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.

Trends in utilization and costs of migraine medications, 2017-2020.

OBJECTIVE: This study examines changes in utilization and costs trends associated with migraine medications. BACKGROUND: Migraine attacks are a burden to many patients. There are many pharmacotherapy options available with newer migraine drug classes entering the market in the past decade. Little is known about the use, associated costs, and the impact of the newer agents. METHODS: This retrospective, cross-sectional study examined 2017-2020 administrative claims from a large national pharmacy benefits manager. Patients aged ≥ 18 years enrolled in commercial, Medicare, Medicaid, or health insurance exchange insurance plans who filled ≥ 2 prescription claims for triptans, ergotamines, isometheptenes, gepants, ditans, and CGRP mABs were included. A two-sample t-test was conducted to estimate whether differences in mean utilization and costs between 2017 and 2020 were statistically significant for migraine drug classes, except for CGRP mABs, which were estimated between 2018 and 2020. RESULTS: The sample ranged from 161,369 (2017) to 240,330 (2020) patients. 84.5% (n = 203,110; 2020) of patients were women. The number of 30-day adjusted prescription fills for prophylaxis remained stable over the four-year period, except for CGRP mABs, which increased from 0.5% (n = 0.007; 2018) to 5.3% (n = 0.075; 2020). Antiepileptics, antidepressants and beta blockers were the most common prophylaxes, while triptans, non-steroidal anti-inflammatory drugs/non-narcotic analgesics and opioids were the most common treatments utilized. CGRP mABs were the most expensive, while utilization of triptans were the highest. CGRP mABs had the largest increase in utilization (177.5%) and costs (166.3%) PPPM in 2020 ($291.17) compared to 2018 ($109.35), the year they were first available (p < 0.001). Between 2018 and 2020, costs increased overall and for commercial and Medicare enrollees, but remained unchanged for Medicaid and HIX members. CONCLUSION: Our study demonstrates a shift in migraine medication utilization from 2017-2020, where increased use of CGRP mABs had a significant contribution to increased costs. These increased pharmacy costs must be weighed against the improved tolerability of these agents likely resulting in other healthcare and indirect cost savings.

A scoping review of US insurers' use of patient-reported outcomes.

OBJECTIVES: To complete a scoping review of US health insurers' use of health-related quality of life (HRQOL) patient-reported outcome measures (PROMs). STUDY DESIGN: Literature review. METHODS: A literature search was constructed for articles that contained an insurer-related term and an HRQOL-related term between 1999 and 2019 using the MEDLINE, Embase, Web of Science, Cochrane Database of Systematic Reviews, EconLit, and Business Source Complete databases. RESULTS: The search identified 14,253 unduplicated records, of which 2340 passed abstract screening and 350 were included in the review. The populations addressed in these studies included both populations with specific health conditions (eg, diabetes) and an entire member population. The most common purpose of the article was to evaluate a policy or program (n = 255; 72.9%); the range of interventions evaluated included federal policy, subgroup management strategies, and identification of individual patients. The most common insurance mechanism was Medicare (n = 205; 58.6%). The most common source of data was collected specifically for a research project (n = 172; 49.1%), and the least common source of data was collected by providers at the point of care (n = 34; 9.7%). The most commonly addressed age group was 65 years and older (n = 262; 74.9%), and the least commonly addressed was younger than 18 years (n = 36; 10.3%). The most commonly used PROMs were single-item self-rated health (n = 138; 47.1%) and activities of daily living (n = 88; 30.0%), with validated depression questionnaires (n = 56; 19.1%) being the most common disease-focused questionnaire. CONCLUSIONS: This review found a wide variety of articles across insurance providers, health conditions, and uses of PROMs. There is a noted paucity of data in pediatric populations and little information about the use of data collected within health care settings that is transmitted to health insurers.

Patient and medication-related factors associated with opioid use disorder after inpatient opioid administration.

BACKGROUND: Examine baseline factors associated with a new diagnosis of opioid use disorder (OUD) within 12 months postdischarge among opioid-naïve patients who received an opioid prescription in the inpatient setting. DESIGN/SETTING: Retrospective cohort (surgery and nonsurgery) study of opioid-naive patients who had at least one prescription for an opioid during an inpatient hospitalist between 2014 and 2017. PARTICIPANTS: Twenty-three thousand and thirty-three patients were included. OBJECTIVE: The primary objective was to determine baseline factors associated with a new OUD diagnosis within 12 months of discharge. Baseline covariates included demographic information, clinical characteristics, medication use, characteristics related to index hospital encounter, and discharge location. FINDINGS: 2.1% of the sample had a new diagnosis of OUD within a year after receiving an opioid during hospital admission. Patients between ages 25 and 34 had higher odds of a new OUD diagnosis compared to those 65 years of age and older (odds ratio [OR]: 6.98, 95% confidence interval [CI]: 4.02-12.1 [nonsurgery] and 4.69, 95% CI: 2.63-8.37 [surgery]). Patients from a high opioid geo-rank region had higher odds of OUD diagnosis (OR: 2.08, 95% CI: 1.31-3.31 [nonsurgery] and 1.80, 95% CI: 1.03-3.15 [surgery]). History of nonopioid-related drug disorder, tobacco use disorder, mental health conditions, and gabapentin use 12 months prior to index date and white race were associated with higher odds of new OUD diagnosis. CONCLUSIONS: It is important to identify and evaluate factors associated with developing a new diagnosis of OUD following hospitalization. This can inform pain management strategies within the hospital and at discharge, and prompt clinicians to screen for risk of OUD.

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.

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.

Effect of Social Determinants of Health Interventions on Adults Living With Disabilities: A Scoping Review.

OBJECTIVE: To investigate social determinants of health (SDoH) interventions on individual health outcomes, population health, and cost for persons in the United States over age 18 living with disabilities and receiving long-term services and supports (LTSS) in noninstitutional settings. DATA SOURCES: A review using Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines was conducted of literature from PubMed, PsycINFO, REHABDATA, and Web of Science Core Collection published between January 1997 and July 2020. STUDY SELECTION: Search terms were based on the primary SDoH domains identified by the Centers for Medicare and Medicaid's Accountable Health Communities Model. A total of 5082 abstracts were screened based on identification criteria of persons age 18 and above living in non-institutional, community-based settings receiving LTSS. DATA EXTRACTION: During Level 2 review, articles were reviewed based on population focus, type of LTSS (personal assistance services, home care, adult day care, home modification, durable medical equipment, community transition services, caregiver supports and/or prevention services related to home- and community-based care), SDoH intervention and association with health outcomes, population health and/or cost. A total of 1037 abstracts underwent Level 2 review, yielding 131 publications or 1.3% for full review. DATA SYNTHESIS: Studies (n=33) designed a priori to test outcomes of interventions were rated according to Grading Recommendations Assessment Development and Evaluation (GRADE) criteria. Qualifying articles that did not include interventions (n=98) were included in our summary of the literature but were not assessed by GRADE. CONCLUSIONS: The preponderance of research surrounding SDoH and health outcomes has focused on older adults living with disabilities, and most interventions scored low or very low using GRADE criteria. Evidence is limited to the extent SDoH interventions are measured against outcomes for persons of all ages living with disabilities. Robust evaluation of models that feature SDoH interventions in partnership with community-based organizations is recommended as home and community-based care infrastructure expands in response to the American Rescue Plan Act of 2021.

Real-World Use and Outcomes of Oral Antiplatelets Among Patients with Acute Coronary Syndrome: A Retrospective Cohort Study.

BACKGROUND: Acute coronary syndrome (ACS)-related readmission is an important hospital quality measure. Medication management therapy, especially adherence to antiplatelet agents post discharge, could play an important role in reducing readmission rates. Newer agents such as ticagrelor and prasugrel have been shown, in randomized control trials, to have superior effectiveness to cardiovascular outcomes compared to clopidogrel, but they are more expensive and have more common adverse events such as bleeding and dyspnea. OBJECTIVE: We compared real-world readmission rates and adherence to antiplatelet agents among patients who initiated these agents post discharge. METHODS: This was a retrospective cohortstudy of patients with an index ACS-related hospitalization between 1 July 2017 and 31 December 2018. Using integrated pharmacy and medical claims data from a large national pharmacy benefits manager for commercially insured adults aged ≥ 18 years, we compared ACS-related readmission and medication adherence (as medication possession ratio (MPR)) among the three agents. ANOVA and logistic regression, controlling for demographics such as age, gender, and Charlson Comorbidity Index, were used to estimate any association between the agents and 365-day readmission rates. RESULTS: Of the 948 eligible patients, 86, 342, and 520 were initiated on prasugrel, ticagrelor, and clopidogrel (PTC), respectively. There were 4.7%, 5.3%, and 8.5% readmissions rates in the PTC cohorts, respectively, but these were not statistically significant in either the ANOVA or the logistic regression analyses. MPR was highest in the ticagrelor (88.1%) cohort, followed by the prasugrel (79.1%) and clopidogrel (76.4%) cohorts. CONCLUSION: Ticagrelor cohort had the highest medication adherence. Clopidogrel cohort had the highest readmission rate but the difference with the other cohorts was statistically insignificant.

Infection incidence and management in multiple sclerosis patients after initiating disease-modifying therapy.

Disease-modifying therapies for multiple sclerosis (MS) are effective, but frequently cost $70,000+/year and can predispose patients to serious infections. This retrospective cohort analysis (N = 3,204) compared rates of infections over a 24-month period by MS medication route of administration and antimicrobial use. Infection rates were: 38.7% (oral), 37.3% (infused), and 36.8% (injectable). Of those infections, antimicrobials were prescribed in 86.5% (oral), 84.3% (infused), and 85.5% (injectable) cases. We found differences within bacterial and herpes zoster infection rates (and antimicrobial use) among new users by medication route of administration. Our findings suggest that pharmacovigilance may inform the shared-decision processes when choosing MS medications.

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.

Health care utilization and costs associated with switching from DPP-4i to GLP-1RA or SGLT2i: an observational cohort study.

BACKGROUND: Because of improved clinical outcomes, recent American Diabetes Association guidelines recommend the use of newer antidiabetic agents-glucagon-like peptide-1 receptor agonists (GLP-1RA) and sodium-glucose cotransporter 2 inhibitors (SGLT2i)-by those with cardiovascular disease. It is unclear, however, how switching to these newer agents affects health care utilization and costs. OBJECTIVE: To compare health care utilization and costs between users of dipeptidyl peptidase-4 inhibitors (DPP-4i) who switch to GLP-1RA or SGLT2i and nonswitchers. METHODS: We used claims data from a large pharmacy benefit manager. Patients included were commercially insured adults with type 2 diabetes and a prescription claim for DPP-4i in 2016 or 2017. Using propensity score methods, we matched patients who switched to SGLT2i or GLP-1RA with those who remained on DPP-4i. Among matched samples, we conducted multivariable negative binomial regression to examine differences in the incidence of inpatient and emergency room (ER) visits and generalized linear regression to examine differences in health care costs. RESULTS: Among 47,953 patients who used DPP-4i in 2016 and 2017, 507 switched to SGLT2i and 808 switched to GLP-1RA. Propensity score matching of 1:6 resulted in 3,042 nonswitchers/507 switchers for the SGLT2i cohort and 4,848 nonswitchers/808 switchers for the GLP-1RA cohort. Switchers to SGLT2i experienced a 39% reduction (incidence rate ratio [IRR] = 0.61, 95% CI = 0.38-0.96), and GLP-1RA switchers experienced a 29% reduction (IRR = 0.71, 95% CI = 0.52-0.97) in inpatient hospitalizations. ER visit rates did not differ significantly between switchers and nonswitchers. Switchers to SGLT2i did not have statistically significant differences in medical or pharmacy costs compared with DPP-4i users, while switchers to GLP-1RA had significantly higher total pharmacy costs (adjusted difference of $2,453.10, 95% CI = $1,837.20-$3,069.00). CONCLUSIONS: Switching from DPP-4i to GLP-1RA or SGLT2i was associated with fewer hospitalizations; however, higher pharmacy costs may outweigh savings from reduced hospitalizations, especially for GLP-1RAs. As newer diabetes guidelines steer specific populations to these drug classes, it is important to optimize drug pricing to realize their true value. DISCLOSURES: No outside funding supported this study. Neilson, Good, Swart, and Huang are employees of UPMC Center for Value-Based Pharmacy Initiatives and High-Value Care. Parekh reports employment at UPMC until July 2019. Munshi and Henderson are employed by Express Scripts. Newman has no disclosures to report.

Impact of Marijuana Legalization on Opioid Utilization in Patients Diagnosed with Pain.

BACKGROUND: Given efforts to reduce opioid use, and because marijuana potentially offers a lower-risk alternative for treating chronic pain, there is interest in understanding the public health impact of marijuana legalization on opioid-related outcomes. OBJECTIVE: Assess the impact of recreational and medical marijuana legalization on opioid utilization among patients receiving pharmacotherapy for pain. DESIGN: Retrospective claims-based study of commercially insured patients continuously eligible for pharmacy and medical benefits from July 8, 2014 to June 30, 2017. Index pain prescription period was defined between January 8, 2015 and June 30, 2015, and longer-term opioid use examined during 2-year follow-up. Marijuana state policy on July 1, 2015, was assigned: none; medical only; or medical and recreational. PARTICIPANTS: Patients aged 18-62 without cancer diagnosis. MAIN MEASURES: Patient receiving (1) opioid at index; (2) > 7 days' supply of index opioid; (3) opioid during follow-up; and (4) ≥ 90 days' opioid supply during follow-up. Multivariable regression assessed associations between opioid utilization and state marijuana policy, adjusting for age, gender, overall disease burden, mental health treatment, concomitant use of benzodiazepine or muscle relaxant, and previous pain prescription. KEY RESULTS: Of 141,711 patients, 80,955 (57.1%) resided in states with no policy; 56,494 (39.9%) with medical-only; and 4262 (3.0%) with medical and recreational. Patients in states with both policies were more likely to receive an index opioid (aOR = 1.72, 95% CI = 1.61-1.85; aOR = 1.90, 95% CI = 1.77-2.03; P < 0.001) but less likely to receive > 7 days' index supply (aOR = 0.84, 95% CI = 0.77-0.91; aOR = 0.76, 95% CI = 0.70-0.83; P < 0.001) than patients in states with no policy or medical-only, respectively. Those in states with both policies were more likely to receive a follow-up opioid (aOR = 1.87, 95% CI = 1.71-2.05; aOR = 2.20, 95% CI = 2.01-2.42; P < 0.001) than those in states with no policy or medical-only, respectively, and more likely to receive ≥ 90 cumulative follow-up opioid days' supply (aOR = 1.18, 95% CI = 1.07-1.29; P < 0.001) than those in states with no policy. CONCLUSIONS: Our analysis does not support the supposition that access to marijuana lowers use of chronic opioids for pain.

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 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.

Impact of Healthcare Delivery System Type on Clinical, Utilization, and Cost Outcomes of Patient-Centered Medical Homes: a Systematic Review.

BACKGROUND: As healthcare reimbursement shifts from being volume to value-focused, new delivery models aim to coordinate care and improve quality. The patient-centered medical home (PCMH) model is one such model that aims to deliver coordinated, accessible healthcare to improve outcomes and decrease costs. It is unclear how the types of delivery systems in which PCMHs operate differentially impact outcomes. We aim to describe economic, utilization, quality, clinical, and patient satisfaction outcomes resulting from PCMH interventions operating within integrated delivery and finance systems (IDFS), government systems including Veterans Administration, and non-integrated delivery systems. METHODS: We searched PubMed, the Cochrane Library, and Embase from 2004 to 2017. Observational studies and clinical trials occurring within the USA that met PCMH criteria (as defined by the Agency for Healthcare Research and Quality), addressed ambulatory adults, and reported utilization, economic, clinical, processes and quality of care, or patient satisfaction outcomes. RESULTS: Sixty-four studies were included. Twenty-four percent were within IDFS, 29% were within government systems, and 47% were within non-IDFS. IDFS studies reported decreased emergency department use, primary care use, and cost relative to other systems after PCMH implementation. Government systems reported increased primary care use relative to other systems after PCMH implementation. Clinical outcomes, processes and quality of care, and patient satisfaction were assessed heterogeneously or infrequently. DISCUSSION: Published articles assessing PCMH interventions generally report improved outcomes related to utilization and cost. IDFS and government systems exhibit different outcomes relative to non-integrated systems, demonstrating that different health systems and populations may be particularly sensitive to PCMH interventions. Both the definition of PCMH interventions and outcomes measured are heterogeneous, limiting the ability to perform direct comparisons or meta-analysis.

Impact of community pharmacist-led interventions in chronic disease management on clinical, utilization, and economic outcomes: An umbrella review.

BACKGROUND: Chronic disease represents a significant burden to the United States (US) health care system, with approximately 50% of all adults in the US having one or more chronic disease conditions. Pharmacist-led chronic disease management interventions are of special interest since 80% of medical treatments involve the use of prescription drugs. Moreover, community pharmacists are among the most accessible health care professionals to provide care for populations with chronic diseases. The impact of care provided by community pharmacists isn't well defined, with interventions taking on diverse forms with varied effects on outcomes. OBJECTIVE: The purpose of this review is to summarize evidence from secondary literature on community pharmacist-led chronic disease management interventions and the impact on clinical, utilization, and economic outcomes. METHODS: We conducted a systematic search of systematic reviews, meta-analyses, and narrative reviews using MEDLINE via PubMed, EMBASE.com and Cochrane Library databases published between January 1, 2007 and October 17, 2017. The following data were extracted: citation details, review type, number of primary studies included, disease state, description of the intervention, outcomes assessed, and results. RESULTS: Our search strategy retrieved 2296 titles and abstracts of which 15 references met our inclusion criteria. Selected articles covered 7 main diseases -diabetes, asthma, chronic obstructive pulmonary disease (COPD), hypertension, heart failure, hyperlipidemia, and human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS). Community pharmacist-led interventions mostly consisted of patient consultations and education. In diabetes, interventions achieved significant reductions in hemoglobin A1c, total cholesterol, and low-density lipoprotein (LDL). Reviews also reported favorable reductions in blood pressure, improved medication adherence and reduced readmission rates in patients with heart failure, improved lung function in patients with respiratory conditions, and increased medication adherence in those with HIV/AIDs. Literature reporting economic and utilization outcomes were limited and mostly focused on pharmacy interventions in diabetes. In some cases, community pharmacy services demonstrated a decrease in medical and health care costs in patients with diabetes. CONCLUSION: We found that community pharmacists can improve clinical outcomes in a wide array of chronic diseases, including diabetes, hyperlipidemia, HIV/AIDS, cardiovascular and respiratory diseases. More robust studies are needed to further assess the impact of specific interventions on economic and utilization outcomes.

Optimizing the Role of Community Pharmacists in Managing the Health of Populations: Barriers, Facilitators, and Policy Recommendations.

The shift to a value-based health care system has incentivized providers to implement strategies that improve population health outcomes while minimizing downstream costs. Given their accessibility and expanded clinical care models, community pharmacists are well positioned to join interdisciplinary care teams to advance efforts in effectively managing the health of populations. In this Viewpoints article, we discuss the expanded role of community pharmacists and potential barriers limiting the uptake of these services. We then explore strategies to integrate, leverage, and sustain these services in a value-based economy. Although community pharmacists have great potential to improve population health outcomes because of their accessibility and clinical interventions that have demonstrated improved outcomes, pharmacists are not recognized as merit-based incentive eligible providers and, as a result, may be underutilized in this role. Additional barriers include lack of formal billing codes, which limits patient access to services such as hormonal contraception; fragmentation of Medicare, which prevents alignment of medical and pharmaceutical costs; and continued fee-for-service payment models, which do not incentivize quality. Despite these barriers, there are several opportunities for continued pharmacist involvement in new care models such as patient-centered medical homes (PCMH), accountable care organizations, and other value-based payment models. Community pharmacists integrated within PCMHs have demonstrated improved hemoglobin A1c, blood pressure control, and immunization rates. Likewise, other integrated, value-based models that used community pharmacists to provide medication therapy management services have reported a positive return on investment in overall health care costs. To uphold these efforts and effectively leverage community pharmacist services, we recommend the following: (a) recognition of pharmacists as providers to facilitate full participation in performance-based models, (b) increased integration of pharmacists in emerging delivery and payment models with rapid cycle testing to further clarify the role and value of pharmacists, and (c) enhanced collaborative relationships between pharmacists and other providers to improve interdisciplinary care. DISCLOSURES: This article was funded by the National Association of Chain Drug Stores. The authors have no potential conflicts of interest to report.

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.

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.