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Background: In 2012 U.S. diabetes costs were estimated to be $245 billion, with $176 billion related to direct diabetes treatment and associated complications. Although a few studies have reported positive glycemic and economic benefits for diabetes patients treated under primary care physician (PCP)-pharmacist collaborative practice models, no studies have evaluated the cost-effectiveness of an endocrinologist-pharmacist collaborative practice model treating complex diabetes patients versus usual PCP care for similar patients., Objective: To estimate the cost-effectiveness and cost benefit of a collaborative endocrinologist-pharmacist Diabetes Intense Medical Management (DIMM) "Tune-Up" clinic for complex diabetes patients versus usual PCP care from 3 perspectives (clinic, health system, payer) and time frames., Methods: Data from a retrospective cohort study of adult patients with type 2 diabetes mellitus (T2DM) and glycosylated hemoglobin A1c (A1c) ≥ 8% who were referred to the DIMM clinic at the Veterans Affairs San Diego Health System were used for cost analyses against a comparator group of PCP patients meeting the same criteria. The DIMM clinic took more time with patients, compared with usual PCP visits. It provided personalized care in three 60-minute visits over 6 months, combining medication therapy management with patient-specific diabetes education, to achieve A1c treatment goals before discharge back to the PCP. Data for DIMM versus PCP patients were used to evaluate cost-effectiveness and cost benefit. Analyses included incremental cost-effectiveness ratios (ICERs) at 6 months, 3-year estimated total medical costs avoided and return on investment (ROI), absolute risk reduction of complications, resultant medical costs, and quality-adjusted life-years (QALYs) over 10 years., Results: Base case ICER results indicated that from the clinic perspective, the DIMM clinic costs $21 per additional percentage point of A1c improvement and $115-$164 per additional patient at target A1c goal level compared with the PCP group. From the health system perspective, medical cost avoidance due to improved A1c was $8,793 per DIMM patient versus $3,506 per PCP patient (P = 0.009), resulting in an ROI of $9.01 per dollar spent. From the payer perspective, DIMM patients had estimated lower total medical costs, a greater number of QALYs gained, and appreciable risk reductions for diabetes-related complications over 2-, 5- and 10-year time frames, indicating that the DIMM clinic was dominant. Sensitivity analyses indicated results were robust, and overall conclusions did not change appreciably when key parameters (including DIMM clinic effectiveness and cost) were varied within plausible ranges., Conclusions: The DIMM clinic endocrinologist-pharmacist collaborative practice model, in which the pharmacist spent more time providing personalized care, improved glycemic control at a minimal cost per additional A1c benefit gained and produced greater cost avoidance, appreciable ROI, reduction in long-term complication risk, and lower cost for a greater gain in QALYs. Overall, the DIMM clinic represents an advanced pharmacy practice model with proven clinical and economic benefits from multiple perspectives for patients with T2DM and high medication and comorbidity complexity., Disclosures: No outside funding supported this study. The authors declare no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. Preliminary versions of the study data were presented in abstract form at the American Pharmacists Association Annual Meeting & Exposition; March 27, 2015; San Diego, California, and the Academy of Managed Care Pharmacy Annual Meeting; April 21, 2016; San Francisco, California. Study concept and design were contributed by Hirsch, Bounthavong, and Edelman, along with Morello and Morreale. Arjmand, Ourth, Ha, Cadiz, and Zimmerman collected the data. Data interpretation was performed by Ha, Morreale, and Morello, along with Cadiz, Ourth, and Hirsch. The manuscript was written primarily by Hirsch and Zimmerman, along with Arjamand, Ourth, and Morello, and was revised by Hirsch and Cadiz, along with Bounthavong, Ha, Morreale, and Morello.

Background: The types of pharmacist-provided medication therapy management (MTM) services provided to patients with human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS) and the effects of MTM on medication adherence and patient outcomes have only recently begun to be studied. Although available studies suggest that patients receiving MTM services have better antiretroviral therapy (ART) adherence and outcomes, only 1 study has examined a large group of patients with HIV/AIDS, and none has examined adherence or outcomes for more than 1 year. A pilot program conducted by the California Department of Health Care Services (DHCS) and Medi-Cal (California's Medicaid program) provided an opportunity to examine ART adherence and outcomes in a large patient population receiving MTM services in community pharmacies over 3 years., Objectives: To examine an HIV/AIDS pharmacy MTM compensation pilot program over a 3-year period (2005- 2007) in a sample of Medi-Cal beneficiaries by describing the associations between use of pilot pharmacies and (a) adherence to ART regimens; (b) medication utilization, including number and type of ART medication regimens and use of contraindicated ART regimens; (c) occurrence of opportunistic infections; and (d) all-cause pharmacy and medical costs., Methods: This was a cohort study examining Medi-Cal pharmacy and medical claims data (2005-2007) for patients with HIV/AIDS who were served by pilot pharmacies versus other (nonpilot) pharmacies. The study groups, pilot and nonpilot pharmacy patients with HIV/AIDS, consisted of Medi-Cal beneficiaries aged 18 years or older as of January 1, 2005, who were continuously enrolled from January 1, 2004, through December 31, 2007, and who received both a diagnosis of HIV/AIDS and at least 1 ART pharmacy claim during both the index period (2004) and the study period (January 1, 2005, through December 31, 2007). Pilot pharmacy patients were identified as having filled 50% or more of their ART prescriptions each year at 1 of the 10 pilot pharmacies. Patients for whom comprehensive medication data were not available, including those enrolled in managed care plans and/or Medicare, were excluded. Adherence was defined as a medication possession ratio (MPR) of 80%-120% and excess medication fills as MPR greater than 120%. Logistic regression was used to investigate the factors associated with adherence. Comparisons were made between groups using bivariate statistics (Pearson chi-square for categorical variables and t-tests for continuous variables). For comparisons of costs, generalized linear models were used including predictor variables for age, gender, and race/ethnicity. RESEARCH RESULTS: The study sample consisted of 2,234 patients meeting the study inclusion criteria. The proportion of study patients receiving the majority of their prescription medications (ART plus non-ART) at pilot pharmacies was 19.7% in 2005 and increased to 27.6% in 2006 and 28.1% in 2007. The demographic profile of pilot pharmacy patients was similar to that of patients receiving medications at nonpilot pharmacies, except that pilot pharmacies had a higher proportion of Latino patients (e.g., 19.7% vs. 14.9% in 2007, respectively, P = 0.006). A greater percentage of pilot than nonpilot pharmacy patients were adherent to their ART medication regimens (e.g., 2007: 69.4% vs. 47.3%, respectively, P < 0.001). After controlling for age, gender, and ethnicity/race in logistic regression analysis, use of a pilot pharmacy (odds ratio [OR] = 2.74, 95% CI = 2.44-3.10) was the most important factor associated with likelihood of adherence. Each year, pilot pharmacy patients were more likely than nonpilot pharmacy patients to remain on a single type of ART regimen (e.g., 2007: 71.7% vs. 49.1%, respectively, P < 0.001) and less likely to have excess fills (e.g., 2007: 12.9% vs. 35.5%, respectively, P < 0.001) and to use contraindicated regimens (e.g., 2007: 8.9% vs. 12.2%, respectively, P = 0.027). The percentages of patients experiencing opportunistic infections were similar between groups each year, approximately 35% (P = 0.809-0.945). In the generalized linear model analyses, the between-group differences in predicted mean (standard error [SE]) total health care costs per patient were not significantly different in any year (e.g., 2007: $38,983 [$1,023] vs. $38,856 [$633], respectively, P = 0.915). In each year, predicted non- ART medication costs were approximately 30%-40% greater in the pilot pharmacy than nonpilot pharmacy group (e.g., 2007: $10,815 [$538] vs. $8,190 [$252], respectively, P < 0.001); however, predicted expenditures for inpatient services were significantly lower (e.g., 2007: $3,083 [$293] vs. $5,186 [$300], respectively, P < 0.001). Payment from the DHCS Medi-Cal program for MTM services was approximately $1,000 per pilot pharmacy patient per year., Conclusions: Over a 3-year period, patients at pilot pharmacies consistently had higher medication adherence rates, were more likely to remain on a single type of ART regimen throughout the year, had fewer excess fills, and used fewer contraindicated regimens than nonpilot pharmacy patients. There were no significant differences in mean total cost per patient per group, and the additional MTM services payment added less than 3% to the total cost.

Background: The advent of combined antiretroviral therapy (ART) has increased treatment effectiveness but created new challenges for patients infected with human immunodeficiency virus (HIV) and for community pharmacists managing patients' drug therapy. The ability of pharmacist-provided medication therapy management (MTM) services to increase medication adherence, improve health outcomes, and reduce overall medical costs has been demonstrated in community pharmacies for chronic diseases such as diabetes and hypertension. However, the effectiveness of pharmacist-provided MTM services in HIV/acquired immune deficiency syndrome (AIDS) has not been well studied. In January 2005, a pilot program to evaluate MTM services for patients with HIV/AIDS began in California, allowing 10 HIV/AIDS specialty pharmacies to receive compensation for the MTM services that they provided to HIV/AIDS patients., Objectives: To examine the first year of the HIV/AIDS pharmacy MTM compensation pilot program, which described and compared pilot and nonpilot pharmacies with respect to (a) patient characteristics; (b) intermediate outcomes including type and number of ART medication regimens used, rates of adherence and excess medication fills for ART, use of contraindicated ART regimens, and occurrence of opportunistic infections; and (c) pharmacy and medical costs., Methods: This was a cohort study examining 2005 Medi-Cal pharmacy and medical claims data for patients with HIV/AIDS who were served by pilot pharmacies versus other pharmacies. The HIV/AIDS patients were Medi-Cal beneficiaries aged 18 years or older as of January 1, 2005, who were continuously enrolled from January 1, 2004, through December 31, 2005, and diagnosed with HIV/AIDS, identified by receipt of at least 1 ART prescription and at least 1 medical claim with a diagnosis (primary or secondary) of HIV/AIDS (ICD-9-CM code 042.0) during both the index period (the year before pilot program implementation, 2004) and the intervention period (the study year, 2005). The only difference in the inclusion criteria for the 2 cohorts was that the pilot pharmacy patients were required to have filled 50% or more of their antiretroviral prescriptions in 2005 at 1 of the 10 pilot pharmacies. Adherence was defined as a medication possession ratio (MPR) of 80%-120% and excess medication fills as MPR greater than 120%. Comparisons were made between groups using bivariate statistics (Pearson chi-square for categorical variables and t-tests for continuous variables). For comparisons of costs, generalized linear models assuming a gamma distribution and log link function were used; predictor variables for the models included age, gender, race/ethnicity, and dual coverage under Medicare., Results: A total of 7,018 HIV/AIDS patients in the Medi-Cal population were identified as meeting the study criteria. Of these, 19.3% (n=1,353) were pilot pharmacy patients. The demographic profile of pilot pharmacy patients was similar, but not identical, to that of patients receiving medications at other pharmacies. A larger percentage of pilot pharmacy patients were on protease inhibitor-based ART medication regimens (63.8% vs. 54.8%, P<0.001), remained on a single type of ART therapy throughout the study year (56.8% vs. 34.2%, P<0.001), and were classified as adherent (56.3% vs. 38.1%, P<0.001), compared with other pharmacy patients. Fewer pilot pharmacy patients used contraindicated regimens (11.6% vs. 16.6%, P<0.001) or had excess medication fills (19.7% vs. 44.8%, P<0.001). The rate of opportunistic infections did not differ significantly between groups (28.2% vs. 26.1%, P=0.121). The total mean (standard error) annual health care cost per patient was 10% higher in pilot pharmacies than in other pharmacies ($40,596 [$889] vs. $36,937 [$479], P=0.001); driven by use of (a) medications (primarily non-ART medications) and (b) mental health services. Payment from the California Department of Health Care Services for MTM services averaged $1,014 per pilot pharmacy study patient., Conclusion: Study findings for the first year of the MTM program suggest that the pilot pharmacy patients received more appropriate HIV treatment. The degree to which these differences are affected by selfselection of patients into the pilot pharmacies is unknown. Longer-term outcomes and costs of the pilot program will be examined when data for subsequent years are available.