The All Wales Medicines Strategy Group (AWMSG) is the first national assessment body to recommend Sativex® Oromucosal Spray for use within NHS Wales for the treatment of spasticity associated with multiple sclerosis (MS).
Bayer Healthcare announced that Sativex Oromucosal Spray has been recommended by the AWMSG for use within NHS Wales for symptom improvement in adult patients with moderate to severe spasticity due to multiple sclerosis (MS).(1,2)
First national recommendation for Sativex
This is the first national recommendation for Sativex, derived from whole plant extracts from the cannabis sativa plant containing both delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), meaning Wales is the first country in the UK to robustly review this treatment, which has been proved to provide significant improvement of this debilitating symptom.(1,3)
Commenting on the recommendation, Dr Sajida Javaid, Consultant in Rehabilitation Medicine, Neath Port Talbot Hospital, said, “The AWMSG’s recognition of the value of Sativex is a significant milestone for the treatment of spasticity. Improved access to Sativex has been long awaited by clinicians and patients since its launch in 2010, so it is encouraging to see that patients in Wales will now have improved access to a treatment that has been proven to provide significant relief from the spasms and cramps associated with spasticity.”
The recommendation from the AWMSG states: delta-9-tetrahydrocannabinol/cannabidiol (Sativex) is recommended as an option for use within NHS Wales as treatment for symptom improvement in adult patients with moderate to severe spasticity due to MS who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity-related symptoms during an initial trial of therapy.(1)
Sativex is only available on prescription from a physician with experience in treating MS spasticity. It should be sprayed on to different sites of the oromucosal surface, changing the application site each time it is used. The MS patient decides how many sprays they need in any one day with a typical patient taking four sprays a day (daily limit of up to 12 sprays).(2)
In the phase III clinical trial, Sativex was shown to provide significant improvement in the 0–10 numeric rating scale (NRS) spasticity score and spasm frequency compared with placebo. After a 4-week, single-blind therapeutic trial period in 572 patients, Sativex reduced a mean spasticity 0–10 NRS score by 3.01 points, from a baseline of 6.91 points.(4) Forty-eight percent of patients achieved a ≥20% improvement in mean spasticity 0–10 NRS during this initial period.(3,4) Of these responders, 241 proceeded into a 12-week, randomised, placebo-controlled trial phase.(3,5) At the end of the trial, Sativex had reduced the mean spasticity 0–10 NRS in responders by significantly more than placebo (estimated treatment difference 0.84 points; p=0.0002).(4,5) The percentage of patients achieving a clinically relevant response during the randomised phase of the trial (≥30% improvement in mean spasticity 0–10 NRS from baseline), was significantly greater in the Sativex group than the placebo group (74% versus 51%; p=0.0003).(4,5)
The most common side effects of Sativex is dizziness, which occurs mainly in the first few weeks of treatment, and fatigue. These reactions are usually mild to moderate and improve within a few days even if treatment is continued.(2)
Cost of Sativex
The NHS price of Sativex is £125 per 10ml vial; however, Bayer has a scheme to help with the cost of identifying those who respond to Sativex by funding the first pack of treatment free of charge to NHS Wales.(6) Bayer HealthCare is dedicated to working with the NHS in the rest of the UK to ensure that eligible patients in England, Scotland and Northern Ireland have better access to Sativex for the treatment of moderate to severe spasticity associated with MS.
- Sativex® Summary of Product Characteristics. Available at: http://www.medicines.org.uk/EMC/medicine/23262/SPC/Sativex+Oromucosal+Spray/<redir.aspx?C=hUhDox248kW7_4BXv_o8b3b1bi0xjNEI4VwfZAhYZFS6-PwxWyet3LlqetrLSERhJsXSrco9EME.&URL=http%3a%2f%2fwww.medicines.org.uk%2fEMC%2fmedicine%2f23262%2fSPC%2fSativex%2bOromucosal%2bSpray%2f> (last accessed 14/08/14).
- Montalbán X, Wright S. Trial period for new symptomatic treatments: Lessons learnt from a Sativex in MS spasticity clinical trial. Oral session 131 presented at the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). September 2009.
- Novotna A et al. A randomized, double-blind, placebo-controlled, parallel-group, enriched-design study of nabiximols* (Sativex(®) ), as add-on therapy, in subjects with refractory spasticity caused by multiple sclerosis. Eur J Neurol 2011;18:1122–31.
- Ambler Z et al. A two-phase study of Sativex® in the relief of spasticity due to multiple sclerosis: Phase A single-blind response assessment followed by Phase B double-blind, randomised, placebo-controlled, parallel-group study. Poster 844 presented at the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). September 2009.
- MIMS. Drug details: Sativex. Available at: http://www.mims.co.uk/Drugs/musculoskeletal-disorders/muscle-spasm/sativex/<redir.aspx?C=hUhDox248kW7_4BXv_o8b3b1bi0xjNEI4VwfZAhYZFS6-PwxWyet3LlqetrLSERhJsXSrco9EME.&URL=http%3a%2f%2fwww.mims.co.uk%2fDrugs%2fmusculoskeletal-disorders%2fmuscle-spasm%2fsativex%2f> (last accessed: 14/08/14).
- Multiple Sclerosis Society. What is MS? Available at: http://www.mssociety.org.uk/about_ms/index.html (last accessed: 14/08/14).