United Kingdom: two cannabis medicines to be reimbursed

The prescription and reimbursement of two cannabis-based medications have been approved by the English National Health Service (NHS).

NICE, the agency that monitors the cost-effectiveness of the NHS, has thus updated its guidelines and now recommends the use of Epidyolex for the treatment of epilepsy in patients with Lennox-Gastaut syndrome (LGS) or Dravet syndrome, two rare and severe forms of childhood epilepsy, and Sativex for spasticity associated with multiple sclerosis. Both of these products are manufactured by GW Pharmaceuticals, a British company.

This is the first time that NICE has recommended the use of a plant-based cannabis-derived medication and its coverage by the NHS in England. Until now, the NICE did not recommend the use of Epidyolex, but changed its position after GW agreed to lower the price of the drug.

Epidyolex has been Approved in Europe for the treatment of severe epilepsy last September. Sativex was first registered in the United Kingdom in 2010 and approved for the French market in 2014, though it never actually made it onto pharmacy shelves, for various reasons.

Last year, The United Kingdom has decided that cannabis-based medicines and without a prescription could legally be prescribed by a hospital physician for certain conditions that do not respond to other treatments, particularly epilepsy and multiple sclerosis. Access to cannabis-based treatments However, it proved to be difficult for the patients.

The NICE decision obviously pleased Chris Tovey, head of operations at GW, for whom «This is a »major opportunity for British patients and families who have been waiting for many years for cannabis-based medicines that have been tested, verified, and approved by regulatory authorities and that are to be covered by the NHS.'".

However, there is still no legal pathway providing access to CBD-based medications for the treatment of chronic pain. The association End Our Pain said on Twitter that the guidelines «do not go far enough to help patients […] with the greatest needs, or for whom medical cannabis containing THC has a significant impact on their lives.».

In addition, patients with other forms of epilepsy are also excluded from access to cannabis-based products, as are those with many forms of treatment-resistant chronic pain that generally respond well to THC-based treatments.

GW has stated that it is working with the relevant agencies in the United Kingdom, Germany, Spain, France, and Italy to secure reimbursement before the planned launch of Epidyolex in those countries. This may provide an opportunity to bring the issue of access to Sativex in France back to the negotiating table.

Wales and Northern Ireland also follow NICE guidelines, while their Scottish counterpart, the Scottish Medicines Consortium (SMC), is set to make a decision regarding Epidyolex next year. It states that GW has not submitted an application for approval to prescribe Sativex for the treatment of spasticity associated with multiple sclerosis.

NICE has also recommended the use of nabilone, a synthetic form of THC, to relieve chemotherapy-related nausea in adults.