Online First

Value-Based Care Management Medicare Program Changes for 2020 and Beyond

Joe Bailes, MD; Gena Cook

December 2019, Vol 10, No 6 - Online First, Value-Based Care

Medicare models for value-based care in oncology started with the Oncology Care Model (OCM), which was launched in July 2016 and will run until June 2021. Value-based care is here to stay, as the Centers for Medicare & Medicaid Services (CMS) continues to develop and test more value-based models and tools through the Center for Medicare & Medicaid Innovation. CMS recently released an informal Request for Information on a proposed Oncology Care First model to succeed the first OCM. Commercial payers and state governments are also introducing their own value-based agreements with community oncology practices, hospitals, and health systems. [ Read More ]

Udenyca, Second Biosimilar to Neulasta, FDA-Approved to Reduce Risk for Infection in Patients with Nonmyeloid Malignancies

December 2018, Vol 9, No 4 - FDA Approvals, News & Updates, Online First

On November 2, 2018, the FDA approved pegfilgrastim-cbqv (Udenyca; Coherus BioSciences), as the second biosimilar to pegfilgrastim (Neulasta), to reduce the risk for infection in patients with nonmyeloid malignancies who receive myelosuppressive chemotherapy, which may result in febrile neutropenia. [ Read More ]

Talzenna Approved for HER2-Negative, Locally Advanced Breast Cancer with Germline BRCA Mutations

December 2018, Vol 9, No 4 - FDA Approvals, News & Updates, Online First

On October 16, 2018, the FDA approved talazoparib (Talzenna; Pfizer), a poly (ADP-ribose) polymerase (PARP) inhibitor, for the treatment of patients with HER2-­negative, locally advanced or metastatic breast cancer and deleterious or suspected deleterious germline BRCA mutation, as identified by an FDA-approved test. [ Read More ]

Alecensa a New First-Line Treatment for NSCLC with ALK Mutation

December 2017, Vol 8, No 5 - FDA Approvals, News & Updates, Online First

On November 6, 2017, the FDA approved alectinib (Alecensa; Genentech) for the treatment of patients with ALK mutation–positive, metastatic non–small-cell lung cancer (NSCLC), as detected by an FDA-approved test. On the same day, the FDA also converted alectinib’s initial accelerated approval to a full approval for the treatment of patients with metastatic NSCLC and ALK mutation whose disease progressed with or who were intolerant of crizotinib (Xalkori). [ Read More ]

Verzenio a New CDK4/CDK6 Inhibitor Approved for Metastatic Breast Cancer

December 2017, Vol 8, No 5 - FDA Approvals, News & Updates, Online First

On September 28, 2017, the FDA approved abemaciclib (Verzenio; Eli Lilly), a cyclin-dependent kinase (CDK)4/CDK6 inhibitor, in combination with fulvestrant, for the treatment of women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer that progressed after endocrine therapy, and as monotherapy for HR-positive, HER2-­negative advanced or metastatic breast cancer that progressed after endocrine therapy and previous chemotherapy in the metastatic setting. [ Read More ]

Yescarta Second Gene Therapy Approved by FDA and First CAR T-Cell Therapy for Large B-Cell Lymphoma

December 2017, Vol 8, No 5 - FDA Approvals, News & Updates, Online First

On October 18, 2017, the FDA approved axicabtagene ciloleucel (Yescarta; Kite Pharma), a CD19-directed genetically modified CAR T-cell immunotherapy, for the treatment, after ≥2 lines of systemic therapies, of adults with several types of relapsed or refractory large B-cell lymphoma, including (1) diffuse large B-cell lymphoma (DLBCL) not otherwise specified, (2) primary mediastinal large B-cell lymphoma, (3) high-grade B-cell lymphoma, and (4) DLBCL arising from follicular lymphoma. [ Read More ]