Inhaled Corticosteroids Drug Class Prior Authorization Protocol Line of Business: Medicaid P&T Approval Date: February 21, 2018 Effective Date: April 1, 2018 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. Drug Requiring Prior Authorization Review: Aerospan (flunisolide), Advair Diskus, Advair HFA (fluticasone/salmeterol), Alvesco (ciclesonide), Arnuity Ellipta (fluticasone furoate), Asmanex (mometasone), Breo Ellipta (fluticasone/vilanterol), Dulera (mometasone/formoterol), Symbicort (budesonide/formoterol) Formulary Alternative: Airduo RespiClick (fluticasone/salmeterol), Flovent HFA, Flovent Diskus (fluticasone), Fluticasone propionate/salmeterol, Pulmicort Respules, Pulmicort Flexhaler (budesonide), Qvar (beclomethasone) Criteria: A. Drug: Advair HFA 1. Diagnosis: Asthma Criteria: Must meet all of the following requirements: a. Members aged 12 and older b. Failure or clinically significant adverse effects to optimal and regular use of formulary generic fluticasone propionate/salmeterol inhaler. Quantity Limit: 1 device per month (30 days)
B. Drug: Advair Diskus 100/50mcg, 250/50mcg 1. Diagnosis: Asthma Criteria: Must meet 1 of the following requirements: a. Must meet all of the following: i. Asthma for members aged 12 and older ii. Failure or clinically significant adverse effects to optimal and regular use of formulary generic fluticasone propionate/salmeterol inhaler or AirDuo. b. Must meet all of the following: i. Asthma for members aged 4 to 11 years ii. Failure or clinically significant adverse effects to optimal and regular use of 2 formulary inhaled corticosteroids (e.g. Asmanex, Qvar, Flovent). Quantity Limit: 60 blisters per month (30 days) 2. Diagnosis: COPD Criteria: Must meet the following requirement: a. Failure or clinically significant adverse effects to 1 formulary long acting bronchodilator: Incruse Ellipta, Stiolto Respimat, Tudorza or Serevent. Quantity Limit: 60 blisters per month (30 days)
C. Drug: Advair Diskus 500/50mcg 1. Diagnosis: Asthma Criteria: Must meet all of the following requirements: a. Aged 12 and older b. Failure or clinically significant adverse effects to optimal and regular use of formulary fluticasone propionate/salmeterol inhaler. Quantity Limit: 60 blisters per month (30 days) b. Confirmed stability. 2. Diagnosis: COPD Criteria: Must meet the following requirement: a. Failure or clinically significant adverse effects to 1 formulary long acting bronchodilator: Incruse Ellipta, Stiolto Respimat, Tudorza or Serevent. Quantity Limit: 60 blisters per month (30 days) D. Breo Ellipta
1. Diagnosis: Asthma Criteria: Must meet all of the following requirements: c. Aged 18 and older d. Failure or clinically significant adverse effects to optimal and regular use of formulary fluticasone propionate/salmeterol inhaler. Quantity Limit: 1 device per month (30 days) 2. Diagnosis: COPD Criteria: Must meet the following requirement: a. Failure or clinically significant adverse effects to 1 formulary long acting bronchodilator: Incruse Ellipta, Stiolto Respimat, Tudorza or Serevent. Quantity Limit: 1 device per month (30 days) E. Drug: Symbicort 1. Diagnosis: Asthma Criteria: Must meet 1 of the following requirements: e. Must meet all of the following: i. Age 5 to 11 years old ii. Failure or clinically significant adverse effects to optimal and regular use of 2 formulary inhaled corticosteroids (e.g. Asmanex, Qvar,
Flovent). f. Must meet all of the following: i. Age 12 or older ii. Failure or clinically significant adverse effects to optimal and regular use of formulary fluticasone propionate/salmeterol inhaler or AirDuo. g. Must meet all of the following: i. At least one asthma exacerbation in the past year (365 days). ii. Failure or clinically significant adverse effects to optimal and regular use of 2 formulary inhaled corticosteroids (e.g. Asmanex, Qvar, Flovent). Quantity Limit: 1 device per month (30 days) 2. Diagnosis: COPD Criteria: Must meet the following requirement: a. Failure or clinically significant adverse effects to 1 formulary long acting bronchodilator: Incruse Ellipta, Stiolto Respimat, Tudorza or Serevent. Quantity Limit: 1 device per month (30 days) F. Alvesco, Aerospan, Arnuity Ellipta, Asmanex HFA Diagnosis: Asthma Criteria: Must meet the following requirement:
a. Failure or clinically significant adverse effects to adequate trial with 2 formulary inhaled corticosteroids (e.g. Qvar, Pulmicort Flexhaler, Asmanex). Quantity Limit: 1 device per month (30 days) Duration of therapy: 1 year (365 days)
Clinical Justification: 2011 Guidelines from the National Asthma Education and Prevention Program Expert Panel Report 3
2018 Global Initiative for Chronic Obstructive Lung Disease Key points for inhalation of drugs Choice of inhaler device has to be individually tailored and will depend on access, cost, prescriber, and most importantly, patient s ability and preference. It is essential to provide instructions and to demonstrate the proper inhalation technique when prescribing a device, to ensure that inhaler technique is adequate and re-check at each visit that patients continue to use their inhaler correctly. Inhaler technique and adherence to therapy should be assessed before concluding that the current therapy requires modifications. Key points for the use of bronchodilators LABAs and LAMAs are preferred over short acting agents except for patients with only occasional dyspnea. Patients may be started on single long acting bronchodilator therapy or dual long acting bronchodilator therapy. In patients with persistent dyspnea on one bronchodilator treatment should be escalated to two. Inhaled bronchodilators are recommended over oral bronchodilators. Theophylline os not recommended unless other long term treatment bronchodilators are unavailable to unaffordable. Key points for the use of anti-inflammatory agents Long term monotherapy with ICS is not recommended. Long term treatment with ICS may be considered in association with LABAs for patients with a history of exacerbations despite appropriate treatment with long acting bronchodilators. Long term therapy with oral corticosteroids is not recommended. In patients with exacerbations despite LABA/ICS or LABA/LAMA/ICS, chronic bronchitis and severe to very severe airflow obstruction, the addition of a PDE4 inhibitor can be considered. In former smokers with exacerbations despite appropriate therapy, macrolides can be considered. Statin therapy is not recommended to prevention of exacerbation. Antioxidant mucolytics are recommended only in select patients. Key points for the use of other pharmacological treatments Patients with severe hereditary alpha-1 antitrypsin deficiency and established emphysema may be candidates for alpha-1 antitrypsin augmentation therapy. Antitussives cannot be recommended.
Drugs approved for primary pulmonary hypertension are not recommended for patients with pulmonary hypertension secondary to COPD. Low dose long acting oral and parenteral opioids may be considered for treating dyspnea in COPD patients with severe disease. References: 1. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (Updated 2018) @ 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, 2007. 3. 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):CD004106. 5. 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, 2008. Available at: http://www.nice.org.uk/nicemedia/pdf/ta138guidance.pdf. 6. Oregon Drug Effectiveness Review Project. Drug class review. Controller Medications for Asthma. Portland, OR: Oregon Health and Sciences University; 2008. 7. Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease 2018 Report. Change Control Date Change 02/21/2018 Updated Symbicort criteria Updated to 2018 GOLD Guidance