A gradual decline in testosterone is a natural part of the aging process in men. However, when testosterone falls below normal levels and when related symptoms, such as erectile dysfunction, increased fatigue, loss of bone mineral density, or sleep disturbance are present, pharmaceutical treatments may be prescribed. For the most part, the treatment for low testosterone is testosterone replacement therapy. Testosterone treatments are available in a variety of formulations, with each method of administration providing different levels of convenience and risk of unintended exposure to others. Using national patient-level claims data, this report analyzes physician adherence to the Endocrine Society’s treatment guidelines by exploring the use of key therapies in the newly diagnosed and recently treated low-testosterone patient populations. Among newly diagnosed patients, we provide a quantitative analysis of treatment patterns and share by line of therapy, as well as progression between lines and the duration of treatment on each line. Use of concomitant treatment in this condition is rare. Additional analyses explore persistency and patient compliance by brand.

Questions Answered in This Report:

  • Newly diagnosed patients: Approximately 45% of diagnosed low-testosterone patients begin treatment with a key therapy within a year of their initial diagnosis. What percentage of these patients progress to a second- or third-line drug within the first year? Which products capture the most patient share in the first, second, and third lines of treatment? How often is combination therapy used in each line of therapy?

  • Recently treated patients: The generically-available depo-testosterone injection captures the majority of recently treated patient prescriptions, while Androgel is the most commonly prescribed topical treatment. Which specific drugs garner the most patient share for recently treated low-testosterone patients? When do patients progress from one therapy to the next in low testosterone, and how does this pattern differ among key drugs? Are the most recently treated patients with each key brand coming through new (adds/switches) or continuing business?

  • Pathways to key therapies: Longitudinal claims data reveal relatively consistent use patterns of key therapies among recently treated patients; use of newer testosterone agents increases in the later lines of therapy. Which therapies have experienced market growth or decline over the key therapy periods studied? To what extent are key therapies prescribed concomitantly to recently treated patients? What has been the impact of recently approved drugs for low testosterone?

Scope:

Primary patient-level data: Quantitative findings from our analysis of data covering approximately 40 million lives providing 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 with claims that are less than six months old at the time of publication.

Patient Sample:

Patients who are continuously enrolled for the complete two-year study period must meet the following condition: At least one claim with a diagnosis code for testicular hypofunction (International Classification of Diseases, Ninth Revision [ICD-9] diagnostic code 257.2) during the study period. Patients must be aged 18 or older to qualify for the analysis.

Quantified lines of therapy analysis showing exact share of each agent in each line of therapy including rate of progression between lines and length of time patients are on each line.

Newly Diagnosed Patients:

- Patient share by drug class and key products across three lines of therapy, within one year of diagnosis.

- Patient flowchart 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.

- Drug persistence and compliance.

- Quarterly trending of patient share for all key therapies.