Symposium Discusses Emerging Type 2 Diabetes Treatment Strategies

San Francisco—Proper glycemic control is crucial in the management of type 2 diabetes to prevent long-term complications and reduce overall healthcare expenditures. With insulin use decreasing and use of new agents increasing, treatment regimens for patients with type 2 diabetes have changed substantially. The availability of new treatment options may affect rates of glycemic control but may also add to the complexity of clinical decision-making, as well as the management of benefits for plans and payers. Managed care organizations can play a vital role in reducing overall healthcare costs for this patient population by bridging the gap between recommended evidence-based diabetes care and actual care.

Evolving type 2 diabetes treatments and their impact on healthcare costs were discussed at the AMCP meeting during a satellite symposium titled Emerging Type 2 Diabetes Treatment Strategies: Practical Solutions for a Complex and Swiftly Changing Environment. Presentations were given by Susan Ann Cornell, PharmD, CDE, FAPhA, FAADE, assistant professor in the department of pharmacy practice, Chicago College of Pharmacy at Midwestern University; Lawrence Blonde, MD, FACP, FACE, director of the Ochsner Diabetes Clinical Research Unit; John M. Cruickshank, DO, MBA, CPE, chief medical officer, Lovelace Health Plan; and James T. Kenney, Jr, RPh, MBA, pharmacy operations manager, Harvard Pilgrim Health Care, Inc.

Adherence Is Key

Dr. Cornell opened the forum by discussing the importance of treatment adherence and the effect nonadherence continues to have on the rising cost of healthcare. She referenced a study in which researchers found that nonadherence accounts for up to 11% of all hospital admissions and 40% of nursing home admissions, and 50% of prescriptions are stopped within the first 6 months of treatment. This finding is a significant problem for diabetes patients considering that the first 3 to 6 months of a new therapy are crucial for long-term adherence.

Patient- and medication-related factors contribute to nonadherence. Patient factors include mental illness, substance abuse, financial concerns, living conditions, and health beliefs. Medication-related factors include increased daily doses of medicines, concurrent medications, adverse events, and long-term therapy. She noted 32 million Americans use ≥3 medications daily, 75% of adults are nonadherent in ≥1 way; the average adherence rate for medicines taken once daily is 80%, and 50% for medicines taken 4 times daily. For seniors ≥65 years of age, the number of medicines taken goes up considerably: 51% take ≥5 prescriptions daily, 1 in 4 take between 10 to 19 medications daily; 57% admit forgetting to take their medication.

To improve adherence, Dr. Cornell explained that clinicians need to be able to recognize patients who are failing to adhere and why (Table). She offered the following strategies for improving adherence:

• Make the patient central to the treatment plan

• Increase motivation by enlisting the patient in the decision-making process such as creating an education plan specific for each patient

• Determine what the patient’s expectations are and explain why some of them may not be met; Provide information and education on illness including consequences of nonadherence; and

• Get to know the patient’s other healthcare providers and work together for optimal patient care. 

Incretin-based Therapies for Glycemic Control

The second presentation, given by Dr. Blonde, focused on the fact that patients with type 2 diabetes need therapeutic interventions to control glycemic levels. While lifestyle modifications remain the cornerstone of therapy, most patients will require combination pharmacotherapy along with lifestyle changes.

He also explained that conventional antihyperglycemic therapies are not meeting patients’ needs. These therapies include metformin, insulin, sulfonylureas, short- and long-acting glucagon-like peptide-1 (GLP-1) agonists, and dipeptidyl peptidase-4 inhibitors. Dr. Blonde said that many conventional therapies are associated with weight gain. Insulin and insulin secretagogue therapies are associated with significant risk for hypoglycemia. Most therapies fail to adequately control postprandial hyperglycemia and maintain long-term glycemic control. Furthermore, conventional therapies are associated with additional adverse events, which include gastrointestinal side effects and edema.

Incretin-based therapies however, offer an alternative option for treating type 2 diabetes, according to Dr. Blonde. These therapies include exenatide, liraglutide, sitagliptin, saxagliptin, and linaglipin. Incretin-related agents have good glycemic lowering efficacy, a low risk of hypoglycemia, weight neutrality, or weight loss.

Dr. Blonde highlighted a study by Buse, et al that found improved hemoglobin A1c (HbA1c) and decreased weight gain among patients who received insulin glargine and exenatide versus insulin glargine and placebo. Findings showed that HbA1c decreased by 1.74% in the exenatide group and 1.04% in the placebo group. Furthermore, weight decreased by 1.8 kg in the exenatide group and increased by 1.0 kg in the placebo group. The estimated rate of hypoglycemia was similar between groups.

Diabetes Toll on Healthcare

The diabetes crisis and the growing prevalence this disease has on healthcare was the focus of Mr. Cruickshank’s presentation. Diabetes currently affects approximately 25.8 million US adults. If trends persist, 15% of adults will have diabetes by 2021 with costs totaling $3.5 trillion. He pointed out that total costs for plan members with diabetes are 2.7 times higher versus patients without the disease. As HbA1c rises, so do the out-of-pocket costs for patients. The projected annual cost of medical care for a patient with an HbA1c of 6% is $8576, compared with $11,629 for a patient with a HbA1c of 10%. Therefore, more aggressive treatment is needed to have a greater impact on cost benefit. Managed care can help manage costs and ensure quality of care with the use of step therapy and treatment algorithms, suggested Mr. Cruickshank.

The American Diabetes Association and the American Association of Clinical Endocrinologists/American College of Endocrinology treatment guidelines emphasize early diagnosis and intensification of therapy to achieve and maintain HbA1c goals. Dr. Cruickshank noted, however, that guidelines must reflect the most recent advances in medical therapy to be relevant. Further revision of the guidelines will be needed because it likely that several new incretin-based therapies will become available in the coming years.

Data show that as the total cost of diabetes therapy increases, compliance decreases. A strong correlation appears to exist between increased patient out-of-pocket expense, such as copayments, and medication discontinuation. Reducing patient out-of-pocket costs through reduced copayments may prove to be a successful strategy to increase compliance, explained Mr. Cruickshank.

Value-based benefit design is a strategy shown to increase compliance in treating type 2 diabetes.

Value-based benefit design:

• Emphasizes high-value medical services by lowering patient copayments to encourage plan member use;

• Adjusts patients’ out-of-pocket costs for specific services based on assessment of the clinical benefit achieved; and

• Results indicate a 10% to 15% improvement in medication compliance when copayments are reduced.

New payment and delivery models are also creating incentives for coordinated care and increased quality. He said that leveraging opportunities with accountable care organizations, medical homes, and the Centers for Medicare & Medicaid Services’ 5-Star Rating can impact outcomes for type 2 diabetes.

Disease-based Pharmacoeconomic Models

During the final presentation, Mr. Kenney introduced several disease-based pharmacoeconomic models to aid formulary decision-making when long-term outcomes data are lacking.

He discussed the value of comparative effectiveness research (CER) treatments for patients with type 2 diabetes. CER includes perspectives from across the continuum of care. This tool considers the needs of patients, clinicians, purchasers, and policymakers; addresses a broad range of topics including tests, treatments, prevention strategies, care delivery, and monitoring; includes study populations that are commonly seen in clinical practice; and focuses on patient-centered decision-making to tailor tests and treatments to specific patients.

CER modeling using indirect treatment comparisons (ITCs) is becoming more widespread, but neither the FDA nor European Medicines Agency has adopted a formal position on the use of indirect comparisons to support a claim. ITCs can be used to assess new agents against existing treatments without having data from conventional head-to-head trials. Both direct and indirect measures can be combined using a mixed treatment comparison.

He said an emerging approach to assess safety, efficacy, and cost outcomes is CER modeling using Bayesian techniques. Bayesian analysis can be applied to predict patient outcomes in scenarios where clinical trials are not feasible. Bayesian methods have been developed to conduct “network meta-analysis” of multiple treatments and to combine direct and indirect evidence.

Mr. Kenney also highlighted 2 other models—Markov and the core diabetes model (CDM). Markov modeling is used to estimate outcomes over time. Under Markov modeling, disease is broken into separate states where a patient cannot be in >1 state at a time. In a diabetes model, states might include “on treatment with hypoglycemia.” Furthermore, running the model for several cycles provides estimations of the long-term health outcomes or costs associated with a disease or particular intervention. He highlighted a study in which Markov modeling demonstrated that treatment of type 2 diabetes with a GLP-1 agonist is cost-effective versus other agents over the long term.

The CDM is another tool used to predict economic outcomes. CDM is a validated model that utilizes standard decision analysis techniques. It uses the best currently available epidemiologic and treatment data and calculates long-term (≥5 years) clinical and health outcomes. CDM includes various economic parameters, takes a third-party payer perspective, and uses a 35-year time horizon to capture any long-term complications. Mr. Kenney concluded his presentation by highlighting research in which CDM demonstrated GLP-1 agonists are cost-effective for the treatment of type 2 diabetes.