Medical Drug and Step Therapy Prior Authorization List for Medicare Plus Bluesm and BCN Advantagesm Members Revised September 2021

Total Page:16

File Type:pdf, Size:1020Kb

Medical Drug and Step Therapy Prior Authorization List for Medicare Plus Bluesm and BCN Advantagesm Members Revised September 2021 Medical Drug and Step Therapy Prior Authorization List for Medicare Plus BlueSM and BCN AdvantageSM members Revised September 2021 This document lists the medical benefit drugs that have authorization or step therapy requirements for Medicare Advantage members. See the revision history at the end of this document for information about changes to this list. Prior authorization Submit authorization requirement effective date request through AIM HCPCS Step therapy Medicare BCN Specialty codes Generic name Trade name requirement Plus Blue Advantage NovoLogix® Health® C9076 Lisocabtagene maraleucel Breyanzi® 2/11/2021 2/11/2021 C9078 Trilaciclib Cosela™ 5/24/2021 5/24/2021 C9079 Evinacumab-dgnb Evkeeza™ 6/22/2021 6/22/2021 C9080 Melphalan flufenamide Pepaxto® 5/24/2021 5/24/2021 G2082 Esketamine Spravato® 2020 2020 (up to 56 mg plus observation) G2083 Esketamine Spravato® 2020 2020 (greater than 56 mg plus observation) 1 Medical Drug and Step Therapy Prior Authorization List for Medicare Plus BlueSM and BCN AdvantageSM members Revised September 2021 Prior authorization Submit authorization requirement effective date request through AIM HCPCS Step therapy Medicare BCN Specialty codes Generic name Trade name requirement Plus Blue Advantage NovoLogix® Health® J0129 Abatacept Orencia® 2017 2018 Try/fail Inflectra® or Renflexis®. These preferred drugs don’t require authorization. J0178 Aflibercept Eylea® 2017 2017 J0179 Brolucizumab-dbll Beovu® 2020 2020 J0180 Agalsidase beta Fabrazyme® 2017 2017 J0221 Alglucosidase alfa, 10mg Lumizyme® 2017 2017 J0222 Patisiran Onpattro® 2019 2019 J0223 Givosiran Givlaari® 2020 2020 J0224 Lumasiran Oxlumo™ 6/22/2021 6/22/2021 J0256 Alpha 1-proteinase inhibitor Aralast NP®, 2017 2017 (human), NOS, 10mg Prolastin C®, Zemaira® J0257 Alpha 1-proteinase inhibitor Glassia® 2017 2017 (human), 10mg J0490 Belimumab Benlysta® 2017 2018 J0517 Benralizumab Fasenra® 2018 2018 J0565 Bezlotoxumab Zinplava™ 2019 2019 2 Medical Drug and Step Therapy Prior Authorization List for Medicare Plus BlueSM and BCN AdvantageSM members Revised September 2021 Prior authorization Submit authorization requirement effective date request through AIM HCPCS Step therapy Medicare BCN Specialty codes Generic name Trade name requirement Plus Blue Advantage NovoLogix® Health® J0584 Burosumab-twza Crysvita® 2019 2019 J0585 Injection,onabotulinumtoxin A Botox® 2017 2017 J0586 Injection,abobotulinumtoxin A Dysport® 2017 2017 J0587 Injection,rimabotulinumtoxin B Myobloc® 2017 2017 J0588 Injection,incobotulinumtoxin A Xeomin® 2017 2017 J0638 Canakinumab Ilaris® 2020 2020 J0641 Levoleucovorin Fusilev® 2020 2020 J0642 Levoleucovorin Khapzory™ 2020 2020 J0717 Certolizumab pegol Cimzia® 2017 2018 J0775 Collagenase clostridium Xiaflex® 2017 2017 histolyticum J0791 Crizanlizumab Adakveo® 2020 2020 J0896 Luspatercept-aamt Reblozyl® 2020 2020 J0897 Denosumab Prolia® 2017 2017 J0897 Denosumab Xgeva® 2020 2017 J1300 Eculizumab Soliris® 2017 2018 J1301 Edaravone Radicava® 2019 2019 J1303 Ravulizumab-cwvz Ultomiris® 2019 2019 3 Medical Drug and Step Therapy Prior Authorization List for Medicare Plus BlueSM and BCN AdvantageSM members Revised September 2021 Prior authorization Submit authorization requirement effective date request through AIM HCPCS Step therapy Medicare BCN Specialty codes Generic name Trade name requirement Plus Blue Advantage NovoLogix® Health® J1322 Elosulfase alfa Vimizim® 2017 2017 J1325 Epoprostenol Flolan®, 2017 2017 Veletri® J1427 Viltolarsen Viltepso® 1/1/2021 1/1/2021 J1428 Eteplirsen Exondys 51® 2020 2020 J1429 Golodirsen Vyondys 53® 2020 2020 J1442 Filgrastim Neupogen® 2020 2020 Use the following preferred filgrastim biosimilar drugs first: Nivestym or Zarxio. Submit authorization requests for these preferred drugs to AIM. J1447 Tbo-filgrastim Granix® 2020 2020 Use the following preferred filgrastim biosimilar drugs first: Nivestym or Zarxio. Submit authorization requests for these preferred drugs to AIM. J1458 Galsulfase Naglazyme® 2017 2017 4 Medical Drug and Step Therapy Prior Authorization List for Medicare Plus BlueSM and BCN AdvantageSM members Revised September 2021 Prior authorization Submit authorization requirement effective date request through AIM HCPCS Step therapy Medicare BCN Specialty codes Generic name Trade name requirement Plus Blue Advantage NovoLogix® Health® J1459 Immune globulin IV (human), Privigen® 2017 2018 10% liquid J1460 Immune globulin (human), IM GamaSTAN®, 2017 2018 GamaSTAN S/D® J1554 Immune globulin Intravenous Asceniv™ 2019 2019 (human) slra 10% J1555 Immune globulin Subcutaneous Cuvitru® 2020 2020 (Human) 20% J1556 Immune globulin Intravenous Bivigam® 2017 2017 (human), 10% J1557 Immune globulin Intravenous Gammaplex® 2017 2017 (human) J1558 Immune globulin subcutaneous Xembify® 2020 2020 (human)-klhw J1559 Immune globulin Subcutaneous Hizentra® 2017 2017 (human), 20% J1560 Immune globulin (human), IM GamaSTAN®, 2017 2018 (Over 10 mL) GamaSTAN S/D® J1561 Immune globulin Injection Gamunex-C®, 2017 2017 (human), 10% Gammaked™ 5 Medical Drug and Step Therapy Prior Authorization List for Medicare Plus BlueSM and BCN AdvantageSM members Revised September 2021 Prior authorization Submit authorization requirement effective date request through AIM HCPCS Step therapy Medicare BCN Specialty codes Generic name Trade name requirement Plus Blue Advantage NovoLogix® Health® J1566 Immune globulin Intravenous Carimune® 2017 2017 (human) NF, Gammagard S/D® Less IgA J1568 Immune globulin Intravenous Octagam® 2017 2017 (human) J1569 Immune globulin Infusion Gammagard® 2017 2017 (human) 10% Liquid J1572 Immune globulin Intravenous Flebogamma 2017 2017 (human) Dif® J1575 Immune globulin Infusion 10% Hyqvia® 2017 2017 (human) with recombinant human hyaluronidase J1599 Immune globulin subcutaneous Cutaquig® 2020 2020 (human)-hipp J1599 Immune globulin Intravenous Panzyga® 2020 2020 (human) – ifas 10% J1602 Golimumab Simponi Aria® 2017 2018 J1743 Idursulfase Elaprase® 2017 2017 6 Medical Drug and Step Therapy Prior Authorization List for Medicare Plus BlueSM and BCN AdvantageSM members Revised September 2021 Prior authorization Submit authorization requirement effective date request through AIM HCPCS Step therapy Medicare BCN Specialty codes Generic name Trade name requirement Plus Blue Advantage NovoLogix® Health® J1745 Infliximab Remicade® 2017 2017 Use the following preferred infliximab biosimilar drugs: Inflectra or Renflexis. These preferred drugs don’t require authorization. J1746 Ibalizumab-uiyk Trogarzo® 2019 2019 J1786 Imiglucerase Cerezyme® 2017 2017 J1823 Inebilizumab-cdon Uplizna® 2020 2020 J1931 Laronidase Aldurazyme® 2017 2017 J2182 Mepolizumab Nucala® 2018 2017 J2326 Nusinersen Spinraza® 2018 2018 J2357 Omalizumab Xolair® 2018 2018 J2503 Pegaptanib Macugen® 2017 2017 J2505 Pegfilgrastim Neulasta® 2020 2020 J2507 Pegloticase Krystexxa® 2017 2018 J2562 Plerixafor Mozobil® 2020 2020 J2778 Ranibizumab Lucentis® 2017 2017 7 Medical Drug and Step Therapy Prior Authorization List for Medicare Plus BlueSM and BCN AdvantageSM members Revised September 2021 Prior authorization Submit authorization requirement effective date request through AIM HCPCS Step therapy Medicare BCN Specialty codes Generic name Trade name requirement Plus Blue Advantage NovoLogix® Health® J2786 Reslizumab Cinqair® 2018 2017 J2793 Rilonacept Arcalyst® 9/13/2021 9/13/2021 J2796 Romiplostim Nplate® 2017 2018 J2820 Sargramostim Prokine®, 2020 2020 Leukine® J2840 Sebelipase alfa Kanuma® 2019 2017 J2860 Siltuximab Sylvant® 2019 2019 J3032 Eptinezumab-jjmr Vyepti® 2020 2020 Try/fail botulinum toxins AND CGRP antagonists. J3060 Taliglucerase alfa Elelyso® 2017 2017 J3111 Romosozumab-aqqg Evenity® 2019 2019 J3241 Teprotumumab Tepezza® 2020 2020 J3245 Tildrakizumab-asmn Ilumya™ 2019 2019 Try/fail Inflectra or Renflexis. These preferred drugs don’t require authorization. 8 Medical Drug and Step Therapy Prior Authorization List for Medicare Plus BlueSM and BCN AdvantageSM members Revised September 2021 Prior authorization Submit authorization requirement effective date request through AIM HCPCS Step therapy Medicare BCN Specialty codes Generic name Trade name requirement Plus Blue Advantage NovoLogix® Health® J3262 Tocilizumab Actemra® 2017 2017 Try/fail Inflectra or Renflexis. These preferred drugs don’t require authorization. J3285 Treprostinil Remodulin® 2017 2017 J3304 Triamcinolone-acetonide Zilretta® 2019 2019 extended release J3357 Ustekinumab Stelara®SQ 2019 2019 Try/fail Inflectra or Renflexis. These preferred drugs don’t require authorization. J3358 Ustekinumab Stelara®IV 2019 2019 Try/fail Inflectra or Renflexis. These preferred drugs don’t require authorization. 9 Medical Drug and Step Therapy Prior Authorization List for Medicare Plus BlueSM and BCN AdvantageSM members Revised September 2021 Prior authorization Submit authorization requirement effective date request through AIM HCPCS Step therapy Medicare BCN Specialty codes Generic name Trade name requirement Plus Blue Advantage NovoLogix® Health® J3380 Vedolizumab Entyvio® 2017 2018 Try/fail Inflectra or Renflexis. These preferred drugs don’t require authorization. J3385 Velaglucerase alfa VPRIV® 2017 2017 J3397 Vestronidase alfa-vjbk Mepsevii® 2019 2019 J3398 Voretigene neparvovec-rzyl Luxturna® 2018 2018 J3399 Onasemnogene abeparvovec- Zolgensma® 2020 2020 xioi J3490 Avalglucosidase alfa-ngpt Nexviazyme® 9/1/2021 9/1/2021 J3490, Dinutuximab
Recommended publications
  • Letter to FDA on Review of Biogen's Drug
    June 2, 2021 Janet Woodcock, M.D. Acting Commissioner of Food and Drugs Food and Drug Administration 10903 New Hampshire Ave Silver Spring, MD 20993-0002 RE: Food and Drug Administration’s Review of Biogen’s drug Aducanumab for Alzheimer’s disease Dear Acting Commissioner Woodcock: The American Geriatrics Society (AGS), an organization dedicated to improving the health and quality of life of all older adults, is writing to express our concern that the Food and Drug Administration’s (FDA) upcoming review and potential approval of Aducanumab for use in treating patients with mild cognitive impairment (MCI) and Alzheimer’s disease (AD) is premature given the lack of sufficient evidence to support that Aducanumab reduces progression of Alzheimer’s disease and that the potential benefits as a treatment for patients with MCI and AD could outweigh the potential harms. The AGS is a not-for-profit organization comprised of nearly 6,000 geriatrics health professionals who are devoted to improving the health, independence, and quality of life of all older adults. Our members include geriatricians, geriatrics nurse practitioners, social workers, family practitioners, physician assistants, pharmacists, and internists who are pioneers in advanced-illness care for older individuals, with a focus on championing interprofessional teams, eliciting personal care goals, and treating older people as whole persons. We provide leadership to healthcare professionals, policymakers, and the public by implementing and advocating for programs in patient care, research, professional and public education, and public policy. We are familiar with the information that has been released to date. Aducanumab, a human monoclonal antibody developed by Biogen, was assessed in two identical phase III randomized controlled trials, ENGAGE and EMERGE, planned to provide 18-month outcome data in patients with MCI and AD, all with positive amyloid PET scans.
    [Show full text]
  • Refreshing the Biologic Pipeline 2020
    news feature Credit: Science Lab / Alamy Stock Photo Refreshing the biologic pipeline 2020 In the absence of face-to-face meetings, FDA and industry implemented regulatory workarounds to maintain drug and biologics approvals. These could be here to stay. John Hodgson OVID-19 might have been expected since 1996) — a small miracle in itself “COVID-19 confronted us with the need to severely impair drug approvals (Fig. 1 and Table 1). to better triage sponsors’ questions,” says Cin 2020. In the event, however, To the usual crop of rare disease and Peter Marks, the director of the Center for industry and regulators delivered a small genetic-niche cancer treatments, 2020 Biologics Evaluation and Research (CBER) miracle. They found workarounds and also added a chimeric antigen receptor at the FDA. “That was perhaps the single surrogate methods of engagement. Starting (CAR)-T cell therapy with a cleaner biggest takeaway from the pandemic related in January 2020, when the outbreak veered manufacturing process and the first to product applications.” Marks says that it westward, the number of face-to face approved blockbuster indication for a became very apparent with some COVID- meetings declined rapidly; by March, small-interfering RNA (siRNA) — the 19-related files that resolving a single they were replaced by Webex and Teams. European Medicines Agency’s (EMA) issue can help a sponsor enormously and (Secure Zoom meeting are to be added registration of the RNA interference accelerate the development cycle. Before this year.) And remarkably, by 31 December, (RNAi) therapy Leqvio (inclisiran) for COVID-19, it was conceivable that a small the US Food and Drug Administration cardiovascular disease.
    [Show full text]
  • Horizon Scanning Status Report June 2019
    Statement of Funding and Purpose This report incorporates data collected during implementation of the Patient-Centered Outcomes Research Institute (PCORI) Health Care Horizon Scanning System, operated by ECRI Institute under contract to PCORI, Washington, DC (Contract No. MSA-HORIZSCAN-ECRI-ENG- 2018.7.12). The findings and conclusions in this document are those of the authors, who are responsible for its content. No statement in this report should be construed as an official position of PCORI. An intervention that potentially meets inclusion criteria might not appear in this report simply because the horizon scanning system has not yet detected it or it does not yet meet inclusion criteria outlined in the PCORI Health Care Horizon Scanning System: Horizon Scanning Protocol and Operations Manual. Inclusion or absence of interventions in the horizon scanning reports will change over time as new information is collected; therefore, inclusion or absence should not be construed as either an endorsement or rejection of specific interventions. A representative from PCORI served as a contracting officer’s technical representative and provided input during the implementation of the horizon scanning system. PCORI does not directly participate in horizon scanning or assessing leads or topics and did not provide opinions regarding potential impact of interventions. Financial Disclosure Statement None of the individuals compiling this information have any affiliations or financial involvement that conflicts with the material presented in this report. Public Domain Notice This document is in the public domain and may be used and reprinted without special permission. Citation of the source is appreciated. All statements, findings, and conclusions in this publication are solely those of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI) or its Board of Governors.
    [Show full text]
  • Treatment of Alzheimer's Disease and Blood–Brain Barrier Drug Delivery
    pharmaceuticals Review Treatment of Alzheimer’s Disease and Blood–Brain Barrier Drug Delivery William M. Pardridge Department of Medicine, University of California, Los Angeles, CA 90024, USA; [email protected] Received: 24 October 2020; Accepted: 13 November 2020; Published: 16 November 2020 Abstract: Despite the enormity of the societal and health burdens caused by Alzheimer’s disease (AD), there have been no FDA approvals for new therapeutics for AD since 2003. This profound lack of progress in treatment of AD is due to dual problems, both related to the blood–brain barrier (BBB). First, 98% of small molecule drugs do not cross the BBB, and ~100% of biologic drugs do not cross the BBB, so BBB drug delivery technology is needed in AD drug development. Second, the pharmaceutical industry has not developed BBB drug delivery technology, which would enable industry to invent new therapeutics for AD that actually penetrate into brain parenchyma from blood. In 2020, less than 1% of all AD drug development projects use a BBB drug delivery technology. The pathogenesis of AD involves chronic neuro-inflammation, the progressive deposition of insoluble amyloid-beta or tau aggregates, and neural degeneration. New drugs that both attack these multiple sites in AD, and that have been coupled with BBB drug delivery technology, can lead to new and effective treatments of this serious disorder. Keywords: blood–brain barrier; brain drug delivery; drug targeting; endothelium; Alzheimer’s disease; therapeutic antibodies; neurotrophins; TNF inhibitors 1. Introduction Alzheimer’s Disease (AD) afflicts over 50 million people world-wide, and this health burden costs over 1% of global GDP [1].
    [Show full text]
  • Tables-Of-Phase-3-Mabs.Pdf
    Table 3. Monoclonal antibodies in Phase 2/3 or 3 clinical studies for cancer indications Most advanced Primary sponsoring company INN or code name Molecular format Target(s) phase Phase 3 indications Therapeutic area Janssen Research & Development, LLC JNJ-56022473 Humanized mAb CD123 Phase 2/3 Acute myeloid leukemia Cancer Murine IgG1, Actinium Pharmaceuticals Iomab-B radiolabeled CD45 Phase 3 Acute myeloid leukemia Cancer Humanized IgG1, Seattle Genetics Vadastuximab talirine ADC CD33 Phase 3 Acute myeloid leukemia Cancer TG Therapeutics Ublituximab Chimeric IgG1 CD20 Phase 3 Chronic lymphocytic leukemia Cancer Xencor XMAB-5574, MOR208 Humanized IgG1 CD19 Phase 2/3 Diffuse large B-cell lymphoma Cancer Moxetumomab Murine IgG1 dsFv, AstraZeneca/MedImmune LLC pasudotox immunotoxin CD22 Phase 3 Hairy cell leukemia Cancer Humanized scFv, Viventia Bio Oportuzumab monatox immunotoxin EpCAM Phase 3 Bladder cancer Cancer scFv-targeted liposome containing Merrimack Pharmaceuticals MM-302 doxorubicin HER2 Phase 2/3 Breast cancer Cancer MacroGenics Margetuximab Chimeric IgG1 HER2 Phase 3 Breast cancer Cancer Gastric cancer or gastroesophageal junction Gilead Sciences GS-5745 Humanized IgG4 MMP9 Phase 3 adenocarcinoma; ulcerative colitis (Phase 2/3) Cancer; Immune-mediated disorders Depatuxizumab Humanized IgG1, AbbVie mafodotin ADC EGFR Phase 2/3 Glioblastoma Cancer AstraZeneca/MedImmune LLC Tremelimumab Human IgG2 CTLA4 Phase 3 NSCLC, head & neck cancer, bladder cancer Cancer NSCLC, head & neck cancer, bladder cancer, breast AstraZeneca/MedImmune
    [Show full text]
  • The Two Tontti Tudiul Lui Hi Ha Unit
    THETWO TONTTI USTUDIUL 20170267753A1 LUI HI HA UNIT ( 19) United States (12 ) Patent Application Publication (10 ) Pub. No. : US 2017 /0267753 A1 Ehrenpreis (43 ) Pub . Date : Sep . 21 , 2017 ( 54 ) COMBINATION THERAPY FOR (52 ) U .S . CI. CO - ADMINISTRATION OF MONOCLONAL CPC .. .. CO7K 16 / 241 ( 2013 .01 ) ; A61K 39 / 3955 ANTIBODIES ( 2013 .01 ) ; A61K 31 /4706 ( 2013 .01 ) ; A61K 31 / 165 ( 2013 .01 ) ; CO7K 2317 /21 (2013 . 01 ) ; (71 ) Applicant: Eli D Ehrenpreis , Skokie , IL (US ) CO7K 2317/ 24 ( 2013. 01 ) ; A61K 2039/ 505 ( 2013 .01 ) (72 ) Inventor : Eli D Ehrenpreis, Skokie , IL (US ) (57 ) ABSTRACT Disclosed are methods for enhancing the efficacy of mono (21 ) Appl. No. : 15 /605 ,212 clonal antibody therapy , which entails co - administering a therapeutic monoclonal antibody , or a functional fragment (22 ) Filed : May 25 , 2017 thereof, and an effective amount of colchicine or hydroxy chloroquine , or a combination thereof, to a patient in need Related U . S . Application Data thereof . Also disclosed are methods of prolonging or increasing the time a monoclonal antibody remains in the (63 ) Continuation - in - part of application No . 14 / 947 , 193 , circulation of a patient, which entails co - administering a filed on Nov. 20 , 2015 . therapeutic monoclonal antibody , or a functional fragment ( 60 ) Provisional application No . 62/ 082, 682 , filed on Nov . of the monoclonal antibody , and an effective amount of 21 , 2014 . colchicine or hydroxychloroquine , or a combination thereof, to a patient in need thereof, wherein the time themonoclonal antibody remains in the circulation ( e . g . , blood serum ) of the Publication Classification patient is increased relative to the same regimen of admin (51 ) Int .
    [Show full text]
  • Antibodies to Watch in 2021 Hélène Kaplona and Janice M
    MABS 2021, VOL. 13, NO. 1, e1860476 (34 pages) https://doi.org/10.1080/19420862.2020.1860476 PERSPECTIVE Antibodies to watch in 2021 Hélène Kaplona and Janice M. Reichert b aInstitut De Recherches Internationales Servier, Translational Medicine Department, Suresnes, France; bThe Antibody Society, Inc., Framingham, MA, USA ABSTRACT ARTICLE HISTORY In this 12th annual installment of the Antibodies to Watch article series, we discuss key events in antibody Received 1 December 2020 therapeutics development that occurred in 2020 and forecast events that might occur in 2021. The Accepted 1 December 2020 coronavirus disease 2019 (COVID-19) pandemic posed an array of challenges and opportunities to the KEYWORDS healthcare system in 2020, and it will continue to do so in 2021. Remarkably, by late November 2020, two Antibody therapeutics; anti-SARS-CoV antibody products, bamlanivimab and the casirivimab and imdevimab cocktail, were cancer; COVID-19; Food and authorized for emergency use by the US Food and Drug Administration (FDA) and the repurposed Drug Administration; antibodies levilimab and itolizumab had been registered for emergency use as treatments for COVID-19 European Medicines Agency; in Russia and India, respectively. Despite the pandemic, 10 antibody therapeutics had been granted the immune-mediated disorders; first approval in the US or EU in 2020, as of November, and 2 more (tanezumab and margetuximab) may Sars-CoV-2 be granted approvals in December 2020.* In addition, prolgolimab and olokizumab had been granted first approvals in Russia and cetuximab saratolacan sodium was first approved in Japan. The number of approvals in 2021 may set a record, as marketing applications for 16 investigational antibody therapeutics are already undergoing regulatory review by either the FDA or the European Medicines Agency.
    [Show full text]
  • Review at Launch Medication List
    UnitedHealthcare® Community Plan Medical Benefit Drug List Review at Launch Medication List Last Modified Date: August 16, 2021 Table of Contents Page Instructions for Use ....................................................................... 1 Applicable Medications ................................................................. 1 List History/Revision Information ................................................. 1 Instructions for Use This Review at Launch Medication List provides the names of medications that are subject to the Medical Benefit Drug Policy titled Review at Launch for New to Market Medications and therefore, require review prior to administration. When deciding coverage, the federal, state or contractual requirements for benefit plan coverage must be referenced. The terms of the federal, state or contractual requirements for benefit plan coverage may differ greatly from the standard benefit plan upon which the aforementioned Review at Launch Drug Policy is based. In the event of a conflict, the federal, state or contractual requirements for benefit plan coverage supersede said drug policy. All reviewers must first identify member eligibility, any federal or state regulatory requirements, and the contractual requirements for benefit plan coverage prior to use. Other Policies and Coverage Determination Guidelines may apply. UnitedHealthcare reserves the right, in its sole discretion, to modify its Policies and Guidelines as necessary. Applicable Medications This medication list includes new medications that are: Food
    [Show full text]
  • (12) Patent Application Publication (10) Pub. No.: US 2017/0172932 A1 Peyman (43) Pub
    US 20170172932A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2017/0172932 A1 Peyman (43) Pub. Date: Jun. 22, 2017 (54) EARLY CANCER DETECTION AND A 6LX 39/395 (2006.01) ENHANCED IMMUNOTHERAPY A61R 4I/00 (2006.01) (52) U.S. Cl. (71) Applicant: Gholam A. Peyman, Sun City, AZ CPC .......... A61K 9/50 (2013.01); A61K 39/39558 (US) (2013.01); A61K 4I/0052 (2013.01); A61 K 48/00 (2013.01); A61K 35/17 (2013.01); A61 K (72) Inventor: sham A. Peyman, Sun City, AZ 35/15 (2013.01); A61K 2035/124 (2013.01) (21) Appl. No.: 15/143,981 (57) ABSTRACT (22) Filed: May 2, 2016 A method of therapy for a tumor or other pathology by administering a combination of thermotherapy and immu Related U.S. Application Data notherapy optionally combined with gene delivery. The combination therapy beneficially treats the tumor and pre (63) Continuation-in-part of application No. 14/976,321, vents tumor recurrence, either locally or at a different site, by filed on Dec. 21, 2015. boosting the patient’s immune response both at the time or original therapy and/or for later therapy. With respect to Publication Classification gene delivery, the inventive method may be used in cancer (51) Int. Cl. therapy, but is not limited to such use; it will be appreciated A 6LX 9/50 (2006.01) that the inventive method may be used for gene delivery in A6 IK 35/5 (2006.01) general. The controlled and precise application of thermal A6 IK 4.8/00 (2006.01) energy enhances gene transfer to any cell, whether the cell A 6LX 35/7 (2006.01) is a neoplastic cell, a pre-neoplastic cell, or a normal cell.
    [Show full text]
  • Monoclonal Antibodies As Neurological Therapeutics
    pharmaceuticals Review Monoclonal Antibodies as Neurological Therapeutics Panagiotis Gklinos 1 , Miranta Papadopoulou 2, Vid Stanulovic 3, Dimos D. Mitsikostas 4 and Dimitrios Papadopoulos 5,6,* 1 Department of Neurology, KAT General Hospital of Attica, 14561 Athens, Greece; [email protected] 2 Center for Clinical, Experimental Surgery & Translational Research, Biomedical Research Foundation of the Academy of Athens (BRFAA), 11527 Athens, Greece; [email protected] 3 Global Pharmacovigilance, R&D Sanofi, 91385 Chilly-Mazarin, France; vid.stanulovic@sanofi.com 4 1st Neurology Department, Aeginition Hospital, National and Kapodistrian University of Athens, 11521 Athens, Greece; [email protected] 5 Laboratory of Molecular Genetics, Hellenic Pasteur Institute, 129 Vasilissis Sophias Avenue, 11521 Athens, Greece 6 Salpetriere Neuropsychiatric Clinic, 149 Papandreou Street, Metamorphosi, 14452 Athens, Greece * Correspondence: [email protected] Abstract: Over the last 30 years the role of monoclonal antibodies in therapeutics has increased enormously, revolutionizing treatment in most medical specialties, including neurology. Monoclonal antibodies are key therapeutic agents for several neurological conditions with diverse pathophysio- logical mechanisms, including multiple sclerosis, migraines and neuromuscular disease. In addition, a great number of monoclonal antibodies against several targets are being investigated for many more neurological diseases, which reflects our advances in understanding the pathogenesis of these
    [Show full text]
  • Lääkeaineiden Yleisnimet (INN-Nimet) 21.6.2021
    Lääkealan turvallisuus- ja kehittämiskeskus Säkerhets- och utvecklingscentret för läkemedelsområdet Finnish Medicines Agency Lääkeaineiden yleisnimet (INN-nimet) 21.6.
    [Show full text]
  • Rxoutlook® 4Th Quarter 2020
    ® RxOutlook 4th Quarter 2020 optum.com/optumrx a RxOutlook 4th Quarter 2020 While COVID-19 vaccines draw most attention, multiple “firsts” are expected from the pipeline in 1Q:2021 Great attention is being given to pipeline drugs that are being rapidly developed for the treatment or prevention of SARS- CoV-19 (COVID-19) infection, particularly two vaccines that are likely to receive emergency use authorization (EUA) from the Food and Drug Administration (FDA) in the near future. Earlier this year, FDA issued a Guidance for Industry that indicated the FDA expected any vaccine for COVID-19 to have at least 50% efficacy in preventing COVID-19. In November, two manufacturers, Pfizer and Moderna, released top-line results from interim analyses of their investigational COVID-19 vaccines. Pfizer stated their vaccine, BNT162b2 had demonstrated > 90% efficacy. Several days later, Moderna stated their vaccine, mRNA-1273, had demonstrated 94% efficacy. Many unknowns still exist, such as the durability of response, vaccine performance in vulnerable sub-populations, safety, and tolerability in the short and long term. Considering the first U.S. case of COVID-19 was detected less than 12 months ago, the fact that two vaccines have far exceeded the FDA’s guidance and are poised to earn EUA clearance, is remarkable. If the final data indicates a positive risk vs. benefit profile and supports final FDA clearance, there may be lessons from this accelerated development timeline that could be applied to the larger drug development pipeline in the future. Meanwhile, drug development in other areas continues. In this edition of RxOutlook, we highlight 12 key pipeline drugs with potential to launch by the end of the first quarter of 2021.
    [Show full text]