Osteoporosis is a common bone disease estimated to have affected million patients in 2014, although owing to the asymptomatic nature of osteoporosis, the disease remains underdiagnosed. physicians generally follow the guidelines put forth by the American National Osteoporosis Foundation (NOF) (most recently updated in 2014) for the diagnosis and treatment of osteoporosis. The goal of therapy in osteoporosis is ultimately to reduce the risk of fracture, with an emphasis on the more serious and debilitating nonvertebral fractures (, those of the hip or tibia). First-line pharmacological therapy for treating osteoporosis is typically an oral bisphosphonate. Generic alendronate (Merck & Co.’s Fosamax, generics) is the most commonly used first-line therapy in the United States. Since 2012, the osteoporosis market has experienced the entry of numerous generically available treatment options—all but a single branded bisphosphonate now face generic competition. The genericization of the majority of the bisphosphonates will increase pressure on physicians to prescribe these alternatives ahead of more expensive branded options, including Amgen’s Prolia (denosumab).
Using national patient-level claims data, the Treatment Algorithms in Osteoporosis report explores the use of key therapies and drug classes among newly diagnosed and recently treated osteoporosis patient populations. Concerning the newly diagnosed patients, the report provides a quantitative analysis of percentage drug-treated and time to treatment, treatment patterns and share by line of therapy, progression between lines, recent patient-share trends, and use of concomitant treatment. Among recently treated patients, the report quantifies a drug’s overall drug share, use in combination with other therapies, and source of business compared with its competitors, detailing which drugs precede others through an analysis of add-versus-switch patterns. Two additional claims database queries explore persistency and compliance by therapy.
Questions Answered in This Report:
- Newly diagnosed patients: Only one-fifth of newly diagnosed osteoporosis patients initiate pharmacotherapy with an osteoporosis treatment within the first year of diagnosis. What percentage of these patients progress to a second- or third-line drug within the first year, and how quickly do patients progress? Which products capture the most patient share in the first, second, and third lines of treatment? How has the 2010 market entry of Prolia, the first in-class RANKL inhibitor, affected treatment patterns involving newly diagnosed osteoporosis patients?
- Recently treated patients: In Q4 2014, the use of bisphosphonates dominated the osteoporosis treatment landscape. Which specific drugs garner the most patient share for recently treated osteoporosis patients? Have any therapies experienced market growth or decline over the key therapy periods studied?
- Pathways to key therapies: Among patient share leaders for osteoporosis, alendronate is the most likely treatment to precede other agents, consistent with this drug’s leading position in early lines of therapy. How long does it take osteoporosis patients to progress to each key therapy? What are the various sources of business for each agent (i.e., new, add/switches, or continuing business)?
Primary patient-level data: This report provides quantitative findings from our analysis of data covering approximately 40 million lives and provides the most representative sample of U.S. treatment practice for Medicare and commercially insured patients. This report is delivered as a key findings slide deck and a dashboard that can be accessed using the Internet and presents claims that are between 6-12 months old at time of publication.
Patient Sample: · Patients who are continuously enrolled for the complete three-year study period must meet the following condition: at least one claim with a diagnosis code for osteoporosis (International Classification of Diseases, Ninth Revision [ICD-9] diagnostic codes: 733.0, 733.00, 733.01, 733.02, 733.03, 733.09) during the study period. All patients must be aged fifty or older to qualify.
Newly diagnosed patients:
- Patient share by drug class and key products across three lines of therapy, within one year of diagnosis.
- Patient flowcharts through one year of treatment for all first-line products, including progression rates and add/switch behavior.
- Polypharmacy and key concomitant therapies by line of therapy.
- Quarterly trending of patient share by line of therapy.
Recently treated patients:
- Quarterly snapshot of patient share by drug class and key products.
- Pathway to key therapy flowcharts tracking the preceding therapy patterns for all key therapies, including add/switch behavior.
- Brand source of business including share for continuing, new (switches/adds), and new (initial therapy) business.
- Polypharmacy and key concomitant therapies.
- Quarterly trends in patient share for all key therapies.
Drug persistence (One year, all-brand).
Drug compliance (six-month medication possession ratio [MPR]).