Cannabis-Based Medicines Approved for Use in England and Wales

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LONDON — Cannabis-based medicines were approved on Monday for use by the National Health Service in England and Wales, a milestone decision that could change the lives of thousands of patients.

Three treatments using medicinal cannabis were authorized by the National Institute for Health and Care Excellence, a public body that provides guidance on health care practices. The decision comes a year after Sajid Javid, then the British home secretary, said that some doctors could legally prescribe the drug in special cases.

Cannabis-based medicine will be restricted to treatments for one of two relatively rare forms of childhood epilepsy, multiple sclerosis, or chemotherapy-induced vomiting and nausea, according to the guidelines published by the institute.

All marijuana-based medicines must initially be prescribed by specialist doctors, the institute said in a statement. A spokesman said in an email on Monday that the recommendations could immediately be applied for England and Wales, with Northern Ireland expected to consider use on a case-by-case basis. The rules do not apply in Scotland, which has its own health care guidance body.

Simon Wigglesworth, the deputy chief executive of Epilepsy Action, a British charity, said in a statement on Monday that he welcomed the institute’s decision to allow the use of cannabis-based medicines for the treatment of patients with Dravet syndrome and Lennox-Gastaut syndrome, both rare forms of epilepsy.

“Today’s announcements represent an important step forward for people affected by severe and treatment-resistant epilepsies,” he said.

Laws on cannabis are generally stricter in Britain than in the rest of Europe. Several countries have decriminalized small amounts of marijuana for recreational use, and others allow medicinal cannabis.

The change in the guidance in England and Wales comes after two highly publicized cases of young epileptic patients in Britain who were dependent on the treatments.

In June 2018, the cannabis-based medicine of one of those young patients with life-threatening seizures, Billy Caldwell, then 12, was confiscated at Heathrow Airport. Earlier, the mother of Alfie Dingley, then 6, said that the government had vowed to help explore alternative treatments for her son, who has as many as 150 seizures a month, but that the promise had not been fulfilled.

Both boys were issued temporary special licenses for cannabis-based medicines, and their cases added pressure on the government to commission a review of such products.

About 63,400 people age 18 and younger suffer from epilepsy in Britain, Louise Cousins, a spokeswoman for Epilepsy Action, said in an email. She added that around 5,000 adults and children in England are estimated to have Lennox-Gastaut syndrome and about 3,000 had Dravet syndrome.

More than 30,000 people are thought to have Lennox-Gastaut in the United States, according to the LGS Foundation, a nonprofit organization focused on raising awareness about the condition.

The National Institute for Health and Care Excellence also recommended the offering of a four-week trial of a cannabis-based oral spray for the treatment of muscle spasms caused by multiple sclerosis, if other treatments have had no effect. The spray was already available in Wales.

Genevieve Edwards, the director of external affairs at the Multiple Sclerosis Society, a British charity, said that the group had been campaigning for access to the spray “for years,” but she criticized the institute’s guidelines as not going far enough.

“No cannabis-based treatments have been recommended to treat pain, a common symptom” of multiple sclerosis, Ms. Edwards said in a statement on Monday. The charity said in an email that more than 100,000 people in Britain live with multiple sclerosis.

Local commissioners and health care providers are expected to apply the advice “in the context of local and national priorities for funding and developing services,” according to the institute’s guidance.

Paul Griffin, 49, who is from Bradford, in northern England, has had multiple sclerosis for 23 years. He said that access to the spray, called Sativex, and to the relief afforded from the constant pain induced by spasms would be “life changing.”

“It’s been incredibly frustrating to know Sativex could help, yet it’s been out of reach for so long,” he said.

The institute also recommended the consideration of nabilone, a manufactured cannabis-based product, as a supplementary treatment for patients who are at least 18 years old and have chemotherapy-induced vomiting and nausea that conventional drugs have failed to stop.

Charlotte Caldwell, the mother of Billy Caldwell, told Sky News on Monday that she was delighted about the new regulations.

“This is how our N.H.S. should be,” she said. “It is an incredible day for the U.K.”





Source : Nytimes