Azacitidine access program for Belgian patients with myelodysplastic syndromes, acute myeloid leukemia or chronic myelomonocytic leukemia

AbstractObjective:Azacitidine (Vidaza) is approved in Europe for treatment of myelodysplastic syndromes(MDS), acute myeloid leukemia (AML) with 20–30% bone marrow (BM) blasts, and chronic myelomonocytic leukemia(CMML) with 10–29% BM blasts and no myeloproliferative syndrome (i.e. <13.000/μL white blood cells). In Belgium, the azacitidinereimbursement process can take several months, and is often delayed at submission for medical assessment by the Belgian National Institute for Health and Disability Insuranceof incomplete patient dossiers, due to disease complexity and classification, and administrative burden. We describe the Vidaza Access Program and its application to an initial 175 patients. Individual medical dossiers were reviewed for completeness to facilitate patient access to treatment in Belgium.Methods:A standardized anonymized patient information form is completed by the physician and sent for review to the Belgian Celgene Medical Department. The form is reviewed within three working days a...