NICE and NHS challenge Sativex and recommend more research on cannabinoids
To treat spasticity in people with multiple sclerosis a draft guidance published by the National Institute for Excellence in Health and Care (NICE) and the UK's National Health Service (NHS) calls for more research to be conducted on medical cannabis for the multiple sclerosis and other diseases.
For reasons related to its profitability, NICE also recommends not prescribing Sativex as a treatment for spasticity, muscular stiffness and exaggeration of the osteotendinous reflex. spasticity being a rapid stretch of a muscle that too easily causes it to contract reflex in people with MS.
The directives of the Council on Cannabis Medicines, to be published shortly on November 4, follows the reclassification of these products last year to allow their use by patients whose clinical needs can not be met by approved drugs.
The evaluation looked at the clinical efficacy and cost-effectiveness of most cannabis products, including Sativex (by GW Pharmaceuticals). The institute also considered treatments for nausea and vomiting due to chemotherapy, chronic pain, and severe treatment-resistant epilepsy.
Eight separate recommendations for further research have been formulated for all indications and all products covered which, according to NICE, reflected the complete lack of evidence of clinical benefit and cost-effectiveness of these products.
Sativex is not recommended for treating spasticity due to multiple sclerosis because it has been shown to be unprofitable, its price is too high. The guide also recommends against using other options for the same purpose outside of a clinical trial due to a "lack of clear evidence that these treatments provide benefits," says NICE in its Press release.
Due to the limited benefits versus the high costs, no cannabis product should be used to treat chronic pain other than plant-based cannabidiol in clinical trials, he adds. However, the synthetic cannabinoid, nabilone, can be used as an adjunct to adults with nausea and vomiting caused by chemotherapy and unresponsive to conventional medications.
No recommendations have been made regarding the use of cannabis-based drugs in the treatment of severe resistant epilepsy, again because there is no clear evidence of their benefits.
“We recognize that some people will be disappointed that we have not been able to recommend a wider use of cannabis-based medicines,” said Paul Chrisp, director of the Center for Guidelines at NICEin the press release.
According to Chrisp, concerns about the lack of solid evidence for the existence of these "mostly unlicensed products" were present when NICE began developing its guidelines. “After reviewing all the available evidence, it is therefore not surprising that the committee was not able to make many positive recommendations on their use,” he said.
NICE's call for more research also echoes a recent call from the National Institute of Health Research. "NICE welcomes the recent suggestion by the House of Commons Health and Social Services Committee to encourage companies to undertake or permit research on their medicinal cannabis products," said Chrisp.
The UK's National Health Service (NHS) has assessed the barriers to prescribing such treatments when they are safe and clinically appropriate. After listening to families and doctors specializing in relevant fields, the NHS journal is also calling for more research, especially clinical trials including children and young adults, and for clearer and more consistent guidelines. It also promotes the establishment of a network of clinical experts capable of providing advice to prescribing health professionals.
“It is clear that clinicians are very reluctant to prescribe medical cannabis,” said Keith Ridge, director of pharmaceuticals for the NHS.
NHS England concluded that the lack of data on safety and long-term efficacy was a key factor in clinicians' decisions on whether or not to prescribe medical treatments with cannabis. Two clinical trials are recommended to help overcome this limitation.
“These recommendations are intended to help us build an evidence base to understand how safe these products are and to ensure that UK clinicians have access to information and expert advice to helping them across the country, ”Ridge said.
Sativex and nabilone are the only cannabis-based medicines approved for use in adults in the UK.