Nabiximols, the cannabis-based oral spray sold as Sativex, is available for reimbursement as an adjunctive treatment for moderate to severe spasticity in adults with multiple sclerosis (MS) in Ireland who have not responded as expected from other spasticity medications.
Marked by muscle stiffness and involuntary spasms or contractions, spasticity is found in approximately 90% of MS patients.
The medicine is available under a Managed Access Program (MAP) from the Health Service Executive (HSE), Ireland’s state-funded healthcare system. MAPs provide access to treatment to patients for whom the drug is expected to be most effective and cost-effective.
MS Ireland has been campaigning for many years to make this medicine available, Ava Battles, managing director of MS Ireland, said in a company press release. We supported the legislative changes and made representations on behalf of the MS community throughout the reimbursement process. The announcement of the managed access program is good news.
Although approved for MS patients in Ireland, the cost of Sativex was not covered
Sativex’s MAP opened on October 1, as part of what is known as the HSE’s “high-tech” reimbursement program. Reimbursement of out-of-pocket costs is limited to patients who have been prescribed Sativex by neurologists registered with the Irish Medical Council. These doctors must also agree to the terms of the MAP and be approved by the HSE; details are available on this agency webpage.
Although it was approved for use in Ireland in 2013, Sativex could not be prescribed to patients that year due to existing legislation regarding the misuse of cannabis-based medicines. Legislation changed in 2014 to allow prescriptions for Sativex, MS Ireland reported, but the cost of the therapy was not covered.
These direct payments can now be returned to eligible patients.
10 years ago…we supported a change in legislation that was needed before this drug could even be prescribed, Battles said in a company statement in April. Subsequently, we took numerous steps on behalf of the MS community… as part of the reimbursement process.
Developed by GW Pharmaceuticals, now part of Jazz Pharmaceuticals, nabiximols is an oral spray containing extracts of the cannabis plant delta-9 tetrahydrocannabinol (THC) and cannabidiol (CBD).
THC is primarily responsible for the euphoria associated with cannabis consumption, while CBD is said to have anti-inflammatory and analgesic effects on the body. The spray is available in a 10 ml bottle.
Sativex is approved to treat MS-related spasticity in many countries, including Canada and much of Europe, but not in the United States. Disappointing results from a phase 3 trial, called RELEASE MSS1 (NCT04657666), led the company to abandon its research project in the United States. approval.
Alleviation of spasticity observed in some phase 3 trials, but not in all advanced studies
Several clinical trials have tested nabiximols in people with MS-related spasticity, including the phase 3 studies GWSP0604 (NCT00681538) and SAVANT (NCT00711646) which included a total of 375 patients.
Pooled data from these trials showed that patients who received nabiximols consistently reported less severe spasticity than those who received a placebo for three months.
Use of nabiximols was also associated with a decrease in the number of reported daily spasms, with a more dramatic difference reported in patients experiencing more frequent spasms before starting treatment.
Due to common side effects, including dizziness, drowsiness and fatigue, Hugh Kearney, PhD, consultant neurologist and MS specialist at St. James Hospital in Dublin, noted that Sativex may not be suitable to all MS patients with moderate to severe spasticity. .
Kearney was quite supportive of patients always considering occupational therapy and physical therapy in the management of MS.
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