The cannabis sativa plant extract Sativex is a cost-effective therapy for spasticity in multiple sclerosis (MS) and can be offered to patients in England needing it on at least a monthlong trial basis, the National Institute for Health and Care Excellence (NICE) said in issuing a final recommendation on the treatment.
This decision reverses a previous draft guidance that NICE, which evaluates treatments and makes recommendations on health and social care in the United Kingdom, released in August.
Under the new guidance, Sativex will be available through local National Health Service (NHS) authorities for people with moderate-to-severe MS-related spasticity, who were not helped by other spasticity treatments, for an initial four weeks. If their symptoms are found to have eased by at least 20% with Sativex’s use at this trial period’s end, patients may continue taking the medication.
GW Pharmaceuticals, which markets Sativex, must also make this treatment available to the NHS “according to its pay-for-responders scheme,” NICE said.
Spasticity is one of the most common MS symptoms, causing muscles to feel stiff and heavy, and making movement difficult. It is an unwieldy symptom because it may or may not manifest regularly, and can differ from person to person or even within the same person at various times. The condition, which can range from mild stiffness to painful and severe muscle spasms, is estimated to affect about 60% to 90% of MS patients at some point.
“As a charity, we have campaigned over a long period for Sativex to be widely available, and we are delighted that NICE has listened to our calls for a fair assessment of its cost effectiveness. We know that access to this drug will greatly improve quality of life for many in the MS community. At the same time, we also recognize that some local health authorities will not be able to fund continued treatment with Sativex. The challenge ahead is to ensure that everyone eligible can access this treatment,” Martin added.
Sativex is a mouth spray containing equal amounts of two cannabinoids: tetrahydrocannabinol (THC) and cannabidiol (CBD). The number of sprays is gradually increased daily until a dosage is reached that, with the fewest side effects, relieves muscle stiffness.
On the MS Trust website, Jen, whose husband experiences MS spasticity and accompanying spasms, spoke of the benefits she has seen with Sativex. “When Dave has a full-body spasm, it’s almost looks like somebody has shot 50,000 volts through him. His body just stiffens up like an ironing board and then he starts violently shaking,” she said.
“Dave has tried different treatments for spasms and spasticity, but nothing worked for him. But then he was prescribed Sativex and it has massively, massively improved his quality of life. It’s not a miracle cure … it doesn’t work for everybody, but I do believe that anybody with MS who suffers from spasms and spasticity, and has tried all the first line treatments, should have the opportunity to at least try it and see if it works for them,” Jen added.
According to the MS Trust, Sativex is licensed in the U.K. as an add-on spasticity treatment in cases where other treatments failed. Only experts in MS spasticity may prescribe the medicine, including neurologists, and rehabilitation and pain specialists. Future prescriptions for patients whose spasticity eases by 20% or more with its use may be managed by a general practitioner.
Sativex is not considered to be cost effective for the NHS in Scotland or Northern Ireland. It is approved and considered cost effective in Wales, but its availability is limited.
The legal status of cannabis was amended in the U.K. last year to allow specialists to prescribe cannabis-based products to those with exceptional medical need. In light of this change, NICE reviewed evidence for the benefits and costs of cannabis-based medicinal products.
Sativex is not approved for use in the United States.