The government had drafted a decree to authorize Avastin for the treatment of AMD. Imposing a drug for economic reasons is not authorized in Europe, recalled the Council of State.
In March 2014, the Parisian indicated that the Minister of Health, Marisol Touraine, had submitted to the Council of State a draft decree concerning the anticancer drug Avastin (Roche). This drug was soon to be approved for the treatment of AMD, an eye disease that results from gradual deterioration of the macula, a small area in the center of the retina that allows you to see details and colors with precision. This decree had to be published because this product offers an alternative and economical solution to Lucentis (Novartis), the only specialty authorized for the moment in this pathology. If the treatment with Lucentis costs 900 € per injection, its “competitor” only asks for 30 €. By proposing this decree, the Minister of Health was actually forcing the Swiss laboratory Roche. The latter has in fact not requested authorization to prescribe Avastin in the treatment of AMD. But this Wednesday, The Parisian indicates that the “Avastin decree” might be “stillborn.” “
Unfavorable opinion of the Council of State
According to their information, the confidential opinion of the Council of State on this text has been issued. And to the surprise of many players in this file, it would be unfavorable. On the motivations side, the magistrates would have considered that imposing a drug for economic reasons is contrary to European regulations.
Nevertheless, as specified The Parisian, the Ministry of Health could not respect this decision because it is a simple opinion which has no binding force for the government. And it is perhaps towards this option that the Ministry of Health could move. Yesterday, the regulatory commission of the National Health Insurance Fund ruled on a new draft decree. This time around, Avastin could see the light of day with a temporary recommendation for use (RTU) for “public health reasons.” The only problem for this commission, in this pathology, another drug already exists (Lucentis). Public health is therefore not threatened.
Over 400 million euros “wasted” every year
However, recently, the union of general medicine (SMG) recalled in a open letter to the President of the Republic that 400 million euros were “wasted” every year because of this blockage. “In the serious circumstances in France, it seems unthinkable to waste some 400 million euros a year in pure loss”, explained the union. Lucentis is indeed at the top of the most reimbursed drugs. It is the first drug expenditure item of the Health Insurance with 438 million euros reimbursed in 2013.
Finally, among its other requests, the SMG also requested the referral of the Competition Authority to open an investigation “on the suspicion of an illicit agreement between the Roche and Novartis groups, with a view to blocking the marketing of the Avastin as an ophthalmic preparation. The competition authority has already carried out searches of the premises of the two laboratories in April.
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