DOCSLIB.ORG

Provider Administered Drugs – Site of Care – Oxford Clinical Policy

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Provider Administered Drugs – Site of Care – Oxford Clinical Policy UnitedHealthcare® Oxford Clinical Policy Provider Administered Drugs – Site of Care Policy Number: PHARMACY 276.34 T2 Effective Date: October 1, 2021 Instructions for Use Table of Contents Page Related Policies ® Coverage Rationale ........................................ 2 • Actemra (Tocilizumab) Injection for Intravenous Infusion Documentation Requirements ....................... 3 ® • Adakveo (Crizanlizumab-Tmca) Definitions ....................................................... 3 • Alpha1-Proteinase Inhibitors Prior Authorization Requirements ................. 3 ™ • Amondys 45 (Casimersen) Applicable Codes ........................................... 4 ® • Benlysta (Belimumab) Clinical Evidence ............................................ 5 ® • Cimzia (Certolizumab Pegol) References ...................................................... 6 ® ® • Complement Inhibitors (Soliris & Ultomiris ) Policy History/Revision Information .............. 8 ® Instructions for Use ........................................ 8 • Crysvita (Burosumab) • Denosumab (Prolia® & Xgeva®) • Drug Coverage Guidelines • Entyvio® (Vedolizumab) • Evkeeza™ (Evinacumab-dgnb) • Exondys 51® (Eteplirsen) • Givlaari® (Givosiran) • Home Health Care • Ilaris® (Canakinumab) • Ilumya™ (Tildrakizumab-Asmn) • ™ ® ® ® Infliximab (Avsola , Inflectra , Remicade , Renflexis ) • Intravenous Enzyme Replacement Therapy (ERT) for Gaucher Disease • Long-Acting Injectable Antiretroviral Agents for HIV • Medical Therapies for Enzyme Deficiencies • Oncology Medication Clinical Coverage • Onpattro® (Patisiran) • Orencia® (Abatacept) Injection for Intravenous Infusion • Oxlumo™ (Lumasiran) • Radicava® (Edaravone) • Reblozyl® (Luspatercept-Aamt) • Respiratory Interleukins (Cinqair®, Fasenra®, and Nucala®) • Simponi Aria® (Golimumab) Injection for Intravenous Infusion • Specialty Pharmacy for Certain Specialty Medications Administered in an Outpatient Hospital Setting ® • Stelara (Ustekinumab) • ® Tepezza (Teprotumumab-Trbw) ® • Trogarzo (Ibalizumab-Uiyk) ™ • Uplizna (Inebilizumab-Cdon) ® • Viltepso (Viltolarsen) ™ • Vyepti (Eptinezumab-Jjmr) ™ • Vyondys 53 (Golodirsen) Provider Administered Drugs – Site of Care Page 1 of 8 UnitedHealthcare Oxford Clinical Policy Effective 10/01/2021 ©1996-2021, Oxford Health Plans, LLC Coverage Rationale This policy addresses the criteria for consideration of allowing hospital outpatient facility specialty medication infusion services. This includes claim submission for hospital-based services with the following CMS/AMA Place of Service codes: 19 Off-Campus - Outpatient Hospital; and 22 On-Campus - Outpatient Hospital Alternative sites of care, such as non-hospital outpatient infusion, physician office, ambulatory infusion or home infusion services are well accepted places of service for medication infusion therapy. If an individual does not meet criteria for outpatient hospital facility infusion, alternative sites of care may be used. Outpatient hospital facility-based intravenous medication infusion is medically necessary for individuals who meet at least one of the following criteria (submission of medical records is required): Documentation that the individual is medically unstable for administration of the prescribed medication at the alternative sites of care as determined by any of the following: o The individual’s complex medical status or therapy requires enhanced monitoring and potential intervention above and beyond the capabilities of the office or home infusion setting; or o The individual’s documented history of a significant comorbidity (e.g., cardiopulmonary disorder) or fluid overload status that precludes treatment at an alternative Site of Care; or o Outpatient treatment in the home or office setting presents a health risk due to a clinically significant physical or cognitive impairment; or o Difficulty establishing and maintaining patent vascular access o To initiate, re-initiate products for a short duration (e.g., 4 weeks) or • Documentation (e.g., infusion records, medical records) of episodes of severe or potentially life-threatening adverse events (e.g., anaphylaxis, seizure, thromboembolism, myocardial infarction, renal failure) that have not been responsive to acetaminophen, steroids, diphenhydramine, fluids, infusion rate reductions, or other pre-medications, thereby increasing risk to the individual when administration is in the home or office setting; or • Initial infusion or re-initiation of therapy after more than 6 months; or • Homecare or infusion provider has deemed that the individual, home caregiver, or home environment is not suitable for home infusion therapy (if the prescriber cannot infuse in the office setting). Ongoing outpatient hospital facility-based infusion duration of therapy will be no more than 6 months to allow for reassessment of the individual’s ability to receive therapy at an alternative Site of Care. This policy applies to these specialty medications that require healthcare provider administration: ® ® ® Actemra (tocilizumab) Fasenra (benralizumab) Reblozyl (luspatercept-aamt) ® ® ® Adakveo (crizanlizumab-tmca) Givlaari (givosiran) Remicade (infliximab) ® ® ® Aldurazyme (laronidase) Glassia (A1-PI) Renflexis (infliximab-abda) ™ ® ® Amondys 45 (casimersen) Ilaris (canakinumab) Revcovi (elapegademase-lvlr) ® ™ ® Aralast NP (A1-PI) Ilumya (tildrakizumab-asmn) Simponi Aria (golimumab) ™ ® ® Avsola (infliximab-axxq) Inflectra (infliximab-dyyb) Soliris (eculizumab) ® ® ® Benlysta (belimumab) Kanuma (sebelipase alfa) Stelara (ustekinumab) ® ™ Cabenuva (cabotegravir; rilpiverine) Lumizyme (alglucosidase alfa) Tepezza (teprotumumab-trbw) ® ™ ® Cerezyme (imiglucerase) Mepsevii (vestronidase alfa-vjbk) Trogarzo (ibalizumab) ® ® ® Cimzia (certolizumab pegol) Naglazyme (galsulfase) Ultomiris (ravulizumab-cwvz) ® ® ™ Cinqair (reslizumab) Nucala (mepolizumab) Uplizna (inebilizumab-cdon) ® ™ ® Crysvita (burosumab) Nulibry (fosdenopterin) Viltepso (viltolarsen) ® ® ® Elaprase (idursulfase) Onpattro (patisiran) Vimizim (elosulfase alfa) ® ® ® Elelyso (taliglucerase) Orencia (abatacept) VPRIV (velaglucerase) ® ™ ™ Entyvio (vedolizumab) Oxlumo (lumasiran) Vyepti (eptinezumab-jjmr) ™ ® ™ ™ Evkeeza (evinacumab) Prolastin -C (A1-PI) Vyondys 53 (golodirsen) ® ® ® Exondys 51 (eteplirsen) Prolia (denosumab) Zemaira (A1-PI) ® ® Fabrazyme (agalsidase beta) Radicava (edaravone) Provider Administered Drugs – Site of Care Page 2 of 8 UnitedHealthcare Oxford Clinical Policy Effective 10/01/2021 ©1996-2021, Oxford Health Plans, LLC Documentation Requirements Benefit coverage for health services is determined by the member specific benefit plan document and applicable laws that may require coverage for a specific service. The documentation requirements outlined below are used to assess whether the member meets the clinical criteria for coverage but do not guarantee coverage of the service requested. Specialty Medication Required Clinical Information Actemra® (tocilizumab) Naglazyme® (galsulfase) Refer to Protocol titled Medical Record Adakveo® (crizanlizumab-tmca) Nucala® (mepolizumab) Requirements for Pre-Service Reviews for documentation requirements. Aldurazyme® (laronidase) Nulibry™ (fosdenopterin) ™ ™ Amondys 45 (casimersen) Onpattro (patisiran) Note: Once in the Medical Record Aralast NP® (A1-PI) Orencia® (abatacept) Requirements for Pre-Service Reviews Avsola™ (infliximab-axxq) Oxlumo™ (lumasiran) document, search for the medication name. Benlysta® (belimumab) Prolastin®-C™ (A1-PI) Cabenuva (cabotegravir; rilpiverine) Prolia® (denosumab) Cerezyme® (imiglucerase) Radicava® (edaravone) Cimzia® (certolizumab pegol) Reblozyl® (luspatercept-aamt) Cinqair® (reslizumab) Remicade® (infliximab) Crysvita® (burosumab-twza) Renflexis® (infliximab-abda) Elaprase® (idursulfase) Revcovi® (elapegademase-lvlr) Elelyso® (taliglucerase) Simponi Aria® (golimumab) Entyvio® (vedolizumab) Soliris® (eculizumab) Evkeeza™ (evinacumab) Stelara® (ustekinumab) Exondys 51® (eteplirsen) Tepezza® (teprotumumab-trbw) Fabrazyme® (agalsidase beta) Trogarzo® (ibalizumab-uiyk) Fasenra® (benralizumab) Ultomiris® (ravulizumab-cwvz) Givlaari® (givosiran) Uplizna™ (inebilizumab-cdon) Glassia® (A1-PI) Viltepso® (viltolarsen) Ilaris® (canakinumab) Vimizim® (elosulfase alfa) Ilumya™ (tildrakizumab-asmn) VPRIV® (velaglucerase) Inflectra® (infliximab-dyyb) Vyepti™ (eptinezumab-jjmr) Kanuma® (sebelipase alfa) Vyondys 53™ (golodirsen) Lumizyme® (alglucosidase alfa) Zemaira® (A1-PI) Mepsevii™ (vestronidase alfa-vjbk) Definitions Site of Care: Choice for physical location of infusion administration. Sites of care include hospital inpatient, hospital outpatient, physician office, ambulatory infusion suite, or home-based setting. Prior Authorization Requirements Prior authorization is required through Oxford’s Medical Management Department for administration of any drug listed in this policy in a hospital outpatient facility. Provider Administered Drugs – Site of Care Page 3 of 8 UnitedHealthcare Oxford Clinical Policy Effective 10/01/2021 ©1996-2021, Oxford Health Plans, LLC Participating hospitals are required to purchase Actemra® (tocilizumab), Entyvio® (vedolizumab), Infliximab (Remicade®, Inflectra®, Renflexis®), Orencia® (abatacept), Simponi Aria® (golimumab), Tepezza® (teprotumumab-trbw), and Vyepti™ (eptinezumab-jjmr) from Optum Specialty Pharmacy when the medication is administered in an outpatient hospital setting; refer to the Clinical Policy titled Specialty Pharmacy for Certain Specialty Medications Administered in an Outpatient Hospital Setting for
Load more

Recommended publications
  • Fig. L COMPOSITIONS and METHODS to INHIBIT STEM CELL and PROGENITOR CELL BINDING to LYMPHOID TISSUE and for REGENERATING GERMINAL CENTERS in LYMPHATIC TISSUES
    (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date Χ 23 February 2012 (23.02.2012) WO 2U12/U24519ft ft A2 (51) International Patent Classification: AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, A61K 31/00 (2006.01) CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, (21) International Application Number: HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, PCT/US201 1/048297 KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, (22) International Filing Date: ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, 18 August 201 1 (18.08.201 1) NO, NZ, OM, PE, PG, PH, PL, PT, QA, RO, RS, RU, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, (25) Filing Language: English TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, (26) Publication Language: English ZW. (30) Priority Data: (84) Designated States (unless otherwise indicated, for every 61/374,943 18 August 2010 (18.08.2010) US kind of regional protection available): ARIPO (BW, GH, 61/441,485 10 February 201 1 (10.02.201 1) US GM, KE, LR, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, 61/449,372 4 March 201 1 (04.03.201 1) US ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, (72) Inventor; and EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, ΓΓ, LT, LU, (71) Applicant : DEISHER, Theresa [US/US]; 1420 Fifth LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, Avenue, Seattle, WA 98101 (US).
    [Show full text]
  • Pros and Cons of Entry and Fusion Inhibitors (Review)
    MOLECULAR MEDICINE REPORTS 19: 1987-1995, 2019 Investigational drugs in HIV: Pros and cons of entry and fusion inhibitors (Review) EMMANUELE VENANZI RULLO1,2, MANUELA CECCARELLI1, FABRIZIO CONDORELLI3, ALESSIO FACCIOLÀ1, GIUSEPPA VISALLI4, FRANCESCO D'ALEO1, IVANA PAOLUCCI1, BRUNO CACOPARDO5, MARILIA RITA PINZONE2-5, MICHELE DI ROSA6, GIUSEPPE NUNNARI1 and GIOVANNI F. PELLICANÒ7 1Department of Clinical and Experimental Medicine, Unit of Infectious Diseases, University of Messina, I-90124 Messina, Italy; 2Department of Pathology and Laboratory Medicine, School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA; 3Department of Pharmacological Sciences, University of Eastern Piedmont ‘A. Avogadro’, I-13100 Novara; 4Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, I-90124 Messina; 5Department of Clinical and Experimental Medicine, University of Catania, I-95123 Catania; 6Department of Biomedical and Biotechnological Sciences, Human Anatomy and Histology Section, University of Catania, I-95123 Catania; 7Department of Human Pathology of the Adult and the Developmental Age ‘G. Barresi’, Unit of Infectious Diseases, University of Messina, I-98122 Messina, Italy Received September 2, 2018; Accepted November 29, 2018 DOI: 10.3892/mmr.2019.9840 Abstract. Despite the profound changes and improve- 4. Gp41 antagonists ments reached in the field of HIV treatment, tolerability and 5. CD4 antagonists adherence to highly active antiretroviral therapy remains a 6. Discussion challenge. Furthermore, multi-experienced patients could take advantage of drugs with different mechanisms of action to combat the spread of resistance to actual therapy. For these 1. Introduction reasons identification of new HIV drugs is crucial. Among all the molecules that at present are under investigation, entry HIV continues to be an important challenge and a major and fusion inhibitors pose an interesting class owing to their global public health issue.
    [Show full text]
  • Pharmacologic Considerations in the Disposition of Antibodies and Antibody-Drug Conjugates in Preclinical Models and in Patients
    antibodies Review Pharmacologic Considerations in the Disposition of Antibodies and Antibody-Drug Conjugates in Preclinical Models and in Patients Andrew T. Lucas 1,2,3,*, Ryan Robinson 3, Allison N. Schorzman 2, Joseph A. Piscitelli 1, Juan F. Razo 1 and William C. Zamboni 1,2,3 1 University of North Carolina (UNC), Eshelman School of Pharmacy, Chapel Hill, NC 27599, USA; [email protected] (J.A.P.); [email protected] (J.F.R.); [email protected] (W.C.Z.) 2 Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; [email protected] 3 Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; [email protected] * Correspondence: [email protected]; Tel.: +1-919-966-5242; Fax: +1-919-966-5863 Received: 30 November 2018; Accepted: 22 December 2018; Published: 1 January 2019 Abstract: The rapid advancement in the development of therapeutic proteins, including monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs), has created a novel mechanism to selectively deliver highly potent cytotoxic agents in the treatment of cancer. These agents provide numerous benefits compared to traditional small molecule drugs, though their clinical use still requires optimization. The pharmacology of mAbs/ADCs is complex and because ADCs are comprised of multiple components, individual agent characteristics and patient variables can affect their disposition. To further improve the clinical use and rational development of these agents, it is imperative to comprehend the complex mechanisms employed by antibody-based agents in traversing numerous biological barriers and how agent/patient factors affect tumor delivery, toxicities, efficacy, and ultimately, biodistribution.
    [Show full text]
  • 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)
    [Show full text]
  • Where Do Novel Drugs of 2016 Fit In?
    FORMULARY JEOPARDY: WHERE DO NOVEL DRUGS OF 2016 FIT IN? Maabo Kludze, PharmD, MBA, CDE, BCPS, Associate Director Elizabeth A. Shlom, PharmD, BCPS, SVP & Director Clinical Pharmacy Program Acurity, Inc. Privileged and Confidential August 15, 2017 Privileged and Confidential Program Objectives By the end of the presentation, the pharmacist or pharmacy technician participant will be able to: ◆ Identify orphan drugs and first-in-class medications approved by the FDA in 2016. ◆ Describe the role of new agents approved for use in oncology patients. ◆ Identify and discuss the role of novel monoclonal antibodies. ◆ Discuss at least two new medications that address public health concerns. Neither Dr. Kludze nor Dr. Shlom have any conflicts of interest in regards to this presentation. Privileged and Confidential 2016 NDA Approvals (NMEs/BLAs) ◆ Nuplazid (primavanserin) P ◆ Adlyxin (lixisenatide) ◆ Ocaliva (obeticholic acid) P, O ◆ Anthim (obitoxaximab) O ◆ Rubraca (rucaparib camsylate) P, O ◆ Axumin (fluciclovive F18) P ◆ Spinraza (nusinersen sodium) P, O ◆ Briviact (brivaracetam) ◆ Taltz (ixekizumab) ◆ Cinqair (reslizumab) ◆ Tecentriq (atezolizumab) P ◆ Defitelio (defibrotide sodium) P, O ◆ Venclexta (venetoclax) P, O ◆ Epclusa (sofosburvir and velpatasvir) P ◆ Xiidra (lifitigrast) P ◆ Eucrisa (crisaborole) ◆ Zepatier (elbasvir and grazoprevir) P ◆ Exondys 51 (eteplirsen) P, O ◆ Zinbyrta (daclizumab) ◆ Lartruvo (olaratumab) P, O ◆ Zinplava (bezlotoxumab) P ◆ NETSTPOT (gallium Ga 68 dotatate) P, O O = Orphan; P = Priority Review; Red = BLA Privileged and Confidential History of FDA Approvals Privileged and Confidential Orphan Drugs ◆FDA Office of Orphan Products Development • Orphan Drug Act (1983) – drugs and biologics . “intended for safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S.
    [Show full text]
  • Novartis R&D and Investor Update
    Novartis AG Investor Relations Novartis R&D and investor update November 5, 2018 Disclaimer This presentation contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, that can generally be identified by words such as “potential,” “expected,” “will,” “planned,” “pipeline,” “outlook,” “agreement to acquire,” or similar expressions, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this presentation, or regarding potential future revenues from such products, or regarding the proposed acquisition of Endocyte, Inc. (Endocyte) by Novartis including the potential outcome and expected timing for completion of the proposed acquisition, and the potential impact on Novartis of the proposed acquisition, including express or implied discussions regarding potential future sales or earnings of Novartis, and any potential strategic benefits, synergies or opportunities expected as a result of the proposed acquisition. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this presentation will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future.
    [Show full text]
  • New Biological Therapies: Introduction to the Basis of the Risk of Infection
    New biological therapies: introduction to the basis of the risk of infection Mario FERNÁNDEZ RUIZ, MD, PhD Unit of Infectious Diseases Hospital Universitario “12 de Octubre”, Madrid ESCMIDInstituto de Investigación eLibraryHospital “12 de Octubre” (i+12) © by author Transparency Declaration Over the last 24 months I have received honoraria for talks on behalf of • Astellas Pharma • Gillead Sciences • Roche • Sanofi • Qiagen Infections and biologicals: a real concern? (two-hour symposium): New biological therapies: introduction to the ESCMIDbasis of the risk of infection eLibrary © by author Paul Ehrlich (1854-1915) • “side-chain” theory (1897) • receptor-ligand concept (1900) • “magic bullet” theory • foundation for specific chemotherapy (1906) • Nobel Prize in Physiology and Medicine (1908) (together with Metchnikoff) Infections and biologicals: a real concern? (two-hour symposium): New biological therapies: introduction to the ESCMIDbasis of the risk of infection eLibrary © by author 1981: B-1 antibody (tositumomab) anti-CD20 monoclonal antibody 1997: FDA approval of rituximab for the treatment of relapsed or refractory CD20-positive NHL 2001: FDA approval of imatinib for the treatment of chronic myelogenous leukemia Infections and biologicals: a real concern? (two-hour symposium): New biological therapies: introduction to the ESCMIDbasis of the risk of infection eLibrary © by author Functional classification of targeted (biological) agents • Agents targeting soluble immune effector molecules • Agents targeting cell surface receptors
    [Show full text]
  • Pharmacy Prior Authorization Grid ALTCS, and Pharmacy
    Please Note: Refer to the other PA grids for applicable covered services that require PA. PA Grids: Medical, Behavioral Health, Pharmacy Prior Authorization Grid ALTCS, and Pharmacy. (Effective Date of Service 1/1/2021) Injectables that require Prior Authorization All chemotherapeutic drugs must be used for FDA-approved indications and/or in accordance with NCCN guidelines *Indicates prior authorization required if billed charges are greater than $400 PA Required HMO 13 HCPCS Short Description (BUCA- Code SNP) 90378 Respiratory Syncytial Virus Immune Globulin Yes C9036 Patisiran Yes C9047 Caplacizumab-yhdp Yes C9061 Teprotumumab-trbw Yes C9063 Eptinezumab-jjmr Yes C9131 Factor VIII antihemophilic factor pegylated-auci Yes C9132 Prothrombin Complex Concentrate (Human), Kcentra Yes C9133 Factor IX (Antihemophilic Factor, Recombinant), Rixibus Yes C9399 Mipomersen (Kynamro) Yes J0129 Abatacept Yes J0135 Adalimumab Yes J0178 Aflibercept Yes J0179 Brolucizumab-dbll, 1 mg Yes J0180 Agalsidase Beta Yes J0205 Alglucerase Yes J0215 Alefacept Yes J0220 Alglucosidase Alfa (Myozyme) Yes J0221 Alglucosidase Alfa (Lumizyme) Yes J0222 Patisiran, 0.1 mg Yes J0223 Givosiran 0.5 mg Yes J0256 Alpha 1-Proteinase Inhibitor Yes J0257 Alpha 1-Proteinase Inhibitor (Glassia) Yes J0275 Alprostadil Urethral Suppository Yes J0490 Belimumab Yes J0517 Benralizumab Yes J0567 Cerliponase alfa Yes J0570 Buprenorphine implant Yes J0584 Burosumab-twza 1 mg Yes J0585 Onabotulinumtoxina (Botox) Yes J0586 Abobotulinumtoxina (Dysport) Yes J0587 Rimabotulinumtoxinb (Myobloc)
    [Show full text]
  • Keeping up with FDA Drug Approvals: 60 New Drugs in 60 Minutes Elizabeth A
    Keeping Up with FDA Drug Approvals: 60 New Drugs in 60 Minutes Elizabeth A. Shlom, PharmD, BCPS Senior Vice President & Director Clinical Pharmacy Program | Acurity, Inc. Privileged and Confidential April 10, 2019 Privileged and Confidential Program Objectives By the end of the presentation, the pharmacist or pharmacy technician participant will be able to: ▪ Identify orphan drugs and first-in-class medications approved by the FDA in 2018. ▪ List five new drugs and their indications. ▪ Identify the place in therapy for three novel monoclonal antibodies. ▪ Discuss at least two new medications that address public health concerns. Dr. Shlom does not have any conflicts of interest in regard to this presentation. Both trade names and generic names will be discussed throughout the presentation Privileged and Confidential 2018 NDA Approvals (NMEs/BLAs) ▪ Lutathera (lutetium Lu 177 dotatate) ▪ Braftovi (encorafenib) ▪ Vizimpro (dacomitinib) ▪ Biktarvy (bictegravir, emtricitabine, ▪ TPOXX (tecovirimat) ▪ Libtayo (cemiplimab-rwic) tenofovir, ▪ Tibsovo (ivosidenib) ▪ Seysara (sarecycline) alafenamide) ▪ Krintafel (tafenoquine) ▪ Nuzyra (omadacycline) ▪ Symdeko (tezacaftor, ivacaftor) ▪ Orilissa (elagolix sodium) ▪ Revcovi (elapegademase-lvir) ▪ Erleada (apalutamide) ▪ Omegaven (fish oil triglycerides) ▪ Tegsedi (inotersen) ▪ Trogarzo (ibalizumab-uiyk) ▪ Mulpleta (lusutrombopag) ▪ Talzenna (talazoparib) ▪ Ilumya (tildrakizumab-asmn) ▪ Poteligeo (mogamulizumab-kpkc) ▪ Xofluza (baloxavir marboxil) ▪ Tavalisse (fostamatinib disodium) ▪ Onpattro (patisiran)
    [Show full text]
  • B Cell Checkpoints in Autoimmune Rheumatic Diseases
    REVIEWS B cell checkpoints in autoimmune rheumatic diseases Samuel J. S. Rubin1,2,3, Michelle S. Bloom1,2,3 and William H. Robinson1,2,3* Abstract | B cells have important functions in the pathogenesis of autoimmune diseases, including autoimmune rheumatic diseases. In addition to producing autoantibodies, B cells contribute to autoimmunity by serving as professional antigen- presenting cells (APCs), producing cytokines, and through additional mechanisms. B cell activation and effector functions are regulated by immune checkpoints, including both activating and inhibitory checkpoint receptors that contribute to the regulation of B cell tolerance, activation, antigen presentation, T cell help, class switching, antibody production and cytokine production. The various activating checkpoint receptors include B cell activating receptors that engage with cognate receptors on T cells or other cells, as well as Toll-like receptors that can provide dual stimulation to B cells via co- engagement with the B cell receptor. Furthermore, various inhibitory checkpoint receptors, including B cell inhibitory receptors, have important functions in regulating B cell development, activation and effector functions. Therapeutically targeting B cell checkpoints represents a promising strategy for the treatment of a variety of autoimmune rheumatic diseases. Antibody- dependent B cells are multifunctional lymphocytes that contribute that serve as precursors to and thereby give rise to acti- cell- mediated cytotoxicity to the pathogenesis of autoimmune diseases
    [Show full text]
  • Crizanlizumab, Voxelotor, and L-Glutamine for Sickle Cell Disease: Effectiveness and Value
    Crizanlizumab, Voxelotor, and L-Glutamine for Sickle Cell Disease: Effectiveness and Value Evidence Report Posted March 12, 2020 Updated February 9, 2021 Prepared for This evidence report was updated on February 9, 2021 with minor wording changes. ©Institute for Clinical and Economic Review, 2020 ICER Staff University of Calgary Pamela Bradt, MD, MPH Eldon Spackman, PhD Chief Scientific Officer Assistant Professor ICER Community Health Sciences & O'Brien Institute of Public Health University of Calgary Patricia G. Synnott, MALD, MS Director, Evidence Review ICER Rick Chapman, PhD, MS Director of Health Economics ICER Molly Beinfeld, MPH Research Lead, Evidence Synthesis ICER David M. Rind, MD, MSc Chief Medical Officer ICER Steven D. Pearson, MD, MSc President ICER The role of the University of Calgary is limited to the development of the cost-effectiveness model, and the resulting ICER reports do not necessarily represent the views of the University of Calgary. None of the above authors disclosed any conflicts of interest. How to cite this document: Bradt P, Spackman E, Synnott PG, Chapman R, Beinfeld M, Rind DM, Pearson SD. Crizanlizumab, Voxelotor, and L-Glutamine for Sickle Cell Disease: Effectiveness and Value. Institute for Clinical and Economic Review, January 23, 2020. https://icer.org/wp-content/uploads/2020/10/ICER_SCD_Evidence- Report_031220-FOR-PUBLICATION.pdf DATE OF PUBLICATION: March 12, 2020 Pamela Bradt served as the lead author for the report. Patricia Synnott led the systematic review and authorship of the comparative clinical effectiveness section in collaboration with Serina Herron-Smith and Avery McKenna. Patricia Synnott and Molly Beinfeld authored the chapter describing what ICER learned from patients (Chapter 2.
    [Show full text]
  • Investor Presentation
    Participants Company overview Pharmaceuticals Oncology Financial review Conclusion Appendix References Q1 2021 Results Investor presentation 1 Investor Relations │ Q1 2021 Results Participants Company overview Pharmaceuticals Oncology Financial review Conclusion Appendix References Disclaimer This presentation contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, that can generally be identified by words such as “potential,” “expected,” “will,” “planned,” “pipeline,” “outlook,” or similar expressions, or by express or implied discussions regarding potential new products, potential new indications for existing products, potential product launches, or regarding potential future revenues from any such products; or regarding the impact of the COVID-19 pandemic on certain therapeutic areas including dermatology, ophthalmology, our breast cancer portfolio, some newly launched brands and the Sandoz retail and anti-infectives business, and on drug development operations; or regarding potential future, pending or announced transactions; regarding potential future sales or earnings of the Group or any of its divisions; or by discussions of strategy, plans, expectations or intentions; or regarding the Group’s liquidity or cash flow positions and its ability to meet its ongoing financial obligations and operational needs; or regarding our collaboration with Molecular Partners to develop, manufacture and commercialize potential medicines for the prevention and treatment of COVID- 19 and our joining of the industry-wide efforts to meet global demand for COVID-19 vaccines and therapeutics by leveraging our manufacturing capacity and capabilities to support the production of the Pfizer-BioNTech vaccine and to manufacture the mRNA and bulk drug product for the vaccine candidate CVnCoV from CureVac.
    [Show full text]