concernee dans son AMM. Ainsi, selo

concernee dans son AMM. Ainsi, selon l'article L. 5121-12-1 precite, la prescription « hors AMM »
n'est admise :

qu'en « l'absence d'alternative medicamenteuse appropriee disposant d'une autorisation de mise sur le marche ou d'une autorisation temporaire d'utilisation » ;

uniquement si celle-ci est jugee par le medecin comme « indispensable, au regard des donnees acquises de la science (...) pour ameliorer ou stabiliser J'etat clinique du patient» ;
a condition d'informer le patient du caractere « hors AMM » de sa prescription.

358. S'agissant en l'espece des patients traites pour un SCA, il ne fait aucun doute qu'il existe une specialite appropriee disposant d'une AMM, puisque Plavix contient l'indication SCA dans son AMM.

359. De plus, comme il a ete explique ci-dessus (pts. 118 a 125), l'absence d'indication SCA des generiques de clopidogrel peut conduire certains patients, ne voyant pas figurer dans I'AMM de leur medicament (et done dans sa notice) l'indication pour laquelle ils sont traites, a interrompre leur traitement. Des lors, quand bien meme son origine est brevetaire, le risque de mauvaise observance pouvait justifier, au regard du profil de certains patients, que les medecins inscrivent
« NS » sur leurs ordonnances.

360. l'influence de cet element sur le taux de « NS » est d'autant plus credible que l'indication SCA represente un nombre important de patients, environ 25 %, et que ces patients sont aussi les plus fragiles, done ceux pour lesquels le medecin est le plus enclin a prendre des precautions dans sa prescription.

361. Pour realiser une comparaison plus pertinente entre le taux de « NS » de Plavix et le taux moyen de « NS » toutes molecules confondues, il conviendrait :

d'exclure les ordonnances « NS » observees pour l'indication SCA, c'est-a-dire lorsque le clopidogrel est delivre en bitherapie avec de l'aspirine, puisque ces ordonnances correspondent a une indication qui n'etait pas « accessible » aux generiques dont les AMM ne contenaient pas cette indication ;

ne conserver que les ordonnances « NS » observees dans les autres indications, c'est-a­
dire lorsque le clopidogrel est delivre en monotherapie (sans aspirine), puisque ces ordonnances correspondent a des indications non protegees par un brevet et figurant dans les AMM des generiques.

362. Nous ne disposons pas des donnees utilisees par la CNAMTS dans son etude precitee, qui auraient permis de corriger directement le taux de « NS » en excluant du perimetre les ordonnances « NS » observees en bitherapie. Cependant, de maniere conservatrice, on pourrait supposer qu'il y a 20 % de plus d'ordonnances « NS » en matiere de bitherapie (indication SCA) qu'en matiere de monotherapie (autres indications). Cette hypothese est particulierement conservatrice car elle revient a considerer que les medecins apposeraient la mention « NS » dans
mains d'un tiers des cas de SCA, alors que theoriquement, on pourrait s'attendre a ce que 100 %
des ordonnances de SCA fassent l'objet d'une mention « NS » afin de garantir aux patients une prescription disposant de cette indication dans son AMM.

363. Le taux calcule par la CNAMTS sur l'ensemble du clopidogrel apparait comme une moyenne entre le taux de mentions « NS » pour le SCA et le taux de mentions « NS » pour les autres indications, ponderee par le poids de chacune de ces deux categories. Formellement, ce taux est obtenu par le calcul suivant :

Résultats (Anglais) 1:

question in his amm. thus, according to the article. 5121-12-1 cited above, prescribing "off amm»
is accepted

that "no alternative medication APPROPRIATE with permission of placing on the market or a temporary authorization Use ";

only if it is tried by the doctor as" indispensable, given the data acquired Science (...) To improve or stabilize the patient's clinical condition I ";
a requirement to inform the patient of the character" amm out "of his prescription

358.. the case in the present case of patients treated for a sca, there is no doubt that there is an appropriate specialty with a amm since plavix contains the indication in its sca amm.
359. Moreover, as was explained above (Pts.118 to 125), there is no indication of sca generic clopidogrel may lead some patients, not seeing i'amm included in their medication (and therefore its instructions) the indication for which they are processed, to interrupt treatment. of time, even when its origin is well brevetaire the risk of poor compliance could justifylook at the profile of some patients that doctors fall
"ns" on their orders.
360. the influence of this element on the rate of "ns" is all the more credible indication that the SCA represents a significant number of patients, about 25%, and these patients are also more fragile,therefore those for which the doctor is more likely to take precautions in prescribing.
361. to realize a more meaningful comparison between the rate of "ns" of plavix and average "ns" all molecules together, should

exclusion orders "ns" observed for the indication sca,that is to say, when clopidogrel is issued in combination with aspirin, because these orders correspond to an indication that was not "available" to generic amm which did not contain this indication

just keep that orders "ns" observed in other indications, that is to say
when clopidogrel is issued as monotherapy (without aspirin)since these orders match has not protected by a patent and information contained in the generic amm.
362. we do not have the data used by the CNAMTS in the study cited above, which would have corrected rate "ns" directly excluding the perimeter orders "ns" observed in combination. however, so as conservativeone might assume that there are 20% more orders "ns" in matters of combination therapy (indication sca) in matter of monotherapy (other indications). This hypothesis is particularly conservative as she returns to consider that doctors apposeraient marked "ns"
hands in a third of cases of SCA, while theoretically, one could expect that 100%
sca orders are subject to a marked "ns" to ensure that patients have a prescription for this indication in its amm.
363. the rate calculated by the CNAMTS across the clopidogrel appears to be an average of the rate of mentions "ns" for sca and the rate of mentions "ns" for other indications,weighted by the weight of each of these two categories. formally, this rate is obtained by the following calculation:

Résultats (Anglais) 2:

concerned in the AMM. Thus, according to article l. 5121-12-1 supra, "off-label" prescribing
is allowed:

and "lack of alternative drug proper with an authorization for placing on the market or a temporary authorisation";

only if it is judged by the doctor as «essential, given the data acquired from the science (...»') to improve or stabilize I clinical condition of the patient ";
provided that they inform the patient of the character 'off-label' his prescription.

358. With regard to in the case of patients treated for a SCA, there is doubt that there is a specialty appropriate boasting a marketing authorisation, since Plavix contain the SCA indication in the AMM.

359. In addition, as it has been explained above (pts. 118a 125), the absence of SCA from clopidogrel generics can lead some patients seeing not included in I'AMM of their drug (and done in his record) the indication for which they are processed, a treatment interruption. Therefore, when even though its origin is sanofi, the risk of poor adherence could justify, with regard to the profile of some patients, physicians fall
'NS' on their orders.

360. the influence of this element on the 'NS' rate is all the more credible that indication SCA represents a large number of patients, about 25%, and that these patients are also the most fragile, done for which the physician is more inclined to take precautions in his prescription.

361. To ensure a more relevant comparison between the rate of 'NS' of Plavix and the average rate of 'NS' all molecules combined, should be:

to exclude orders 'NS' observed for the SCA indication, that is when clopidogrel is issued in combination therapy with aspirin, since these orders puisque ces ordonnances correspondent match was an indication that was not 'accessible' to generics with the AMM does not contain this indication;

save orders 'NS' observed in other indications, it's - a
say when clopidogrel is issued as monotherapy (without aspirin), Since these orders correspond has indications not protected by a patent and contained in the marketing Authorisations of generic

362. We do not have data used by the CNAMTS in his aforementioned study, that would directly address the rate of 'NS' excluding perimeter orders 'NS' observed in combination therapy. However, in a conservative manner,. It might be assumed that there are 20% more orders 'NS' bitherapy (indication SCA) as monotherapy (other indications). This assumption is particularly conservative as she returns to consider that physicians explode the mention 'NS' in
hands one-third of cases of SCA, while theoretically, one might expect a 100%
.SCA orders subject to mention 'NS' in order to guarantee patients a prescription with this indication in its AMM.

363. The rate calculated by the CNAMTS throughout clopidogrel appears as an average between the mentions 'NS' for the SCA rate and the rate of 'NS' endorsements for the other indications, weighted by the weight of each of these two categories. Formally, this rate is obtained by the following calculation:

Résultats (Anglais) 3:

Concerned in its AMM. Thus, according to article L. 5121-12-1 Supra, the prescription "off AMM "
is permitted:

that in "the absence of alternative appropriate drug with a permission of placing on the market or a temporary authorization to use " ;

only if the latter is considered by the doctor as "indispensable, in relation to the acquired data of science ( ...) To Improve or stabilize I clinical status of the patient" ;
a condition to inform the patient of the character "nonapproved" of its prescription.

358. If acting in the case of patients treated for a SCA, there is no doubt that there is a specialty appropriate with a AMM, since Plavix contains the indication SCA in its AMM.

359. In addition, as has been explained above (pts.118 To 125), the absence of indication of SCA generic of clopidogrel may lead some patients, light does not appear in I'AMM of their medication (and done in its leaflet) the indication for which they are treated, has interrupt their treatment. Therefore, when well even its origin is brevetaire, the risk of poor adherence could justify,In the light of the profile of certain patients, that the doctors part
"NS" on their orders.

360. The influence of this element on the rate of "NS" is all the more credible that the indication SCA represents a significant number of patients, approximately 25 %, and that these patients are also the most fragile,Done those for which the doctor is the most inclined to take precautions in its prescription.

361. To achieve a more meaningful comparison between the rate of "NS" of Plavix and the average rate of "NS" all molecules together, it should be :

to exclude the orders "NS" observed for the indication SCA,It is-a-say when clopidogrel is issued in bitherapy with aspirin, since these orders correspond has an indication which was not "accessible" to the generic which the AMM does not contain this indication ;

keep only the orders "NS" observed in other indications, that is-a­
say when clopidogrel is issued as monotherapy (without aspirin),Since these orders correspond has information not protected by a patent and contained in the AMM of generic.

362. We do not have the data used by the CNAMTS in his study cited above, which would have allowed to correct directly the rate of "NS" by excluding the perimeter the orders "NS" observed in bitherapy. However, in a conservative way,One could assume that there is 20 per cent more of orders "NS" in respect to bitherapy (indication SCA) that in matters of monotherapy (other indications). This assumption is particularly conservative because it returns a consider that doctors apposeraient the mention "NS" in
hands of a third party of the case of SCA, while theoretically, one could expect that 100 %
Orders of SCA should be the subject of a mention "NS" in order to guarantee patients a prescription with this indication in its AMM.

363. The rate calculated by the CNAMTS on the whole of clopidogrel appears as an average between the rate of mentions "NS" for the SCA and the rate of mentions "NS" for other indications,Weighted by the weight of each of these two categories. Formally, this rate is obtained by the following calculation: