2021;384(19):1800-1809. 2. text-decoration: underline; Tezepelumab in adults and adolescents with severe, uncontrolled asthma. TEZSPIRE - Specialty Infusion In an update to our July 25 story, Medicare Administrative Contractors (MACs) publicly announced removal of Tezspire from their Self-Administration Drug (SAD) exclusion lists. Disease or Condition: Thymic stromal lymphopoietin: its role and potential as a therapeutic target in asthma. 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 . Thousand Oaks, CA: Amgen Inc.; and Wilmington, DE: AstraZeneca Pharmaceuticals LP; December 2021. Patient-reported outcomes (PROs) were assessed using the asthma control questionnaire-6 (ACQ-6) and the asthma quality of life questionnaire (standardized) for patients aged 12 years or older (AQLQ[S]+12). N Engl J Med. are breastfeeding or plan to breastfeed. Appendix to: Tezepelumab in adults with uncontrolled asthma. AstraZeneca [AMGEN] recommends use of TEZPIRE only in accordance with its approved Prescribing Information. Lancet Respir Med. Menzies-Gow A, Corren J, Bourdin A, et al. 2 Hypersensitivity reactions such as rash or allergic conjunctivitis can occur after getting an injection of Tezspire. All rights reserved. This biologic is not self-administered. Therefore, the use of live attenuatedvaccines should be avoided in patients receiving Tezspire. 8. The concomitant use of TEZSPIRE and live attenuated vaccines has not been evaluated. Patient continues to experience moderate to severe adverse events on Tezspire based on documentation submitted, despite receiving premedication such as acetaminophen, steroids, diphenhydramine, fluids, etc. Tezspire is a medicine used to treat adults and adolescents (12 years of age and older) with severe asthma. 5. N Engl J Med. Tezspire is given by injection by a doctor once every 4 weeks. 5. list-style-type: lower-alpha; 4. Thousand Oaks, CA: Amgen Inc.; and Wilmington, DE: AstraZeneca Pharmaceuticals LP; December 2021. Response to Comment (RTC) articles list issues raised by external stakeholders during the Proposed LCD comment period. 2019;50(4):975-991. } padding: 10px; 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. Tezspire (tezepelumab) approved in the US for severe asthma - AstraZeneca AstraZeneca [AMGEN] manufactures TEZSPIRE and provided sponsorship/funding for the studies discussed. Lancet Respir Med. Respiratory symptoms, "asthma attack" exacerbation, may include wheeze, chest tightness, shortness of breath, and/or cough, which can vary in frequency and intensity over time. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. 06/01/2014- Moved J3357 Ustekinumab from the list of excluded codes to the Non-Excluded list, Annual Review; Some older versions have been archived. References: 1. 2017;377(suppl):1-54. CPT codes, descriptions and other data only are copyright 2021 American Medical Association. Some articles contain a large number of codes. Diver S, Khalfaoui L, Emson C, et al; CASCADE study investigators. Template you can reference when writing a Letter of Medical Necessity to your patients insurance company, reinforcing the need for TEZSPIRE coverage. Tezspire is intended for administration by a healthcare provider. Your MCD session is currently set to expire in 5 minutes due to inactivity. Ask your doctor if TEZSPIRE is right for you. The Asthma Daily Diary questionnaire was used to assess changes in overall symptom severity. You may also contact us at ub04@aha.org. Gauvreau GM, Sehmi R, Ambrose CS, Griffiths JM. 10/01/2016- Added etanercept-szzs (Erelzi) (J3490)-effective 11/15/2016. 3. text-decoration: line-through; Where will this drug be administered? NDC 55513-112-01 Tezspire - NDCList.com Limitations of Use: TEZSPIRE is not indicated for the . 2015;16(1):45-56. Tezepelumab in adults with uncontrolled asthma. 4. Tezepelumab in adults and adolescents with severe, uncontrolled asthma. Obtaining TEZSPIRE PA & Appeals Checklist .newText { color: blue Tezspire subcutaneous: Uses, Side Effects, Interactions - WebMD Tezspire is approved by the U.S. Food and Drug Administration (FDA) for the treatment of severe asthma as add-on maintenance therapy. Tezspire is supplied as a single-dose vial or prefilled syringe containing 210mg/1.91mL of tezepelumab-ekko. FDA Approves Tezspire for Severe Asthma | Anton Rx Report Tezepelumab in adults and adolescents with severe, uncontrolled asthma. Immunity. TEZSPIRE should not be used to treat acute asthma symptoms, acute exacerbations, acute bronchospasm, or status asthmaticus. For purpose of this exclusion, "the term 'usually' means more than 50 percent of the time for all Medicare beneficiaries who use the drug. hives. N Engl J Med. Menzies-Gow A, Corren J, Bourdin A, et al. After struggling to control her severe asthma for many years, finding a treatment plan that works for Julie has been a positive experience for her and her specialist. Removed the following: J3490 Daclizumab (ZINBRYTA) (taken off the worldwide market due to safety concerns); J3590 Abatacept (Orencia)(has true code) ; J3590 Peginterferon alfa-2a, (Pegasys)(has true code); removed Roferon A from J9213 (no longer available); and Q0515 Injection, Sermorelin Acetate, 1 Microgram (Geref) (discontinued drug product). Acceptable Evidentiary Criteria Available- Peer reviewed medical literature,- Standards of medical practice,- Evidence-based practice guidelines,- FDA approved label, and- Package inserts. N Engl J Med. TEZSPIRE is an add-on maintenance treatment for people aged 12 and older with severe asthma. Thousand Oaks, CA: Amgen Inc.; and Wilmington, DE: AstraZeneca Pharmaceuticals LP; December 2021. Tezepelumab-ekko (Tezspire) C9399, J3490, and J3590 have been removed from SAD List. There 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. Appendix to: Tezepelumab in adults and adolescents with severe, uncontrolled asthma. Tezepelumab in adults and adolescents with severe, uncontrolled asthma. 2021;384(19):1800-1809. TSLP is an epithelial-cell-derived cytokine implicated in the pathogenesis of asthma.. 2019;50(4):975-991. Do not use to treat sudden breathing problems. Thousand Oaks, CA: Amgen Inc.; and Wilmington, DE: AstraZeneca Pharmaceuticals LP; December 2021. Appendix to: Tezepelumab in adults and adolescents with severe, uncontrolled asthma. 2021;384(19):1800-1809. TEZSPIRE (tezepelumab-ekko) [package insert]. TEZSPIRE (tezepelumab-ekko) [package insert]. Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with TEZSPIRE. Hypersensitivity reactions can occur within hours of administration, but in someinstances have a delayed onset (i.e., days). "For people with severe asthma who are having difficulty, dont give up!. 2021;384(19):1800-1809. The use of the JA and JB modifiers is required for drugs which have one HCPCS Level II (J or Q) code but multiple routes of administration. TEZSPIRE (tezepelumab-ekko) [package insert]. Hypersensitivity Reactions. Frequently Asked Questions (FAQ) | TEZSPIRE (tezepelumab-ekko 2021;384(19):1800-1809. @media print { 2021;384(19):1800-1809. For precertification of tezepelumab-ekko (Tezspire), call (866) 752-7021 (commercial), (866) 503-0857 (Medicare), or fax (888) 267-3277. 2021;384(19):1800-1809. References: 1. TEZSPIRE is not a rescue medication. The concomitant use of TEZSPIRE and live attenuated vaccines has not been evaluated. Dosage information - 210 mg administered by subcutaneous injection once every 4 weeks Patients must have a documented history of at least 2 asthma exacerbation events or at least 1 severe asthma exacerbation resulting in hospitalization within the 12 months prior to first study visit. Data on file, REF-134673, AZPLP. Gauvreau GM, Sehmi R, Ambrose CS, Griffiths JM. Billing and Coding articles provide guidance for the related Local Coverage Determination (LCD) and assist providers in submitting correct claims for payment. You may report side effects related to AstraZeneca products by clicking here. The recommended dosage of TEZSPIREis210 mg administered subcutaneously once every 4 weeks. N Engl J Med. The cytokines of asthma. The cytokines of asthma. Reductions incorticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. The AMA is a third party beneficiary to this Agreement. of the Medicare program. CMS believes that the Internet is TEZSPIRE is a registered trademark of Amgen Inc. and AstraZeneca. Office Administered (NDC: 55513-112-01) SIG: 210 mg administered SC once every 4 weeks Quantity Dispensed:* 1 Refills:* 11 Fast Start: Optional program that provides up to 12 free doses of TEZSPIRE to eligible commercially insured patients whose plans do not cover TEZSPIRE or require a PA Office Administered (NDC: 55513-112-01) You can collapse such groups by clicking on the group header to make navigation easier. Utilization Management Policy on Site of Care for Specialty Drug Infusions. To license the electronic data file of UB-04 Data Specifications, contact Tim Carlson at (312) 893-6816. 9. Tezspire, a new biologic that is used to treat severe asthma in patients, is administered every four weeks. FDA Approves First-in-Class Drug for Severe Asthma - Medscape TEZSPIRE is administered every 4 weeks subcutaneously. Acute Asthma Symptoms or Deteriorating Disease. Posted 06/09/2022 Added C9399, J3490, and J3590 ofatumumab (Kesimpta) subcutaneous use* to the CPT/HCPCS Codes-Table effective 07/24/2022. It is unknown if TEZSPIRE will influence a patients response against helminth infections. Menzies-Gow A, Corren J, Bourdin A, et al. TEZSPIRE is the first and only treatment for severe asthma that is not limited to a specific type. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 2. 2. TEZSPIRE may cause serious side effects, including: Before using TEZSPIRE, tell your healthcare provider about all of your medical conditions, including if you: Do not change or stop taking your other asthma medicines unless instructed to do so by your healthcare provider. 3. Tezspire is administered once every four weeks by a health care professional. DISCLOSED HEREIN. apply equally to all claims. It is unknown if TEZSPIRE will influence a patients response against helminth infections. 2. This end point was also assessed in patients with baseline blood eosinophil counts of less than 300 cells per microliter. FDA News Release. 5. N Engl J Med. Lambrecht BN, Hammad H, Fahy JV. 2017;377(suppl):1-54. color: red!important; Tezspire eligible for coverage under the medical benefit - AmeriHealth Days ) versions have been removed from SAD list ) -effective 11/15/2016 are! Cms believes that the Internet is tezspire is intended for administration by a health Care.! 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