Mepolizumab (Nucala??, GlaxoSmithKline plc.) for the treatment of severe asthma with eosinophilia: effectiveness, value, and value-based price benchmarks : final report
- Collection:
- Health Policy and Services Research
- Author(s):
- Tice, Jeffrey A., author Ollendorf, Daniel A., author Campbell, Jonathan D., author Chapman, Rick, author Shore, Karen K., author Weissberg, Jed, author Whittington, Melanie, author Pearson, Steven D., author
- Contributor(s):
- California Technology Assessment Forum, issuing body. Institute for Clinical and Economic Review, issuing body.
- Publication:
- [Boston, MA] : Institute for Clinical and Economic Review, March 14, 2016
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Adrenergic beta-2 Receptor Agonists -- economics Adrenergic beta-2 Receptor Agonists -- therapeutic use Anti-Asthmatic Agents -- administration & dosage Anti-Asthmatic Agents -- economics Antibodies, Monoclonal, Humanized -- administration & dosage Antibodies, Monoclonal, Humanized -- economics Asthma -- drug therapy Asthma -- immunology Eosinophilia -- drug therapy Interleukin-5 -- immunology Cost-Benefit Analysis Glucocorticoids -- administration & dosage Humans United States
- Genre(s):
- Technical Report
- Abstract:
- Background. An estimated 22 million Americans have asthma, which causes the airways of the lungs to narrow or become blocked, making it hard to breathe. Among both young and old, asthma can have a significant impact on health and limit the ability to pursue many activities. Although only 5-10% of people with asthma have severe asthma, they account for approximately 50% of all costs. In addition to requiring daily inhaled corticosteroids (ICS) and long-acting beta agonist (LABA) therapy, these patients are often treated with oral corticosteroids, which may have detrimental clinical effects from long-term use. Topic in Context. In summarizing the contextual considerations for appraisal of a health care intervention, we seek to highlight the four following specific issues: (1) Is there a particularly high burden/severity of illness? (2) Do other acceptable treatments exist? (3) Are other, equally or more effective treatments nearing introduction into practice? (4) Would other societal values accord substantially more or less priority to providing access to this treatment for this patient population? There are a number of treatments available for asthma. Short-acting beta agonists (SABA), such as albuterol, are the primary treatment for mild intermittent asthma. ICS are usually added for persistent asthma. More severe asthma is treated with the combination of ICS and a LABA. Additional therapies for severe asthma include leukotriene inhibitors, theophylline, and omalizumab. Oral corticosteroids are used for short-term therapy to control asthma exacerbations and chronically for severe asthma that cannot be controlled without these drugs. Physicians try to avoid chronic oral corticosteroid therapy because it is associated with many long-term complications including growth suppression in children, osteoporosis, Cushing's syndrome, adrenal insufficiency, muscle weakness, diabetes, cataracts, joint necrosis, and an increased risk for infections. Treatment is progressive from Step 1 (SABA as needed) to Step 3 (low dose ICS + LABA) to Step 5 (high dose ICS + LABA with consideration of omalizumab in patients with allergies). Finally, Step 6 is high dose ICS + LABA + oral corticosteroids. Severe asthma is characterized by daily symptoms, awakening most nights due to symptoms, significant limitations in normal activities, forced expiratory volume in one second (FEV1) <60% of the normal predicted volume, and two or more exacerbations requiring oral corticosteroids in the past year. Well-controlled asthma is defined by symptoms less than or equal 2 times per week, nocturnal awakening less than or equal 2 times per month, no interference with normal activity, and an FEV1 >80% of predicted. Asthma has been divided into subtypes, some of which are associated with airway inflammation with eosinophils. About half of individuals with severe asthma exhibit the eosinophilic phenotype with elevated eosinophil levels (a marker of inflammation) in both the blood and airways. Activated eosinophils can increase airway smooth muscle contraction and mucous secretion, which are hallmarks of asthma. Interleukin-5 (IL-5) is an important cellular signal in eosinophilic inflammation. Therapies that decrease IL-5 levels, and thus decrease eosinophils in lung tissue, are therefore being explored as treatments for asthma. Mepolizumab Mepolizumab (Nucala??, GlaxoSmithKline plc.) is a humanized monoclonal antibody to IL-5. Mepolizumab binds to IL-5, which decreases IL-5 signaling leading to decreased eosinophils in the blood and tissue. In November 2015, the Food and Drug Administration (FDA) approved mepolizumab for the treatment of severe eosinophilic asthma for patients aged 12 years and older. Mepolizumab 100 mg must be reconstituted by a healthcare professional, and is administered subcutaneously once every 4 weeks in a physician's office. Office administration is required in order to monitor patients for hypersensitivity reactions, a common practice following administration of biologic agents. In this review, we sought to assess the comparative clinical effectiveness and comparative value of adding mepolizumab to standard treatment for severe asthma (inhaled corticosteroids and other daily controller medications).
- Copyright:
- Reproduced with permission of the copyright holder. Further use of the material is subject to CC BY license. (More information)
- Extent:
- 1 online resource (1 PDF file (i-ii, ES1-ES9, 73 pages))
- Illustrations:
- Illustrations
- NLM Unique ID:
- 101678996 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/101678996