Unfortunately, it remains challenging for UK patients to access medical cannabis – but rapidly expanding provider Cellen Therapeutics is working to break down those barriers.
In response to a persistent lack of access to medical cannabis after its rescheduling in 2018, NHS England published ‘Barriers to accessing cannabis-based products for medicinal use on NHS prescription’ in August 2019. The report highlighted the difficulties faced by UK patients in obtaining prescriptions for cannabis-based products for medicinal use (CBPMs) and the lack of high quality evidence available for clinicians to make informed prescribing decisions. The three main barriers discussed in the report were:
- Clinical evidence;
- Guidance to support clinicians; and
- Cost and supply.
COVID-19 has exposed the fact that the same barriers still exist. During lockdown, patients have been unable to travel abroad to purchase their CBPMs; while importation supply chains have been affected by interruptions. The body of clinical evidence is still building, and education to healthcare professionals in the UK is therefore still sparse. To date, figures show that only four patients have received NHS-funded prescriptions for unlicensed CBPMs. These patients have been only able to access unlicensed THC/CBD products through individual requests to trusts and Clinical Commissioning Groups (CCGs), leaving remaining patients covering the cost of their medications themselves through the private market – yet a 2019 YouGov poll placed the number of people self-medicating with cannabis in the UK at around 1.4 million.
Cellen is an independent, UK-based medical cannabis provider which is tackling the issue of patient access. Cellen’s team is led by NHS clinicians and is dedicated to improving the health and wellbeing of people living with chronic conditions. The company provides CBPMs to Europe’s largest body of observational evidence on medical cannabis, Project Twenty21; and is backed by the Mayor of London’s Business Growth Programme as a ‘High Potential Business’. Uniquely, Cellen puts patient welfare at the heart of its products; and CEO Eric Bystrom has previously driven to a clinic in order to pick up an urgent prescription and deliver it personally to the pharmacy. Cellen aims to uphold the market to a high standard of quality, driven by empirical research; and is using evidence and innovation to break down barriers to patient access in the UK.
Cost and supply
As Cellen is UK based, it has been able to bring down the cost of CBPMs dramatically and can assure rapid delivery time to patients’ doors. Cellen works with best-in-class pharmacy partners to quickly and securely turn around prescriptions, meaning that during COVID-19 they have been able to support patients that would have otherwise depended on imported products for prescription fulfilment.
The 2019 NHS report found that most CBPMs are not manufactured in the UK and must therefore rely on importing and adhering to export procedures: this causes delays and difficulty in sourcing correct products. The report stated: “We understand this process for obtaining CBPMs can be a time-consuming process with import/export forms needing to be filled in, often by clinicians or pharmacists. UK-based wholesalers have told us that they are unable to guarantee stock as market demand in the UK is so uncertain. 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.”
Cellen responded to this by being a UK-based provider which is able to guarantee stock; and has fast become a reliable source for prescription fulfilment for patients and clinicians in the UK. Cellen’s European supply chain operates to the EU’s rigorous Good Agricultural and Collection Practice (EU GACP), Good Manufacturing Practice (EU GMP) and Good Distribution Practice (EU GDP) standards and is built for pharmaceutical purpose from seed to patient. This means that all stages of the production chain, from the way the plants are cultivated to the processing of raw materials and the manufacturing process, are each specifically certified. According to the Medicines and Healthcare products Regulatory Agency (MHRA), Cellen’s products rank as a preferred choice among unlicensed medicines, as they are UK-manufactured specials made in MHRA-licensed facilities.
The 2019 report noted: “If CBPMs are to be routinely commissioned across the NHS, the science and the evidence base supporting use needs to be significantly better developed. This will also need a reliable supply of high quality, consistent products.”
The UK’s National Institute for Health and Care Excellence (NICE) has put out a call for research on key topic areas such as chronic pain, epilepsy and fibromyalgia. In order to understand clinical benefit, cost effectiveness and patient safety there must be a wider body of evidence available. Cellen’s Chief Medical Officer Dr Benjamin Viaris de Lesegno spoke at the 2019 GIANT Health Event, explaining that the UK market is cautious and reliant on scientific evidence.
Cellen has partnered with the key medical cannabis research studies taking place in the UK, including Project Twenty21, which aims to observe 20,000 patients taking medical cannabis over two years. This will form the largest single body of evidence on the topic in Europe.
Cellen is also able to create bespoke formulations of THC:CBD for patients and researchers depending on their individual needs. They have also been known to adapt the oil bases, using common substitutes such as coconut oil when a patient has an intolerance.
Real world evidence will only grow as the number of prescriptions increases, and it is hoped that more National Institute for Health Research (NIHR) and UK government grants will become available to respond to NICE’s call for research. Ultimately, if clinical evidence delivers, this promises to lead to more patients being able to have the cost of this medication covered by the NHS.
Guidance to support clinicians
A publication in the British Journal of Pain showed that in a survey of chronic pain trainees and consultants, 92.8% of respondents had been asked by patients to prescribe medical cannabis, but most did not have confidence in prescribing it.
The 2019 NHS report stated: “The complexity of the cases involved and the speed in which Controlled Drugs legislation changed in 2018 has left some clinicians, and particularly those with a generalist role, feeling that they do not have the specialist professional education needed to make fully informed prescribing decisions in cases where a CBPM may be appropriate.”
Cellen has undergone an initial consultation with prescribers across the UK to understand their barriers to prescribing and the educational gaps they experience. Cellen has partnered with the Medical Cannabis Clinicians Society (MCCS) through an educational grant; and works with partner clinics to write safeguarding policies, prescribing guidelines and clinical governance support for individual patient cases.
What about patients?
There is clearly a lot to be done in the space to ensure patient safety and access to medical cannabis in the UK market, and specifically in the NHS. Empowering patients to take control of their care should not be forgotten though too.
Dr Viaris de Lesegno has spoken with patients and seen the risks when patients do not fully understand the medication they are taking. One reason for this is the blurred line between the consumer CBD market, where unsubstantiated medical claims abound, and the pharmaceutical side of medical cannabis. Patients with complicated diseases have turned to high street shops for relief and have been met with the absence of therapeutic effect – or worse, unwanted side effects from products that they have bought.
UK patients are, unfortunately, not fully informed about the differences in the two markets, including the quality of the products, the traceability of the supply chain and the safety procedures during the manufacturing process. This is also extended to medical cannabis products imported into the UK. There are discrepancies between local and the EU GMP regulations: many unlicensed CBPMs are manufactured in countries outside of the EU and then are legally sold in Europe, without meeting all the EU GMP requirements. Patients have anecdotally reported variations in clinical results from one month to another and, from testing their imported products in independent labs, have seen differences in concentration of the active pharmacological ingredients.
Only a fully EU GMP compliant supply chain can bring the level of confidence to patients and healthcare staff that is required in a pharmaceutical product. With Cellen establishing a research led and patient-centred approach, the UK market is responding with optimism on the future of this medication.
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