tezspire reimbursement

Tezspire (tezepelumab), a monoclonal antibody under review at the FDA to treat patients with asthma, would need to be priced at between $9,000 and $12,000 annually to meet standard thresholds for cost-effectiveness, according to a review by the Institute for Clinical and Economic Review (ICER). In July 2021, Tezspire was the first and only biologic to be granted Priority Reviewin the U.S. for the treatment of asthma by the FDA. Tezspire is a potential first-in-class monoclonal antibody that targets thymic stromal lymphopoietin (TSLP), a key cytokine that in allergic, eosinophilic and other airway inflammation associated with severe asthma. TEZSPIRE is also in development for other potential indications including chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria and eosinophilic esophagitis (EoE). An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials forAmgen's manufacturing activities, the distribution ofAmgen's products, the commercialization ofAmgen's product candidates, andAmgen's clinical trial operations, and any such events may have a material adverse effect onAmgen's product development, product sales, business and results of operations. hb`````ZpAX,DM}0H40F^>HL``KKk`qqk @Z%A|O[W>i?xEZ!KSLrfxCW4#(0D0pH+cl bRFP |* "For the first time, many people living with severe asthma have the opportunity to receive treatment regardless of the cause of their inflammation. Amgen Inc (AMGN) SEC Filing 8-K Material Event for the period ending Thursday, November 3, 2022 Two recently launched products, TEZSPIRE and LUMAKRAS, are off to solid starts. The approval of Tezspire is long-awaited positive news for the asthma community," said Tonya Winders, president and chief executive officer at the Allergy & Asthma Network (AAN) and president of the Global Allergy and Airways Patient Platform (GAAPP). All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd., Kyowa-Kirin Co., Ltd., or any collaboration to manufacture therapeutic antibodies against COVID-19), the performance of Otezla (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), the Five Prime Therapeutics, Inc. acquisition, or the Teneobio, Inc. acquisition, as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic on our business, and other such estimates and results. USE IN SPECIFIC POPULATIONSThere are no available data on TEZSPIRE use in pregnant women to evaluate for any drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. No forward-looking statement can be guaranteed and actual results may differ materially from those we project. THOUSAND OAKS, Calif., Dec. 17, 2021 /PRNewswire/ --Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Amgen and AstraZeneca's Tezspire(tezepelumab-ekko) for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.1, To view the Multimedia News Release, please visit: https://www.multivu.com/players/English/8812852-amgen-fda-approval-tezepelumab-severe-asthma-inflammation/, Tezspire was approved following a Priority Review by the FDA and based on results from the PATHFINDER clinical trial program. About the NAVIGATOR and the PATHFINDER Clinical Trial ProgramIn addition to the Phase 2b PATHWAY trial, the Phase 3 PATHFINDER program included two trials, NAVIGATORand SOURCE. STAY IN THE KNOW WITH THE TEZSPIRE PATIENT PORTAL The Amgen's results may be affected by its ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing its products and global economic conditions. For more information about. %PDF-1.7 % Available at: Varricchi G, et al. Tezspireis under regulatory review in the EU, Japan and several other countries around the world. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. TEZSPIRE is performing well in asthma and we have studies underway for several other indications for that product as well. Rabe KF, Busse W, Pavord I, Castro M. Raising the clinical bar beyond current biologics in uncontrolled persistent asthma: translating emerging data in future clinical decisions. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe asAmgenmay have believed at the time of entering into such relationship. Connect with a Reimbursement Specialist by calling 1-888-TZSPIRE ( 1-888-897-7473) or submitting a request through the Healthcare Provider Portal. Patients who participated in our Phase 3 clinical trials were eligible to continue in DESTINATION, a Phase 3 extension trial assessing long-term safety and efficacy.16, About TEZSPIRE (tezepelumab-ekko)TEZSPIRE is a first-in-class human monoclonal antibody that works on the primary source of inflammation: the airway epithelium, which is the first point of contact for viruses, allergens, pollutants and other environmental insults. NAVIGATOR is the first Phase 3 trial to show benefit in severe asthma irrespective of eosinophils by targeting TSLP.2 These results support the U.S.Food and Drug Administration Breakthrough Therapy Designationgranted to TEZSPIREinSeptember 2018for patients with severe asthma, without an eosinophilic phenotype. 439 0 obj <> endobj Treat patients with pre-existing helminth infections before initiating therapy with TEZSPIRE. Elevated Expression of IL-33 and TSLP in the Airways of Human Asthmatics In Vivo: A Potential Biomarker of Severe Refractory Disease. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Severe, uncontrolled asthma is debilitating with patients experiencing frequent exacerbations, significant limitations on lung function and a reduced quality of life.20-22 Patients with severe uncontrolled asthma have twice the risk of asthma-related hospitalizations.25,26 There is also a significant socio-economic burden with these severe uncontrolled asthma patients accounting for 50% of asthma-related costs.28, Multiple inflammatory pathways are involved in the pathogenesis of asthma.27-29Eosinophilic asthma, and more broadly, T2 inflammation-driven asthma, accounts for about two-thirds of patients with severe asthma.29These patients are typically characterized as having elevated levels of inflammatory biomarkers, including blood eosinophils, serum IgE and FeNO.30,31However, many patients do not fit the criteria for eosinophilic or allergic asthma, may have unclear or multiple drivers of inflammation, and may not qualify for or respond well to a current biologic medicine.31. For more information about the Tezspire Together Program, call 1-888-TZSPIRE (1-888-897-7473) or visit Tezspire.com. Under the amended agreement, Amgen and AstraZeneca will jointly commercialize Tezspire in North America. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability ofAmgen's systems andAmgen's data. 1996-2022 Amgen Inc. All Rights Reserved. ", TEZSPIREis a first-in-class biologic for severe asthma that acts at the top of the inflammatory cascade by targeting thymic stromal lymphopoietin (TSLP), an epithelial cytokine.2TEZSPIRE is the first and only biologic for severe asthma that does not have a phenotypeeosinophilic or allergicor biomarker limitation within its approved label.4-11 TEZSPIRE consistently and significantly reduced asthma attacks across Phase 2 and 3 clinical trials which included a broad population of severe asthma patients irrespective of key biomarkers, including blood eosinophil counts, allergic status and fractional exhaled nitric oxide (FeNO).2,3, The most common adverse reactions (incidence 3% and more common than placebo) of TEZSPIRE are pharyngitis, arthralgia, and back pain.1. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. In October 2021, tezepelumab was granted Orphan Drug Designation by the FDA for the treatment of EoE. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. Tezspire is a medicine used to treat adults and adolescents (12 years of age and older) with severe asthma. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. CONTACT: Amgen, Thousand OaksMichael Strapazon, 805-313-5553 (media)Megan Fox, 805-447-1423 (media)Arvind Sood, 805-447-1060 (investors), View original content to download multimedia:https://www.prnewswire.com/news-releases/tezspire-tezepelumab-ekko-now-available-in-the-united-states-for-the-treatment-of-severe-asthma-301460118.html. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. SoC was treatment with medium- or high-dose inhaled corticosteroids (ICS) plus at least one additional controller medication with or without daily oral corticosteroid treatment. GoodRx's cash prices are based on multiple sources, including published price lists, purchases, claims records, and data provided by pharmacies. Product Packages NDC 55513-112-01 Package Description: 1 SYRINGE in 1 CARTON > 1.91 mL in 1 SYRINGE 2,12-14 The program includes additional mechanistic and long-term safety trials.15, NAVIGATOR is a Phase 3, randomized, double-blinded, placebo-controlled trial in adults (1880 years old) and adolescents (1217 years old) with severe, uncontrolled asthma, who were receiving standard of care (SoC). The information provided on this site is intended for use by healthcare professionals practicing in the US. hbbd``b` 1 HK@$yDD u ,Z d$@,6W H, Am J Respir Crit Care Med. 0 The inclusion of a code does not imply any right to reimbursement or guarantee claim . About Severe AsthmaGlobally, there are approximately 2.5 million patients with severe asthma who are uncontrolled or biologic eligible, with approximately 1 million in theU.S. endstream endobj startxref Thymic Stromal Lymphopoietin Isoforms, Inflammatory Disorders, and Cancer. Thymic Stromal Lymphopoietin Isoforms, Inflammatory Disorders, and Cancer. Abrupt Reduction of Corticosteroid DosageDo not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with TEZSPIRE. News - UCB, Tezspire, Neurological Flurry of Japanese drug approvals. In 2021, Amgen was named one of the 25 World's Best Workplaces by Fortune and Great Place to Work and one of the 100 most sustainable companies in the world by Barron's. Parasitic (Helminth) InfectionIt is unknown if TEZSPIRE will influence a patient's response against helminth infections. 3 it is the first and only biologic to consistently and significantly reduce asthma exacerbations across phase 2 and 3 clinical trials, which included a broad population Key secondary endpoints included the effect of Tezspire on lung function, asthma control and health-related quality of life.3. In a busy day for the Japanese regulator, the Japanese Ministry of Health, Labor and Welfare (MHLW) has cleared three new medicines from European drugmakers for . All aspects of the collaboration are under the oversight of joint governing bodies. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. Godar M, Blanchetot C, de Haard H, et al. The application included results from the pivotal NAVIGATOR Phase 3 trial in which Tezspire demonstrated superiority across every primary and key secondary endpoint in patients with severe asthma, compared to placebo, when added to standard therapy.2, "Today's approval by the FDA marks the first time patients and their physicians will have a biologic option for severe asthma without phenotypic limitations and irrespective of biomarker levels," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. In addition,Amgencompetes with other companies with respect to many of its marketed products as well as for the discovery and development of new products. Live Attenuated Vaccines The concomitant use of TEZSPIRE and live attenuated vaccines has not been evaluated. Placental transfer of monoclonal antibodies such as Tezepelumab-ekko is greater during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy. NAVIGATOR is the first Phase 3 trial to show benefit in severe asthma irrespective of eosinophils by targeting TSLP.2 These results support the U.S.Food and Drug Administration Breakthrough Therapy Designationgranted to TezspireinSeptember 2018for patients with severe asthma, without an eosinophilic phenotype. TEZSPIRE (tezepelumab-ekko) Subcutaneous Injection 210 mg For . Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise. Indication TEZSPIRE is a prescription medicine used with other asthma medicines for the maintenance treatment of severe asthma in people 12 years of age and older whose asthma is not controlled with their current asthma medicine. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. A new medical policy listing coverage criteria for the drug will become effective April 11, 2022. . 2,12-14 The program includes additional mechanistic and long-term safety trials.15, NAVIGATOR is a Phase 3, randomized, double-blinded, placebo-controlled trial in adults (1880 years old) and adolescents (1217 years old) with severe, uncontrolled asthma, who were receiving standard of care (SoC). As part of prespecified analyses, the AAER over 52 weeks was also assessed in patients grouped by baseline blood eosinophil count, FeNO level and serum specific immunoglobin E (IgE) status (perennial aeroallergen sensitivity positive or negative).3 These are inflammatory biomarkers used by clinicians to inform treatment options and involve tests analyzing a patient's blood (eosinophils/IgE) and exhaled air (FeNO). We may not be able to access the capital and credit markets on terms that are favorable to us, or at all. For more information, visitwww.amgen.comand follow us onwww.twitter.com/amgen. In 2021, Amgen was named one of the 25 World's Best Workplaces by Fortune and Great Place to Work and one of the 100 most sustainable companies in the world by Barron's. TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus. Tezepelumab in adults with uncontrolled asthma [supplementary appendix; updated. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd., Kyowa Kirin Co., Ltd., or any collaboration to manufacture therapeutic antibodies against COVID-19), the performance of Otezla(apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), the Five Prime Therapeutics, Inc. acquisition, or the Teneobio, Inc. acquisition, as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic onAmgen's business, and other such estimates and results. Amgen will record product sales in the U.S., with AstraZeneca recording its share of U.S. profits as Collaboration Revenue. For patients with eosinophilic asthma, Tezspires improvement in annualized asthma exacerbation rate (AAER) was similar to that seen with Dupixent. The trial comprised a five-to-six-week screening period, a 52-week treatment period and a 12-week post-treatment follow-up period. US biotech major Amgen reported its quarterly financial results late Thursday. Amgen's business may be impacted by government investigations, litigation and product liability claims. Tezspire helps prevent severe asthma attacks (exacerbations) and can improve your breathing. About the NAVIGATOR and the PATHFINDER Clinical Trial ProgramIn addition to the Phase 2b PATHWAY trial, the Phase 3 PATHFINDER program included two trials, NAVIGATORand SOURCE. Global economic conditions may magnify certain risks that affect our business. The October 2022 Medicare Part B Drug and Biological Average Sales Price Quarterly Payment files are located in the "Downloads" section below. tezspire is the first and only biologic approved in europe for severe asthma that acts at the top of the inflammatory cascade by blocking thymic stromal lymphopoietin (tslp), an epithelial cytokine. Peters MC, Mekonnen ZK, Yuan S, et al. Qualifying biosimilars are noted in the notes column. ADVERSE REACTIONS The most common adverse reactions (incidence 3%) are pharyngitis, arthralgia, and back pain. The length of time that it takes forAmgento complete clinical trials and obtain regulatory approval for product marketing has in the past varied andAmgenexpects similar variability in the future. The Tezspire Together Program offers provider and patient product resources and support, including information related to coverage, reimbursement and distribution. Experienced Market Access/Reimbursement Manager with extensive experience in biotechnology access/ reimbursement, as well as vaccine, pharmaceutical, and medical device sales. Specifically, Tezspire targets and blocks TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and initiates an overreactive immune response to allergic, eosinophilic and other types of airway inflammation associated with severe asthma.3,17 TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles.3,17Expression of TSLP is increased in the airways of patients with asthma and has been correlated with disease severity.3,18Blocking TSLP may prevent the release of pro-inflammatory cytokines by immune cells, resulting in the prevention of asthma exacerbations and improved asthma control.3,18By working at the top of the cascade, Tezspirehelps stop inflammation at the source and has the potential to treat a broad population of severe asthma patients.3,18. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of our systems and our data. TEZSPIRE helps prevent severe asthma attacks (exacerbations) and can improve your breathing. 20550 INJECTION (S); SINGLE TENDON SHEATH, OR LIGAMENT, APONEUROSIS (EG, PLANTAR ''FASCIA'') - Fee schedule amount - $ 59.62 26989 UNLISTED PROCEDURE, HANDS OR FINGERS 29130 APPLICATION OF FINGER SPLINT; STATIC Fee schedule amount - $41.82 C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS J3590 UNCLASSIFIED BIOLOGICS For claims submitted to the Part B MAC TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.Limitations of Use:TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus. TEZSPIREwas approved for a broad population of people living with severe asthma, and we look forward to getting this important medicine into the hands of millions of patients who have had an unmet medical need. Fahy JV. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. Under the amended agreement, Amgen and AstraZeneca will jointly commercialize TEZSPIRE in North America. Commitment to Patient SupportAmgen and AstraZeneca are committed to providing appropriate patients who are prescribed Tezspire with affordable access to the medicine. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. For patients with allergic, asthma Tezspires improvements in symptoms was similar to Xolair, although Tezspire achieved a higher improvement in the exacerbation rate. 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