Summary of Product Characteristics [FDA]: Imfinzi (durvalumab) [PDF] AstraZeneca, Apr 2017. Asterisks are no longer used or included within the product and package code segments to indicate certain configurations of the NDC. IMFINZI may be used with the chemotherapy medicines etoposide and carboplatin or cisplatin as your first treatment when your SCLC has spread within your lungs or to other parts of the body (extensive-stage small cell lung . The annual benefit can be FDA Press Release: FDA expands approval of Imfinzi to reduce the risk of non-small cell lung cancer progressing 16/02/2018. You may request advisory comments on proposed introductory advertising and promotional labeling. All products and services are provided by or through such operating subsidiaries and not by Cigna Corporation. Imfinzi 500mg available with us. email, texting, or phone about the Program and about other products, programs, or services that might interest me or for which I may be eligible; contact me in order to ensure that I have received the medicines AstraZeneca plc () Imfinzi (durvalumab) has been approved in China for the 1st-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC), in combination with standard of care platinum chemotherapy (etoposide plus a choice of either carboplatin or cisplatin).. pricing for any budget. Durvalumab is an FDA-approved immunotherapy for cancer, developed by Medimmune. . Finished Product: Form of Medicine: Injection . Please complete form, sign, and fax all pages to 1-844-329-2360. Yes! 3. Imfinzi isn't currently available in biosimilar form, which is a very similar version of the parent brand-name biologic drug. NDCs and labelers of "IMFINZI": NDC Trade Name . For questions or . SEER*Stat Database Details; Variables and Recode Definitions; . Durvalumab (Imfinzi) cited on: 27/09/2017. 1 Patient Information First Name: Last Name: Patient DOB: Gender: M F UNIFORM PHARMACY PRIOR AUTHORIZATION REQUEST FORM CONTAINS CONFIDENTIAL PATIENT INFORMATION Complete this form in its entirety and send to Rocky Mountain Health Plans at 833-787-9448 Urgent 1 Non-Urgent Requested Drug Name: Imfinzi (durvalumab) - Medicaid Patient Information: Prescribing Provider Information: Patient Name: Prescriber Name: Updated results from the CASPIAN Phase III trial showed AstraZeneca's IMFINZI (durvalumab) in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin, demonstrated a sustained, clinically meaningful overall survival (OS) benefit at three years for adults with extensive . Thank you for choosing Find-A-Code , please Sign . A multi-page enrollment form to capture necessary patient, provider, and prescription information to start a new request for support. newsletter free subscription. 1-844-329-2360. Price: Rs 85,000 / Vial Get Latest Price. FAX: 1-888-267-3277 . I am Interested. Get Best Quote. Most eligible patients will pay $0 per infusion and may have access to up to $26,000 per year to assist with IMFINZI out-of-pocket costs. You will pay a set amount of your out-of-pocket costs, based on the product, and your pharmacy or healthcare provider . Marketplace - recommended products & services; News - industry news & Find . coverage for AstraZeneca products; coordinate prescription fulfillment and financial assistance; . . UNIFORM PHARMACY PRIOR AUTHORIZATION REQUEST FORM CONTAINS CONFIDENTIAL PATIENT INFORMATION Complete this form in its entirety and send to Rocky Mountain Health Plans at 833-787-9448 Urgent 1 Non-Urgent Requested Drug Name: Imfinzi (durvalumab) - Advantage Four - Tier Patient Information: Prescribing Provider Information: A generic drug, on the other hand, is an exact copy of a brand-name . FDA.gov: Approved drugs. You may report side effects related to AstraZeneca products by clicking here . As part of a broad development program, IMFINZI is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with NSCLC, SCLC, bladder cancer, hepatocellular carcinoma, biliary tract cancer (a form of liver cancer), esophageal cancer, gastric and gastroesophageal cancer, cervical cancer, ovarian . . 00310-4611: IMFINZI: AstraZeneca Pharmaceuticals LP: free demo request yours today. IMFINZI, IRESSA, LYNPARZA, and TAGRISSO are registered trademarks, and KOSELUGO, AZ&Me, and AstraZeneca Access 360 are . Phone: 1-866-752-7021. FASLODEX Enrollment Form. Please complete form, sign, and fax all pages. Approx. NDC Product Information CanMED and the Oncology Toolbox. Access 360 provides: To learn more about the AstraZeneca Access 360 program, please call 1-844-ASK-A360 ( 1-844-275-2360) Monday to Friday, 8 AM -8 PM ET, or visit www . "This is a significant result for AstraZeneca, commercially and scientifically, from a trial that is 'off-the-radar' for most investors," commented Bernstein . About IMFINZI (durvalumab) IMFINZI (durvalumab, previously known as MEDI4736) is a human monoclonal antibody directed against PD-L1, which blocks the interaction of PD-L1 with PD-1 and CD80. . 4. The approval by China's National Medical Products Administration was based on positive results from the . To do so, submit, in triplicate, a cover letter requesting advisory comments, the proposed materials in draft or mock-up form with annotated references, and the Prescribing Information to: OPDP Regulatory Project Manager Food and Drug Administration II. IMFINZI is a prescription medicine used to treat adults with a type of lung cancer called small cell lung cancer (SCLC). It is a human immunoglobulin G1 kappa monoclonal antibody that blocks the interaction of programmed cell death ligand 1 with the PD-1. E. PRODUCT INFORMATION. Facing the big dogs in the PD-(L)1 space, AstraZeneca has taken its own contender Imfinzi into blockbuster territory in its four years on the market but sees even bigger . The labeler code, product code, and package code segments of the National Drug Code number, separated by hyphens. Product NDC: 0310-4500 8: Opdyta 100mg. Comparison of Data Products; How to Request the Data; Documentation for Data. Aetna Precertification Notification . About; NDC; HCPCS; Product NDC: 00310-4611 Brand Name: Imfinzi Generic Name: Durvalumab Dosage Form Name: INJECTION, SOLUTION . (FLS) Request. . Longest survival follow-up ever reported for immunotherapy treatment in this setting. How to Complete an Access 360 Enrollment Form . CanMED: NDC. Address: Cigna Pharmacy Services, PO Box 42005, Phoenix AZ 85080-2005. If this is an URGENT request, please call (800) 882-4462 (800.88.CIGNA) . Find Imfinzi coding and reimbursement materials to ease the process. Request is for: Imfinzi (durvalumab): Dose: Frequency: F. DIAGNOSIS INFORMATION - Please indicate primary ICD code and specify any other where . For questions or assistance, please call Access 360, Monday through Friday, 8 am - 8 pm at 1-844-275-2360. DOWNLOAD. Medication Precertification Request Page 1 of 2 . Exporter of Anti Cancer Drugs - Imfinzi 500mg Durvalumab, Thiotepa 15mg / 100mg Inj, Opdyta 100mg and Pomalid Capsules offered by Hardik Onco Care, Ahmedabad, Gujarat. 2. The AstraZeneca Access 360 program provides personal support to connect patients to affordability programs and streamline access and reimbursement for IMFINZI. How to Complete an Access 360 Enrollment Form . DOWNLOAD. If you are applying for assistance with CALQUENCE (acalabrutinib), FASENRA (benralizumab), FASLODEX (fulvestrant), IMFINZI (durvalumab), IRESSA (gefitinib), KOSELUGO (selumetinib), SAPHNELO (anifrolumab-fnia), LYNPARZA (olaparib) or TAGRISSO (osimertinib), please use the Application for Specialty Care Products. In a letter dated, January 9, 2018, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of IMFINZI represented the first permitted commercial marketing or use of the product. IMFINZI Patient Savings Program The goal of the IMFINZI Patient Savings Program is to assist eligible patients with their out-of-pocket costs for IMFINZI (durvalumab). Thereafter, the USPTO requested that FDA determine the product's regulatory review period. IMFINZI - NDC drug/product. If you meet the program eligibility criteria, a Patient Savings Program account will be created for you. Title: Imfinzi CCRD Prior Authorization Form Author: Medical Subject: Prior . For Medicare Advantage Part B: Phone . Imfinzi (durvalumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy; or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Request Callback. PACIFIC's success could bring an extra $1.7bn in sales for the product, analysts suggest, and there is nothing to bother Imfinzi in terms of near-term direct competition for this setting. A multi-page enrollment form to capture necessary patient, provider, and prescription information to start a new request for support. If you are requesting Benefits Investigation, Prior Authorization Support, or Appeals Support, you only need to complete page 1. You can also enroll yourself by contacting AstraZeneca Access 360 TM at 1-844-ASK-A360 ( 1-844-275-2360) (1-844-275-2360) .
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