Sativex, also known as Delta-9-tetrahydrocannabinol (THC)/Cannabidiol (CBD), is an oromucosal spray available in a 10 ml vial. Each single 100-microliter spray contains 2.7 mg THC and 2.5 mg CBD from Cannabis sativa L. It is specifically indicated for the treatment of moderate-to-severe spasticity due to multiple sclerosis in adult patients who have not responded adequately to other anti-spasticity medications. The medication is intended to be used alongside a patient's current anti-spasticity medication.
Managed Access Approach
Under the Managed Access Program, Sativex will be available for reimbursement only for the licensed indication mentioned above. Reimbursement will be supported on an individual patient basis through the Health Service Executive (HSE) - Primary Care Reimbursement Service (PCRS) online application system. High Tech prescriptions generated on the High Tech Hub (HTH) will be eligible for reimbursement. The program is scheduled to commence from October 1, 2023.
Advocacy by MS Ireland
Ava Battles, Chief Executive of MS Ireland, expressed her delight at the announcement, acknowledging the significant impact this decision will have on individuals with MS who have struggled to access the treatment due to its costs. She stated, "MS Ireland has been advocating for this medication to be made available for many years. We've been supporting legislative changes and making representations on behalf of the MS community throughout the reimbursement process. The announcement of the managed access programme is welcome news.”
Consultant Neurologist Dr. Hugh Kearney emphasised that while Sativex is an important addition to pharmacological treatments for spasticity in MS, it may not be suitable for everyone due to its possible side effects. He highlighted the continued importance of therapies like physiotherapy and occupational therapy in MS management.
This announcement marks the culmination of a decade-long journey, from advocating for legislative changes in 2013 to patient group submissions in recent years. MS Ireland acknowledges the tireless efforts of its Advocacy Officers past and present in championing this cause.
To find out more visit the HSE here