Retrospective database analysis of the impact of prior authorization for type 2 diabetes medications on health care costs in a Medicare Advantage Prescription Drug Plan population.

BACKGROUND: Health plans and pharmacy benefit managers have implemented utilization management strategies for newer type 2 diabetes mellitus (T2DM) medications to control pharmacy expenditures. Little is known about the impact of utilization management strategies on overall health care costs and subsequent use of T2DM medications among members who request, but do not receive, a T2DM medication requiring prior authorization (PA).  OBJECTIVE: To examine the relationship between the receipt of a T2DM medication requiring PA, health care costs, and subsequent treatment for T2DM.  METHODS: A retrospective cohort study using pharmacy, medical, and laboratory claims data was conducted among Medicare Advantage Prescription Drug plan members with a denied claim for a T2DM medication requiring PA (sitagliptin, a dipeptidyl peptidase-4 inhibitor [DPP-4i], and exenatide, an incretin mimetic) between January 1, 2008, and June 30, 2009. Subjects were required to have 12 months of continuous enrollment both before and after the index date. The entire study period was 24 months in duration, including a 12-month pre-index and 12-month post-index period. Three cohorts were identified: 1 that received a medication requiring PA (denied claim, subsequent fill) and 2 nonfilling control groups. Both control groups requested a medication requiring PA, as evidenced by the denied claim, but neither received the medication, either because the medication was not authorized or the member chose not to fill. Claims-based estimates were used to infer whether the individual likely met the criteria for PA, with 1 control group designated as having met the claims-based criteria (qualifying nonfilling cohort) and the other not having done so (nonqualifying nonfilling cohort.) The primary endpoint evaluated was the relationship between PA medication fill status and plan-paid costs (medical [including laboratory] and pharmacy) over the 12-month post-denial period, with generalized linear models adjusting for key covariates including demographics, concomitant medications, pre-index costs, pre-index adherence, and comorbidities. The secondary endpoint of T2DM medication use (post-denial) among the 2 nonfilling control groups was also evaluated.  RESULTS: There were 1,728 members identified who received medication for T2DM requiring PA (the received authorization cohort) and 2,373 who did not (606 qualifying nonfilling cohort; 1,767 nonqualifying nonfilling cohort.) Cohorts were similar with regard to age and gender, but the nonfilling cohort had more comorbidities. Total unadjusted plan-paid 12-month costs were lowest among the received authorization cohort ($11,739), slightly higher ($11,980) for the qualifying nonfilling cohort, and notably higher for the nonqualifying nonfilling cohort ($12,962), although no differences were statistically significant. After adjusting for key covariates, the difference between the nonqualifying nonfilling cohort ($11,980) and the received authorization cohort ($11,729) was statistically significant (P = 0.034). Large differences in plan-paid medical costs ($10,127 for the nonqualifying nonfilling cohort vs. $8,192 for the received authorization cohort) appeared to drive the overall cost totals and were significant in both the unadjusted (P = 0.005) and adjusted models (P less than 0.001). Pharmacy costs were significantly lower for the nonqualifying nonfilling cohort in the adjusted model and for the qualifying nonfilling cohort in both models (all P less than 0.001), but the lower pharmacy costs were not offset by the higher medical costs. In examining the use of medication for treatment of T2DM following the denied claim, 10.6% of the qualifying nonfilling cohort and 13.4% of the nonqualifying nonfilling cohort added another oral therapy, 10.2% and 5.8% added insulin, and 11.9% and 7.1% had treatment intensification, respectively. More than half (56.1%) of the qualifying nonfilling cohort, but only 32.1% of the nonqualifying nonfilling cohort, maintained current therapy.   CONCLUSIONS: This study found higher plan-paid health care costs (overall and medical alone) among members who requested a type 2 diabetes medication requiring PA, but never received it, compared with those who qualified for and received the requested medication. A notable number of individuals who were assumed to have met the criteria based on a claims-based equivalent, but who never received the medication, made no change to their current therapy. Failure of a member to take medication deemed necessary by his or her physician could translate to inadequate control of the diabetic condition and result in an excess of resource utilization and costs for treating the disease and associated comorbidities. In light of the present findings, health plans should consider not only the impact of utilization management strategies on reducing pharmacy costs, but the broader implication for overall health care costs and subsequent treatment patterns among members. 

Hemoglobin A1c outcomes and health care resource use in type 2 diabetes mellitus patients treated with combination oral antidiabetic drugs through step therapy and loose-dose and fixed-dose combinations.

PURPOSE: To compare outcomes of type 2 diabetes mellitus (T2DM) patients initiating therapy with FDC vs. those with loose-dose combination (LDC) or step therapy (ST) in a managed care population. DESIGN: A retrospective claims database analysis. METHODOLOGY: Treatment-naive T2DM patients who were continuously enrolled in a health plan during 2006-2009 were studied. Eligible patients were assigned to FDC, LDC, or ST cohorts. Glycated hemoglobin goal attainment (HbA1c < 7%) was assessed using the American Diabetes Association (ADA) treatment guidelines. Health care resources use and costs, including inpatient, emergency room (ER), and ambulatoryvisits, were measured during the 12 months after therapy initiation. All-cause and diabetes-related use and costs were assessed. PRINCIPAL FINDINGS: 21,048 patients met study criteria (FDC n = 8,416, ST n = 8,407, LDC n = 4,225), and 1,926 of these patients had HbA1c results. FDC patients had lower rates of post-index all-cause inpatient stays and ER visits compared with the other cohorts. FDC patients had lower average counts of diabetes-related ambulatory visits (2.7) compared with ST (3.7; p < 0.001) and LDC (3.2; p < 0.001) and significantly lower average post-index all-cause and diabetes-related costs compared with the other cohorts, with average all-cause costs for FDC, ST, and LDC of $8,445, $10,515, and $9,688, respectively, and diabe-tes-related costs of $1,641, $2,099, and $1,900, respectively. FDC patients had higher rates of achieving HbA1c goal (61%) compared to ST (48%; p < 0.001) or LDC (52%; p = 0.015). Differences in outcomes remained following multivariate analyses. CONCLUSION: Treatment with FDC was associated with lower health care resources use and costs and better likelihood of HbA1c goal attainment.

Medical care costs and hospitalization in patients with bipolar disorder treated with atypical antipsychotics.

BACKGROUND: A large proportion of costs associated with the treatment of bipolar disorder are attributable to patient hospitalization. OBJECTIVE: To investigate medical care costs and hospitalization rates among patients with bipolar disorder who were managed with aripiprazole compared with olanzapine, quetiapine, risperidone, or ziprasidone. METHODS: This retrospective cohort study assessed patients who were aged 18 to 64 years, diagnosed with bipolar disorder, and who were receiving therapy with aripiprazole, olanzapine, quetiapine, risperidone, or ziprasidone. This study was based on data from the PharMetrics claims database between January 1, 2003, and September 30, 2008. The study used a time-to-event framework. Cox proportional hazards models were used to assess the impact of each atypical antipsychotic on time to hospitalization, including all-cause and mental health-related reasons. Generalized linear models were used to compare costs per treated patient per month between the groups. Aripiprazole therapy was the reference group for all comparisons. RESULTS: Aripiprazole therapy showed a significantly lower hazard ratio (HR) for all-cause hospitalizations compared with olanzapine (HR, 1.4), quetiapine (HR, 1.4), risperidone (HR, 1.2), and ziprasidone (HR, 1.7); and for mental health-related hospitalizations compared with olanzapine, quetiapine, risperidone (HR, 1.3 each), and ziprasidone (HR, 1.7). Ziprasidone had higher unadjusted all-cause medical costs (US $1151 ± $2928) and unadjusted mental health-related costs (US $711 ± $2263) than the other antipsychotics that were included in this study, whereas aripiprazole had the lowest all-cause (US $804 ± $2523) and mental health-related costs (US $475 ± $2145) compared with the other antipsychotics. Quetiapine had the highest all-cause costs (US $1221; 95% confidence interval [CI], 1180-1263), and ziprasidone had the highest mental health-related costs (US $823; 95% CI, 754-898). Adjusted inpatient and emergency department all-cause costs were significantly lower for aripiprazole compared with all other atypical antipsychotics (P <.05), except olanzapine; however, the adjusted inpatient and emergency department mental health-related costs were significantly lower for aripiprazole only when compared with ziprasidone (P <.05). CONCLUSIONS: The costs of medical care for patients with bipolar disorder differ based on the type of medication used, which can affect the rate of hospitalization. Treatment with aripiprazole was associated with fewer hospitalizations, longer time to hospitalization, and therefore the lowest all-cause and mental health-related medical costs compared with olanzapine, quetiapine, risperidone, or ziprasidone. Therefore, aripiprazole may offer an economic advantage over other atypical antipsychotics in patients with bipolar disorder.