DOCSLIB.ORG

Where Do Novel Drugs of 2016 Fit In?

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read 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. or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.” . Incentives to pharmaceutical manufacturers: o Federal funding for clinical trials o Tax credit – 50% of clinical testing costs o 7 years market exclusivity from date of approval o FDA approval via priority status (6 vs 10 month approval; fee waived) • 7000 rare diseases affecting 25-30 million people in U.S. www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/ucm2005525.htm Privileged and Confidential Orphan Drugs ◆Orphan Drug Approvals • Average of 8 Orphan drugs approved per year • 349 Orphan drugs approved 1983-2009 . Rising rate of approvals: 33% (1983-2005), 37% (2009-2015), 47% (2015) . 65% are NME vs. 35% are BLA • Drug categories . 28% oncology . 15% infectious diseases (including HIV) . 11% neurological/psychiatric . 10% enzyme deficiencies • Increasing Orphan drugs targeting biomarker-defined disease subsets (e.g. ALK+ NSCLC, BRAF V600E met melanoma) Kesselheim AS. Innovation and the Orphan Drug Act, 1983-2009: Regulatory and Clinical Characteristics of Approved Orphan Drugs. Kesselheim AS, Treasure CL, Joffe S. Biomarker-defined subsets of common diseases:: Policy and economic mplications of orphan drug act coverage. PLoS Med 2017;14(1):e1002190. Privileged and Confidential Hepatobiliary Diseases ◆Defitelio® (defibrotide sodium) ◆Epclusa® (sofosbuvir and velpatasvir) ◆Zepatier® (elbasvir and grazoprevir) ◆Ocaliva® (obeticholic acid) Privileged and Confidential Defitelio® (defibrotide) by Jazz Pharmaceuticals ◆ Indication1: treatment of hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction after hematopoietic stem-cell transplantation (HSCT) in adults and pediatric patients ◆ Veno-occlusive disease (VOD)/SOS2 • Occurs when damaged endothelial cells are torn away from the sinusoid leading to fibrin deposition and evenutally red blood cells entering the space are blocked in very small blood vessels within the liver • Incidence rate is estimated to be approximately 10–15% and occurs within 20–30 days of the transplant • Untreated hepatic VOD/SOS accompanied by multi-organ failure (MOF) is associated with >80% mortality ◆ Mechanism of action2 • Oligonucleotide mixture with profibrinolytic properties • Promotes the breakdown of fibrin and protects endothelial cells from harmful effects of chemotherapy • Posseses anti-inflammatory, anti-ischemic, antithrombotic, and thrombolytic properties 1. Defitelio®[prescribing information]. Palo Alto, CA: Jazz Pharmaceuticals. March 2016 2. Stein C et a. Mol Ther Nucleic Acids. 2016 Aug; 5(8): e346. 2016 Aug; 5(8): e346. Privileged and Confidential Defitelio® (defibrotide) by Jazz Pharmaceuticals ◆ Dose1 • 6.25 mg/kg every 6 hours • Use weight prior to the preparative regimen for HSCT to calculate dose ◆ Administration1 • Infuse over 2 hours using a 0.2 micron in-line filter • Administer for a minimum of 21 days and until the signs and symptoms of VOD have resolved or up to a maximum of 60 days • Must be used within 4 hours if stored at room temperature or within 24 hours if stored under refrigeration ◆ Safety • ADE's (incidence ≥10%): Hypotension, diarrhea, vomiting, nausea and epistaxis, • Serious ADRs: Hypotension (11%) and pulmonary alveolar hemorrhage (7%) ◆ Ordering2 • Verify your institution has a contract with McKesson Plasma and Biologics before ordering ◆ Contraindications1 • Antithrombotic agents 1.Defitelio®[prescribing information]. Palo Alto, CA: Jazz Pharmaceuticals. March 2016; 2. https://defitelio.com/ Privileged and Confidential Defitelio® (defibrotide) by Jazz Pharmaceuticals Study Design N Dose & Administration % Survived after 100 days of transplantation Study 1 prospective study, patients had a diagnosis of 102 6.25 mg/kg every 6 hours for a minimum 38% Day +100 survival after VOD with an associated diagnosis of multi- of 21 days until discharge from hospital transplantation organ dysfunction (pulmonary, renal, or both) by Day+28 post-HSCT Study 2 prospective study, diagnosis of hepatic VOD 75 6.25 mg/kg infused every 6 hours for a 44% Day +100 survival after and multi-organ dysfunction following HSCT minimum of treatment duration of 14 days transplantation Study 3 expanded access program for defibrotide for 351 6.25 mg/kg infused every 6 hours 45% Day +100 survival after the treatment of adult and pediatric patients transplantation who developed hepatic VOD after had received a HSCT and developed hepatic VOD with renal or pulmonary dysfunction. Privileged and Confidential Epclusa® (sofosbuvir/velpatasvir) by Gilead Sciences ◆ First completely oral pan-genotypic single tablet regimen for the treatment hepatitis C virus (HCV) infection ◆ Indication • Treatment of adult patients with chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection • Can be use in patients co-infected with HIV (expanded labeling August 2017) ◆ Potential to eliminate genotype testing ◆ Direct-acting antiviral agent ◆ NS5B polymerase inhibitor (sofosbuvir) and NS5A inhibitor (velpatasvir) ◆ Dose/Administration • Fixed-dose combination of sofosbuvir 400 mg/ velpatasvir 100 mg once daily for 12 weeks • Single tablet for patients without cirrhosis or with compensated cirrhosis • In combination with ribavirin for decompensated cirrhosis Epclusa®[prescribing information]. Foster City, CA: Gilead Sciences. February 2017 Privileged and Confidential Zepatier® (elbasvir/grazoprevir) by Merck Sharp & Dohme Zepatier Dosage Regimens and Durations ◆ Indication Genotype Patient Population Therapy Duration • Treatment of hepatitis C genotypes 1 or 4 infection in adults with 1a Treatment-naïve or Zepatier alone 12 weeks or without ribavirin PegIFN/RBV ◆ Direct-acting antiviral agent experienced* without baseline NS5A ◆ Oral fixed-dose combination of a NS5A inhibitor polymorphisms† (elbasvir) and a NS3/4A protease inhibitor 1a Treatment-naïve or Zepatier plus 16 weeks (grazoprevir) PegIFN/RBV- ribavirin ◆ Safety experienced* with • Zepatier alone: fatigue, headache, nausea baseline NS5A • Zepatier with ribavirin: anemia and headache polymorphisms† ◆ Dosage 1b Treatment-naïve or Zepatier alone 12 weeks • Elbasvir 50 mg /grazoprevir 100 mg once daily PegIFN/RBV • Renal impairment experienced* . No dosage adjustments including dialysis 1a or 1b PegIFN/RBV/PI- Zepatier plus 12 weeks • Hepatic Impairment experienced‡ ribavirin . No adjustment in mild impairment 4 Treatment-naïve Zepatier alone 12 weeks . Contraindicated in moderate or severe impairment 4 PegIFN/RBV- Zepatier plus 16 weeks experienced* ribavirin *Peginterferon alfa (PegIFN) + ribavirin (RBV) †Polymorphisms at amino acid positions 28, 30, 31, or 93. Zepatier®[prescribing information]. Whitehouse, NJ: Merch Sh.arp & Dohme Corp. February 2017 ‡Peginterferon alfa + ribavirin + HCV NS3/4A protease inhibitor. Privileged and Confidential Approval History of Direct-Acting Antiviral Agents for HCV WARNING: Risk of hepatitis B reactivation in patients coinfected with HCV and HBV Daklinza® Zepatier® (elbasvirsvir/grazoprevir) Sovaldi® (daclatasvir) Genotype: 1, 4 (sofosbuvir) Genotype: 3 Approval: Jan 2016 Genotype: 1, 2, 3, 4 Approval: Jul 2015 Approval: Dec 2013 Viekira Pak ® Genotype: 1 Approval: Dec 2014 2013 2014 2015 2016 Harvoni® Olysio® Eplcusa® (ledipasvir/sofosbuvir) (simeprevir) (sofosbuvir /velpatasvir) Genotype: 1, 4, 5, 6 Genotype 1 Genotype: 1, 2, 3, 4, 5, or 6 Approval: Nov 2015 Approval: Nov 2014 Approval: June 2016 Privileged and Confidential Ocaliva® (obeticholic acid) by Intercept Pharmaceuticals ◆ Indication • For the treatment of primary biliary cholangitis (PBC) in
Load more

Recommended publications
  • Old and New Challenges in Uveitis Associated with Behçet's Disease
    Journal of Clinical Medicine Review Old and New Challenges in Uveitis Associated with Behçet’s Disease Julie Gueudry 1,* , Mathilde Leclercq 2, David Saadoun 3,4,5 and Bahram Bodaghi 6 1 Department of Ophthalmology, Hôpital Charles Nicolle, F-76000 Rouen, France 2 Department of Internal Medicine, Hôpital Charles Nicolle, F-76000 Rouen, France; [email protected] 3 Department of Internal Medicine and Clinical Immunology, AP-HP, Centre National de Références Maladies Autoimmunes et Systémiques Rares et Maladies Autoinflammatoires Rares, Groupe Hospitalier Pitié-Salpêtrière, F-75013 Paris, France; [email protected] 4 Sorbonne Universités, UPMC Univ Paris 06, INSERM, UMR S 959, Immunology-Immunopathology-Immunotherapy (I3), F-75005 Paris, France 5 Biotherapy (CIC-BTi), Hôpital Pitié-Salpêtrière, AP-HP, F-75651 Paris, France 6 Department of Ophthalmology, IHU FOReSIGHT, Sorbonne-AP-HP, Groupe Hospitalier Pitié-Salpêtrière, F-75013 Paris, France; [email protected] * Correspondence: [email protected]; Tel.: +33-2-32-88-80-57 Abstract: Behçet’s disease (BD) is a systemic vasculitis disease of unknown origin occurring in young people, which can be venous, arterial or both, classically occlusive. Ocular involvement is particularly frequent and severe; vascular occlusion secondary to retinal vasculitis may lead to rapid and severe loss of vision. Biologics have transformed the management of intraocular inflammation. However, the diagnosis of BD is still a major challenge. In the absence of a reliable biological marker, diagnosis is based on clinical diagnostic criteria and may be delayed after the appearance of the onset sign. However, therapeutic management of BD needs to be introduced early in order to control inflammation, to preserve visual function and to limit irreversible structural damage.
    [Show full text]
  • 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]
  • 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]
  • Predictive QSAR Tools to Aid in Early Process Development of Monoclonal Antibodies
    Predictive QSAR tools to aid in early process development of monoclonal antibodies John Micael Andreas Karlberg Published work submitted to Newcastle University for the degree of Doctor of Philosophy in the School of Engineering November 2019 Abstract Monoclonal antibodies (mAbs) have become one of the fastest growing markets for diagnostic and therapeutic treatments over the last 30 years with a global sales revenue around $89 billion reported in 2017. A popular framework widely used in pharmaceutical industries for designing manufacturing processes for mAbs is Quality by Design (QbD) due to providing a structured and systematic approach in investigation and screening process parameters that might influence the product quality. However, due to the large number of product quality attributes (CQAs) and process parameters that exist in an mAb process platform, extensive investigation is needed to characterise their impact on the product quality which makes the process development costly and time consuming. There is thus an urgent need for methods and tools that can be used for early risk-based selection of critical product properties and process factors to reduce the number of potential factors that have to be investigated, thereby aiding in speeding up the process development and reduce costs. In this study, a framework for predictive model development based on Quantitative Structure- Activity Relationship (QSAR) modelling was developed to link structural features and properties of mAbs to Hydrophobic Interaction Chromatography (HIC) retention times and expressed mAb yield from HEK cells. Model development was based on a structured approach for incremental model refinement and evaluation that aided in increasing model performance until becoming acceptable in accordance to the OECD guidelines for QSAR models.
    [Show full text]
  • Review Anti-Cytokine Biologic Treatment Beyond Anti-TNF in Behçet's Disease
    Review Anti-cytokine biologic treatment beyond anti-TNF in Behçet’s disease A. Arida, P.P. Sfikakis First Department of Propedeutic Internal ABSTRACT and thrombotic complications (1-3). Medicine Laikon Hospital, Athens, Unmet therapeutic needs in Behçet’s Treatment varies according to type and University Medical School, Greece. disease have drawn recent attention to severity of disease manifestations. Cor- Aikaterini Arida, MD biological agents targeting cytokines ticosteroids, interferon-alpha and con- Petros P. Sfikakis, MD other than TNF. The anti-IL-17 anti- ventional immunosuppressive drugs, Please address correspondence to: body secukinumab and the anti-IL-2 such as azathioprine, cyclosporine-A, Petros P. Sfikakis, MD, receptor antibody daclizumab were not cyclophosphamide and methotrexate, First Department of Propedeutic superior to placebo for ocular Behçet’s and Internal Medicine, are used either alone or in combination Laikon Hospital, in randomised controlled trials, com- for vital organ involvement. During the Athens University Medical School, prising 118 and 17 patients, respec- last decade there has been increased use Ag Thoma, 17, tively. The anti-IL-1 agents anakinra of anti-TNF monoclonal antibodies in GR-11527 Athens, Greece. and canakinumab and the anti-IL-6 patients with BD who were refractory E-mail: [email protected] agent tocilizumab were given to iso- to conventional treatment or developed Received on June 7, 2014; accepted in lated refractory disease patients, who life-threatening complications (4, 5). revised form on September 17, 2014. were either anti-TNF naïve (n=9) or Anti-TNF treatment has been shown to Clin Exp Rheumatol 2014; 32 (Suppl. 84): experienced (n=18).
    [Show full text]
  • Tocilizumab in the Treatment of Severe and Refractory Parenchymal Neuro
    TAB0010.1177/1759720X20971908Therapeutic Advances in Musculoskeletal DiseaseJ Liu, D Yan 971908research-article20202020 Therapeutic Advances in Musculoskeletal Disease Case Series Ther Adv Musculoskel Dis Tocilizumab in the treatment of severe and 2020, Vol. 12: 1–8 DOI:https://doi.org/10.1177/1759720X20971908 10.1177/ refractory parenchymal neuro-Behçet’s 1759720X20971908https://doi.org/10.1177/1759720X20971908 © The Author(s), 2020. Article reuse guidelines: syndrome: case series and literature review sagepub.com/journals- permissions Jinjing Liu* , Dong Yan*, Zhimian Wang, Yunjiao Yang, Shangzhu Zhang, Di Wu, Lingyi Peng, Zhichun Liu and Wenjie Zheng Abstract Correspondence to: Objectives: This study aimed to investigate the efficacy and safety of tocilizumab (TCZ) in Wenjie Zheng severe and refractory parenchymal neuro-Behçet’s syndrome (p-NBS). Department of Rheumatology and Clinical Methods: We retrospectively analyzed five patients with p-NBS treated with TCZ in our center Immunology, Peking Union between 2013 and 2020, and six cases from literature research with the index terms “neuro- Medical College Hospital, Chinese Academy of Behçet’s syndrome” and “tocilizumab” on PubMed NCBI. Medical Sciences & Peking Union Medical Results: A total of 11 patients with p-NBS were enrolled (5 males, 6 females), with a mean College, Key Laboratory of age of 34.5 ± 8.0 years at the onset. All the patients had parenchymal neurological lesions, Rheumatology and Clinical Rheumatology, Ministry six patients (54.5%) suffered from multiple lesions, and nine patients (81.8%) were disabled. of Education, National Clinical Research Center Before TCZ administration, all the patients had failed conventional therapy, eight patients for Dermatologic and (72.7%) received two or more immunosuppressants, and five patients showed insufficient Immunologic Diseases, No.
    [Show full text]
  • Classification Decisions Taken by the Harmonized System Committee from the 47Th to 60Th Sessions (2011
    CLASSIFICATION DECISIONS TAKEN BY THE HARMONIZED SYSTEM COMMITTEE FROM THE 47TH TO 60TH SESSIONS (2011 - 2018) WORLD CUSTOMS ORGANIZATION Rue du Marché 30 B-1210 Brussels Belgium November 2011 Copyright © 2011 World Customs Organization. All rights reserved. Requests and inquiries concerning translation, reproduction and adaptation rights should be addressed to [email protected]. D/2011/0448/25 The following list contains the classification decisions (other than those subject to a reservation) taken by the Harmonized System Committee ( 47th Session – March 2011) on specific products, together with their related Harmonized System code numbers and, in certain cases, the classification rationale. Advice Parties seeking to import or export merchandise covered by a decision are advised to verify the implementation of the decision by the importing or exporting country, as the case may be. HS codes Classification No Product description Classification considered rationale 1. Preparation, in the form of a powder, consisting of 92 % sugar, 6 % 2106.90 GRIs 1 and 6 black currant powder, anticaking agent, citric acid and black currant flavouring, put up for retail sale in 32-gram sachets, intended to be consumed as a beverage after mixing with hot water. 2. Vanutide cridificar (INN List 100). 3002.20 3. Certain INN products. Chapters 28, 29 (See “INN List 101” at the end of this publication.) and 30 4. Certain INN products. Chapters 13, 29 (See “INN List 102” at the end of this publication.) and 30 5. Certain INN products. Chapters 28, 29, (See “INN List 103” at the end of this publication.) 30, 35 and 39 6. Re-classification of INN products.
    [Show full text]
  • Inflammatory Conditions – Kevzara™ (Sarilumab for Subcutaneous Injection)
    Cigna National Formulary Coverage Policy Prior Authorization Inflammatory Conditions – Kevzara® (sarilumab for subcutaneous injection) Table of Contents Product Identifier(s) National Formulary Medical Necessity ................ 1 59231 Conditions Not Covered....................................... 2 Background .......................................................... 2 References .......................................................... 3 Revision History ................................................... 3 INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation.
    [Show full text]
  • As a Group, Anti- Inflammatories Will
    THERAPEUTIC FOCUS Sandoz’s Zarxio in March opened the door The inflammatory disease space exalts the for an established regulatory pathway here. approval of moderate-to-severe plaque Zarxio is biosimilar to Amgen’s neutrope- psoriasis treatment Cosentyx (secukinu- nia drug Neupogen (filgrastim), originally mab). “This is the first drug in the last 10 licensed in 1991. years with published studies showing clear According to Lindqvist, the US entry of superiority to the current standard of treat- biosimilars will dent the sales of a number ment,” observes Marcin Ernst, MD, VP of of individual branded biologic franchises, clinical development at INC Research (see Autoimmune but the impact is likely to pale in compari- “Clinical Corner,” p. 52). son to the generic competition for “white Eli Lilly’s ixekizumab and AstraZeneca/ pill” small-molecule drugs. Looking ahead, “As a group, anti- Amgen’s brodalumab, both of which target Biosimilars are threatening to chip away at established blockbusters. Industry giants are N+1 Singer analysts believe the biolog- inflammatories will the IL-17A cytokine, are expected to elbow battling to devise better therapies for celiac, Crohn’s and lupus even as they work around ics market will reach about $300 billion in their way into the picture. Both companies annual global sales by 2020, including about continue to top the plan regulatory submissions for psoriasis the clock to protect their turf in RA and psoriasis. Welcome to the autoimmune category— $50 billion from biosimilars. best-selling drug list. this year. in which, Rebecca Mayer Knutsen explains, there’s never a dull moment But the regulatory pathway for biosimilars These drugs are high- A few companies are jockeying to bring is murky, Buthusiem says.
    [Show full text]
  • New Biologics in Psoriasis: an Update on IL-23 and IL-17 Inhibitors
    New Biologics in Psoriasis: An Update on IL-23 and IL-17 Inhibitors Joanna Dong, BA; Gary Goldenberg, MD PRACTICE POINTS • The newest biologics for treatment of moderate to severe plaque psoriasis are IL-23 and IL-17 inhibitors with unprecedented efficacy of complete skin clearance compared to older biologics. • Risankizumab, guselkumab, and tildrakizumab are new IL-23 inhibitors currently in phase 3 trials with promising early efficacy and safety results. • Ixekizumab, which recently was approved, and brodalumab, which is pending US Food and Drug Administration review, are new IL-17 inhibitors that achieved total skin clearance in more than one-quarter of phase 3 participants after 12 weeks of treatment. copy not As immune-related pathways involved in the he role of current biologic therapies in pso- pathogenesis of psoriasis are elucidated, new riasis predicates on the pathogenic role of biologic treatments targeting these steps of the Tupregulated, immune-related mechanisms psoriatic immune cascade are developed. In Dothis that result in the activation of myeloid dendritic article, we review the literature on IL-23 and IL-17 cells, which release IL-17, IL-23, and other cytokines inhibitors in the pipeline for use in moderate to to activate T cells, including helper T cell TH17. severe psoriasis. Numerous pipeline biologic Along with other immune cells, TH17 produces therapies, including risankizumab, guselkumab, IL-17. This proinflammatory cascade results in kera- tildrakizumab, ixekizumab, and brodalumab, are tinocyte proliferation, angiogenesis, and migration being investigated in phase 2 and 3 studies to of immune cells toward psoriatic lesions.1 Thus, the establish the efficacy and safety of these new newest classes of biologics target IL-12, IL-23, and agents.
    [Show full text]
  • Bezlotoxumab (Zinplava®)
    Zinplava Swiss Risk Management Plan Summary V1.5 Swiss Summary of the Risk Management Plan (RMP) for Zinplava® (Bezlotoxumab 1000mg) Concentrate for solution for infusion Version 1.5 (November 2016) The Risk Management Plan (RMP) is a comprehensive document submitted as part of the application dossier for market approval of a medicine. The RMP summary contains information on the medicine's safety profile and explains the measures that are taken in order to further investigate and follow the risks as well as to prevent or minimise them. The RMP summary of Zinplava® is a concise document and does not claim to be exhaustive. As the RMP is an international document, the summary might differ from the “Arzneimittelinformation / Information sur le médicament” approved and published in Switzerland, e.g. by mentioning risks occurring in populations or indications not included in the Swiss authorisation. Please note that the reference document which is valid and relevant for the effective and safe use of Zinplava® in Switzerland is the “Arzneimittelinformation / Information sur le médicament” (see www.swissmedicinfo.ch) approved and authorized by Swissmedic. MSD Merck Sharp & Dohme AG is fully responsible for the accuracy and correctness of the content of the published summary RMP of Zinplava®. Zinplava Swiss Risk Management Plan Summary V1.5 1 Elements for Summary Tables in the EPAR 1.1 Summary Table of Safety Concerns Table 1 Summary of Safety Concerns Important identified risks None Important potential risks Infusion-related Reactions Including
    [Show full text]
  • Asthma Agents
    APPROVED PA Criteria Initial Approval Date: July 10, 2019 Revised Date: January 20, 2021 CRITERIA FOR PRIOR AUTHORIZATION Asthma Agents BILLING CODE TYPE For drug coverage and provider type information, see the KMAP Reference Codes webpage. MANUAL GUIDELINES Prior authorization will be required for all current and future dose forms available. All medication-specific criteria, including drug-specific indication, age, and dose for each agent is defined in Table 1 below. Benralizumab (Fasenra®) Dupilumab (Dupixent®) Mepolizumab (Nucala®) Omalizumab (Xolair®) Reslizumab (Cinqair®) GENERAL CRITERIA FOR INITIAL PRIOR AUTHORIZATION: (must meet all of the following) • Must be approved for the indication, age, and not exceed dosing limits listed in Table 1. • Must be prescribed by or in consultation with a pulmonologist, allergist, or immunologist.1,2 • For all agents listed, the preferred PDL drug, which treats the PA indication, is required unless the patient meets the non-preferred PDL PA criteria. • Must have experienced ≥ 2 exacerbations within the last 12 months despite meeting all of the following (exacerbation is defined as requiring the use of oral/systemic corticosteroids, urgent care/hospital admission, or intubation: o Patient adherence to two long-term controller medications, including a high-dose inhaled corticosteroid 1,2 (ICS) and a long-acting beta2-agonist (LABA) listed in Table 2. ▪ Combination ICS/LABA and ICS/LABA/LAMA products meet the requirement of two controller medications. o Patient must have had an adequate trial (at least 90 consecutive days) of a leukotriene modifier or a long-acting muscarinic antagonist (LAMA) as a third long-term controller medication listed in Table 2.
    [Show full text]