Days Of Supply Research Articles

Impact of the COVID-19 Controlled Drugs and Substances Act exemption on pharmacist prescribing of opioids, benzodiazepines and stimulants in Ontario: A cross-sectional time-series analysis.

Due to the coronavirus disease 2019 (COVID-19) pandemic, Health Canada issued an exemption to the Controlled Drugs and Substances Act (CDSA) on March 19, 2020, enabling pharmacists to act as prescribers of controlled substances to support continuity of care. Our study investigates utilization of the CDSA exemption by Ontario pharmacists with the intent to inform policy on pharmacist scope of practice and to improve future patient outcomes. We conducted a time-series analysis of pharmacist-prescribed opioid, benzodiazepine and stimulant claims data using Ontario Narcotics Monitoring System (NMS) data between January 2019 and December 2021. We used ARIMA modelling to measure the change to these classes of claims and to opioid claims containing quantities greater than a 30-day supply. Postexemption, the average weekly number of pharmacist-prescribed opioid, benzodiazepine and stimulant claims rose by 146% (160 to 393 claims/week), 960% (49 to 515 claims/week) and 2150% (8 to 177 claims/week), respectively. There was a 2-week lag period between the time of announcement and the statistically significant increase in claims on April 5, 2020(p < 0.0001). The total number of claims for opioid quantities exceeding a 30-day supply decreased by 60%. Cumulative pharmacist-prescribed claims accounted for under 2% of the total NMS claims. Ontario pharmacists used the CDSA exemption but were prescribing at low rates. These findings suggest an effective change to pharmacy practice as the low rates show pharmacists used the exemption as a last line of defense. This may lead to further studies exploring treatment breaks during the COVID-19 pandemic and future changes to pharmacist scope to benefit patients.

CLL-492 Real-World Adherence to First-Line Ibrutinib and Acalabrutinib Single-Agent Among Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Treatment guidelines recommend Bruton's tyrosine kinase inhibitors (BTKi) ibrutinib (once-daily) and acalabrutinib (twice-daily) as preferred regimens for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). However, data are limited for adherence, which has been demonstrated as being higher in chronic diseases for once-daily versus twice-daily regimens and thus may inform treatment effectiveness. To compare refill adherence between CLL/SLL patients treated with first-line (1L) ibrutinib or acalabrutinib single-agent. Specialty pharmacy electronic medical records from academic integrated care networks (01/01/2017-11/30/2020) were used. Adult CLL/SLL patients with ≥12 months of data availability without antineoplastic agent use before ibrutinib or acalabrutinib single-agent initiation (index date) were included. Adherence was measured by the proportion of days covered (PDC) and medication possession ratio (MPR) during fixed periods of time during the ibrutinib/acalabrutinib line of therapy (LOT), which lasted until the earliest of second-line treatment initiation, death, or end of data. PDC and MPR were calculated as the sum of days of supply (DOS) divided by the duration of the period of interest; PDC calculations shifted forward prescriptions with overlapping DOS; MPR counted all DOS. The proportion of adherent patients (PDC/MPR ≥80%) was compared between ibrutinib versus acalabrutinib using logistic regression models adjusted for baseline characteristics. Among 288 and 80 patients treated with ibrutinib and acalabrutinib, mean age was 70.9 and 73.2 years, 35.8% and 45.0% were female, and mean LOT duration was 19.3 and 10.1 months, respectively. At all time points (first 3, 6, 9, and 12 months of the LOT), patients treated with ibrutinib were more likely to be adherent based on the proportion of patients with PDC/MPR ≥80% (odds ratio [OR] ranges=1.58-2.17 and 1.64-2.37); while results did not reach statistical significance at 3 and 12 months, they did at 6 months (PDC: 76.4% [ibrutinib] versus 60.0% [acalabrutinib], OR [95%CI]=2.17 [1.12-4.21]; MPR: 76.8% versus 60.0%, OR=2.20 [1.13-4.28]) and 9 months (PDC: 66.5% versus 46.3%, OR =2.05 [1.02-4.12]; MPR: 69.2% versus 46.3%, OR=2.37 [1.18-4.77]). CLL/SLL patients initiating 1L ibrutinib single-agent had higher adherence than those initiating 1L acalabrutinib single-agent. Characterization of BTKi adherence rates may inform treatment effectiveness in the real-world.

Clinical and economic impact of long-acting injectable antipsychotics in patients previously treated with short-acting oral antipsychotics.

BACKGROUND: Available literature supports the use of long-acting injectable (LAI) antipsychotics over short-acting oral (SAO) formulations. The majority of evidence is centered on patients with schizophrenia insured under the Medicaid benefit. OBJECTIVE: To assess real-world clinical and economic outcomes of LAI compared with SAO antipsychotics in patients with psychiatric conditions insured under commercial, health care exchange, or Medicare plans. METHODS: In this exploratory treatmenteffectiveness study, a retrospective, before and after study design was used to evaluate differences in clinical and economic outcomes in patients switching from SAO to LAI antipsychotics. Patients who had at least 1 claim for an LAI antipsychotic and a psychiatric diagnosis were considered eligible for the study if they were continuously enrolled in a commercial, health care exchange, or Medicare plan for 12 months before (preperiod) and 12 months after (postperiod) their first LAI antipsychotic claim. During the preperiod, patients were required to have filled at least a 30-day supply of any SAO antipsychotic medication. Clinical outcomes included health care resource utilization (eg, hospitalizations per member per year [PMPY]), adherence measures, and medication switch trends. Economic outcomes included total per member per month (PMPM) spending across the medical benefit alone, the pharmacy benefit alone, and the combined spending across both benefits. Additionally, we examined patient costs and health plan spending within each of these categories. RESULTS: There was a significant decrease in overall hospitalizations PMPY (1.80 vs 0.88; P < 0.001) and psychiatric hospitalizations PMPY (0.65 vs 0.20; P <0.001) when comparing patients treated with SAO antipsychotics in the preperiod to the same patients treated with LAI antipsychotics in the postperiod, respectively. No differences were observed in the percentage of days covered with SAO and LAI agents (87.4% vs 85.8%; P=0.312). More patients switched between SAO antipsychotics during the preperiod, as compared with the number who switched between LAI antipsychotics during the postperiod (57.4% vs 10.3%; P < 0.001). On average, patients switched medications sooner in the preperiod vs the postperiod (114.50 vs 211.26 days; P < 0.001). No difference was observed between the preperiod and postperiod in total spending PMPM ($3,798.76 vs $3,702.63; P = 0.826) CONCLUSIONS: Patients switching from SAO to LAI antipsychotics experienced fewer hospitalizations, with no change in overall spending. Adherence was similar, though fewer medication switches occurred and there was a longer time before switching medications with LAI compared with SAO antipsychotics DISCLOSURES: Funding for this study was provided by Highmark Inc., but the sponsor had no role in the study outside the final review of the submitted manuscript.

Effects of Real-time Prescription Benefit Recommendations on Patient Out-of-Pocket Costs

Rising drug costs contribute to medication nonadherence and adverse health outcomes. Real-time prescription benefit (RTPB) systems present prescribers with patient-specific out-of-pocket cost estimates and recommend lower-cost, clinically appropriate alternatives at the point of prescribing. To investigate whether RTPB recommendations lead to reduced patient out-of-pocket costs for medications. In this cluster randomized trial, medical practices in a large, urban academic health system were randomly assigned to RTPB recommendations from January 13 to July 31, 2021. Participants were adult patients receiving outpatient prescriptions during the study period. The analysis was limited to prescriptions for which RTPB could recommend an available alternative. Electronic health record data were used to analyze the intervention's effects on prescribing. Data analyses were performed from August 20, 2021, to June 8, 2022. When a prescription was initiated in the electronic health record, the RTPB system recommended available lower-cost, clinically appropriate alternatives for a different medication, length of prescription, and/or choice of pharmacy. The prescriber could select either the initiated order or one of the recommended options. Patient out-of-pocket cost for a prescription. Secondary outcomes were whether a mail-order prescription and a 90-day supply were ordered. Of 867 757 outpatient prescriptions at randomized practices, 36 419 (4.2%) met the inclusion criteria of having an available alternative. Out-of-pocket costs were $39.90 for a 30-day supply in the intervention group and $67.80 for a 30-day supply in the control group. The intervention led to an adjusted 11.2%; (95% CI, -15.7% to -6.4%) reduction in out-of-pocket costs. Mail-order pharmacy use was 9.6% and 7.6% in the intervention and control groups, respectively (adjusted 1.9 percentage point increase; 95% CI, 0.9 to 3.0). Rates of 90-day supply were not different. In high-cost drug classes, the intervention reduced out-of-pocket costs by 38.9%; 95% CI, -47.6% to -28.7%. This cluster randomized clinical trial showed that RTPB recommendations led to lower patient out-of-pocket costs, with the largest savings occurring for high-cost medications. However, RTPB recommendations were made for only a small percentage of prescriptions. ClinicalTrials.gov Identifier: NCT04940988; American Economic Association Registry: AEARCTR-0006909.

Overspending driven by dose-specific packaging of Lenvatinib for endometrial cancer (018)

Objectives: The current packaging for a 30-day supply of lenvatinib is based on daily dose and requires that new 30-day packs be dispensed for most dose reductions. We sought to quantify the expected annual overspending due to current packaging associated with lenvatinib dose reductions in patients with advanced or recurrent microsatellite stable/mismatch repair proficient (MSS/pMMR) endometrial cancer in the United States. Methods: Based on the KEYNOTE-775/Study 209 randomized controlled trial, which led to FDA approval of lenvatinib/pembrolizumab for patients with recurrent MSS endometrial cancer after platinum therapy, we constructed a decision model in TreeAge Pro Healthcare 2020 to estimate the annual overspending due to dose reductions during a treatment period of six months. We assumed a starting daily dose of 20mg, with patients requiring dose reductions based on the KEYNOTE-775/Study 309. All dose reductions required a new dose pack, except a dose reduction from 18mg to 14mg. We estimated the cost of six months of treatment if alternative packaging or a no-cost pill exchange program were offered. Overspending was calculated as the difference between the two 6-month estimates. An alternative scenario assuming a starting dose of 18mg or 14mg was also modeled based on clinical relevance. Model parameters are detailed in Table 1. Results: The cost of a 30-day dose pack of lenvatinib is $23,624.40 per patient, irrespective of the daily dose. Based on our assumptions, approximately 7,985 endometrial cancer patients annually in the US will be eligible to receive lenvatinib. Assuming a 20mg starting dose and accounting for expected dose reductions, the 6-month cost of lenvatinib for this population is estimated to be $1,312,760,659. If a starter pack or a no-cost pill exchange were offered, the 6-month cost of lenvatinib for this population would be $1,131,845,004. Overspending due to the current dose packaging is estimated to be $180,915,655. An alternative scenario assuming an 18mg or 14mg starting dose would reduce the estimated overspending to $46,941,682. Objectives: The current packaging for a 30-day supply of lenvatinib is based on daily dose and requires that new 30-day packs be dispensed for most dose reductions. We sought to quantify the expected annual overspending due to current packaging associated with lenvatinib dose reductions in patients with advanced or recurrent microsatellite stable/mismatch repair proficient (MSS/pMMR) endometrial cancer in the United States. Methods: Based on the KEYNOTE-775/Study 209 randomized controlled trial, which led to FDA approval of lenvatinib/pembrolizumab for patients with recurrent MSS endometrial cancer after platinum therapy, we constructed a decision model in TreeAge Pro Healthcare 2020 to estimate the annual overspending due to dose reductions during a treatment period of six months. We assumed a starting daily dose of 20mg, with patients requiring dose reductions based on the KEYNOTE-775/Study 309. All dose reductions required a new dose pack, except a dose reduction from 18mg to 14mg. We estimated the cost of six months of treatment if alternative packaging or a no-cost pill exchange program were offered. Overspending was calculated as the difference between the two 6-month estimates. An alternative scenario assuming a starting dose of 18mg or 14mg was also modeled based on clinical relevance. Model parameters are detailed in Table 1. Results: The cost of a 30-day dose pack of lenvatinib is $23,624.40 per patient, irrespective of the daily dose. Based on our assumptions, approximately 7,985 endometrial cancer patients annually in the US will be eligible to receive lenvatinib. Assuming a 20mg starting dose and accounting for expected dose reductions, the 6-month cost of lenvatinib for this population is estimated to be $1,312,760,659. If a starter pack or a no-cost pill exchange were offered, the 6-month cost of lenvatinib for this population would be $1,131,845,004. Overspending due to the current dose packaging is estimated to be $180,915,655. An alternative scenario assuming an 18mg or 14mg starting dose would reduce the estimated overspending to $46,941,682.

Institutional Trends in Opioid Prescribing and Utilization after Primary Cleft Lip and Palate Repair.

Outpatient prescriptions for postoperative pain play an important role in the opioid epidemic. Prescribing guidelines are an effective target for intervention but require procedure-specific data to be successful. The aim of this study was to examine opioid prescribing patterns and pain control after primary cleft lip and palate repair at a large academic center. Children undergoing cleft lip and palate repair from April of 2018 to July of 2019 were included in a prospective cohort study. Data on discharge prescriptions, refills, and emergency room visits were obtained from the medical record. Caregivers were surveyed 7 to 21 days after surgery regarding pain control, opioid use, education exposure, storage, and disposal. Chi-square tests and one-way analysis of variance were used to examine predictors of pain control, opioid consumption, safe storage, and disposal. After screening, 59 children were included in the study. Patients were 55.8 percent male with a median age of 12 months (interquartile range, 5 to 15). Ninety percent of patients received an opioid prescription at discharge with a mean quantity of 10 doses (interquartile range, 5 to 15). Ninety-seven percent of caregivers used adjunct medication. Opioids were given for a median of 3 days (interquartile range, 2 to 6.5). Seventy-six percent of caregivers gave less opioid than prescribed. There was no association between pain control and opioid quantity ( p = 0.68). Twenty-four percent of caregivers used locked storage. Thirty-four percent of respondents with leftover medication reported disposal. Opioids are often overprescribed after cleft lip and palate repair. Providers should consider limiting prescriptions to a 3-day supply to help reduce the quantity of opioids available in the community.

Improving equity and access to buprenorphine treatment through telemedicine at syringe services programs

Background and aimsIn the United States, access to buprenorphine remains low and disparities regarding who receives treatment have emerged. Federal laws have regulated buprenorphine delivery, ultimately limiting its implementation more broadly. At the onset of the COVID-19 pandemic, federal agencies acted quickly to remove a legal barrier, effectively allowing people with opioid used disorder (OUD) to initiate buprenorphine treatment via telemedicine. Leveraging this policy shift, a low barrier buprenorphine treatment initiative via telemedicine was started at syringe service programs in California. We assessed early findings from participants reached by this model of treatment.MethodsIn May 2020, buprenorphine treatment was offered through a virtual platform to SSP participants in California. SSP staff connected interested participants to virtual appointments with medical providers in a private location. During these visits, clinicians conducted clinical assessments for diagnosing participants with OUD and developed an unsupervised home induction plan for individuals who were eligible. Participants were prescribed a 7-day supply of up to 16 mg daily buprenorphine or 16 mg buprenorphine-2 mg naloxone and asked to return the following week if interested in continuing treatment.ResultsFrom May 2020 to March 2021, the SSP-buprenorphine virtual care initiative inducted 115 participants onto treatment with 87% of participants inducted on the same day as their referral. Of those inducted, 58% were between the ages of 30 and 49 and 28% were cisgender female. Regarding participants’ method of payment to reimburse buprenorphine costs, 92% of participants were covered by Medicare/Medicaid. Overall, 64% of participants returned for a second buprenorphine prescription refill.ConclusionsThese early findings suggest that this could be a promising approach to improve equity and access to buprenorphine treatment. We encourage policymakers to continue allowing buprenorphine delivery via telemedicine and researchers to study whether this approach improves equity and access to treatment throughout the United States.

Medicare Part D Coverage Restrictions and Patient Cost-Sharing for Opioids Commonly Used for Cancer Pain, 2015-2021.

Nation-wide rapid declines in prescription opioid dispensing gave rise to concerns regarding restricted access to effective pain management for patients with cancer-related pain. One important mechanism for such restrictions could be through more restrictive insurance coverage for opioids. This study aims to assess recent changes in Medicare Part D formulary designs for opioids commonly used for cancer-related pain. We used data from the 2015-2021 Medicare Prescription Drug Plan (PDP) Formulary Files to assess formulary changes for six opioid-dose combinations commonly used for cancer-related pain. We estimated % of PDPs adopting prior authorization, quantity limits (and limits adopted), and a higher cost-sharing tier for each opioid-dose combination. We further estimated median and mean out-of-pocket (OOP) costs across all PDPs for a 30-day supply of the drug. Trends in proportions were tested using the Cochrane-Armitage test; trends in continuous measures were tested using the Jonckheere-Terpstra test. Proportion of PDPs adopting prior authorization increased from close to 0% to about 50% for two long-acting opioids (P < .001). Distribution of quantity limits across PDPs shifted over time to being more restrictive for all opioids considered (P < .001). For four of the six opioids, the proportion of PDPs adopting tier 3 or above increased from below or about 50% to well over 70% (P < .001). For the same four opioids, median OOP costs doubled to quadrupled (P < .001). Medicare PDP coverage has become increasingly restrictive for opioids commonly used for cancer-related pain, with multifold increases in patient OOP costs over the past 7 years. These changes pose concerns for patients with cancer needing opioid therapies for pain control and call for strategies to effectively exempt cancer-related pain from insurance and pharmacy rules intended to apply to opioids for noncancer chronic pain.

Acceptability and feasibility of leveraging community-based HIV counselling and testing platforms for same-day oral PrEP initiation among adolescent girls and young women in Eastern Cape, South Africa.

IntroductionCommunity‐based delivery of HIV pre‐exposure prophylaxis (PrEP) to South African adolescent girls and young women's (AGYW) could increase access but needs evaluation. We integrated PrEP services via home‐based services and pop‐up tents into existing community‐based HIV testing services (CB‐HTS) in Eastern Cape Province, South Africa.MethodsAfter accessing CB‐HTS via a “pop‐up” tent or home‐based services, HIV‐negative AGYW aged 16–25 years were invited to complete a baseline questionnaire and referred for PrEP services at a community‐based PrEP site co‐located with pop‐up HTS tents. A 30‐day supply of PrEP was dispensed. PrEP uptake, time‐to‐initiation, cohort characteristics and first medication refill within 90 days were measured using descriptive statistics.ResultsOf the 1164 AGYW who tested for HIV, 825 (74.3%) completed a questionnaire and 806 (97.7%) were referred for community‐based PrEP. Of those, 624 (77.4%) presented for PrEP (482/483 [99.8%] from pop‐up HTS and 142/323 [44.0%] from home‐based HTS), of which 603 (96.6%) initiated PrEP. Of those initiating PrEP following home‐based HTS, 59.1% initiated within 0–3 days, 25.6% within 4–14 days and 15.3% took ≥15 days to initiate; 100% of AGYW who used pop‐up HTS initiated PrEP the same day. Among AGWY initiating PrEP, 37.5% had a detectable sexually transmitted infection (STI). Although AGYW reported a low self‐perception of HIV risk, post‐hoc application of HIV risk assessment measures to available data classified most study participants as high risk for HIV acquisition. Cumulatively, 329 (54.6%) AGYW presented for a first medication refill within 90 days of accepting their first bottle of PrEP.ConclusionsLeveraging CB‐HTS platforms to provide same‐day PrEP initiation and refill services was acceptable to AGYW. A higher proportion of AGYW initiated PrEP when co‐located with CB‐HTS sites compared to those referred following home‐based HTS, suggesting that proximity of CB‐HTS and PrEP services facilitates PrEP uptake among AGYW. The high prevalence of STIs among those initiating PrEP necessitates the integration of STI and HIV prevention programs for AGYW. Eligibility for PrEP initiation should not be required among AHYW in high HIV burden communities. Community‐based service delivery will be crucial to maintaining access to PrEP services during the COVID‐19 pandemic and future health and humanitarian emergencies.

Length of initial prescription at hospital discharge and long-term medication adherence for elderly, post-myocardial infarction patients: a population-based interrupted time series study

BackgroundPreliminary evidence suggests that providing longer duration prescriptions at discharge may improve long-term adherence to secondary preventative cardiac medications among post-myocardial infarction (MI) patients. We implemented and assessed the effects of two hospital-based interventions—(1) standardized prolonged discharge prescription forms (90-day supply with 3 repeats for recommended cardiac medications) plus education and (2) education only—on long-term cardiac medication adherence among elderly patients post-MI.MethodsWe conducted an interrupted time series study of all post-MI patients aged 65–104 years in Ontario, Canada, discharged from hospital between September 2015 and August 2018 with ≥ 1 dispensation(s) for a statin, beta blocker, angiotensin system inhibitor, and/or secondary antiplatelet within 7 days post-discharge. The standardized prolonged discharge prescription forms plus education and education-only interventions were implemented at 2 (1,414 patients) and 4 (926 patients) non-randomly selected hospitals in September 2017 for 12 months, with all other Ontario hospitals (n = 143; 18,556 patients) comprising an external control group. The primary outcome, long-term cardiac medication adherence, was defined at the patient-level as an average proportion of days covered (over 1-year post-discharge) ≥ 80% across cardiac medication classes dispensed at their index fill. Primary outcome data were aggregated within hospital groups (intervention 1, 2, or control) to monthly proportions and independently analyzed using segmented regression to evaluate intervention effects. A process evaluation was conducted to assess intervention fidelity.ResultsAt 12 months post-implementation, there was no statistically significant effect on long-term cardiac medication adherence for either intervention—standardized prolonged discharge prescription forms plus education (5.4%; 95% CI − 6.4%, 17.2%) or education only (1.0%; 95% CI − 28.6%, 30.6%)—over and above the counterfactual trend; similarly, no change was observed in the control group (− 0.3%; 95% CI − 3.6%, 3.1%). During the intervention period, only 10.8% of patients in the intervention groups received ≥ 90 days, on average, for cardiac medications at their index fill.ConclusionsRecognizing intervention fidelity was low at the pharmacy level, and no statistically significant post-implementation differences in adherence were found, the trends in this study—coupled with other published retrospective analyses of administrative data—support further evaluation of this simple intervention to improve long-term adherence to cardiac medications.Trial registrationClinicalTrials.gov: NCT03257579, registered June 16, 2017Protocol available at: https://pubmed.ncbi.nlm.nih.gov/33146624/.

130-OR: The Association between High Out-of-Pocket Costs and Incidence of Treatment Intensification with an SGLT2 Inhibitor (SGLT2i) or GLP-1 Agonist (GLP-1a) in Patients with Type 2 Diabetes and Established Cardiovascular Disease: A Retrospective Cohort Study

The use of SGLT2i and GLP-1RA in patients with T2D remains low despite their known CV benefits. This may be due in part to high drug costs. We sought to assess the association between out-of-pocket (OOP) costs and the likelihood of initiating these two classes in patients with T2D and established CVD. We conducted a cohort study using claims data (Optum) , which included commercial and Medicare Advantage beneficiaries. Adults with T2D on metformin monotherapy between 12/5/17 and 12/31/were eligible. We excluded those:1) not continuously enrolled for ≥1 yr prior to their first metformin dispensing,2) with no evidence of established CVD, or3) whose OOP costs (defined as the sum of copays and deductibles for a 30-day supply) for SGLT2i or GLP-1RA could not be determined. We used Cox proportional hazards models adjusting for demographics, clinical characteristics, insurance plan, provider and laboratory characteristics to estimate hazard ratios (HR) of initiation across quartiles (Q) of OOP costs, with Q1 representing the lowest and Q4 the highest OOP costs. The cohort included 72,743 patients (mean[SD] age 72[9.4], 56% male) followed for a median of 914 days. Most (88%) were covered by a Medicare Advantage plan. The unadjusted incidence of initiating a SGLT2i (or GLP-1RA) was 2.8% (2.1%) in Q4 vs. 3.8% (2.8%) in Q1 of OOP costs. The median time to initiation of a SGLT2i/GLP-1RA was longer in Q4 (418/325 days) vs. Q1 (395/3 days) of OOP costs. In fully adjusted models, the HR for Q4 vs. Q1 of OOP costs was 0.79 (95%CI 0.70 to 0.90) for initiating a SGLT2i and 0.88 (95%CI: 0.77 to 1.01) for a GLP-1RA. In this national cohort of patients w/ T2D and established CVD, beneficiaries enrolled in plans in the highest quartile of OOP costs were significantly less likely to initiate a SGLT2i or GLP-1RA compared to those enrolled in plans in the lower quartile. Disclosure J.Luo: None. R.Feldman: None. S.D.Rothenberger: None. I.Hernandez: Consultant; Bristol-Myers Squibb Company, Pfizer Inc. M.T.Korytkowski: None. W.F.Gellad: None. Funding NIDDK (K23DK120956) NCATS (KL2TR001856)

132-OR: Trends in Total Payments, Net Payments, and Rebates for a 30-Day Supply of Glucose-Lowering Drugs (GLDs) from 2010–2017

The rapid increase in total payments for GLDs may not reflect the change in actual economic burden, because a growing portion of the total payments were returned to the payers in the form of manufacturer rebates. This study explored trends in rebates for GLDs from 2010-17. We defined total payments as the retail amount the pharmacy received, including two components:1) rebates, the estimated proportion of the total payments retroactively passed through to pharmacy benefit managers and the payers; and2) net payments, the net spending for the GLDs. We used data from the 2010-17 Medical Expenditure Panel Survey to estimate the total payments including out-of-pocket payments, and data from the SSR Health and Medicaid programs to estimate the net payments and rebates. Four high-cost GLDs were included in this study: basal insulin, bolus insulin, GLP-1 Receptor Agonists (GLP-1RA) , and SGLT2 inhibitors (SGLT2i) . Costs were adjusted to 2017 U.S. dollars. While the total payments for a 30-day supply of bolus insulin, basal insulin and GLP-1RA increased by almost 200% from 20 to 2017, the rebates increased by more than 300%, attenuating the increase in net payments. By 2016-17, rebates accounted for 59%, 54%, 37%, and 49% of total payments for bolus insulin, basal insulin, GLP-1RA, and SGLT2i, respectively (Figure 1) . Our study is the first to quantify rebates for GLDs by class from a payer’s perspective. Disclosure Y.Ding: None. L.Shi: None. Y.Lin: None. H.Shao: Board Member; BRAVO4HEALTH, LLC.

898-P: Impact of Switching to a High-Deductible Health Plan on Patients’ Out-of-Pocket Expenditures for Glucose-Lowering Drugs

High deductible health plans (HDHPs) have become increasingly common as a means of increasing access to health insurance while curbing total utilization. However, high out-of-pocket (OOP) expenditures faced by HDHP enrollees may disincentivize high value care, particularly for people with chronic but costly health conditions like diabetes. Glucose-lowering drugs are a large part of direct costs of diabetes management and contribute to cost-related non-adherence, burden of treatment, and poor health outcomes. We examined the changes in OOP expenses for a 30-day supply of each class of glucose-lowering drugs among 43,900 adults with diabetes included in OptumLabs® Data Warehouse between 20 and 2018 who switched from non-HDHPs to HDHPs, compared to 333,803 adults who did not switch. The mean OOP expenses, standardized to 20$US, were higher for HDHP beneficiaries (Table) . Switching to a HDHP significantly increased OOP expenditures for all glucose-lowering classes, ranging from 5% increase (sulfonylurea) to 48% increase (glitazone) . This increased expense for patients may hinder adherence and adversely impact glycemic management and health outcomes among HDHP enrollees. Clinicians should be aware that HDHP enrollees may be more sensitive to OOP costs when choosing medications, and policy makers should exempt evidence-based prescription drugs from high deductibles. Disclosure D.H.Jiang: None. J.Herrin: Consultant; Johnson &amp; Johnson Medical Devices Companies. H.Van houten: None. R.G.Mccoy: Consultant; Emmi. Funding National Institute of Diabetes and Digestive and Kidney Diseases grant number K23DK114497

Raising the Question: Medication Mix-Up or Diversion

Max is an 8-year-old boy with autism spectrum disorder and long-standing challenges with sleep maintenance, the latter of which persist despite behavioral intervention and environmental modification. When Max wakes in the early morning hours, he tends to wander the house, which causes his mother to be awake to monitor his safety. Given the impact of Max's fragmented sleep on his functioning and that of his family, you begin a trial of gabapentin liquid to promote sleep maintenance. Soon after, Max's mother reports that he is sleeping through the night, for the first time in his life.Two months later, you receive a message from Max's mother requesting an early refill of his 90-day supply because of having spilled the bottle. You provide a new prescription, and Max's insurance company allows the early refill. Six weeks after that, Max's mother calls to say that she needs another gabapentin prescription because Max has run out. You confirm that she is giving the prescribed dose but are unsure as to why Max is out of medication weeks early. Given these events, you begin to question whether Max's gabapentin prescription is being diverted. What would you do next?

The effects of patient out-of-pocket costs for insulin on medication adherence and health care utilization in patients with commercial insurance; 2007-2018.

BACKGROUND: High out-of-pocket costs (OOPCs) for insulin can lead to cost-related nonadherence and poor outcomes, prompting payers to limit insulin OOPCs. However, data are scarce on whether insulin OOPCs at policy-relevant levels is associated with improved adherence and outcomes. OBJECTIVE: To identify associations between insulin OOPCs and insulin adherence, noninsulin antihyperglycemic (AHG) medication adherence, and diabetes-related emergency department (ED) visits and hospitalizations. METHODS: This retrospective cohort study was conducted using OptumLabs Data Warehouse, a longitudinal, real-world data asset with deidentified administrative claims and electronic health record data. Individuals with type 1 diabetes (T1D) or type 2 diabetes (T2D), insulin use on January 1 of a study year (index date: 2007-2018), continuous commercial health plan eligibility 12 months pre-index and post-index date, and at least 1 insulin claim during the 12-month follow-up period were included. Average insulin OOPCs per 30-day supply in the follow-up period was identified and categorized ($0, > $0-$20 [referent group], > $20-$35, > $35-$50, and > $50). The proportion of patients with a gap in insulin supply of 60 or more continuous days, AHG nonadherence per modified proportion of days covered less than 0.80, and a diabetes-related ED visit or hospitalization were identified and compared by insulin OOPC category vs more than $0 to $20 using pairwise chi-square tests and multivariable logistic regression. RESULTS: The study included 21,085 individuals with T1D and 72,512 with T2D. Patients with average OOPCs more than $50 were more likely to have a gap in insulin supply vs those with OOPCs more than $0 to $20, with an odds ratio (OR) of 1.14 (95% CI =1.05-1.24) and 1.38 (95% CI = 1.32-1.45) for T1D and T2D, respectively. Those with T2D and OOPCs more than $35 were also more likely to have a 60-day gap in insulin supply (OR 1.17; 95% CI = 1.11-1.23). Odds of having a diabetes-related hospitalization or ED visit did not increase with higher OOPCs; rather, associations tended to be inverse. Nonadherence to AHG medications in the T2D cohort was higher with insulin OOPCs more than $20 vs those more than $0-$20 (P < 0.05 for all). CONCLUSIONS: Individuals with T2D were more likely to have a 60-day gap in insulin supply when the OOPC was more than $35 per 30-day supply and with the OOPC more than $50 in those with T1D. These findings suggest that health plans can facilitate adherence to insulin therapy and possibly to noninsulin AHG medications by protecting patients with diabetes from experiencing high insulin OOPC. A study with a longer follow-up period is warranted to fully assess ED and hospitalization outcomes. DISCLOSURES: This study was funded by the Robert Wood Johnson Foundation, Health Data for Action Research Program. The study sponsor played no role in the design or conduct of this study. The views expressed here do not necessarily reflect the views of the Foundation.

Telehealth to improve continuity for patients receiving buprenorphine treatment for opioid use disorder.

Buprenorphine is medication-assisted treatment for opioid use disorder. It is a controlled substance and most states limit the dispensing to a 30-day supply. Patients with opioid use disorder often have social determinants of health barriers that make it difficult to engage with the health system to obtain a new supply of buprenorphine every month. Telehealth can be used to reduce barriers to accessing care and improve continuity of care for patients receiving buprenorphine treatment. To assess the rates of patient continuity for patients receiving buprenorphine treatment via tele-health versus in-person in a primary care outpatient setting. Review of patients receiving buprenorphine treatment for opioid use disorder and rates of continuity by visit type during a 2-year time period May 2019-May 2021. EPIC electronic medical records from an urban university-affiliated ambulatory primary care practice in New Jersey. Patients scheduled for a visit in the outpatient primary care clinic. Approximately 69% were African American, 22% Hispanic, and 9% other. The majority were enrolled in Medicaid. 80% of patients faced one or more barriers to social determinants of health including transportation, housing, and economic stability. Establishment and implementation of HIPAA compliant tele-health following approved state guidelines for buprenorphine prescribing via tele-health. Appointments were scheduled in-person or tele-health by patients' preference. Rates of continuity by visit type for patients receiving buprenorphine treatment during the study time period compared by chi-square. Of the 487 patients seen via tele-health, 297 (61%) continued to receive follow up care. Of the 811 patients seen in-person, 400 (49.3%) continued to receive follow up care, p<.0001. The patients who did not continue to receive follow up care were lost to follow up despite attempts to reach patients to re-engage in care. Our study shows that rates of continuity of care are higher using tele-health for patients receiving medication assisted therapy for opioid use disorder. In an urban underserved population, tele-health can result in improved continuity of care for patients with opioid use disorder. Telehealth may reduce barriers to accessing care including transportation, work schedule, childcare, and other competing demands.

Opioid Prescribing by Dentists in the Veterans Health Administration

Nonopioid analgesics are more effective for most oral pain, but data suggest that dental prescribing of opioids is excessive. This study evaluates the extent to which opioids exceed recommendations and the characteristics associated with opioid overprescribing by Veterans Health Administration dentists. This was a national cross-sectional study of Veterans' dental visits from 2015 to 2018. Overprescribing was defined per national guidelines as >120 morphine milligram equivalents (primary outcome). The association of dental visit and patient demographic and medical characteristics was modeled with overprescribing (defined as >120 morphine milligram equivalents) using Poisson regression with clustering by facility and patient. A secondary analysis assessed opioid prescriptions >3 days' supply. The dates of analysis were January 2020‒May 2021. Of the 196,595 visits, 28.7% exceeded 120 morphine milligram equivalents. Friday visits and people with chronic oral pain or substance misuse were associated with a higher prevalence of overprescribing. Women, older Veterans, and Black and Latinx Veterans were less likely to be overprescribed than men, younger Veterans, and White Veterans, respectively. Routine dental visits had a higher prevalence of opioid overprescribing than invasive visits. Opioid overprescribing decreased over time. White Veterans were more likely to receive oxycodone and hydrocodone, whereas people of Black race and Latinx ethnicity were more likely to receive codeine and tramadol. In the secondary analysis, 68.5% of opioid prescriptions exceeded a 3-day supply. Nearly 1 in 3 opioids prescribed by Veterans Health Administration dentists exceed guidelines. Prescribing higher potency and quantities of opioids, especially on Fridays and to certain demographic groups, should be addressed as part of dental opioid stewardship programs.

Medication adherence in Medicare-enrolled older adults with asthma before and during the coronavirus disease 2019 pandemic

BackgroundData regarding medication adherence in older adults with asthma before and during the coronavirus disease 2019 (COVID-19) pandemic are lacking. ObjectiveTo evaluate medication adherence and determine factors associated with adherence in Medicare-enrolled older adults with asthma before and during the COVID-19 pandemic. MethodsThis was a retrospective cohort analysis of Medicare-enrolled patients with asthma. Medication adherence was measured using rates of proportion of days covered for dates January to July 2019 and January to July 2020. Patients less than 65 years of age, with chronic obstructive pulmonary disease, or with cystic fibrosis were excluded. Paired t tests assessed change in adherence between 2019 and 2020. Logistic regression evaluated association of age, sex, depression, moderate or severe asthma, use of a 90-day supply, having 3 or more albuterol fills, number of medications, medication-related problems, prescribers, pharmacies, controller medication classes, and systemic corticosteroid fills with high adherence (proportion of days covered ≥ 80%). ResultsMean adherence to asthma controller medications ranged from 75% to 90%, in 2019. Adherence significantly decreased (P < .001) from 51% to 70% for all controller medications, except theophylline in 2020. Similar results were observed among patients with moderate or severe asthma. In 2019 and 2020, number of controller medications, 3 or more albuterol fills, and having a 90-day supply were associated with high adherence (P < .001). ConclusionAdherence to asthma controller medications decreased considerably during the COVID-19 pandemic among Medicare-enrolled patients with asthma. Patients with markers for more severe asthma, overuse of albuterol, and a 90-day supply of controller medications were more likely to have high adherence. These findings can be used to identify opportunities to improve adherence and prescribing among adult patients with asthma.

Distribution of Opioid Prescribing and High-Risk Prescribing Among U.S. Dentists in 2019

It is unknown whether certain dentists account for disproportionate shares of dental opioid prescriptions and high-risk prescriptions. Identifying and characterizing such dentists could inform the targeting of initiatives to improve the appropriateness and safety of dental opioid prescribing. In May 2021, the authors conducted a cross-sectional analysis using the IQVIA Longitudinal Prescription Database, which reports dispensing from 92% of U.S. pharmacies, and 2 provider databases (IQVIA OneKey, National Plan and Provider Enumeration System). Analyses included opioid prescriptions from dentists dispensed in 2019 to patients aged >12 years. High-risk prescriptions were those considered high risk by any of 3 metrics (prescriptions to opioid-naïve patients exceeding a 3-day supply, prescriptions with daily opioid dosage ≥50 morphine milligram equivalents, opioid prescriptions with benzodiazepine overlap). Among all prescriptions and high-risk prescriptions, the authors calculated the proportion accounted for by high-volume dentists -- those with prescription counts in the 95th percentile or higher. Using logistic regression, the characteristics associated with being a high-volume dentist were identified. In 2019, a total of 141,345 dentists accounted for 10,736,743 opioid prescriptions dispensed to patients aged >12 years; 4,242,634 (39.5%) were high-risk prescriptions. The 7,079 high-volume dentists, a group representing 5.0% of the 141,345 dentists, accounted for 46.9% of all prescriptions and 47.5% of high-risk prescriptions. Male sex, younger age, non‒Northeast location, and specialization in oral and maxillofacial surgery were associated with a higher risk of being a high-volume dentist. In 2019, high-volume dentists accounted for almost half of dental opioid prescriptions and high-risk prescriptions. Quality improvement initiatives targeting these dentists may be warranted.

Phytosterol Therapy Effectively Reduces LDL-C in Middle-Aged, Borderline Risk South Asians

<h3>Lead Author's Financial Disclosures</h3> Nothing to disclose. <h3>Study Funding</h3> Piper Biosciences. <h3>Background/Synopsis</h3> The effectiveness of a plant sterol gummy supplement was studied in a South-Asian (SA) patient population with low to moderate cardiovascular disease (CVD) risk as defined by an Atherosclerotic Cardiovascular Disease (ASCVD) Risk Score of < 7.5%, and a low density lipoprotein (LDL)-C level of 120-189 mg/dl. Statin therapy is often not recommended to patients with ASCVD score < 7.5% even in the presence of risk accelerators such as SA ethnicity, to which the 2018 National Lipid Association (NLA) guidelines call attention. <h3>Objective/Purpose</h3> Phytosterols are known to lower LDL-C and are included in NLA and other global guidelines. This study aimed to establish their impact on LDL-C levels in 'borderline' risk SAs. <h3>Methods</h3> 50 SAs were recruited during the COVID 19 pandemic, mainly from a preventive cardiology clinic dedicated to reducing SA heart disease risk. Eligible subjects had a 10-year CV risk score (ASCVD) <7.5% and LDL-C level of 120-193mg/dl at study enrollment. Subjects intolerant of or refusing statins were also recruited. The study was administered with a fully decentralized design, leveraging mailed supplements, televisits, remote lab collection, and SMS-based communications. Upon completing baseline labs and surveys, subjects were provided a 90-day supply of 1400mg phytosterol gummy supplements in individual packets (Piper Biosciences, Los Altos, CA) to be ingested twice daily. Subjects were instructed to continue current lifestyle habits and report major dietary pattern deviations. The primary endpoint was LDL-C reduction at 3 months. Pre- and post-study surveys were administered to assess diet and lifestyle. <h3>Results</h3> 33 of the 50 subjects successfully completed the protocol. A significant overall reduction in LDL-C of 5.8% was observed (p=0.03) (Table 1, Figure 1). Subgroup A (n=27) completed the protocol with no significant dietary variation, demonstrating a significant LDL-C reduction of 6.5% (p=0.002), as well as a total cholesterol (TC) reduction of 4.4% (p=0.01). There was no significant change in other metrics, including BMI, fasting glucose, or HbA1C. Patients who completed the protocol but reported worsening dietary habits (Subgroup B, n=6) showed an average increase in LDL-C of 6% (p=0.2) and in TC of 8% (p=0.002). Survey responses indicate that 94% of subjects would be interested in long-term supplementation if recommended by physician and 80% would prefer taking it proactively to manage cholesterol levels. <h3>Conclusions</h3> Plant sterols are an effective and sustainable means to lower LDL-C in middle-aged SAs, whose CV risk is often underestimated. To our knowledge this study represents the first demonstration of phytosterol effectiveness in the highest coronary disease risk population globally.