The Agenzia Italiana del Farmaco (AIFA: Italian Medicines Agency) announced a new reimbursement strategy called “pagamento al risultato” or “payment as a result” to be tested on Novartis’ CART-T—cell therapy Kymriah (tisagenlecleucel). Developed for B-cell acute lymphoblastic leukemia (ALL) in refractory, in relapse post-transplant or in second or later relapse and for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) post two or more lines of systemic therapy.
Neil Grubert in LinkedIn reports that Adnkronos Salute reports that this new initiative build son the momentum of Italy’s payment by results (PbR) reimbursement model. This model fits nicely into a world where drug makers are introducing product high-cost advanced therapies with little history of performance.
Grubert notes that it would appear that pagamento al risultato adds deferred payment to PbR—actually in three installments including 1) the first time of the infusion of Kymriah 2) the second payment after six months and 3) the third payment after 12 months. Payment could be made over a five-year period. Noteworthy, if the drug doesn’t produce the agreed upon results in the 12 month period than the provider will not have to make any subsequent payments. In the standard PbR model drug makers receive full payment in advance and if the treatment fails then manufacturers pay a refund.
What Funds the Payments
In Italy, Kymriah is funded from the fondo speciale per I farmaci innovative oncologici (special fund for innovative oncology drugs) controlling a annual budget of €500 million. Adnkronos reports the cost of Kymriah will be about €300,000 higher than was reported €150-200,00 by La Stampa in July.