In guidelines published Monday, the UK’s National Institute for Health and Care Excellence (NICE) reaffirmed the position it took on medical cannabis products last September: studies on efficacy are low-quality and product costs are too-high. While NICE ultimately recommended three cannabis-based products, it did not recommend their use for chronic pain.
Doctors had been waiting for this report from NICE, the advisory body to the National Health Service (NHS), since last fall, when the therapeutic use of cannabis was legalized. Lacking top-down guidance and approval, doctors have been hesitant to prescribe these products. According to the NHS, no more than 126 patients have a prescription for a cannabis-based product.
Costs too high, benefits too low, for chronic pain patients
In its guidelines, NICE tried to answer a simple question: should the NHS reimburse patients for the cost of cannabis-based products? When it comes to chronic pain, it doesn’t think the benefits justify the cost and, in its guidelines, provides a detailed cost-utility analysis to prove its point.
The report, which puts a strong emphasis on the economics of introducing cannabis-based products, uses the assessment criteria “Quality-Adjusted Life Years” or QALY, commonly used to help governments determine how to allocate healthcare resources. NICE explains that its usual accepted threshold of pounds (£) allocated per QALY gained from a drug is usually £20,000 to £30,000. Anything above that means the drug is too expensive for the benefits it provides.
When looking at Sativex, a pharmaceutical spray made of plant-derived THC and CBD, for chronic pain, for example, their economic model showed a cost over £150,000 per QALY gained.
Overall, the committee, which examined previous studies, found that the improvement in pain from Sativex and other cannabis-based products showed on average a 0.4 increase on a scale from 0 to 10. These products, the report notes, “would have to either be around 8 times more effective or around 6 times less expensive,” to be worthwhile for chronic pain.
Despite high hopes among patients suffering from chronic pain, NICE is unequivocal: “Do not offer the following to manage chronic pain in adults: nabilone, dronabinol, THC (delta-9-tetrahydrocannabinol), a combination of cannabidiol (CBD) with THC.” The committee, which examined previous studies, determined that “the potential benefits offered were small compared with the high and ongoing costs, and the products were not an effective use of NHS resources.”
Sativex, Epydiolex, and Nabilone approved for other conditions
The committee of experts changed its mind about the benefits of Sativex for adults with multiple sclerosis. While the committee previously didn’t support the use of the oral spray for spasticity, it acknowledged in the report that the long-term benefits of the product “are likely to outweigh any potential harms.”
The experts applied their economic model comparing standard treatment alone to standard treatment with cannabis added. The result was £19,512 per QALY gained, just below NICE’s £20,000 threshold.
Still, the committee was cautious, and noted that the studies on Sativex for spasticity are of “low quality” and “it was not clear how benefits related to improvements in quality of life.”
NICE also gave the green light to Epidyolex, which is, like Sativex, produced by GW Pharmaceuticals, but contains only CBD, for use by patients with seizures as a result of Dravet and Lennox-Gastaut syndromes. But, just like for Sativex, the experts consider the current research to be too “limited and of low quality” to assess the efficacy of the drug. (This product was approved in June 2018 by the US Food and Drug Administration, but under the name Epidiolex, and is the first cannabis plant-based drug to become available by prescription in the US.)
Still, the experts wanted to acknowledge that some patients, described as stakeholders in the report, experienced a decrease in their seizures thanks to Epidyolex and therefore agreed not to make a recommendation against it so that they don’t interrupt a treatment that has benefited them. “However, people seeking treatment for severe epilepsy should be made aware that currently there is no clear evidence of the safety and effectiveness of cannabis-based medicinal products,” they wrote.
Adult patients suffering from chemotherapy-induced nausea and vomiting will be able to take, as an “add-on” treatment, Nabilone, a THC-based drug which, unlike GW Pharmaceuticals’ products, is synthetic. The committee didn’t apply their economic model to this product, but looked at more than 1,800 observational studies to make their assessment. NICE made a research recommendation for patients under 18, which means more studies with a focus on younger patients should be developed.
With these new guidelines on cannabis-based products, the hope among patients is that the NHS will encourage more doctors to prescribe them. The scarcity of prescriptions has created an outcry, with frustrated patients stating in interviews and op-eds that access to prescribing specialists is reserved for those who can afford private medical insurance.
Meanwhile, a private group called Drug Science recently launched something called Project 21, a trial in which they say about 20,000 patients will be enrolled by the end of 2021. It aims to produce the largest data set in Europe on the effects of cannabis-based drugs and, according to the website, by “proving favorable risk-benefit ratio of medical cannabis,” to convince the NHS it should make cannabis-based products more widely “available and affordable.”
