DOCSLIB.ORG

Prior Authorization Criteria

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Prior Authorization Criteria Prior Authorization Criteria Effective August 1, 2021 The following is the listing of Prescryptive Health prior authorization criteria that will be used to evaluate prior authorization requests. Prescryptive Health’s prior authorization criteria are based on clinical monographs and National Pharmacy and Therapeutics guidelines. Prior Authorization Criteria will be updated regularly to reflect ongoing changes and is subject to change without notice. Prior Authorization Requests for Tier 4 Medications and Non-Preferred Medications Tier 4 and non-preferred medications may be authorized when there is clinical justification for doing so. Clinicians can submit a prior authorization (PA) request to initiate a review with the following steps: 1. Download the Prior Authorization Request Form. This form can be found at: www.prescryptive.com/prescriber 2. Fax the completed form with supporting documentation to 1 (848) 456-5463 for both standard and urgent requests. Note: Urgent requests should be clearly labeled “URGENT” at the top of the prior authorization request form. © 2021 PRESCRYPTIVE. ALL RIGHTS RESERVED. pg. 1 www.prescryptive.com 2021.03 Contents Off-Label Uses ....................................................................................................................... 8 Step Therapy Exception ......................................................................................................... 9 Quantity Limit Exception ........................................................................................................10 Safety Edit Exception ............................................................................................................11 Oral And Self Injectable Oncolytics ........................................................................................12 Compounded Medications .....................................................................................................14 Short-acting Analgesic Narcotics ...........................................................................................15 Long-acting Opioids ...............................................................................................................18 Butorphanol (Stadol NS) ........................................................................................................20 Dupilumab (Dupixent) ............................................................................................................21 Acitretin (Soriatane) ...............................................................................................................23 Succimer (Chemet)................................................................................................................24 Deferasirox (Jadenu & Exjade) & Deferiprone (Ferriprox) ......................................................25 Wilson’s Disease ...................................................................................................................27 Non-Formulary Test Strips/Quantity Limit Exception ..............................................................28 Non-Formulary Blood Glucose Meters ...................................................................................30 Somatropin (Growth Hormone Preparations) .........................................................................31 Tesamorelin Injection (Egrifta) ...............................................................................................35 Octreotide (Bynfezia, Mycapssa) & Pegvisomant (Somavert) ................................................36 Teriparatide (Forteo) ..............................................................................................................38 Denosumab (Prolia & Xgeva) ................................................................................................39 Romosozumab (Evenity) .......................................................................................................40 Miglustat (Zavesca) And Eliglustat (Cerdelga) .......................................................................41 Deflazacort (Emflaza) ............................................................................................................43 Constipation Agents ..............................................................................................................45 Cholic Acid (Cholbam) ...........................................................................................................47 Obeticholic Acid (Ocaliva)......................................................................................................49 Thrombocytopenia .................................................................................................................50 White Blood Cell Stimulators .................................................................................................52 Erythropoietin Stimulating Agents (ESAs) ..............................................................................54 Hereditary Angioedema .........................................................................................................56 Nitisinone (Orfadin and Nityr) ................................................................................................58 Pyrimethamine (Daraprim) .....................................................................................................59 © 2021 PRESCRYPTIVE. ALL RIGHTS RESERVED. pg. 2 www.prescryptive.com 2021.03 Azole Antifungals ...................................................................................................................60 Hepatitis C .............................................................................................................................62 Bedaquiline (Sirturo) ..............................................................................................................65 Sodium Oxybate (Xyrem) & Oxybate Salts (Xywav) ..............................................................66 Drugs For Movement Disorders .............................................................................................68 Dextromethorphan/Quinidine (Nuedexta) ..............................................................................70 Phosphate Binders ................................................................................................................71 Glutamine (Endari) ................................................................................................................72 Hydroxyprogesterone Caproate (Makena ..............................................................................73 Idiopathic Pulmonary Fibrosis ................................................................................................74 Cystic Fibrosis .......................................................................................................................75 Leukotriene Receptor Antagonists .........................................................................................78 Narcotic Withdrawal Therapy Agents .....................................................................................79 Nafarelin (Synarel) & Elagolix (Orilissa) .................................................................................80 Ingenol (Picato) .....................................................................................................................82 Asfotase Alfa (Strensiq) .........................................................................................................83 Teduglitide (Gattex) ...............................................................................................................84 Prednisone DR (Rayos) .........................................................................................................85 Naloxone Auto-Injector (Evzio) ..............................................................................................86 Droxidopa (Northera) .............................................................................................................87 Parathyroid Hormone (Natpara).............................................................................................89 Metreleptin (Myalept) .............................................................................................................90 Mifepristone (Korlym) ............................................................................................................91 Interleukin 1 Antagonists .......................................................................................................92 Familial Hypercholesterolemia ...............................................................................................95 Emicizumab-Kxwh (Hemlibra) ...............................................................................................97 Migalastat (Galafold) ...........................................................................................................100 Urea Cycle Disorders ..........................................................................................................102 Cannabidiol (Epidiolex .........................................................................................................103 Belimumab (Benlysta) .........................................................................................................104 Apomorphine (Apokyn, Kynmobi) ........................................................................................106 Amikacin (Arikayce) .............................................................................................................107
Load more

Recommended publications
  • Pharmacological Management of Acromegaly: a Current Perspective
    Neurosurg Focus 29 (4):E14, 2010 Pharmacological management of acromegaly: a current perspective SUNIL MANJILA , M.D.,1 Osmo N D C. WU, B.A.,1 FAH D R. KHAN , M.D., M.S.E.,1 ME H ree N M. KHAN , M.D.,2 BAHA M. AR A F AH , M.D.,2 AN D WA rre N R. SE L M AN , M.D.1 1Department of Neurological Surgery, The Neurological Institute, and 2Division of Clinical and Molecular Endocrinology, University Hospitals Case Medical Center, Cleveland, Ohio Acromegaly is a chronic disorder of enhanced growth hormone (GH) secretion and elevated insulin-like growth factor–I (IGF-I) levels, the most frequent cause of which is a pituitary adenoma. Persistently elevated GH and IGF-I levels lead to substantial morbidity and mortality. Treatment goals include complete removal of the tumor causing the disease, symptomatic relief, reduction of multisystem complications, and control of local mass effect. While trans- sphenoidal tumor resection is considered first-line treatment of patients in whom a surgical cure can be expected, pharmacological therapy is playing an increased role in the armamentarium against acromegaly in patients unsuitable for or refusing surgery, after failure of surgical treatment (inadequate resection, cavernous sinus invasion, or transcap- sular intraarachnoid invasion), or in select cases as primary treatment. Three broad drug classes are available for the treatment of acromegaly: somatostatin analogs, dopamine agonists, and GH receptor antagonists. Somatostatin analogs are considered as the first-line pharmacological treatment of acromegaly, although effica- cy varies among the different formulations. Octreotide long-acting release (LAR) appears to be more efficacious than lanreotide sustained release (SR).
    [Show full text]
  • Cross Discipline Team Leader Review
    CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 203255Orig1s000 CROSS DISCIPLINE TEAM LEADER REVIEW Cross Discipline Team Leader Review pituitary adenoma (pituitary acromegaly) and only very rarely to an ectopic source of GH. Therefore for practical purposes, acromegaly is a pituitary disease. Although the treatment of choice of pituitary acromegaly is surgical removal of the pituitary mass via transsfenoidal route, the success rate is variable (90% in patients with microadenoma and below 50% in patients with macroadenomas). Patients who fail surgery (or cannot undergo surgery for a variety of reasons) benefit from radiation or pharmacological therapy. Because the effects of radiation may take years to reach effectiveness, medical therapy is almost invariably used in patients who respond poorly or incompletely to surgical management. Tight GH control and a normalization of serum IGF-1 are the goals of medical treatment. GH reductions to ≤1 μg/L using a modern sensitive immunoassay (approximately equivalent to 2.5 μg/L measured by RAI)2 following an oral glucose load are desirable. There are three drug products that have been approved by the FDA for the medical treatment of acromegaly. From a mechanism of action perspective they belong to two distinct classes: somatostatin analogs (octreotide and lanreotide) and GH receptor antagonists (pegvisomant). Pegvisomant (SOMAVERT) is a pegylated GH analog and acts as a GH receptor antagonist. It competes with endogenous GH for GH receptor binding. Once bound to the GH receptor it prevents receptor dimerization and subsequent intracellular signaling, thus blocking generation of IGF-1. The major safety signal identified with pegvisomant is transient liver enzyme elevation; however, no drug-induced liver failure has been documented to date.
    [Show full text]
  • To Download a List of Prescription Drugs Requiring Prior Authorization
    Essential Health Benefits Standard Specialty PA and QL List July 2016 The following products require prior authorization. In addition, there may be quantity limits for these drugs, which is notated below. Therapeutic Category Drug Name Quantity Limit Anti-infectives Antiretrovirals, HIV SELZENTRY (maraviroc) None Cardiology Antilipemic JUXTAPID (lomitapide) 1 tab/day PRALUENT (alirocumab) 2 syringes/28 days REPATHA (evolocumab) 3 syringes/28 days Pulmonary Arterial Hypertension ADCIRCA (tadalafil) 2 tabs/day ADEMPAS (riociguat) 3 tabs/day FLOLAN (epoprostenol) None LETAIRIS (ambrisentan) 1 tab/day OPSUMIT (macitentan) 1 tab/day ORENITRAM (treprostinil diolamine) None REMODULIN (treprostinil) None REVATIO (sildenafil) Soln None REVATIO (sildenafil) Tabs 3 tabs/day TRACLEER (bosentan) 2 tabs/day TYVASO (treprostinil) 1 ampule/day UPTRAVI (selexipag) 2 tabs/day UPTRAVI (selexipag) Pack 2 packs/year VELETRI (epoprostenol) None VENTAVIS (iloprost) 9 ampules/day Central Nervous System Anticonvulsants SABRIL (vigabatrin) pack None Depressant XYREM (sodium oxybate) 3 bottles (540 mL)/30 days Neurotoxins BOTOX (onabotulinumtoxinA) None DYSPORT (abobotulinumtoxinA) None MYOBLOC (rimabotulinumtoxinB) None XEOMIN (incobotulinumtoxinA) None Parkinson's APOKYN (apomorphine) 20 cartridges/30 days Sleep Disorder HETLIOZ (tasimelteon) 1 cap/day Dermatology Alkylating Agents VALCHLOR (mechlorethamine) Gel None Electrolyte & Renal Agents Diuretics KEVEYIS (dichlorphenamide) 4 tabs/day Endocrinology & Metabolism Gonadotropins ELIGARD (leuprolide) 22.5 mg
    [Show full text]
  • Hypothalamic-Pituitary Axes
    Hypothalamic-Pituitary Axes Hypothalamic Factors Releasing/Inhibiting Pituitary Anterior Pituitary Hormones Circulating ACTH PRL GH Hormones February 11, 2008 LH FSH TSH Posterior Target Pituitary Gland and Hormones Tissue Effects ADH, oxytocin The GH/IGF-I Axis Growth Hormone Somatostatin GHRH Hypothalamus • Synthesized in the anterior lobe of the pituitary gland in somatotroph cells PITUITARY • ~75% of GH in the pituitary and in circulation is Ghrelin 191 amino acid single chain peptide, 2 intra-molecular disulfide bonds GH Weight; 22kD • Amount of GH secreted: IGF-I Women: 500 µg/m2/day Synthesis IGF- I Men: 350 µg/m2/day LIVER Local IGF-I Synthesis CIRCULATION GH Secretion: Primarily Pulsatile Pattern of GH Secretion Regulation by two hypothalamic in a Healthy Adult hormones 25 Sleep 20 Growth - SMS Hormone 15 Somatostatin Releasing GHRH + GH (µg/L) Hormone Inhibitory of 10 Stimulatory of GH Secretion GH Secretion 05 0 GHRH induces GH Somatostatin: Decreases to allow 0900 2100 0900 synthesis and secretion Clocktime GH secretory in somatotrophs Bursts GH From: “Acromegaly” by Alan G. Harris, M.D. 1 Other Physiological Regulators of GH Secretion Pharmacologic Agents Used to Stimulate GH Secretion Amino Sleep Exercise Stress Acids Fasting Glucose Stimulate hypothalamic GHRH or Inhibit Somatostatin Hypothalamus GHRH SMS Hypoglycemia(Insulin) Pituitary L-dopa Arginine Clonidine GHRH + - SMS Pyridostigmine GH Target Tissues Metabolic & Growth Promoting GH Effects IGF-I Insulin-like growth factor I (IGF-I) Major Determinants of Circulating
    [Show full text]
  • Long-Term Treatment with Pegvisomant
    6 179 M Buchfelder and others Findings from pegvisomant use 179:6 419–427 Clinical Study in ACROSTUDY Long-term treatment with pegvisomant: observations from 2090 acromegaly patients in ACROSTUDY Michael Buchfelder1, Aart-Jan van der Lely2, Beverly M K Biller3, Susan M Webb4, Thierry Brue5, Christian J Strasburger6, Ezio Ghigo7, Cecilia Camacho-Hubner8, Kaijie Pan9, Joanne Lavenberg9, Peter Jönsson10 and Juliana H Hey-Hadavi8 1Department of Neurosurgery, University of Erlangen-Nürnberg, Erlangen, Germany, 2Department of Medicine, Erasmus University MC, Rotterdam, the Netherlands, 3Neuroendocrine Unit, Massachusetts General Hospital, Boston, Massachusetts, USA, 4Endocrinologia (Malalties de la Hipòfisi), Hospital Sant Pau, Universitat Autònoma de Barcelona (UAB), Barcelona, Spain, 5Department of Endocrinology, Centre de Référence des Maladies Rares d’Origine Hypophysaire, Hôpital de la Conception, Marseille, France, 6Department of Medicine for Endocrinology, Diabetes and Nutritional Correspondence Medicine, Charité Universitätsmedizin, Campus Mitte, Berlin, Germany, 7University Hospital Città Salute e Scienza, should be addressed Turin, Italy, 8Endocrine Care Global Medical Affairs, Pfizer Inc., New York City, New York, USA, 9Endocrine Care to M Buchfelder Global Clinical Affairs, Pfizer Inc., Collegeville, Pennsylvania, USA, and 10Endocrine Care, Pfizer Health AB, Email Sollentuna, Sweden Michael.Buchfelder@ uk-erlangen.de Abstract Objectives: ACROSTUDY is an international, non-interventional study of acromegaly patients treated with pegvisomant (PEGV), a growth hormone receptor antagonist and has been conducted since 2004 in 15 countries to study the long-term safety and efficacy of PEGV. This report comprises the second interim analysis of 2090 patients as of May 12, 2016. Methods: Descriptive analyses of safety, pituitary imaging and outcomes on PEGV treatment up to 12 years were performed.
    [Show full text]
  • Laboratory Investigations in the Diagnosis and Follow-Up of GH
    review Laboratory investigations in the diagnosis and follow-up of GH-related disorders 1 Medizinische Klinik und Poliklinik Katharina Schilbach1 IV, Klinikum der Universität http://orcid.org/0000-0002-8667-0296 München, Munich, Germany Martin Bidlingmaier1 http://orcid.org/0000-0002-4681-6668 ABSTRACT In addition to auxiological, clinical and metabolic features measurements of growth hormone (GH) and insulin-like growth factor I (IGF-I) complement our tools in diagnosis and follow-up of GH-related disorders. While comparably robust during the pre-analytical phase, measurement and interpretation of concentrations of both hormones can be challenging due to analytical issues and biological confounders. Assay methods differ in terms of antibody specificity, interference from binding proteins, reference preparations and sensitivity. GH assays have different specificity towards different GH- isoforms (e.g. 20 kDa GH, placental GH) and interference from the GH antagonist Pegvisomant. The efficacy to prevent binding protein interference is most important in IGF-I assays. Methodological differences between assays require that reference intervals and diagnostic cut-offs are assay-specific. Among biological variables, pubertal development and age are most relevant for IGF-I, making detailed Correspondence to: reference intervals mandatory for interpretation. GH has pulsatile secretion and short half-life. Its Martin Bidlingmaier concentration is modified by acute factors such as stress, exercise and sleep, but also by intake of oral Medizinische Klinik und Poliklinik IV Klinikum der Universität München estrogens and anthropometric factors (e.g. BMI). Other GH dependent biomarkers such as free IGF-I, Ziemssenstr. 1 IGF binding protein 3 (IGFBP 3) and acid labile subunit (ALS) have been proposed.
    [Show full text]
  • Understanding Acromegaly and What to Expect with SOMAVERT
    Indication and Important Safety Information Living with acromegaly can be challenging— Understanding acromegaly and SOMAVERT can help you stay on track what to expect with SOMAVERT INDICATION SOMAVERT is a prescription medicine for acromegaly. It is for patients whose disease has not been controlled by surgery or radiation, or patients for whom these options are not appropriate. The goal of treatment with SOMAVERT is to have a normal IGF-I level in the blood. Visit SOMAVERT.com for more information IMPORTANT SAFETY INFORMATION and to learn about patient support Do not use SOMAVERT® (pegvisomant for injection) if you are allergic to SOMAVERT or anything that is in it. Be sure to tell your doctor if you use narcotic painkillers (opioid medicines) because the dose of SOMAVERT may need to be changed. I thought there was no one who really got what it’s like to live with Blood sugar levels may go down when taking SOMAVERT. Be sure to tell your doctor if you use insulin or other acromegaly. Today I know there are people out there who can help medicines (oral hypoglycemic medicines) for diabetes. The dose of these medicines may need to be reduced when support others with acromegaly. I want you to know, there is hope you use SOMAVERT. “ and there are people to guide you on your journey. Some people who have used SOMAVERT have developed liver problems. These problems generally disappeared —Jenifer, actual SOMAVERT patient when those people stopped taking SOMAVERT. ” Stop the drug right away and call your doctor if you get any of these symptoms: • Your skin or the white part of your eyes turns yellow (jaundice) • Your urine turns dark • Your bowel movements (stools) turn light in color • You do not feel like eating for several days INDICATION • You feel sick to your stomach (nausea) SOMAVERT is a prescription medicine for acromegaly.
    [Show full text]
  • Long-Term Treatment of Acromegaly with Pegvisomant, a Growth Hormone Receptor Antagonist
    ARTICLES Long-term treatment of acromegaly with pegvisomant, a growth hormone receptor antagonist Aart Jan van der Lely, R Kent Hutson, Peter J Trainer, G Michael Besser, Ariel L Barkan, Laurence Katznelson, Anne Klibanski, Vivien Herman-Bonert, Shlomo Melmed, Mary Lee Vance, Pamela U Freda, Paul M Stewart, Keith E Friend, David R Clemmons, Gudmundur Johannsson, Stavros Stavrou, David M Cook, Lawrence S Phillips, Christian J Strasburger, Suzanne Hacker, Kenneth A Zib, Robert J Davis, John A Scarlett, Michael O Thorner Summary significantly decreased (p<0·05). Two patients experienced progressive growth of their pituitary tumours, and two Background Pegvisomant is a new growth hormone receptor other patients had increased alanine and asparate antagonist that improves symptoms and normalises insulin- aminotransferase concentrations requiring withdrawal from like growth factor-1 (IGF-1) in a high proportion of patients treatment. Mean pituitary tumour volume in 131 patients with acromegaly treated for up to 12 weeks. We assessed followed for a mean of 11·46 months (0·70) decreased by the effects of pegvisomant in 160 patients with acromegaly 0·033 cm3 (0·057; p=0·353). treated for an average of 425 days. Interpretation Pegvisomant is an effective medical treatment Methods Treatment efficacy was assessed by measuring for acromegaly. changes in tumour volume by magnetic resonance imaging, and serum growth hormone and IGF-1 concentrations in 152 Lancet 2001; 358: 1754–59 patients who received pegvisomant by daily subcutaneous See Commentary 1743 injection for up to 18 months. The safety analysis included 160 patients some of whom received weekly injections and Introduction are excluded from the efficacy analysis.
    [Show full text]
  • RECEPTOR ANTAGONISTS Pegvisomant
    11 RECEPTOR ANTAGONISTS Pegvisomant: structure and function S Pradhananga, I Wilkinson and R J M Ross Division of Clinical Sciences, University of Sheffield, Northern General Hospital, Sheffield S5 7AU, UK (Requests for offprints should be addressed to R Ross, Clinical Sciences, Northern General Hospital, Sheffield S5 7AU, UK; Email: [email protected]) Abstract Pegvisomant is the pegylated form of mutant growth hormone (B2036). B2036 has increased affinity in one binding site and lowered affinity in its second binding site, it has been shown that this molecule still enables dimerisation of the growth hormone receptor at the cell surface but does not allow the necessary conformational changes for signalling. Pegylation decreases the antagonistic activity of B2036, however the rate of clearance of the pegylated B2036 is greatly reduced compared to the unpegylated form. Even though the antagonistic activity of pegvisomant is lower than B2036, the reduced rate of clearance makes it an effective clinical drug for the treatment of conditions such as acromegaly. Journal of Molecular Endocrinology (2002) 29, 11–14 Introduction gated to this core B2036 molecule. Pegylation has little effect on the affinity of pegvisomant for GHBP The growth hormone (GH) antagonist, pegviso- but reduces affinity for the cell surface receptor. mant, is the first specific growth hormone receptor Therefore, there is a high dose requirement for antagonist to be developed for the treatment of pegvisomant in clinical practice; however pegy- acromegaly (Trainer et al. 2000, van der Lely et al. lation has a benefit in that it increases the half life 2001). In this review, the relationship between of clearance.
    [Show full text]
  • Pegvisomant Interference in GH Assays Results in Underestimation of GH Levels
    CLINICAL STUDY Pegvisomant interference in GH assays results in underestimation of GH levels A N Paisley, K Hayden2, A Ellis3, J Anderson1, G Wieringa1 and P J Trainer Department of Endocrinology, Christie NHS Trust, Wilmslow Road, Withington, Manchester M20 4BX, UK, 1Department of Biochemistry, Christie Hospital, Manchester, UK, 2Department of Clinical Biochemistry, University Hospital Aintree, Liverpool, UK and 3UK NEQAS, Department of Clinical Biochemistry, Royal Infirmary, Edinburgh, UK (Correspondence should be addressed to P J Trainer; Email: [email protected]) Abstract Introduction: Pegvisomant use in acromegaly negates the use of GH levels to monitor disease activity. To Normalisation of IGF-I has been reported in 97% patients on this therapy with concomitant improvement in associated intermediary metabolic abnormalities such as glucose intolerance (7). Pegvisomant is commenced at a starting dose of of 20 000 mg/l. In all of these assays, measured GH levels then fell progressively with further increases in pegvisomant concentrations (Fig. 1). Sample 2 (Baseline GH w3.9 mg/l) For most assays, measured GH fell as the pegvisomant concentration rose. Exceptions were the Beckman Access Dxl assay where a ninefold increase in measured GH was seen at 30 mg/l and the Diasorin assay where measured levels increased to 10 mg/l, in both cases at pegvisomant concentrations of 9000 mg/l. Modest increases were also seen in the Tosoh assay. As before GH levels then fell progressively as the pegvisomant concentration increased (Fig. 2). Sample 3 (Baseline GH w7.7 mg/l) Results were similar to those reported when baseline GH was w3.9 mg/l where a progressive fall in measured GH was seen with increasing pegvisomant concen- trations.
    [Show full text]
  • Pasireotide: a New Option for Treatment of Acromegaly
    Available online at www.medicinescience.org Medicine Science CASE REPORT International Medical Journal Medicine Science 2020;9(2):518-21 Pasireotide: A new option for treatment of acromegaly Filiz Eksi Haydardedeoglu, Okan Bakiner Baskent University Faculty of Medicine, Department of Endocrinology and Metabolism, Adana,Turkey Received 28 April 2020; Accepted 28 May 2020 Available online 03.06.2020 with doi: 10.5455/medscience.2020.09.9253 Abstract Acromegaly is characterized by excess production of growth hormone (GH) and insulin-like growth factor-1 (IGF-1). Although surgery is the first treatment option, soma- tostatin receptor analogs (SSRAs) can be used in selected cases which surgery is contraindicated. A patient who has been diagnosed as acromegaly was admitted to our hospital. Hypophyseal adenomectomy had been performed one year ago. The patient was taking lanreotide for 6 months and disease was not under control. She had loss of vision. Although she had a residual tumor, second surgery couldn’t be performed due to the location of tumor. The patient was followed for 6 years. Radiotherapy and other medical treatment options were tried but none of them were successful. At the end of six years, pasireotide was started. At the third month of treatment, biochemical control was achieved. Pasireotide may be a treatment option for some patients with acromegaly that are inadequately controlled by first generation SSRAs. Keywords: Acromegaly, pasireotide, somatostatin analog Introduction treatment option in most patients especially in those including a microadenoma or intrasellar macroadenoma. In experienced centers, Acromegaly is a rare endocrine disease caused by excess secretion of biochemical remission rates can be achieved by surgery up to 80%.
    [Show full text]
  • Sensitivity and Specificity of the Macimorelin Test for Diagnosis of AGHD
    ID: 20-0491 10 1 J M Garcia et al. Post hoc analyses of 10:1 76–83 macimorelin test for AGHD RESEARCH Sensitivity and specificity of the macimorelin test for diagnosis of AGHD Jose M Garcia1, Beverly M K Biller2, Márta Korbonits3, Vera Popovic4, Anton Luger5, Christian J Strasburger6, Philippe Chanson7, Ronald Swerdloff8, Christina Wang8, Rosa Rosanna Fleming9, Fredric Cohen9, Nicola Ammer10, Gilbert Mueller10, Nicky Kelepouris11, Frank Strobl11, Vlady Ostrow11 and Kevin C J Yuen12 1GRECC VA Puget Sound HCS/University of Washington, Seattle, Washington, USA 2Massachusetts General Hospital, Neuroendocrine Unit, Boston, Massachusetts, USA 3Barts and the London School of Medicine, Queen Mary University of London, Endocrinology, London, UK 4University of Belgrade, Medical Faculty, Belgrade, Serbia 5Division of Endocrinology and Metabolism, Medical University, General Hospital, Vienna, Austria 6Charité-Universitätsmedizin, Clinical Endocrinology CCM, Berlin, Germany 7Assistance Publique-Hôpitaux de Paris, Hôpital de Bicêtre, Service d’Endocrinologie et des Maladies de la Reproduction, Centre de Référence des Maladies Rares de l’Hypophyse, and Université Paris-Saclay, Univ. Paris-Sud, Inserm, Signalisation Hormonale, Physiopathologie Endocrinienne et Métabolique, Le Kremlin-Bicêtre, France 8The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, California, USA 9Strongbridge Biopharma, Trevose, Pennsylvania, USA 10Aeterna Zentaris GmbH, Frankfurt, Hessen, Germany 11Novo Nordisk Inc., Plainsboro, New Jersey, USA 12University of Arizona College of Medicine and Creighton School of Medicine, Barrow Pituitary Center, Barrow Neurological Institute, Phoenix, Arizona, USA Correspondence should be addressed to N Kelepouris: [email protected] Abstract Objective: The macimorelin test is approved for the diagnosis of adult growth hormone Key Words deficiency (AGHD) based on its efficacy vs the insulin tolerance test (ITT).
    [Show full text]