Barriers Limit Sativex Access for Patients With Spasticity in UK

Sativex (nabiximols), a cannabis-based oral spray approved in the U.K. to ease spasticity — or muscle stiffness and spasms — in adults with multiple sclerosis (MS), remains unavailable to many patients there, according to a report by the MS Society UK.

Sativex is the only licensed form of medical cannabis for MS in the U.K., and has been deemed cost-effective by the National Institute for Health Case and Excellence (NICE). But fewer than half of the local health bodies in England are funding the therapy, the society reported, so that only around 13% of eligible patients can access Sativex.

“It’s completely unacceptable that two years after receiving NICE approval, Sativex is only available in 49 out of 106 health areas in England,” Fredi Cavander-Attwood, the MS Society’s policy manager, said in a press release. “MS can be relentless, painful and disabling, and getting the treatment you need shouldn’t be a game of chance.”

Eligible patients in Wales, Scotland, and Northern Ireland are also facing barriers to accessing Sativex.

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The society urges people to help overcome these barriers by joining its recently launched #ApprovedButDenied campaign, and taking action by calling local health bodies to provide Sativex for people with MS.

The report, “Approved but denied: Access to Sativex to treat MS-related spasticity in England,” was written by Ruth MacLeod, senior policy officer at the MS Society.

“The MS Society’s report highlights the problems people continue to face and we support their recommendations to ensure that everyone eligible can access this treatment,” David Martin, CEO of the MS Trust, a U.K. charity that provides support to people with MS, said in a separate press release.

Sativex, marketed by Jazz Pharmaceuticals, is approved as an add-on therapy for adults with moderate-to-severe MS spasticity who have failed to respond to other anti-spastic treatments.

The treatment contains equal amounts of two compounds — tetrahydrocannabinol (THC) and cannabidiol (CBD) — that have been extracted from the cannabis plant. It may be sprayed under the tongue or inside the cheek, and the number of sprays can be being gradually increased each day until an optimum dose is reached (up to a maximum of 12 sprays a day).

Sativex’s efficacy and safety have been tested in various studies, including a real-world study in Belgium, which reported a significant reduction in spasticity after three months of treatment in about 74% of patients.

Two ongoing Phase 3 clinical trials — RELEASE MSS1 (NCT04657666) and RELEASE MSS3 (NCT04203498) — recruiting participants at sites in Czechia and Poland, are also investigating Sativex as a treatment for MS-related spasticity.

A third Phase 3 clinical trial, called RELEASE MSS5 (NCT04984278), is planned to start this year. While study locations for the RELEASE MSS5 clinical trial have yet to be announced, basic contact information is available here.

Guidance published by the NICE, a U.K. healthcare advisory board, recommends that a four-week trial of Sativex should be offered to people with moderate to severe spasticity as an add-on therapy to their existing treatment, provided the local health body agrees to pay for continued treatment. At the end of that trial period, patients can continue to receive Sativex if their spasticity has improved by at least 20%.

“The MS Trust has called for a fair assessment of Sativex since it was licenced in 2010 and we have made strong cases for its approval in appraisals by NICE and other decision makers. Sativex doesn’t work for everyone but when it does it can greatly improve quality of life for people with MS and their carers,” Martin said.

National health services in Scotland and Northern Ireland have ruled that Sativex does not represent a cost-effective treatment. In England and Wales, it is considered cost-effective.

Reasons for its limited availability include a failure to revisit the funding decisions by local health bodies, especially during the COVID-19 pandemic; a perceived lack of effectiveness; and a lack of pathways for assessing spasticity or passing the responsibility of prescribing Sativex to general practitioners.

“Right now, some people with MS are having to choose between living with excruciating spasms or paying as much as £500 a month for a private Sativex prescription — it costs the NHS under £300 to provide the same dose,” Cavander-Attwood said.

“Some are even being forced to break the law by buying cannabis illegally,” he added. “This cruel postcode lottery must end, and health bodies across England need to ensure that everyone who meets the criteria is able to access Sativex.”

Sativex is an approved MS treatment across most of Europe and in Canada; it is not approved for use in the U.S.