Only an arbitration from the Ministry of Health seems to be able to put an end to the blocking of negotiations around Sativex, which has been at a standstill for two years.
“What must be done to move the file forward?” Stomp, cry, roll on the ground? I am ready to do it ”. The exasperation appears this Thursday on the face of the boss of Almirall, the Spanish laboratory which markets Sativex. It must be said that for two years and obtaining market authorization for this cannabis-based drug, indicated in the symptomatic treatment of certain pain associated with multiple sclerosis, man must be patient. . With the French health authorities, negotiations have stalled. The price offered by the company remains higher than that granted by the CEPS (Economic Committee for Health Products), where a bitter tug-of-war is being played out.
“Postures”
“There are ideological positions around this issue! denounced the director of the laboratory, during a press point organized at the Saint-Antoine hospital. The question of price is only a pretext. In reality, the problem is that there is cannabis in this drug – and it is only in France that I encounter such a blockage, ”says Christophe Vandeputte.
Which is not quite true. Marketed at 440 euros on average in 23 countries (including 17 in Europe), the Sativex remains on hold in the Netherlands, where negotiations have also dragged on for four years. And one can hardly suspect the country of rigorism vis-a-vis cannabis.
The divided CEPS
In reality, the Sativex dossier is confronted with several questions, the main one being that of its cost-effectiveness. On this point, the Transparency Commission of the HAS, which issues a “note” to drugs, is rather negative. In its opinion, delivered at the end of 2014, it considers the Service Médical Rendu (SMR) “weak” and the ASMR (improvement of the SMR) “non-existent” – two criteria which weigh heavily in the negotiation of the price of a drug reimbursed by the company. ‘Health Insurance. “This is only an opinion, sweeps Christophe Vandeputte. No one has to follow him. Some within CEPS may follow him too much ”.
In fact, within the body that sets drug prices, consensus is far from reigning. According to our information, part of the committee wants more flexibility in order to find a solution allowing the product to be marketed. But the majority of members consider the drug too ineffective to validate the price proposed by the laboratory.
“They charge a price six to seven times higher than that of comparators,” explains an internal source. The comparators are the therapies currently delivered to patients with multiple sclerosis, which could possibly be replaced by Sativex – in this case, baclofen, dantrolene or even benzodiazepines.
To find out whether it should follow the opinion of the Transparency Commission, or give the product a chance despite unfavorable ratings, the CEPS turned to the Directorate General of Health (DGS). Which confirmed that there was no reason to shy away from the first opinion.
Political arbitration
So we are there. The last proposal put on the table by the company dates from October 2015. It includes not only the price of the therapy, but also studies to assess the risks and the real-life effectiveness of the drug. According to the director of Almirall, CEPS wants to rely on the Ministry of Health to end the blockage through political arbitration.
For her part, Marisol Touraine has always been in favor of Sativex, she who announced – a little quickly no doubt – its marketing in the first quarter of 2015, after having amended by decree the law on the manufacture of cannabis-based drugs. “But since then, it’s been radio silence”, specifies Christophe Vandeputte.
How will the department intervene in this matter? The question remains unresolved. In the meantime, demand from patients remains strong, since despite a relative efficacy, Sativex has been proven in patients in whom other therapies have proved ineffective.
In other European states, however, health authorities remain cautious. The United Kingdom, the first country on the continent to distribute Sativex, do not recommend it due to unfavorable cost-effectiveness. It is a fact: unless the case is taken over by the Ministry of Health – and this, before the 2017 presidential elections – Sativex is not ready to see the light of day in France.
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