Medicare Expenditures of Atezolizumab for a Withdrawn Accelerated Approved Indication
Menée aux Etats-Unis, cette étude analyse les coûts associés à l'utilisation de l'atézolizumab en traitement de deuxième ligne chez les patients atteints d'un carcinome urothélial et bénéficiant du système Medicare
The US Food and Drug Administration (FDA) grants accelerated approval for products that address serious or life-threatening illnesses that fill an unmet medical need; such products, which are initially approved using clinical surrogate end points, are then required to demonstrate clinical benefit through confirmatory trials. While the program has been praised as an important means to bring new products to market, the pathway has also been criticized as setting unacceptably low standards governing market entry or expansion. In addition, accelerated approval raises the prospect that payers will incur expenditures for products or indications that are ultimately withdrawn. In March 2021, drug manufacturers withdrew indications for 4 oncology drugs after confirmatory trials failed to demonstrate clinical benefits. We quantified 2018 and 2019 US Medicare expenditures for 1 of these indications, atezolizumab as a second-line treatment for malignant urothelial carcinoma. While this indication received accelerated approval in October 2016, the manufacturer’s confirmatory trial did not identify benefits.
JAMA Oncology 2021