The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines, 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.
In line with the 2013 Act and the national framework agreed with industry, if a company would like a medicine to be reimbursed by the HSE, the company must submit an application to the HSE to have the new medicine added to the reimbursement list.
Reimbursement is for licenced indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.
I am advised by the HSE that it has received an application for reimbursement of Delta-9-tetrahydrocannabinol/Cannabidiol, THC/CBD (Sativex) in February 2018.
A rapid review by the National Centre for Pharmacoeconomics (NCPE) was completed on 3 April 2018 and a full pharmacoeconomic assessment was recommended to assess the clinical and cost effectiveness of this medicine compared with the current standard of care.
The HSE commissioned a full health technology assessment with respect to this indication in April 2018. On 12 August 2019, the NCPE received the applicant's submission. On 10 February 2020, the NCPE sent a preliminary review to the applicant and are currently awaiting their response.
Until such time as a decision has been made in relation to the reimbursement of Sativex by the HSE, this product will not be available under the community drug schemes.