Changes in Type 2 Diabetes Medication Utilization and Costs in the United States, 2014-2019.

OBJECTIVE: The objective of this study was to describe national changes in utilization and associated costs of antidiabetic medications in the United States from 2014 to 2019, across different drug classes and insurance plans. RESEARCH DESIGN AND METHODS: This retrospective, cross-sectional study examined administrative claims from a large national pharmacy benefits manager from January 1, 2014, to December 31, 2019. Patients aged 18 years and above enrolled in commercial, Medicare, or Medicaid health plans who filled ≥1 prescription claim for an antidiabetic medication(s) during the 6-year period were included. Utilization was examined as the total number of 30-day adjusted prescription fills per user per month (PUPM). Gross costs were calculated as the sum of plan costs (net of rebates) and member out-of-pocket costs. Differences in mean utilization and costs PUPM between 2014 and 2019 for each medication class were calculated. RESULTS: The final analytic sample increased from 745,290 patients in 2014 to 1,596,006 in 2019. Antidiabetic medication utilization increased by 8.8% from 2014 to 2019, driven by increases in sodium-glucose cotransporter 2 inhibitor (48.7%; P<0.001), glucagon-like peptide 1 receptor agonist (11.8%; P<0.001), insulin (8.1%; P<0.001), and metformin (2.9%; P<0.05) utilization. Average costs PUPM rose 47.5% (P<0.001), from $126.52 in 2014 to $186.58 in 2019. Sodium-glucose cotransporter 2 inhibitors, glucagon-like peptide 1 receptor agonists, and combination drugs contributed significantly to these increased costs, with 6-year cost differences of 57.3%, 46.9%, and 47.2%, respectively (all P<0.001). CONCLUSION: Our study demonstrates a shift in antidiabetic medication class utilization from 2014 to 2019, where associated costs net of rebates significantly increased to a disproportionately greater extent than the significant increase in utilization PUPM.

Identifying Outcome Measures for Migraine Value-Based Contracting Using the Delphi Method.

OBJECTIVE: To identify meaningful migraine outcome measures among key stakeholders to inform value-based contracts for migraine medications. BACKGROUND: Value-based contracts linking medication payments to predefined performance metrics aim to promote value through aligned incentives and shared risk between manufacturers and payers. The emergence of new and expensive pharmaceuticals for migraine presents an opportunity for value-based contract development. However, uncertainty remains around which outcomes are most meaningful to all migraine stakeholders. METHODS: This study utilized a Delphi survey to incorporate views from 82 stakeholders, including patients (n = 21), providers (n = 23), payers (n = 10), employers (n = 18), and pharmaceutical company representatives (n = 10). A list of 15 migraine-related outcomes was created from a literature review and subject matter expert consultation. Stakeholders reported on the value of these outcomes through a 5-point Likert scale and selection of their top 3 most meaningful outcomes. All participants except patients and employers also used a 5-point Likert scale to rate the feasibility of collecting each outcome measure. Consensus was defined as ≥75% agreement on the importance and feasibility of an outcome (Likert scores ≥4/5 or selection of an outcome as most meaningful). RESULTS: After 2 rounds, consensus was achieved for importance of 9 outcomes on the Likert scale. "Decrease in migraine frequency" reached 100% agreement (82/82), followed by "increased ability to resume normal activities" (96%, 79/82). When asked to choose the 3 most meaningful outcomes, stakeholders selected "decrease in migraine frequency" (88%, 72/82) followed by "decrease in migraine severity" (80%, 66/82). The 2 measures rated as most feasibly collected were "decrease in emergency department/urgent care visits" (95%, 40/42) and "decrease in migraine frequency" (90%, 38/42). There were statistically significant differences between non-patient and patient stakeholders in selection of "decrease in emergency department/urgent care visits" [20% (12/61) vs 0% (0/21), P = .031]; and employer and patient stakeholders in selection of "decrease in work days missed" [44% (8/18) vs 5% (1/21), P = .006] and "decrease in emergency department/urgent care visits" [22% (4/18) vs 0% (0/21), P = .037] as most meaningful outcomes. CONCLUSIONS: The measures "decrease in migraine frequency" followed by "decrease in migraine severity" were identified as top priority migraine outcome measures.

Disease-Modifying Medications in Patients with Rheumatoid Arthritis in the USA: Trends from 2016 to 2021.

BACKGROUND: Disease-modifying anti-rheumatic drugs (DMARDs), since their introduction in 1990, have revolutionized the management of rheumatoid arthritis. Newer DMARDs have recently been approved, influencing treatment patterns and clinical guidelines. OBJECTIVE: To update the current prescribing patterns of DMARDs in the pharmacotherapy of rheumatoid arthritis (RA) to include the pandemic era. METHODS: This was a retrospective cross-sectional multi-year study. Using Optum's Clinformatics® Data Mart Database, we summarized trends in the prevalence of DMARD use in the USA from 2016 to 2021 by year for adult patients ≥ 18 years old with at least one medical RA claim and one pharmacy/medical claim of a DMARD medication. Trends included type of DMARD, class of DMARD (conventional (csDMARDs), biologics [tumor necrosis factor (TNFi) and Non-TNFi), and Janus kinase inhibitors (JAKs)], and triple therapy [methotrexate (MTX), hydroxychloroquine (HCQ), sulfasalazine (SUL)] used. RESULTS: The total sample from 2016 to 2021 was 670,679 commercially insured patients. The average age was 63.7 years (SD 13.6), and 76.7% were female and 70% were White. csDMARDs remain the most prescribed (ranging from 77.2 to 79.2%). Although JAKs were the least prescribed DMARD class, their proportion more than doubled from 2016 (1.5%) to 2021 (4%). MTX utilization declined from 40% in 2016 to 34% in 2021. In contrast, HCQ use increased during the pandemic era from < 25% in 2018 to 30% in 2021. Although there is evidence of the therapeutic benefit of triple therapy, its use was very low (~ 1%) compared to biologics only (~ 17%) or biologics+MTX (~ 10%). CONCLUSION: About half of patients with RA were on DMARDs. As expected, csDMARDs were highly used consistently. The COVID-19 pandemic might have influenced the use of HCQ and infusion DMARDs. Triple therapy use remains low.

Assessing the impact of a financial incentive and refill reminder program on medication adherence and costs.

BACKGROUND: Improving medication adherence remains an important goal to improve therapeutic outcomes and lower health care costs. Point-of-sale prescription costs and forgetfulness remain top reasons why patients do not adhere to medications. Programs using both text message-based reminders and financial incentives may encourage patients to refill their prescriptions on time by reducing copays through discounts at the point of sale. Sempre Health, the subject of our analysis, provides both text message refill reminders and a dynamic discount incentive program to improve medication adherence. OBJECTIVE: To evaluate the impact of a financial incentive/refill reminder program on medication adherence and total cost of care for patients taking the antithrombotic agents ticagrelor, apixaban, or rivaroxaban in a large regional health plan. METHODS: After propensity-score matching on demographics, socioeconomic status, baseline copay, prior pharmacy/medical spend, and morbidity, we compared-using a difference-in-differences analytic approach-adherence (measured by proportion of days covered), unplanned health care utilization, and costs (total cost of care, medical, and pharmacy cost) of health plan members who did and did not enroll in the financial incentive/refill reminder program between February 1, 2019, and October 31, 2021, over 1 and 2 years. Because of differences in patient characteristics, we analyzed patients on ticagrelor (the antiplatelet group), apixaban, and rivaroxaban (the anticoagulant group) separately. RESULTS: There were a total of 1,292 one-to-one program and control propensity-matched patients: 166 each for the antiplatelet group and 480 each for the anticoagulant group. The average age of the anticoagulant group was 62 years; more than 60% were male, and approximately 45% had no prior unplanned care events. In contrast, the average age of the antiplatelet group was 57 years; more than 70% were male, and approximately 21% had no prior unplanned care events. In the antiplatelet group, the proportions adherent (proportion of days covered ≥80%) were 63.3% vs 42.8% (P = 0.0002) for program vs controls. Similarly, in the anticoagulant group, the proportion adherent was 77.9% vs 60.2% (P < 0.0001) for program vs controls. Reflecting improved adherence, costs of apixaban and rivaroxaban increased by $79 per member per month (PMPM) (P < 0.0001), with no statistically significant differences in other costs. Similarly, the cost of ticagrelor increased by $77 PMPM (P = 0.0102) with no statistically significant differences in other costs. Finally, there was a 16% (P = 0.032) reduction in emergency department use for those in the program. CONCLUSIONS: The financial incentive and refill reminder program was associated with improved adherence to antithrombotic medications, reduced emergency department use, and increased medication costs, but not in total pharmacy, medical, or total cost of care in both subgroups.

Real-world impact of empagliflozin on total cost of care in adults with type 2 diabetes: Results from an outcomes-based agreement.

BACKGROUND: Value-based health care is expanding through payment models such as outcomes-based agreements between manufacturers and payers. OBJECTIVE: To describe the total-cost-of-care outcomes of an outcomes-based agreement evaluating the real-world impact of empagliflozin vs other type 2 diabetes mellitus (T2DM) drugs among all patients with T2DM, with and without cardiovascular disease (within and beyond the requirement of the agreement). METHODS: In this prospective real-world analysis, members from the health plan of an integrated health care delivery system from the commercial and Medicare Advantage lines of business, who qualify under the confines of the contract, were included for analysis. Thus, members aged 18 years and older who were continuously enrolled in the identification (January 1, 2018, to December 31, 2018) and measurement periods (≤1 year post-index) with a T2DM diagnosis were retained. Patients using empagliflozin and empagliflozin-combination drugs constituted the empagliflozin group; those using all other antihyperglycemics, the nonempagliflozin group. Patients with type 1 diabetes, or those using metformin or insulin monotherapy, at index were excluded. Eligible members were followed for up to the earliest occurrence of disenrollment date, discontinuation (60-day medication fill gap allowed) of empagliflozin (or nonempagliflozin containing) medication, or the end of the measurement period. We compared, using Student's t-test and summary statistics (for reporting the outcomes agreement) and a propensity-matched difference-in-difference model (for the followup evaluation beyond the requirement of the agreement), the mean all-cause total cost of care (pharmacy plus medical) per patient per month (PPPM) between the 2 groups, including a subgroup of members with a baseline cardiovascular disease diagnosis. RESULTS: There were 4,577 (3,069 and 1,508 in the commercial and Medicare) and 33,712 (15,571 and 18,141 in the commercial and Medicare) in the empagliflozin and nonempagliflozin groups, respectively. The difference in mean total cost PPPM was $75 lower for empagliflozin vs nonempagliflozin groups, driven mainly by lower medical costs in the empagliflozin group (-$465 PPPM). However, the difference was not statistically significant in the propensity score-matched model. CONCLUSIONS: Although empagliflozin had higher pharmacy costs, the total cost of care for patients with T2DM and with established cardiovascular disease were comparable to the group of patients with all other T2DM, driven mainly by lower medical costs. DISCLOSURES: The authors report no conflicts of interest beyond being employees of the 2 organizations involved in this outcomes-based agreement. Ms. Palli is a former employee of Boehringer Ingelheim Pharmaceuticals, Inc., who was affiliated at the time of study conduct.

Ticagrelor versus clopidogrel for recurrent myocardial infarction: An outcomes-based agreement.

Background: Outcomes-based agreements (OBA) are performance-based risk-sharing agreements between manufacturers and payers which provide the opportunity for collection and evaluation of real-world outcomes to supplement clinical trials. Objectives: To describe an OBA comparing ticagrelor to clopidogrel in patients admitted with acute coronary syndrome (ACS) and proportion of recurrent myocardial infarction (MI) in a real-world setting. Methods: Commercial (CM) and Medicare (MC) insurance patients of a large regional health plan, who presented with ACS and were prescribed either ticagrelor or clopidogrel were prospectively analyzed. The cohort consisted of adults (18-85 years) discharged between January 1, 2019, and December 31, 2020, who were adherent to the study medications, within the confines of the OBA. The primary outcome of interest was the proportion of recurrent MI hospitalizations within one year of discharge. Results: There were 500 patients who met inclusion criteria in the ticagrelor cohort and 648 in the clopidogrel cohort. The mean age of patients in the ticagrelor cohort was 61.5 ± 10.5 years old and 66.5 ± 10.2 years in the clopidogrel cohort. The proportion of patients with type 2 diabetes, hypertension, or a history of congestive heart failure at baseline in the ticagrelor cohort was 31%, 85%, 14% respectively, and 43%, 90%, and 32% respectively in the clopidogrel cohort. The overall proportion of hospitalization for recurrent MI was 1.00% in the ticagrelor and 3.13% in the clopidogrel cohorts. In the follow-up propensity-matched analysis, although recurrent MI hospitalization was higher in the clopidogrel cohort (1.69% vs 1.21%) it was not statistically significant (p-value 0.5242). Conclusion: Patients presenting with ACS and treated with ticagrelor had a lower rate of hospitalization for recurrent MI compared to patients treated with clopidogrel cohort within the confines of an OBA in a real-world setting.

Identifying outcome measures for atrial fibrillation value-based contracting using the Delphi method.

BACKGROUND: Value-based contracts that tie payments for pharmaceuticals to predefined outcomes aim to promote value through shared risk and aligned incentives between manufacturers and payers. METHODS: We conducted a Delphi study among diverse stakeholders (patients, providers, payers, pharmacy benefits managers, pharmaceutical company representatives) to identify top meaningful outcomes for inclusion in value-based contracts for atrial fibrillation medications. The final panel (n = 55) rated the importance of each outcome on a 5-point Likert scale and selected their top 3 most meaningful outcomes. Non-patient participants rated the feasibility of collecting each outcome on a 5-point Likert scale. Consensus was defined as ≥75% agreement (Likert scores ≥4/5 or selection of an outcome as most meaningful). Differences between stakeholder groups were examined using Fisher's Exact Test. RESULTS: Consensus was achieved for importance of 10 outcomes (Likert scale), where "preventing stroke or mini-stroke" reached 100% agreement (55/55). Eighty-one percent (44/54) of participants selected "preventing stroke or mini-stroke" as the most meaningful outcome (rank order question). The measures rated as most feasibly collected were "reducing hospitalizations" (97%, 36/37) followed by "preventing stroke or mini-stroke" and "reducing emergency department visits" (both 92%, 34/37). There were statistically significant differences between patients and non-patients [0% (0/17) vs 22% (8/37), P = 0.047] and patients and providers [0% (0/17) vs 39% (7/18), P = 0.008] in selection of "improving health-related quality of life" as a most meaningful outcome. CONCLUSIONS: These findings will inform the design of atrial fibrillation value-based pharmaceutical contracts and provide additional insight into preferences for outcomes which could be used to improve the quality of atrial fibrillation care.

Twelve month oral contraceptive pill prescriptions: Role of policy mandates on utilization.

Recent studies have suggested that extended duration oral contraceptive pills (OCP), such as the 12-month duration, have a positive impact on pregnancy rates but negative impact on pill wastage. Several states have since been mandating health plans to offer extended duration OCP as an option for women. The objective of the study was to evaluate the impact of these mandates on utilization of extended duration OCPs. Using claims data of a large pharmacy benefit manager for commercially insured women from 2018 to 2019, use, adherence, continuity, and wastage of OCPs by women dispensed one-month only, three-months only, 6 or 12-months only, and other months (which includes other months and mixed duration OCP) was retrospectively analyzed. OCP dispensed by year, and adherence, continuity, wastage over a 15-month period were summarized using Chi square and ANOVA. There were 874,420 and 875,914 women in this study in 2018 and 2019 respectively. Of these, 34% were from states with the mandate (SWM). Most women filled the one-month and three-month duration, with very low overall 6 or 12-month duration claims. Proportion of utilizers of 6 or 12- month duration was higher in SWM than in those without, although differences in absolute rates were very low. Patients with OCP discontinuation, gaps ≥7 and 14 days, were fewer among those filling 6 or 12-month duration but conversely, wastage was higher in this group compared to those filling one or three-month duration. Our findings suggest that, among commercially insured women, extended duration OCP mandates have so far not had much influence on use of 6 or 12-month duration OCP prescriptions.

Economic assessment of changes to an existing medication therapy management program of a large regional health plan.

BACKGROUND: Although medication therapy management (MTM) has specific eligibility criteria and is mandated for specific Medicare Part D enrollees, some health plans have expanded MTM eligibility beyond the minimum criteria to include other Medicare Part D enrollees, Medicaid, and commercial health plan patients. Differences exist in the mode of delivery, location of services, type of personnel involved in managing the service, and the subsequent outcomes. The type and intensity of MTM services delivered have evolved with time to more streamlined and robust interventions, necessitating ongoing evaluation of the effect on clinical and economic outcomes. OBJECTIVE: To assess the effect of changes to an existing MTM program on cost of care, utilization, and medication adherence. METHODS: UPMC Health Plan made changes to an existing MTM program by expanding eligibility (customized by the type of health plan), intervention types, pharmacist involvement, and patient followup contacts. After matching our intervention cohort (identified January 2017-June 2018) with the pre-2016 MTM historical controls (patients identified January 2014-June 2015 who would have been eligible if we used the intervention cohort eligibility criteria), we estimated that the effect of the program changes with a difference-in-difference model (preintervention [2014-2016] and postintervention [2017-2019]). Outcomes of interest included cost (total cost of care including medical, pharmacy, and unplanned care [i.e., unscheduled health care use such as emergency department visits] in 2017 U.S. dollars); utilization; medication adherence (proportion of days covered); and return on investment (ROI). Target population included continuously enrolled patients aged ≥ 21 years in the commercial, Medicare, and Medicaid health plans. RESULTS: Total propensity score-matched members was 10,747, 55% of which were in the historic control group. The average (SD) ages after matching the groups were similar (historical control group: 57.08 years [14.23], intervention group: 56.79 years [14.21]) and the majority was female (57%). Comorbidities identified most for patients included hypertension (77%), dyslipidemia (70%), and diabetes (52%). Forty-one percent were in the commercial, 37% in the Medicaid, and 23% in the Medicare health plans. Proportion of care activities undertaken in the intervention period compared with the control period were significantly different: "sent letter to physician" (67% vs. 87%), "sent letter to member" (15% vs. 0%), "pharmacist phone call to physician" (15% vs. 0.1%), and "pharmacist phone call to member" (13% vs. 7%). There were statistically significant reductions in unplanned care across all health plans especially in the Medicare population, in total cost of care, and increases in medication adherence in 4 therapeutic classes: anticoagulants (OR = 1.25, P = 0.005), cardiac medications (OR = 1.20, P < 0.001), statins (OR = 1.21, P < 0.001), and antidepressants (OR = 1.15, P < 0.001). There was a positive ROI of $18.50 per dollar spent, which equated to a cumulative net savings of $11 million over 24 months. CONCLUSIONS: In a large health plan, expanding MTM eligibility, intensifying patient follow-up contact and pharmacist involvement, and improving provider awareness had favorable clinical and economic benefits. DISCLOSURES: There was no funding for this project except employees' time. All authors are employees of UPMC and have no conflicts of interest to report.

Effect of Carving in Pharmacy Benefits on Utilization and Costs.

BACKGROUND: Rising medical costs are a significant concern for employers offering health benefits to employees, and there is interest in identifying insurance plan designs that optimize the effect of pharmacy benefits on overall costs. For instance, employers must decide between plans that carve in pharmacy benefits (where medical and pharmacy benefits are integrated into 1 package through an insurer) versus plans that carve out pharmacy benefits (where pharmacy benefits are separately administered through a pharmacy benefit manager). Little is known about the effect of carving in pharmacy benefits on medical utilization and costs. OBJECTIVE: To compare the effect of carving in versus carving out pharmacy benefits on medical utilization, medical costs, and health management program participation in commercial health plans. METHODS: We performed a propensity score-matched analysis comparing carve-in and carve-out members of a regional health plan in 2018. Our primary outcomes were medical utilization (annual medical claims/1,000 members) and costs (medical costs per member per month [PMPM]). We categorized these into the following domains: inpatient, emergency department, outpatient/ambulatory surgery, urgent care, primary care, specialist services, and diagnostics (laboratory testing/imaging). We additionally assessed participation in health plan-based health management programs. RESULTS: We analyzed 9,633 carve-in members matched with 9,633 carve-out members. Compared with carving out pharmacy benefits, carving in was associated with 3.7% lower medical costs, with an $8.73 reduction in PMPM ($225.87 vs. $234.60), and no significant difference in medical utilization; significantly lower inpatient and urgent care claims (reduction of 9.29 claims/1,000 and 51.3 claims/1,000, respectively) and costs ($10.08 and $0.12 PMPM reduction, respectively); lower injectable medical therapy costs ($4.32 PMPM reduction); and higher durable medical equipment costs ($2.14 PMPM increase). Carve-in members also experienced 4.9% higher health management program participation. CONCLUSIONS: As employers attempt to understand the value of carving in versus carving out pharmacy benefits to health plans, our findings suggest that carving in pharmacy benefits is associated with reduced medical costs and hospitalizations. Our findings can assist in informing employer decision-making processes and, as a result, reducing costs of care. DISCLOSURES: No outside funding supported this study. Parekh was and Huang and Good are employed by the UPMC Centers for High-Value Health Care and Value-Based Pharmacy Initiatives. Manolis is employed by the UPMC Health Plan within the UPMC Insurance Services Division. Papa, Drnach, and Spiegel are employed by WorkPartners within the UPMC Insurance Services Division.

Using the Delphi method to identify meaningful and feasible outcomes for pharmaceutical value-based contracting.

In an effort to demonstrate measurable value of pharmaceuticals in the United States, many payers and drug manufacturers have entered into value-based purchasing contracts that link payment for prescription medications to patient outcomes, creating shared risk between the 2 entities. These agreements have emerged as part of a larger movement within the health care landscape to transition away from volume-based payment models and towards value-based designs that promote high-quality and affordable care. Key to the success of pharmaceutical value-based contracting is agreement on meaningful and measurable outcomes that reflect drug performance. Traditional value-based contracts are developed by pharmaceutical companies and payers and may not reflect values of other important stakeholders, such as patients, providers, and employers (when applicable). One approach to more effectively align the interests of all key stakeholders and to maximize the effect and transparency of value-based pharmaceutical contracts is to use the validated Delphi surveying technique, which can gather information and build stakeholder consensus on key elements before contract development. In this Viewpoints article, we describe our experience conducting Delphi studies in 5 disease contexts to inform pharmaceutical value-based contract development, including insights learned and practical considerations for real-world application. In addition, we outline advantages to using this validated consensus-building tool to solicit vital and underrepresented stakeholder input, foster transparency in the contract development process, and promote shared learning for future value-based initiatives. DISCLOSURES: No outside funding supported this project. All authors are or were employed by UPMC Health Plan at the time of this study and have no other disclosures to declare.

Identifying Outcome Measures for Coronary Artery Disease Value-Based Contracting Using the Delphi Method.

INTRODUCTION: Value-based contracts (VBCs) that link drug payments to disease-related performance metrics aim to increase the value and lower the cost of medications by aligning incentives and sharing risk between payers and pharmaceutical manufacturers. This study sought to identify outcome measures that are meaningful to key stakeholders to inform VBCs for coronary artery disease (CAD) medications. METHODS: We administered a modified Delphi survey to gather expert opinion from a diverse panel of patients (n = 9), cardiologists (n = 4), primary care physicians (n = 5), payers (n = 2), pharmacy benefits managers (n = 3), and pharmaceutical company representatives (n = 2). A list of 16 CAD-associated clinical indicators was generated from the literature and expert consultation. Delphi participants rated the importance of each outcome on a five-point Likert scale, and selected the three most meaningful outcomes. We defined consensus as ≥ 75% agreement on the importance of an outcome (Likert scores 4 or 5 or selection of an outcome as most meaningful). RESULTS: Eleven of 13 outcomes reached consensus for importance on the Likert scale. "Preventing heart attacks" was selected as the most meaningful outcome (80%) while "preventing death" ranked second (76%). CONCLUSIONS: Our study results verify the utility of a widely used clinical CAD outcome measure, myocardial infarction events, for the purpose of pharmaceutical value-based contracting.

Identifying Outcome Measures for Type 2 Diabetes Value-Based Contracting Using the Delphi Method.

BACKGROUND: Value-based contracts (VBCs) between payers and pharmaceutical manufacturers link drug payments to predefined performance measures and require shared risk between both entities. It is unclear how outcome measures were selected in previously reported VBCs, and many VBCs have focused on surrogate endpoints often used in the conduct of clinical trials, which may not be valued by or of importance to patients. OBJECTIVE: To identify outcome measures that are meaningful to key stakeholders and feasibly measured to inform VBCs for diabetes medications. METHODS: We conducted a modified Delphi survey to incorporate views from patients (n = 9), endocrinologists (n = 5), primary care physicians (n = 4), payers (n = 3), pharmacy benefit managers (n = 3), and pharmaceutical company representatives (n = 2). A list of 12 diabetes-related outcome measures was generated from the literature and consultations with subject matter experts. Participants rated the importance of each outcome on a 5-point Likert scale and selected the 3 most meaningful outcomes. Nonpatient participants then used a Likert scale to rate the feasibility of collecting each outcome. Consensus was defined as ≥ 75% agreement on the importance and feasibility of an outcome (Likert scores 4 or 5 or selection of an outcome as most meaningful). A 2-sample test of proportions was performed to examine differences between patient and nonpatient stakeholder rankings of outcomes. RESULTS: All 12 outcomes reached consensus for importance on the Likert scale. The measure "reducing risk of heart attacks" was the most meaningful outcome (84%), while "reducing A1c levels" ranked second (68%). The 2 measures rated as most feasibly collected were "reducing A1c levels" and "reducing risk of hospitalizations from diabetes" (93.8% each). The measures "weight loss," "reducing risk of diabetes-related kidney disease," "reducing risk of emergency room visits from diabetes," and "reducing risk of diabetes-related amputations and foot ulcers" also reached consensus for feasibility. There were statistically significant differences between patient and nonpatient stakeholders in the selection of "reducing A1c levels" (37.5% vs. 82.3%, respectively; P = 0.03) and "reducing risk of diabetes-related kidney disease" (50.0% vs. 11.8%, respectively; P = 0.03) as most meaningful outcomes. CONCLUSIONS: The measures "reducing risk of heart attacks" and "reducing A1c levels" were identified as top priority diabetes outcome measures. DISCLOSURES: Express Scripts provided research funding for this study to the UPMC Center for Value-Based Pharmacy Initiatives. Henderson is employed by Express Scripts and was involved in the conception and design of the study and manuscript approval. The other authors are employed by the UPMC Center for Value-Based Pharmacy Initiatives and have nothing to disclose.

Determination of Multiple Sclerosis Indicators for Value-Based Contracting Using the Delphi Method.

BACKGROUND: Value-based contracts link medication payments to performance measures with the ultimate goal of lowering costs while improving patient outcomes. Previous multiple sclerosis (MS) value-based contracts have focused on indicators easily collected from claims or electronic health record data as their value-based outcomes, even though numerous other MS clinical indicators of interest exist. Uncertainty remains regarding which MS indicators are most meaningful to all stakeholders affected by a value-based contract. OBJECTIVE: To identify meaningful MS indicators among key stakeholders for the purpose of informing a value-based contract for MS medications. METHODS: Using a modified Delphi method, we surveyed 26 diverse stakeholders, including 8 patients and caregivers; 9 providers (neurologists, nurses, physician assistants, and specialty pharmacists); 2 pharmaceutical company representatives; 5 payers; and 2 pharmacy benefits managers. A list of 12 MS indicators was created from subject matter expert consultation and a literature review. All stakeholders reported on the meaningfulness and value of these 12 indicators through a 5-point Likert scale and forced selection of the 3 most meaningful indicators. All nonpatient stakeholders were additionally surveyed on collection feasibility of the same 12 indicators using a 5-point Likert scale. We defined consensus as ≥ 75% agreement on the meaningfulness and feasibility of an indicator (Likert scores 4 or 5). We performed a Fisher's exact test to assess differences between nonpatient and patient stakeholder rankings of indicators. RESULTS: Consensus was reached for at least 1 indicator for all questions after 2 rounds. "Worsening physical disability" and "functional impairment" achieved 92% agreement on a Likert-scale question assessing indicator value, and 100% of participants selected "worsening physical disability" when asked to choose the 3 most meaningful indicators. "MS flares requiring an emergency department visit" and "MS flares requiring inpatient admission" were rated as the 2 most feasibly collected indicators (both received 89% agreement). CONCLUSIONS: Using the Delphi method, we identified that disability and functional impairment are meaningful MS indicators to diverse stakeholders. These findings support the incorporation of important patient-reported outcomes into value-based contracts for MS medications. DISCLOSURES: This study was supported by a grant from Express Scripts Holding Company, which provided research funding to the UPMC Center for Value-Based Pharmacy Initiatives for work on this study. Swart, Neilson, Good, and Parekh are employed by the UPMC Center for Value-Based Pharmacy Initiatives. Manolis is the Chief Pharmacy Officer of UPMC Health Plan, and Shrank was the Chief Medical Officer of UPMC Insurance Services Division at the time of this study. Henderson is employed by Express Scripts Holding Company.

Biosimilars: Opportunities to Promote Optimization Through Payer and Provider Collaboration.

A panel was convened that consisted of 1 medical director, 2 pharmacy directors, and 2 oncologists, who represented the University of Pittsburgh Medical Center Health Plan, an integrated delivery network, and Florida Blue, a progressive regional health plan. This panel met in order to share ideas, discuss challenges, and develop practical solutions to promote optimal utilization in order to encourage collaboration between payers and providers to help ensure the success of biosimilar entrants into the marketplace. Live meetings were conducted in Orlando, Florida, and Pittsburgh, Pennsylvania, and were followed by virtual meetings to solidify ideas and concepts for this supplement. It is important for biosimilar manufacturers to identify potential payer, provider, and patient obstacles in order to develop strategic and tactical plans to preemptively address these potential obstacles. Gathering payer and provider insights will shed light on various issues such as access and reimbursement. Biosimilar manufacturers must be proactive in the education of payers, providers, and patients to ensure access to biosimilars. A strong factor emphasized among this group was that the assumption surrounding biosimilar development and use is the potential for health care cost savings. According to the panel, payers and providers must carefully consider economic implications and potential cost-effectiveness in order to increase the acceptance or understanding of biosimilars in clinical practice. The group identified 3 major challenges surrounding biosimilar adoption: (1) provider confidence in biosimilar education and clinical value, (2) provider confidence in reimbursement for new biosimilars, and (3) creating shared payer and provider cost-savings. After identification of the 3 challenges, the group posed potential solutions to help with biosimilar adoption.

Evaluating the Impact of Sample Medication on Subsequent Patient Adherence.

BACKGROUND: Medication nonadherence is problematic throughout health care practice. Patient nonadherence is a result of several factors, such as financial issues, confusion about the medication, or concerns about possible side effects. Efforts to improve adherence have been implemented, but new strategies are needed to ensure that patients fill their medication prescriptions and adhere to their prescribed use. OBJECTIVE: To investigate whether providing patients with a free 30-day supply of medication at the point of care via a dispensing kiosk-a secure, computerized cabinet placed in the prescriber's office-that provides sample medication and educational materials had a measurable impact on adherence and health care cost. METHODS: The study sample consisted of patients drawn from the electronic health records of a large health care provider who were prescribed medications to treat diabetes, hypertension, and dyslipidemia. The comparison groups included a treatment group of patients who each received a 30-day generic sample of medication and a control group of patients who did not receive a sample. The study outcome was primary medication non-adherence (PMN), defined as whether a patient filled a prescription within 90, 180, or 365 days of prescribing. Only patients receiving a prescription for the first time were considered; patients on a medication before receipt of the sample were dropped. Postprescription medication adherence (PPMA), measured as proportion of days covered (PDC) and proportion of days covered ≥ 80% (PDC80), was also examined. Propensity score methods and multivariate regression models were used to examine the outcomes and group differences. Costs to the patient before and after the prescription were also analyzed. Key informant interviews were conducted with physicians, and qualitative analyses were performed. RESULTS: Patients who received a 30-day generic medication sample had a higher probability of filling a first prescription within 90 days (72.2% for treatment patients vs. 37.6% for controls, P < 0.001); 180 days (79.1% vs. 43.3%, respectively, P < 0.001); and 365 days (85.5% vs. 48.6%, P < 0.001). The medication sample had a positive effect on PDC for 90 days, with treatment patients having 72.8% adherent days versus 35.1% adherent days for controls (average treatment effect [ATE] = 37.5%, P < 0.001). At 180 days, PDC adherence was 57.1% for treatment patients versus 35.4% for controls (ATE = 21.5%, P < 0.001), and 43.6% versus 33.9%, respectively (ATE = 9.5%, P < 0.001) for the 365-day period. PDC80 was significantly better among treatment patients at 90 days (53.5% vs. 31.2%, respectively, ATE = 22.4%, P < 0.001) and 180 days (38.4% vs. 29.1%, ATE = 9.2%, P < 0.001), but not at 365 days (23.7% vs. 23.7%, ATE = -0.02, not significant). Costs were reduced by $395 for the treatment group. Interviews with clinicians indicated a positive view of the program. CONCLUSIONS: Providing a free sample medication improved the probability of patients filling their initial prescriptions and adhering to those medications. This program can affect health care costs, as evidenced by lower costs for the treatment group. DISCLOSURES: Financial support for this study was provided by MedVantx. UMPC Health Plan reviewed and commented on the manuscript. Hogue is an employee of MedVantx and also reviewed the manuscript. Manolis is employed by UPMC Health Plan. The remaining authors report no other conflicts of interest. Study concept and design were contributed by Pringle. Aldridge took the lead in data collection, along with Kearney. Data interpretation was performed primarily by Radack, along with Kearney and Grasso. The manuscript was written by Kearney, Aldridge, and Radack and revised by Kearney, Manolis, Hogue, and Radack.

Health care expenditures and therapeutic outcomes of a pharmacist-managed anticoagulation service versus usual medical care.

STUDY OBJECTIVE: To evaluate the differences in health care expenditures and therapeutic outcomes of patients receiving warfarin therapy management by a pharmacist-managed anticoagulation service compared with those receiving warfarin management by usual medical care. DESIGN: Retrospective, matched-cohort study. DATA SOURCE: University of Pittsburgh Medical Center (UPMC) and UPMC Health Plan. PATIENTS: Three hundred fifty adults who received warfarin therapy; 175 were managed by the pharmacist-managed anticoagulation service for at least 2 months between October 1, 2007, and September 30, 2008, (case patients) and 175 received usual care (matched comparison group). MEASUREMENTS AND MAIN RESULTS: Medical claims data compared were direct anticoagulation cost and overall medical care costs, anticoagulation-related adverse events, hospitalizations and emergency department visits, frequency of international normalized ratio (INR) testing, and quantity of warfarin refills. Operational costs of the anticoagulation service were also calculated. The INR values and time within therapeutic range were assessed through anticoagulation service reports and laboratory results. The direct anticoagulation care cost was $35,465 versus $111,586 and the overall medical care cost was $754,191 versus $1,480,661 for the anticoagulation service group versus the usual care group. Accounting for operational and drug expenditure costs, the cost savings was $647,024 for the anticoagulation service group. The anticoagulation service group had significantly fewer anticoagulation-related adverse events (14 vs 41, p<0.0001), hospital admissions (3 vs 14, p<0.00001), and emergency department visits (58 vs 134, p<0.00001). The percentage of INR values in range and the percentage of time the INR values were in range were significantly higher in the anticoagulation service group (67.2% vs 54.6%, p<0.0001, and 73.7% vs 61.3%, p<0.0001, respectively). Compared with the usual care group, the anticoagulation service group had significantly more INR tests performed but demonstrated no significant difference in the quantity of drug refills. CONCLUSION: After accounting for operational costs, pharmacist-managed anticoagulation leads to reduced health care expenditure while improving therapeutic outcomes compared with usual medical care.