FDA Approvals
On January 12, 2024, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) with chemoradiotherapy (CRT) for patients with FIGO 2014 Stage III-IVA cervical cancer.
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On January 19, 2024, the Food and Drug Administration approved erdafitinib (Balversa, Janssen Biotech) for adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations, as determined by an FDA-approved companion diagnostic test, whose disease has progressed on or after at least one line of prior systemic therapy. Erdafitinib is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy. This approval amends the indication previously granted under accelerated approval for patients with mUC with susceptible FGFR3 or FGFR2 alterations after prior platinum-containing chemotherapy.
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The FDA has granted full approval to KEYTRUDA® (pembrolizumab) Injection 100 mg, in combination with enfortumab vedotin, and expanded the indication to: treatment of adult patients with locally advanced or metastatic urothelial cancer. The combination initially received accelerated approval in April 2023 for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.
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The FDA has approved WELIREG® (belzutifan) 40-mg tablets for the treatment of adult patients with advanced renal cell carcinoma (RCC) following a programmed death receptor-1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).
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Coding and Reimbursement Updates
View the January E-Reimbursement Newsletter.
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CMS & Noridian Updates
CMS has finalized the Interoperability and Prior Authorization “e-PA” Rule requiring MA plans to establish electronic PA systems. Starting in 2026 MA plans must send PA decisions within 72 hours for expedited requests and 7 days for standard requests, detail a specific reason for denying a PA appeal, and report PA metrics as part of new transparency and reporting requirements. This rule impacts MA, Medicaid, CHIP, Medicare, and ERISA plans. This rule does not require HHS to establish a list of items/services eligible for real-time decisions as in Seniors’ Act.
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Governor Gavin Newsom and the State of California received federal approval from the Centers for Medicare & Medicaid Services (CMS) of its MCO tax federal waiver application. Effective January 1, 2024, rates for primary care (including nurse practitioners and physician assistants), maternity care (including OB/GYNs and doulas), and non-specialty mental health services will be increased to at least 87.5 percent of Medicare rates.
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National Guideline Updates
NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas. These NCCN Guidelines® are currently available as Version 1.2024.
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Other
View the ASCO in Action January newsletter.
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Register for Bristol Myers Squibb’s, “A Treatment Option for Patients with Unresectable or Metastatic Melanoma regardless of BRAF status & Metastatic NSCLC Regardless of PD-L1 Expression” on Wednesday, February 28, 2024 at 6:30 PM – PST.
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