PCN340 FAST CHANGING APPROPRIATE COMPARATORS IN GERMAN AMNOG BENEFIT ASSESSMENTS IN MULTIPLE MYELOMA

Abstract

Within the German Act on the Reform of the Market for Medical Products (AMNOG) process the medical benefit is evaluated against an appropriate comparator, determined by the G-BA. Study aim was to assess the change in appropriate comparators for Multiple Myeloma (MM) over time. A database containing all AMNOG dossiers published until end of April 2019 was screened for MM dossiers; information on appropriate comparators and added benefit was extracted for relevant dossiers. Twelve relevant assessments were identified including 15 subpopulations. Of these, seven were orphan drugs, where the added benefit is set by law and no appropriate comparator is defined. For the remaining assessments, G-BA assigned appropriate comparators depending on treatment line and suitability for targeted therapy treatment. For newly diagnosed patients, Daratumumab was the only assessed drug. G-BA initially assigned the appropriate comparators Bortezomib+Melphalan+Prednisone and Thalidomide+Melphalan+Prednisone. During the assessment process G-BA subsequently updated the list of appropriate comparators repeatedly, resulting in combination therapy at the discretion of the physician taking recommendations of clinical guidelines into account. For patients with at least one prior therapy G-BA assigned the appropriate comparators Bortezomib, Bortezomib+pegylated liposomal Doxorubicin, Bortezomib+Dexamethasone and Lenalidomide+Dexamethasone for Elotuzumab. G-BA assigned a minor added benefit against Lenalidomide+Dexamethasone. As a result, G-BA replaced Bortezomib monotherapy by Elotuzumab+Lenalidomide+Dexamethasone in the list of appropriate comparators for Carfilzomib and Daratumumab in 2017. Although Carfilzomib, Daratumumab and Ixazomib were previously granted an added benefit as orphan drug, they weren’t considered as appropriate comparators. For patients with at least two prior therapies, patient individual therapy at the discretion of the physician was defined as appropriate comparator for Pomalidomide in 2015. Contemporaneously, G-BA aligned the initially defined appropriate comparator for Daratumumab. For MM, assigned appropriate comparators by G-BA change quickly as G-BA takes recently published resolutions, current developments and clinical guidelines into consideration.