Kymriah Outcomes Based Agreement

Conclusions: The experience of Kymriah® and Yescarta® shows an increase in appetite for results-based reimbursement (OBR) in the EU5, especially in Italy and Spain, new approaches are being applied (progressive results-based payments). Thus, real evidence (RWE) has become an increasingly powerful lever to demonstrate the value of health benefits in the clinical environment. To ease regulatory barriers in Medicare and Medicaid, the Centers for Medicare – Medicaid Services (CMS) can perform more paid payment systems or based on results similar to Novartis` agreement for their $475,000 Kymriah leukemia drug. In the past, Germany was at the close with regard to the OBR, but Kymriah® and Yescarta® were adopted with results-based discount systems that cover about half of the German population (total). It is assumed that these systems are primarily used as a means of encouraging the introduction during the 12-month period of free prices (during national price negotiations) and the main research shows that manufacturers are supposed to prefer simple rebates as soon as the implementation period of the OBR expires. It should be noted, however, that GWQ ServicePlus (one of the groups of health insurers that handled the results-based rebate for Kymriah®) also adopted a performance contract for the treatment of multiple sclerosis in 2018 [57.58]. This indicates that innovative repayment systems are increasingly accepted by German payers when traditional framework restrictions are limited in managing uncertainties. The terms of Novartis` agreement with the CMS inevitably raise the following question: is this a trend? According to the Von Fierce Pharma website, Bernstein analyst Tim Anderson believes that if Novartis went first to the government to enter into this type of paid contract, it will likely come up with similar terms with private insurance companies. This is not surprising, as drug expert Peter Bach writes on the Stat News website that previous contracts based on results have generally been concluded between pharmaceutical companies and private insurance agencies. In addition, Novartis intends to continue to work with CMS on results-based pricing „to potentially extend the approach to other products and disease conditions.“ TC considered kymriah® a significant actual clinical benefit (SMR: significant) and a moderate improvement in value added compared to available therapies (ASMR:III) for the treatment of B-Cellular LAL based on high rates of complete remission.