The first medicinal cannabis product to be licensed in Ireland has been rejected for inclusion in Health Service Executive-funded drug schemes.
The National Centre for Pharmaco-Economics, which assesses the potential benefits and costs of new medicines, has ruled that Sativex is not cost-effective at the price quoted by its manufacturer, Almirall. The drug is used to increase mobility among patients with moderate to severe multiple sclerosis.
The final decision on whether to make Sativex, which contains extracts from the leaf and flower of the cannabis plant, a reimbursable medicine under State drug schemes now rests with the HSE.
In its latest decision, the centre raises a number of concerns about the claims made for Sativex and the projected cost. The NCPE estimates Sativex will cost about €4,500 to €5,000 a patient, but it says there is a “substantial degree of uncertainty” about how many doses a patient would use.
The application assumed six applications by spray a day but the maximum dose is 12 sprays.
The drug is expected to benefit 830 patients, giving a yearly cost of €400,000 in the first year, rising to €800,000 after five years.