New Drugs Update: Clinical, Fiscal, and PDL Edits for July 2023
Explore the latest updates on new drugs including clinical indications and edits for Daybue, Filspari, Lamzede, Leqembi, Oxbryta, and Furoscix. The fiscal and PDL edits cover medications like Amjevita and Atorvaliq. Stay informed about the pharmaceutical landscape with these detailed insights.
Download Presentation
Please find below an Image/Link to download the presentation.
The content on the website is provided AS IS for your information and personal use only. It may not be sold, licensed, or shared on other websites without obtaining consent from the author. Download presentation by click this link. If you encounter any issues during the download, it is possible that the publisher has removed the file from their server.
E N D
Presentation Transcript
http://www.nmcfamilyresourcecenter.com/images/dss.gif MO HEALTHNET PHARMACY PROGRAM NEW DRUGS AND EDITS WITH NO ANNUAL CHANGES MHD JULY 2023 ADVISORY COMMITTEE MEETINGS OLIVIA RUSH, PHARM D PROGRAM INTEGRITY PHARMACIST
NEW DRUGS CLINICAL EDITS Common Trade Name Ingredient Name Indications Daybue 200mg/mL Solution Trofinetide Indicated for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older. Daybue Clinical Edit To be discussed today Filspari 200mg Tablet Filspari 400mg Tablet Sparsentan Indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression, generally a urine protein-to- creatinine ratio 1.5 g/g. Filspari Clinical Edit To be discussed today Lamzede 10mg Vial Velmanase Alfa-tycv Indicated for the treatment of non-central nervous system manifestations of alpha- mannosidosis in adult and pediatric patients. Enzyme Deficiency, Select Agents Clinical Edit Leqembi 200mg/2mL Vial Leqembi 500mg/5mL Vial Lecanemab-irmb Indicated for the treatment of Alzheimer s disease. Anti-Amyloid Monoclonal Antibody Clinical Edit Oxbryta 300mg Tablet Voxelotor Indicated for the treatment of sickle cell disease in adults and pediatric patients 4 years of age and older. Sickle Cell Disease Clinical Edit 2
NEW DRUGS FISCAL EDITS Common Trade Name Ingredient Name Indications Furoscix 80mg/10mL On-Body Kit Furosemide Indicated for the treatment of congestion due to fluid overload in adults with NYHA Class II/III chronic heart failure. Prior Authorization Required Fiscal Edit 3
NEW DRUGS PDL EDITS Common Trade Name Ingredient Name Indications Amjevita 20mg/0.4mL Syringe Amjevita 40mg/0.8mL Syringe Amjevita 40mg/0.8mL Autoinjector Adalimumab-atto Indicated for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn s disease, ulcerative colitis and plaque psoriasis. TIMS, TNF Inhibitors PDL Edit Non-Preferred To be discussed today Biosimilar vs Reference Products Fiscal Edit Non-Preferred Aponvie 32mg/4.4mL Vial Aprepitant Indicated for the management of postoperative nausea and vomiting. Antiemetic 5-HT3 and NK1 Agents, Injectable PDL Edit Non-Preferred 4
NEW DRUGS PDL EDITS Common Trade Name Ingredient Name Indications Atorvaliq 20mg/5mL Suspension Atorvastatin Calcium Indicated: To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD. o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia Statins (HMG-CoA Reductase Inhibitors) and Combinations PDL Edit Non-Preferred 5
NEW DRUGS PDL EDITS Common Trade Name Ingredient Name Indications Briumvi 150mg/6mL Vial Ublituximab-xiiy Indicated for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Multiple Sclerosis Agents, Injectable PDL Edit Preferred To be discussed today Erleada 240mg Tablet Apalutamide Indicated for the treatment of patients with: Metastatic castration-sensitive prostate cancer Non-metastatic castration-resistant prostate cancer Antiandrogenic Agents PDL Edit Non-Preferred Konvomep 2-84mg/mLOral Suspension Omeprazole/ Sodium Bicarbonate Indicated in adults for: Treatment of active benign gastric ulcer Reduction of risk of upper gastrointestinal bleeding in critically ill patients Proton-Pump Inhibitors (PPIs) PDL Edit Non-Preferred Lupron Depot-Ped45mg 6mo Kit Leuprolide Acetate Indicated in the treatment of children with central precocious puberty. Luteinizing Hormone Releasing Hormone (LHRH)/Gonadotropin Releasing Hormone (GnRH) Agents, Non-Oral PDL Edit Non-Preferred To be discussed today Dose Opt Fiscal Edit 1 kit per 143 days Naloxone 10mg Auto-Injector Naloxone HCl Indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. Opioid Emergency Reversal Agents PDL Edit Non-Preferred 6
NEW DRUGS PDL EDITS Common Trade Name Ingredient Name Indications Norgesic 25-385-30mg Tablet Orphenadrine/Aspirin/Caffeine Indicated for: Symptomatic relief of mild pain to moderate pain of acute musculoskeletal disorders Adjunct for the relief of discomfort associated with acute painful musculoskeletal conditions Skeletal Muscle Relaxants PDL Edit Non-Preferred Orenitram Month1 Titration Kit Orenitram Month2 Titration Kit Orenitram Month3 Titration Kit Treprostinil Diolamine Indicated for the treatment of pulmonary arterial hypertension (WHO Group 1) to delay disease progression and to improve exercise capacity. Pulmonary Arterial Hypertension (PAH) Agents, Prostacyclin Pathway Agonists, Oral PDL Edit Preferred Oxybutynin 2.5mg Tablet Oxybutynin Chloride Indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder. Urinary Tract Antispasmodics PDL Edit Non-Preferred To be discussed today Ozempic 0.25-0.5mg Dose Pen Semaglutide Indicated for the treatment of type 2 diabetes mellitus. GLP-1 Receptor Agonist & Combination Agents PDL Edit Non-Preferred To be discussed today Pradaxa 20mg Pellet Pack Pradaxa 30mg Pellet Pack Pradaxa 40mg Pellet Pack Pradaxa 50mg Pellet Pack Pradaxa 110mg Pellet Pack Pradaxa 150mg Pellet Pack Dabigatran Etexilate Mesylate Indicated for the risk reduction, and treatment, of venous thromboembolic events in pediatric patients 3 months to <12 years of age who have been treated with a parenteral anticoagulant for at least 5 days. Anticoagulants, Oral and Subcutaneous PDL Edit Non-Preferred Trial and failure of Xarelto suspension for participants <10 years of age Dose Opt Fiscal Edit 20 and 150mg: 2 per day 30, 40, 50 and 110mg: 4 per day 7
NEW DRUGS PDL EDITS Common Trade Name Ingredient Name Indications Rezvoglar 100 Unit/mL Kwikpen Insulin Glargine-aglr Indicated to improve glycemic control in: Adults and pediatric patients with type 1 diabetes mellitus Adults with type 2 diabetes mellitus Insulins, Long Acting PDL Edit Non-Preferred To be discussed today Biosimilar vs Reference Products Fiscal Edit Non-Preferred Sogroya 5mg/1.5mL Pen Sogroya 10mg/1.5mL Pen Sogroya 15mg/1.5mL Pen Somapacitan-beco Indicated for the: Replacement of endogenous growth hormone in adults with growth hormone deficiency Treatment of pediatric patients aged 2.5 years and older who have growth failure due to inadequate secretion of endogenous growth hormone Growth Hormone Agents, Somatropin PDL Edit Non-Preferred To be discussed today Sunlenca 463.5mg/1.5mL Vial Sunlenca 300mg Tablet Lenacapavir Sodium Indicated for use in combination with other antiretroviral(s) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment- experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations. Antiretroviral Therapy (ART) PDL Edit Non-Preferred, Group B Non-STR Takhzyro 150mg/mL Syringe Landelumab-flyo Indicated for prophylaxis to prevent attacks of hereditary angioedema in pediatric patients 2 to <12 years of age. Hereditary Angioedema Treatment Agents PDL Edit Preferred Tezspire 210mg/1.91mL Pen Tezepelumab-ekko Indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. TIMS, Misc. Allergy and Asthma Related Monoclonal Antibodies PDL Edit Non-Preferred To be discussed today 8
NEW DRUGS OPEN ACCESS Common Trade Name Ingredient Name Indications Syfovre 15mg/0.1mL Vial Pegcetacoplan/pf Indicated for the treatment of geographic atrophy secondary to age-related macular degeneration. 9
CLINICAL & FISCAL EDITS: NO ANNUAL CHANGES Ampyra Clinical Edit Besremi Clinical Edit C5 Complement Inhibitors Clinical Edit CAR-T Cell Therapy Clinical Edit Crysvita Clinical Edit Duchenne Muscular Dystrophy (DMD) Clinical Edit Gamifant Clinical Edit Iron Injectable Step Therapy Edit Koselugo Clinical Edit Luxturna Clinical Edit Neuromyelitis Optica Spectrum Disorder (NMOSD) Clinical Edit Reblozyl Clinical Edit TIMs, Small Molecule Janus Kinase (JAK) Inhibitors Clinical Edit Tolvaptan Clinical Edit Vyvgart Clinical Edit Zometa Clinical Edit 10
PREFERRED DRUG LIST EDITS: NO ANNUAL CHANGES Alpha-Glucosidase Inhibitors Amylin Analogs Biguanides & Combinations Cyropyrin-Associated Periodic Syndrome (CAPS) DPP-IV Inhibitors & Combinations Erythropoiesis Stimulating Agents GLP-1 Receptor Agonists & Combination Agents Insulin, Mixed Insulin, Non-Analogs Insulin, Rapid Acting Luteinizing Hormone Releasing Hormone (LHRH)/Gonadotropin Releasing Hormone (GnRH) Agents, Oral Meglitinides Methotrexate Agents Psoriasis Agents, Oral Sulfonylureas, Second Generation Thiazolidinediones & Combinations TIMs, IL17 Antibody/IL17 Receptor Antagonists TIMs, IL23 Inhibitors and IL23/IL12 Inhibitors 11
