Nplate® (Romiplostim)
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DRUGS REQUIRING PRIOR AUTHORIZATION in the MEDICAL BENEFIT Page 1
Effective Date: 08/01/2021 DRUGS REQUIRING PRIOR AUTHORIZATION IN THE MEDICAL BENEFIT Page 1 Therapeutic Category Drug Class Trade Name Generic Name HCPCS Procedure Code HCPCS Procedure Code Description Anti-infectives Antiretrovirals, HIV CABENUVA cabotegravir-rilpivirine C9077 Injection, cabotegravir and rilpivirine, 2mg/3mg Antithrombotic Agents von Willebrand Factor-Directed Antibody CABLIVI caplacizumab-yhdp C9047 Injection, caplacizumab-yhdp, 1 mg Cardiology Antilipemic EVKEEZA evinacumab-dgnb C9079 Injection, evinacumab-dgnb, 5 mg Cardiology Hemostatic Agent BERINERT c1 esterase J0597 Injection, C1 esterase inhibitor (human), Berinert, 10 units Cardiology Hemostatic Agent CINRYZE c1 esterase J0598 Injection, C1 esterase inhibitor (human), Cinryze, 10 units Cardiology Hemostatic Agent FIRAZYR icatibant J1744 Injection, icatibant, 1 mg Cardiology Hemostatic Agent HAEGARDA c1 esterase J0599 Injection, C1 esterase inhibitor (human), (Haegarda), 10 units Cardiology Hemostatic Agent ICATIBANT (generic) icatibant J1744 Injection, icatibant, 1 mg Cardiology Hemostatic Agent KALBITOR ecallantide J1290 Injection, ecallantide, 1 mg Cardiology Hemostatic Agent RUCONEST c1 esterase J0596 Injection, C1 esterase inhibitor (recombinant), Ruconest, 10 units Injection, lanadelumab-flyo, 1 mg (code may be used for Medicare when drug administered under Cardiology Hemostatic Agent TAKHZYRO lanadelumab-flyo J0593 direct supervision of a physician, not for use when drug is self-administered) Cardiology Pulmonary Arterial Hypertension EPOPROSTENOL (generic) -
Treatment of MDS in 2014 and Beyond Treatment Goals in MDS
5/22/2014 Treatment of MDS in 2014 and Beyond Treatment goals in MDS • Get rid of it May 17, 2014 • If you can’t do that, make life better and longer – Improve blood counts Gail J. Roboz, M.D. – Improve quality of life Director, Leukemia Program – Decrease time to progression/leukemia Associate Professor of Medicine Hematopoietic Growth Factors: Hematopoietic Growth Factors: What are they? What are they? • Erythropoietin (EPO,Procrit®, Epogen®) – red • Synthetic versions of proteins normally • Granulocyte colony stimulating factor (GCSF, made in the body to stimulate growth of red Neupogen®) – white cells, white cells and platelets • Granulocyte-macrophage colony stimulating • Promote growth and differentiation factor (GM-CSF, Leukine®) – white • Thrombopoietin (TPO, romiplostim, Nplate®) – • Inhibitors of apoptosis (cell death) platelets • Darbepoietin (Aranesp®) • Peg-filgrastim (Neulasta®) • Note, these are not FDA-approved for MDS Erythropoietin (epo) in MDS Erythropoietin (epo) in MDS • Anemia is presents in >80% of MDS pts at dx • Often high endogenous epo levels • Transfusions help, but many issues • Many different doses and schedules • Recombinant EPO is FDA-approved for treating • Higher response rates with epo + G-CSF if anemia associated with kidney failure epo ≤500 mU/mL and transfusions <2 • Has been used since about 1990 in MDS U/month • Response rates in about 15-30% of patients • Poor probability of response if epo >500 • Many different studies including >1000 patients mU/mL and transfusions >2 U/month • Part of the NCCN MDS treatment guidelines 1. Casadevall N, et al. Blood. 2004;104:321-327. 2. Hellstrom-Lindberg E. Br J Haematol. 1995;89:67-71. -
Tavalisse™ (Fostamatinib) (Oral) Document Number: IC-0361 Last Review Date: 02/02/2021 Date of Origin: 06/01/2018 Dates Reviewed: 06/2018, 02/2019, 02/2020, 02/2021
Tavalisse™ (fostamatinib) (Oral) Document Number: IC-0361 Last Review Date: 02/02/2021 Date of Origin: 06/01/2018 Dates Reviewed: 06/2018, 02/2019, 02/2020, 02/2021 I. Length of Authorization Coverage is provided for six months and may be renewed. II. Dosing Limits A. Quantity Limit (max daily dose) [NDC Unit]: 100 mg tablets – 2 tablets per day 150 mg tablets – 2 tablets per day B. Max Units (per dose and over time) [HCPCS Unit]: 300 mg daily III. Initial Approval Criteria 1,2 Coverage is provided in the following conditions: Patient is at least 18 years of age; AND Universal Criteria 1 Patient is not receiving a thrombopoietin receptor agonist or mimetic (e.g., romiplostim, eltrombopag, lusutrombopag, avatrombopag, etc.); AND Laboratory values are current (i.e., drawn within the previous 28 days); AND Fostamatinib is not being used to attempt to normalize platelet count; AND Patient will avoid concomitant therapy with any of the following: o Coadministration with strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, ketoconazole, etc.), or if therapy is unavoidable, the patient will be monitored closely for adverse reaction and/or dose modifications will be implemented; AND o Coadministration with strong CYP3A inducers (e.g., rifampin, carbamazepine, St. John’s Wort, etc.); AND Chronic Immune Thrombocytopenia (ITP) † 1-5 Patient has had persistent/chronic ITP for at least 3 months; AND Proprietary & Confidential © 2021 Magellan Health, Inc. Patient has previously failed any of the following treatments for ITP: Patient has failed previous therapy with corticosteroids (i.e., patient had no response to at least a 3-month trial or is corticosteroid-dependent); OR Patient has failed previous therapy with immunoglobulins; OR Patient has had a splenectomy; OR Patient has failed previous therapy with a thrombopoietin receptor agonist; AND The patient is at increased risk for bleeding as indicated by platelet count of less than 30 × 109/L (30,000/mm³) † FDA Approved Indication(s) IV. -
Blood Modifier Agents Policy #: Rx.01.208
Pharmacy Policy Bulletin Title: Blood Modifier Agents Policy #: Rx.01.208 Application of pharmacy policy is determined by benefits and contracts. Benefits may vary based on product line, group, or contract. Some medications may be subject to precertification, age, quantity, or formulary restrictions (ie limits on non-preferred drugs). Individual member benefits must be verified. This pharmacy policy document describes the status of pharmaceutical information and/or technology at the time the document was developed. Since that time, new information relating to drug efficacy, interactions, contraindications, dosage, administration routes, safety, or FDA approval may have changed. This Pharmacy Policy will be regularly updated as scientific and medical literature becomes available. This information may include new FDA-approved indications, withdrawals, or other FDA alerts. This type of information is relevant not only when considering whether this policy should be updated, but also when applying it to current requests for coverage. Members are advised to use participating pharmacies in order to receive the highest level of benefits. Intent: The intent of this policy is to communicate the medical necessity criteria for eltrombopag olamine (Promacta®), fostamatinib disodium (Tavalisse™), avatrombopag (Doptelet®), lusutrombopag (Mulpleta®) as provided under the member's prescription drug benefit. Description: Idiopathic thrombocytopenia purpura (ITP): ITP is an immune disorder in which the blood doesn't clot normally. ITP can cause excessive bruising and bleeding and can be characterized as an unusually low level of platelets, or thrombocytes, in the blood results in ITP. Thrombocytopenia in patients with hepatitis C: Thrombocytopenia can occur in patients with chronic hepatitis C virus (HCV) infection. -
Multiple Technology Appraisal Avatrombopag and Lusutrombopag
Multiple Technology Appraisal Avatrombopag and lusutrombopag for treating thrombocytopenia in people with chronic liver disease needing an elective procedure [ID1520] Committee papers © National Institute for Health and Care Excellence 2019. All rights reserved. See Notice of Rights. The content in this publication is owned by multiple parties and may not be re-used without the permission of the relevant copyright owner. NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE MULTIPLE TECHNOLOGY APPRAISAL Avatrombopag and lusutrombopag for treating thrombocytopenia in people with chronic liver disease needing an elective procedure [ID1520] Contents: 1 Pre-meeting briefing 2 Assessment Report prepared by Kleijnen Systematic Reviews 3 Consultee and commentator comments on the Assessment Report from: • Shionogi 4 Addendum to the Assessment Report from Kleijnen Systematic Reviews 5 Company submission(s) from: • Dova • Shionogi 6 Clarification questions from AG: • Questions to Shionogi • Clarification responses from Shionogi • Questions to Dova • Clarification responses from Dova 7 Professional group, patient group and NHS organisation submissions from: • British Association for the Study of the Liver (BASL) The Royal College of Physicians supported the BASL submission • British Society of Gastroenterology (BSG) 8 Expert personal statements from: • Vanessa Hebditch – patient expert, nominated by the British Liver Trust • Dr Vickie McDonald – clinical expert, nominated by British Society for Haematology • Dr Debbie Shawcross – clinical expert, nominated by Shionogi © National Institute for Health and Care Excellence 2019. All rights reserved. See Notice of Rights. The content in this publication is owned by multiple parties and may not be re-used without the permission of the relevant copyright owner. MTA: avatrombopag and lusutrombopag for treating thrombocytopenia in people with chronic liver disease needing an elective procedure Pre-meeting briefing © NICE 2019. -
S. No. Name of the Firm Date of Permission No. Name of the Indication Dosage Form & Strength
List of new drugs (r-DNA origin) approved for mannufacture and marketing in India for the Year 2021 S. No. Name of the firm Date of Permission No. Name of the Indication Dosage Form & Strength Rheumatoid Arthritis (RA)–Etanercept in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate.Etanercept can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriateEtanercept is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Etanercept, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical functionJuvenile Idiopathic Arthritis (JIA) – Treatment of polyarthritis (rheumatoid factor positive or negative)and extended oligoarthritis in children and adolescents from the age of 2 years who have had aninadequate response to, or who have proved intolerant of, methotrexate.Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.Treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response Solution for subcutaneous Injection (single use)Pre- Mylan Pharmaceuticals to, or who have proved intolerant of, conventional therapy.Etanercept has not been studied in children aged less than 2 filled syringe:(i). 50 mg/mL in Prefilled Syringes(ii). -
Novel Concepts of Treatment for Patients with Myelofibrosis And
cancers Review Novel Concepts of Treatment for Patients with Myelofibrosis and Related Neoplasms Prithviraj Bose * , Lucia Masarova and Srdan Verstovsek Department of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA; [email protected] (L.M.); [email protected] (S.V.) * Correspondence: [email protected] Received: 30 August 2020; Accepted: 1 October 2020; Published: 9 October 2020 Simple Summary: Myelofibrosis (MF) is an advanced form of a group of rare, related bone marrow cancers termed myeloproliferative neoplasms (MPNs). Some patients develop myelofibrosis from the outset, while in others, it occurs as a complication of the more indolent MPNs, polycythemia vera (PV) or essential thrombocythemia (ET). Patients with PV or ET who require drug treatment are typically treated with the chemotherapy drug hydroxyurea, while in MF, the targeted therapies termed Janus kinase (JAK) inhibitors form the mainstay of treatment. However, these and other drugs (e.g., interferons) have important limitations. No drug has been shown to reliably prevent the progression of PV or ET to MF or transformation of MPNs to acute myeloid leukemia. In PV, it is not conclusively known if JAK inhibitors reduce the risk of blood clots, and in MF, these drugs do not improve low blood counts. New approaches to treating MF and related MPNs are, therefore, necessary. Abstract: Janus kinase (JAK) inhibition forms the cornerstone of the treatment of myelofibrosis (MF), and the JAK inhibitor ruxolitinib is often used as a second-line agent in patients with polycythemia vera (PV) who fail hydroxyurea (HU). In addition, ruxolitinib continues to be studied in patients with essential thrombocythemia (ET). -
Management of Flood Syndrome: What Can We Do Better? Strainiene S, Peciulyte M, Strainys T, Stundiene I, Savlan I, Liakina V, Valantinas J
ISSN 1007-9327 (print) ISSN 2219-2840 (online) World Journal of Gastroenterology World J Gastroenterol 2021 August 28; 27(32): 5297-5459 Published by Baishideng Publishing Group Inc World Journal of W J G Gastroenterology Contents Weekly Volume 27 Number 32 August 28, 2021 OPINION REVIEW 5297 Management of Flood syndrome: What can we do better? Strainiene S, Peciulyte M, Strainys T, Stundiene I, Savlan I, Liakina V, Valantinas J REVIEW 5306 Radiomics and machine learning applications in rectal cancer: Current update and future perspectives Stanzione A, Verde F, Romeo V, Boccadifuoco F, Mainenti PP, Maurea S 5322 Could the burden of pancreatic cancer originate in childhood? Diaconescu S, Gîlcă-Blanariu GE, Poamaneagra S, Marginean O, Paduraru G, Stefanescu G MINIREVIEWS 5341 Application of artificial intelligence in preoperative imaging of hepatocellular carcinoma: Current status and future perspectives Feng B, Ma XH, Wang S, Cai W, Liu XB, Zhao XM 5351 Artificial intelligence application in diagnostic gastrointestinal endoscopy - Deus ex machina? Correia FP, Lourenço LC 5362 Faecal microbiota transplantation enhances efficacy of immune checkpoint inhibitors therapy against cancer Kang YB, Cai Y 5376 Immune checkpoint inhibitor-related hepatotoxicity: A review Remash D, Prince DS, McKenzie C, Strasser SI, Kao S, Liu K ORIGINAL ARTICLE Basic Study 5392 Therapeutic effect of Cistanche deserticola on defecation in senile constipation rat model through stem cell factor/C-kit signaling pathway Zhang X, Zheng FJ, Zhang Z 5404 Recombinant angiopoietin-like -
Nplate (Romiplostim) Discard Any Unused Portion of the Single-Use Vial
HIGHLIGHTS OF PRESCRIBING INFORMATION Do not shake during reconstitution; protect reconstituted Nplate from These highlights do not include all the information needed to use Nplate light; administer reconstituted Nplate within 24 hours. (2.2) safely and effectively. See full prescribing information for Nplate. The injection volume may be very small. Use a syringe with graduations to 0.01 mL. (2.2) ® Nplate (romiplostim) Discard any unused portion of the single-use vial. (2.2) For subcutaneous injection ---------------------DOSAGE FORMS AND STRENGTHS---------------------- 250 mcg or 500 mcg of deliverable romiplostim in single-use vials ( 3) Initial U.S. Approval: 2008 ---------------------------RECENT MAJOR CHANGES--------------------------- -------------------------------CONTRAINDICATIONS ---------------------------- Indications and Usage (1) 07/2011 None (4) Dosage and Administration, Nplate Distribution removal 12/2011 -----------------------WARNINGS AND PRECAUTIONS------------------------ Program (2) In patients with MDS, Nplate increases blast cell counts and increases Warnings and Precautions: Progression of Myelodysplastic the risk of progression to acute myelogenous leukemia. (5.1) Syndromes (5.1) 07/2011 Thrombotic/thromboembolic complications may result from increases in Warnings and Precautions: Thrombotic/Thromboembolic platelet counts with Nplate use. Portal vein thrombosis has been Events (5.2) 07/2011 reported in patients with chronic liver disease receiving Nplate. Use Warning and Precaution: Bone Marrow Reticulin Formation with additional caution in ITP patients with chronic liver disease. (5.2) and Fibrosis (5.3) 12/2011 Discontinuation of Nplate may result in worsened thrombocytopenia Warnings and Precautions: Laboratory Monitoring (5.6) 12/2011 than was present prior to Nplate therapy. Monitor complete blood Warnings and Precautions: Nplate Distribution removal 12/2011 counts (CBCs), including platelet counts, for at least 2 weeks following Program (5.7) Nplate discontinuation. -
Nutrition and Blood
Greater Manchester Joint Formulary Chapter 9: Nutrition and Blood For cost information please go to the most recent cost comparison charts Contents 9.1. Anaemias and some other blood disorders 9.2 Fluids and electrolytes 9.3 Not listed 9.4. Oral nutrition 9.5 Minerals 9.6 Vitamins Key Red drug see GMMMG RAG list Click on the symbols to access this list Amber drug see GMMMG RAG list Click on the symbols to access this list Green drug see GMMMG RAG list Click on the symbols to access this list If a medicine is unlicensed this should be highlighted in the template as follows Drug name Not Recommended OTC Over the Counter In line with NHS England guidance, GM do not routinely support prescribing for conditions which are self-limiting or amenable to self-care. For further details see GM commissioning statement. Order of Drug Choice Where there is no preferred 1st line agent provided, the drug choice appears in alphabetical order. Return to contents Chapter 9 – page 1 of 16 V5.2 Greater Manchester Joint Formulary BNF chapter 9 Nutrition and Blood Section 9.1. Anaemias and some other blood disorders Subsection 9.1.1 Iron-deficiency anaemias Subsection 9.1.1.1 Oral iron First choice Ferrous fumarate 322 mg tabs (100 mg iron) Ferrous fumarate 305 mg caps (100 mg iron) Alternatives Ferrous fumarate 210 mg tabs (68 mg iron) Ferrous sulphate 200 mg tabs (65 mg iron) Ferrous fumarate 140 mg sugar free syrup (45 mg of iron/5 mL) Sodium feredetate 190 mg sugar free elixir (27.5 mg of iron/5 mL) Grey drugs Ferric maltol capsules Items which Criterion 2 (see RAG list) are listed as For treatment of iron deficiency anaemia in patients with Grey are intolerance to, or treatment failure with, two oral iron deemed not supplements. -
Doptelet® (Avatrombopag) (Oral) Document Number: IC-0369 Last Review Date: 02/04/2020 Date of Origin: 07/03/2018 Dates Reviewed: 07/2018, 02/2019, 08/2019, 02/2020
Doptelet® (avatrombopag) (Oral) Document Number: IC-0369 Last Review Date: 02/04/2020 Date of Origin: 07/03/2018 Dates Reviewed: 07/2018, 02/2019, 08/2019, 02/2020 I. Length of Authorization Thrombocytopenia due to CLD Coverage is provided for one 5-day course of therapy and may not be renewed. Chronic ITP Coverage is provided for three months and may be renewed. II. Dosing Limits A. Quantity Limit (max daily dose) [NDC unit]: 20 mg tablets: 3 tablets per day B. Max Units (per dose and over time) [HCPCS Unit]: Thrombocytopenia 60 mg daily Chronic ITP 40 mg daily III. Initial Approval Criteria1 Coverage is provided in the following conditions: Universal Criteria Patient age 18 years or older; AND Patient is not on any other thrombopoietin receptor agonist or mimetic (e.g., romiplostim, eltrombopag, lusutrombopag, etc.) or fostamtinib; AND Avatrombopag is not being used to attempt to normalize platelet count; AND Laboratory values are current (i.e., drawn within the previous 28 days); AND Thrombocytopenia due to Chronic Liver Disease (CLD) † Proprietary & Confidential © 2020 Magellan Health Inc. Patient is scheduled to undergo a procedure with a risk of bleeding which would necessitate a platelet transfusion; AND Patient will not be undergoing any of the following procedures: Neurosurgical intervention; Thoracotomy; Laparotomy; Organ resection; AND The patient is at increased risk for bleeding as indicated by platelet count of less than < 50 x 109/L Chronic Immune Thrombocytopenia (ITP) † Patient has had chronic ITP for -
Romiplostim Reverts the Thrombocytopenia in Dengue Hemorrhagic Fever
View metadata, citation and similar papers at core.ac.uk brought to you by CORE provided by Elsevier - Publisher Connector letter Romiplostim reverts the 160 thrombocytopenia in den- gue hemorrhagic fever 140 120 To the Editor: First-genera- /L) tion thrombopoietic agents were 9 100 recombinant forms of human thrombopoietin (TPO), but their 80 development was discontinued due to the onset of neutralizing auto- 60 Platelet count (×10 antibodies cross-reacting with 40 endogenous TPO. Second-gen- eration thrombopoiesis-stimulat- 20 ing molecules (romiplostim and 0 eltrombopag), have completed 0 10 20 0 40 50 55 60 70 80 90 100 110 120 10 140 150 160 170 180 190 200 210 220 20 phase III trials in primary im- Time in days mune thrombocytopenia, whereas 9 phase II and III trials are ongoing Figure 1. Platelet count (x10 /L) by day. Arrows denote doses of romiplostim (4 µg/kg). in other conditions characterized by thrombocytopenia.1 Dengue gen and IgM antibodies were pres- DHF in which romiplostim has is the most prevalent arthropod- ent; the bone marrow had hypo- been successfully used. An immune borne virus affecting humans to- plasia and no evidence of myeloma mechanism of thrombocytopenia day causing a spectrum of disease, was found. The patient was treated due to increased platelet destruc- ranging from a mild febrile illness with intravenous hydrocortisone tion appears to be operative in pa- to a life-threatening dengue hem- (300 mg/day) and subcutaneous tients with DHF;9 however, in the orrhagic fever (DHF).2 The main filgrastim (300 ug/day), with the case that we are reporting, the previ- hematological findings of dengue neutropenia resolving 4 days later.