Sativex reimbursed in Ireland for eligible MS patients with spasticity

Nabiximols, the cannabis-based oral spray sold as Sativex, is available for reimbursement as an add-on therapy for moderate to severe spasticity in adults with multiple sclerosis (MS) in Ireland who failed to respond as intended to other spasticity medications.

Marked by muscle stiffness and involuntary spasms or twitches, spasticity is found in about 90% of MS patients.

The medication is available under a managed access program (MAP) of the Health Service Executive (HSE), Ireland’s publicly funded healthcare system. MAPs allow treatment access to patients in whom the medicine is expected to be most effective and cost-effective.

“MS Ireland has been advocating for this medication to be made available for many years,” Ava Battles, chief executive of MS Ireland, said in a society press release. “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 program is welcome news.”

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While approved for MS patients in Ireland, Sativex’s cost was not covered

Sativex’s MAP opened on Oct. 1, under what is called the HSE’s “high-tech” reimbursement scheme. Return of out-of-pocket costs is limited to patients prescribed Sativex by neurologists registered with the Irish Medical Council. These doctors also need to agree to the MAP’s terms and to be approved by the HSE; details are available on this agency webpage.

Although approved for use in Ireland in 2013, Sativex could not be prescribed to patients that year due to existing legislation concerning the misuse of cannabis-based drugs. The legislation changed in 2014 to allow Sativex prescriptions, MS Ireland reported, but the therapy’s cost was not covered.

Those out-of-pocket payments now may be returned to eligible patients.

“10 years ago … we were supporting a change in legislation which was required before this medication could even be prescribed,” Battles said in an April society release. “Following on from that we made numerous representations 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 mouth spray containing extracts from the cannabis plant — delta-9 tetrahydrocannabinol (THC) and cannabidiol (CBD).

THC is mainly responsible for the high associated with cannabis use, while CBD is thought to have anti-inflammatory and anxiety-relieving effects on the body. The spray is available as a 10 mL vial.

Sativex is approved to treat MS-related spasticity in many countries, including Canada and much of Europe, but not in the U.S. Disappointing results in a Phase 3 trial, called RELEASE MSS1 (NCT04657666), has led the company to discontinue plans to seek U.S. approval.

Easing in spasticity seen in some Phase 3 trials, but not in all advanced studies

Several clinical trials tested nabiximols in people with MS-related spasticity, including the Phase 3 GWSP0604 (NCT00681538) and SAVANT (NCT00711646) studies that included a total of 375 patients.

Pooled data from these trials showed that patients given nabiximols consistently reported less severe spasticity than those given a placebo for three months.

Nabiximols’ use also was linked to fewer reported daily spasms, with a more dramatic difference reported among patients with more frequent spasms before starting on the treatment.

Due to common side effects that include dizziness, sleepiness, and fatigue, Hugh Kearney, PhD, a consultant neurologist and MS specialist at St. James’s Hospital in Dublin, noted that Sativex may not be suitable for all MS patients with continuing moderate to severe spasticity.

Rather, Kearney favored that patients still consider occupational and physical therapy in managing MS.