their assessment for Ocrelizumab (Ocrevus) indicated for the treatment of adult patients with early primary progressive multiple sclerosis (PPMS). They did not recommend that Ocrelizumab (Ocrevus) be reimbursed for this indication.
The HSE is the statutory decision-making body for medicine reimbursement. It will make the final decision on whether Ocrelizumab (Ocrevus) will be reimbursed for each of these indications, taking into consideration the statutory criteria contained in the 2013 Health Act.
I am advised by the HSE that there has been considerable engagement between the HSE and the manufacturer over the past number of months and that commercial discussions are ongoing.