EPIDIOLEX AVAILABILITY - UPDATE AND COMMENT.

21 November 2018.

Families 4 Access sister campaign group, The Centre for Medicinal Cannabis (CMC), established to promote evidence-based policy-making relating to cannabis-based medicinal products (CBMP), has responded to an NHS update on availability and access to medicinal cannabis.

The NHS says that it and the Government have been working closely with UK-based GW Pharmaceuticals over recent weeks to ensure that specialist clinicians can prescribe US approved medicine Epidiolex (cannabidiol oral solution – CBD) to appropriate epilepsy patients as outlined within the British Paediatric Neurology Association (BPNA) guidance of November 1, 2018.

Andy Yates, pharmacy lead with the CMC, said: "We are completely supportive of the Government engaging relevant industry and cannabis experts and look forward to seeing their consultations broaden with other expert groups and companies with interests and expertise in supplying high quality cannabis-based medicinal products (CBMP).

"It is important to remember that Epidiolex contains only CBD in an oral solution form which may not be suitable for patients with conditions outside of the Lennox-Gastaut syndrome and Dravet syndrome in which it was tested.

"Some patients will require other cannabinoids to control their condition (i.e. THC) and others may find other forms of CBMP - oral droplets, pills, capsules and sprays - more acceptable.

"Therefore ensuring a quality compliant source of other CBMP above CBD oral solution needs to be a priority for the UK government; particularly as there are already routes available to get Epidiolex via compassionate use and clinical trials programmes.

"It is important to note that the list price is likely to be very high. It is $32,500 per year in the USA; this could have a negative impact on the usage of CBMP if similar prices are being charged in the UK, both from an NHS budgetary impact and private patient co-pay perspective.

"The UK government needs to ensure that pricing does not become a barrier to usage for what could be a cost-effective drug."

More than 60 UK-based patients have been treated as part GW's previous compassionate use programme, and on November 12, 2018, the company launched a free-of-charge Early Access Programme (EAP) for an agreed number of paediatric and adult patients with severe treatment-resistant Lennox-Gastaut syndrome and Dravet syndrome (both rare forms of epilepsy).

EAP has been developed in partnership with NHS epilepsy specialists and is available now through agreed expert centres across the UK.

Specialist clinicians can also prescribe Epidiolex to suitable epilepsy patients via the "specials" route outlined in the MHRA’s guidance note 14. Clinicians wishing to purchase Epidiolex through this route can contact specialist medical wholesaler Durbin at: GWPharma@DurbinGlobal.com.

Meanwhile, Epidiolex is currently under regulatory review by the European Medicines Agency with a decision expected in early 2019. If the drug is licensed, consideration will be given whether it becomes routinely available on the NHS. The CMC itself was established to promote evidence-based policy-making after medicinal cannabis was legalised in the aftermath of several high profile campaigns this summer involving two children who were denied access to cannabis-based treatments for epilepsy.

The CMC will publish its first report - Medicinal Cannabis in the UK; a Blueprint authored by Dr Saoirse O’Sullivan on December 10, 2018. Dr O'Sullivan PhD, is a prominent cannabinoid researcher and Associate Professor at The University of Nottingham,Saoirse has been researching the role and effects of endocannabinoids and phytocannabinoids through basic and clinical research since 2002. Saoirse works with patient groups and healthcare professionals to educate them on the benefits of cannabis-based medicines. Associate Professor at the University of Nottingham - see Saoirse’s research on Research Gate and Google Scholar. She runs an independent consulting business CanPharmaConsultingand is a science advisor to several pharmaceutical companies.

Click here to see the supplementary letter provides further guidance to clinicians and organisations following the re-scheduling of cannabis-based products for medicinal use on November 1st 2018.

BASIA ZIENIEWICZ