TREND of Reimbursement for Second Therapeutic Indications in Italy

OBJECTIVES. This study aims to assess the evolution of the negotiating conditions (discount, Managed Entry Agreement [MEA], innovation) of drugs after the approval of second therapeutic indications. METHODS. We reviewed the CHMP Meeting Highlights referred to 2016-2018 in order to collect all the new indications approved by EMA and we analysed the reimbursement of the second indications in Italy. RESULTS. 67 second therapeutic indications received a positive opinion by EMA’s CHMP in 2016-2018. Until April 2020, 45 (67%) drugs weren’t reimbursed in Italy for the new indication: 60% didn’t undergo a negotiation, 20% are still under evaluation, 20% failed the reimbursement. The remaining 22 (33%) drugs, are reimbursed for the second indication, and most of them (19 [86%]) were already reimbursed for the first indication. Out of these 19 drugs, almost all (95%) were negotiated with a discount; 63% had already a discount for the first indication and, among them, all preserved it for the second one. 7 new indications had a discount even though they didn’t have it before. 32% of the drugs were negotiated through a MEA for the first indication, half of them were negotiated with a Cost-Sharing agreement and the other half with a capping; among them, 67% didn’t receive a MEA for the second indication. For two drugs, a MEA was introduced during the negotiation for the new indication. 16% were granted the conditional innovation status – oncological drugs – for the second indication; 67% of them weren’t considered innovative for the first indication. CONCLUSIONS. The study allows to observe that MEAs generally are not maintained after a negotiation for a second indication. On the other hand, discounts are maintained or, if not present, are added. This is consistent with the overall change in trend in the negotiating conditions observed in the last years.