Assessing the added benefit of new ophthalmic drugs : Which additional insights can be extracted from the early benefit assessment?

Abstract

Until now six ophthalmic agents have undergone the German early benefit assessment according to §35aSocial Security Code (SGB)V in atotal of eleven indications. Only one agent (ocriplasmin) was recognized by the Federal Joint Committee as having an added benefit based on submitted study data for asubpopulation (indication of aconsiderable added benefit, limited for 5years) and another agent, idebenone, received an added benefit due to its orphan drug designation (proof of anot quantifiable added benefit, limited for 2years). All remaining agents (aflibercept, bromfenac, nepafenac and tafluprost/timolol) were not recognized as having an added benefit. The analysis showed that there was alack of suitable evidence. Some reasons for the inappropriateness of the conducted trials for the usage in the early benefit assessment are the comparative therapy, the patient population included or the dosage regimens. For two agents (bromfenac and nepafenac) the pharmaceutical company did not even submit avalue dossier. The examples from ophthalmology illustrate the methodological and procedural shortcomings of the assessment process and that results of an early benefit assessment should be interpreted with caution.