Prescription Drug Costs Research Articles

First Salvage Therapy for Relapsed or Refractory Acute Myeloid Leukemia: Associated Health Care Resource Use and Costs

BackgroundFor relapsed/refractory acute myeloid leukemia (R/R AML), treatments used include high-intensity cytotoxic chemotherapy regimens (HIC); low-intensity chemotherapy (LIC); targeted therapies administered as either a single agent or as part of combination therapy; or venetoclax, often in combination with LIC. As options increase for patients with R/R AML, an understanding of the real-world health care resource use (HRU) and costs associated with different treatment regimens is needed.ObjectiveWe described HRU and costs associated with HIC alone, LIC alone, and select novel, orally administered therapies (alone or in combination with chemotherapy) to better understand HRU and costs of first salvage therapy for AML.MethodsThis was a retrospective analysis using the IBM MarketScan ® database which contains medical and drug data from ~40 million people annually who are covered by employer-sponsored private health insurance in the United States. The time frame for this claims analysis was 1/1/2017-12/31/2019. HRU and costs were estimated for 5 mutually exclusive treatment groups: HIC alone, LIC alone, gilteritinib, other FLT3 tyrosine kinase inhibitors (TKIs), and venetoclax. Gilteritinib, other FLT3 TKIs, and venetoclax treatments could be single-agent or in combination with chemotherapy. Patients aged ≥18 years at AML diagnosis with continuous health plan enrollment for ≥180 days prior to first AML diagnosis and through start of first salvage therapy were included in the analysis. Evidence of R/R AML was determined by diagnosis code and use of a treatment-based algorithm (Grinblatt DL, et al. Blood. 2020;136[Suppl. 1]:24-25). Descriptive statistics were used to characterize baseline patient demographic and clinical characteristics and HRU and costs through treatment. HRU and costs were reported as per-patient per-month (PPPM).ResultsMost baseline characteristics were similar across treatment groups (eg, % male, 45.6%-57.1%; mean Charlson comorbidity scores, 3.07-3.86; and mean all-cause health care costs during 6-months pretreatment, $201,583-$253,437). Mean (SD) patient age overall was 54.1 (14.9) years; the venetoclax group appeared older (61.2 years). The frequency of prior HIC treatment in the overall sample was 38.1%; a majority of patients treated with gilteritinib (64.3%) and other FLT-3 TKIs (55.9%) had prior HIC treatment. Of patients receiving gilteritinib, other FLT3 TKIs, and venetoclax, 6 (42.9%), 33 (48.5%), and 77 (96.3%) respectively, were receiving concomitant chemotherapy. Almost all patients were hospitalized during HIC; the percentage of patients requiring hospitalization was lower and comparable across other treatment groups (Table). Hospital length of stay was highest in the HIC group and lowest in the gilteritinib group. Intensive care unit stays PPPM were highest in the HIC and venetoclax groups and lowest in the gilteritinib group. In the outpatient setting, physician office visits and outpatient hospital visits PPPM were higher in the LIC, other FLT3 TKIs, and venetoclax groups and lower in the HIC and gilteritinib groups (Table). Transfusion-related physician office and outpatient hospital visits PPPM were higher in the venetoclax group than in the other groups. The highest health care costs PPPM were in the HIC group with costs being similar for the other treatment groups (Table). Inpatient costs were highest in the HIC group and lowest in the gilteritinib group; outpatient costs were highest in the LIC and venetoclax groups and lowest in the HIC, gilteritinib, and other FLT3 TKI groups. Transfusion costs in the outpatient setting were the highest in the venetoclax group and the lowest in the gilteritinib group. Prescription claim costs were the highest in the gilteritinib group and lower in the HIC, LIC, and venetoclax groups.ConclusionAcross select treatments for R/R AML in first salvage, inpatient HRU was generally the highest for the HIC group while outpatient HRU was generally the highest in the LIC and venetoclax groups, with the highest number of outpatient transfusion visits noted in the venetoclax group. Analyses of total all-cause costs showed that costs were the highest in the HIC group and similar in the LIC, gilteritinib, other FLT3 TKIs, and venetoclax groups. Although prescription drug costs were high in the gilteritinib group, these high costs were partially offset by low HRU in both the inpatient and outpatient settings. [Display omitted] DisclosuresMuffly: Adaptive: Honoraria, Other: fees for non-CME/CE services: , Research Funding; Astellas, Jasper, Adaptive, Baxalta: Research Funding; Pfizer, Amgen, Jazz, Medexus, Pfizer: Consultancy. Young: Astellas Pharma, Inc.: Current Employment. Nimke: Astellas Pharma, Inc.: Current Employment. Sullivan: Astellas Pharma, Inc.: Current Employment. Feng: Astellas Pharma, Inc.: Current Employment. Pandya: Astellas Pharma, Inc.: Current Employment.

Generics and Biosimilars: Barriers and Opportunities

Generics and Biosimilars: Barriers and Opportunities

High-Cost Users of Prescription Drugs: National Health Insurance Data from South Korea.

In OECD countries, pharmaceutical spending reached around 800 billion USD in 2013, accounting for about 20% of total spending in the retail sector. Pharmaceutical expenditures are steadily increasing in South Korea, necessitating strategies to promote efficiency. This study investigated factors associated with high-cost users (HCUs), who account for the majority of outpatient prescriptions in the total South Korean population. The top 20 frequently prescribed therapeutic subgroups were also investigated. This is an observational study performed using health insurance claims data in 2019. In total, 44,744,632 people (including 6,806,339 aged 65 years or older) who were prescribed outpatient medications were included. HCUs were defined as those for whom prescription drug costs were in the top 5%. Multivariate logistic regression analysis was performed using factors including age, insurance type, number of prescription drugs, outpatient visit days, prescription treatment days, and chronic diseases. HCUs accounted for 3.6 million (5% of the total population) and 1.4 million (21.1% of those 65 years or older). Furthermore, 4.1% of HCUs in the total population had few comorbidities. Male sex, older age, insurance (Medical Aid), comorbidities, chronic diseases, number of prescription drugs, outpatient visit days, and prescription days were all associated with an increased probability of being an HCU. The highest spending was found for B01 (antithrombotic agents) with 0.4 billion USD, followed by C10 (lipid-modifying agents) and A10 (drugs used in diabetes). The proportion of spending for HCUs among the general population was highest in L01 (antineoplastic agents), at 98.2%, and L04 (immunosuppressants), at 87.8%, whereas among the elderly, the highest proportions were found for B01 (antithrombotic agents), at 44.5%, and N06 (antidepressants), at 44.3%. Age and multiple chronic conditions were strongly associated with HCUs, and it seems necessary to reduce drug prescriptions in patients without complex comorbidities. Several measures should target those without multiple chronic conditions who are nonetheless HCUs.

Impact of the National Centralized Drug Procurement Policy (4 + 7 policy) on the drug expenditures of patients treated in outpatient and emergency departments in a large tertiary level-A hospital in China: A single centre, interrupted time series.

Like many countries in the world, China is also facing growing drug expenditures year by year. In particular, the rising cost of prescription drugs has been one of the critical factors leading to the serious burden on health insurance programs. The high cost of prescription drugs not only threatens the health budget but also limits the nation's investment in other public sectors. China implemented the National Centralized Drug Procurement (NCDP) policy, also known as the "4 + 7" policy, in tertiary hospitals in various provinces and cities across the country on 18 December 2019, aiming to lessen personal and national health insurance burdens by reducing drug procurement prices. The aim of this study is to explore the impact of the implementation of the NCDP policy on the drug expenditures of patients treated in outpatient and emergency departments and on national health insurance expenditures. This study adopts interrupted time series (ITS) to evaluate the impact of China's implementation of the NCDP policy on the drug expenditures of patients treated in outpatient and emergency departments in a tertiary hospital. The NCDP policy was officially implemented on 18 December 2019. A segmented regression model is utilized to analyse the average monthly drug expenditures of patients treated in outpatient and emergency departments from January 2018 to June 2021, including the average monthly per-visit drug expenditures of all patients and the average monthly per-visit drug expenditures of patients who paid for drugs with health insurance and those who did not use health insurance. After the implementation of the NCDP policy, the overall average monthly per-visit drug expenditures of patients treated in outpatient and emergency departments were immediately reduced by 233.954 CNY (p<0.01). Compared with the continued downward trend for drug expenditures before the implementation of the NCDP policy, the long-term trend after policy implementation was not obvious (p=0.051973>0.05). Similarly, the average monthly per-visit drug expenditures of patients treated in outpatient and emergency departments who use health insurance to procure drugs also immediately decreased by 505.287 CNY (p<0.01), but the long-term trends before (p=0.469>0.05) and after policy implementation (p=0.51>0.05) did not exhibit obvious change. For the average monthly per-visit drug expenditures of patients treated in outpatient and emergency departments who did not use health insurance, the implementation of the NCDP policy did not produce an immediate reduction in drug expenditures (p=0.3603>0.05). Although the average monthly per-visit drug expenditures decreased by 9.078 CNY (p<0.01) before policy implementation, this trend ended after the policy was implemented (p=0.0735>0.05), and no other changes were triggered. This study reviews the data for a period of time before and after the implementation of the NCDP policy. The policy is shown to significantly decrease the average monthly per-visit drug expenditures of patients treated in outpatient and emergency departments.

Pain-related health care costs for long-term care residents

BackgroundWe tested for differences in direct health care costs among long-term care (LTC) residents age 65 and older with clinically significant pain (CSP) and with no pain or non-daily mild pain (NP/NDMP). We are not aware of any other large scale investigation that examined the cost of pain in LTC environments.MethodsPopulation-based administrative health data from Saskatchewan, Canada for 2004 to 2015 were used to compare direct health care costs for CSP and NP/NDMP groups up to one year after admission to LTC. Total accumulated costs for hospitalization, physician services, LTC, and prescription drugs were calculated in 2015 Canadian dollars. Group differences were tested using generalized linear models with generalized estimating equations.ResultsAmongst 24,870 LTC residents, 8289 (33.3%) were censored due to death or discharge in the 365-day study observation period. Of the 16,581 (66.7%) observed residents, 5683 (34.3%) had CSP at admission. Residents (66.3% female) had a mean age of 85 years (SD = 7.4). The mean annual total direct health care cost per resident was higher among the CSP group (CAD $8063) than the NP/NDMP group (CAD $6455). This difference was found even after including LTC costs, and for each cost component (i.e., CSP residents had higher hospitalization, physician, and prescription drug costs). Similar results were obtained after controlling for demographics, comorbidities, physical and cognitive impairment, prior health care costs, and facility characteristics.ConclusionThe higher costs incurred by CSP residents compared to NP/NDMP residents are likely underestimated because pain problems are often missed in residents with dementia, who comprise a large portion of the LTC population. Improved pain care can reduce such costs and improve quality of life.

Spending and Utilization on Drugs Prescribed by Otolaryngologists to Medicare Beneficiaries, 2013 to 2017.

The significant and rising cost of prescription drugs is a pressing concern for patients and payers. However, little is known about spending on and utilization of drugs prescribed by otolaryngologists. Utilizing publicly available Medicare Part D Prescriber Public Use data, we conducted a retrospective cross-sectional analysis of 34 small-molecule drugs commonly prescribed by otolaryngologists (defined as 2017 Medicare Part D spending ≥$500 000) to Medicare beneficiaries. Prescription data was characterized by drug type (brand name vs generic). Primary outcomes for each prescription drug included the total annual cost and the total annual number of days supplied. From 2013 to 2017, spending on drugs prescribed by otolaryngologists to Medicare beneficiaries decreased by $32.1 million ($131.7-$99.5 million; relative decrease 24.4%; compound annual growth rate [CAGR] -5.4%), while total utilization increased by 24.9 million days supplied (74.6-99.5 million; relative increase 33.3%; CAGR 5.9%). For brand name drugs, there was a decrease in spending ($71.1-$26.7 million; relative decrease -62.4%; CAGR -17.8%) and utilization (11.2-3.1 million days supplied; relative decrease -72.5%; CAGR -22.8%). In contrast, generic drugs demonstrated increased spending ($60.6-$72.8 million; relative increase 20.2%; CAGR 3.7%) and utilization (63.5-96.4 million days supplied; relative increase 51.9%; CAGR 8.7%). Spending on drugs prescribed by otolaryngologists to Medicare Part D beneficiaries declined between 2013 and 2017 in part due to a transition from brand name drugs to lower-cost generic equivalents.

Eligible but Not Enrolled: Consequences of Forgoing Prescription Drug Subsidies Among Low‐Income Medicare Beneficiaries with Diabetes

Research ObjectiveTo estimate take‐up of the Part D Low‐Income Subsidy (LIS) among Medicare beneficiaries with diabetes, and to examine differences in out‐of‐pocket costs and prescription drug use between enrollees and LIS‐eligible non‐enrollees. The LIS lowers prescription drug costs for Medicare beneficiaries with incomes ≤150% of the Federal Poverty Level (FPL), and caps out‐of‐pocket costs for beneficiaries with incomes ≤135% of FPL. Although a number of recent policy proposals seek to address rising drug costs, the LIS itself remains underutilized. The value of forgoing this benefit among chronically ill beneficiaries has not previously been studied.Study DesignWe used data from the Health and Retirement Study (HRS) to estimate take‐up of the LIS among Medicare beneficiaries with diabetes. Using propensity score‐weighted analyses, we compared out‐of‐pocket costs, prescription drug use, and cost‐related drug non‐adherence among LIS enrollees and eligible non‐enrollees. We stratified the analyses according to whether respondents' income was ≤100% vs. &gt;100% to ≤150% of FPL because of differences in the generosity and take‐up of Medicaid benefits above vs. below 100% of FPL, and because individuals with Medicaid automatically receive the LIS.Population StudiedCommunity‐dwelling HRS respondents surveyed biennially between 2008–2016 who were enrolled in Medicare Part D, had an established diagnosis of diabetes, and were eligible for the LIS (income ≤150% FPL and assets below LIS limit).Principal FindingsAmong Medicare beneficiaries with diabetes, 56.9% of those with incomes &gt;100% to ≤150% of FPL received the LIS, while 90.3% of those with incomes ≤100% received the LIS, reflecting automatic enrollment from Medicaid. Based on these take‐up rates, we estimate that 322,746 LIS‐eligible individuals with diabetes do not enroll in the LIS annually. For those with incomes &gt;100% to ≤150% of FPL, compared to LIS enrollees, eligible non‐enrollees incurred higher annual out‐of‐pocket drug spending ($518, p &lt; 0.001), had 20% fewer fills for diabetes, hypertension, and hyperlipidemia prescription drugs (p = 0.003), and were 9 percentage points more likely to report skipping drugs due to cost (p = 0.04).ConclusionsA substantial proportion of Medicare beneficiaries with diabetes are eligible for but not enrolled in the LIS. Low take‐up was concentrated among beneficiaries with income &gt;100% to ≤150% of FPL. Forgoing the LIS was associated with higher out‐of‐pocket costs and cost‐related non‐adherence, and lower use of medications used to treat chronic conditions. Our findings demonstrate the extent to which out‐of‐pocket costs may be reduced, and use of chronic disease medications increased, if a higher proportion of LIS‐eligible Medicare beneficiaries receive this benefit.Implications for Policy or PracticeProposals to lower out‐of‐pocket drug costs for Medicare beneficiaries often overlook the fact that existing prescription drug subsidy programs are underutilized. Because the LIS reduces cost sharing for all Part D covered drugs and caps annual out‐of‐pocket costs for most recipients, increasing LIS take‐up would likely provide better financial protection for seniors with chronic conditions than a flat subsidy or price caps limited to certain drugs. Policies to streamline or automate LIS enrollment for low‐income Medicare beneficiaries could help to mitigate the impact of rising drug costs in this vulnerable population.Primary Funding SourceAgency for Healthcare Research and Quality.

National Trends in Out-of-Pocket Costs Among U.S. Adults With Diabetes Aged 18-64 Years: 2001-2017.

To assess national trends in out-of-pocket (OOP) costs among adults aged 18-64 years with diabetes in the U.S. Using data from the 2001-2017 Medical Expenditure Panel Survey, we estimated total per person annual OOP costs (insurance premiums, prescription drug costs, inpatient and outpatient deductibles, copays, and other payments not covered by insurance) and high OOP cost rate, defined as the percentage of people with OOP spending >10% of their family's pretax income. We examined trends overall, by subgroup (insurance type, income level, insulin use, size of patient's employer, and whether the patient was enrolled in a high deductible health plan), and by type of service. Changes in trends were identified using joinpoint analysis; costs were adjusted to 2017 U.S. dollars. From 2001 to 2017, OOP costs decreased 4.3%, from $4,328 to $4,139, and the high OOP cost rate fell 32%, from 28 to 19% (P < 0.001). Changes in the high OOP cost rate varied by subgroup, declining among those with public or no insurance and those with an income <200% of the federal poverty level (P < 0.001) but remaining stable among those with private insurance and higher income. Drug prescription OOP costs decreased among all subgroups (P < 0.001). Decreases in total (-$58 vs. -$37, P < 0.001) and prescription (-$79 vs. -$68, P < 0.001) OOP costs were higher among insulin users than noninsulin users. OOP costs among U.S. nonelderly adults with diabetes declined, especially among those least able to afford them. Future studies may explore factors contributing to the decline in OOP costs and the impact on the quality of diabetes care and complication rates.

Effectiveness of a ketogenic diet and virtual coaching intervention for patients with diabetes: A difference-in-differences analysis.

To test the effectiveness of a ketogenic diet and virtual coaching intervention in controlling markers of diabetes care and healthcare utilization. Using a difference-in-differences analysis with a waiting list control group-a quasi-experimental methodology-we estimated the 5-month change in HbA1c, body mass index, blood pressure, prescription medication use and costs, as well as healthcare utilization. The analysis included 590 patients with diabetes who were also overweight or obese, and who regularly utilize the Veterans Health Administration (VA) for healthcare. We used data from VA electronic health records from 2018 to 2020. The ketogenic diet and virtual coaching intervention was associated with significant reductions in HbA1c (-0.69 [95% CI -1.02, -0.36]), diabetes medication fills (-0.38, [-0.49, -0.26]), body mass index (-1.07, [-1.95, -0.19]), diastolic blood pressure levels (-1.43, [-2.72, -0.14]), outpatient visits (-0.36, [-0.70, -0.02]) and prescription drug costs (-34.54 [-48.56, -20.53]). We found no significant change in emergency department visits (-0.02 [-0.05, 0.01]) or inpatient admissions (-0.01 [-0.02, 0.01]). This real-world assessment of a virtual coaching and diet programme shows that such an intervention offers short-term benefits on markers of diabetes care and healthcare utilization in patients with diabetes.

Health care Affordability and Associated Concerns Among Adults Aged 65 and above in Florida.

This study assessed affordability of care in a diverse sample of Floridians aged ≥ 65 to ascertain concerns about health care costs. We surveyed 170 adults (40.6% white, 27.6% black, and 31.8% Hispanic) and conducted three race/ethnic-stratified focus groups (n = 27). Most participants had Medicare (97.1%). Among whites, 11.6% reported problems paying medical bills in the past 12 months versus 14.9% of blacks and 24.1% of Hispanics. In addition, 13% of whites, 19.2% of blacks, and 20.4% of Hispanics reported not getting needed prescription drugs because of costs. The most frequently identified concerns from the focus groups were the cost of prescription drugs, out-of-pocket expenses, and medical billing. Concerns about medical billing included understanding bills, transparency, timely postings, and uncertainty about who to contact about problems. Our findings suggest that practices that help older adults effectively manage medical bills and costs may alleviate their concerns and guard against financial burdens.

Factors Associated With Manufacturer Drug Coupon Use at US Pharmacies

Drug companies offer coupons to lower the out-of-pocket costs for prescription drugs, yet little is known about why they do so for some drugs but not for others. To examine whether the following factors are associated with manufacturer drug coupon use: (1) patient-cost characteristics (mean per-patient cost per drug, mean patient copay); (2) drug characteristics (generics availability or "later-in-class-entrant" drugs); (3) drug-class characteristics (in-class coupon use among competitors; in-class generic competition; in-class mean cost and copay). This was a retrospective cohort analysis of anonymized transactional pharmacy claims sourced from retail US pharmacies from October 2017 to September 2019, supplemented with information derived from Medi-Span, Red Book, and FDA.gov. Data were analyzed from September 2020 to February 2021. The primary outcome was availability of a manufacturer's coupon. The secondary outcome was the mean proportion of transactions in which a coupon was used for each product. The sample of 2501 unique brand-name prescription drugs accounted for a total of 8 995 141 claims. Manufacturers offered a coupon for 1267 (50.7%) of these drugs. When the manufacturer offered a coupon, it was used in a mean (SD) 16.3% (20.3%) of the transactions. Within a drug class, higher mean total cost per patient was positively associated with the likelihood of coupon use (odds ratio [OR], 1.03 per 10% increase; 95% CI, 1.01-1.04), but higher mean patient copay was inversely associated (OR, 0.98; 95% CI, 0.97-0.99). For drug characteristics, single-source later-in-class-entrant products were associated with a greater likelihood of coupon use compared with first entrants and multisource brands (OR, 1.44; 95% CI, 1.09-1.89). The intensity of coupon use was associated with later-in-class-entrant products and the class mean per-patient cost (4.16-percentage-point increase; 95% CI, 1.20-7.13; 0.27 per 10% increase; 95% CI, 0.09-0.44). Drugs with a new in-class brand-name competitor had greater mean coupon use compared with drugs without a new competitor (10.2% of claims with a coupon vs 5.9%). In this cohort study of transactional pharmacy claims, higher mean per-patient total cost within a class was significantly associated with the likelihood of coupon use, but not patient out-of-pocket cost. Manufacturers' coupons were more likely to be used for expensive later-in-class-entrant products facing within-class competition where coupon use was prevalent.

Pursuing Value-Based Prices for Drugs:A Comprehensive Comparison of State Prescription Drug-Pricing Boards.

Rising prescription drug costs are consuming a growing proportion of state and private budgets. In response, lawmakers have experimented with a variety of policies to contain spending and achieve value in prescription drugs. As part of this series of reforms, some state legislatures have recently authorized prescription drug-pricing boards to address the high prices of brand-name prescription drugs and assess the value of those drugs. We identified state prescription drug-pricing boards in the United States, defined as any agency authorized by a state legislature to review specific drugs and pursue value-based drug prices. To describe the characteristics of the boards, we obtained public records of authorizing legislation, guidance documents, and board meeting minutes. We compared the boards' powers and responsibilities and analyzed completed pricing reviews. Six state drug-pricing boards in five states met our definition; their design varied substantially. Two of the boards (New York Medicaid and Massachusetts) have authority over drug rebates paid by state Medicaid programs, one (New York Drug Accountability Board) has jurisdiction over state-regulated commercial insurance, and another three (Maine, Maryland, and New Hampshire) oversee non-Medicaid, state-funded insurance. Three boards are authorized to require manufacturers to confidentially submit information related to the pricing and clinical effectiveness of reviewed drugs to inform value determinations. Only one board (New York Medicaid) had completed pricing reviews as of June 3, 2021. Boards' structure, scope, and statutory leverages to compel manufacturers to negotiate lower net costs are key factors that influence whether and to what extent boards can achieve cost savings for states. Though legal constraints may limit the effective reach of prescription drug-pricing boards, these agencies can enable states to address rising prescription drug costs, in part by virtue of their very existence. To overcome practical limitations, states seeking to implement similar policies can build on the experiences and designs of current boards.

Employer-sponsored behavioral health program impacts on care utilization and cost.

To examine the impact of an employer-sponsored behavioral health (BH) program on all-cause health care utilization and cost. Retrospective analysis of health insurance claims data obtained from a large employer in western New York covering a 25-month period between 2016 and 2018. Those employees treated by the employer-sponsored BH program were compared against a contemporaneous comparison group of employees of the same employer who had eligible BH diagnoses for the program but were treatedelsewhere. A difference-in-differences method was used to estimate the program's impact on all-cause care utilization (physician office visits and acute care utilization) and total cost of care, including prescription drug costs. Program participation was associated with a reduction of approximately 28% in total cost of care including prescription drug costs (P = .043) over an 18-month period following the initial program encounter, as well as 27% reductions in primary care provider (PCP) visits (P = .001) and non-BH specialist visits (P = .005). No significant impacts were observed for acute care utilization and BH specialist visit rates. The results suggest that the employer-sponsored BH program implementation may have shifted treatments of certain BH conditions away from PCPs and non-BH specialists who may not have the proper training or resources to manage such conditions. Therefore, these results are consistent with the expectation that improved access to BH care is likely to improve efficiency in the health care system via provision of more appropriate care for those who need it.

'Fitting in the pharmacist' - a qualitative analysis of the perceived relationship between community pharmacists and older adults with complex care needs.

To explore the current perceived relationship between older adults with varying levels of frailty and healthcare needs and community pharmacists. This qualitative study conducted a thematic analysis of focus groups with older adults and older adult caregivers and community pharmacist participants. Participants were recruited following a maximum variation sampling technique. Verbatim transcripts were inductively coded using NVivo to develop key findings. Four major themes emerged: (i) Pharmacy Landscape, (ii) Prescription and Non-Prescription Drug Safety, (iii) Patient-Pharmacist Relationship and (iv) Recommendations for Pharmacy Practice. Themes demonstrate three key findings: (1) older adults approach drug information with a key focus on safety and cost of both prescription and non-prescription drugs, (2) there is a demonstrated opportunity, recognized by older adults and practitioners, for community pharmacists to expand their role in the care of older adults, (3) community pharmacists are able, interested and/or have already incorporated frailty assessments into their practice to better support their care of the older adult population with varying levels of frailty. The results demonstrate a reason for the community pharmacist role to shift. The unique knowledge and skills of community pharmacists, coupled with their accessibility and strong patient-clinician relationship, have the potential to better support older adults with varying levels of frailty.

DIR reform, supply chain security, and more

DIR reform, supply chain security, and more

Adverse Events, Resource Use, and Economic Burden in Patients with Mantle Cell Lymphoma in the United States

Introduction : In patients with mantle cell lymphoma (MCL), adverse events (AEs) can impair patient adherence to planned therapeutic regimens. In addition, moderate to severe AEs generally require medical attention and therefore are often associated with increased health care resource use (HRU) and costs. Real-world data on HRU and costs associated with MCL and its treatments are sparse in current literature. The goals of this study were: (1) assess HRU and direct costs of MCL; (2) examine variation in costs across treatment types; and (3) document the economic burden associated with MCL treatment-related AEs.Methods :A retrospective cohort analysis was performed using MarketScan databases that contain employer- and health-plan-sourced administrative claims data, including information on diagnoses, procedures, and associated utilization of health care services for over 60 million privately insured individuals across the US. Cost information in the data include patient copay, coinsurance, charges, and the actual amounts paid by the payers. Patients were included if they were aged ≥18 years, had at least two medical claims on separate dates with a diagnosis code for MCL (ICD-9-CM code 200.4x or ICD-10-CM code C83.1x) during July 2010-June 2015, and were continuously enrolled in medical and drug plans for ≥12 months before the date of first MCL diagnosis (ie, study index date). Patients with evidence of MCL diagnosis or MCL treatment in the 12 months before the study index date were excluded. Mean per-patient monthly HRU and costs were assessed overall and by care setting (eg, inpatient, outpatient, pharmacy). Both all-cause and MCL-related costs were calculated; all cost data, adjusted to 2016 US dollars using the Medical Care component of the US Consumer Price Index, were assessed from the payer's perspective. The incremental HRU and costs associated with AEs were assessed by stratifying these measures according to patients' AE status (AE or no AE) and the number of AEs experienced (0, 1-2, 3-5, ≥6) during follow-up. Additionally, subgroup analyses were conducted to assess the association of AEs with mean HRU and costs among patients receiving specific regimens. All analyses were descriptive in nature.Results :In total, 783 patients with MCL (median age, 65 years [range, 19-99 years]) met the study selection criteria. Mean (standard deviation [SD]) all-cause and MCL-related monthly costs were $8393 ($16,276) and $6730 ($14,779), respectively. Inpatient admission costs ($4817 [$14,267]) and office visit costs ($1493 [$3250]) were the largest drivers of total all-cause costs. Among patients receiving systemic therapies, mean all-cause monthly costs were highest for rituximab/cyclophosphamide/doxorubicin/vincristine (R-CHOP), followed by ibrutinib monotherapy, bendamustine/rituximab (B-R), and rituximab alone (including rituximab maintenance therapy) (Figure 1); prescription drug costs were highest in patients receiving ibrutinib ($14,038 [$21,936]). The median length of stay per all-cause inpatient admission was 3.0 days (range, 2-4) among patients with no AE, which increased to 5.2 days (range, 1-50) among those with six or more AEs, as observed during all available follow-up (Figure 2). A corresponding increase in the length of stay per admission was also observed, with increasing numbers of AEs. The mean (SD) all-cause monthly costs were $4298 ($10,082) among those with no AEs and more than twofold higher ($10,335 [$16,868]) among those with at least six AEs during follow-up (Figure 3).Conclusions :This is the largest series of patients with MCL in which real-world economic burden data have been reported. Our results demonstrate that the economic burden of MCL is substantial, with mean monthly costs varying considerably by treatment regimen and care setting. We found that inpatient admissions and office visits were the largest drivers of total costs for patients treated with R-CHOP, B-R, and rituximab, while prescription drug costs were the largest component of total costs for patients receiving ibrutinib. Patients experiencing more AEs were observed to have higher monthly costs than those experiencing few AEs. [Display omitted] DisclosuresKarve:AstraZeneca: Employment, Other: Stocks. Nagar:RTI Health Solutions: Research Funding. Goyal:RTI Health Solutions: Research Funding. Kaye:RTI Health Solutions: Research Funding. Mato:Regeneron: Research Funding; TG Therapeutics: Membership on an entity's Board of Directors or advisory committees, Research Funding; Portola: Research Funding; Janssen: Consultancy; Pharmacyclics: Research Funding; DTRM: Research Funding; Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees; Gilead Sciences, Inc.: Membership on an entity's Board of Directors or advisory committees; AbbVie: Consultancy, Research Funding; Acerta: Research Funding; AstraZeneca: Consultancy; Kite: Consultancy.

PRS5 Direct Medical and Mortality Related Costs Among COPD Patients in the United States, 2017-2018

This study aims to provide a nationally representative estimate of the economic burden of chronic obstructive pulmonary disease (COPD) by examining direct medical costs, out-of-pocket costs, frequently used and expensive prescription drugs, and mortality costs among individuals aged >=45 years in the United States (US). Data from the Medical Expenditure Panel Survey (2017-2018) and WONDER online tool were used to estimate the direct medical costs and mortality costs associated with COPD. COPD-related costs were determined for the various service categories by: 1) using the sum of disease-specific medical expenditures (attribution) approach; and 2) calculating the incremental expenditures using a two-part regression-based statistical approach. Mortality costs were determined using the value of statistical life approach. The number of patient-years with COPD over two years in a total sample of 23,590 patient-years was 1,073. Among COPD patients, using the attributable costs approach, the mean annual COPD-related costs per patient were 2018 US $3,385.57 (Standard Error (SE): 276.33). Using the incremental expenditures approach, the mean annual COPD-related costs per patient were $3954.49 (SE: 578.47). The mean out-of-pocket costs for COPD-related expenses among COPD patients was $255.34 (SE: 26.10) per patient-year which contributed to 11.88% of the total prescription drug costs. Further, the 5 most commonly prescribed COPD-related prescription drugs were Spiriva, Symbicort, Ventolin HFA, Proair HFA, and Albuterol. Likewise, the most burdensome COPD-related prescription drugs among COPD patients were in a descending order Spiriva, Symbicort, Advair diskus, Bronchodilator combinations, and Breo ellipta. Mortality related costs associated with a COPD patient were estimated at $1,543.86 billion. This study provides updated estimates of the significant economic burden of COPD among a nationally representative sample of individuals across multiple payers in the US. Our results also quantify the significant mortality related costs of COPD as well as economic burden of comorbidly in COPD in the US.

Characterizing patient assistance program use and patient responsiveness to specialty drug price for multiple sclerosis in a mid-size integrated health system.

BACKGROUND: There is concern that increasingly common use of patient assistance programs (PAPs), out-of-pocket assistance provided by manufacturers or foundations, distorts our understanding of patient behavior and insurance design incentives. Yet the current literature on prescription drug cost sharing largely overlooks their use. PAPs prevalence and impact on drug demand and price elasticity is a major knowledge gap. OBJECTIVE: To examine the use of PAPs among patients with multiple sclerosis (MS) and the association with drug demand in a specialty pharmacy program within a regional integrated health system that facilitates their use. METHODS: We used pharmaceutical claims data from December 2017 to December 2018 linked to detailed payer information from Kaiser Permanente Washington to characterize the prevalence of PAPs for users of 7 MS specialty drug molecules. We estimated price elasticity of demand (PED) in a two-part model by using the presence of copayment assistance as a source of cost variation. The first part estimated marginal probability of a claim in a given month with a probit model, comparing PAP users and nonusers, whereas the second part estimated days supplied of a medication, given a claim was made as a measure for demand. RESULTS: Of 789 unique patients, 480 (60.7%) used PAPs in at least 1 drug claim during the 13-month time frame, and 248 patients (31.4%) used PAPs for all of their MS drug claims. When used, copay assistance covered 100% of out-of-pocket (OOP) charges for 98% of claims and reduced patient annual OOP cost by $3,493 on average. People who used PAPs had much higher OOP charges, a lower Charlson comorbidity score, and were more likely to have insurance through an exchange. The OOP costs charged to patients was higher for claims where patient assistance was used than claims where assistance was not used ($294 vs $42, P < 0.001). Total claim amount was higher for claims that used assistance ($6,169) than claims that did not ($5,503, P < 0.001). The probability of a patient having a drug claim in a given month was 1.9% higher among those using patient assistance, although this finding was not significant (P = 0.258). An average change in price of -$168.21 with PAP use led to an average change in demand of -0.05 days, for an overall price elasticity of demand (SD = 0.028, P = 0.852) given PAP use of 0.005, indicating that the presence of PAPs did not significantly affect demand. PED estimates were not statistically significant by drug, and the exclusion of Medicare patients did not change this interpretation. CONCLUSIONS: In a mid-size integrated health system in the state of Washington, a program that promotes adherence to specialty drugs via facilitated PAP use was found to reduce patient OOP costs but had no effect on prescription drug utilization. Payers may consider embracing PAPs to remove patient financial barriers to necessary medications and use tools other than cost sharing to influence patient consumption of specialty drugs. DISCLOSURES: This manuscript was funded in part through a Pre-Doctoral Fellowship in Health Outcomes from the PhRMA Foundation awarded to Brouwer for the completion of her dissertation work. Yeung receives some salary support from Kaiser Permanente. The other authors have nothing to disclose.

Correlation Between Changes in Brand-Name Drug Prices and Patient Out-of-Pocket Costs

List prices set by manufacturers for brand-name prescription drugs in the US have been increasing faster than inflation, although confidential manufacturer rebates offset some of these increases. Most commercially insured patients pay at least some out-of-pocket costs for prescription drugs, and higher patient spending is associated with lower adherence and worse health outcomes. To examine whether price changes for brand-name drugs are correlated with changes in patient out-of-pocket spending and whether this association varies by insurance benefit design. A cohort study of 79 brand-name drugs with available pricing data from January 2015 to December 2017 was conducted, with data obtained from a national commercial insurance claims database. Change in the list prices set by manufacturers and estimated net prices after rebates among non-Medicaid payers. Change in median out-of-pocket spending among all patients and stratified by insurance pharmacy benefit design, including high-deductible insurance plans and plans with any amount of deductibles or coinsurance. Among 79 drugs, median increases were 16.7% (interquartile range [IQR], 13.6%-21.1%) for list prices, 5.4% (IQR, -3.9% to 11.7%) for net prices, and 3.5% (IQR, 1.4%-9.1%) for out-of-pocket spending from 2015 to 2017. Changes in list prices were correlated with changes in net prices (r = 0.34; P = .002). Overall, changes in out-of-pocket spending were not correlated with changes in list prices (r = 0.14; P = .22) or net prices (r = 0.04; P = .71). Among 53.7% of patients who paid any drug deductible or coinsurance, median out-of-pocket spending increased by 15.0%, and changes were moderately correlated with changes in list prices (r = 0.38; P = .001) but not net prices (r = 0.06; P = .62). Some commercially insured patients who pay only prescription drug copayments appear to be insulated from increases in drug prices. However, more than half of patients pay deductibles or coinsurance and may experience substantial increases in out-of-pocket spending when drug prices increase. Among these patients, there was no evidence that manufacturer rebates to insurers are associated with patients' out-of-pocket spending. Policies to rein in unregulated annual increases in list prices for brand-name drugs may have important consequences for patient out-of-pocket spending.

Economic Burden of Treatment-Resistant Depression among Adults with Chronic Non-Cancer Pain Conditions and Major Depressive Disorder in the US.

Major depressive disorder (MDD) and chronic non-cancer pain conditions (CNPC) often co-occur and exacerbate one another. Treatment-resistant depression (TRD) in adults with CNPC can amplify the economic burden. This study examined the impact of TRD on direct total and MDD-related healthcare resource utilization (HRU) and costs among commercially insured patients with CNPC and MDD in the US. The retrospective longitudinal cohort study employed a claims-based algorithm to identify adults with TRD from a US claims database (January 2007 to June 2017). Costs (2018 US$) and HRU were compared between patients with and without TRD over a 12-month period after TRD/non-TRD index date. Counterfactual recycled predictions from generalized linear models were used to examine associations between TRD and annual HRU and costs. Post-regression linear decomposition identified differences in patient-level factors between TRD and non-TRD groups that contributed to the excess economic burden of TRD. Of the 21,180 adults with CNPC and MDD, 10.1% were identified as having TRD. TRD patients had significantly higher HRU, translating into higher average total costs (US$21,015TRD vs US$14,712No TRD) and MDD-related costs (US$1201TRD vs US$471No TRD) compared with non-TRD patients (all p< 0.001). Prescription drug costs accounted for 37.6% and inpatient services for 30.7% of the excess total healthcare costs among TRD patients. TRD patients had a significantly higher number of inpatient (incidence rate ratio [IRR] 1.30, 95% CI 1.14-1.47) and emergency room visits (IRR 1.21, 95% CI 1.10-1.34) than non-TRD patients. Overall, 46% of the excess total costs were explained by differences in patient-level characteristics such as polypharmacy, number of CNPC, anxiety, sleep, and substance use disorders between the TRD and non-TRD groups. TRD poses a substantial direct economic burden for adults with CNPC and MDD. Excess healthcare costs may potentially be reduced by providing timely interventions for several modifiable risk factors.