Institut national d'assurance maladie-invalidité - Règle interprétative pour le remboursement de la spécialité pharmaceutique KeytrudaR (pembrolizumab)., de 4 décembre 2017
Article M.
Règle interprétative pour le remboursement de la spécialité pharmaceutique KeytrudaR (pembrolizumab).
Question:
Dans quelle mesure la spécialité pharmaceutique Keytruda (pembrolizumab) peut-elle être remboursée pour le traitement de première ligne des patients adultes atteints d'un cancer bronchique non à petites cellules (CBNPC) métastatique dont les tumeurs expriment PD-L1 avec un score de proportion tumorale (TPS) > ou = 50 %, dans le cas ou l'absence de mutations tumorales d'EGFR ou d'ALK n'a pas été démontrée?
Réponse:
Si un patient est atteint d'un cancer bronchique non à petites cellules (CBNPC) métastatique dont la tumeur exprime PD-L1 avec un score de proportion tumorale (TPS) > ou = 50 %, et la tumeur est un carcinome épidermoïde, l'absence d'une mutation EGFR ou d'une translocation ALK ne doit pas être démontrée par un test pour bénéficier du remboursement du Keytruda, vu que les études montrent que ces aberrations sont extrêmement rares dans cette histologie. Des tests moléculaires exceptionnels doivent être réalisés conformément aux lignes directrices belges pour les tests moléculaires dans le CBNPC (Pauwels et al., Belgian J Med Oncol 2016; 10 (4): 123-131).
Cependant, s'il...
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