Assessment of racial and ethnic inequities in copay card utilization and enrollment in copay adjustment programs.

BACKGROUND: Increases in consumer cost sharing lead to decreases in the use of both high- and low-value care. Copay assistance was designed to reduce out-of-pocket (OOP) cost burden. Commercial insurers have recently instituted copay adjustment programs (CAPs), which exclude copay assistance from deductibles and OOP cost maximums, thereby effectively increasing the financial burden on patients. The utilization of these programs by specific demographic populations is unknown. OBJECTIVE: To assess utilization of copay assistance and CAP exposure in a commercially insured patient population and examine potential differences in the use of each of these programs by non-White and by White patients. METHODS: A retrospective, cross-sectional study using IQVIA Longitudinal Access and Adjudication Data, linked to Experian Marketing Solutions, LLC consumer data, identified unique patients who were younger than 65 years, covered by commercial insurance, had at least 1 pharmacy claim for treatment within prespecified therapeutic areas, and had full financial data visibility on paid claims (ie, nonmissing data on costs associated with the pharmacy claim and the secondary payer) between January 1, 2019, and September 30, 2021. Analyses of copay card use or CAP exposure (defined as the likelihood to be included in the accumulator or maximizer program) between non-White and White patient populations were adjusted for age, gender, household income, patient state of residence, pharmacy benefit manager, state-level CAP policy, and overall drug cost. RESULTS: In total, 4,073,599 unique patients (5.6% of the total database population) were included in the copay card analysis. In adjusted analyses, there were no significant differences in copay card utilization between non-White patients and White patients (odds ratio [OR] = 0.995, 95% CI = 0.99-1.00; P = 0.0964). However, among copay card users, non-White patients were significantly more likely to be exposed to CAPs, as either maximizers (OR = 1.27, 95% CI = 1.22-1.33; P < 0.0001) or accumulators (OR = 1.31, 95% CI = 1.26-1.36; P < 0.0001), compared with White patients. CONCLUSIONS: In an adjusted analysis of this selected sample of a commercially insured population, there was no difference in the use of copay cards between non-White and White patients. CAP exposure, however, was significantly higher among non-White patients. This increased exposure suggests a disproportionate effect due to this reduction in copay assistance benefits, which has the potential to exacerbate racial and ethnic disparities in access to medications. DISCLOSURES: This study was sponsored by Janssen Scientific Affairs, LLC. Mr Ingham, Dr Sadik, and Dr Song are employees of Janssen Scientific Affairs, LLC. Dr Zhao is an employee of IQVIA. Dr Fendrick is a consultant for AbbVie, Amgen, Bayer, CareFirst BlueCross BlueShield, Centivo, Community Oncology Association, Covered California, EmblemHealth, Exact Sciences, Freedman Health, GRAIL, Harvard University, Health & Wellness Innovations, Health at Scale Technologies, HealthCorum, Hygeia, MedsIncontext, MedZed, Merck, Mercer, Montana Health Cooperative, Pair Team, Penguin Pay, Phathom Pharmaceuticals, Proton Intelligence, Risalto Health, Risk International, Sempre Health, Silver Fern Health, State of Minnesota, Teladoc Health, US Department of Defense, Virginia Center for Health Innovation, Wellth, Wildflower Health, Yale New Haven Health System, and Zansors; received research funds from Agency for Healthcare Research and Quality (AHRQ), Boehringer-Ingelheim, Gary and Mary West Health Policy Center, Arnold Ventures, National Pharmaceutical Council, Patient-Centered Outcomes Research Institute (PCORI), Pharmaceutical Research and Manufacturers of America (PhRMA), Robert Wood Johnson (RWJ) Foundation, State of Michigan/The Centers for Medicare & Medicaid Services (CMS); and has an outside position at the American Journal of Managed Care (AJMC; co-editor), Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) member, VBID Health (partner).

Treatment patterns, glycemic control and bodyweight with canagliflozin 300 mg versus GLP1RAs in Type II diabetes patients.

Aim: Real-world effectiveness of canagliflozin 300 mg versus glucagon-like peptide-1 receptor agonists (GLP1RAs) was examined in patients with Type II diabetes. Patients & methods: Patients were selected from the Optum integrated database of administrative claims and electronic health record data (1 January 2013 to 31 March 2015). Results: Patients were less likely to discontinue (p < 0.0001) or switch (p = 0.0048), more likely to add-on treatment (p = 0.0314), and achieve HbA1c <8.0% (p = 0.0364) or weight loss ≥5% (p < 0.0001) with canagliflozin versus GLP1RAs over 9 months. Mean HbA1c was similar at 3-month intervals over 9 months with canagliflozin and GLP1RAs. Conclusion: Patients were less likely to discontinue or switch with canagliflozin than GLP1RA, and were more likely to add-on. Canagliflozin patients were more likely to achieve HbA1c <8.0% and weight loss ≥5% than GLP1RA patients.

An investigation into the durability of glycemic control in patients with type II diabetes initiated on canagliflozin or sitagliptin: A real-world analysis of electronic medical records.

AIMS: The aims of this study were to assess glycemic control, weight loss, and durability of glycemic control in patients initiated on canagliflozin (CANA) versus sitagliptin (SITA). METHODS: Adults with type II diabetes mellitus initiated on CANA or SITA (index date) were identified from IQVIA™ Real-World Data Electronic Medical Records - US database (03/29/2012-04/30/2016). Inverse probability of treatment weighting accounted for baseline differences between cohorts. Outcomes were compared using weighted Cox regression and Kaplan-Meier curves and included time to reaching HbA1c thresholds (<7%[53 mmol/mol], <8%[64 mmol/mol], <9%[75 mmol/mol]), weight loss ≥5%, failure to maintain HbA1c below threshold, new antihyperglycemic (AHA) prescription, and failure to maintain HbA1c/new AHA prescription. RESULTS: Weighted cohorts were well balanced (NCANA = 14,542; NSITA = 15,151). CANA patients were 12-15% more likely to reach the HbA1c thresholds, 47% more likely to lose ≥5% of body weight, 31% less likely to have a new AHA prescription, 10-15% less likely to fail to maintain HbA1c, and 13-26% less likely to fail to maintain HbA1c or have a new AHA, versus SITA patients. CONCLUSIONS: CANA patients were more likely to reach HbA1c and weight loss thresholds and maintain HbA1c below threshold versus SITA patients, while being less likely to have a prescription for a new AHA, suggesting more durable glycemic control with CANA.

HBA1C CONTROL AND COST-EFFECTIVENESS IN PATIENTS WITH TYPE 2 DIABETES MELLITUS INITIATED ON CANAGLIFLOZIN OR A GLUCAGON-LIKE PEPTIDE 1 RECEPTOR AGONIST IN A REAL-WORLD SETTING.

OBJECTIVE: To compare glycated hemoglobin (HbA1c) control and medication costs between patients with type 2 diabetes mellitus (T2DM) treated with canagliflozin 300 mg (CANA) or a glucagon-like peptide 1 receptor agonist (GLP-1 RA) in a real-world setting. METHODS: Adults with T2DM newly initiated on CANA or a GLP-1 RA (index date) were identified from IQVIA™ Real-World Data Electronic Medical Records U.S. database (March 29, 2012-April 30, 2016). Inverse probability of treatment weighting accounted for differences in baseline characteristics. HbA1c levels at 3-month intervals were compared using generalized estimating equations. Medication costs used wholesale acquisition costs. RESULTS: For both cohorts (CANA: n = 11,435; GLP-1 RA: n = 11,582), HbA1c levels decreased at 3 months postindex and remained lower through 30 months. Absolute changes in mean HbA1c from index to 3 months postindex for CANA and GLP-1 RA were -1.16% and -1.21% (patients with baseline HbA1c ≥7% [53 mmol/mol]); -1.54% and -1.51% (patients with baseline HbA1c ≥8% [64 mmol/mol]); and -2.13% and -1.99% (patients with baseline HbA1c ≥9% [75 mmol/mol]), respectively. Postindex, CANA patients with baseline HbA1c ≥7% had similar HbA1c levels at each interval versus GLP-1 RA patients, except 9 months (mean HbA1c, 7.75% [61 mmol/mol] vs. 7.86% [62 mmol/mol]; P = .0305). CANA patients with baseline HbA1c ≥8% and ≥9% had consistently lower HbA1c numerically versus GLP-1 RA patients and statistically lower HbA1c at 9 (baseline HbA1c ≥8% or ≥9%), 27, and 30 months (baseline HbA1c ≥9%). Continuous 12-month medication cost $3,326 less for CANA versus GLP-1 RA. CONCLUSION: This retrospective study demonstrated a similar evolution of HbA1c levels among CANA and GLP-1 RA patients in a real-world setting. Lower medication costs suggest CANA is economically dominant over GLP-1 RA (similar effectiveness, lower cost). ABBREVIATIONS: AHA = antihyperglycemic agent BMI = body mass index CANA = canagliflozin 300 mg DCSI = diabetes complications severity index eGFR = estimated glomerular filtration rate EMR = electronic medical record GLP-1 RA = glucagon-like peptide 1 receptor agonist HbA1c = glycated hemoglobin ICD-9-CM = International Classification of Diseases-Ninth Revision-Clinical Modification ICD-10-CM = International Classification of Diseases-Tenth Revision-Clinical Modification IPTW = inverse probability of treatment weighting ITT = intent-to-treat MPR = medication possession ratio PDC = proportion of days covered PS = propensity score PSM = propensity score matching Quan-CCI = Quan-Charlson comorbidity index SGLT2 = sodium-glucose cotransporter 2 T2DM = type 2 diabetes mellitus WAC = wholesale acquisition cost.

Quality goal attainment and maintenance in patients with type II diabetes mellitus initiated on canagliflozin or a glucagon-like peptide-1 receptor agonist in an actual practice setting.

OBJECTIVE: To compare achievement of quality goals (HbA1c, weight loss/body mass index [BMI], systolic blood pressure [SBP]), including maintaining HbA1c, between patients with type 2 diabetes mellitus (T2DM) treated with canagliflozin 300 mg (CANA) or a GLP-1 in an actual practice setting. METHODS: Adults with T2DM newly initiated on CANA or a GLP-1 were identified from the IQVIATM Real-World Data Electronic Medical Records-US database (2012Q2-2016Q1). To account for differences in baseline characteristics, inverse probability of treatment weighting was used. Outcomes were compared using Cox models (hazard ratios [HRs] and 95% confidence intervals [CIs]) and Kaplan-Meier analyses. RESULTS: CANA (n = 11,435) and GLP-1 (n = 11,582) cohorts had similar attainment of HbA1c < 8.0% (64 mmol/mol) and HbA1c < 9.0% (75 mmol/mol; HbA1c < 8.0%: HR [CI] = 0.98 [0.91-1.06]; HbA1c < 9.0%: HR [CI] = 1.02 [0.93-1.12]), while GLP-1 patients were 10% more likely to achieve HbA1c < 7.0% (53 mmol/mol). CANA and GLP-1 patients were similar in maintaining HbA1c < 7.0%, < 8.0%, or <9.0%, achieving weight loss ≥5% (HR [CI] = 1.05 [0.99-1.12]), achieving BMI <30 kg/m2 (HR [CI] = 1.11 [0.98-1.27]), and achieving SBP <140 mmHg (HR [CI] = 1.07 [0.98-1.17]). CANA patients were 30% less likely to discontinue treatment, 28% less likely to have a prescription for a new anti-hyperglycemic, and 17-21% less likely to fail to maintain HbA1c < 8.0% or 9.0% or have a prescription for a new anti-hyperglycemic (composite outcome) vs GLP-1. No significant difference was observed for the composite outcome using the HbA1c < 7.0% threshold. CONCLUSIONS: This retrospective study in an actual practice setting showed that CANA patients were generally as likely as GLP-1 patients to achieve HbA1c, weight, and blood pressure thresholds, and to maintain glycemic control while being less likely to discontinue treatment and/or have a new anti-hyperglycemic prescribed.

Quality measure and weight loss assessment in patients with type 2 diabetes mellitus treated with canagliflozin or dipeptidyl peptidase-4 inhibitors.

BACKGROUND: Achieving control of glycated hemoglobin (HbA1c), blood pressure (BP), and body weight (BW) remains a challenge for most patients with type 2 diabetes mellitus (T2DM). In clinical trials, canagliflozin (CANA), an inhibitor of sodium-glucose co-transporter 2, has shown significant improvement compared to some dipeptidyl peptidase-4 (DPP-4) inhibitors in the achievement of such quality measures. This study used recent electronic medical records (EMR) data to assess quality measure achievement of HbA1C, BP, and BW loss in patients treated with CANA versus DPP-4 inhibitors. METHODS: Adult patients with ≥1 T2DM diagnosis and ≥12 months of clinical activity (baseline) before first CANA or DPP-4 prescription (index) were identified in the QuintilesIMS Health Real-World Data EMRs-US database (03/29/2012-10/30/2015). Patients were observed from the index to last encounter. Inverse probability of treatment weighting (IPTW) was used to adjust for observed baseline confounders between groups. Kaplan-Meier (KM) rates and Cox proportional hazard models were used to compare achievement of HbA1c < 7% (among patients <65 years old), HbA1c < 8%, systolic BP < 140 mmHg, diastolic BP < 90 mmHg, and BW loss ≥ 5% among patients not meeting these respective targets at baseline. RESULTS: A total of 10,702 CANA and 17,679 DPP-4 patients were selected. IPTW resulted in balanced baseline demographic, comorbidity, and disease characteristics (CANA: N = 13,793, mean age: 59.0 years; DPP-4: N = 14,588, mean age: 58.9 years). Up until 24 months post-index, CANA patients were more likely to reach an HbA1c < 7% (hazard ratio [HR] = 1.10, P = 0.007, KM rates: 42.8% vs. 40.3%), an HbA1c < 8% (HR = 1.16, P < 0.001, KM rates: 63.7% vs. 60.0%), and a BW loss ≥ 5% (HR = 1.46, P < 0.001, KM rates: 55.2% vs. 46.2%), compared to DPP-4 patients. Up until 12 months post-index, CANA patients were more likely to reach a systolic BP < 140 mmHg (HR = 1.07, P = 0.04, KM rates: 87.8% vs. 83.9%). but not a diastolic BP < 90 mmHg (HR = 0.95, P = 0.361), compared to DPP-4 patients. CONCLUSIONS: This retrospective study of EMR data covering up to 30 months after CANA approval (March 2013) suggests that patients initiated on CANA were more likely to reach HbA1c, systolic BP, and weight loss objectives specified by general diabetes care guidelines than patients initiated on DPP-4 inhibitors.

Shared decision-making for biologic treatment of autoimmune disease: influence on adherence, persistence, satisfaction, and health care costs.

BACKGROUND: Shared decision-making (SDM), a process whereby physicians and patients collaborate to select interventions, is not well understood for biologic treatment of autoimmune conditions. METHODS: This was a cross-sectional survey of adults initiating treatment for Crohn's disease or ulcerative colitis (inflammatory bowel disease, IBD) or psoriatic arthritis or rheumatoid arthritis (RA/PA). Survey data were linked to administrative claims for 6 months before (baseline) and after (follow-up) therapy initiation. Measures included the Shared Decision Making Questionnaire, Patient Activation Measure (PAM), Morisky Medication Adherence Scale (MMAS), general health, and treatment satisfaction. Claims-based Quan-Charlson comorbidity scores, persistence, medication possession ratio (MPR), and health care costs were examined. Patients were compared by participation (SDM) and nonparticipation (non-SDM) in SDM. RESULTS: Among 453 respondents, 357 were eligible, and 306 patients (204 RA/PA and 102 IBD) were included in all analyses. Overall (n=357), SDM participants (n=120) were more often females (75.0% vs 62.5%, P=0.018), had lower health status (48.0 vs 55.4, P=0.005), and higher Quan-Charlson scores (1.0 vs 0.7, P=0.035) than non-SDM (n=237) participants. Lower MMAS scores (SDM 0.17 vs non-SDM 0.41; P<0.05) indicated greater likelihood of adherence; SDM participants also reported higher satisfaction with medication and had greater activation (PAM: SDM vs non-SDM: 66.9 vs 61.6; P<0.001). Mean MPR did not differ, but persistence was longer among SDM participants (111.2 days vs 102.2 days for non-SDM; P=0.029). Costs did not differ by SDM status overall, or among patients with RA/PA. The patients with IBD, however, experienced lower (P=0.003) total costs ($9,404 for SDM vs $25,071 for non-SDM) during follow-up. CONCLUSION: This study showed greater likelihood of adherence and satisfaction for patients who engaged in SDM and reduced health care costs among patients with IBD who engaged in SDM. This study provides a basis for defining SDM participation and detecting differences by SDM participation for biologic treatment selection for autoimmune conditions.

Retrospective Study on the Impact of Adherence in Achieving Glycemic Goals in Type 2 Diabetes Mellitus Patients Receiving Canagliflozin.

INTRODUCTION: Adherence is poor among patients taking antihyperglycemic agents (AHAs) for type 2 diabetes mellitus (T2DM). Inadequate adherence has been linked to decreased glycemic control and increased healthcare costs and hospitalizations. We examined the impact of real-world adherence on glycemic control in T2DM patients treated with canagliflozin. METHODS: This retrospective study used US administrative claims data from commercial and Medicare Advantage healthcare enrollees. Study subjects were adult T2DM patients with baseline HbA1c ≥7.0% and a pharmacy claim for canagliflozin between April 01, 2013 and August 31, 2014. Outcomes included treatment patterns, HbA1c reductions and goal attainment, pharmacy costs, and patient characteristics. Adherence, measured by the proportion of days covered (PDC), was calculated as the number of days of canagliflozin availability divided by the length of the follow-up period. Results were analyzed overall and compared between patients who were highly adherent (HA) (PDC ≥0.8) versus less than highly adherent (LHA) (PDC <0.8). RESULTS: The study population included 2261 patients. At the end of follow-up, patients had an overall mean reduction in HbA1c of 0.97%. Those HA had larger reductions in HbA1c than those LHA (1.17% versus 0.73%, respectively, p < 0.001); 24.6% and 59.4% of patients achieved HbA1c goals of <7.0% and <8.0%, respectively. Highly adherent patients were more likely to achieve goals than those LHA. Less than highly adherent patients increased insulin use by 5.4% in the follow-up period, while HA patients decreased the use of most oral AHAs and had no change in insulin use. CONCLUSIONS: Patients had an HbA1c reduction of 0.97% in the 12 months following the first canagliflozin fill. Highly adherent patients achieved a greater reduction in HbA1c at the end of the follow-up period and were more likely to reach HbA1c goals. Highly adherent patients also had reductions in the use of most oral AHAs, while LHA patients saw a small increase in insulin use.

Effectiveness of step therapy policies for specialty pharmaceuticals in immune disorders.

OBJECTIVE: To assess the effectiveness of managed care plans that limited access to infusion biologics via a step therapy policy. STUDY DESIGN: This was a retrospective cohort study using Symphony Health Solutions claims databases that included payer, prescription (Rx), diagnosis (Dx) and procedure (Px) information with unique anonymized patient identifiers. METHODS: The percentage of patients with claims for infusion and subcutaneous (SQ) biologics were evaluated across three increasingly restrictive cohorts: (1) patients in step therapy plans versus all others in the database (population), (2) patients in step therapy plans versus patients that were members of plans that were roughly matched (matched) and (3) a subsample of patients that were members of step therapy plans that had sufficient data for a pre/post analysis (pre/post). RESULTS: The population analysis comparison showed 5.1% fewer patients (p < 0.0001) with claims for infusion biologics among step therapy plans than among the overall plans. The more controlled matched and pre/post analyses showed a greater percentage of patients with claims for intravenous products in the plans with step therapy policies versus plans without step therapy policies, differences of +7.0% (p < 0.0001) and +2.8% (p = 0.0522), respectively. CONCLUSIONS: Policies designed to limit utilization of infusion biologics showed equivocal results. In the near term, the intended effects of implementing step therapy policies may be limited by relatively small numbers of patients that are affected relative to the total number of users.

The cost-effectiveness of atypicals in the UK.

BACKGROUND: In 2002, the National Institute for Health and Clinical Excellence (NICE), recommended atypical antipsychotics over conventional ones for first-line schizophrenia treatment, based on their lower risk of extrapyramidal symptoms. OBJECTIVE: To estimate the incremental cost-effectiveness of atypical relative to conventional antipsychotics for the treatment of schizophrenia in the UK. METHODS: A discrete event simulation (DES) model was adopted to reflect the treatment of schizophrenia in the UK. The model estimates symptoms (using the Positive and Negative Symptom Score [PANSS]), psychiatrist visits, pharmacological treatment and treatment location, number and duration of psychotic relapses, level of compliance, quality-adjusted life-years (QALYs), and side effects over a 5-year time period. Probabilistic sensitivity analyses were carried out. Following NICE's "atypical" recommendation, the cost-effectiveness of atypical versus conventional antipsychotics was estimated in a scenario analysis, assuming both groups differ only in side-effect profile. RESULTS: When comparing conventional and atypical antipsychotics, the model predicts that the latter would decrease 5-year costs by 1633 Pound per patient and result in a QALY gain of 0.101. The probabilistic sensitivity analysis suggests these results are robust. The sensitivity analyses indicate that incremental costs and effects are most sensitive to the differential efficacy of atypicals and conventionals, as measured by PANSS. When it is assumed that the only differences between atypicals and conventionals are found in side-effect profiles, the incremental cost-effectiveness ratio of the atypicals is 45,000 Pound per QALY gained. CONCLUSION: According to this DES model for schizophrenia, atypical antipsychotics are cost-effective compared to the conventional antipsychotics. The assumptions used in the model need further validation through large naturalistic based studies with reasonable follow-up to determine the real-life differences between atypicals and conventional antipsychotics.