OBJECTIVES: To evaluate the incidence of conditional G-BA approvals in the AMNOG process, identify analyse reasons and understand the impact of conditional approval on assessment outcomes, price negotiations and the reimbursement price.

METHODS: We collected and analysed the outcome of all 309 G-BA assessments (as of June 11, 2018) and identified all assessments with G-BA conditional approval until June 2018. We qualitatively and quantitatively analysed the underlying reasons for the conditional G-BA approvals and the resulting implications in terms of HTA assessment outcomes and price before and after delivery of G-BA requested additional data.

RESULTS: As of June 15 2018, 309 assessments for new drugs and indication expansions were conducted and finalized by the G-BA. Out of those, 46 assessments were associated with a G-BA conditional approval, whereof 16 were orphan drugs. In 14 cases, a G-BA conditional approval is associated with conditional EMA approval, whereas in the remainder G-BA itself decided to apply a time limit. Products with a G-BA conditional approval achieved additional benefit in 78% of cases. As of June 2018, 20 assessments with G-BA conditional approval had expired and already been converted into regular assessments, whereas in 11 cases the additional benefit improved. The impact on price still needs to be analysed by comparing negotiated rebates (using LauerTaxe PpU data) after the initial, conditional assessment versus the negotiated rebates after the final assessment with the full dataset available

CONCLUSIONS: More often than not, the G-BA defines conditional approval by itself and does not follow conditional EMA approval. This implies that manufacturers, specifically of orphan drugs, need to be prepared to deliver subsequent analysis and data to the G-BA, even without conditional EMA approval. It seems only in some cases helped additional data (e.g. RWE Data) after expiry of the time limit to improve HTA outcomes and reimbursement price.