OBJECTIVES : “Pay-for-performance” (P4P) is an agreement between payer and manufacturer where “the price level and/or revenue received is related to the future performance of the product in either a research or a real-world environment.” - A Towse, 2010. The objective of this study is to demonstrate a successful P4P solution for ensuring market access of a CDK4/6 inhibitor for the treatment of HR+/HER2− advanced breast cancer used in combination with aromatase Inhibitors (AI).

METHODS : Based on the results from the pivotal trial, Clinical benefit rate (CBR) at 6th month is used as a performance milestone in the calculation of the payment for outcomes. CBRs not met are translated into price reductions.

RESULTS : As the new technology + AI had significantly better efficacy than AI, the manufacturer agrees to receive payments only for CBRs met, fixed at the level of 79.6%. Based on the expected treatments per year, the payer gets cost reduction of 208 298 BGN (152 512 €; 120 056 $) the first year, 559 000 BGN the second year (285 817 €; 322 190 $) and 698 465 BGN the third year (357 125 €; 402 574 $) or a cumulative saving of 1 465 763 BGN (749 444€; 844 820$) for total number of 200 patients treated. The model has been appraised and approved by the national HTA competent authority.

CONCLUSIONS : P4P provides new approach to pay for innovative high-cost therapies, allows sharing the risk and limits total budget impact.