Pluvicto prior authorization criteria

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August undefined, 2024

WebFeb 1, 2024 · Confirm the amount of radioactivity delivered to the patient with an appropriately calibrated dose calibrator prior to and after Pluvicto administration. ... Patients were excluded if any lesions exceeding size criteria in short axis [organs ≥ 1 cm, lymph nodes ≥ 2.5 cm, bones (soft tissue component) ≥ 1 cm] had uptake less than or equal ... WebPluvicto is indicated for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who …

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WebMar 24, 2024 · The Food and Drug Administration (FDA) has approved Pluvicto ™ (lutetium Lu 177 vipivotide tetraxetan) for the treatment of adults with prostate-specific membrane antigen (PSMA)-positive ... WebLutetium Lu 177 vipivotide tetraxetan 1000MBq/mL (27mCi/mL); soln for IV inj or infusion; preservative-free. the 510 k program guidance

Pluvicto (lutetium Lu 177 vipivotide tetraxetan)

WebMay 1, 2024 · Patients were required to have received at least 1 androgen-receptor pathway inhibitor, and 1 or 2 prior taxane-based chemotherapy regimens. Patients in the treatment arm (n = 551) received 7.4 GBq (200 mCi) Pluvicto every 6 weeks for a total of up to 6 doses plus best standard of care. The remaining 280 patients in the control arm received ... WebAAA PatientConnect http://resources.allwayshealthpartners.org/medicalpolicy/Pluvicto.pdf the 51-30 chrono

FDA approves Pluvicto for metastatic castration-resistant prostate …

Utilization Review Policy 287 POLICY - media.ucare.org

WebPrior Authorization is recommended for medical benefit coverage of Pluvicto. Approval is recommended for those who meet the Criteria and Dosing for the listed indication. … WebPLUVICTO (lutetium Lu 177 vipivotide tetraxetan) POLICY I. INDICATIONS The indications below including FDA-approved indications and compendial uses are considered a covered … the 514 washington moWebPLUVICTO can cause severe and life-threatening myelosuppression. In the VISION study, grade 3 or 4 decreased hemoglobin (15%), decreased platelets (9%), decreased leukocytes (7%), and decreased neutrophils (4.5%) occurred in patients treated with PLUVICTO. Grade ≥3 pancytopenia occurred in 1.1% of patients (including 2 fatal events). the 515 montreal

"WebCoverage of Pluvicto is recommended in those who meet the following criteria: FDA-Approved Indication 1. Prostate Cancer - Metastatic Castration Resistant (mCRPC). … " - Pluvicto prior authorization criteria

Pluvicto prior authorization criteria

Pluvicto (lutetium Lu 177 vipivotide tetraxetan)

WebPluvicto Prior Authorization Request CVS Caremark administers the prescription benefit plan for the patient identified. This patient’s benefit plan requires prior authorization for certain medications in order for the drug to be covered. To make an appropriate determination, providing the most accurate diagnosis for the use of the http://resources.allwayshealthpartners.org/medicalpolicy/Pluvicto.pdf

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WebGrade 2: Withhold until improvement to Grade 1 or baseline Grade ≥3: Withhold until improvement to Grade 1 or baseline, reduce dose by 20% to 5.9 GBq (160 mCi) Recurrent Grade >3 myelosuppression...

WebThe FDA approved indications for Pluvicto include treatment of adult patients with prostate-specific membrane antigen (PSMA)- positive metastatic castration-resistant prostate … WebPeptide receptor radionuclide therapy (PRRT) using Lutetium-177 (177Lu) based radiopharmaceuticals has emerged as a therapeutic area in the field of nuclear medicine and oncology, allowing for personalized medicine. Since the first market authorization in 2024 of [¹⁷⁷Lu]Lu-DOTATATE (Lutathera®) targeting somatostatin receptor type 2 in the treatment …

WebCriteria for Initial Approval Prostate Cancer Aetna considers lutetium Lu 177 vipivotide tetraxetan (Pluvicto) medically necessary for treatment (up to 6 total doses) of prostate cancer when all of the following criteria are met: The member has metastatic castration-resistant prostate cancer; and WebPrior to administration with PLUVICTO, a saline flush with ≥10 mL of 0.9% sterile sodium chloride must be administered to ensure patency of the IV line and minimize the risk of …

WebMar 23, 2024 · On March 23, 2024, the Food and Drug Administration approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan, Advanced Accelerator Applications USA, Inc., a …

WebThe most common adverse reactions (≥20%) occurring at a higher incidence in patients who received PLUVICTO plus best standard of care (BSoC) were fatigue, dry mouth, nausea, anemia, decreased appetite, and constipation. Clinically relevant adverse reactions in <5% of patients included dry eye, vertigo, and pancytopenia (including bicytopenia). the 513 groupWeb• Pluvicto meets a need in the third-line setting for mCRPC, providing a new mechanism of action that can be used in patients with prostate-specific membrane antigen (PSMA) + metastatic CRPC. Considering that PSMA is expressed in > 80% of men with prostate cancer, Pluvicto is likely to be highly utilized in this late-stage prostate cancer the 519 glitterbugWebBefore administration of PLUVICTO, you should drink plenty of water in order to urinate as often as possible during the first hours after administration. The most common side … the519org