EXCLUSIVE – The decree fixing the reimbursement of Avastin in AMD has just been published. Roche took legal action against the temporary use recommendation.
Avastin will be well managed for the treatment of age-related macular degeneration (AMD). This August 27, a stop was published in the Official Journal. It authorizes the reimbursement of this anticancer drug marketed by Roche. The Minister of Health, Marisol Touraine, thus maintains her promise of care from September 1, 2015.
But the Roche laboratory continues to protest against this measure “for economic purposes”. And for good reason: Avastin is 30 times cheaper than Lucentis (Novartis), the reference treatment, while it is also effective.
Last June, the Swiss laboratory strongly criticized the news Temporary recommendation for use (RTU), which enables the use of the anticancer drug Avastin in AMD.
The decree published on August 27 sets the conditions for taking charge of the drug, and especially its price. “The price cut, after an RTU, it’s a normal process”, comments Sylvie Caccia, legal director of Roche France, contacted by Why actor. Each syringe will cost 10 euros. Sylvie Caccia said all the same “astonished that the text resumes that of the RTU”.
An imposed monitoring protocol
The decree opens the reimbursement, but the heart of the battle is around the use of Avastin. To date, the product is not packaged for use in the treatment of AMD. Hospital pharmacies will therefore have to repackage the product.
First pitfall for Roche. “Last week we attacked the decree of December 30, 2014. We filed an appeal for annulment and an appeal for suspension, explains Sylvie Caccia. In the interest of the patient, we remind you that Avastin is not suitable for injection. The laboratory insists that the drug is not the only possibility of treatment of AMD: Lucentis (Novartis) and Eylea (Bayer) also have an authorization.
If Roche is so vehement, it is also because the RTU imposes on it the responsibility of monitoring patients, as well as “the collection and analysis of efficacy and safety data throughout the duration of the RTU. ”
This is the last straw for the legal director of the Swiss laboratory. “France is the only country in the world to have placed these obligations on Roche. We don’t do any reconditioning. ANSM (National Medicines Safety Agency, editor’s note) has decided on a protocol of which we are not part, and yet, we are given responsibility for the product, denounces Sylvie Caccia. We do not wish to set up the follow-up protocol. ”
And the representative of the laboratory to confirm that the said protocol will not be organized before the court decisions are rendered.
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