On Thursday, the United Kingdom’s National Health Service published a report addressing the prescription of cannabis-based products for medical use, which includes a list of recommendations to improve patient access.
The report, which comes less than a year after these products were rescheduled, follows a March 2019 meeting, in which Matt Hancock, Secretary of State for Health and Social Care, met with a number of families to discuss their concerns. After the meeting, Hancock called for a review of the National Health Service’s system in order to identify barriers and how to address them.
The review is the result of a collaboration between the National Health Service and the All-Party Parliamentary Group on Medical Cannabis under Prescription, as well as other patient groups. Together, they identified twenty-one patient cases, which ultimately yielded ten key recommendations, including: the establishment of a UK-wide pediatric specialist clinical network “to assist in evidence generation”; issuing a reminder to doctors and pharmacists to clarify the procedure for prescribing and supplying cannabis-based products; developing a UK-wide registry to collect data on patients who have been prescribed a cannabis-based product; and working to ensure consistent ratios of cannabidiol (CBD) and tetrahydrocannabinol (THC) between batches. The report also calls for the National Health Service to collaborate with suppliers to gain access to the “best value,” as well as to look into domestically-manufactured options.
Additionally, the report indicates that the National Institute for Health Research should prioritize research in five areas relating to the use of cannabis-based products, including: CBD as an add on treatment for adult patients with Fibromyalgia or persistent treatment-resistant neuropathic pain; chronic pain in children and young people; spasticity; CBD for severe treatment-resistant epilepsy in children, young people, and adults; and the effects of THC, in combination with CBD, on seizure frequency, brain structure, and neurophysiological performance, as compared with CBD.
According to the report, clinicians said that the lack of quality randomized control trial data attesting to the safety and cost effectiveness of cannabis-based products is a major obstacle for prescriptions. Additionally, most of the clinicians that were part of the review said that they would not prescribe products containing THC, “primarily because of the lack of evidence, a lack of knowledge about the products and a lack of long-term safety data,” citing a “higher risk of impaired mental health from longer term exposure to THC and the need to proceed with caution.”
In turn, parents and guardians acknowledged that “the evidence base is limited, [but] feel that clinicians are not adequately considering the international observational study data.” They also pointed out “that their children are already prescribed several other antiepileptic medicines, including some that are off-label or unlicensed, many of which have significant adverse effects.” What they would like is for cannabis-based products to be prescribed “either in addition to, or instead of, existing treatment.”
Currently, nearly all cannabis-based products are categorized as “unlicensed medicines,” which are prescribed as “specials” (a product that “has been specially manufactured or imported to the order of a doctor, dentist, nurse,” etc.). Moreover, in contrast to licensed medicines, cannabis-based products have not been subject to tests for quality, safety, and efficacy. As a result, “local medicines governance arrangements will always include robust arrangements to safeguard patients,” with the exception of dronabinol, Sativex, and nabilone, which have been rescheduled under the Misuse of Drugs Regulations 2001 and have been granted a marketing authorization. Epidiolex, a CBD-only product, is currently in the process of being considered for a European marketing authorization.
The National Health Service also noted that, while there have been more CBD product prescriptions, there has been no increase in prescriptions of THC-containing products. Moreover, 111 patients have accessed Epidiolex through “compassionate use and early access programmes ahead of a licensing decision by the European Medicines Agency.”
Moreover, according to data from the National Health Service’s Business Services Authority, which runs up to March 2019, less than ten prescriptions for cannabis-based products have been issued in primary care since November 2018. In conversation with the agency, some families said that because of the “lack of clarity around the availability of [National Health Service] funding or a delay in obtaining it, they have obtained a private prescription, imposing a very considerable and often unsustainable financial burden on themselves.” In its report, the agency underscored that patients “should not be expected to travel abroad in order to obtain a suitable product as there are lawful routes of supply that can be utilised.”
Last year, the government provided guidance for prescribing cannabis-based products based on advice from medical societies. This information will soon be updated, as the National Institute for Health and Care Excellence has been tasked with producing a clinical guideline on prescribing cannabis-based products for medical use, which will be available in October 2019.
