Dáil Éireann Debate, Wednesday - 18 April 2018
140. Deputy Fiona O'Loughlin asked the Minister for Health if he has received correspondence from a company (details supplied) in relation to a new drug scheme for persons with MS; and his plans to meet the company to discuss the matter further [16844/18]
Amharc ar fhreagraThe HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the 2013 Act. The Act specifies the criteria for decisions on the reimbursement of medicines.
The 2013 Act does not give the Minister for Health any powers in this regard. The HSE does not require approval or consent from the Minister or Government when making a reimbursement decision.
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.
As outlined in the IPHA agreement, 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:
1. add the medicine to the reimbursement list or agree to reimburse it as a hospital medicine,
2. refuse to reimburse the medicine.
The HSE strives to reach a decision in as timely a manner as possible and within the 180 days. 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. Successful price negotiations also allow for further drugs to be approved within the finite budget available.
I have been informed that the NCPE are currently conducting a health technology assessment on Ocrelizumab for the treatment of adult patients with early primary progressive multiple sclerosis (PPMS) and for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS).
I can confirm that I received a letter from Roche Products (Ireland) Ltd in December 2017 concerning Ocrelizumab, however as I have stated, the drug in question is being assessed in accordance with the statutory procedure in place. I am keen to engage with Industry and to explore ways in which new medicines might be more easily introduced in Ireland. However, any innovative approaches that may be tabled must be compatible with the statutory provisions which are in place and must also recognise the fundamental pricing/funding issues in the context of finite Exchequer resources.
My Department will be engaging with Industry over the coming months to explore avenues for securing more timely and affordable access to new medicines.
