The following summaries represent a sample of diabetes-related real-world, evidence-based studies presented at the 29th Annual Meeting of the Academy of Managed Care Pharmacy (AMCP), March 27-30, 2017, in Denver, CO.
- Medication Adherence a Continuing Challenge in Sustaining Glycemic Control for Patients with Type 2 Diabetes
- Significant Variations in Coverage Policies Across Medicare Part D Plans for Newer Diabetes Drugs
- Pharmacist-Directed Wellness Program Improves Glycemic Control in Patients with Diabetes
- Pharmacists’ Interventions in Clinical Trials Improve Medication Adherence in Patients with Inadequately Controlled Type 2 Diabetes
Medication Adherence a Continuing Challenge in Sustaining Glycemic Control for Patients with Type 2 Diabetes
Diabetes continues to present a significant clinical and economic burden on the US healthcare system: the incidence of diabetes continues to rise in the United States and is projected to reach 15 per 1000 people by 2050. Despite the introduction of new medications for the treatment of type 2 diabetes, sustaining glycemic control remains a challenge.
Maintaining glycemic control, as measured by hemoglobin (Hb)A1c levels, in patients with type 2 diabetes is crucial for reducing the serious clinical complications and subsequent economic costs associated with this chronic disease. However, according to real-world data in the 2007-2010 National Health and Nutrition Examination Survey, the proportion of patients reaching an HbA1c goal of <7.0% is slightly more than 50%.
Using real-world claims data from 2012 to 2014, Kathryn Fitch, RN, MEd, Principal and Healthcare Management Consultant, Milliman, and colleagues, compared HbA1c laboratory data for commercially insured patients with type 2 diabetes and findings reported in the medical literature.
Multiple studies have shown that adherence to antidiabetes therapies is suboptimal. For example, according to one meta-analysis, only 67.9% of patients were adherent to antidiabetes therapy, meaning that >30% of patients were not. In another meta-analysis of 27 studies between 2004 and 2013, adherence rates to diabetes drugs ranged from 38.5% to 93.1%. Not surprisingly, suboptimal adherence to diabetes therapy is associated with increased healthcare utilization and costs, in part because of high hospitalization rates.
In their study, Fitch and colleagues divided the patients into 3 cohorts to identify trends in medication adherence and HbA1c levels.
Cohort 1 included 4600 patients who had coverage eligibility for the 3-year period and at least 1 HbA1c test in each year. In this cohort, glycemic control was suboptimal and difficult to sustain over time; the proportion of patients achieving HbA1c levels <7% decreased from 44% in 2012 to 38% in 2014, and of those with HbA1c levels <7% in 2012, only 70% maintained that level by 2013 and 64% sustained it by 2014. Overall in cohort 1, only 24% of patients maintained glycemic control throughout the 3 years of the study.
In addition, medication adherence, as measured by the proportion of days covered (PDC) ≥80%, was also difficult to maintain. Although the PDC increased from 40% in 2012 to 42% in 2014, this is still a suboptimal level, and adherence remained a challenge over time. Only 61% of patients in cohort 2 who were adherent in 2012 were still adherent in 2014. In addition, of the nonadherent patients in 2012, 70% remained nonadherent in 2014. Overall, only 18% of patients in cohort 1 remained adherent to therapy throughout the 3-year study period.
Cohort 2 included 36,233 patients who had eligibility in 2013 and for at least 1 month in 2014 and at least 1 HbA1c test in 2014. In this cohort, patients with poor glycemic control incurred higher costs than patients with glycemic control, which was primarily attributed to high spending on diabetes drugs in patients with elevated HbA1c levels. For example, the costs for patients with HbA1c levels ≥7% were 8.1% higher than the costs for patients with HbA1c levels <7% ($17,427 vs $16,119, respectively). In addition, the costs for patients with HbA1c levels ≥8% were 6% higher than for patients with HbA1c levels <8% ($17,524 vs $16,537, respectively). Overall, the diabetes-related pharmacy cost was 120% higher for HbA1c levels ≥7% versus HbA1c levels <7%, and 78% higher for HbA1c levels ≥8% versus HbA1c levels <8%.
“Diabetes prescription drug spending was the primary driver of the cost difference between the cohorts with and without glycemic control, highlighting the challenge of achieving expected value for higher drug spend,” stated Fitch and colleagues. “These findings highlight the need for evaluating the financial and population health outcomes of diabetes medications and delivery systems that can improve adherence and HbA1c control,” they noted.
Cohort 3 included 79,933 patients with >191,000 elevated HbA1c episodes between 2012 and 2014. In this cohort, medication adherence was inversely correlated with HbA1c levels: 44% of patients with elevated HbA1c episodes who adhered to therapy had HbA1c levels <7% compared with 36% of those who did not adhere to therapy. Every 10% increase in PDC was associated with a 0.12% decrease in HbA1c levels; this inverse relationship was greatest for patients who received oral plus injectable therapies.
“Our analysis illustrated that adherence was lower for injectable-only episodes as well as episodes during which both orals and injectables were used,” noted Fitch and colleagues. “Studies have reported adherence to be lower when the treatment itself is perceived to be more difficult or inconvenient. This is particularly true for insulin, which has been found to be a significant predictor of nonadherence,” they added.
This study underlines that the type of medication and mode of administration can influence adherence to diabetes therapies, and the complexity of the treatment regimen may contribute to lower adherence in patients with type 2 diabetes. Adherence as measured by PDC ≥80% was exhibited in 53% of patients using oral-only therapy versus 43% with injectable-only therapy and 40% with oral therapy plus injectable therapy.
“Our results are consistent with findings in the literature that better diabetes medication adherence is correlated with better HbA1c control, and that HbA1c control and diabetes medication adherence among commercially insured patients is suboptimal. These findings highlight the need for evaluating medications and systems of care from the standpoint of real-world HbA1c control and health outcomes,” concluded Fitch and colleagues.
[Source: Fitch K, Engle T, Pyenson B. Real-world insights & economic considerations in type 2 diabetes: the challenge of sustaining glycemic control & medication adherence over time. March 2017. Milliman white paper.]
Significant Variations in Coverage Policies Across Medicare Part D Plans for Newer Diabetes Drugs
To contain the rising cost of healthcare, many Medicare Part D plans have resorted to cost-sharing, formulary restrictions, prior authorizations, step therapy, and other risk-sharing approaches. However, information regarding formulary restrictions and cost-sharing practices under Medicare Part D plans for the newer diabetes drugs, including glucagon-like peptide (GLP)-1 receptor agonists, dipeptidyl peptidase (DPP)-4 inhibitors, and sodium glucose co-transporter (SGLT)-2 inhibitors, is lacking.
Using characteristics files and formulary files for Medicare Part D plans from the Centers for Medicare & Medicaid Services between 2007 and 2013, Penxiang Li, PhD, University of Pennsylvania, Philadelphia, and colleagues examined the cross-sectional and longitudinal variations in formulary coverage, utilization management restrictions (eg, prior authorization and step therapy policies), and cost-sharing practices for insulin, GLP-1 receptor agonists, DPP-4 inhibitors, and SGLT-2 inhibitors to profile the trends in coverage across 1031 Medicare Part D plans.
In 2013, the percentage of Medicare Part D plans with a diabetes drug being excluded from the plan formulary ranged from 4.8% to 45.5% for GLP-1 receptor agonists; 3.4% to 36.7% for DPP-4 inhibitors; 6.9% to 24.6% for insulins; and 79.3% for SGLT-2 inhibitors. Because SGLT-2 inhibitors are a newer class of diabetes drugs, “the utility of data in this class is low,” suggested Dr Li and colleagues.
Overall, prior authorization and step therapy policies decreased across all diabetes drug classes between 2007 and 2013. However, there was still considerable variation among plans. In 2013, the percentage of plans with prior authorization policies ranged from 2.3% to 16.6% for GLP-1 receptor agonists, 0% to 0.4% for DPP-4 inhibitors, 0.2% for insulins, and 2.8% for SGLT-2 inhibitors. Furthermore, the percentage of Medicare Part D plans with step therapy models ranged from 21.4% to 34.3% for GLP-1 receptor agonists, 0% to 21.9% for DPP-4 inhibitors, 0% for insulins, and 0.5% for SGLT-2 inhibitors.
With regard to cost-sharing practices, approximately 33% of plans required coinsurance for the antidiabetes drugs, with the exception of the DPP-4 inhibitor alogliptin (92% of plans required coinsurance) and the SGLT-2 inhibitor canagliflozin (52% of plans required coinsurance). The percentage of plans requiring coinsurance ranged from 23% to 43% for GLP-1 receptor agonists, 20% to 30% for DPP-4 inhibitors, 1% to 25% for SGLT-2 inhibitors, and 20% to 25% for insulins.
Furthermore, the mean copayments per 30-day prescriptions ranged from $39 to $55 for GLP-1 receptor agonists, $40 to $78 for DPP-4 inhibitors, $38 for canagliflozin (SGLT-2 inhibitor), and $37 to $38 for insulin.
These results have important implications for patients with diabetes, indicated Dr Li and colleagues. Foremost, these findings highlight the significant variability among Medicare Part D plans in their formulary coverage of diabetes medications as well as cost-sharing practices for the newer diabetes drugs, suggesting that patients with diabetes should carefully review the different Medicare Part D plans before selecting a specific plan to be able to choose the best plan that fits their needs.
“Large variations in formulary restrictions and cost-sharing practices identified across Medicare Part D plans and over time suggest that beneficiaries need to carefully select plans during the annual open-enrollment period to ensure access to essential antidiabetes drugs,” concluded Dr Li and colleagues.
[Source: Li P, Huo H, Ladage V, et al. Medicare Part D plan formulary coverage, utilization management tools, and cost sharing for insulins and other newer antidiabetic drugs.]
Pharmacist-Directed Wellness Program Improves Glycemic Control in Patients with Diabetes
Diabetes affects more than 29 million people in the United States and continues to rise. In addition to being the seventh leading cause of death in the country, diabetes is associated with serious complications, including kidney failure and heart disease, still the leading cause of death in the United States. Furthermore, the estimated medical cost associated with diabetes management in the United States totals $245 billion annually, highlighting the need for better support and self-management education for patients. Overall, approximately $1 in $10 associated with healthcare cost is spent on diabetes.
According to Patty Taddei-Allen, PharmD, BCACP, College of Pharmacy, University of Florida, and colleagues, clinical care pharmacists work independently and in collaboration with the entire care team and are therefore in an ideal position to help in improving diabetes management, because they assess, educate, and monitor the disease progression of patients. Dr Taddei-Allen and colleagues evaluated the effectiveness of a pharmacist-led diabetes wellness clinical outreach program that was provided by a pharmacy benefits manager.
Dr Taddei-Allen and colleagues selected a sample of 50 patients who participated in a pharmacy-led diabetes wellness clinical outreach program and compared their hemoglobin (Hb)A1c levels and the HbA1c levels of 50 patients who did not participate in the program between October 2015 and September 2016. The team recorded the medications used by patients with diabetes, including statins, angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers, as well as medication adherence rates for the 2 groups.
Although there were no significant intergroup differences in the rate of medication adherence or in the use of medications, participation in the program did lead to improved glycemic control. The average HbA1c level was significantly lower (6.4%) in the cohort of patients who were enrolled in the pharmacist-led wellness program compared with the patients who were not enrolled in the program (7.6%; P <.001).
The reduction in HbA1c level that was seen in the pharmacist-led wellness program was the result of several factors associated with the intervention provided by the clinical pharmacists. First, clinical care pharmacists conducted thorough therapy reviews at every office visit, allowing for frequent dose increases and therapeutic optimization.
In addition, continuously educating patients about diabetes, with emphasis on leading an active lifestyle, eating a healthy diet, and glucose monitoring, was an important component of every visit between patients and their pharmacists. Furthermore, the one-on-one relationship between pharmacists and patients helped to build trust and accountability, with a shared goal of improving glycemic control, which translated to improved outcomes.
“Implementing a pharmacist-led multi-factorial diabetes wellness program that addresses appropriate medication, diet, and weight management results in significant decreases in A1c levels. The value of personal one-on-one interactions with patients and the CCP [clinical care pharmacist] aligns goals of therapy to help manage diabetes,” concluded Dr Taddei-Allen and colleagues.
[Source: Taddei-Allen P, Banks J, Page R. Pharmacist-Led Diabetes Wellness Clinical Outreach Program Significantly Decreases Hemoglobin A1c.]
Pharmacists’ Interventions in Clinical Trials Improve Medication Adherence in Patients with Inadequately Controlled Type 2 Diabetes
The cost of developing a drug typically exceeds $2.5 billion, and only 10% of drugs that are in clinical trials get approved by the US Food and Drug Administration. Consequently, it is crucial that patients who participate in clinical trials are adherent to their therapy throughout the study period to obtain trustworthy and accurate clinical trial data. However, adherence rates to long-term medications is only 59%, which may, in part, be attributed to the complexity of the drug regimen, underlining an unmet need in patients with chronic diseases, such as diabetes, who require increased support during their treatment.
Previous studies have shown that pharmacists can be instrumental in improving patient adherence to therapy by educating patients and answering their questions. But no studies have examined the effectiveness of using pharmacist interventions to improve medication adherence in clinical trials involving patients with diabetes.
Joseph Martinez, RPh, PDE, PPD, and Gerald Finken, RPh, MS, Center Point Clinical Services, sought to quantify the frequency and level of pharmacist interventions in clinical trials of investigational medicines and the pharmacists’ effect on patient adherence to treatment.
Martinez and Finken evaluated 11 clinical trials involving 2 noninsulin, glucose-lowering drugs in 3212 patients with inadequately controlled diabetes. Pharmacists called study participants at specific time points to provide medication education and intervention, and the number and type of interventions by call and by patients were documented.
Pharmacists completed a mean of 294 first calls, 285.3 second calls, 154.6 third calls, 37 fourth calls, and 66.3 fifth calls or more with patients. The mean number of pharmacist calls with interventions increased from 40.4 for patients who received first calls to 62.5 for patients who required 2 or more calls regarding the same intervention, and decreased to 34 at the second call, then to 16.7 at the third call, and to 3.3 for those who required a fourth call. Overall, 4.4% of patients with a first-call intervention required a follow-up intervention.
In addition, 71.8% of patients understood the importance of medication adherence from the first call, 96.7% of patients learned from the second call, and 86.3% of patients learned from any call.
These results underline the value of using pharmacist interventions for improving adherence to diabetes therapies in a clinical trial setting, because doing so may ultimately increase the reliability of the study results and lead to improved new medications.
“These pharmacist interventions identified and addressed patient compliance and adherence issues that would have, if gone unchecked, negatively impacted the trial results and outcomes,” concluded Martinez and Finken.
[Source: Martinez J, Finken G. Evaluating the impact of pharmacist support for medication adherence and patient compliance in clinical trials for two NIGLMS in sub-optimally controlled patients with diabetes.]