While the ANSM urges him to be ready in September, Roche attacks the decree allowing the temporary use of the anticancer drug Avastin in AMD.
Since March 2015, France has authorized the drug Avastin for the treatment of age-related macular degeneration (AMD). In addition to being thirty times less expensive than Lucentis, this anticancer drug has shown equal effectiveness in the treatment of this pathology. However, at the present time, the treatment remains inaccessible to patients because the Roche laboratory is still opposed to the French RTU (Temporary Recommendation for Use) arguing a risk to the health of patients.
But faced with the attitude of the Roche laboratory, the National Medicines Safety Agency (ANSM) remains firm. She announced on Friday that the RTU concerning the off-label use of Avastin “will enter into force as of September 1, 2015”. What put pressure on the pharmaceutical laboratory which immediately replied.
The art of saving time
Contacted by Agence France Presse (AFP), the Roche group announced that it had attacked the Council of State against the decree allowing the temporary use of this drug. The legal director of Roche in France, Sylvie Caccia, quoted in a press release, specifies that the group “attacked the decree of December 30, 2014 opening the possibility of setting up this type of RTU despite the existence of several duly approved alternatives, therefore in the absence of therapeutic need and of public health interest ”. On this point, “the administrative courts have not yet ruled”, insists the legal director. Once again the lab is trying to save time.
Roche will use any legal remedy
And now the group no longer hides its intentions since it says it examines “the decision of the ANSM with effect from September 1 and will use any legal remedy open to it to assert its position”, it is written in the press release.
Asked by Why actor a few days ago, Dr Yannick Pletan, medical director of Roche France, explained “that originally, an RTU applies if there is no therapeutic alternative. The new text proposes to remove this condition, but also to allow the implementation of an RTU for economic reasons. However, we consider that the interests of the patient come before everything, even before the budgetary considerations of the States. So we attacked this decree before the Council of State and we won ”.
“The decree has been rewritten and no longer takes into account the economic reason for requesting an RTU. On the other hand, the existence of alternative therapies no longer constitutes an obstacle to an RTU, ”he concluded.
.
