The National Institute for Health and Care Excellence and NHS England, yesterday, (August 8th), released a draft report and guidelines for the use of medicinal Cannabis. This follows the rescheduling of Cannabis last November, theoretically making Cannabis-based medical products (CBMPs), available for prescription by specialist doctors.
The draft report assesses the cost and clinical effectiveness of the use of CBMPs when used to treat intractable nausea and vomiting as a result of chemotherapy; chronic pain; spasticity, and severe treatment-resistant epilepsy. The report consistently came to the conclusion that there was not sufficient evidence for the efficacy of the products.
In fact, the NICE recommended eight times throughout the report that further clinical research be carried out. In addition, it recommends that two clinical trials be set up to supplement the evidence of the long term safety and effectiveness of CBMPs.
The lack of evidence in all areas assessed “has weighed heavily on prescribing decisions”. It is estimated that less than 20 prescriptions have been granted in the UK, since the schedule change of Cannabis, last year. These prescriptions were almost all from private clinics, and cost patients a large amount of money.
Dr Keith Ridge, chief pharmaceutical officer at NHS England, said:
“Without sufficient evidence to help them balance potential benefits against potential harms when they are deciding whether to prescribe medicinal cannabis to children with very severe epilepsy, it is clear clinicians are very reluctant to prescribe.”
The 2018 rescheduling of Cannabis, made medical products available to patients, following the campaigns of the parents of children suffering with rare forms of severe treatment-resistant epilepsy. These children had experienced drastic improvements in the regularity of their seizures, through the use of Cannabis oil.
Despite this, the committee was unable to make recommendations for the use of CBMPs in this context. This was, again, due to a lack of clinical evidence. The NICE predicts that the lack of evidence in this area is largely due to only a small amount of patients in the UK suffering from these forms of epilepsy.
The committe recommended that Sativex (a licensed CBMP), shouldn’t be used to treat spasticity in people with Multiple Sclerosis. It also highlighted that other CBMPs should not be used in these cases, unless as part of a clinical trial.
The draft guidance also states that no CBMPs should be used to treat chronic pain. This includes the use of cannabinoids in clinicial trials – apart from CBD. The committee claims that the use of these products would not be cost-effective, compared to their potential benefits.
Paul Chrisp, director of the Centre for Guidelines at NICE, said:
“We recognise that some people will be disappointed that we have not been able to recommend the wider use of cannabis-based medicinal products. Having now considered all the available evidence it’s therefore not surprising that the committee has not been able to make many positive recommendations about their use.”
However, the draft guidelines does recommend the use of Nabilone (a synthetic drug similar to compounds found in Cannabis). Nabilone is recommended as an add-on treatment for adults suffering from chemotherapy-induced nausea and vomiting.
Despite the lack of positive recommendations in the draft guidance, NICE and NHS England agree that “companies should be encouraged to undertake or enable research into their medicinal cannabis products.”
The Health and Social Care Committee recently suggested that medical Cannabis companies should enable clinical research into their products. NICE believes that this would allow more informed recommendations to be made in the future.
The official report is expected to be published this later this year. For now, the draft guidelines are open to public consultation until 5th September 2019.