Drug Class Monograph

Transcription

1 Drug Class Monograph Class: Inhaled Corticosteroids Drugs: Aerospan (flunisolide), Advair Diskus, Advair HFA (fluticasone/salmeterol), Alvesco (ciclesonide), Arnuity Ellipta (fluticasone furoate), Asmanex (mometasone), Breo Ellipta (fluticasone/vilanterol), Dulera (mometasone/formoterol), Flovent HFA, Flovent Diskus (fluticasone), Pulmicort Respules, Pulmicort Flexhaler (budesonide), Qvar (beclomethasone), Symbicort (budesonide/formoterol) Formulary medications: Asmanex (mometasone), Flovent HFA, Flovent Diskus (fluticasone), Pulmicort Respules, Pulmicort Flexhaler (budesonide), Qvar (beclomethasone) Line of Business: Medi-Cal Effective Date: February 15, 2017 Revision Date: February 15, 2017 This policy has been developed through review of medical literature, consideration of medical necessity, generally accepted medical practice standards, and approved by the IEHP Pharmacy and Therapeutics Subcommittee. Policy/Criteria: 1. Advair HFA (fluticasone/salmeterol), Dulera (mometasone/formoterol) a. Confirmed diagnosis of asthma; i. One of the following: 1) Failure or clinically significant adverse effects to optimal and regular use of two formulary inhaled corticosteroids (e.g. Asmanex, Qvar, Flovent, Pulmicort Flexhaler etc.); For patients who have symptomatic asthma despite high-dose Flovent, requests will be reviewed by IEHP pharmacist; 2) Documentation of very poorly controlled asthma defined by NAEPP (e.g. FEV 1 <60%, 2 or more asthma exacerbations in the previous year, recent hospitalization due to asthma). 2. Advair Diskus (fluticasone/salmeterol), Breo Ellipta (fluticasone/vilanterol), Symbicort (budesonide/formoterol) a. Confirmed diagnosis of asthma; i. One of the following: 1) Failure or clinically significant adverse effects to optimal and regular

2 use of two formulary inhaled corticosteroids (e.g. Asmanex, Qvar, Flovent, Pulmicort Flexhaler etc.); For patients who have symptomatic asthma despite high-dose Flovent, requests will be reviewed by IEHP pharmacist; 2) Documentation of very poorly controlled asthma defined by NAEPP (e.g. FEV 1 <60%, 2 or more asthma exacerbations in the previous year, recent hospitalization due to asthma). b. Confirmed diagnosis of COPD; i. Failure or clinically significant adverse effects to one formulary long-acting anticholinergic (e.g. Incruse Ellipta, Tudorza) or one formulary long-acting beta-agonist (e.g. Serevent). 3. Alvesco (ciclesonide), Aerospan (flunisolide), Arnuity Ellipta (fluticasone furoate), Asmanex HFA (mometasone) a. Confirmed diagnosis of asthma; i. Failure or clinically significant adverse effects to adequate trial with two formulary inhaled corticosteroids (e.g. Qvar, Flovent, Pulmicort Flexhaler, Asmanex). Clinical Justification: Comparison of FDA-Approved Indications Aerospan (flunisolide) Advair Diskus (fluticasone/salmeterol) Advair HFA (fluticasone/salmeterol) Alvesco (ciclesonide) Arnuity Ellipta (fluticasone furoate) Breo Ellipta (fluticasone/vilanterol) Dulera (mometasone/formoterol) Symbicort (budesonide/formoterol) FDA Approved Indications Treatment of asthma in patients aged 6 years and older Treatment of asthma in patients aged 4 years and older Treatment of COPD Treatment of asthma in patients aged 12 years and older Treatment of asthma in patients aged 12 years and older Treatment of asthma in patients aged 12 years and older Treatment of asthma in patients aged 18 years and older Treatment of COPD (100/25 mcg only) Treatment of asthma in patients aged 12 years and older Treatment of asthma in patients aged 12 years and older Treatment of COPD (160/4.5mcg only)

3 2011 Guidelines from the National Asthma Education and Prevention Program Expert Panel Report 3

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8 2017 Global Initiative for Chronic Obstructive Lung Disease Inhaled bronchodilators in COPD are central to symptom management and commonly given on a regular basis to prevent or reduce symptoms (Evidence A). Regular and as-needed use of SABA or SAMA improves FEV 1 and symptoms (Evidence A). Combinations of SABA and SAMA are superior compared to either medication alone in improving FEV 1 and symptoms (Evidence A). LABAs and LAMAs significantly improve lung function, dyspnea, health status and reduce exacerbation rates (Evidence A). LAMAs have a greater effect on exacerbation reduction compared with LABAs (Evidence A) and decrease hospitalizations (Evidence B). Combination treatment with a LABA and LAMA increases FEV 1 and reduces symptoms compared to monotherapy (Evidence A). Combination treatment with a LABA and LAMA reduces exacerbations compared to monotherapy (Evidence B) or ICS/LABA (Evidence B). Tiotropium improves the effectiveness of pulmonary rehabilitation in increasing exercise performance (Evidence B). An ICS combined with a LABA is more effective than the individual components in improving lung function and health status and reducing exacerbations in patients with exacerbations and moderate to very severe COPD (Evidence A). Regular treatment with ICS increases the risk of pneumonia especially in those with severe disease (Evidence A). Triple inhaled therapy of ICS/LAMA/LABA improves lung function, symptoms and health status (Evidence A) and reduces exacerbation (Evidence B) compared to ICS/LABA or LAMA monotherapy.

9 2015 Global Initiative for Chronic Obstructive Lung Disease

10 References: 1. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (Updated Global Initiative for Chronic Obstructive Lung Disease, Inc. 2. National Asthma Education and Prevention Program. Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. Bethesda, MD. National Heart, Lung, and Blood Institute, Facts and Comparisons Formulary Monograph Service. Wolters Kluwer Health, St. Louis, MO. 4. Lasserson TJ, Cates CJ, Ferrara G, Casali L. Combination fluticasone and salmeterol versus fixed dose combination budesonide and formoterol for chronic asthma in adults and children. Cochrane Database Syst Rev 2008 Jul 16;(3):CD National Institutes for Health and Clinical Excellence (NICE). Inhaled corticosteroids for the treatment of chronic asthma in adults and children aged 12 years and over. March, Available at: 6. Oregon Drug Effectiveness Review Project. Drug class review. Controller Medications for Asthma. Portland, OR: Oregon Health and Sciences University; Global Initiative For Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease 2017 Report. Available at: Accessed January 30, 2017.

11 Change Control Date Change 02/15/2017 Revised combination ICS/LABA criteria; Asthma: Must meet one of the following: o Failure or clinically significant adverse effects to optimal and regular use of two formulary inhaled corticosteroids (e.g. Asmanex, Qvar, Flovent) o Documentation of very poorly controlled asthma (e.g. FEV 1 <60%, frequent asthma exacerbation, recent hospitalization due to asthma) o For patients who have symptomatic asthma despite high-dose Flovent, requests will be reviewed by IEHP pharmacist