This sheet provides the contact information of authorized Specialty Pharmacy Providers and Specialty Distributors, from which IMFINZI can be obtained. There are no contraindications for IMFINZI ® (durvalumab).. Immune-Mediated Adverse Reactions. Advise females of reproductive potential to use effective contraception during treatment with IMBRUVICA® and for 1 month after the last dose. Grade 3 or greater hypertension occurred in 8% of patients. Compare prices, print coupons and get savings tips for Imfinzi () and other Bladder Cancer drugs at CVS, Walgreens, and other pharmacies. CVS Specialty ® dispenses a wide array of specialty medication used to treat many health conditions. Simply bring the coupon below to the pharmacy, and save on Imfinzi at CVS, Walgreens, Walmart, Safeway, Albertsons, Rite Aid, Target, Kroger, and many other drug stores! Monitor and evaluate patients for fever and infections and treat appropriately. Consider prophylaxis according to standard of care in patients who are at increased risk for opportunistic infections. The mechanism for the bleeding events is not well understood. Savings calculated based on the pharmacy’s cash price. Cytopenias: In 645 patients with B-cell malignancies who received IMBRUVICA® as a single agent, grade 3 or 4 neutropenia occurred in 23% of patients, grade 3 or 4 thrombocytopenia in 8% and grade 3 or 4 anemia in 3%, based on laboratory measurements. Imfinzi® and Idhifa® now available at Humana Specialty Pharmacy We’re in-network with most major Medicare plans Humana Specialty Pharmacy (HSP) goes beyond filling prescriptions by delivering … Search for covered brand and generic medications by condition, or download the CVS Specialty … Grade 3 or greater ventricular tachyarrhythmias occurred in 0.2% of patients, Grade 3 or greater atrial fibrillation and atrial flutter occurred in 4%, and Grade 3 or greater cardiac failure occurred in 1% of 1,476 patients who received IMBRUVICA® in clinical trials. This piece provides information for those patients seeking affordability for their IMFINZI … Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Previously Treated Marginal Zone Lymphoma*, Previously Treated Chronic Graft Versus Host Disease, You are leaving the patient and caregiver site and entering the US Healthcare professional site. Your use of the information on this site is subject to the terms of the Legal Notice and new Privacy Policy of Pharmacyclics LLC. Prices start at $7,412.21 Dose modifications of IMBRUVICA® may be recommended when used concomitantly with posaconazole, voriconazole, and moderate CYP3A inhibitors. Federal Pharmacists are essential to health care access and delivery in the United States; recognized as health care providers of patient-centered primary and specialty … Specialty Pharmacy Times, July/August 2017, Volume 8, Issue 5. The information contained in this site is intended for US Healthcare professionals only. Consider the risks and benefits of anticoagulant or antiplatelet therapy when co-administered with IMBRUVICA®. ... Imfinzi was approved in May to treat patients with metastatic urothelial carcinoma, the most common type of bladder cancer. IMBRUVICA® (ibrutinib) is covered by U.S. The most common Grade 3 or higher adverse reactions (≥5%) reported in patients with cGVHD were pneumonia (14%), fatigue (12%), diarrhea (10%), neutropenia (10%)*, sepsis (10%), hypokalemia (7%), headache (5%), musculoskeletal pain (5%), and pyrexia (5%). Hypertension: Hypertension occurred in 19% of 1,476 patients who received IMBRUVICA® in clinical trials. Avoid concomitant use of other strong CYP3A inhibitors. Mantle cell lymphoma (MCL) who have received at least one prior therapy. At baseline and then periodically, monitor patients clinically for cardiac arrhythmias and cardiac failure. Hemorrhage: Fatal bleeding events have occurred in patients who received IMBRUVICA®. Our goal is to help make your life better. Major hemorrhage (≥ Grade 3, serious, or any central nervous system events; e.g., intracranial hemorrhage [including subdural hematoma], gastrointestinal bleeding, hematuria, and post procedural hemorrhage) occurred in 4% of patients, with fatalities occurring in 0.4% of 2,838 patients who received IMBRUVICA® in 27 clinical trials. The indications below including FDA-approved indications and compendial uses are considered a covered … It is always the provider's responsibility to determine and submit appropriate codes and modifiers based on the services rendered and the provider's medical judgment. These coupons … Page 4 | IMFINZI® (durvalumab) Prior Auth Criteria Proprietary Information. Second Primary Malignancies: Other malignancies (10%), including non-skin carcinomas (4%), occurred among the 1,476 patients who received IMBRUVICA® in clinical trials. Manage cardiac arrhythmias and cardiac failure appropriately, and if it persists, consider the risks and benefits of IMBRUVICA® treatment and follow dose modification guidelines. It is provided for informational purposes only and does not guarantee coverage or payment. Imfinzi ™ (durvalumab) – New drug approval. Adverse reactions leading to dose reduction occurred in 26% of patients. This network of pharmacies can also provide information about the prior authorization process and provide eligible patients with information about co-pay support options. Access 360 provides: • Assistance with understanding patient insurance coverage and pharmacy options • Prior authorization support • Claims and appeal process support • Eligibility requirements and enrollment assistance for specialty … Marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy. DOWNLOAD. Providers should contact the payer for coding and billing guidance. Specialty Pharmacy Provider (SPP) ACCREDO: AVELLA BIOLOGICS CVS SPECIALTY DIPLOMAT US BIOSERVICES No Preference* *If you have questions about in-network SPP(s) for your patient, contact Access 360 at 1-844-275-2360. Use of either anticoagulant or antiplatelet agents concomitantly with IMBRUVICA® increases the risk of major hemorrhage. Aetna Precertification Notification . Approximately 4-10% (CLL/SLL), 9% (MCL), and 7% (WM [5%] and MZL [13%]) of patients discontinued due to adverse reactions. Monitor for signs and symptoms of bleeding.Â. Imfinzi (durvalumab) is a member of the anti-PD-1 monoclonal antibodies drug class and is commonly used for Non-Small Cell Lung Cancer, and Small Cell Lung Cancer. These medications usually require a higher degree of management, are high in cost and are generally not stocked at retail pharmacies. Accelerated approval was granted for this indication based on overall response rate. Assess the baseline risk (e.g., high tumor burden) and take appropriate precautions. Pharmacyclics LLC and Janssen Biotech, Inc. do not endorse the use of any of the listed distributors in particular. In patients with mild or moderate impairment, reduce recommended IMBRUVICA® dose and monitor more frequently for adverse reactions of IMBRUVICA®. The addition of antiplatelet therapy with or without anticoagulant therapy increased this percentage to 4.4%, and the addition of anticoagulant therapy with or without antiplatelet therapy increased this percentage to 6.1%. CVS Caremark Specialty Pharmacy 2211 Sanders Road NBT - 6 Northbrook, IL 60062 Phone: 1-888-877-0518 Fax: 1-855-330-1720 www.caremark.com Chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy. Imfinzi Coupon. Specialty Pharmacy Providers (SPPs) IMFINZI is available for order from these authorized SPPs who also provide support to help patients with their prescribed treatments: ACCREDO p: 1-877-732-3431 f: 1-877 … The following specialty distributors are authorized to sell IMBRUVICA® and are able to service qualified accounts. IMFINZI is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who: • have disease progression during or following platinum-containing chemotherapy. On average, fourteen percent of RxSaver by RetailMeNot prescription purchases receive savings of 85% or more. Find out if your medication is available through CVS Specialty. SPECIALTY GUIDELINE MANAGEMENT . This site is published by Pharmacyclics LLC which has developed the content in conjunction with Janssen Biotech, Inc. Any information that is collected on this site may be shared between Pharmacyclics LLC and Janssen Biotech, Inc. Approximately 9% (CLL/SLL), 14% (MCL), 14% (WM) and 10% (MZL) of patients had a dose reduction due to adverse reactions. Imfinzi SGM – 12/2020. It’s important to note that you may have to get Imfinzi at a specialty pharmacy. Consider the benefit-risk of withholding IMBRUVICA® for at least 3 to 7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding. Obtain an ECG for patients who develop arrhythmic symptoms (e.g., palpitations, lightheadedness, syncope, chest pain) or new onset dyspnea. Imfinzi ® (durvalumab) – New indication. Hemorrhage:Fatal bleeding events have occurred in patients who received IMBRUVICA®. Bleeding events of any grade including bruising and petechiae occurred in 39%, and excluding bruising and petechiae occurred in 23% of patients who received IMBRUVICA®, respectively. Â. Cardiac Arrhythmias and Cardiac Failure: Fatal and serious cardiac arrhythmias and cardiac failure have occurred with IMBRUVICA®. Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL). Based on data from 1,124 of these patients, the median time to onset was 5.9 months (range, 0.03 to 24 months). Advise pregnant women of the potential risk to a fetus. I. A sample form letter that can be used to request authorization for IMBRUVICA®. A. Interrupt IMBRUVICA® if strong inhibitors are used short-term (e.g., for ≤ 7 days). For any questions about the Pharmacyclics Privacy Policy, please visit www.pharmacyclics.com. Information about the network of specialty pharmacies and distributors that are authorized to dispense IMBRUVICA® and are able to service qualified accounts. … • have disease progression within 12 months of neoadjuvant or adjuvant treatment … Major hemorrhage (≥ Grade 3, serious, or any central nervous system events; e.g., intracranial hemorrhage [including subdural hematoma], gastrointestinal bleeding, hematuria, and post procedural hemorrhage) occurred in 4% of patients, with fatalities occurring in 0.4% of 2,838 patients who received IMBRUVICA® in 27 clinical trials. Imfinzi® (durvalumab) Injectable Medication Precertification Request Page 1 of 2. This section is designed to provide important information regarding reimbursement, the  IMBRUVICA® Dose Exchange Program, specialty pharmacies, and other product information that may be helpful to your practice. Imfinzi 120 mg/2.4 mL single-dose vial: 00310-4500-xx Imfinzi 500 mg/10 mL single-dose vial: 00310-4611-xx . The Specialty Pharmacy Drug List is a guide of medications available through CVS Specialty®. See dose modification guidelines in USPI sections 2.3 and 7.1. Prescriptions may be faxed to any one of these specialty pharmacies. cßÎC­…j[µ_q÷(ºã¶¼Xaݲ†Lä�‘šºO¾(ªÑ©ÒTw`D+ÍDª†•“ß©ÒùqSòÀE­(æ[k ߥǀ†É¤.Ê´tæXš– ÎNXû‚& �0OV. streamline access and reimbursement for IMFINZI. Monitor patients closely and treat as appropriate. This information is intended for use by our customers, patients, and healthcare professionals in the United States and Puerto Rico only. With more than 40 years of experience, CVS Specialty provides quality care and service. IMFINZI® (durvalumab) Distribution Card. Specialty Pharmacy Providers (SPPs) IMFINZI is available for order from these authorized SPPs who also provide support to help patients with their prescribed … Embryo-Fetal Toxicity: Based on findings in animals, IMBRUVICA® can cause fetal harm when administered to a pregnant woman. The most common Grade ≥ 3 adverse reactions (≥5%) in patients with B-cell malignancies (MCL, CLL/SLL, WM and MZL) were neutropenia (20.7%)*, thrombocytopenia (13.6%)*, pneumonia (8.2%), and hypertension (8.0%). Quantity Limit (max daily dose) [Pharmacy Benefit]: Imfinzi 120 mg single-dose vial: 2 vials per 14 days Imfinzi 500 mg single-dose vial: 2 vials per 14 days B. Max Units (per dose and over … By clicking "OK" below you will be taken to a website that may contain links or references to other websites to which our Privacy Policy may not apply. IMFINZI Affordability Brochure. March 30, 2020 - AstraZeneca announced the FDA approval of Imfinzi (durvalumab), in combination with etoposide and either carboplatin or cisplatin, for the first … Restricted … Bleeding events, including bruising and petechiae, occurred in 39% of patients who r… Such information may be subject to continual change and interpretation. The most frequent second primary malignancy was non-melanoma skin cancer (6%). INDICATIONS . Dosing Modifications for Adverse Reactions, Support & Resources: NCCN Guidelines Recommendations, Support & Resources: Dose Exchange Program, https://www.accessdata.fda.gov/scripts/cder/ob/default.cfm. May 1, 2017 – AstraZeneca and its global biologics research and development arm, MedImmune, announced the FDA approval of Imfinzi (durvalumab), … Important Safety Information. IMFINZI (durvalumab) POLICY . Most specialty medications can be filled at: Fairview Specialty Pharmacy… Infections: Fatal and non-fatal infections (including bacterial, viral, or fungal) have occurred with IMBRUVICA® therapy. The discount coupons offered by … Monitor blood pressure in patients treated with IMBRUVICA® and initiate or adjust anti-hypertensive medication throughout treatment with IMBRUVICA® as appropriate. In addition to being available via specialty distribution, IMFINZI can also be dispensed by Biologics as a specialty pharmacy option. Twenty-four percent of patients receiving IMBRUVICA® in the cGVHD trial discontinued treatment due to adverse reactions. *Treatment-emergent decreases (all grades) were based on laboratory measurements. Patents, which are listed in FDA's Orange Book (available at https://www.accessdata.fda.gov/scripts/cder/ob/default.cfm). Pharmacyclics LLC and Janssen Biotech, Inc., are working with 4 specialty pharmacies to distribute IMBRUVICA® (ibrutinib) throughout the United States. Hepatic Impairment (based on Child-Pugh criteria): Avoid use of IMBRUVICA® in patients with severe hepatic impairment. ... IMFINZI … Â. Click “OK” below if you are a healthcare professional. CYP3A Inhibitors: Co-administration of IMBRUVICA® with strong or moderate CYP3A inhibitors may increase ibrutinib plasma concentrations. Important immune-mediated adverse reactions listed under Warnings … Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Click here for affordability information and resources or call 1-877-877-3536. This type of pharmacy is authorized to carry specialty medications. Imfinzi Prices. For Medicare Advantage Part B: Phone: 1 … Tumor Lysis Syndrome: Tumor lysis syndrome has been infrequently reported with IMBRUVICA®. We encourage you to read the Privacy Policy of every website you visit. The specialty pharmacies listed here are authorized to dispense IMBRUVICA® and are able to service most commercial and Medicare Part D plans. Welcome to the Department of Veterans Affairs Pharmacy Benefits Management (PBM) Services. We remain committed to supporting you and your patients during these challenging times. Across clinical trials, 3.1% of 2,838 patients who received IMBRUVICA® without antiplatelet or anticoagulant therapy experienced major hemorrhage. Grade 3 or greater infections occurred in 21% of 1,476 patients who received IMBRUVICA® in clinical trials. Cases of progressive multifocal leukoencephalopathy (PML) and Pneumocystis jirovecii pneumonia (PJP) have occurred in patients treated with IMBRUVICA®. CYP3A Inducers: Avoid coadministration with strong CYP3A inducers. B-cell malignancies: The most common adverse reactions (≥30%) in patients with B-cell malignancies (MCL, CLL/SLL, WM and MZL) were thrombocytopenia (54.5%)*, diarrhea (43.8%), fatigue (39.1%), musculoskeletal pain (38.8%), neutropenia (38.6%)*, rash (35.8%), anemia (35.0%)*, and bruising (32.0%). In addition to being available via specialty distribution, IMFINZI can also be dispensed by Biologics as a specialty pharmacy option. Specialty Pharmacy Drug List Specialty medicines are usually prescribed by doctors who treat chronic and complex disease. Advise males with female partners of reproductive potential to use effective contraception during the same time period. IMBRUVICA® (ibrutinib) is a kinase inhibitor indicated for the treatment of adult patients with: Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion. Pharmacyclics LLC recognizes that the Internet is a global communication medium; however laws, regulatory requirements, and medical practices vary from country to country. The cost for Imfinzi intravenous solution (50 mg/mL) is around $942 for a supply of 2.4 milliliters, depending on the pharmacy … FAX: 1-888-267-3277 . These events have occurred particularly in patients with cardiac risk factors, hypertension, acute infections, and a previous history of cardiac arrhythmias. Phone: 1-866-752-7021 . cGVHD: The most common adverse reactions (≥20%) in patients with cGVHD were fatigue (57%), bruising (40%), diarrhea (36%), thrombocytopenia (33%)*, muscle spasms (29%), stomatitis (29%), nausea (26%), hemorrhage (26%), anemia (24%)*, and pneumonia (21%).
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