New Drugs and Edits in MO HealthNet Pharmacy Program Advisory Committee Meeting - April 2023
The MO HealthNet Pharmacy Program Advisory Committee Meeting in April 2023 discusses new drugs and clinical/fiscal edits. Notable introductions include Etranacogene Dezaparvovec-drlb for Hemophilia B, Noxafil for prophylaxis of fungal infections, and Tzield for delaying Stage 3 type 1 diabetes onset. Fiscal edits feature Auvelity ER for major depressive disorder and Pedmark for reducing ototoxicity risk. Rebyota is introduced for preventing recurrent Clostridioides difficile infection. Detailed medical necessity criteria and prior authorizations are highlighted for these new medications.
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http://www.nmcfamilyresourcecenter.com/images/dss.gif MO HEALTHNET PHARMACY PROGRAM NEW DRUGS AND EDITS WITH NO ANNUAL CHANGES MHD APRIL 2023 ADVISORY COMMITTEE MEETINGS OLIVIA RUSH, PHARM D PROGRAM INTEGRITY PHARMACIST
NEW DRUGS CLINICAL EDITS Common Trade Name Ingredient Name Indications Hemgenix *Please see the Drugs with Coverage Limitations and New Drug Review document for all strengths. Etranacogene Dezaparvovec-drlb Indicated for the treatment of adults with Hemophilia B (congenital Factor IX deficiency) who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes. Hemgenix Clinical Edit To be discussed today Noxafil 300mg PowderMix Suspension Posaconazole Indicated for the prophylaxis of invasive Aspergillus and Candida infections in pediatric patients 2 years of age and older (who weigh 40 kg or less) who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant recipients with graft-versus-host disease or those with hematologic malignancies with prolonged neutropenia from chemotherapy. Systemic Antifungals Clinical Edit Must provide medical necessity as to why the participant cannot utilize the immediate release oral suspension To be discussed today Tzield 2mg/2mL Vial Teplizumab-mzwv Indicated to delay the onset of Stage 3 type 1 diabetes in adults and pediatric patients aged 8 years and older with Stage 2 type 1 diabetes. Tzield Clinical Edit To be discussed today 2
NEW DRUGS FISCAL EDITS Common Trade Name Ingredient Name Indications Auvelity ER 45mg-105mg Tablet Dextromethorphan HBr/ Bupropion Indicated for the treatment of major depressive disorder in adults. Prior Authorization Required Fiscal Edit Must provide medical necessity as to why the participant cannot utilize: Other generic therapies for depression AND Individual ingredients Ermeza 150mcg/5mL Oral Solution Levothyroxine Sodium Indicated in adult and pediatric patients, including neonates, for: Hypothyroidism: as replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism Pituitary thyrotropin (Thyroid-Stimulating Hormone, TSH) suppression: as an adjunct to surgery and radioiodine therapy in the management of thyrotropin- dependent well-differentiated thyroid cancer Prior Authorization Required Fiscal Edit Must provide medical necessity as to why the participant cannot utilize generic levothyroxine tablets 3
NEW DRUGS FISCAL EDITS Common Trade Name Ingredient Name Indications Pedmark 12.5 Gram/100mL Vial Sodium Thiosulfate Indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors. Prior Authorization Required Fiscal Edit Clinical consultant review required for medical necessity Rebyota Rectal Suspension Fecal Microbiota, Live-jslm Indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older, following antibiotic treatment for recurrent CDI. Prior Authorization Required Fiscal Edit Approval Criteria: Prescribed by or in consultation with a gastroenterologist, infectious disease specialist, or other specialist in the treated disease state Age 18 years Diagnosis of at least 1 recurrent episode of CDI ( 2 total CDI episodes) Current episode of CDI must be controlled ( 3 unformed/loose stools/day for 2 consecutive days) Positive stool test for C. difficile within 30 days before prior authorization request Quantity limit of 1 treatment course FMT prior to covering Rebyota 4
NEW DRUGS PDL EDITS Common Trade Name Ingredient Name Indications Allopurinol 200mg Tablet Allopurinol Indicated for the management of patients with: Signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) Leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels Recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients Antihyperuricemic Agents PDL Edit Non-Preferred Prior Authorization Required Fiscal Edit Must provide medical necessity as to why the participant cannot utilize generic allopurinol 100mg or 300mg tablets Entadfi 5mg 5mg Capsule Finasteride/ Tadalafil Indicated to initiate treatment of the signs and symptoms of benign prostatic hyperplasia in men with an enlarged prostate for up to 26 weeks. Benign Prostatic Hyperplasia Agents PDL Edit Non-Preferred Documented diagnosis of benign prostatic hyperplasia Denial Criteria: Documented diagnosis of erectile dysfunction OR Claim history documents use of nitrates or ritonavir therapy in the past 30 days OR Documented contraindication to tadalafil: History of MI in the past 90 days History of unstable angina History of NYHA Class II or greater heart failure History of stroke in the past 6 months History of uncontrolled arrhythmias 5
NEW DRUGS PDL EDITS Common Trade Name Ingredient Name Indications Fragmin 10,000 Unit/4mL Vial Dalteparin Sodium, Porcine Indicated for: Prophylaxis of ischemic complications in unstable angina and non-Q-wave myocardial infarction Prophylaxis of deep vein thrombosis Extended treatment of symptomatic venous thromboembolism (VTE) in adults with cancer Treatment of VTE in pediatrics Anticoagulants, Oral and Subcutaneous PDL Edit Preferred Fylnetra 6mg/0.6mL Syringe Pegfilgrastim-pbbk Indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Colony Stimulating Factors PDL Edit Non-Preferred Leuprolide Acetate 22.5 mg Vial Leuprolide Acetate Indicated for palliative treatment of advanced prostate cancer. Luteinizing Hormone Release Hormone (LHRH)/Gonadotropin Releasing Hormone (GnRH) Agents, Non-Oral PDL Edit Non-Preferred 6
NEW DRUGS PDL EDITS Common Trade Name Ingredient Name Indications Methylphenidate ER 45mg Tab Methylphenidate ER 63mg Tab Methylphenidate HCL Indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults (up to the age of 65 years) and pediatric patients 6 years of age and older. ADHD, Methylphenidate, Long Acting PDL Edit Non-Preferred Must provide medical necessity as to why the participant cannot utilize generic Concerta Rolvedon 13.2mg/0.6 mL Syringe Eflapegrastim-xnst Indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. Colony Stimulating Factors PDL Edit Non-Preferred Skyrizi 180mg/1.2mL On-Body Risankizumab-rzaa Indicated in adults for the treatment of moderately to severely active Crohn's disease. Targeted Immune Modulators, IL-23 Inhibitors and IL-23/IL-12 Inhibitors PDL Edit Non-Preferred 7
NEW DRUGS PDL EDITS Common Trade Name Ingredient Name Indications Stimufend 6mg/0.6mL Syringe Pegfilgrastim-fpgk Indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Colony Stimulating Factors PDL Edit Non-Preferred Tascenso ODT 0.5mg Tablet Fingolimod Lauryl Sulfate Indicated for the treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Multiple Sclerosis Agents, Oral PDL Edit Non-Preferred Cyclosporine Indicated for the treatment of vernal keratoconjunctivitis in children and adults. Keratoconjunctivitis Agents PDL Edit Non-Preferred Requires therapeutic trial of both brand Restasis and Cequa Verkazia 0.1% Eye Emulsion Dextroamphetamine Indicated for the treatment of attention-deficit hyperactivity disorder in adults and children 6 years of age and older. ADHD, Amphetamine, Long Acting PDL Edit Non-Preferred Xelstrym 4.5mg/9hr Patch Xelstrym 9mg/9hr Patch Xelstrym 13.5mg/9hr Patch Xelstrym 18mg/9hr Patch 8
NEW DRUGS OPEN ACCESS Common Trade Name Ingredient Name Indications Relyvrio 3GM-1GM Powder Pkt Sodium Phenylbutyrate/ Taurursodiol Indicated for the treatment of amyotrophic lateral sclerosis in adults. 9
CLINICAL & FISCAL EDITS: NO ANNUAL CHANGES Acne or Rosacea, Select Topical Agents Fabry Disease Givlaari Imcivree Isturisa Megestrol Nulibry Oxervate Oxlumo Scenesse Sickle Cell Disease Spravato Systemic Antifungals Tavneos Voxzogo Zokinvy Zulresso 10
PREFERRED DRUG LIST EDITS: NO ANNUAL CHANGES Actinic Keratosis Agents, Topical Androgenic Agents Beta Adrenergic Agents, Short Acting Corticosteroids, Ophthalmic Soft Antibiotics, Inhaled Anticholinergics, LABA Combinations Anticholinergics, Short Acting and Combinations Inhaled Corticosteroids, Oral Inhaled Corticosteroids, Topical Cough/Cold Preparations Fluoroquinolones, Ophthalmic Fluoroquinolones, Otic Hepatitis C Agents Antifungals, Topical Antihistamines & Antihistamine/Decongestant Combinations, 2nd Generation Antihistamines, Intranasal Leukotriene Receptor Modifiers Mast Cell Stabilizers, Ophthalmic NSAIDs, Ophthalmic Antiparasitics, Topical Antivirals, Herpes Oral Benzoyl Peroxide/Antibiotic Combinations Pancreatic Enzymes Retinoids, Topical Beta Adrenergic Agents, Nebulized 11
