Z Os Adcd 1.13 122

As defined in Aetna commercial policies, health care services are not medically necessary when they are more costly than alternative services that are at least as likely to produce equivalent therapeutic or diagnostic results. Avastin (bevacizumab), Alymsys (bevacizumab-maly), Vegzelma (bevacizumab-adcd), and Zirabev (bevacizumab-bvzr) are more costly to Aetna than other vascular endothelial growth factor inhibitors for certain indications. There is a lack of reliable evidence that Avastin (bevacizumab), Alymsys (bevacizumab-maly), Vegzelma (bevacizumab-adcd), and Zirabev (bevacizumab-bvzr) are superior to the lower cost vascular endothelial growth factor inhibitor for oncology indications: Mvasi (bevacizumab-awwb). Therefore, Aetna considers Avastin (bevacizumab), Alymsys (bevacizumab-maly), Vegzelma (bevacizumab-adcd), and Zirabev (bevacizumab-bvzr) to be medically necessary only for members who have a contraindication, intolerance, or ineffective response to the available equivalent alternative vascular endothelial growth factor inhibitor for oncology indications: Mvasi (bevacizumab-awwb).

Precertification of bevacizumab (Avastin), bevacizumab-maly (Alymsys), bevacizumab-awwb (Mvasi), bevacizumab-adcd (Vegzelma), and bevacizumab-bvzr (Zirabev), for oncology indications only, is required of all Aetna participating providers and members in applicable plan designs. For precertification of bevacizumab (Avastin), bevacizumab-maly (Alymsys), bevacizumab-awwb (Mvasi), bevacizumab-adcd (Vegzelma), and bevacizumab-bvzr (Zirabev), for oncology indications only, call (866) 752-7021 (Commercial), or fax (888) 267-3277. For Statement of Medical Necessity (SMN) precertification forms, see Specialty Pharmacy Precertification.

Z Os Adcd 1.13 122

Download File 🔥 https://urloso.com/2xZtBs 🔥

On September 28, 2022, the U.S. Food and Drug Administration (FDA) approved Vegzelma (bevacizumab-adcd), a biosimilar referencing Avastin for the treatment of six types of cancer: metastatic colorectal; recurrent or metastatic non-squamous non-small cell lung cancer (nsNSCLC); recurrent glioblastoma; metastatic renal cell carcinoma; persistent, recurrent, or metastatic cervical cancer; and epithelial ovarian, fallopian tube, or primary peritoneal cancer. The FDA approval of Vegzelma was based on supporting data from a pivotal phase 3 trial in patients with recurrent or metastatic nsNSCLC, which showed that Vegzelma is highly similar to the reference bevacizumab product with regard to efficacy, safety, and pharmacokinetics. Vegzelma marks the fourth bevacizumab biosimilar approval in the U.S., following the approvals of Mvasi (2017), Zirabev (2019), and Alymsys (2022) (Celltrion, 2022a).

In a randomized, double-blind, placebo-controlled trial, Gilbert et al (2014) treated adults who had centrally confirmed glioblastoma with radiotherapy (60 Gy) and daily temozolomide. Treatment with bevacizumab or placebo began during week 4 of radiotherapy and was continued for up to 12 cycles of maintenance chemotherapy. At disease progression, the assigned treatment was revealed, and bevacizumab therapy could be initiated or continued. The trial was designed to detect a 25 % reduction in the risk of death and a 30 % reduction in the risk of progression or death, the 2 co-primary end-points, with the addition of bevacizumab. A total of 978 patients were registered, and 637 underwent randomization. There was no significant difference in the duration of OS between the bevacizumab group and the placebo group (median of 15.7 and 16.1 months, respectively; hazard ratio [HR] for death in the bevacizumab group, 1.13). Progression-free survival was longer in the bevacizumab group (10.7 months versus 7.3 months; HR for progression or death, 0.79). There were modest increases in rates of hypertension, thrombo-embolic events, intestinal perforation, and neutropenia in the bevacizumab group. Over time, an increased symptom burden, a worse QOL, and a decline in neurocognitive function were more frequent in the bevacizumab group. The authors concluded that first-line use of bevacizumab did not improve OS in patients with newly diagnosed glioblastoma; PFS was prolonged but did not reach the pre-specified improvement target.

We performed detailed characterization of SARS-CoV-2 spike-directed antibodies and their functional activity after mRNA-based SARS-CoV-2 vaccination in 21 patients with CLL (18 not on active therapy, 3 on BTKi; Figure 4). Using a bead-based multiplex immunoassay, we detected SARS-CoV-2 spike IgG1, IgG3, IgM, and IgA antibodies in all tested patients, in most cases at titers and binding capacities similar to vaccinated non-CLL controls, with the exception of lower IgG3 titers and higher FcR3B binding in patients with CLL (Figure 4A-B; supplemental Figure 4). Spike-specific ADCP responses to wild-type SARS-CoV-2 virus were preserved in patients with CLL compared with non-CLL controls, whereas ADCD and ADNP responses were slightly diminished (Figure 4D-E). IgG, IgM, and IgA subclasses, Fc-receptor binding, and spike-specific ADCP, ADNP, and ADCD responses were demonstrated against the (B.1.1.7), (B.1.351), (P.1), and (B.1.617) variants (supplemental Figure 4). As expected, SARS-CoV-2 spike IgG1 levels appeared higher (1.17-log; P = NS), and ADCP (1.06-log; P = NS), ADNP (1.13-log; P = NS), and ADCD (1.35-log; P = .0126) responses appeared more robust among patients with CLL with RBD immunoassay response (Figure 4C). be457b7860