Evidence-Based Diabetes Protocol Development: Approaches and a Case Study

Managed care faced an interesting dilemma in 2012 when the American Diabetes Association (ADA) released new guidelines for the treatment of type 2 diabetes mellitus (T2DM).¹ The new guidelines replaced the previous iteration that was algorithmic in its recommendations of drug therapy with one that was more individualized to the patient. While diabetes is not a one-size-fits-all disease, the new guidelines did not recommend a preferred second- or third-line medication. Many diabetic medications are still branded and associated with a relatively high cost compared with older generic medications. Furthermore, newer medications continue to come to market in these newer categories, such as DPP-4 inhibitors, GLP-1 agonists, and SGLT-2 inhibitors. Despite comparative glycated hemoglobin (A1C)-lowering data, these medications have little clinical differentiation in terms of outcomes and safety. This should allow health plans to streamline their approach in managing drugs that treat diabetes.

Managed care continues to evaluate efficacy, safety, and cost as part of any drug review process. However, with little clinical differentiation, this approach allows organizations to focus on cost differences and comparative cost efficacy. It is also important to take rebates into consideration in these discussions for net cost comparisons. For example, in a medication class where there are 4 medications with the same mechanism of action and no clinical differentiation, a managed care organization can leverage rebates and market share to provide an overall cost savings to the health plan or employer group. It is not realistic that a payer should need to cover all the medications in this class. This is particularly important in the treatment of T2DM when there are more than 10 classes of medications available for the treatment of the disease. Therefore, approaches that a plan can apply include:

• Comparative effectiveness research (CER): As defined by the Federal Coordinating Council for CER, this is the conduct and synthesis of systematic research comparing different interventions and strategies to prevent, diagnose, treat, and monitor health conditions. The purpose of this research is to inform patients, providers, and decision makers, responding to their expressed needs, about which interventions are most cost-effective for which patients under specific circumstances.² This requires multiple data sources. Managed care is in the unique position of having data from clinical trials, administrative claims, laboratory draws, and access to all of the healthcare stakeholders involved in the delivery of care.

• Closed formularies: These allow flexibility in driving prescribing to preferred agents while still allowing appropriate clinical choice.

• Integrated care management: The old model of traditional disease management has proved largely ineffective. Approaches like mailing letters and newsletters or utilizing automated voice messaging to remind patients to take medication, etc, do not have significant influence upon behavioral change. New approaches are needed that empower patients to become active participants in their healthcare.

• Generic incentive: The goal of a generic utilization improvement program is to conduct direct member outreach to curb inappropriate and wasteful spending among patients who are utilizing high-cost branded medications that have generic alternatives within their specific therapeutic class. By targeting nonadherent patients among this group, managed care organizations have an opportunity to improve quality outcome measures by positively impacting individuals who struggle to achieve their therapy goals due to an unknown understanding that equally effective lowercost choices are readily available.

At VRx, after an evidence-based CER approach to pharmacy and therapeutics, and after applying a closed formulary benefit, a novel and innovative approach to collaborating with patients and providers has been incorporated— Veridicus Care Management (VCM).

VCM Case Report

Background: VCM provides integrated care management using a team comprising clinical pharmacists, nurse case managers, and mental health specialists. Our VCM program utilizes population management tools and predictive modeling to identify high-risk populations based on various clinical triggers. These services are offered to provide quality improvement solutions to pharmacy benefit managers (PBMs), health plans, and employer groups. One of the clinical tracks focuses on patients with “gaps in care,” such as diabetic patients who haven’t had an A1C drawn, lack an office visit, are missing key medications (ie, ACE-I/ARB and statin therapy). These targeted “gaps in care” are defined based on the National Council of Quality Assurance Healthcare Effectiveness Data and Information Set measures that promote improved quality in the delivery of care.

Case Details:

The VCM team identified a diabetic patient who was flagged as having “gaps in care,” who lacked treatment with an ACE-I/ARB and was noncompliant with his diabetic medications. The clinical pharmacist contacted the patient to address these issues and to provide comprehensive education regarding the patient’s specific expectations and goals of therapy. Upon further discussion, it was determined that the patient was noncompliant with his DPP-4 inhibitor due to the significantly high cost burden. Additionally, the patient also reported taking metformin 500 mg daily without any prior dose titration. The most recent A1C was 8.7% and the patient’s primary care provider had discussed initiating a new therapy with an SGLT2 inhibitor. The clinical pharmacist discussed the possibility of titrating the metformin to 2000 mg per day in divided doses, and replacing the DPP-4 inhibitor with generic pioglitazone. The case was then presented in the weekly VCM Clinical Coordination meeting, where additional insight was provided by the nurse case managers. The patient was then contacted by a nurse, who provided further diet and exercise education to supplement the recommended changes in medication therapy. All information related to the case was communicated to the patient’s primary care provider.

Upon follow-up with the clinical pharmacist, the patient reported successfully switching to a pioglitazone/metformin combination product with proper titration to 2000 mg per day. The clinical pharmacist assessed compliance and tolerability of the new medication regimen. At a 3-month follow-up, the patient demonstrated a 1.5% reduction in his A1C (to 7.2%).

Summary

EBDM

New approaches are needed in the current healthcare environment, and more specifically, in the treatment of diabetes. Old methods of patient-outreach are largely ineffective. Models should include CER, closed formulary benefit design, and improved coordination of care. Integrated care management improves on the old model of disease management by involving all stakeholders in the treatment of diabetes. By using an integrated model, these stakeholders become empowered to collectively take responsibility for all clinical and financial outcomes. Healthcare is slowly shifting to an outcomes- oriented, collaborative team-based approach to patient management. An integrated care management model is a natural fit for managed care organizations to participate in the future of healthcare, which will consist of Patient-Centered Medical Homes and Accountable Care Organizations.

Author Information: Jeffrey D. Dunn, PharmD, MBA, is senior vice president of VRx Pharmacy Services.

Alexander Bitting, PharmD, is clinical pharmacy manager, Medicare Part D programs at VRx Pharmacy Services.

Alan D. Pannier, PharmD, MBA, is a managed care resident at VRx Pharmacy Services.

References

1. American Diabetes Association. Standards of medical care in diabetes — 2012. Diabetes Care. 2012;35(suppl1):S11-S63.

2. Health Services Research Information Central. Comparative Effective Research (CER). US National Library of Medicine, National Institutes of Health. http://www.nlm.nih.gov/hsrinfo/cer.html. Updated July 28, 2010. Accessed February 7, 2014.

For information contact Jeffrey D. Dunn, VRx Services, 19 E. 200 S., Floor 10, Salt Lake City, UT 84111.