TEXAS MEDICAID VENDOR DRUG PROGRAM DRUG UTILIZATION REVIEW BOARD MEETING - RETROSPECTIVE DRUG USE PROPOSALS Friday, April 23, 2021 http://www.txvendordrug.com/ REVISED CRITERIA

1. Aerosolized Agents - Metered-Dose Inhalers (MDIs): Anti- Drugs 2. Aerosolized Agents - Metered-Dose Inhalers (MDIs): Anti-Inflammatory Drugs 3. Aerosolized Agents - Metered-Dose Inhalers (MDIs): Beta2 Adrenergic Drugs (Long-Acting) 4. Aerosolized Agents - Metered-Dose Inhalers (MDIs): Beta2 Adrenergic Drugs (Short-Acting) 5. Anti-Depressants, Oral (Other) 6. Anti-Depressants, Selective Serotonin Reuptake Inhibitors REVISED CRITERIA: AEROSOLIZED AGENTS - METERED-DOSE INHALERS (MDIS): ANTI-CHOLINERGIC DRUGS REVISED CRITERIA: AEROSOLIZED AGENTS - METERED-DOSE INHALERS (MDIS): ANTI- CHOLINERGIC DRUGS

• Dosage • Updated GINA recommendations for Step 4 & Step 5 add-on therapy with tiotropium in adolescents & children 6 years of age or older • Clarified “2020 Focused Updates to the Management Guidelines” do not address short acting muscarinic antagonists • Removed: • Seebri Neohaler® (glycopyrrolate) • Utibron Neohaler® (/ glycopyrrolate) REVISED CRITERIA: AEROSOLIZED AGENTS - METERED-DOSE INHALERS (MDIS): ANTI- CHOLINERGIC DRUGS

• Dosage • Added Duaklir Pressair® (aclidinium bromide/ fumarate) • Updated indication of Trelegy Ellipta® (, umeclidinium, & ) to include asthma management in patients 18 years of age and older • Added paragraph about removal of Seebri Neohaler® & Utibron Neohaler® from market REVISED CRITERIA: AEROSOLIZED AGENTS - METERED-DOSE INHALERS (MDIS): ANTI- CHOLINERGIC DRUGS

• Dosage, Continued (Adults) • Table 1. Maximum Recommended Adult Metered-Dose Inhaler Daily Dose- Monotherapy • Removed Seebri Neohaler® (glycopyrrolate) • Table 2. Maximum Recommended Adult Anticholinergic Metered-Dose Inhaler Daily Dose- Combination Therapy • Added Duaklir Pressair® (aclidinium bromide/ formoterol fumarate) • Added asthma indication, dosage strength, & dosing information for Trelegy ® (fluticasone, umeclidinium, & vilanterol) • Removed Utibron Neohaler® (indacaterol/ glycopyrrolate) REVISED CRITERIA: AEROSOLIZED AGENTS - METERED-DOSE INHALERS (MDIS): ANTI- CHOLINERGIC DRUGS • Duration of Therapy • Table 4. Days’ Supply for Anticholinergic Metered-Dose Inhaler Products- Monotherapy • Added 30 actuation (15 days’ supply) aclidinium powder for inhalation • Removed Seebri Neohaler® (glycopyrrolate) • Removed 28 actuation (14 day’s supply) tiotropium inhalation spray 1.25 mcg/ actuation • Table 5. Days’ Supply for Anticholinergic Metered-Dose Inhaler Products- Combination Therapy • Added Duaklir Pressair® (aclidinium bromide/ formoterol fumarate) • Added Trelegy® (fluticasone, umeclidinium, & vilanterol) 200 mcg/ 62.5 mcg/ 25 mcg/ actuation • Clarified umeclidinium/ vilanterol comes as two strips containing each drug • References - updated REVISED CRITERIA: AEROSOLIZED AGENTS – METERED-DOSE INHALERS (MDIS): ANTI-INFLAMMATORY DRUGS REVISED CRITERIA: AEROSOLIZED AGENTS – METERED-DOSE INHALERS (MDIS): ANTI- INFLAMMATORY DRUGS

• Dosage • Updated indication of Dulera® (/formoterol) to include children 5 years of age and older with asthma • Updated indication of Breo Ellipta® (fluticasone/ vilanterol) to include maintenance therapy for asthma • Updated indication of Trelegy Ellipta® (fluticasone, umeclidinium, & vilanterol) to include asthma management in patients 18 years of age and older • Table 1. Maximum Daily Recommended Adult Doses for ICS as Monotherapy in Asthma • Removed Aerospan® () HFA. Product discontinued • Added ArmonAir Digihaler® () • Removed ArmonAir RespiClick® (fluticasone propionate). Product discontinued REVISED CRITERIA: AEROSOLIZED AGENTS – METERED-DOSE INHALERS (MDIS): ANTI- INFLAMMATORY DRUGS

• Dosage, Continued (Adults) • Table 2. Maximum Adult Daily Recommended Doses for ICS as Combination Therapy for Asthma and COPD • Added Wixela Inhub® as generic formulation of Advair Diskus® (fluticasone propionate/ ) • Added AirDuo Digihaler® (fluticasone propionate/ salmeterol) • Added asthma indication, dosage strength, & dosing information for Trelegy® (fluticasone, umeclidinium, & vilanterol) REVISED CRITERIA: AEROSOLIZED AGENTS – METERED-DOSE INHALERS (MDIS): ANTI- INFLAMMATORY DRUGS

• Dosage, Continued (Pediatrics) • Table 3. Maximum Recommended Pediatric Doses for ICS as Monotherapy in Asthma • Removed Aerospan® (flunisolide) & ArmonAir RespiClick® (fluticasone propionate) • Added ArmonAir Digihaler® (fluticasone propionate) & Asmanex HFA® (mometasone) 50 mcg/ actuation formulation • Updated aerosolized ICS/ LABA therapy is approved for children > 5 years of age (Dulera®) • Table 4. Maximum Pediatric Recommended Doses for ICS as Combination Therapy for Asthma • Added AirDuo Digihaler® (fluticasone propionate/ salmeterol) & Dulera® (mometasone/ formoterol) 50 mcg/ 5 mcg/ actuation REVISED CRITERIA: AEROSOLIZED AGENTS – METERED-DOSE INHALERS (MDIS): ANTI- INFLAMMATORY DRUGS

• Duration of Therapy • Table 5. Days Supply for Available ICS as Monotherapy When Maximum Doses are Utilized (Adults and Children) • Removed Aerospan® (flunisolide) • Added 14 blister strips to Arnuity Ellipta® (fluticasone furoate) • Added 28 blister strips to Flovent Diskus® (fluticasone propionate) • Removed ArmonAir RespiClick ® (fluticasone propionate) • Added ArmonAir Digihaler® (fluticasone propionate) • Added Asmanex HFA® (mometasone) 50 mcg/ actuation formulation REVISED CRITERIA: AEROSOLIZED AGENTS – METERED-DOSE INHALERS (MDIS): ANTI- INFLAMMATORY DRUGS

• Duration of Therapy, Continued • Table 6. Days Supply for Available ICS as Combination Therapy When Maximum Doses are Utilized (Adults and Children) • Removed Advair Diskus® (fluticasone propionate/ salmeterol) 28 blister strip • Added Advair Diskus® (fluticasone propionate/ salmeterol) 14 blister strip • Added Trelegy® (fluticasone, umeclidinium, & vilanterol) 200 mcg/ 62.5 mcg/ 25 mcg/ actuation • Added Dulera® (mometasone/ formoterol) 50 mcg/ 5 mcg/ actuation • Added Dulera® (mometasone/ formoterol) 60 actuation formulation • Updated Symbicort® (/ formoterol) to include patients > 6 years of age • Updated Dulera® (mometasone/ formoterol) to include patients > 5 years of age REVISED CRITERIA: AEROSOLIZED AGENTS – METERED-DOSE INHALERS (MDIS): ANTI- INFLAMMATORY DRUGS

• Duplicative Therapy • Clarified that the use of multiple inhaled corticosteroids is not recommended even when using single maintenance and reliever therapy (SMART) as described in the “2020 Focused Updates to the Asthma Management Guidelines” • Clarified that the use of multiple inhaled corticosteroids is not recommended when using intermittent ICS therapy • References - updated Revised criteria: Aerosolized Agents – Metered-dose Inhalers (MDIS): Beta2 Adrenergic Drugs (long-acting) REVISED CRITERIA: AEROSOLIZED AGENTS – METERED-DOSE INHALERS (MDIS): BETA2 ADRENERGIC DRUGS (LONG-ACTING)

• Dosage • Updated Symbicort® (budesonide/ formoterol) to include patients > 6 years of age • Updated Dulera® (mometasone/ formoterol) to include patients > 5 years of age • Added AirDuo Digihaler® (fluticasone/ salmeterol) • Added asthma as indication to Symbicort® (budesonide/ formoterol) REVISED CRITERIA: AEROSOLIZED AGENTS – METERED-DOSE INHALERS (MDIS): BETA2 ADRENERGIC DRUGS (LONG-ACTING)

• Dosage, Continued • Added asthma as indication for Breo Ellipta® (fluticasone/ vilanterol) • Updated indication of Trelegy Ellipta® (fluticasone, umeclidinium, & vilanterol) to include asthma management in patients 18 years of age and older • Added Duaklir Pressair® (aclidinium bromide/ formoterol) • Added statement indicating discontinuation of Utibron Neohaler® (indacaterol/glycopyrrolate), Seebri Neohaler® (glycopyrrolate), and Arcapta Neohaler® (indacaterol) REVISED CRITERIA: AEROSOLIZED AGENTS – METERED-DOSE INHALERS (MDIS): BETA2 ADRENERGIC DRUGS (LONG-ACTING)

• Dosage, Continued (Adults) • Table 1. LABA Maximum Daily Dosage Recommendations in Adults with Asthma and COPD: Monotherapy • Removed Arcapta Neohaler® (indacaterol) • Table 2. LABA Maximum Daily Dosage Recommendations in Adults with Asthma and COPD: Combination Therapy • Added Duaklir Pressair® (aclidinium bromide/ formoterol) • Added Wixela Inhub® as generic formulation of Advair Diskus® (fluticasone propionate/ salmeterol) • Added AirDuo Digihaler® (fluticasone/ salmeterol) • Added asthma indication, dosage strength, & dosing information for Trelegy® (fluticasone, umeclidinium, & vilanterol) • Removed Utibron Neohaler® (indacaterol/glycopyrrolate) REVISED CRITERIA: AEROSOLIZED AGENTS – METERED-DOSE INHALERS (MDIS): BETA2 ADRENERGIC DRUGS (LONG-ACTING)

• Dosage, Continued (Pediatrics) • Table 4. Pediatric LABA Maximum Daily Dosage Recommendations for Asthma: Combination Therapy • Added AirDuo Digihaler® (fluticasone/ salmeterol) • Added Dulera® (mometasone/ formoterol) 50 mcg/ 5 mcg/ actuation REVISED CRITERIA: AEROSOLIZED AGENTS – METERED-DOSE INHALERS (MDIS): BETA2 ADRENERGIC DRUGS (LONG-ACTING)

• Duration of Therapy • Removed references to Seebri Neohaler® (glycopyrrolate) and Utibron Neohaler® (indacaterol/glycopyrrolate) • Table 5. Days’ Supply for Available Long-Acting Beta2-Adrenergic Metered-Dose Inhalers (Adult and Pediatric Patients) - Monotherapy • Removed Arcapta Neohaler® (indacaterol) • Removed 28 blister package size of Serevent Diskus® (salmeterol) REVISED CRITERIA: AEROSOLIZED AGENTS – METERED-DOSE INHALERS (MDIS): BETA2 ADRENERGIC DRUGS (LONG-ACTING)

• Duration of Therapy, Continued • Table 6. Days’ Supply for Available Long-Acting Beta2-Adrenergic Metered-Dose Inhalers (Adult and Pediatric Patients) – Combination Therapy • Added Duaklir Pressair® (aclidinium bromide/ formoterol) • Added Trelegy® (fluticasone, umeclidinium, & vilanterol) 200 mcg/ 62.5 mcg/ 25 mcg/ actuation • Removed Utibron Neohaler® (indacaterol/glycopyrrolate) • Added Dulera® (mometasone/ formoterol) 50 mcg/ 5 mcg/ actuation REVISED CRITERIA: AEROSOLIZED AGENTS – METERED-DOSE INHALERS (MDIS): BETA2 ADRENERGIC DRUGS (LONG-ACTING)

• Duration of Therapy, Continued • Table 6. Days’ Supply for Available Long-Acting Beta2-Adrenergic Metered-Dose Inhalers (Adult and Pediatric Patients) – Combination Therapy, Continued • Updated Stiolto Respimat® (tiotropium/ ) to indicate package size of 28 discontinued & package size of 10 now available • Clarified umeclidinium/ vilanterol comes as two strips containing each drug • Clarified AirDuo Digihaler® (fluticasone/ salmeterol) is approved for > 12 years of age • Clarified Dulera® (mometasone/ formoterol) 50 mcg/ 5 mcg/ actuation dosage form is approved for > 5 years • References- Updated Revised criteria: Aerosolized Agents – Metered-Dose Inhalers (MDIS): Beta2 Adrenergic Drugs (Short-Acting) REVISED CRITERIA: AEROSOLIZED AGENTS – METERED-DOSE INHALERS (MDIS): BETA2 ADRENERGIC DRUGS (SHORT-ACTING)

• Dosage (Adults)

• Table 1. Maximum Adult Daily Dose for Inhalational Beta2-Adrenergic Agents (Short-Acting) – Monotherapy • Added ProAir Digihaler® (albuterol inhalation powder) • Dosage (Pediatrics) • Updated to include ProAir RespiClick® (albuterol inhalation powder) and ProAir Digihaler® (albuterol inhalation powder)

• Table 3. Maximum Recommended Pediatric Daily Dose for Inhalational Beta2-Adrenergic Agents (Short-Acting) – Monotherapy • Added ProAir Digihaler® (albuterol inhalation powder) REVISED CRITERIA: AEROSOLIZED AGENTS – METERED-DOSE INHALERS (MDIS): BETA2 ADRENERGIC DRUGS (SHORT-ACTING)

• Duration of Therapy

• Table 4. Days’ Supply for Available Short-Acting Beta2-Adrenergic Agent Metered-Dose Inhalers (Adult and Pediatric Patients) – Monotherapy • Added ProAir Digihaler® (albuterol inhalation powder) • References- Updated ANTI-DEPRESSANTS, ORAL (OTHER) ANTI-DEPRESSANTS, ORAL (OTHER)

• Dosage (Adults) • Table 3. Adult and Elderly Maximum Recommended Antidepressant Dosages (Monotherapy) – Monoamine Oxidase Inhibitors • Added EMSAM® (selegiline) transdermal patch • Table 4. Adult and Elderly Maximum Recommended Antidepressant Dosages (Monotherapy) – Serotonin and Norepinephrine Reuptake Inhibitors • Increased maximum recommended dose of venlafaxine to 400 mg daily • Added Drizalma Sprinkle® (duloxetine) • Table 6. Adult and Elderly Maximum Recommended Antidepressant Dosages (Monotherapy) – Miscellaneous Agents • Added 100 mg & 150 mg dosage formulations to bupropion 12-hour ER tablets ANTI-DEPRESSANTS, ORAL (OTHER)

• Dosage, Continued (Pediatrics) • Added columns to tables 8-11 including literature-based dosing recommended in the “Texas Health and Human Services Psychotropic Medication Utilization Parameters for Children and Youth in Texas Public Behavioral Health (6th Version)” • Table 8. Pediatric Maximum Recommended Antidepressant Drug Dosages (Monotherapy) – Tricyclic Antidepressants • Added weight-based dosing for nocturnal enuresis • Table 9. Pediatric Maximum Recommended Antidepressant Drug Dosages (Monotherapy)– Monoamine Oxidase Inhibitors • Added EMSAM® (selegiline) transdermal patch ANTI-DEPRESSANTS, ORAL (OTHER)

• Dosage, Continued (Pediatrics) • Table 10. Pediatric Maximum Recommended Antidepressant Drug Dosages (Monotherapy) – Serotonin and Norepinephrine Reuptake Inhibitors • Added Pristiq®, Khedezla®, generics (desvenlafaxine) • Added fibromyalgia as indication for duloxetine in patients 13 years of age and older • Added Table 11 • Table 11. Pediatric Maximum Recommended Antidepressant Drug Dosages (Monotherapy) - Tetracyclic Antidepressants • Added Remeron® () • Updated numbers for Tables 12-16 • References- Updated ANTI-DEPRESSANTS, SELECTIVE SEROTONIN REUPTAKE INHIBITORS ANTI-DEPRESSANTS, SELECTIVE SEROTONIN REUPTAKE INHIBITORS

• Dosage (Adults) • Table 1. Oral SSRI Medications - Adult Maximum Recommended Dosages – Monotherapy • Clarified maximum dose for citalopram is 20 mg daily for > 60 years of age • Added dosage strength for Prozac Weekly® (fluoxetine) formulation • Added Prozac Pulvules® (fluoxetine). To be used in combination with • Clarified mesylate & paroxetine HCl are different products • Added obsessive-compulsive disorder (OCD), panic disorder (PD), generalized anxiety disorder (GAD), and major depressive disorder (MDD) to paroxetine HCl indications • Added paroxetine HCl suspension ANTI-DEPRESSANTS, SELECTIVE SEROTONIN REUPTAKE INHIBITORS

• Dosage, Continued (Pediatrics) • Added columns to tables 3-4 including literature-based dosing recommended in the “Texas Health and Human Services Psychotropic Medication Utilization Parameters for Children and Youth in Texas Public Behavioral Health (6th Version)” • Table 3. Recommended SSRI Antidepressant Drug Dosages for Pediatric Patients – Monotherapy • Added Prozac Pulvules® (fluoxetine). To be used in combination with olanzapine • References- Updated TEXAS MEDICAID VENDOR DRUG PROGRAM DRUG UTILIZATION REVIEW BOARD MEETING - RETROSPECTIVE DRUG USE PROPOSALS Friday, April 23, 2021 http://www.txvendordrug.com/