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.
In regard to new treatments for multiple sclerosis, I wish to advise you that the NCPE completed a health technology assessment in August 2018 on ocrelizumab for adult patients with relapsing forms of multiple sclerosis. The NCPE recommended that ocrelizumab not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments.
In addition, in October 2018 the NCPE completed its assessment of ocrelizumab for adult patients with early primary progressive multiple sclerosis and did not recommend that it be reimbursed for this indication.
The HSE has advised that there has been considerable engagement with the applicant and commercial discussions are ongoing. The HSE's final decision on reimbursement will take into consideration the statutory criteria contained in the 2013 Health Act.
The HSE has also commissioned an HTA for Delta-9-tetrahydrocannabinol/cannabidiol (THC/CBD). This is indicated for symptom improvement in adult patients with moderate to severe spasticity due to multiple sclerosis, who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity-related symptoms during an initial trial. The NCPE is currently awaiting information from the applicant for the HTA.