A new study sheds light on the economic and clinical costs associated with "maintaining a failing T2DM treatment regimen."
Insulin therapy for persons with type 2 diabetes (T2DM) is traditionally added to an antihyperglycemic regimen at the time in the disease process when a combination of oral agents no longer controls HbA1c (A1c) levels. This stepwise strategy often leads to complex treatment regimens that have become more expensive to maintain as the cost of oral agents and noninsulin injectables reach parity with insulin. Could adding insulin earlier in treatment help reduce cost and produce clinical benefits as well?
A study published recently in the Journal of Managed Care & SpecialtyPharmacy began with that hypothesis. The results suggest that earlier introduction of insulin could save money, help more patients reach A1c goals, and decrease diabetes-related complications and mortality.
“Delay in escalating treatments for T2DM is driven by many factors related to both the physician and the patient,” commented first author Harry Smolen, MS, president and CEO of Medical Decision Modeling, Inc., Indianapolis, Indiana. “Patients with T2DM usually have multiple health issues that need to be dealt with in a short clinic appointment.
“Primary care physicians, in particular, have a very limited amount of time with patients,” Smolen added. “The purpose of the study is not to apportion ‘blame’ for this delay. The study is about helping clinicians make rational decisions based on sound evidence.”
The researchers used a microsimulation model to estimate T2DM complications, mortality, costs, and newly diagnosed patients who reached a target A1c of less than 7.0%. They used results from randomized controlled clinical trials to estimate treatment efficacy. Standard of care was based on guidelines from the American Diabetes Association (ADA) and European Agency for the Study of Diabetes (EASD) and from the American Association of Clinical Endocrinologists-American College of Endocrinology (AACE-ACE): ie, metformin first; followed by metformin with a sulfonyurea; then addition of a DPP-4 inhibitor, a thiazolidinedione, or a noninsulin injectable; followed by initiating basal insulin and removing the sulfonylurea; and finally adding bolus insulin.
The researchers also analyzed two categories of treatment: two-stage insulin (basal with oral antidiabetics followed by biphasic insulin plus metformin); and one-stage insulin (biphasic with metformin). Using a time frame of 5 years, they analyzed various strategies within each category, resulting in a range of results for each.
Compared to standard of care, findings showed:
- Target A1c: Reached by 0.10% to 1.79% more patients with the two-stage approach, and 0.50% to 2.63% more patients with the one-stage approach.
- Major diabetes complications: decreased by 0.38% to 17.46% with the two-stage approach, and 0.72% to 25.92% with the one-stage approach.
- Severe hypoglycemia: Increased by 17.97% to 60.43% with the two-stage approach and 6.44% to 68.87% with the one-stage approach.
- Incremental costs: Ranged from $95 to $3,267 with the two-stage approach, and from $1642 to $1177 with the one-stage approach
- The cost savings for the one-stage approach may have been related to lower pharmacy costs and reductions in T2DM complications
- Both approaches were linked to reaching target A1c earlier, fewer diabetes complications, and reduced mortality.
When considering earlier initiation of insulin, Smolen and colleagues recommend that clinicians take into account the ability of patients to regularly self-monitor glucose and make appropriate insulin adjustments. Clinicians should also consider whether the patient can maintain regular interaction with healthcare providers.
“Costs for advanced non-insulin treatments, such as DPP-4 and GLP-1 inhibitors, are approaching and even exceeding those of insulin,” Smolen emphasized, ”We feel that the costs for these treatments may have risen to the point where the use of insulin earlier in treatment should be reevaluated when clinically appropriate for the patient. Our results indicate that medical cost savings from improved glycemic control can potentially offset increased treatment costs in certain instances.”
In addition to outcomes and costs, Smollen stressed, there are other important considerations inherent in managing patients with T2DM. These include a clear understanding of patient preferences and needs, as well as what outcomes are important to patients, eg, avoiding weight gain, minimizing hypoglycemia, and having a flexible regimen.
Smolen also points out that the target A1c of 7% used in this study may not be appropriate for all patients and should be evaluated on an individual basis.
“Our work highlights the increase in health care costs from maintaining a failing T2DM treatment regimen,” Smolen concluded. “We do not contradict current practice, but reinforce the need for patients and treating physicians to engage more actively in treatment evaluation and modification.”
Smolen HJ, Murphy DR, Gahn JC, Yu X, Curtis BH. The evaluation of clinical and cost outcomes associated with earlier initiation of insulin in patients with type 2 diabetes mellitus. J Manag Care Pharm. 2014;20:968-984. http://www.amcp.org/WorkArea/DownloadAsset.aspx?id=18474