Diabetes is a chronic, progressive metabolic disease in which the body lacks or is resistant to endogenous insulin, leading to a state of persistent high blood sugar (referred to as hyperglycemia). The most common form of the disease is type 2 diabetes, whereby the body becomes resistant to insulin, most often as a result of obesity and sedentary lifestyle. The primary goal of treatment of type 2 diabetes is to achieve and maintain glycemic control and to reduce the risk of both microvascular complications (e.g., diabetic neuropathy, retinopathy, nephropathy) and macrovascular complications (e.g., myocardial infarction, stroke). Because of the progressive nature of type 2 diabetes, the number of antidiabetic medications used tends to increase as the patient progresses. Physicians and treatment guidelines acknowledge the role of metformin as the gold-standard first-line therapy in treating type 2 diabetes. Further therapies (primarily oral agents such as DPP-IV inhibitors, SGLT-2 inhibitors, and sulfonylureas) are typically added as second- and third-line agents to help maintain long-term glycemic control. A significant number of patients progress toward additional therapy with injectable treatments such as the GLP-1 receptor agonists and insulins. Using U.S. patient-level claims data, this report analyzes the use of key therapies in the newly diagnosed and recently treated type 2 diabetes patient populations. With respect to newly diagnosed patients, the report provides a prospective analysis of treatment patterns and share by line of therapy, as well as progression between lines, duration of treatment on each line, and use of concomitant treatment. For recently treated patients, the report quantifies a drug’s source of business compared with its competitors and details which drugs precede others through a retrospective analysis of patient claims data. Additional analyses explore persistency and compliance by brand.
Questions Answered in This Report:
- Newly diagnosed patients: Type 2 diabetes treatment guidelines recommend lifestyle modifications and metformin therapy at diagnosis. Additional therapies are added if patients do not achieve target blood glucose levels. How closely do prescribing physicians follow the ADA guidelines when initiating treatment of newly diagnosed patients, and what are the major barriers to initiating therapy? What are the prescribing rates of branded early-line treatments such as Januvia (Merck’s sitagliptin)? How frequent is early-line prescribing of insulin analogues such as Lantus (Sanofi-Aventis’s insulin glargine) and Levemir (Novo Nordisk’s insulin detemir)?
- Recently treated patients: Type 2 diabetes treatment is characterized by polypharmacy; as a patient’s disease progresses, agents such as Victoza (Novo Nordisk’s liraglutide) and Januvia are added to metformin and the sulfonylureas. How do the pathways to each drug used to treat type 2 diabetes differ? How frequently are patients switched between agents in the same class (e.g., Januvia and Onglyza [AstraZeneca’s saxagliptin]? If patients are switched between classes, which classes are benefiting and at whose expense? How is the SGLT-2 inhibitor Invokana being incorporated in the treatment algorithm of the different lines of therapy?
- Pathways to key therapies: Longitudinal claims data reveal that metformin is the leading agent in first- and second-line therapy for type 2 diabetes. The data also detail which agents in a given class are placed ahead of other agents in lines of therapy. Which drugs are used most often with metformin? Which drugs precede the use of GLP-1 receptor agonists such as Bydureon [AstraZeneca’s exenatide LAR] and Victoza? When do physicians turn to insulin analogues such as Lantus? What do these patterns say about how physicians use each agent?
Primary patient-level data: Quantitative findings from our analysis of data cover ~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 between 6 to 12 months old at the time of publication.
Patient Sample: To qualify for inclusion, patients had to be older than 18 years of age and meet one of the following conditions:
- At least one prescription from the drug list and at least one claim with a diagnosis code for type 2 diabetes (International Classification of Diseases, Ninth Revision [ICD-9] diagnostic codes 250.00, 250.02, 250.10, 250.12, 250.20, 250.22, 250.30, 250.32, 250.40, 250.42, 250.50, 250.52, 250.60, 250.62, 250.70, 250.72, 250.80, 250.82, 250.90, 250.92) during the study period OR
- At least two claims with a diagnosis code for type 2 diabetes (see above) in the two-year period (the two claims must be 30 days apart) OR
- At least one claim with a diagnosis code for type 2 diabetes (see above) and at least two laboratory codes for a HbA1c test (CPT 83036) in the second year of this period only OR
- At least one prescription for an oral antidiabetic agent (OAA) and one prescription for either insulin or Symlin irrespective of ICD-9 diagnosis codes OR
- At least one claim with any of the above diagnosis codes for type 2 diabetes in the two-year period and at least two claims for a fasting glucose test (CPT 82947) OR
- At least one claim with any of the above diagnosis codes for type 2 diabetes in the two-year period and at least two claims for a diabetes screening test (G8777).
Of the patients above, patients aged 18-40 who had at least one prescription for insulin or Symlin without an accompanying prescription for an OAA were excluded because these patients were considered likely to have type 1 diabetes. Although type 1 diabetes patients older than 40 could be captured in our analysis, we strongly believe that the vast majority of sampled patients are accurately diagnosed with type 2 diabetes.
Quantified lines of therapy analysis shows the exact share of each agent in each line of therapy, including the rate of progression between lines and the 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 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.
- Drug persistence and compliance.
- Quarterly trending of patient share for all key therapies.