PDG62 Outcomes of Benefit Reassessments of Medicinal Products in Germany after Expiry of the Limitation of G-BA Resolution

Abstract

Benefit assessments of orphan and non-orphan drugs in Germany can be limited for a reasonable time period if the study results are considered insufficient for a conclusive decision about the drug’s added benefit, leading to a benefit reassessment after expiry of the limitation. The objective of the current study is to evaluate the development of the added benefit and the negotiated price rebate after reassessment. Outcomes of all limited benefit assessments of orphan and non-orphan drugs that were completed by May 2020 were analyzed. The share of the total population with a granted added benefit as well as the resulting negotiated rebate were determined across all limited assessments for which reassessment due to limitation expiry and price negotiations were completed, respectively. 27% of all orphan-drug and 16% of all non-orphan drug assessments were limited for a mean time span of 29,7 and 26,6 months, respectively. Among non-orphan drugs, the mean share of the total population with a granted added benefit decreased by 13% after reassessment. However, the rebate after reassessment increased by an average of only 1,5% among orphan and 4% among non-orphan drugs. Interestingly, the mean annual therapy costs of non-orphan drugs with a limited assessment were 23% higher than the costs of unlimited non-orphan drugs. Among all orphan-drug assessments, mean annual therapy costs of drugs with a limited assessment were even 45% higher than the costs for orphan drugs with no limitation. Although the mean share of the patient population with a granted added benefit decreased after reassessment, the overall increase in price rebate is low. However, especially for costly drugs, the careful evaluation of the limitation probability as well as the potential risks and benefits of the expected clinical results in each individual case is crucial to prevent harmful outcomes of the reassessment.