A decade of early benefit assessment of ophthalmic drugs in Germany: success story or not?

Objective: To analyze how ophthalmic drugs fared in the early benefit assessment (EBA) after its introduction in Germany up to 2020 and to quantify its impact on their negotiated prices.

Methods: Relevant documents were screened and essential content on added benefit outcomes and the underlying evidence was extracted next to pricing information. In addition to descriptive statistics, cross-stakeholder analyses and agreement statistics were implemented.

Results: Thirteen completed EBA were identified involving eight drugs. Only four drugs (30.8%) received an added benefit. The OR for no added benefit of ophthalmic drugs versus all other drugs was 2.971 (0.902-9.781). The agreement between manufacturers' claims and decision-maker appraisals is fair (kappa 0.435). In all cases, evidence was derived for RCTs, but for different reasons, not all of them allowed direct comparisons with the comparator as defined by the decision-maker. The negotiated rebates on manufacturer's selling prices varied from 6.8% up to 47.4%. Nevertheless, the rebates for ophthalmic drugs (median 14.5%) were lower than those for all negotiated drugs (median 24%).

Conclusion: Over the past decade, the EBA of ophthalmic drugs was not necessarily a success story, but in most of the cases, the drugs were successful in the market.