Jill Johnson-2018 06 07 APA New Drugs Presentation Update 5-10-18[1]
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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. -
Revised 6/29/2020 GEORGIA MEDICAID FEE-FOR-SERVICE
GEORGIA MEDICAID FEE-FOR-SERVICE BIOLOGIC IMMUNOMODULATORS PA SUMMARY Preferred Non-Preferred Arcalyst (rilonacept) Actemra subcutaneous (tocilizumab) Benlysta subcutaneous (belimumab) Cimzia (certolizumab) Enbrel (etanercept) Cosentyx (secukinumab) Humira (adalimumab) Dupixent (dupilumab) Ilaris (canakinumab) Fasenra Pen (benralizumab autoinjector)Kevzara Xeljanz (tofacitinib) (sarilumab) Xeljanz XR (tofacitinib extended-release) Kineret (anakinra) Nucala Pen (mepolizumab autoinjector) Olumiant (baricitinib) Orencia subcutaneous (abatacept) Otezla (apremilast) Rinvoq (upadacitinib) Siliq (brodalumab) Simponi (golimumab) Stelara (ustekinumab) Skyrizi (risankizumab) Taltz (ixekizumab) Tremfya (guselkumab) The drug names above include all available oral or subcutaneous formulations under the same primary name. LENGTH OF AUTHORIZATION: Varies NOTES: ▪ All preferred and non-preferred products require prior authorization. Intravenous (IV) formulations of the biologic immunomodulators are not covered under Pharmacy Services. ▪ The criteria details below are for the outpatient pharmacy program. If a medication is being administered in a physician’s office or clinic, then the medication must be billed through the DCH physician services program and not the outpatient pharmacy program. Information regarding the physician services program is located at www.mmis.georgia.gov. PA CRITERIA: Actemra Subcutaneous ❖ Approvable for members 2 years of age or older with a diagnosis of moderately to severely active polyarticular juvenile idiopathic arthritis -
Fasenra, INN-Benralizumab
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Fasenra 30 mg solution for injection in pre-filled syringe Fasenra 30 mg solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Pre-filled syringe Each pre-filled syringe contains 30 mg benralizumab* in 1 mL. Pre-filled pen Each pre-filled pen contains 30 mg benralizumab* in 1 mL. *Benralizumab is a humanised monoclonal antibody produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection in pre-filled syringe (injection) Solution for injection in pre-filled pen (injection) (Fasenra Pen) Clear to opalescent, colourless to yellow solution and may contain translucent or white to off-white particles. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Fasenra is indicated as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β-agonists (see section 5.1). 4.2 Posology and method of administration Fasenra treatment should be initiated by a physician experienced in the diagnosis and treatment of severe asthma. After proper training in the subcutaneous injection technique and education about signs and symptoms of hypersensitivity reactions (see section 4.4), patients with no known history of anaphylaxis or their caregivers may administer Fasenra if their physician determines that it is appropriate, with medical follow-up as necessary. -
BCBSVT Specialty Drug List Effective 2021.07.01.Xlsx
Effective Date: 07/01/2021 SPECIALTY DRUG LIST Revised Date: 05/07/2021 DOSAGE EXCLUDED ON NATIONAL DRUG CLASS DRUG NAME GENERIC NAME FORM PERFORMANCE FORMULARY ANEMIA ARANESP SOLN DARBEPOETIN ALFA SOLN INJ ANEMIA ARANESP SOSY DARBEPOETIN ALFA SOLN PREFILLED SYRINGE ANEMIA EPOGEN SOLN EPOETIN ALFA INJ X ANEMIA PROCRIT SOLN EPOETIN ALFA INJ X ANEMIA REBLOZYL SOLR LUSPATERCEPT-AAMT FOR SUBCUTANEOUS INJ ANEMIA RETACRIT SOLN EPOETIN ALFA-EPBX INJ ANTI-GOUT AGENT KRYSTEXXA SOLN PEGLOTICASE INJ (FOR IV INFUSION) ANTI-INFECTIVE PREVYMIS SOLN LETERMOVIR IV SOLN ANTI-INFECTIVE PREVYMIS TABS LETERMOVIR TAB ASTHMA CINQAIR SOLN RESLIZUMAB IV INFUSION SOLN ASTHMA FASENRA SOSY BENRALIZUMAB SUBCUTANEOUS SOLN PREFILLED SYRINGE ASTHMA FASENRA PEN SOAJ BENRALIZUMAB SUBCUTANEOUS SOLN AUTO-INJECTOR ASTHMA NUCALA SOAJ MEPOLIZUMAB SUBCUTANEOUS SOLUTION AUTO-INJECTOR ASTHMA NUCALA SOLR MEPOLIZUMAB FOR INJ ASTHMA NUCALA SOSY MEPOLIZUMAB SUBCUTANEOUS SOLUTION PREF SYRINGE ASTHMA XOLAIR SOLR OMALIZUMAB FOR INJ ASTHMA XOLAIR SOSY OMALIZUMAB SUBCUTANEOUS SOLN PREFILLED SYRINGE CARDIOVASCULAR VYNDAMAX CAPS TAFAMIDIS CAP CARDIOVASCULAR VYNDAQEL CAPS TAFAMIDIS MEGLUMINE (CARDIAC) CAP CENTRAL NERVOUS SYSTEM AGENTS AUSTEDO TABS DEUTETRABENAZINE TAB CENTRAL NERVOUS SYSTEM AGENTS ENSPRYNG SOSY SATRALIZUMAB-MWGE SUBCUTANEOUS SOLN PREF SYRINGE CENTRAL NERVOUS SYSTEM AGENTS HETLIOZ CAPS TASIMELTEON CAPSULE CENTRAL NERVOUS SYSTEM AGENTS HETLIOZ LQ SUSP TASIMELTEON ORAL SUSP CHEMOTHERAPY PROTECTANT AMIFOSTINE SOLR AMIFOSTINE CRYSTALLINE FOR INJ CHEMOTHERAPY PROTECTANT ELITEK -
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. -
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. -
Emerging Therapies in Psoriasis: a Systematic Review
CLINICAL REVIEW Emerging Therapies In Psoriasis: A Systematic Review Erica B. Lee, BS; Mina Amin, BS; Tina Bhutani, MD; Jashin J. Wu, MD soriasis is a chronic, autoimmune-mediated disease PRACTICE POINTS estimated to affect 2.8% of the US population.1 The pathogenesis of psoriasis is thought to involve a • Tumor necrosis factor α, I L-23, and IL-17A are key P targets for psoriasis therapy based on an under- complex process triggered by a combination of genetic standing of the key role that these cytokines play and environmental factors that induce tumor necrosis in the pathophysiology of disease. factor (TNF) α secretion by keratinocytes, which in turn • The biologic agents secukinumab and ixekizumab activates dendritic cells. Activated dendritic cells produce 2,3 are approved for use in the management of pso- IL-23, leading to helper T cell (TH17) differentiation. riasis. Other biologics—brodalumab, bimekizumab, TH17 cells secrete IL-17A, which has been shown to pro- guselkumab, tildrakizumab, risankizumab, and cer- mote psoriatic skincopy changes.4 Therefore, TNF-α, IL-23, tolizumab pegol—have been (and some continue to and IL-17A have been recognized as key targets for pso- be) the focus of phase 2 and phase 3 clinical trials. riasis therapy. • Findings of several of those trials support the idea that The newest biologic agents targeting IL-17– therapies targeting IL-23, specifically its p19 subunit, mediated pathways include ixekizumab, brodalumab, but that spare IL-12 are effective against psoriasis. andnot bimekizumab. Secukinumab, the first US Food and • Longer-term studies are needed to determine whether Drug Administration (FDA)–approved IL-17 inhibitor, the agents reviewed here, including those approved for has been available since 2015 and therefore is not clinical use, are suitable for prolonged administration. -
2020 Hospital Regulatory Update
2020 Hospital Regulatory Update BY TERI BEDARD, BA, RT(R)(T), CPC he Hospital Outpatient Prospective finalized CF. To determine this payment rate, ASCs to be approximately $4.96 billion, an Payment System (OPPS) is one of the CMS utilized data released in the inpatient increase of approximately $230 million from T Medicare payment systems that prospective payment system (IPPS) final rule CY 2019 payments. applies to facility-based settings, which for FY 2020, which had a 3 percent increase CMS finalized to continue applying a wage include, hospitals, ambulatory surgical for inpatient services, slightly lower than index of 1.000 for frontier state hospitals centers (ASCs), critical access hospitals proposed, and minus 0.4 percent for the (Montana, Wyoming, North Dakota, South (CAHs) and excepted off-campus provid- multifactor productivity (MFP) adjustment. Dakota, and Nevada), this policy has been in er-based departments. As indicated in the CY Due to wage index changes, a budget place since CY 2011. This ensures that lower 2019 OPPS final rule, the overarching goal of neutrality factor of 0.9981 was also applied population states are not “penalized” for the Centers for Medicare & Medicaid Services for CY 2020. reimbursement due to the low number of (CMS) is “to make payments for all services CMS is maintaining the rural adjustment people per square mile when compared to under the OPPS more consistent with those of factor of 7.1 percent to OPPS payments to other states. CMS also finalized for CY 2020 a prospective payment system and less like certain rural sole community hospitals to continue additional payments to cancer those of a per-service fee schedule, which pays (SCHs), including essential access commu- hospitals. -
Changes in Serum Micrornas After Anti-IL-5 Biological Treatment of Severe Asthma
International Journal of Molecular Sciences Article Changes in Serum MicroRNAs after Anti-IL-5 Biological Treatment of Severe Asthma Manuel J. Rial 1,2, José A. Cañas 2,3 , José M. Rodrigo-Muñoz 2,3 , Marcela Valverde-Monge 1 , Beatriz Sastre 2,3 , Joaquín Sastre 1,3 and Victoria del Pozo 2,3,* 1 Allergy Unit, Hospital Universitario Fundación Jiménez Díaz, 28040 Madrid, Spain; [email protected] (M.J.R.); [email protected] (M.V.-M.); [email protected] (J.S.) 2 Department of Immunology, IIS-Fundación Jiménez Díaz, 28040 Madrid, Spain; [email protected] (J.A.C.); [email protected] (J.M.R.-M.); [email protected] (B.S.) 3 CIBER de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, 28029 Madrid, Spain * Correspondence: [email protected]; Tel.: +34-9155-048-91 Abstract: There is currently enough evidence to think that miRNAs play a role in several key points in asthma, including diagnosis, severity of the disease, and response to treatment. Cells release different types of lipid double-membrane vesicles into the extracellular microenvironment, including exosomes, which function as very important elements in intercellular communication. They are capable of distributing genetic material, mRNA, mitochondrial DNA, and microRNAs (miRNAs). Serum miRNA screening was performed in order to analyze possible changes in serum miRNAs in 10 patients treated with reslizumab and 6 patients with mepolizumab after 8 weeks of treatment. The expression of miR-338-3p was altered after treatment (p < 0.05), although no significant differences between reslizumab and mepolizumab were found. Bioinformatic analysis showed that miR-338-3p regulates important pathways in asthma, such as the MAPK and TGF-β signaling pathways and the Citation: Rial, M.J.; Cañas, J.A.; biosynthesis/degradation of glucans (p < 0.05). -
MEP-AST Mepolizumab Versus Placebo for Asthma
MEP-AST Mepolizumab versus placebo for asthma Mepolizumab versus placebo for asthma Review information Review type: Intervention Review number: MEP-AST Authors Colin Powell1, Stephen J Milan2, Kerry Dwan3, Lynne Bax4, Nicola Walters5 1Department of Child Health, Institute of Molecular and Experimental Medicine, Cardiff University School of Medicine, Cardiff, UK 2Lancaster Health Hub, Lancaster University, Lancaster, UK 3Department of Biostatistics, University of Liverpool, Liverpool, UK 4Lancashire Care NHS Foundation Trust, Preston, UK 5Chest Unit, St George's University Hospitals NHS Foundation Trust, London, UK Citation example: Powell C, Milan SJ, Dwan K, Bax L, Walters N. Mepolizumab versus placebo for asthma. Cochrane Database of Systematic Reviews 2015 , Issue 7 . Art. No.: CD010834. DOI: 10.1002/14651858.CD010834.pub2 . Contact person Colin Powell Senior Lecturer Department of Child Health Institute of Molecular and Experimental Medicine, Cardiff University School of Medicine Cardiff UK E-mail: [email protected] Dates Assessed as Up-to-date:19 November 2014 Date of Search: 19 November 2014 Next Stage Expected: 6 June 2017 Protocol First Published:Issue 11 , 2013 Review First Published: Issue 7 , 2015 Last Citation Issue: Issue 7 , 2015 What's new Date Event Description History Date Event Description Abstract Background Mepolizumab is a human monoclonal antibody against interleukin-5 (IL-5), the main cytokine involved in the activation of eosinophils, which in turn causes airway inflammation. Recent studies have suggested these agents may have a role in reducing exacerbations and improving health-related quality of life (HRQoL). There are no recommendations for the use of mepolizumab in adults or children in the recent update of the BTS/SIGN guidelines (BTS/SIGN 2014). -
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. -
Immunfarmakológia Immunfarmakológia
Gergely: Immunfarmakológia Immunfarmakológia Prof Gergely Péter Az immunpatológiai betegségek döntő többsége gyulladásos, és ennek következtében általában szövetpusztulással járó betegség, melyben – jelenleg – a terápia alapvetően a gyulladás csökkentésére és/vagy megszűntetésére irányul. Vannak kizárólag gyulladásgátló gyógyszereink és vannak olyanok, amelyek az immunreakció(k) bénításával (=immunszuppresszió révén) vagy emellett vezetnek a gyulladás mérsékléséhez. Mind szerkezetileg, mind hatástanilag igen sokféle csoportba oszthatók, az alábbi felosztás elsősorban didaktikus célokat szolgál. 1. Nem-szteroid gyulladásgátlók (‘nonsteroidal antiinflammatory drugs’ NSAID) 2. Kortikoszteroidok 3. Allergia-elleni szerek (antiallergikumok) 4. Sejtoszlás-gátlók (citosztatikumok) 5. Nem citosztatikus hatású immunszuppresszív szerek 6. Egyéb gyulladásgátlók és immunmoduláns szerek 7. Biológiai terápia 1. Nem-szteroid gyulladásgátlók (NSAID) Ezeket a vegyületeket, melyek őse a szalicilsav (jelenleg, mint acetilszalicilsav ‘aszpirin’ használatos), igen kiterjedten alkalmazzák a reumatológiában, az onkológiában és az orvostudomány szinte minden ágában, ahol fájdalom- és lázcsillapításra van szükség. Egyes felmérések szerint a betegek egy ötöde szed valamilyen NSAID készítményt. Szerkezetük alapján a készítményeket több csoportba sorolhatjuk: szalicilátok (pl. acetilszalicilsav) pyrazolidinek (pl. fenilbutazon) ecetsav származékok (pl. indometacin) fenoxiecetsav származékok (pl. diclofenac, aceclofenac)) oxicamok (pl. piroxicam, meloxicam) propionsav