Asthma Treatment, Adherence, and Use of PROs

Asthma affects approximately 19.2 million U.S. adults and 5.5 million children aged younger than 18 years. Each year, asthma causes 10.5 million physician office visits, 1.8 million hospitalizations, and approximately 5,000 deaths.

During a presentation at the Asembia 2020 Summit, Lily P. Duong, PharmD, RPh, chief clinical officer at Therigy, LLC in Maitland, FL; Darrell Hulisz, PharmD, RPh, associate professor in the Department of Family Medicine & Community Health at Case Western Reserve University School of Medicine in Cleveland, OH; and Meghann Randolph, PharmD, ambulatory retail clinical pharmacist of specialty pharmacy and infusion services at the University of Kentucky in Lexington, KY, discussed the pharmacist’s role in managing patients with asthma and the use of patient-reported outcomes (PROs).

Goals of asthma therapy include symptom relief, minimal use of short-acting beta agonists (SABA) rescue, maintenance of normal activity, and prevention of asthma exacerbations. The pharmacist’s involvement in a case should include assessment of signs and symptoms of asthma, pulmonary function, quality of life (QoL) and functional status, history of asthma exacerbations, pharmacotherapy, adherence, side effects, inhaler technique, and follow-up plans.

Dr. Hulisz discussed treatment options for asthma. Treatment with regular daily low-dose inhaled corticosteroids (ICS) is effective in reducing asthma symptoms and risk of asthma-related exacerbations, hospitalization, and death. In adults and adolescents with mild asthma, treatment with low-dose ICS-formoterol reduces the risk of severe exacerbations by about two-thirds compared with SABA-only treatment and is non-inferior to daily low-dose ICS. For patients with persistent symptoms and/or exacerbations despite low-dose ICS, first check their inhaler technique, adherence, allergen exposure, and comorbidities, and step up therapy if asthma remains uncontrolled despite good adherence and inhaler technique.

SABAs are the most effective medication for relief of acute bronchospasm in asthma. Long-active beta agonists (LABA) are not a substitute for anti-inflammatory therapy and are not appropriate for monotherapy; they are beneficial when added to an ICS. The choice of LABA is often dictated by payer formulary. ICS is the most effective long-term control therapy for persistent asthma. Leukotriene modifiers increase capillary permeability and smooth muscle contraction. They are not as effective as ICS and may be beneficial as add-on therapy for patients with aspirin sensitivity and food allergies. Long-active muscarinic antagonists (LAMAs) are anticholinergic agents that have emerged as first-line therapy for chronic obstructive pulmonary disease but are used less often for asthma. When given by inhalation, LAMAs produce bronchodilation by competitively inhibiting cholinergic receptors in bronchial smooth muscle.

Biologics (omalizumab, reslizumab, mepolizumab, benralizumab, and dupilumab) may also be required in some patients with severe disease, including those with excessive morbidity and those who have high use of healthcare resources. Candidates for biologic therapy may include patients who are steroid-dependent, those with severe disease with immunoglobulin E levels of 30 IU/mL to 700 IU/mL and with a positive prick or radioallergosorbent test, or those who are adherent to medications and avoid triggers.

Pharmacists can be involved in patient care, including education, counseling for trigger avoidance and risk factor reduction, counseling for adverse events (AEs), prevention of drug misadventures, and assessing or demonstrating proper inhaler technique. They can also monitor medication refill patterns, coach patients about adherence, provide guidance for prescribers on formulary compliance, aid in financial assistance for patients, and provide smoking cessation interventions.

Patients with asthma may face missed work/school days, limited ability to perform daily activities, fear or embarrassment of exacerbations, sleep disturbances, stress on parents and family members, and medication costs. “The most tangible concern is the financial burden,” said Dr. Duong. “Patients are responsible for copayments and that could be a large amount if patients are on a number of medications. They might be responsible for 20% of the specialty medication costs if their asthma severity requires them to take specialty drugs. These [concerns] definitely present an opportunity to have an asthma management program in place to help alleviate and measure outcomes.”

Providers should select an appropriate treatment that addresses the patient’s conditions as well as follows treatment guidelines and managed care policy drug access. Therapy effectiveness should be measured by outcome measures, QoL measures, and PRO measures (PROMs).

The National Asthma Education and Prevention Program guidelinesrecommend that at the initial patient visit, providers diagnose asthma, assess the disease severity, initiate medication and demonstrate use, develop a written asthma action plan, and schedule follow-up appointments. At follow-up visits, providers should assess and monitor asthma control; review medication technique and adherence, as well as assesses AEs and review environmental control; maintain, step up, or step down medication; review the action plan and revise as needed; and schedule the next follow-up appointment.

Measurable disease outcomes include asthma symptoms, use of SABA, exacerbations, emergency care visits, hospitalizations, loss of lung function, AEs, QoL, and work productivity. According to the Asthma Outcomes Consensus Group of the University of Oxford, the Asthma Control Questionnaire and Asthma QoL Questionnaire are PROMs that can be used for patient care.

Approximately 50% of patients on long-term therapy fail to take medications as directed at least part of the time, and reasons for this include cost, AEs, forgetfulness, drug regimen, administration, and poor adherence. Specialty pharmacy involvement in asthma care can enhance or improve QoL, adherence, asthma symptom control, and activities of daily living. In addition, assessment of comorbidities is important to identify patients who are more likely to have poorer asthma outcomes.

Presentation: Utilization of Patient-Reported Outcomes in Asthma Management: Moving Beyond Adherence Measures. Asembia 2020 Specialty Pharmacy Summit Virtual Experience, May 13, 2020.