I propose to take Questions Nos. 603, 719 and 722 together.
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.
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.
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. This can lead to a protracted deliberation process.
I wish to advise the Deputy that 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). The NCPE 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) and did not recommend that Ocrelizumab be reimbursed for this indication.
I am advised by the HSE that there has been considerable engagement between the HSE and the manufacturer of Ocrelizumab (Ocrevus) over the past number of months and commercial discussions are ongoing. The HSE is the statutory decision-making body for medicine reimbursement and it will make the final decision on whether Ocrelizumab (Ocrevus) will be reimbursed, taking into consideration the statutory criteria contained in the 2013 Health Act.