PBI28 NOVEL MANAGED CARE STRATEGIES CAN IMPROVE ACCESS TO CELLULAR AND GENE THERAPY PRODUCTS

Abstract

To evaluate the effectiveness of innovative managed care strategies implemented in the US in improving market access for CGTPs. We conducted a literature review for novel managed care strategies implemented to overcome access barriers for azficel-T, talimogene laherparepvec, tisagenlecleucel, voretigene neparvovec-rzyl, sipuleucel-T and axicabtagene ciloleucel. We then analyzed the findings to identify the implications of the strategies on minimizing upfront financial costs, reducing the incremental cost-effectiveness ratio and promoting the proper utilization of the therapy. Conventional managed care strategies have been ineffective in providing CGTPs due to their significant financial burden. Nonetheless, the Institute for Clinical and Economic Review calculated that several CGTPs are more cost-effective than current alternatives at list price. However, patients and payers are unable to bear the significant upfront costs. Therefore, there has been a multi-stakeholder effort to encourage novel contracts between payers and pharmaceutical companies. Suggested contracts include outcomes-based agreements, such as the Novartis deal with the CMS for tisagenlecleucel, which required the patient to respond after a month of treatment for payment. This pay-for-performance model, subsequently established with private payers as well, has allowed for over 100 patients to access tisagenlecleucel since launch. There is room to explore more innovative agreements like installment payment plans, managed-entry agreements and the establishment of debt funds. Implementation of these contracts is typically payer-specific and cost-sharing can be complicated by variation in contracts and variability in patient coverage. This has resulted in a greater need for national institutions to help set standard prices, create annuity funds, and streamline contracting. As more of these contracts are set up, the financial burden of CGTPs may significantly lessen. Novel managed care strategies that offer annuity payments to limit upfront costs and provide payer protection from treatment failure through pay-for-performance are essential to promoting access to CGTPs.