DOCSLIB.ORG

Hpra Drug Safety Newsletter 9499Th Edition

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Hpra Drug Safety Newsletter 9499Th Edition September 2020 HPRA DRUG SAFETY NEWSLETTER 9499TH EDITION In this Edition • Erythromycin – Updated warnings • Insulin-containing medicines – Risk of • Xeljanz (tofacitinib) – Updated regarding cardiovascular risks and cutaneous amyloidosis and potential recommendations due to increased infantile hypertrophic pyloric stenosis for associated changes in glycaemic risk of venous thromboembolism and • Vascular Endothelial Growth Factor control serious and fatal infections (VEGF) pathway inhibitors – Risk of • Leuprorelin-containing depot • Risk of respiratory depression and aneurysm and artery dissection medicines – Risk of lack of efficacy sedation associated with Epaclob • Implanon NXT (etonogestrel implant) due to incorrect reconstitution and 1mg/ml and 2mg/ml oral suspension – Updated insertion and removal administration (clobazam) instructions due to risk of neurovascular injury and implant migration Erythromycin – Updated warnings regarding cardiovascular risks and infantile hypertrophic pyloric stenosis Erythromycin* is a macrolide antibiotic and as such is known to be associated with a risk of QT-prolongation and cardiac arrhythmia, as reflected in the approved product information (Summary of Product Characteristics (SmPC) and Package Leaflet (PL)) for these medicinal products. As part of a recent routine periodic assessment of erythromycin-containing medicines, the European Medicines Agency’s (EMA’s) Pharmacovigilance Risk Assessment Committee (PRAC) considered data from observational studies that identified a rare, short-term risk of cardiovascular events associated with macrolides, including erythromycin.1,2,3 These cardiovascular events include arrhythmia, myocardial infarction and cardiovascular mortality. Based on the available data, the PRAC recommended that consideration of cardiovascular risks should be balanced with known treatment benefits when prescribing erythromycin-containing medicines, particularly in patients at high risk of cardiovascular events. Erythromycin should not be given to patients with a history of QT prolongation or ventricular cardiac arrhythmia, nor should it be given to patients with electrolyte disturbances. Similar recommendations were previously introduced for clarithromycin-containing medicines, as highlighted in the 88th Edition of the HPRA’s Drug Safety Newsletter. As part of the PRAC’s assessment, an extensive literature review was undertaken and it was considered that there was consistent evidence across a reasonable body of literature to support an association between exposure to erythromycin in infants and the risk of infantile hypertrophic pyloric stenosis (IHPS). Data from three meta-analyses suggested that erythromycin exposure was associated with a two- to three-fold increase in the risk of IHPS in children less than 6 months of age, particularly in those exposed during the first 14 days of life.4,5,6 The available data suggest a risk of 2.6% following exposure to erythromycin during this time period, while the risk of IHPS in the general population is estimated to be 0.1-0.2%. The product information for erythromycin-containing medicines that are systemically absorbed has been updated to reflect current knowledge regarding the risks associated with treatment, as described above, while details of a recently identified increased risk of bleeding associated with concomitant use of the direct acting oral anticoagulant, rivaroxaban, has also been included. Advice to Healthcare Professionals • Erythromycin should not be given to patients with a history of QT prolongation or ventricular cardiac arrhythmia, nor should it be given to patients with electrolyte disturbances. • Consideration of the cardiovascular risks associated with macrolide antibiotics should be balanced with known treatment benefits when prescribing erythromycin-containing medicines. • The product information for erythromycin-containing medicines that are systemically absorbed has been updated to reflect current knowledge regarding the risks associated with treatment, including cardiovascular risk, risk of IHPS, and bleeding risk in association with concomitant rivaroxaban treatment. 1 Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2, Ireland. T: +353 1 676 4971 E: [email protected] www.hpra.ie Key messages Observational studies have identified a rare, short-term risk of arrhythmia, myocardial infarction and cardiovascular mortality associated with macrolide antibiotics, including erythromycin. Consideration of these findings should be balanced with treatment benefits when prescribing erythromycin in patients at high risk of cardiovascular events. There is evidence of an increased risk of bleeding when erythromycin is used concomitantly with the direct acting oral anticoagulant, rivaroxaban. Epidemiological studies including data from meta-analyses suggest a two- to three-fold increase in the risk of infantile hypertrophic pyloric stenosis (IHPS) following exposure to erythromycin in infancy. Suspected adverse reactions should be reported to the HPRA via the available methods (www.hpra.ie/report). References 1) Cheng YJ, Nie XY, Chen XM et al. The role of macrolide antibiotics in increasing cardiovascular risk. J Am Coll Cardiol. 2015;66(20):2173-84. 2) Gorelik E, Masarwa R, Perlman A, Rotshild V, Muszkat M, Matok I. Systematic Review, Meta-analysis, and Network Meta-analysis of the Cardiovascular Safety of Macrolides. Antimicrob Agents Cemother. 2018 May 25;62(6). 3) Wong AYS, Chan EW, Anand S et al. Managing Cardiovascular Risk of Macrolides: Systematic Review and Meta-Analysis. Drug Saf. 2017 Aug;40(8):663-677. 4) Murchison L, De Coppi P, Eaton S. Post-natal erythromycin exposure and risk of infantile hypertrophic pyloric stenosis: a systematic review and meta- analysis. Pediatr Surg Int. 2016 Dec;32(12):1147-1152. 5) bdellatif M, Ghozy S, Kamel MG et al. Association between exposure to macrolides and the development of infantile hypertrophic pyloric stenosis: a systematic review and meta-analysis. Eur J Pediatr. 2018;178(3):301-314. 6) Almaramhy HH, Al-Zalabani AH. The association of prenatal and postnatal macrolide exposure with subsequent development of infantile hypertrophic pyloric stenosis: a systematic review and meta-analysis. Ital J Pediatr. 2019 Feb 4;45(1)20. Vascular Endothelial Growth Factor (VEGF) pathway inhibitors – Risk of aneurysm and artery dissection Angiogenesis is a complex process by which new blood vessels are formed from the endothelium of a pre-existing vasculature. This process plays a role in both physiological and pathological conditions. Vascular Endothelial Growth Factor (VEGF) and its receptors have a central role in tumour angiogenesis and tumour growth, and it is thought that VEGF pathway inhibitors* exert an effect through blockage of the signal transduction pathways. However, given the crucial physiological role of VEGF in vascular protection and vascular homeostasis, inhibition of VEGF activity may compromise these protective and homeostatic mechanisms and affect the integrity of the vascular matrix. The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has completed a review of VEGF pathway inhibitors with respect to the potential risk of aneurysm and artery dissection. Prior to this review, the product information (Summary of Product Characteristics (SmPC) and Package Leaflet (PL)) for a number of VEGF pathway inhibitors already included warnings regarding the risk of aneurysm and/or artery dissection. Similarly, the product information for VEGF pathway inhibitors for systemic administration already described the risk of hypertension, which is an important predisposing factor for artery dissection and aneurysm. Having considered reports of aneurysm and artery dissection in the EMA’s adverse reaction database (EudraVigilance), some of which were fatal, as well as the totality of available evidence, the product information for all VEGF pathway inhibitors for systemic administration have recently been updated to reflect this risk. However, the review concluded that based on the available evidence, a causal association could not be established between these risks and the two VEGF pathway inhibitors that are authorised for use in ocular conditions and administered by intravitreal injection, ranibizumab (Lucentis) and aflibercept (Eylea). Advice to Healthcare Professionals • The use of VEGF pathway inhibitors for systemic administration in patients with or without hypertension may promote the formation of aneurysm and/or artery dissection, which may be fatal in some cases. • Before initiating treatment, this risk should be carefully considered in patients with additional risk factors such as hypertension or history of aneurysm. • Any modifiable risk factors such as hypertension should be reduced as far as possible in patients treated with VEGF pathway inhibitors for systemic administration. • Monitor and treat patients for hypertension in accordance with recommendations in the Summary of Product Characteristics (SmPC) for the relevant VEGF pathway inhibitors for systemic administration. • The product information for VEGF pathway inhibitors for systemic administration has recently been updated to provide further information on the risk of aneurysm and artery dissection. 2 Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2, Ireland. T: +353 1 676 4971 E: [email protected] www.hpra.ie Key messages The use of VEGF pathway inhibitors for systemic administration in patients with or without hypertension may promote
Load more

Recommended publications
  • 2019 Aetna Pharmacy Drug Guide Aetna Premier Plus Plan
    Plan for your best health 2019 Aetna Pharmacy Drug Guide Aetna Premier Plus Plan aetna.com 05.02.414.1 O (12/19) Aetna is the brand name used for products and services provided by one or more of the Aetna group of subsidiary companies, including Aetna Life Insurance Company and its affiliates (Aetna). Aetna Pharmacy Management refers to an internal business unit of Aetna Health Management, LLC. Aetna Pharmacy Management administers, but does not offer, insure or otherwise underwrite the prescription drug benefits portion of your health plan and has no financial responsibility therefor. 2019 Aetna Commercial Plan (Premier Plus) Table of Contents INFORMATIONAL SECTION..................................................................................................................7 *5-HT4 RECEPTOR AGONISTS*** - DRUGS FOR THE STOMACH................................................ 18 *ADHD/ANTI-NARCOLEPSY/ANTI-OBESITY/ANOREXIANTS* - DRUGS FOR THE NERVOUS SYSTEM.................................................................................................................................18 *AGENTS FOR NARCOTIC WITHDRAWAL*** - DRUGS FOR ADDICTION............................... 22 *AGENTS FOR OPIOID WITHDRAWAL*** - DRUGS FOR ADDICTION......................................22 *AMEBICIDES* - DRUGS FOR INFECTIONS.....................................................................................22 *AMINO ACIDS*** - DRUGS FOR NUTRITION................................................................................ 22 *AMINOGLYCOSIDES* - DRUGS FOR
    [Show full text]
  • Ophthalmologic Policy: Vascular Endothelial Growth Factor (VEGF) Inhibitors
    UnitedHealthcare® Community Plan Medical Benefit Drug Policy Ophthalmologic Policy: Vascular Endothelial Growth Factor (VEGF) Inhibitors Policy Number: CS2021D0042S Effective Date: March 1, 2021 Instructions for Use Table of Contents Page Related Community Plan Policies Application.......................................................................................... 1 • Macular Degeneration Treatment Procedures Coverage Rationale ........................................................................... 1 • Maximum Dosage and Frequency Definitions ........................................................................................... 3 • Oncology Medication Clinical Coverage Applicable Codes .............................................................................. 3 Background ........................................................................................ 3 Commercial Policy Clinical Evidence .............................................................................23 • Ophthalmologic Policy: Vascular Endothelial Growth U.S. Food and Drug Administration ..............................................34 Factor (VEGF) Inhibitors Centers for Medicare and Medicaid Services .............................35 References .......................................................................................35 Policy History/Revision Information..............................................39 Instructions for Use .........................................................................39 Application This Medical Benefit
    [Show full text]
  • Imaging Tumor Angiogenesis
    Imaging tumor angiogenesis Kristy Red-Horse, Napoleone Ferrara J Clin Invest. 2006;116(10):2585-2587. https://doi.org/10.1172/JCI30058. Commentary Since the discovery of vascular-specific growth factors with angiogenic activity, there has been a significant effort to develop cancer drugs that restrict tumorigenesis by targeting the blood supply. In this issue of the JCI, Mancuso et al. use mouse models to better understand the plasticity of the tumor vasculature in the face of antiangiogenic therapy (see the related article beginning on page 2610). They describe a rapid regrowth of the tumor vasculature following withdrawal of VEGFR inhibitors, emphasizing the importance of fully understanding the function of these and similar treatments used in the clinic at the cellular and molecular level. Find the latest version: https://jci.me/30058/pdf commentaries Imaging tumor angiogenesis Kristy Red-Horse and Napoleone Ferrara Genentech Inc., South San Francisco, California, USA. Since the discovery of vascular-specific growth factors with angiogenic activ- in 1 week (Figure 1). In accordance with ity, there has been a significant effort to develop cancer drugs that restrict previous findings (4, 6), posttreatment tumorigenesis by targeting the blood supply. In this issue of the JCI, Mancuso angiogenic growth correlated with the et al. use mouse models to better understand the plasticity of the tumor vas- disappearance of empty basement mem- culature in the face of antiangiogenic therapy (see the related article begin- brane sleeves, suggesting that regrowth ning on page 2610). They describe a rapid regrowth of the tumor vasculature occurred along these structures (Figure 1).
    [Show full text]
  • 020 Medicare Advantage Part B Step Therapy
    Medicare Medical Policy Medicare Advantage Part B Step Therapy Medicare HMO BlueSM and Medicare PPO BlueSM Members Policy Number: 020 Related Policies • Quality Care Cancer Program (Medical Oncology), #099 • Supportive Care Treatments for Patients with Cancer, #105 This policy will only manage non-oncology indications for drugs with both oncology and non- oncology indications. For the management of oncology or supportive care indications, please see related policies above that are managed by AIM (Medical Policy #099 and #105). Note: All preservice authorization requests may be submitted to BCBSMA Clinical Pharmacy Operations by completing the preservice authorization form on the last page of this document. Prescribers may also call BCBSMA Pharmacy Operations department at (800) 366-7778 to request a preservice authorization verbally. Table of Contents NCD/LCD/Article ........................................................................................................................................... 2 Drug Class: Granulocyte Colony Stimulants (filgrastim): Zarxio; Neupogen, Nivestym ............... 2 Drug Class: Erythropoiesis Stimulants: Retacrit; Aranesp, Epogen, Mircera, Procrit ................. 2 Device Class: Hyaluronate and Derivatives: Hyalgan, Hymovis, Synvisc; Durolane, Euflexxa, Gel-One, Gelsyn-3, Genvisc, Monovisc, Orthovisc, Supartz Fx, Triluron, Trivisc, Visco-3 ... 2 Drug Class: Tumor Necrosis Factor (TNF) Blocking Agents: Inflectra; Remicade, Renflexis, Avsola ..........................................................................................................................................................
    [Show full text]
  • Med Pharm PA List to Build Pdfs.Xlsx
    The following medications, typically administered in a provider's office or ambulatory/outpatient infusion center, require authorization prior to utilization. Authorization requests can be submitted via the Portal. Additionally, you are welcome to call our member services line to initiate the Prior Authorization process. This list is updated quaterly. Effective date: 1/1/2021 Therapeutic category Brand Name Generic Name HCPCS Immunologic agent Orencia, IV infusion abatacept J0129 Botulinum toxins Dysport abobotulinumtoxin B J0586 HER-2 receptor drug Kadcyla ado-trastuzumab emtansine J9354 Ophthalmic injectable Eylea afilbercept J0178 Enzyme replacement drug Fabrazyme agalsidase beta J0180 Multiple sclerosis drug Lemtrada alemtuzumab J0202 Enzyme replacement drug Lumizyme alglucosidase alfa J0221 Enzyme replacement drug Strensiq asfotase alfa J3590 (non-specific) PD1-PDL1 drug Tecentriq atezolizumab J9022 PD1-PDL1 drug Bavencio avelumab J9023 CAR-T Therapy Yescarta axicabtageneciloleucel inpatient admin Systemic lupus erythematosus (SLE) drug Benlysta belimumab J0490 Antineoplastic agent Beleodaq belinostat J9032 Antineoplastic Belrapzo bendamustine HCl J9036 Antineoplastic Bendeka bendamustine HCl J9034 Antineoplastic agent Treanda bendamustine HCl J9033 Respiratory injectable Fasenra benralizumab J0517 J9035/J3590 (ophthalmology Antineoplastic Avastin bevacizumab uses this non-specific code) Antineoplastic agent Mvasi bevacizumab-awwb Q5107 Antineoplastic agent Zirabev bevacizumab-bvzr Q5118 Antineoplastic agent Blincyto blinatumomab
    [Show full text]
  • Pegaptanib (Macugen) Reference Number: CP.PHAR.185 Effective Date: 03/16 Coding Implications Last Review Date: 03/17 Revision Log
    Clinical Policy: Pegaptanib (Macugen) Reference Number: CP.PHAR.185 Effective Date: 03/16 Coding Implications Last Review Date: 03/17 Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description The intent of the criteria is to ensure that patients follow selection elements established by Centene® clinical policy for pegaptanib (Macugen®). Policy/Criteria It is the policy of health plans affiliated with Centene Corporation® that Macugen is medically necessary when the following criteria are met: I. Initial Approval Criteria A. Macular Degeneration (must meet all): 1. Diagnosis of neovascular (wet) age-related macular degeneration (AMD); 2. Prescribed dose of Macugen does not exceed 0.3 mg (1 syringe) every six weeks; 3. Macugen will not be used concomitantly with other anti-vascular endothelial growth factor (VEGF) medications; 4. At the time of request, member has no ocular or periocular infections. Approval duration: 6 months B. Other diagnoses/indications: Refer to CP.PHAR.57 - Global Biopharm Policy. II. Continued Approval A. Macular Degeneration (must meet all): 1. Previously received medication via Centene benefit or member has previously met all initial approval criteria; 2. Documentation of positive response to therapy (e.g., detained neovascularization, improvement/stabilization of visual acuity, supportive findings on optical coherence tomography or fluorescein angiography); 3. Prescribed dose does not exceed 0.3 mg (1 syringe) every six weeks; 4. Macugen is not being used concomitantly with other anti-VEGF medications. Approval duration: 6 months B. Other diagnoses/indications (must meet 1 or 2): 1. Currently receiving medication via Centene benefit and documentation supports positive response to therapy; or 2.
    [Show full text]
  • CPT / HCPCS Code Drug Description Approximate Cost Share
    The information listed here is for our most prevalent plan. The amount you pay for a covered drug will depend on your plan’s coverage. Please refer to your Medical Plan GTB for more information. To find out the cost of your drugs, please contact HMSA Customer Service at 1-800-776-4672. If you receive services from a nonparticipating provider, you are responsible for a copayment plus any difference between the actual charge and the eligible charge. Legend $0 = no cost share $ = $100 and under $$ = over $100 to $250 $$$ = over $250 to $500 $$$$ = over $500 to $1000 $$$$$ = over $1000 1 = Please call HMSA Customer Service 1-800-776-4672 for cost share information. 2 = The cost share for this drug is dependent upon the diagnosis. Please call HMSA Customer Service at 1-800-772-4672 for more information. 3 = Cost share information for these drugs is dependent upon the dose prescribed. Please call HMSA Customer Service at 1- 800-772-4672 for more information. CPT / HCPCS approximate Code Drug Description cost share J0129 Abatacept Injection $$$$ J0130 Abciximab Injection 3 J0131 Acetaminophen Injection $ J0132 Acetylcysteine Injection $ J0133 Acyclovir Injection $ J0135 Adalimumab Injection $$$$ J0153 Adenosine Inj 1Mg $ J0171 Adrenalin Epinephrine Inject $ J0178 Aflibercept Injection $$$ J0180 Agalsidase Beta Injection 3 J0200 Alatrofloxacin Mesylate 3 J0205 Alglucerase Injection 3 J0207 Amifostine 3 J0210 Methyldopate Hcl Injection 3 J0215 Alefacept 3 J0220 Alglucosidase Alfa Injection 3 J0221 Lumizyme Injection 3 J0256 Alpha 1 Proteinase Inhibitor
    [Show full text]
  • 343 Intravitreal Angiogenesis Inhibitors for Choroidal Vascular
    Medical Policy Intravitreal Angiogenesis Inhibitors for Choroidal Vascular Conditions Table of Contents • Policy: Commercial • Coding Information • Information Pertaining to All Policies • Policy: Medicare • Description • References • Authorization Information • Policy History Policy Number: 343 BCBSA Reference Number: 9.03.24A NCD/LCD: N/A Related Policies • Epiretinal Radiation Therapy for Age-Related Macular Degeneration, #610 • Photodynamic Therapy for Choroidal Neovascularization, #599 • Transpupillary Thermotherapy for Treatment of Choroidal Neovascularization, #600 Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity Medicare HMO BlueSM and Medicare PPO BlueSM Members Anti-vascular endothelial growth factor therapies (anti-VEGF), ie., pegaptanib (Macugen®*), ranibizumab (Lucentis™*), bevacizumab (Avastin™), and aflibercept (Eylea™*) for the treatment of neovascular (wet) age-related macular degeneration may be MEDICALLY NECESSARY. Anti-vascular endothelial growth factor therapies (anti-VEGF) are MEDICALLY NECESSARY for Choroidal neovascularization due to the following conditions: • Angioid streaks, • Central serous chorioretinopathy, • Choroidal rupture or trauma, • Idiopathic choroidal neovascularization, • Multifocal choroiditis, • Pathologic myopia, • Presumed ocular histoplasmosis syndrome, and • Uveitis. Anti-vascular endothelial growth factor therapies (anti-VEGF) are INVESTIGATIONAL for the treatment of chorioretinal scars. *FDA-approved indication 1 Prior Authorization Information Pre-service approval
    [Show full text]
  • Pdf 111.82 K
    INTERNATIONAL JOURNAL OF Int J Med Rev 2016;3(4):523-524 MEDICAL doi 10.15171/ijmr.2016.14 REVIEWS Letter to Editor The History and Efficacy of Intravitreal Injection of Pegaptanib in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion; The Need for Special Attention Roohollah Ahmadian1, Shahriar Najafizadeh-Sari1,2* 1Student Research Committee, Baqiyatallah University of Medical Science, Tehran, Iran 2Trauma Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran Corresponding Author: Shahriar Najafizadeh-Sari, MD, Student Research Committee, Baqiyatallah University of Medical Science, Tehran, Iran. Tel: +98-9126441288, Fax: +98-2188620826, Email: [email protected] Received December 2, 2016; Accepted December 20, 2016; Online Published December 24, 2016 e have read a recent article about intravitreal year.5 pharmacotherapy for the treatment of macular Pegaptanib is not FDA approved for BRVO yet. Anti-VEGF edema secondary to branch retinal vein drugs revolutionized the treatment of eyes suffering macular Wocclusion (BRVO) with great interest. You have mentioned edema secondary to BRVO, and this result necessitates the that few studies have evaluated the efficacy of pegaptanib further study of pegaptanib monotherapy or in combination in ocular diseases; thus, discussing this the Food and Drug with other effective agents. Administration (FDA)-approved drug is necessary. It would be useful to study more intensely RNA silencing Anti-VEGF therapy is a critical and potent approach for the (siRNA) with
    [Show full text]
  • Picture As Pdfoctober 2020: Reminder Specific Medications
    OCTOBER 2020: REMINDER SPECIFIC MEDICATIONS REQUIRE PRIOR AUTHORIZATION As a part of our continuous efforts to improve the quality of care for our members, Highmark Health Options wanted to send a reminder about the prior authorization process for the following medications. Failure to obtain authorization will result in a claim denial. The prior authorization process applies to all Highmark Health Options Members. Medical necessity criteria for each of the medications listed below are outlined in the specific medication policies available online. To access Highmark Health Options’ medical policies, please paste the following link in your internet browser: https://www.highmarkhealthoptions.com/providers/medication-information.html. PROCEDURE CODES REQUIRING AUTHORIZATION DRUG NAME CODE DESCRIPTION HCPCS DE Medicaid Injection, abatacept, 10 mg (code may be used for Medicare when drug administered under J0129 11/4/2019 the direct supervision of a physician, not for abatacept (Orencia) use when drug is self administered aflibercept (Eylea) Injection, aflibercept, 1 mg J0178 10/1/2018 agalsidase beta (Fabrazyme) Injection, agalsidase beta, 1 mg J0180 6/3/2019 alemtuzumab (Lemtrada) Injection, alemtuzumab, 1 mg J0202 11/4/2019 alglucosidase alfa (Lumizyme) Injection, alglucosidase alfa, (lumizyme), 10 mg J0221 10/1/2018 aprepitant (Cinvanti) Injection, aprepitant, 1 mg J0185 11/4/2019 asparaginase (Erwinaze) Injection, asparaginase (erwinaze), 1,000 iu J9019 11/4/2019 atezolizumab (Tecentriq) Injection, atezolizumab, 10 mg J9022 11/4/2019 Axicabtagene
    [Show full text]
  • Age-Related Macular Degeneration (Amd)
    EUnetHTA Joint Action 3 WP4 Relative effectiveness assessment of pharmaceutical technologies BROLUCIZUMAB FOR THE TREATMENT OF ADULTS WITH NEOVASCULAR (WET) AGE-RELATED MACULAR DEGENERATION (AMD) Project ID: PTJA09 Version 1.0, 12/03/2020 Dec2015 ©EUnetHTA, 2015. Reproduction is authorised provided EUnetHTA is explicitly acknowledged 1 PTJA09 - Brolucizumab for patients with neovascular (wet) AMD DOCUMENT HISTORY AND CONTRIBUTORS Version Date Description V0.1 28/01/2020 First draft V0.2 24/2/2020 Input from dedicated reviewers has been processed V0.3 10/03/2020 Input from medical editor and manufacturer(s) has been processed V1.0 12/03/2020 Final assessment report Disclaimer This Joint Assessment is part of the project / joint action ‘724130 / EUnetHTA JA3’ which has received funding from the European Union’s Health Programme (2014-2020). The content of this Assessment Report represents a consolidated view based on the consensus within the Authoring Team; it cannot be considered to reflect the views of the European Network for Health Technology Assessment (EUnetHTA), EUnetHTA’s participating institutions, the European Commission and/or the Consumers, Health, Agriculture and Food Executive Agency or any other body of the European Union. The European Commission and the Agency do not accept any responsibility for use that may be made of the information it contains. Assessment team Author(s) Finnish Medicines Agency (Fimea), Finland Co-Author(s) Spanish Agency of Medicine and Sanitary Products (AEMPS), Spain Andalusian Unit for Health Technology Assessment (AETSA), Spain Dedicated French National Authority for Health (HAS), France Reviewer(s) Agency for Health Technology Assessment and Tariff System (AOTMiT), Poland Regione Emilia-Romagna (RER), Italy Association of Austrian Social Insurance Institutions (DVSV), Austria Observer HTA Department/EC Ukraine, Ukraine March 2020 EUnetHTA Joint Action 3 WP4 1 PTJA09 - Brolucizumab for patients with neovascular (wet) AMD Further contributors External experts Prof.
    [Show full text]
  • DRUG COVERAGE GUIDELINES Policy Number: PHARMACY 098.175 T0 Effective Date: June 1, 2018
    UnitedHealthcare® Oxford Clinical Policy DRUG COVERAGE GUIDELINES Policy Number: PHARMACY 098.175 T0 Effective Date: June 1, 2018 Table of Contents Page Related Policies INSTRUCTIONS FOR USE ......................................................................... 1 Refer to Payment Guidelines below CONDITIONS OF COVERAGE ..................................................................... 1 DESCRIPTION OF SERVICES ..................................................................... 2 DEFINITIONS ......................................................................................... 3 PAYMENT GUIDELINES ............................................................................. 3 POLICY HISTORY/REVISION INFORMATION ............................................ 161 INSTRUCTIONS FOR USE This Clinical Policy provides assistance in interpreting Oxford benefit plans. Unless otherwise stated, Oxford policies do not apply to Medicare Advantage members. Oxford reserves the right, in its sole discretion, to modify its policies as necessary. This Clinical Policy is provided for informational purposes. It does not constitute medical advice. The term Oxford includes Oxford Health Plans, LLC and all of its subsidiaries as appropriate for these policies. When deciding coverage, the member specific benefit plan document must be referenced. The terms of the member specific benefit plan document [e.g., Certificate of Coverage (COC), Schedule of Benefits (SOB), and/or Summary Plan Description (SPD)] may differ greatly from the standard benefit plan
    [Show full text]