The cannabis-based prescription drug Sativex has received recommendation to be approved by six European countries. However, given poor reviews in the UK, other European national health services may not actually fund it.
On Tuesday, a cannabis drug designed to alleviate spasticity symptoms of multiple sclerosis (MS) was recommended for approval in six European countries.
Sativex, which is injested by spraying it under the tounge, received the go-ahead from the European mutual recognition procedure and is awaiting national approvals from Germany, Austria, the Czech Republic, Denmark, Italy and Sweden later this year.
Developed by United Kingdom’s GW Pharmaceuticals, Sativex was first approved by Health Canada in 2005 and has been on the market in Britain since June 2010.
Spain became the third country to market the drug after its launch earlier this month.
“Today’s news represents a major step forward for the international commercialisation of Sativex,” said Stephen Wright, GW’s research director, in a Reuters interview.
European rollout likely to be slow
But Sativex’s recommendation for approval does not necessarily mean people will benefit from the drug once it’s on the market. In reality, it depends on whether or not doctors in those six EU countries choose to prescribe it.
If the drug’s reception in the United Kingdom is any indication, the launch of Sativex in the rest of the EU might not matter all that much.
“The market is likely to closely follow the UK launch as a barometer for the potential of Sativex in other European markets,” said a report by Nomura Code, a London-based securities firm, adding that market access for any new drug in the UK is a challenge.
Last year, the UK’s National Institute for Health and Clinical Excellence (NICE), the agency that evaluates taxpayer-funded drugs and medical treatments, decided not to fund the prescription drug.
Nomura Code’s report was based on a survey of around 150 local Primary Care Trusts, which individually assess new drugs and whether they should be prescribed to the British public in absence of funding from NICE. The survey concluded that the majority of PCTs were hesitant to endorse Sativex.
This reluctance by the PCTs means that medical consultants face a series of obstacles for prescribing the drug to patients. This includes lengthy bureaucratic processes and the added burden of having the prescription paid for.
Often prescribed as a ‘supplement’
Additionally, Sativex is widely recognized by medical professionals as a supplement to more effective drugs, rather than acting as a stand-alone drug.
“Cannabis provides benefit to patients in numerous symptoms, but the problem is that it doesn’t do a huge amount in those symptoms,” said Dr. Samir Devani, who authored the Nomura report, in an interview with Deutsche Welle.
Devani added that Baclofen is currently the most prescribed drug to treat MS patients suffering from spasticity in the United Kingdom.
Currently, patients seeking a Sativex prescription need to fail treatment by Baclofen and undergo tests that prove that the new drug has positive effects on treating MS symptoms. This increases the burden multiple sclerosis patients have in obtaining a prescription.
However, without funding from NICE, in the UK, Sativex also costs significantly more than its more effective counterpart – a single daily dose costs about 13 euros ($18.50).
Author: Christian Nathler (Reuters)
Editor: Cyrus Farivar