New Drugs and Clinical Edits Overview in MO HealthNet Pharmacy Program
Explore the latest pharmaceutical additions and clinical edits in the MO HealthNet Pharmacy Program for various conditions like Fabry disease, cystic fibrosis, generalized myasthenia gravis, and more. Discover new medications such as Elfabrio, Kalydeco, Rystiggo, and Trikafta along with their indications and dosage optimizations. Stay informed about trade names, ingredients, and clinical recommendations for treating different health issues.
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MO HealthNet Pharmacy Program New Drugs and Edits with No Annual Changes MHD October 2023 Advisory Committee Meetings Olivia Rush, Pharm.D. Program Integrity Pharmacist
New Drugs Clinical Edits Common Trade Name Ingredient Name Indications Elfabrio 20mg/10mL Vial Pegunigalsidasealfa-iwxj Indicated for the treatment of adults with confirmed Fabry disease. Fabry Disease Clinical Edit Kalydeco 5.8mg Granules Pkt Kalydeco 13.4mg Granules Pkt Ivacaftor Indicated for the treatment of cystic fibrosis (CF) in patients age 1 month and older who have at least one mutation in the CFTR gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro. Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Modulators Clinical Edit Rystiggo 280mg/2mLVial * To be discussed today Rozanolixizumab-noli Indicated for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive. Generalized Myasthenia Gravis Clinical Edit (formerly Vyvgart Clinical Edit) Trikafta 80-40-60mg/59.5mg Pkt Trikafta 100-50-75mg/75mg Pkt Elexacaftor/Tezacaftor/ Ivacaftor Indicated for the treatment of cystic fibrosis (CF) in patients aged two years and older who have at least one F508del mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data. Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Modulators Clinical Edit Dose Optimization Fiscal Edit 2 packets per day
New Drugs Clinical Edits Common Trade Name Ingredient Name Indications Tuxarin ER 8-54.3mg Tablet Chlorpheniramine/ Codeine Phosphate Indicated for the relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults 18 years of age and older. Opioids Short Acting Clinical Edit Skyclarys 50mg Capsule * To be discussed today Omaveloxolone Indicated for the treatment of Friedreich s ataxia in adults and adolescents aged 16 years and older. Skyclarys Clinical Edit 9PFU/mL Vial Vyjuvek 5x10 * To be discussed today Beremagene geperpavec-svdt Indicated for the treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene. Vyjuvek Clinical Edit Vyvgart Hytrulo 1,008mg-11,200 Unit Vial * To be discussed today Efgartigimodalfa / Hyaluronidase-qvfc Indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. Generalized Myasthenia Gravis Clinical Edit (formerly Vyvgart Clinical Edit)
New Drugs Clinical Edits Common Trade Name Ingredient Name Indications Xenpozyme 4mg Vial * To be discussed today Olipudase alfa-rpcp Indicated for treatment of non central nervous system manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients. Enzyme Deficiency, Select Agents Clinical Edit Zolgensma14.6-15.0kg Kit Zolgensma15.1-15.5kg Kit Zolgensma15.6-16.0kg Kit Zolgensma16.1-16.5kg Kit Zolgensma17.1-17.5kg Kit Zolgensma18.1-18.5kg Kit Zolgensma18.6-19.0kg Kit Zolgensma19.1-19.5kg Kit Zolgensma19.6-20.0kg Kit Zolgensma 20.1-20.5kg Kit *To be discussed today Onasemnogeneabeparvovec- xioi Indicated for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Spinal Muscular Atrophy (SMA) Clinical Edit
New Drugs Fiscal Edits Common Trade Name Ingredient Name Indications Citranatal Medley Softgel Vit D3/ Vit E/ Vit B6/ Folic Acid/ Calcium Citrate/ Iron/ DHA Indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and non-lactating mothers. Prior Authorization Required Fiscal Edit Must show medical necessity as to why MHD s preferred prenatal vitamins cannot be utilized Cuvrior 300mg Tablet Trientine Indicated for the treatment of adult patients with stable Wilson's disease who are de- coppered and tolerant to penicillamine. Prior Authorization Required Fiscal Edit Must show medical necessity as to why generic trientine cannot be utilized Vit C/ Vit D/ Thiamin/ Riboflovin/ Vitamin B6/ Folate/ Vit B12/ Calcium Carbonate/ Iron/ Iodine Natal NV Tablet Indicated for use throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. Prior Authorization Required Fiscal Edit Must show medical necessity as to why MHD s preferred prenatal vitamins cannot be utilized
New Drugs Fiscal Edits Common Trade Name Ingredient Name Indications Omisirge Infusion Kit Omidubicel-onlv Indicated for use in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection. Prior Authorization Required Fiscal Edit Approval Criteria: Must meet all of the following criteria: Participant is aged 12 years or older; Has a documented diagnosis of a hematologic malignancy planned for umbilical cord blood transplantation (UCBT) following myeloablative conditioning; Is a candidate for myeloablativeallo-hematopoietic stem cell transplantation (HSCT); AND Per prescriber attestation, does NOT have a readily available matched related donor OR matched unrelated donor OR mismatched unrelated donor OR haploidenticaldonor Approval Period: 1 time administration only Denial Criteria: Therapy will deny with presence of one of the following: Documentation of prior allo-HSCT; Active or uncontrolled infection; Active or symptoms of central nervous system disease; OR Participant is currently pregnant
New Drugs Fiscal Edits Common Trade Name Ingredient Name Indications Tirosint 37.5mcg Capsule Tirosint 44mcg Capsule Tirosint 62.5mcg Capsule Levothyroxine sodium Indicated for adults and pediatric patients 6 years and older with: 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 Approval Criteria: Must meet one of the following criteria: Trial of Synthroid or generic Synthroid (90 out of 120 days); OR Documented evidence of adverse drug reaction to Synthroid or generic Synthroid Veozah 45mg Tablet Fezolinetant Indicated for the treatment of moderate to severe vasomotor symptoms due to menopause. Prior Authorization Required Fiscal Edit Approval Criteria: Must meet all of the following criteria: Baseline bloodwork to evaluate for hepatic function and injury before beginning Veozah and at 3 months, 6 months, and 9 months after initiation of therapy and when symptoms suggest liver injury Denial Criteria: Therapy will deny with presence of one of the following: Cirrhosis; Severe renal impairment; OR End stage renal disease
New Drugs Fiscal Edits Common Trade Name Ingredient Name Indications Vowst Capsule Fecal microbiota spores, live- brpk Indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI). Prior Authorization Required Fiscal Edit Approval Criteria: Must meet all of the following criteria: Prescribed by or in consultation with a gastroenterologist, infectious disease specialist, or other specialist in the treated disease state; Participant is aged 18 years and older; Diagnosis of at least 1 recurrent episode of CDI ( 2 total CDI episodes); Complete antibacterial treatment for recurrent CDI 2 to 4 days before initiating treatment; Symptom resolution, defined as < 3 unformed stools in 24 hours for 2 or more consecutive days prior to treatment; Positive stool test for C. difficile within 30 days before prior authorization request; AND Quantity limit of 1 treatment course
New Drugs Preferred Drug List Edits Common Trade Name Ingredient Name Indications Amjevita (CF) 10mg/0.2mL Syringe Adalimumab-atto Indicated for rheumatoidarthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativaand uveitis. TIMS, TNF Inhibitors PDL Edit Non-Preferred Biosimilar vs Reference Products Fiscal Edit Non-Preferred Austedo XR 6mg Tablet Austedo XR 12mg Tablet Austedo XR 24mg Tablet Austedo XR Titration Kit (Week 1-4) Deutetrabenazine Indicated in adults for the treatment of: Chorea associated with Huntington s disease or Tardive dyskinesia Vesicular Monoamine Transporter 2 (VMAT2) Inhibitors PDL Edit Non-Preferred Dose Optimization Fiscal Edit 1 tablet per day 6mg 2 tablets per day 12mg and 24mg Prior Authorization Required Fiscal Edit Must show medical necessity as to why IR cannot be utilized Gralise ER 450 Tablet Gralise ER 750 Tablet Gralise ER 900 Tablet Gabapentin Indicated for the management of postherpeticneuralgia. Neuropathic Pain Agents PDL Edit Non-Preferred Dose Optimization Fiscal Edit 4 tablets per day 450mg 2 tablets per day 750mg and 900mg High Risk Therapies Clinical Edit
New Drugs Preferred Drug List Edits Common Trade Name Ingredient Name Indications Inpefa 200mg Tablet Sotagliflozin Indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with: Heart failure Type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors Sodium-Glucose Co-Transporter (SGLT) Inhibitors & Combination Agents PDL Edit Non-Preferred Dose Optimization Fiscal Edit 2 tablets per day Liqrev 10mg/ml OraL Susp * To be discussed today Sildenafil citrate Indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening. Pulmonary Arterial Hypertension (PAH) Agents,Phosphodiesterase-5 (PDE5) and Soluble Guanylate Cyclase (SGC) Stimulators PDL Edit Non-Preferred Prior Authorization Required Fiscal Edit Must show medical necessity why Revatio cannot be utilized
New Drugs Preferred Drug List Edits Common Trade Name Ingredient Name Indications Mekinist0.05mg/mL Solution Trametinibdimethyl sulfoxide Indicated, as a single agent in BRAF-inhibitor treatment-na ve patients or in combination with dabrafenib, for the treatment of patients with unresectableor metastatic melanoma with BRAF V600E or V600K mutations. Mitogen-activated Extracellular Kinase Inhibitors (MEKi) & Braf Kinase Inhibitors (BRAFi) PDL Edit Non-Preferred Prior Authorization Required Fiscal Edit For those 10 years, must provide medical necessity as to why Mekinisttablets cannot be utilized 15 Day Supply Oral Oncology Fiscal Edit MetforminHCL 625mg Tablet Metformin Indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. Biguanide and Combination Agents PDL Edit Non-Preferred Prior Authorization Required Fiscal Edit Must provide medical necessity as to why other generic strengths of metformin cannot be utilized Miebo 100% Eye Drop * To be discussed today Perfluorohexyloctane/PF Indicated for the treatment of the signs and symptoms of dry eye disease (DED). Keratoconjunctivitis Agents PDL Edit Non-Preferred
New Drugs Preferred Drug List Edits Common Trade Name Ingredient Name Indications Methoxypeg-epoetinbeta Mircera 120mcg/0.3mL Syringe Indicated for the treatment of anemia associated with chronic kidney disease (CKD) in: Adult patients on dialysis and adult patients not on dialysis Pediatric patients 5 to 17 years of age on hemodialysis who are converting from another ESA after their hemoglobin level was stabilized with an ESA Erythropoiesis Stimulating Agents PDL Edit Non-Preferred Nasonex 24HR Allergy 50mcg Spray Mometasone furoate Indicated for the treatment of the nasal symptoms of seasonal allergic and perennial allergic rhinitis. Corticosteroids & Rhinitis Agents, Intranasal PDL Edit Non-Preferred Indicated for the chronic management of adult and pediatric patients weighing 20 kg or greater and with a body surface area of 1.2 m2 or greater, with urea cycle disorders involving deficiencies of carbamylphosphatesynthetase, ornithine transcarbamylase, or argininosuccinicacid synthetase. Urea Cycle Disorder Agents PDL Edit Non-Preferred Olpruva 2 Gram Dose Envelope Olpruva 3 Gram Dose Envelope Olpruva 4 Gram Dose Envelope Olpruva 5 Gram Dose Envelope Olpruva 6 Gram Dose Envelope Olpruva 6.67 Gram Dose Envelope *To be discussed today Sodium phenylbutyrate
New Drugs Preferred Drug List Edits Common Trade Name Ingredient Name Indications Tafinlar 10mg Tablet For Susp Dabrafenib Mesylate Indicated as a single agent for the treatment of patients with unresectableor metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. Mitogen-activated Extracellular Kinase Inhibitors (MEKi) & Braf Kinase Inhibitors (BRAFi) PDL Edit Non-Preferred Prior Authorization Required Fiscal Edit For those 10 years, must provide medical necessity as to why Tafinlar capsules cannot be utilized 15 Day Supply Oral Oncology Fiscal Edit Udenyca 6mg/0.6mL Autoinjector Pegfilgrastim-CBQV Indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Colony Stimulating Factors PDL Edit Non-Preferred Valsartan 4mg/mL Solution * To be discussed today Valsartan Indicated for the treatment of hypertension, heart failure, and for the reduction of cardiovascular mortality in stable persons with left ventricular failure or left ventricular dysfunction post myocardial infarction. Angiotensin Receptor Blockers and Angiotensin Receptor Blocker/Diuretic Combinations PDL Edit Non-Preferred Prior Authorization Required Fiscal Edit Must provide medical necessity as to why liquid ACE inhibitor cannot be utilized
New Drugs Preferred Drug List Edits Common Trade Name Ingredient Name Indications Yusimry (CF) 40mg/0.8mL Pen Adalimumab-aqvh Indicated for rheumatoidarthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn s disease, ulcerative colitis, plaque psoriasis and hidradenitis suppurativa. Targeted Immune Modulators, Tumor Necrosis Factor (TNF) Inhibitors PDL Edit Non-Preferred Biosimilar vs Reference Products Fiscal Edit Non-Preferred Zavzpret 10mg Nasal Spray Zavegepant HCL Indicated for the acute treatment of migraine with or without aura in adults. Anti-Migraine, Alternative Agents PDL Edit Non-Preferred Dose Optimization Fiscal Edit 6 units (1 box) per 22 days Zeposia Starter Kit (28-Day) Ozanimodhydrochloride Indicated for the treatment of: Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults or Moderately to severe active ulcerative colitis (UC) in adults Multiple Sclerosis Agents, Oral PDL Edit Non-Preferred Zolpidem Tartreate 7.5mg Capsule Zolpidem tartrate Indicated for the short-term treatment of transient insomnia characterized by difficulties with sleep initiation in adults younger than 65 years of age. Sedative Hypnotic Agents PDL Edit Non-Preferred Dose Optimization Fiscal Edit 1 capsule per day High Risk Therapy Clinical Edit Prior Authorization Required Fiscal Edit Must provide medical necessity as to why the 5mg tablet (as 1 and tablets) cannot be utilized
New Drugs Open Access Common Trade Name Ingredient Name Indications Indicated for the treatment of amyotrophic lateral sclerosis in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene. Qalsody 100mg/15mL Vial Tofersen
New Drugs Resource List Common Trade Name Ingredient Name Indications Abilify Asimtufii 720mg/2.4mL Abilify Asimtufii 960mg/3.2mL Aripiprazole Indicated for: The treatment of schizophrenia in adults Maintenance monotherapy treatment of bipolar I disorder in adults Antipsychotics 2nd Generation (Atypical) Depot Agents Resource List Non- Resource Approval Criteria: Must meet all of the following criteria: Participant is aged 18 years and older; Documented appropriate diagnosis; AND Documentation of medically necessity as to why other depot formulations of aripiprazole cannot be utilized Dose Optimization Fiscal Edit 1 syringe every 48 days Uzedy ER 50mg/0.14mLSyringe Uzedy ER 75mg/0.21mLSyringe Uzedy ER 100mg/0.28mLSyringe Uzedy ER 125mg/0.35mLSyringe Uzedy ER 150mg/0.42mL Syringe Uzedy ER 200mg/0.56mL Syringe Uzedy ER 250mg/0.7mL Syringe Risperidone Indicated for the treatment of schizophrenia in adults. Antipsychotics 2nd Generation (Atypical) Depot Agents Resource List Non- Resource Approval Criteria: Must meet all of the following criteria: Participant is aged 18 years and older; Documented appropriate diagnosis; AND Documentation of medically necessity as to why other depot formulations of risperidone cannot be utilized Dose Optimization Fiscal Edit 1 syringe every 20 days 50mg, 75mg, 100mg and 125mg 1 syringe every 48 days 150mg, 200mg and 250mg
New Drugs & Product Review Policy Enhancements Beginning with January 2024 Advisory Committee Meetings o Drugs will be reviewed during New Drug section if: New molecular entity; New drug strength; OR New drug dosage forms of existing drug entities o Drugs will NOT be reviewed during New Drug section if: New package sizes of existing drugs; Biosimilars of existing dosage forms; OR Generic drugs
Clinical and Fiscal Edits: No Annual Changes Alpelisib Clinical Edit Emsam Clinical Edit Entresto Clinical Edit Immunoglobulins (IVIG and SCIG) Clinical Edit Narcolepsy Inhibitors Clinical Edit Nuedexta Clinical Edit Palforzia Clinical Edit Parathyroid Hormone and Bone Resorption Suppression Related Agents Clinical Edit Sickle Cell Disease Clinical Edit Spinal Muscular Atrophy (SMA) Clinical Edit SSRI Step Therapy Clinical Edit Transthyretin-Mediated Amyloidosis (ATTR) Clinical Edit Xcopri Clinical Edit
Preferred Drug List Edits: No Annual Changes ACE Inhibitors/Calcium Channel Blocker Combinations ADHD, Amphetamines Short Acting ADHD, Methylphenidate Short Acting ADHD, Non-Stimulants Angiotensin Receptor Blocker/Calcium Channel Blocker Combinations Anticonvulsants, Rescue Agents Antiplatelet Agents Beta Adrenergic Blockers & Beta Adrenergic Blockers/Diuretic Combinations Bone Ossification Agents Calcium Channel Blockers, Dihydropyridine Direct Renin Inhibitors & Combinations Electrolyte Depleting Agents, Phosphate Lowering Niacin Derivatives Proprotein Convertase SubtilisinKexin type 9 (PCSK9) Inhibitors Pulmonary Arterial Hypertension (PAH) Agents, Endothelin Receptor Antagonists (ETRAs) Pulmonary Arterial Hypertension (PAH) Agents, Prostacyclin Pathway Agonists, Inhaled Pulmonary Arterial Hypertension (PAH) Agents, Prostacyclin Pathway Agonists, Injectable Pulmonary Arterial Hypertension (PAH) Agents, Prostacyclin Pathway Agonists, Oral Triglyceride Lowering Agents
