Rijksinstituut voor ziekte- en invaliditeitsverzekering - Interpretatieve regel voor de terugbetaling van de farmaceutische specialiteit Keytruda® (pembrolizumab)., de 4 décembre 2017
Artikel M.
Interpretatieve regel voor de terugbetaling van de farmaceutische specialiteit KeytrudaR (pembrolizumab).
Vraag:
In welke mate mag de farmaceutische specialiteit Keytruda (pembrolizumab) terugbetaald worden voor de eerstelijnsbehandeling van gemetastaseerd niet-kleincellig longcarcinoom (NSCLC) bij volwassenen met tumoren die PD-L1-expressie vertonen met een tumour proportion score (TPS) > of = 50 % indien de afwezigheid van EGFR- of ALK-positieve tumormutaties niet aangetoond is ?
Antwoord :
Indien een patiënt een gemetastaseerd niet-kleincellig longcarcinoom (NSCLC) heeft dat PD-L1-expressie vertoont met een tumour proportion score (TPS) > of = 50 % en dat een plaveiselcelcarcinoom is, moet de afwezigheid van een EGFR mutatie of een ALK translocatie niet aangetoond zijn met een test om te genieten van terugbetaling van Keytruda, gezien studies tonen dat deze aberraties uiterst zelden voorkomen bij deze histologie. Uitzonderlijke moleculaire testing dient te gebeuren conform de Belgische richtlijnen voor moleculaire testing in NSCLC (Pauwels et al, Belg J Med Oncol 2016; 10(4): 123-131).
Indien het echter om een adenocarcinoom gaat, moet de afwezigheid van een EGFR mutatie...
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