Specialty drug use for autoimmune conditions varies by race and wage among employees with employer-sponsored health insurance.

BACKGROUND: The relationship between race and ethnicity, wage status, and specialty medication (SpRx) use among employees with autoimmune conditions (AICs) is poorly understood. Insight into sociodemographic variations in use of these medications can inform health equity improvement efforts. OBJECTIVE: To assess the association of race and ethnicity and wage status on SpRx use and adherence patterns among employees with AICs enrolled in employer-sponsored health insurance. METHODS: In this observational, retrospective cohort analysis, data were obtained from the IBM Watson MarketScan database for calendar year 2018. Employees were separated into race and ethnicity subgroups based on employer-provided data. Midyear employee wage data were used to allocate employees into the following annual income quartiles: $47,000 or less, $47,001-$71,000, $71,001-$106,000, and $106,001 or more. The lowest quartile was further divided into 2 groups ($35,000 or less and $35,001-$47,000) to better evaluate subgroup differences. Outcomes included monthly days SpRx-AIC supply, proportion of days covered (PDC), and medication discontinuation rates. Generalized linear regressions were used to assess differences while adjusting for patient and other characteristics. RESULTS: From a sample of more than 2,000,000 enrollees, race and ethnicity data were available for 617,117 (29.8%). Of those, 47,839 (7.8%) were identified as having an AIC of interest, with prevalence rates of AICs differing by race within wage categories. Among those with AICs, 5,358 (11.2%) had filled at least 1 SpRx-AIC prescription. Following adjustment, except for the highest wage category, prevalence of SpRx-AIC use was significantly less among Black and Hispanic subpopulations. Black patients had significantly lower SpRx-AIC use rates than White patients (≤$35,000: 4.9 vs 9.4%, >$35,000-$47,000: 5.5 vs 10.6%, >$47,000-$71,000: 8.5 vs 11.1%, and >$71,000-$106,000: 9.1 vs 12.7%; P <0.001 for all). For Hispanic patients, prevalence rates were significantly lower than White patients in 3 different wage categories (≤$35,000: 4.5 vs 9.4%, >$35,000-$47,000: 6.1 vs 10.6%, and >$71,000-$106,000: 8.6 vs 12.7%; P < 0.001). PDC and 90-day discontinuation rates did not differ among race and ethnicity groups within the respective wage bands. CONCLUSIONS: Race and ethnicity and wage-related disparities exist in SpRx use, but not PDC or discontinuation rates for treatment of AICs among non-White and low-income populations with employer-sponsored insurance, and may adversely impact clinical outcomes.

Impact of the COVID-19 pandemic on new starts to oral oncology medications in the US.

INTRODUCTION: The COVID-19 pandemic has had a significant impact on healthcare delivery. Although others have documented the impact on new cancer diagnoses, trends in new starts for oncology drugs are less clear. We examined changes in new users of oral oncology medications in the US following COVID-19 stay-at-home orders in 2020 compared to prior years. METHODS: We examined prescription data for members enrolled with a national pharmacy benefits manager in the US from January 1-October 31 of 2018, 2019, and/or 2020. This is a retrospective, observational study comparing new users per 100,000 members per month for all oral oncology drugs, and separately for breast, lung, and prostate cancer, leukemia, and melanoma oral drugs. We performed a difference-in-differences analysis for change in new users from pre-period (prior to pandemic-induced disruption, January-March), to post-period (following pandemic-induced disruption, April-October), between 2020 and 2019, and 2020 and 2018. RESULTS: New oral oncology drug users per 100,000 members per month declined by an additional 11.3% in the 2020 post-period compared to 2019 (p = 0.048). New oral breast cancer drug starts declined by an additional 14.0% in the 2020 post-period compared to 2019 (p = 0.040). Similar but non-significant trends were found between 2020 and 2018. No significant differences were found between post-period monthly new starts of leukemia, melanoma, lung or prostate cancer disease-specific oral medications. CONCLUSIONS: Long-term implications of delays in cancer treatment initiation are unclear, although there is concern that patient outcomes may be negatively impacted.

Commercial coverage of specialty drugs, 2017-2021.

Health plans guide their enrollees' access to specialty drugs through coverage policies. We examined a set of health plan policies to determine if they have become more or less stringent over time. We did so by comparing the consistency of policies with Food and Drug Administration (FDA) label indications. We considered coverage policies for the same 187 specialty drugs issued by 17 large US commercial health plans from 2017 through 2021. Overall, the proportion of policies that were consistent with the FDA label declined from 57.1% in 2017 to 45.1% in 2021; the proportion of policies that were more restrictive than the FDA label increased from 39.5% to 51.7%. The proportion of policies excluding drug coverage remained approximately constant (3.4% in 2017; 3.2% in 2021). Trends in coverage restrictiveness varied across plans. For 13 plans, the proportion of policies with restrictions increased over time, while for 4 plans it declined.

Trends in add-on medications following metformin monotherapy for type 2 diabetes.

BACKGROUND: Although metformin is generally universally recommended as a first-line pharmacologic therapy for most people living with type 2 diabetes, second-line and third-line choices can require a tailored approach to achieve optimal blood glucose and glycated hemoglobin levels. OBJECTIVE: To examine national trends in second- and third-line antihyperglycemic medications following metformin monotherapy, comparing 2015 and 2019. METHODS: This retrospective cohort analysis of deidentified pharmacy claims from a large national pharmacy benefits manager from January 1, 2015, to December 31, 2015, and again in January 1, 2019, to December 31, 2019, included adults (aged ≥ 18 years) continuously enrolled in commercial or Medicare insurance plans who filled an index metformin prescription in either year. Proportions of patients by second-line and third-line antihyperglycemic class were calculated. RESULTS: Second-line use of sulfonylureas (-10.1%; P < 0.001), combination drugs (-3.0%; P < 0.001), and dipeptidyl peptidase-4 inhibitors (-2.0%; P = 0.031) significantly declined, whereas second-line use of sodium-glucose cotransporter 2 inhibitors (SGLT2is) (+4.9%; P < 0.001) and glucagon-like peptide-1 receptor agonists (GLP-1Ras) (+10.0%; P < 0.001) significantly increased. Similarly, third-line use of sulfonylureas declined (-5.5%; P = 0.005), whereas third-line use of SGLT2is (+3.4%; P = 0.005) and GLP-1RAs (+8.3%; P < 0.001) increased. Similar trends between 2015 and 2019 were found in commercial and Medicare subgroups. Among all groups in 2015 compared with 2019, sulfonylureas were the most prescribed second-line class and insulins the most common third-line class. Although SGLT2i and GLP-1RA together represented more than one-third of second-line and third-line prescriptions for commercially insured patients in 2019 (34.3% and 35.0%, respectively), these classes were less frequently prescribed in the Medicare subgroup (18% and 25.6%, respectively). CONCLUSIONS: This report provides updated second-line and third-line antihyperglycemic medication prescribing trends in the United States, which suggests that evidence-based guidelines are being used in practice to prevent complications and individualize diabetes care. DISCLOSURES: Ms Swart and Drs Peasah and Good are employed by UPMC Health Plan. Dr Neilson was employed by UPMC Health Plan at the time of the study. Drs Munshi and Henderson were employed by Evernorth at the time of the study.

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.

Embedding Policy and Procedure Hyperlinks Into the Electronic Health Record to Improve Practice, Usability, and Reduce the Risk of Litigation.

PURPOSE: The purpose of this study was to evaluate the effects of implementing clinical decision support (embedded organizational policy and procedure hyperlinks) within intuitive areas of an electronic health record used by nurses. DESIGN: An interrupted time series design was used in this study. METHODS: Performance testing to determine usability was conducted prior to and following the implementation of two embedded policy and procedure hyperlinks. FINDINGS: Improvement in all three components of usability (efficiency, effectiveness, and satisfaction) was found following the implementation of the hyperlinks. Nurses were not able to recall critical elements of the policy and procedures. CONCLUSIONS: Nurses did not have satisfactory memory recall for policy and procedures and needed access to ensure compliance. Embedding policy and procedure hyperlinks into the electronic health record improved access and usability.

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.

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.

Impact of a diabetes remote monitoring program on medication adherence.

BACKGROUND: Medication nonadherence in diabetes is well documented to be associated with inadequate glycemic control. Through remote blood glucose (BG) monitoring, unlimited test strip and lancet supplies, personal coaching, and online access to clinical information and educational resources, diabetes remote monitoring (DRM) programs may provide a solution. OBJECTIVE: To examine the relationship between patient participation in a DRM solution and adherence to oral antidiabetic drugs (OAD). METHODS: A retrospective, propensity score-matched cohort study was conducted using deidentified administrative claims data from a large pharmacy benefit manager. Commercially insured patients aged 18 years or older and having 2 or more 30-day adjusted OAD claims comprised the target sample. Patients enrolled in insurance plans that implemented DRM, who had at least 1 BG check (ever engaged) between April 1, 2015, and March 31, 2018 (exposure) were matched to patients enrolled in insurance plans that did not implement DRM (nonexposure). After a 1:2 matching on baseline demographics, disease burden proxy, total pharmacy out-of-pocket costs, previous adherence and insulin use, nonexposure group participants were assigned the same first BG check date as their matched DRM participants. Medication adherence measured as proportion of days covered (PDC) in the 365 days following first BG check was examined as a continuous and binary outcome measure (PDC > 80% or adherent vs < 80% or nonadherent). Multivariable linear and logistic regression were conducted to examine differential magnitude in adherence and likelihood of being adherent, respectively. RESULTS: The final sample consisted of 6,002 exposure and 12,004 nonexposure group patients. DRM participants who were ever engaged had a 4.5% higher adherence rate (P < 0.001) and 42% higher odds of being adherent (P < 0.001) in the period after engagement compared with non-DRM participants. Sensitivity analyses showed that patients engaged continuously (> 1 BG check per week) for 3, 6, and 12 months had 5.1%, 5.2%, and 6.4% higher adherence rates, respectively (P < 0.001), and 52%, 64%, and 98% higher odds of being adherent, respectively (P < 0.001), compared with non-DRM participants. CONCLUSIONS: The study findings offer evidence that DRM engagement is associated with higher odds of medication adherence. DRM solutions that provide access to glucose test results, personalized coaching, educational resources, and lower testing supply cost can also influence adherence. Our findings have important implications for payers and patients related to improved health outcomes due to higher medication adherence. DISCLOSURES: Funding for this study was provided by Express Scripts. Munshi, Amelung, Carter, and Henderson are employed by Express Scripts. James and Shah are employed by Livongo, which provided the DRM solution.

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.

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 Star Rating Medication Adherence Measures on Adherence for Targeted and Nontargeted Medications.

BACKGROUND: In 2012, Medicare incorporated medication adherence targeting oral antidiabetic medications, renin-angiotensin system (RAS) antagonists, and statins as highly weighted components in its Star Ratings Program. In the same year, health plans began receiving quality bonus payments for higher star ratings. OBJECTIVE: We aimed to assess how these policy changes affected adherence to targeted and other chronic disease medications in the United States. METHODS: We performed interrupted time series analyses to assess monthly changes in medication adherence from 2010 to 2016 using health plans' Medicare claims submitted to a large pharmacy benefits manager. We conducted 2 sets of analyses. The first examined whether policy changes affected adherence to the 3 targeted therapy classes, and the second assessed the association between policy changes and adherence to 5 chronic disease classes not targeted by star ratings. For the second analysis, we further compared adherence between members who concomitantly used and did not use targeted medications. RESULTS: For star-ratings analyses, we studied 240 811 members on oral antidiabetic medications, 500 958 on RAS antagonists, and 471 135 on statins. Adherence for all star rating-targeted and nontargeted medications increased after 2012 (P < .001). Oral antidiabetic, statin, and RAS antagonist adherence was, respectively, 11.2%, 3.7%, and 8.1% higher than adherence without policy changes (P < .001). Nontargeted antihypertensive and antihyperlipidemic adherence trends were higher among those concomitantly on star rating-targeted medications compared with those who were not (P < .001). CONCLUSIONS: As policy makers strive to identify optimal quality measures for improving healthcare delivery, it is important to consider that incentives can promote improved performance in both targeted measures and related outcomes.

Longitudinal antibiotic prescribing trends among US dental specialists within a pharmacy benefits manager, 2013 through 2015.

BACKGROUND: Reducing inappropriate antibiotic prescriptions (Rxs) is a major quality improvement initiative in the United States. Tracking antibiotic prescribing trends is 1 method of assessing improvement in antibiotic prescribing. The purpose of this study was to assess longitudinal antibiotic prescribing practices among dental specialists. METHODS: This was a retrospective ecological longitudinal trend study. The authors calculated monthly systemic antibiotic Rx counts, and rates per 100,000 beneficiaries, from a pharmacy benefits manager in the United States from 2013 through 2015. The authors calculated average annual antibiotic Rx rates (AARs) for the 3-year study period. The authors used a quasi-Poisson regression model to analyze antibiotic Rx trends. The authors quantified seasonal trends, when present, via peak-to-trough ratios (PTTRs). RESULTS: Dental specialists prescribed 2.4 million antibiotics to the cohort of 38 million insurance beneficiaries during the 3-year study period (AAR = 2,086 Rxs per 100,000 beneficiaries). Oral and maxillofacial surgeons prescribed the most antibiotics (1,172,104 Rxs; AAR = 1,018 Rxs per 100,000 beneficiaries), followed by periodontists (527,038 Rxs; AAR = 457 Rxs per 100,000 beneficiaries), and endodontists (447,362 Rxs; AAR = 388 Rxs per 100,000 beneficiaries). Longitudinal antibiotic prescribing trends were stable among all dental specialties in the regression models (P > .05). The authors observed substantial seasonal variation in antibiotic Rxs in 2 specialties: pediatric dentistry (PTTR, 1.18; 95% confidence interval, 1.13 to 1.25) and orthodontics and dentofacial orthopedics (PTTR, 1.41; 95% confidence interval, 1.21 to 1.71), with the highest rates of antibiotic Rxs in the spring and winter. CONCLUSIONS: Antibiotic prescribing practices for dental specialists remained stable. The authors observed seasonal trends in 2 specialties. PRACTICAL IMPLICATIONS: Public health efforts are needed improve antibiotic prescribing among dental specialties.

Adoption of direct-acting antiviral medications for hepatitis C: a retrospective observational study.

BACKGROUND: Approximately 3.5 million Americans are infected with the hepatitis C virus (HCV). Although many patients with HCV are asymptomatic, HCV is the leading cause of infection-related death in the U.S. With advances in curative medication therapy for HCV, many of these deaths are preventable. Access to innovative therapies may be unevenly distributed. Our objective was to describe medication prescribers' adoption of innovative HCV pharmacotherapy across prescriber, geographical location, and time. METHODS: This is a retrospective, secondary data analysis among a national cohort of patients prescribed direct-acting antiviral HCV medications with curative intent. We assessed prescriptions by time, geographic location, and provider type. RESULTS: The peak of the adoption rate occurred within 45 days; nearly one-sixth of all prescribers had already prescribed one of the new drugs. Geographical regions (Midwest, South, and West all p ≥ 0.05) nor gender (p = 0.455) of a prescriber impacted adoption. Similarly, patient income did not influence the likelihood of a prescriber to adopt the new drugs earlier (p = 0.175). Gastroenterologists or hepatologists were more likely earlier adopters compared to primary care physicians (p = 0.01). CONCLUSIONS: Because of the relative advantage of newer therapies, we anticipated that there would be an initial surge as early adopters prescribed the new medications and use would dwindle over time as the initial HCV cohort was cured. The data demonstrate that our hypothesis is essentially supported. There is a reduction in prescriptions at approximately 5 months post-approval and treatment is typically required for 3 months. There has been a surge in clinicians' adoption of innovative HCV treatments. As patients are cured of their infection, we anticipate a decreased need for chronic management of HCV. TRIAL REGISTRATION: Not applicable.

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.