Let´s Talk About Cannabis

Medical Cannabis Reimbursed

In the 1970s, the British clinical epidemiologist Archie Cochrane, one of the pioneers of evidencebased medicine, defined three concepts related to decision-making when pondering a medical treatment: efficacy, effectiveness, and efficiency. Efficacy determines whether a treatment does more good than harm under controlled conditions, such as those of a clinical trial (can it work?). Effectiveness assesses whether a treatment does more good than harm when administered under normal conditions of healthcare practice (does it work in the real world?). Efficiency measures the effect of an intervention in relation to the resources it requires (is it worth it?).

To date, the clinical evidence about the efficacy of cannabis-based medicinal products (CBMPs) for the management of chronic conditions is still a subject of controversy. A systematic review of randomized controlled trials (RCTs) commissioned by the International Association of the Study of PAIN (IASP) concluded that RCTs in this field have a high risk of bias. It should be kept in mind that most of these trials were aimed at bringing to market two cannabis-based authorized medications, Sativex and Epidiolex, and did not seek to characterize those in chronic pain populations but rather in multiple sclerosis and refractory pediatric epilepsy, respectively. However, a significant body of real-world evidence (RWE) obtained in countries where access to cannabis for therapeutic purposes is permitted is suggesting that chronic pain patients report robust improvements in their quality of life when CMBPs are added to their treatment regimen.

Based on these findings and in contrast to the IASP position, the European Pain Federation recommends considering medical cannabis as a thirdline therapy for chronic neuropathic pain while, for all other cases of chronic pain, the use of CBMPs should be considered as an individual therapeutic trial. This means that, if approved treatments have failed, and after careful analysis and multidisciplinary assessment, physicians could prescribe medicinal cannabis to their patients if they consider that could represent a benefit.1

In 2022, several peer-reviewed publications reported on the effectiveness of CBMPs, including more than 15,000 patients from around the world taken collectively. Studies were performed in Israel,2 Australia,3 Colombia,4 Denmark,5 and the UK,6 and all of them showed similar results, which further help profile those patients that can benefit the most from adding medicinal cannabis to their therapeutic management, as well as relevant details in terms of dosing regimens and associated side effects to better inform medical practice and reassure prescribing physicians.

We can only wish that 2023 will be the year in which the third dimension, that of efficiency, will be tackled. Cannabis derivatives are typically approved only for patients that have trialed and failed other therapeutical options and are usually refractory to treatment. Still, the robust improvement in health-related quality of life reported by chronic patients in observational studies has been a decisive argument for different organizations to compel insurers into covering the cost of this therapeutic option based on quality-adjusted life years (QALYs) associated to CBMPs .7

As prominent examples, in the first weeks of 2023 the Colombian government stablished the mandatory coverage of CBMPs in the National Health Program and the UK’s National Health Service reimbursed for the first time the cost and clinical fees to a patient receiving treatment with CBMPs. Many experts have indicated already that insurance reimbursement represents the ultimate barrier for the actual implementation of cannabis-based treatments, thus protecting legitimate operators and expanding legal markets, such is the case of Germany in Europe and Colombia in Latin America, while increasing treatment adherence and preventing patients from falling back into the black market.

Having a route for patient reimbursement for CBMPs is an important pillar of our global strategy at Khiron Life Sciences which we just finally achieved with mandatory reimbursement in Colombia. It would be, therefore, extremely important we start seeing welldesigned cost-benefit analysis being conducted in legal jurisdictions which can further reassure policy makers of the efficiency of CBMPs as an early therapeutic intervention.

Guillermo Moreno-Sanz, PhD

Global Scientific Director at Khiron Life Sciences Corp.