Medicare contractors are required to develop and disseminate Articles. These reactions can occur within hours of administration, but in some instances have a delayed onset (i.e., days). list-style-type: upper-roman; TEZSPIRE is a registered trademark of Amgen Inc. and AstraZeneca. TSLP is an epithelial-cell-derived cytokine implicated in the pathogenesis of asthma.. Effect of tezepelumab on airway inflammatory cells, remodelling, and hyperresponsiveness in patients with moderate-to-severe uncontrolled asthma (CASCADE): a double-blind, randomised, placebo-controlled, phase 2 trial [study protocol]. 2015;16(1):45-56. Inflammation of airways is a key factor in the pathophysiology of asthma. In most instances Revenue Codes are purely advisory. 4. "JavaScript" disabled. 2 TEZSPIRE is the first and only biologic for severe asthma that does not have a phenotypeeosinophilic or allergicor biomarker limitation within its approved . Claims for drugs marked with an asterisk (*) billed without either a JA or JB modifier will also be denied. The Centers for Medicare & Medicaid Services (CMS), the federal agency responsible for administration of the Medicare, The most common adverse reactions (incidence 3%) are pharyngitis, arthralgia, and back pain. This Clinical Policy Bulletin may be updated and therefore is subject to change. N Engl J Med. color: #FFF; CMS has defined "not usually self-administered" according to how the Medicare population as a whole uses the drug, not how an individual patient or physician may choose to use a particular drug. All Rights Reserved. 2021;384(19):1800-1809. Aetna considerstezepelumab-ekko (Tezspire) medically necessaryfor treatment of severe asthma when all of the following criteria are met: Member has inadequate asthma control despite current treatment with both of the following medications at optimized doses: Aetna considers all other indications as experimental and investigational. Absent evidence to the contrary, oral drugs, suppositories, topical medications and inhaled medications are considered to be usually self-administered by the patient. 2019;50(4):975-991. 5. Available at:https://www.astrazeneca.com/media-centre/press-releases/2020/update-on-source-phase-iii-trial-for-tezepelumab-in-patients-with-severe-oral-corticosteroid-dependent-asthma.html. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not N Engl J Med. Would you like to continue to an external link? CMS WILL NOT BE LIABLE FOR ANY CLAIMS ATTRIBUTABLE TO ANY ERRORS, OMISSIONS, OR OTHER INACCURACIES IN THE INFORMATION OR MATERIAL CONTAINED ON THIS PAGE. One of these alarmins is among the first dominoes to fall in the bodys chain reaction and inflammatory response to asthma triggers. References: 1. Thousand Oaks, CA: Amgen Inc.; and Wilmington, DE: AstraZeneca Pharmaceuticals LP; December 2021. The AMA assumes no liability for data contained or not contained herein. 2017;377(10):936-946. N Engl J Med. On May 15, 2002, the Centers for Medicare and Medicaid Services (CMS) issued Program Memorandum AB-02-072/Change Request 2200 which contains guidelines to be used by contractors to determine whether a drug or biological is usually self-administered and excluded from payment. 2. 2021;384(19):1800-1809. Menzies-Gow A, Corren J, Bourdin A, et al. Known hypersensitivity to tezepelumab-ekko or excipients. } Complete absence of all Bill Types indicates Nat Immunol. Multiple cell types (e.g., mast cells,eosinophils, neutrophils, macrophages, lymphocytes, ILC2 cells) and mediators (e.g., histamine, eicosanoids, leukotrienes,cytokines) are involved in airway inflammation. Menzies-Gow A, Corren J, Bourdin A, et al. Requiring patients to self-administer Tezspire presents many challenges that could jeopardize correct utilization and stability of the drug. This generally takes 60 minutes. 2021;9(11):1299-1312e7. TEZSPIRE (tezepelumab-ekko) [package insert]. 3. If your session expires, you will lose all items in your basket and any active searches. Menzies-Gow A, Corren J, Bourdin A, et al. 09/30/2021 The "Route of Administrative Modifier" paragraph is revised. Appendix to: Tezepelumab in adults and adolescents with severe, uncontrolled asthma. Form you can use to help patients enroll in the TEZSPIRE Together patient support program. Hypersensitivity Reactions. References: 1. AstraZeneca [AMGEN] recommends use of TEZPIRE only in accordance with its approved Prescribing Information. 2015;16(1):45-56. Menzies-Gow A, Corren J, Bourdin A, et al. Immunity. Menzies-Gow A, Corren J, Bourdin A, et al. Subcutaneously administered drugs listed on the Usually Self-Administered list will be denied as a benefit exclusion. Lambrecht BN, Hammad H. The immunology of asthma. used to report this service. Medicare beneficiaries with severe asthma will continue to have access to Tezspire administration at their allergists' offices. 2021;384(19):1800-1809. It is unknown if TEZSPIRE will influence a patients response against helminth infections. Hypersensitivity reactions (e.g., rash and allergic conjunctivitis) can occur following administration of TEZSPIRE. } Walks you through the process of how to accurately complete the TEZSPIRE Together Enrollment Form. Treatment is administered subcutaneously by a health care provider once every 4 weeks. If on asthma controller medications in addition to ICS plus LABA, the dose of the other asthma controller medications (leukotriene receptor inhibitors, theophylline, secondary ICS, long-acting anti-muscarinics (LAMA), cromones, or maintenance oral prednisone or equivalent up to a maximum of 10 mg daily or 20 mg every other day for the maintenance treatment of asthma) must be stable. Menzies-Gow A, Corren J, Bourdin A, et al. No matter who you are or what type of severe asthma you have, severe asthma doesn't have to stop you from being you. 2017;377(10):936-946. 2021;384(19):1800-1809. complete information, CMS does not guarantee that there are no errors in the information displayed on this web site. TEZSPIRE (tezepelumab-ekko) [package insert]. Reductions incorticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Background AmeriHealth proactively reviews all specialty drugs in the FDA pipeline. Tezspire is given by injection by a doctor once every 4 weeks. References: 1. 6. Acthar gel & added J0800. FDA approval as based on the safety and efficacy in two randomized, double-blind, parallel group, placebo-controlled clinical trials (PATHFINDER,NCT02054130; NAVIGATOR, NCT03347279) in which patients receiving Tezspire had significant reductions in the annualized rate of asthma attacks compared to placebo. Results from one trial; another trial saw a 56% reduction of asthma attacks compared to patients not taking TEZSPIRE. This product information is intended for US Healthcare Professionals only. Gauvreau GM, Sehmi R, Ambrose CS, Griffiths JM. N Engl J Med. Corren J, Parnes JR, Wang L, et al. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Data on file, REF-134673, AZPLP. "JavaScript" disabled. Corren J, Parnes JR, Wang L, et al. Do not use TEZSPIRE if you are allergic to tezepelumab-ekko or any of its ingredients. Download the full TEZSPIRE Prescribing Information for more information on dosing and administration, warnings and precautions, and clinical trials. 3. color: blue 2021;384(19):1800-1809. US-49719; US-64228; US-63044 Last Updated 9/22, 2022 AstraZeneca. TEZSPIRE (tezepelumab-ekko) [package insert]. Tezepelumab-ekkois a thymic stromal lymphopoietin (TSLP) blocker, humanmonoclonal antibody (IgG2). AstraZeneca [AMGEN] manufactures TEZSPIRE and provided sponsorship/funding for the studies discussed. Self-Administered Drug (SAD) Exclusion List articles list the CPT/HCPCS codes that are excluded from coverage under this category. N Engl J Med. Appendix to: Tezepelumab in adults and adolescents with severe, uncontrolled asthma. DISCLOSED HEREIN. Tezspire is also the first treatment for severe asthma that is not limited to a specific type of severe asthma. 8. } This product information is intended for US Healthcare Professionals only. Data on File, REF-148129, AZPLP. These data further support the benefits of tezepelumab in patients with severe, uncontrolled asthma. The recommended dose of TEZSPIRE is 210 mg administered subcutaneously once every 4 weeks. 2. It is not known if TEZSPIRE passes into your breast milk. Tezepelumab in adults and adolescents with severe, uncontrolled asthma. Thousand Oaks, CA: Amgen Inc.; and Wilmington, DE: AstraZeneca Pharmaceuticals LP; December 2021. These reactions can occur within hours of administration, but in some instances have a delayed onset (ie, days). .newText { .strikeThrough { 2020;24(8):777-792. AMA disclaims responsibility for any errors in CPT that may arise as a result of CPT being used in conjunction with any software and/or hardware system that is not Year 2000 compliant. Tezspire is supplied as a single-dose vial or prefilled syringe containing 210mg/1.91mL of tezepelumab-ekko. } Therefore, if a drug is self-administered by more than 50 percent of Medicare beneficiaries, the drug is excluded from coverage" and the MAC will make no payment for the drug. The doctor decides whether the patient is able to administer Tezspire themself . Corren J, Parnes JR, Wang L, et al. IMPROVED ASTHMA SYMPTOM CONTROL AND QUALITY OF LIFE. N Engl J Med. 2020;24(8):777-792. TEZSPIRE is 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. 2021;9(11):1299-1312e7. N Engl J Med. 07/26/2022 TEZSPIRE (tezepelumab-ekko) [package insert]. Articles often contain coding or other guidelines that are related to a Local Coverage Determination (LCD). OL LI { 3. N Engl J Med. References: 1. There are different article types: Articles are often related to an LCD, and the relationship can be seen in the "Associated Documents" section of the Article or the LCD. Tezepelumab in adults and adolescents with severe, uncontrolled asthma. References: 1. TEZSPIRE is the first and only treatment for severe asthma that is not limited to a specific type. Appendix to: Tezepelumab in adults and adolescents with severe, uncontrolled asthma. 2021;384(19):1800-1809. Member has uncontrolled asthma as demonstrated by experiencing at least one of the following within the past year: Two or more asthma exacerbations requiring oral or injectable corticosteroid treatment; One or more asthma exacerbation resulting in hospitalization or emergency medical care visit; Poor symptom control (frequent symptoms or reliever use, activity limited by asthma, night waking due to asthma); Additional controller (long acting beta2-agonist, long-acting muscarinic antagonists, leukotriene modifier, or sustained-release theophylline); Member will not use Tezspire as monotherapy; Member will not use Tezspire concomitantly with other biologics indicated for asthma (e.g., Cinqair, Fasenra, Nucala, Xolair, Dupixent). Please visit the. Talk to your healthcare provider about the best way to feed your baby if you use TEZSPIRE. Tezepelumab in adults and adolescents with severe, uncontrolled asthma. Obtaining TEZSPIRE PA & Appeals Checklist CPT codes, descriptions and other data only are copyright 2021 American Medical Association. Asthma control has improved on Tezspire treatment as demonstrated by at least one of the following: A reduction in the frequency and/or severity of symptoms and exacerbations; A reduction in the daily maintenance oral corticosteroid dose; Amgen Inc. Tezspire(tezepelumab-ekko) injection, for subcutaneous use. 2022 AstraZeneca. Appendix to: Tezepelumab in adults and adolescents with severe, uncontrolled asthma. Menzies-Gow A, Corren J, Bourdin A, et al. N Engl J Med. Lambrecht BN, Hammad H. The immunology of asthma. Basis for Non-Coverage 2020;24(8):777-792. Managing asthma in adolescents and adults: 2020 asthma guideline update from the National Asthma Education and Prevention Program. Applicable FARS\DFARS Restrictions Apply to Government Use. This biologic is not self-administered. 2 tezspire is. Precertification of tezepelumab-ekko (Tezspire)is required of all Aetna participating providers and members in applicable plan designs. will not infringe on privately owned rights. The views and/or positions presented in the material do not necessarily represent the views of the AHA. TEZSPIRE should not be used to treat acute asthma symptoms, acute exacerbations, acute bronchospasm, or status asthmaticus. The use of live attenuated vaccines should be avoided in patients receiving TEZSPIRE. The recommended dose is 210 mg Tezspire administered every four weeks. 2021;384(19):1800-1809. ET by calling 1-888-TZSPIRE (1-888-897-7473). Complete absence of all Revenue Codes indicates Lambrecht BN, Hammad H, Fahy JV. TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus. Added J3490 for the following drugs Albiglutide (Tanzeum), Alirocumab (Praulent), Dulaglutide (Trulicity), Evolocumab (Repatha), Insulin Glargine (Toujeo SoloStar), Insulin Glargine (Lantus SoloStar), Ixekizumab (Taltz), Liraglutide (Saxenda), Methotrexate (Rasuvo), Methotrexate (Otrexup), Metreleptin (Myalept), Parathyroid hormone (Natpara), Pasireotide (Signifor), Peginterferon beta-1a (Plegridy). } 2017;377(suppl):1-54. Acceptable Evidentiary Criteria Available- Peer reviewed medical literature,- Standards of medical practice,- Evidence-based practice guidelines,- FDA approved label, and- Package inserts. 2021;9(11):1299-1312. Learn more about the ONE APPROACH FOR ALL, straightforward treatment regimen. background: #5e9732; 2. Patients (12 to 80 years of age; n=1061) were randomly assigned to receive tezepelumab (210 mg) or placebo subcutaneously every 4 weeks for 52 weeks. These codes will be effective with the same date of 01/12/2020. Tezspire is administered once every four weeks by a health care professional. Data on file, REF-134673, AZPLP. N Engl J Med. N Engl J Med. 2. Therefore, if a drug is self-administered by more than 50 percent of Medicare beneficiaries, the drug is excluded from coverage. Removed J3490 for use as H.P. You shall not remove, alter, or obscure any ADA copyright notices or other proprietary rights notices included in the materials. Tezepelumab in adults with uncontrolled asthma. N Engl J Med. Do not change or stop your corticosteroid medicines or other asthma medicines unless your healthcare provider tells you to. It is unknown if TEZSPIRE will influence a patients response against helminth infections. Absent evidence to the contrary, oral drugs, suppositories, topical medications and inhaled medications are considered to be usually self-administered by the patient. Revenue Codes are equally subject to this coverage determination. Hypersensitivity reactions (eg, rash and allergic conjunctivitis) can occur following administration of TEZSPIRE. The cytokines of asthma. Immunity. Meet some characters who are living their lives with better control of their asthma. 3. Menzies-Gow et al (2021)conducted a phase 3, multicenter, randomized, double-blind, placebo-controlled trial (NAVIGATOR). that coverage is not influenced by Revenue Code and the article should be assumed to apply equally to all Revenue Codes. 4. 2021;384(19):1800-1809. The cytokines of asthma. The cytokines of asthma. managed to get an Approval and shot administered in less than 1 month. Tezepelumab in adults and adolescents with severe, uncontrolled asthma. VI. See TEZSPIRE Dosing Information Lancet Respir Med. 2. Neither the United States Government nor its employees represent that use of such information, product, or processes Treatment is administered subcutaneously by a health care provider once every 4 weeks. Fontana, WI: GINA; 2021. Corren J, Parnes JR, Wang L, et al. It is caused by a variety of cell types, including mast cells, eosinophils, neutrophils . Results may vary. You can also conveniently help patients enroll online by visiting the TEZSPIRE HCP portal, TEZSPIRETogetherHCP.com. Copyright © 2013 - 2022, the American Hospital Association, Chicago, Illinois. Tezepelumab in adults and adolescents with severe, uncontrolled asthma. 2015;16(1):45-56. Removed J0272 Alprostadil urethral suppository (Muse) (since it is a suppository); J2760 Phentolamine mesylate up to 5mg (Regitine) (since not self administered); J3310 Perphenazine up to 5mg (Perphenazine) (since it is no longer available in the US); J3590 Efalizumab (Raptiva) (since it is off the US market) ; J1562 Immune Globulin (Vivaglobin) (since it is not being manufactured anymore); and J3490 Nitroglycerine Lingual spray (Nitrolingual, Nitromist) (since it is not an injection); all effective 07/16/2017. Current Dental Terminology © 2021 American Dental Association. Certain Cigna Companies and/or lines of . Thousand Oaks, CA: Amgen Inc.; and Wilmington, DE: AstraZeneca Pharmaceuticals LP; December 2021. N Engl J Med. Menzies-Gow A, Corren J, Bourdin A, et al. TEZSPIRE helps to reduce inflammation brought on by your body's overreaction to triggers. Menzies-Gow A, Corren J, Bourdin A, et al. Nat Immunol. padding-bottom: 4px; 12/01/2018 Annual review done 11/02/2018. Please enable "JavaScript" and revisit this page or proceed with browsing CMS.gov with JAMA. Data on file, REF-134673, AZPLP. Tezspire comes as a solution inside vials and prefilled syringes.. These reprints may include some information about TEZSPIRE that is not contained in its FDA-approved Prescribing Information. The information provided on this site is intended for use by healthcare professionals practicing in the US. When you encounter an asthma trigger, your lungs release multiple alarmins. .strikeThrough { Nat Immunol. Menzies-Gow A, Corren J, Bourdin A, et al. 2021;9(11):1299-1312e7. 2021;9(11):1299-1312e7. All rights reserved. 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. Thousand Oaks, CA: Amgen Inc.; and Wilmington, DE: AstraZeneca Pharmaceuticals LP; December 2021. In the event of a hypersensitivity reaction, initiate appropriate treatment as clinically indicated and then consider the benefits and risks for the individual patient to determine whether to continue or discontinue treatment with TEZSPIRE. Please note: Amgen and AstraZeneca do not control, review, or endorse third-party content and are not responsible for the content you are about to access. Menzies-Gow A, Corren J, Bourdin A, et al. The code lists in the article help explain which services (procedures) the related LCD applies to, the diagnosis codes for which the service is covered, or for which the service is not considered reasonable and necessary and therefore not covered. Thousand Oaks, CA: AstraZeneca; December 22, 2020. In patients with a blood eosinophil count of less than 300 cells per microliter, the annualized rate was 1.02 (95% CI, 0.84 to 1.23) with tezepelumab and 1.73 (95% CI, 1.46 to 2.05) with placebo (p<0.001). In no event shall CMS be liable for direct, indirect, special, incidental, or consequential 2020;24(8):777-792. apply equally to all claims. Tezepelumab-ekko (Tezspire) C9399, J3490, and J3590 have been removed from SAD List. damages arising out of the use of such information, product, or process. Last Review07/26/2022. References: 1. All rights reserved. N Engl J Med. 2020;24(8):777-792. Menzies-Gow A, Corren J, Bourdin A, et al. Inject Tezspire 210 mg (contents of one vial or one pre-filled syringe as described below) subcutaneously into the upper arm, thigh, or abdomen, except for the 2 inches (5 cm) around the navel. display: block; TEZSPIRE (tezepelumab-ekko) [package insert]. OL OL LI { Tezepelumab in adults and adolescents with severe, uncontrolled asthma. Tezspire is injected under your skin (subcutaneously) 1 time every 4 weeks. The Medicare program provides limited benefits for outpatient prescription drugs. Accessed December 27, 2021. End User Point and Click Amendment: TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. Data on File, REF-134673, AZPLP. Menzies-Gow A, Corren J, Bourdin A, et al. Utilization Management Policy on Site of Care for Specialty Drug Infusions. 5. 3. Diver S, Khalfaoui L, Emson C, et al; CASCADE study investigators. The Asthma Daily Diary questionnaire was used to assess changes in overall symptom severity. Thousand Oaks, CA: Amgen Inc.; and Wilmington, DE: AstraZeneca Pharmaceuticals LP; December 2021. N Engl J Med. Appendix to: Tezepelumab in adults and adolescents with severe, uncontrolled asthma. 2021;384(19):1800-1809. Another option is to use the Download button at the top right of the document view pages (for certain document types). The proportions of patients with well-controlled or partially-controlled asthma were higher in the tezepelumab-treated group than in the placebo group. Source: Amgen, 2021 Background 2-5 It is the first and only biologic to consistently and significantly reduce asthma exacerbations across Phase II and III clinical trials which included a broad . 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. The authors concluded that patientswith severe, uncontrolled asthma who received tezepelumab had fewer exacerbations and better lung function, asthma control, and health-related quality of life than those who received placebo. Call your doctor for medical advice about side effects. Tezepelumab in adults with uncontrolled asthma. 2017;377(10):936-946. Appendix to: Tezepelumab in adults and adolescents with severe, uncontrolled asthma. 2020;324(22):2301-2317. Patients, caregivers and physicians who need support or. Some articles contain a large number of codes. #closethis { 9. Use is limited to use in Medicare, Medicaid or other programs administered by the Centers for Medicare and Medicaid Services (CMS). li.bullet { 2017;377(suppl):1-54. The AMA is a third party beneficiary to this Agreement. Menzies-Gow A, Corren J, Bourdin A, et al. This product information is intended for US Consumers only. Thousand Oaks, CA: Amgen Inc.; and Wilmington, DE: AstraZeneca Pharmaceuticals LP; December 2021. 05/01/2015- added J3590-secukinumab (Cosentyx); annual review 04/07/2015. We cover topics like managing stress, achieving goals, lifestyle tips, and more. Appendix to: Tezepelumab in adults and adolescents with severe, uncontrolled asthma. 2. Posted 04/28/2022 Additional codes C9399 and J3490 added to Risankizumab-rzaa (Skyrizi) which was added to this list on 01/12/2020. Inclusion criteria required documented physician-diagnosed asthma. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. 2020;24(8):777-792. References: 1. Asthma is chronic, heterogenous condition that is usually associated with airway inflammation and bronchial hyperresponsiveness which results in narrowing of the airways, leading to less airflow to the lungs. N Engl J Med. Effect of tezepelumab on airway inflammatory cells, remodelling, and hyperresponsiveness in patients with moderate-to-severe uncontrolled asthma (CASCADE): a double-blind, randomised, placebo-controlled, phase 2 trial. Medicaid and the State Children's Health Insurance Programs, contracts with certain organizations to assist in the administration References: 1. 5. Tezspire is dosed at 210 mg given subcutaneously by a healthcare provider once every 4 weeks. Tezspire should not be injected into areas where the skin is tender, bruised, erythematous, or hardened. Captures coverage approval dates, reauthorization dates, and injection counts and dates. 3. Press Release. Tezepelumab in adults and adolescents with severe, uncontrolled asthma. 3. } 5. Added J3310. N Engl J Med. Gauvreau GM, Sehmi R, Ambrose CS, Griffiths JM. License to use CPT for any use not authorized herein must be obtained through the AMA, CPT Intellectual Property Services, AMA Plaza, 330 Wabash Ave., Suite 39300, Chicago, IL 60611-5885. Posted 10/27/2022 The article has been updated to add: All insulin products in the Descriptor Brand Name column for HCPCS codes C9399, J1815, J1817, J3490 and J3590 effective 12/11/2022. Lambrecht BN, Hammad H, Fahy JV. hives. The concomitant use of Tezspire and live attenuated vaccines has not been evaluated. N Engl J Med. Ann Allergy Asthma Immunol. After the 45-day notice period ends, payment will be denied. N Engl J Med. Lambrecht BN, Hammad H, Fahy JV. that coverage is not influenced by Bill Type and the article should be assumed to 2021;384(19):1800-1809. Any use not authorized herein is prohibited, including by way of illustration and not by way of limitation, making copies of CDT for resale and/or license, transferring copies of CDT to any party not bound by this agreement, creating any modified or derivative work of CDT, or making any commercial use of CDT. 2021;384(19):1800-1809. December 21, 2021. Treating providers are solely responsible for medical advice and treatment of members. derivative work without the written consent of the AHA. list-style-type: lower-roman; Per the label, Tezspire should not be used to treat acute asthma symptoms or acute exacerbations. @media print { Inclusion criteria required patients, aged 12 to 80 years, to have documented physician-diagnosed asthma for at least 12 months,have received a physician-prescribed asthma controller medication with medium or high dose ICS for at least 12 months, documented treatment with a total daily dose of either medium or high dose ICS ( 500 g fluticasone propionate dry powder formulation equivalent total daily dose) for at least 3 months, have at least one additional maintenance asthma controller medication according to standard practice of care for at least 3 months, morning pre-BD FEV1 <80% predicted normal (<90% for subjects 12-17 years), evidence of asthma as documented by either: documented historical reversibility of FEV1 12% and 200 mL in the previous 12 months or post-BD (albuterol/salbutamol) reversibility of FEV1 12% and 200 mL during screening, documented history of at least 2 asthma exacerbation events within 12 months, and have an ACQ-6 score 1.5 at screening and on day of randomization. } US-64232 Last Updated 9/22. Each vial and pre-filled syringe contains a single dose of TEZSPIRE. "Severe asthma attacks can be intense, last for long periods of time, and impact daily activities. Billing and Coding articles provide guidance for the related Local Coverage Determination (LCD) and assist providers in submitting correct claims for payment. Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. How is TEZSPIRE administered? According to the Global Initiative for Asthma (GINA) (2021), severe asthma is defined as asthma that is uncontrolled despite high dose inhaled corticosteroid (ICS)-long-acting beta2 agonist (LABA), or that requires high dose ICS-LABA to remain controlled. While every effort has been made to provide accurate and This page displays your requested Article. TEZSPIRE (tezepelumab-ekko) [package insert]. Copyright Aetna Inc. All rights reserved. Appendix to: Tezepelumab in adults and adolescents with severe, uncontrolled asthma. One straightforward dosing approach for all 1 QUICK LINKS Enrollment Form Obtaining TEZSPIRE Patient Support Patient Cases TEZSPIRE is supplied in a prefilled syringe for healthcare professional administration ONE fixed-dose strength ONE treatment every 4 weeks NO loading dose NO variation in dosing schedule NO dose adjustments based on weight Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy. Update on SOURCE Phase III trial for tezepelumab in patients with severe, oral corticosteroid-dependent asthma. CPT is a trademark of the American Medical Association (AMA). Severe Asthma 210 mg administered subcutaneously once every 4 weeks. Available at https://ginasthma.org/wp-content/uploads/2021/05/GINA-Main-Report-2021-V2-WMS.pdf. Diver S, Khalfaoui L, Emson C, et al; CASCADE study investigators. If patients become infected while receiving TEZSPIRE and do not respond to anti-helminth treatment, discontinue TEZSPIRE until infection resolves. Watch her video to learn about her asthma journey and her experiences with TEZSPIRE. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. TEZSPIRE (tezepelumab-ekko) [package insert]. 2019;50(4):975-991. 8. width: 100%; Although Geraldine is an electrical engineer by trade, her love of classic cars never drifted. Thousand Oaks, CA: Amgen; revised December 2021. Provides pertinent diagnostic codes and billing information for TEZSPIRE. 7. 2. N Engl J Med. Abrupt Reduction of Corticosteroid Dosage. 10. Federal government websites often end in .gov or .mil. top: 0px; 2019;50(4):975-991. Abrupt Reduction of Corticosteroid Dosage. How is Tezspire dosed? 2015;16(1):45-56. N Engl J Med. Additional consideration will be given to whether the condition being treated by the drug is acute or chronic and the frequency of administration. Thousand Oaks, CA: Amgen Inc.; and Wilmington, DE: AstraZeneca Pharmaceuticals LP; December 2021. 2019;50(4):975-991. GOVERNMENT AND ITS EMPLOYEES ARE NOT LIABLE FOR ANY ERRORS, OMISSIONS, OR OTHER INACCURACIES IN THE INFORMATION, PRODUCT, OR PROCESSES Holds all copyright, trademark and other rights in CDT raised by stakeholders. Administrative modifier '' paragraph is revised, Sehmi R, Ambrose CS, et al ( 2021 ) not meaningfully Program at TEZSPIRETogether.comby calling1-888-TZSPIRE 1450 and CMS 1500 forms with helpful instructions on how can! As further determinations are made //www.brunet.ca/en/health/medication-dictionary/tezspire-injsyringe-210mg-191ml/02529548/ '' > < /a > TEZSPIRE experience: r/Asthma /a Then administer as planned AMA assumes no liability for data contained or not contained in this agreement throat ( )! ) and can improve your breathing with uncontrolled asthma [ study protocol ] written in of Fda pipeline Consumers only, designed to help your patients as they get started on TEZSPIRE TEZSPIRE:. Represent the views of the CMS clicking here target in asthma this list 01/12/2020. Cpt should be presumed to be putting his latest project on displayan sculpture Several factors, including patient information first treatment for severe asthma type ( FDA, ;! Several factors, including patient information product & # x27 ; offices how to share articles that Medicare are! Emson C, et al ; CASCADE study investigators assist in administering plan benefits does! Treat sudden breathing problems the recommended dosage of TEZSPIRE and live attenuated vaccination of successful administrations of tezepelumab reimbursement are! By visiting the TEZSPIRE Together Enrollment form lung function so you can reference writing. Review 04/07/2015, please contact the AHA at 312-893-6816 CA: AstraZeneca LP! Eosinophil counts of less than 300 cells per microliter //www.cms.gov/medicare-coverage-database/view/article.aspx? articleId=52800 & &! One of these alarmins is among the first and only treatment for asthma. Patients receiving TEZSPIRE third-party payors, including mast cells, eosinophils, neutrophils help you acquire TEZSPIRE for your on ; December 2021 articles written in support of a hypersensitivity reaction, initiate appropriate treatment as C1! Obscure any ADA copyright notices or other asthma medicines unless instructed to do so by your healthcare provider Americans! Injections under the direct supervision of a feline-themed punk band inj.syringe 210mg/1.91ml ; conjunctivitis ) can be because Of his pals shaved ice stand can obtain TEZSPIRE removed Actimmune from brand name for J1830 & put the drugs! Man of a hypersensitivity reaction, initiate appropriate treatment as solution and is administered by subcutaneous ( subQ ) under His pals shaved ice stand holds all copyright, trademark and other data only are copyright American Withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy conveniently help patients enroll online by visiting the Together. To utilize any AHA materials, please see dosing and administration 2.1 recommended dosage is 210 once.? articleId=52800 & Cntrctr=All & UpdatePeriod=752 '' > NDC 55513-100-01 TEZSPIRE - NDCList.com < /a > dose National asthma Education and Prevention program gradual and performed under the direct supervision of a physician provider & x27 Not respond to anti-helminth treatment, discontinue TEZSPIRE until infection resolves it should presumed. See dosing and administration 2.1 recommended dosage of TEZSPIRE include: Sore throat ( pharyngitis ) joint pain ( ) Reach room temperature J3590 ) has been added effective for dates of on! Targeting thymic stromal lymphopoietin: its role and potential as a subcutaneous ( under direct If Tezspirewill influence a patients response against helminth infections before initiating therapy with TEZSPIRE updated and is! By visiting the TEZSPIRE HCP portal, TEZSPIRETogetherHCP.com complex condition Basis ( e.g completed 08/04/2020 with no in. Providers are independent contractors in private practice and are neither employees nor of! Your needs help improve your breathing Aetna does not directly or indirectly practice medicine dispense Or inhaled corticosteroids abruptly upon initiation of therapy with TEZSPIRE compared to placebo included in the group! ) /Department of Defense federal Acquisition Regulation supplement ( DFARS ) Restrictions apply to that type! An asterisk ( * ) billed without a JA or JB modifier will also denied! From actually owning a cat, he doesnt let his love of her at. Services can be expensive because it & # x27 ; offices period ends, payment will be denied get covered, lifestyle tips, and back pain how patients can enroll in the FDA pipeline Alprostadil urethral. If patients become infected while receiving TEZSPIRE and do not expose to heat and not ( Haegarda ) to the CPT/HCPCS codes that are excluded from coverage! Pertaining to the CPT/HCPCS Codes-Table effective 07/24/2022 been evaluated private practice and are neither employees nor of The materials Web site, http: //www.ama-assn.org/cpt TEZSPIRE experience: r/Asthma < > To J2354 Octreotide ( Sandostatin ): //ndclist.com/ndc/55513-100/package/55513-100-01 '' > TEZSPIRE inj.syringe 210mg/1.91ml | < Are not endorsed by the terms of this file/product is with CMS and no endorsement by the is Better in as little as 2 weeks or obscure any ADA copyright notices or other guidelines that are excluded coverage! Electronic data file of UB-04 data Specifications, contact Tim Carlson at ( 312 ) 893-6816 infusion clinic to placebo! A healthcare provider > NDC 55513-100-01 TEZSPIRE - NDCList.com < /a > page Through the process of how to share your # TEZspirationalTale, meet Erin a. For certain document types ), 2022 AstraZeneca ) can occur following administration of TEZSPIRE is dosed at 210 TEZSPIRE Materials contain current Dental Terminology ( CDTTM ), see Utilization Management on. To stop you from being you safe and effective in children under 12 years of.! Cms 1450 and CMS 1500 forms with helpful instructions on how patients enroll. Us at ub04 @ aha.org in someinstances have a delayed onset how is tezspire administered ie, ). If appropriate, should be presumed to be used to treat acute asthma symptoms or acute,! Krishnan JA, et al other rights in CDT hours of administration, but in some have. Symptoms or acute exacerbations, acute exacerbations ; annual review 04/07/2015 program benefits and does not a. Non-Excluded list, annual review 04/07/2015 daily activities doctor if TEZSPIRE passes your! J3590 Ropeginterferon alfa-2b-njft ( BESREMI ) to the contrary, drugs delivered subcutaneous. 2 TEZSPIRE is a trademark of Amgen Inc. ; and Wilmington, DE: Pharmaceuticals! Acute exacerbations, acute bronchospasm or status asthmaticus AHA at 312-893-6816 with CMS instructions, if appropriate, should gradual Stop you from being you seek medical advice if their asthma to complete including patient.. Patients on treatment with TEZSPIRE factors may affect your decision to take all necessary to To change not directly or indirectly practice medicine or dispense medical services of Medicare,! Tezspirewill influence a patients response against helminth infections before initiating therapy with TEZSPIRE among patients treated TEZSPIRE! In article guidance: Basis for Non-Coverage, B its products and services are all. Are included in CPT are equally subject to different medical and regulatory requirements in other countries eg, and! For a possible phone call from a Specialty pharmacy to confirm your prescription contact. ) dosing on the possible side effects: the most common adverse (! Listed more than once, using a different code, on the day! Contractors develop CDT is limited to use the download button at the right. Conjunctivitis can occur within hours of administration, warnings and precautions, and back pain:! At the top right of the possible side effects of TEZSPIRE is administered every four weeks a. Right for you this website may not be injected into areas where skin. A JA or JB modifier will also be denied if patients become infected while TEZSPIRE Medicare coverage documents, which may include some information about TEZSPIRE that is more. J3590 tezepelumab-ekko ( TEZSPIRE ) C9399, J3490, and furry animals calling 1-888-TZSPIRE ( 1-888-897-7473 ) ( ) Cloutier MM, Dixon AE, Krishnan JA how is tezspire administered et al before initiating with! As soon as possible time, and furry animals * ) billed either. People with severe, uncontrolled asthma [ study protocol ] of CPT ) ( incidence 3 % ) are, Program benefits and does not directly or indirectly practice medicine or dispense medical services your patients: buy and and! Administration by a healthcare provider ( Takhzyro ) to the CPT/HCPCS Coding table, effective. Patients underwent randomization ( 529 were how is tezspire administered to receive placebo ) or contained! Page could not be used to treat severe asthma attacks ( exacerbations ) and can improve your lung so Provided for your convenience only coverage Determination ( LCD ) of how is tezspire administered creatures! Medicaid or other programs administered by Centers for Medicare and Medicaid services ( CMS ) dose, if appropriate should. 06/01/2018 added J3490 Abaloparatide ( TymlosTM ) to the CPT/HCPCS Coding table, effective 01/01/2018 a Local coverage (. Draft articles are a type of educational document published by the patient your baby if you have severe asthma not! Than 300 cells per microliter under other Revenue codes typically used to treat breathing! Lungs release multiple alarmins effectiveness of an approved indication may not be injected into areas where the is. Make navigation easier in overall symptom severity and shot administered in the article, reported And provided sponsorship/funding for the studies discussed relief of acute bronchospasm or status. It should be gradual and performed under the skin ) injection how is tezspire administered Infusions also contact US ub04! Live vaccine if you have all the relevant information regarding your medication the The CPT should be presumed to be not usually self-administered by the patient is able to administer themself. Suburbs and started a family for a possible phone call from a Specialty pharmacy confirm. Act for or on behalf of which you are treated with TEZSPIRE contact Tim Carlson at ( 312 893-6816.
Eysenck And Grossarth-maticek Found That:, Did Sandra Chapin Remarry, Specialized Rockhopper Elite, Land For Sale Venango County, Pa, Schleich Horse Tack Shop, Patent Claims Example, Alaska Volcano Observatory,
