Indiana Medicaid Drug Utilization Review Board Newsletter

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1 Indiana Medicaid Drug Utilization Review Board Newsletter Indiana Medicaid DUR Board Room W382 Indiana State Government Center, South 402 West Washington Street Indianapolis, Indiana DUR Board Members Introduction The Management of Asthma Asthma is a chronic lung disease that produces inflammation and constriction of the airways. It is characterized by recurring periods of wheezing, chest tightness, shortness of breath, and coughing. 1 The exact cause of asthma is not known. Researchers believe a combination of various factors interact, causing asthma to develop, most often early in life. Atopy (an inherited tendency to develop allergies) and family history of asthma are believed to contribute to the development of asthma. Contact with airborne allergens or exposure to viral infections, such as respiratory syncytial virus and parainfluenza virus, in infancy or in early childhood are also thought to be factors likely to cause asthma. 1!"# $ %#! & #' ( )& () Inside this Issue The Management of Asthma Top 25 Drug Lists for 2Q2012 Epidemiology Asthma affects people of all ages. In the United States, approximately 24.6 million people have asthma. 2 Asthma is commonly diagnosed in childhood, affecting nearly 7 million children according to 2009 estimates. 1,2 From , asthma in the United States was most prevalent among blacks (11.1 percent), followed by American Indian or Alaska Natives (8.8 percent), Whites (7.8 percent), and Hispanics (6.3 percent). 2 According to national data for 2007, healthcare costs associated with asthma in the United States were reported to be approximately $56 billion, which was 6% higher than the $53 billion spent in Asthma is also associated with significant morbidity and mortality. In 2007, asthma accounted for 3,447 deaths in the United States with a higher rate among adults compared to children. 2 In the same year approximately 456,000 hospitalizations, 1.7 million emergency department visits, and 1.4 million hospital outpatient visits were related to asthma. 2 Continued on page 2

2 VOLUME 15 ISSUE 2 PAGE 2 Management of Asthma The diagnosis of asthma is based on a patient s medical history, physical exam, and results from pulmonary function tests (spirometry can be utilized in children >/= 5 years of age as long as they are physically able). Asthma is further classified by level of severity: intermittent, mild persistent, moderate persistent, or severe persistent. The severity level determines the treatment plan. 1 The goal of asthma management is to achieve control of the disease. Asthma control is defined by: the success in preventing asthma exacerbations that lead to patient emergency room visits or hospitalization preventing progressive loss of lung function the success in preventing chronic and troublesome symptoms such as coughing and shortness of breath the success in reducing the need of quick-relief medicines the success in maintaining normal activity levels and sleeping through the night. 1 To reach these goals, patients and/or their caregivers should actively partner with their healthcare providers to manage their asthma. This partnership involves creating and following an asthma action plan. An asthma action plan gives guidance on taking medications properly, avoiding factors that might aggravate the asthma condition, tracking levels of asthma control, responding to worsening asthma symptoms, and seeking emergency care when needed. Patients should also try to avoid triggers that can result in asthma flare-ups. Asthma is considered "well controlled" if the patient: experiences symptoms no more than 2 days a week and the patient is not awakened from sleep more than one or two nights a month carries out all normal activities uses their short acting beta agonist (SABA) no more than 2 days a week has no more than one asthma attack a year that requires corticosteroids to be taken by mouth sustains peak flow meter readings that do not drop below 80 percent of their personal best number. 1 It is important that all asthma patients, or their caregiver, collaborate with their healthcare provider to develop a personalized, written asthma action plan. The asthma action plan should include: instructions for daily management of asthma control information on how to recognize and manage worsening asthma symptoms that necessitate urgent medication use emergency telephone numbers for physicians, emergency department, and transport services Action plans are especially recommended in patients with moderate to severe persistent asthma, patients with a history of severe exacerbations, and patients with poorly controlled asthma. 1 Everyone involved in the care of a child with asthma, including school nurses, should have access to the child's asthma action plan. Continued on Page 3

3 VOLUME 15 ISSUE 2 PAGE 3 Once developed, it is important to review the plans with the patient at each healthcare provider visit, adjusting as needed. Examples of asthma control plans can be found within the National Education and Prevention Program Expert Panel Report 3 or at the following website: public/lung/asthma/asthma_actplan.pdf. Identifying asthma triggers that can exacerbate the patient s asthmatic condition is another key component of asthma management. The patient should recognize their triggers and take steps to avoid them. Additionally, several comorbid conditions, such as rhinitis, sinusitis, gastroesophageal reflux disease, obesity, psychological stress, and obstructive sleep apnea can make asthma more difficult to manage and should be treated. 1 Asthma Pharmacotherapy Pharmacologic therapy is used to prevent and control the symptoms of asthma, improve quality of life, reduce the frequency and severity of exacerbations, and reverse airway obstruction. 1 Many asthma medications are delivered by an inhaler or nebulizer. This route of administration provides direct drug delivery to the lungs. There are various types of inhalers available, such as the traditional metered-dose inhalers and dry powder inhalers. Inhaler technique and inhaler priming instructions can vary. Patients should be instructed in proper inhaler technique prior to starting inhaled therapy and have their technique assessed at subsequent visits. 1 Controllers versus Rescue Medications Asthma medications are generally categorized as quick-relief rescue medications or controllers. Quickrelief or "rescue" medications are used for immediate relief of asthma symptoms, and include short-acting bronchodilators and anticholinergics. 1 Controllers help reduce airway inflammation and prevent asthma symptoms. They include corticosteroids, immunomodulators, leukotriene modifiers, long-acting beta 2 - agonists (LABA), mast cell stabilizers, and methylxanthines. Inhaled corticosteroids (ICS) are the most potent and most effective long-term control medications for treating mild, moderate, and severe forms of persistent asthma. 1 Other controller medications are considered second-line therapies and can be used as adjunctive therapy to ICS depending on asthma severity. 1 There are many things to consider when selecting asthma medications. Asthma medication selection should be approached in a stepwise manner, taking into consideration asthma severity, level of control, the patients current medication regimen and special situations such as exercise-induced bronchospasm. 1 Stepwise approaches to therapy for both children and adults can be found in the National Education and Prevention Program Expert Panel Report 3 or accompanying summary report located at: Inhaled Corticosteroids Most patients with asthma will require long-term therapy with an ICS because they are the preferred and most effective long-term drug treatment for relieving airway inflammation in both adults and children. 1 ICS therapy is generally safe when taken as prescribed and unlike oral corticosteroid therapy, has minimal systemic absorption. While adverse effects with ICS therapy can occur, the benefits of ICS therapy and preventing asthma attacks far outweigh the risks of adverse effects. 1 Continued on Page 4

4 VOLUME 15 ISSUE 2 PAGE 4 One common adverse effect from ICS therapy is oral candidiasis. This condition can be reduced through the use of a spacer or holding chamber. Additionally, patients should rinse their mouth out with water after using an ICS to further prevent the risk of thrush and/or systemic absorption. 1 Combination Therapy If the patient s asthma symptoms persist while on ICS therapy, a step-up approach to therapy is recommended. Specific recommendations vary depending on patient age, asthma severity, and current asthma regimen. In general, recommendations include increasing the dose of the ICS and/or adding on adjunctive asthma control therapy. 1 These specific stepwise approaches to therapy for both children and adults can be found within the National Education and Prevention Program Expert Panel Report 3 or accompanying summary report. 1 Long-acting beta-agonists are frequently used together with ICS therapy for long-term control and prevention of asthma symptoms in patients with moderate to severe persistent asthma. Long-acting beta-agonists have been the preferred long-term adjunctive therapy to use in combination with ICS for the prevention of asthma symptoms in patients >/= 12 years of age with moderate to severe persistent asthma. 1 Pediatric and adolescent patients who require the addition of a LABA to an inhaled corticosteroid should be considered for use of a combination product containing both an inhaled corticosteroid and a LABA, to ensure compliance with both medications. Despite their benefit in controlling asthma symptoms when used together with ICS agents, their use should be balanced against their increased risk of severe exacerbations associated with daily use. Concerns with LABAs Due to safety concerns, in February of 2010, the FDA announced changes to the labeling of LABAs in asthma therapy. These changes were based upon study findings revealing an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations and even death in some pediatric and adult patients using LABAs for asthma treatment. Label change recommendations include the following: the use of LABAs is contraindicated without the use of an asthma controller medication such as an inhaled corticosteroid LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controller medications alone LABAs should be used for the shortest duration of time required to achieve control of asthma symptoms and discontinued, if possible, once asthma control is achieved. Patients should then be maintained on an asthma controller medication. The FDA is requiring a Risk Evaluation and Mitigation Strategy (REMS) for LABAs which will include a revised Medication Guide written specifically for asthma patients, and a plan to educate healthcare professionals about their appropriate use. Additionally, the FDA is requiring manufacturers to conduct additional clinical trials to further evaluate the safety of LABAs when used in combination with inhaled corticosteroids. The FDA did not request the withdrawal of LABAs from the market because their benefits in improving asthma symptoms when used appropriately with a controller outweigh the potential risks. 3,4 Continued on Page 5

5 VOLUME 15 ISSUE 2 PAGE 5 Monitoring of Drug Therapy Controller medications do not produce an immediate relief of asthma symptoms and should not be used to treat an exacerbation. 1 For this reason, all patients who have asthma need to have a quick-relief medication on-hand for immediate relief of asthma symptoms. Inhaled short-acting beta 2 -agonists (SABAs) are the first choice for quick relief. Short-acting beta-agonists cause bronchodilation when the patient is experiencing an exacerbation or tightness in their chest. SABAs should be used at the first observation of asthma symptoms. Patients should be reminded to always carry a quick-relief inhaler with them at all times in case it is needed. Because quick-relief medications do not reduce inflammation, patients with asthma should understand that quick-relief medicines should not be used in place of their long-term control medicines. If a SABA agent is used more than two days a week, asthma control should be reassessed. If the patient s asthma is not adequately controlled, changes to the patient s asthma treatment regimen and action plan should be made. 2 Conclusion Asthma is a chronic lung disease that affects many people and has a large impact on healthcare costs. Several medication choices are available and comprehensive guidelines exist to allow healthcare providers to effectively control asthma and the symptoms associated with it. However, for successful, comprehensive, and ongoing treatment, patients with asthma should take an active role in managing their disease and build strong partnerships with their doctor and other healthcare providers. For additional information on Asthma and patient education materials, please visit the following websites: American Academy of Family Physicians National Heart Lung and Blood Institute U.S. National Library of Medicine References 1. National Asthma Education and Prevention Program: Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma Available from: Accessed August Akinbami LJ, Moorman JE, Xiang L. Asthma prevalence, health care use, and mortality: United States, National health statistics reports; no 32. Hyattsville, MD: National Center for Health Statistics Available from: Accessed August FDA Drug Safety Communication: New safety requirements for long-acting inhaled asthma medications called Long-Acting Beta-Agonists (LABAs), Food and Drug Administration; February 18, Available from: Accessed August FDA Drug Safety Communication: Drug labels now contain updated recommendations on the appropriate use of long-acting inhaled asthma medications called Long-Acting Beta-Agonists (LABAs), Food and Drug Administration; June 2, Available from:

6 VOLUME 15 ISSUE 2 PAGE 6 Top 25 Drugs For 2nd Quarter 2012 Top 25 Drugs 2nd Quarter 2012 Ranked by Total Number of Paid Claims Drug # Paid Claims Avg. Amount Paid/Claim PROAIR HFA MCG INHALER 50,656 $45.96 LORATIDINE 10MG TABLET 50,384 $4.61 HYDROCODON-ACETAMINOPHEN ,306 $2.47 OMEPRAZOLE DR 20MG CAPSULE 36,611 $7.77 TRAMADOL HCL 50MG TABLET 28,686 $2.75 HYDROCODON-ACETAMINOPHEN ,686 $10.94 ALPRAZOLAM 1MG TABLET 25,437 $2.60 CETIRIZINE HCL 10MG TABLET 25,379 $6.73 AMOXICILLIN 400MG/5ML SUSP 24,539 $7.40 CYCLOBENZAPRINE 10MG TABLET 21,963 $2.40 ALBUTEROL 0.083% INHAL SOLN 21,392 $13.69 DOK 100MG CAPSULE 21,312 $2.19 HYDROCODON-ACETAMINOPHEN ,425 $15.02 CLONAZEPAM 1MG TABLET 20,373 $2.36 FERROUS SULFATE 325MG TABLET 20,038 $0.44 FLUTICASONE PROP 50MCG SPRAY 19,781 $25.46 MAPAP 325MG TABLET 19,594 $1.67 ALPRAZOLAM 0.5MG TABLET 19,242 $2.46 CLONAZEPAM 0.5MG TABLET 18,481 $2.02 CETIRIZINE HCL 1MG/ML SYRUP 17,143 $9.25 CEPHALEXIN 500MG CAPSULE 16,455 $4.44 HYDROCODON-ACETAMINOPHEN ,285 $4.20 AZITHROMYCIN 250MG TABLET 16,165 $5.40 ASPIRIN 81MG CHEWABLE TABLET 16,024 $1.45 OMEPRAZOLE DR 40MG CAPSULE 15,738 $12.45

7 VOLUME 15 ISSUE 2!" PAGE 7 Top 25 Drugs 2nd Quarter 2012 Ranked by Amount Paid Drug Total Amount Paid Avg. Amount Paid/Claim ABILIFY 5MG TABLET $3,286, $ CYMBALTA 60MG CAPSULE $2,823, $ ABILIFY 10MG TABLET $2,507, $ SINGULAIR 10MG TABLET $2,300, $ ADVATE 1,801-2,400 UNITS VIAL $2,234, $34, ADVAIR DISKUS $2,057, $ METHYLPHENIDATE ER 36MG TAB $2,011, $ SINGULAIR 5MG TABLET CHEW $1,951, $ LANTUS 100 UNITS/ML VIAL $1,840, $ INCIVEK 375MG TABLET $1,807, $17, PLAVIX 75MG TABLET $1,660, $ ABILIFY 20MG TABLET $1,606, $ SPIRIVA 18MCG CP-HANDIHALER $1,600, $ PROAIR HFA 90 MCG INHALER $1,496, $45.96 ABILIFY 15MG TABLET $1,406, $ VYVANSE 30MG CAPSULE $1,309, $ INTUNIV ER 2MG TABLET $1,299, $ METHYPHENIDATE ER 54MG TAB $1,250, $ PULMOZYME 1MG/ML AMP $1,248, $2, BENEFIX 2,000 UNIT KIT $1,205, $30, SUBOXONE 8MG-2MG SL FILM $1,176, $ DEXTROAMP-AMPHET ER 20MG CAP $1,150, $$ ABILIFY 2MG TABLET $1,143, $ BUDESONIDE 0.5MG/2ML SUSP $1,127, $ COPAXONE 20MG INJECTION KIT $1,106, $4,039.40

8 VOLUME 15 ISSUE 2 PAGE 8 Preferred Drug List (PDL) Items on Backorder Please call the Xerox (formerly ACS) Call Center when you discover your patient s PDL item is on backorder. The Call Center Staff will assist you in finding other options available on the PDL, and a Clinical Pharmacist is available to suggest therapeutic alternatives/substitutions. The Call Center staff are also available to assist with prior authorization of an alternative if necessary. To obtain prior authorization please call the Xerox Call Center at PDL Listing The Indiana Medicaid PDL listing may be found at the following Web site: Program Assistance All prior authorization requests or questions regarding the PDL should be directed to the Xerox (formerly ACS) Clinical Call Center at The article in this issue of the DUR Newsletter was authored by Debbie Brokhaw PharmD, Clinical Pharmacist, Xerox The content of this newsletter was approved by the Indiana Medicaid DUR Board

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