Drug Expenditures Research Articles

BIOSIMILAR MEDICINAL PRODUCTS – LEGISLATIVE DECISIONS AND MARKET ENTRY

Biosimilar drugs, structurally identical and manufactured similarly to original biologic drugs, offer potential cost reductions in therapeutic practice, albeit with variations in adoption across European countries. This review synthesizes findings from literature examining legislative decisions and their effects on biosimilar market entry in Europe. Drawing from scientific articles and official documents, the review reveals that biologics constitute 36% of European drug expenditure, with the market valued at €78.6 billion in 2021 and growing annually at 10.5% over the past five years. Approximately 15% of new active substances centrally approved by the EMA in 2020 were biologics. The European biosimilars market is projected to reach €8.8 billion in 2021. Various measures are being implemented to boost biosimilar uptake, including pricing strategies, reimbursement policies, and substitution practices. Access, measured in terms of availability and time to entry, is still difficult in a number of countries, but legislative measures are helping biosimilars enter European markets more quickly.

Consumption and expenditure of antidepressants and anxiolitycs in 14 European countries

Abstract Background Since the burden of depressive and anxiety disorders, assessing the use and spending of drugs commonly prescribed for treating such conditions is a valuable barometer of mental health assistance and healthcare services. The current research aims to evaluate the consumption of antidepressants and anxiolytics and the relative expenditure among 14 European countries (Austria, Czech Republic, Finland, Germany, Hungary, Italy, Latvia, Luxembourg, Norway, Portugal, Slovak Republic, Slovenia, Spain and Sweden). Methods A retrospective longitudinal study was assessed based on pooled time series analysis of secondary data over ten years (2012-2021). Defined Daily Doses (DDD) per 1,000 inhabitants and health expenditure per capita (current US$, computed on purchasing power parity) were considered. Linear and quadratic trends were calculated for defining relationships between the variables of interest. Results Prevailing patterns of consumption and spending show an increase in antidepressants and a decrease in anxiolytics. Noteworthy is the growth slope of antidepressant consumption in three selected countries, Portugal, Spain, and Sweden, by over two and a half times from 2012 to 2021. In addition, for a few countries, there is a pattern contrary to most countries for anxiolytics (Latvia, Spain) and discordant between consumption and expenditure for antidepressants (Austria, Hungary). Conclusions The widespread growth of antidepressant use deserves attention. As a public health issue, the prescription and use of antidepressants should be addressed by targeted policies for integrating multifaceted strategies. Key messages • Monitoring consumption and expenditure of antidepressant and anxiolytic drugs represents a valid tool for assessing the efficacy and availability of mental healthcare services among the population. • The growth in the consumption of antidepressants represents a relevant public health issue and deserves attention for the evaluation of an integrated approach of assistance.

Taxpayers' Share of US Prescription Drug and Insulin Costs: a Cross-Sectional Study.

Drug prices affect government budgets directly through spending on public programs like Medicare and Medicaid, and indirectly via private coverage for public employees and tax subsidies for private insurance. Yet, the Senate parliamentarian ruled that the Senate could not use streamlined Budget Reconciliation to extend the Inflation Reduction Act's controls on insulin co-payment or drug prices to private insurers on the grounds that their expenditures do not affect the federal budget. To quantify insulin and other drug costs borne by federal, state, and local governments, including direct expenditures and indirect government subsidies that flow through private insurers. Cross-sectional analysis of expenditures for outpatient retail prescription drugs reported by respondents and their pharmacies in the 2019 Medical Expenditure Panel Survey (adjusted downward for drug rebates), supplemented with information on employment-related insurance from the US Office of Management and Budget and other sources. The civilian non-institutionalized US population. Direct (payments by public health insurance programs) and indirect (taxpayer-funded payments via private insurers) government expenditures for outpatient retail drugs. Direct government expenditures for outpatient retail prescription drugs totaled $154.85 billion in 2019, including $15.68 billion for insulin. Indirect government expenditures channeled through private insurers totaled $53.59 billion (including $5.48 billion for insulins). Those indirect expenditures encompassed $32.32 billion in tax subsidies for employer-sponsored private coverage, $25 million for subsidies to private Affordable Care Act marketplace plans, and $21.24 billion for government-paid premiums for public employees and retirees. Overall, government expenditures for outpatient retail prescription drugs totaled $208.44 billion, 58.76% of all-payer spending and 65.96% of spending for insulin. Governments directly or indirectly fund most drug purchases, including substantial expenditures that flow through private insurers. Hence, prices paid by private insurers impact government budgets, supporting the view that government should be allowed to regulate drug prices.

Evaluation of Intravenous Immunoglobulin Usage in a Teaching Hospital: A Case Series Study in Kerman, Iran

Background: Assessing the utilization of intravenous immunoglobulin (IVIG) is crucial due to its high cost and limited availability. IVIG preparations are utilized in various disorders. This study aimed to investigate the prescribing and consumption patterns of IVIG at Kerman Afzalipour Hospital and to propose strategies for reducing drug expenditures. Materials and Methods: Over one year, physician orders and patient charts of individuals treated with IVIG were reviewed to collect data. Descriptive statistics were employed for data analysis using SPSS software. Results: During the study period, 62 IVIG administrations were documented at the hospital, with 54.1% involving female patients. Of these, 51.4% were prescribed for labeled indications, while 48.6% were for off-label indications. No contraindications were observed, although precaution was warranted in 9.6% of cases, which was not consistently addressed, and laboratory parameters were not evaluated in any case. Conclusion: This study reveals that IVIG infusions for off-label indications were nearly as frequent as those for labeled indications.

Real-World Comparative Analysis of Trastuzumab Originator and Biosimilars: Safety, Efficacy, and Cost Effectiveness.

Despite the global use of trastuzumab biosimilars, concerns remain regarding their efficacy and safety. In particular, when used concurrently with pertuzumab, trastuzumab biosimilars lack extensive real-world data and safety information. Additionally, as cancer drug expenditures continue to rise worldwide, cost savings from biosimilars have become increasingly important. This study aims to assess the safety, efficacy, and cost effectiveness of trastuzumab originators and their biosimilars in real-world clinical settings, focusing on a large patient population. The analysis included 31,661 patients with HER2-positive breast cancer from the Medical Data Vision Co., Ltd. database in Japan. Additionally, adverse event reports for the trastuzumab originator and its biosimilars were obtained for 58,799 patients from the World Health Organization's VigiBase, the global adverse event reporting database. No significant differences were observed in heart failure hospitalizations, liver dysfunction, or infusion reaction rates in both the Medical Data Vision Co., Ltd. database and the World Health Organization's VigiBase. In the Medical Data Vision Co., Ltd. database, the addition of pertuzumab did not significantly influence the incidence of adverse events, and the use of biosimilars significantly reduced medical costs, with no significant difference in breast cancer recurrence rates. By analyzing two large and diverse datasets from multiple perspectives, we obtained reliable results that the trastuzumab originator and its biosimilars have similar safety profiles. The concurrent use of pertuzumab was also found to be safe. The use of biosimilars can lead to cost savings. These findings provide crucial insights for the evaluation and adoption of biosimilars in clinical practice.

The impact of oral oncology drugs in the era of value-based care.

15 Background: Oncology drug expenditures are a significant contributor to increasing total cost of care (TCOC). Oral oncolytics (OO), such as small molecule inhibitors (CDK 4/6 inhibitors, tyrosine kinase inhibitors, etc.), and immunomodulators, have revolutionized the treatment landscape for many cancers. We evaluated the patterns of OO use and spend for Medicare patients over time at a large community oncology practice participating in the Center for Medicare and Medicaid Innovation (CMMI)’s Value-based care (VBC) Program, the Oncology Care Model (OCM), with a focus on the seven cancers that are part of a successor model, the Enhancing Oncology Model. Methods: Using CMMI claims for attributed 6-month OCM episodes, we evaluated drug use and expenditures by performance period (PP) from July 2016 – June 2022 (11 PPs), with an emphasis on OO drugs. We used Part D expenditures as a proxy for OO. Results: From 2016-22, average TCOC per PP increased by 15.5% in the 7 EOM diagnoses (breast, lung, colon, prostate cancer, myeloma, lymphoma, and chronic leukemia). Average drug expenditures per PP grew 33% percent and represented 71% of total cost by PP11, up from 61% in PP1. Average expenditures per episode increased by 11.7% for Part B and 82.6% for Part D drugs (p<0.01). Increase in Part D drug expenditures was partly due to an increase in the number of unique oral drugs which grew by 32% over the evaluation period. The greatest increases in Part D drug expenditures occurred in breast cancer (87%) and lymphoma (153.7%). Table reports average OO expenditures per PP, percent change from PP1 to PP11, and the change in the % Part D drugs contributed to TCOC. Conclusions: Increases in drug expenditures represent the greatest impact on TCOC for cancer patients. OO medicines have an increasing role in the treatment landscape and represent a growing focus in VBC models. Utilization and cost of OO medication have a significant bearing on VBC performance. Diagnosis Avg. OO Expenditures PP1 Avg. OO Expenditures PP11 Avg. OO Expenditures Change Contribution of OO to TCOC Change from PP1 - 11 Breast $4,208 $7,869 87.0% 9.9% Leukemia $25,334 $41,128 62.3% 19.9% CRC $1,206 $2,158 78.9% 3.1% Lung $3,650 $3,625 -0.7% -2.5% Lymphoma $4,193 $10,637 153.7% 13.0% Myeloma $25,109 $39,298 56.5% 6.7% Prostate $18,815 $20,114 6.9% 3.2% Total $8,291 $15,140 82.6% 10.8%

Predicted Expenditure for Prescription Drugs for Multiple Sclerosis in the Italian Market Between 2023 and 2028: Results of the Oracle Project.

Multiple sclerosis (MS) is a chronic neurodegenerative disease that leads to impaired cognitive function and accumulation of disability, with significant socioeconomic burden. Serious unmet need in the context of managing MS has given rise to ongoing research efforts, leading to the launch of new drugs planned for the near future, and subsequent concerns about the sustainability of healthcare systems. This study assessed the changes in the Italian MS market and their impact on the expenditures of the Italian National Healthcare Service between 2023 and 2028. A horizon-scanning model was developed to estimate annual expenditure from 2023 to 2028. Annual expenditure for MS was calculated by combining the number of patients treated with each product (clinical inputs) and the yearly costs of therapy (economic inputs). Baseline inputs (2020-2022) were collected from IQVIA® real-world data, while input estimation for the 5-year forecast was integrated with analog analyses and the insights of clinicians and former payers. The number of equivalent patients treated in 2028 in Italy was estimated at around 67,000, with an increase of 10% versus 2022. In terms of treatment pattern evolution, first-line treatments are expected to reduce their shares from 47% in 2022 to 27% in 2028, and Bruton tyrosine kinase inhibitors are expected to reach 23% of patient shares. Overall, expenditure for MS is estimated to decrease from €721 million in 2022 to €551 million in 2028, mainly due to losses of exclusivity and renegotiation of drug prices. Despite the increase in the number of patients treated for MS and the launch of new molecules that will reach high market penetration, the model confirmed sustainability for the Italian National Healthcare Service.

Systemic barriers to access pharmaceutical-sponsored patient assistance programs: Implications for health equity and care delivery at safety-net systems.

107 Background: The rising cost of cancer care, driven in large by oncology drugs, has a significant impact on access to care and contributes to disparities. Pharmaceutical-sponsored patient assistance programs (PAPs) are intended to improve access to care; however, vulnerable populations may experience delays, denials, and treatment interruptions due to complexity of the application process and variable qualifying requirements. We present the impact of a pharmacy-run process to facilitate access to PAPs at a safety-net institution. Methods: Parkland Health (PH) is the safety-net system for Dallas County, which has one of the highest uninsured rates in the US. PH provides free health care to uninsured patients below 250% of the federal poverty income level. Hematology-Oncology patients who are prescribed medications with an existing PAP are identified in a work queue within the EHR. A team of licensed pharmacy technicians - Medication Access Technicians (MATs) - screen patients and if eligible, assist in filling and submitting the application, and follow up with PAP sponsors to ensure timely review and approvals. MATs also monitor refills and assist in PAP renewals to prevent interruptions in care. In this study, we used the average wholesale price to quantify the value of the medications provided through PAPs. Data for 10/01/22 through 09/30/23 are presented here. Results: During the study period, MATs enrolled 548 uninsured patients (90% Hispanic/Black) in PAPs for 38 unique clinic-administered drugs, with an estimated value of 45.2 million (M), averaging 78,853 per patient. The highest value and most common clinic-administered PAP drugs were pembrolizumab (96 patients, $8 M) and rituximab (159 patients, $5 M), respectively. For oral agents, MATs enrolled 77 uninsured patients (84% Hispanic/Black) in PAPs for 20 unique medications with an estimated value of 8.8 M, averaging 114,711 per patient. Dasatinib was both the most common and highest value PAP oral drug, with 24 patients and an estimated value of 3.6 M. Of the 38 PAPs for clinic-administered drugs, 25 did not include replacement for dispensed medications. Legal US residence was required by 7 PAPs. The institutional investment by PH (MAT salaries) is estimated at 620,000 annually. Conclusions: A dedicated team of MATs at PH facilitated access to care through PAP enrollments, reduced treatment interruptions by renewing applications, and reduced institutional drug expenditure, allowing investment in other care delivery initiatives. PAPs are philanthropic by nature and requirements such as legal residence and no-replacement for dispensed medications may negatively impact specific segments of our communities, or result in treatment delays. Advocacy by professional organization and patient groups is warranted to expand access to these potentially life-saving programs.

Budget impact analysis of high-priced orphan medicinal products intended for the treatment of rare diseases in China: evidence from a densely populated metropolis of Chengdu

BackgroundAn increasing number of orphan medicinal products (OMPs) are being included in social health insurance schemes, significantly improving access to medicines for patients with rare diseases. However, high-priced OMPs are still not covered, primarily due to health equity controversies and inadequate data systems required for economic evaluation. The aim of this study was to estimate the burden of drug expenditures and the size of the reimbursement budget required for high-priced OMPs from the perspectives of society and healthcare payers.MethodsThe study performed a budget impact analysis using data from multiple sources to estimate the reimbursement budget for high-priced OMPs in Chengdu, a densely populated metropolis in China. The budget analysis consisted of three main elements: the number of patients, the price of drugs, and the simulated policy scenario. By adjusting the combinations of these elements, the budget fluctuations for payers were estimated. Furthermore, the study predicted the budget trend for the next three years to validate its sustainability.ResultsThe analysis indicated that 98 rare disease patients in Chengdu required high-priced OMPs in 2019. This suggested a projected budget of CNY 179 million for these patients without reimbursement policies, from a societal perspective. Under six assumed policy scenarios, this budget ranged from CNY 32 million to CNY 156 million. Over the next three years, the annual budget was estimated to range from CNY 200 million to CNY 1.303 billion.ConclusionIntegration of multi-source data helps to obtain more scientifically reliable results on budget impacts. The study found that the budgetary impacts of high-priced OMPs on society and payers are relatively limited. Health policymakers can choose appropriate reimbursement strategies based on financial affordability among a diverse mix of elements. The results of related studies provided insights for optimizing the allocation of health resources and improving patient access to medications.

Trends of drug expenditure in Taiwan National Health Insurance before and during COVID-19 pandemic.

The Taiwanese government adopted the National Health Insurance (NHI) system in March 1995. This study aimed to understand the difference in medication costs before (year 2019) and during the COVID-19 pandemic (2020-2021) among different hospitals for treating their patients. The NHI claims database consisting of claims of prescription drugs for inpatients (IPD) and outpatients (OPD) in Taiwan was used to determine drug expenditure in different hospitals, particularly the top 10 prescription Anatomical Therapeutic Chemical (ATC) categories. In medical centers, L01X (other antineoplastic agents) showed the highest drug expenditure, followed by L04A (immunosuppressants) and J05A (direct-acting antivirals). The drug expenditure pattern in regional hospitals was similar to that in medical centers, with L01X (other antineoplastic agents) showing the highest drug expenditure. L01X (other antineoplastic agents) also showed the highest drug expenditure in district hospitals, followed by N05A (antipsychotics) and A10B (blood glucose-lowering drugs, excluding insulin). In clinics, A10B (blood glucose-lowering drugs, excluding insulin) showed the highest drug expenditure. The total medication costs in 2021 were lower or similar to those in 2019. The use of systemic use anti-infectives decreased over time in OPDs among all hospita1 levels but increased in IPDs in medical centers and district hospitals. Furthermore, our analysis revealed that the trend in drug expenditure closely mirrored the trend in drug prescription volume for the highest annual sum cost item among the top 10 drug subgroups across different hospital levels. Our analysis found that annual drug expenditures in 2021 were lower or similar to those in 2019, suggesting that the COVID-19 pandemic has contributed to this reduction in drug expenditure.

Real-World Amount of Clotting Factor Products and Non-Factor Products Dispensed and Annual Medical Expenditures for Japanese Patients with Haemophilia A.

Treatment for haemophilia A has expanded from plasma-derived factor VIII (pdFVIII) and standard half-life (SHL) recombinant FVIII (rFVIII) to extended half-life (EHL) rFVIII and non-factor products that mimic FVIII activity. To determine amounts of clotting factor concentrates (CFCs) and emicizumab dispensed and associated healthcare expenditures in Japanese patients with haemophilia A. This retrospective, non-interventional, observational study analysed data from 2016 to 2020 from a large-scale, hospital-based administrative database. Patients had haemophilia A without inhibitors and ≥ 2 prescriptions of the same CFC or emicizumab. In total, 974 patients with haemophilia A (median age, 30.0 years; median follow-up, 3.7 years) were included. Outpatient use of EHL rFVIII and emicizumab increased, although pdFVIII/SHL rFVIII were still used over the study. Median annual total healthcare expenditures/patient increased from ¥9,200,230 in 2016 to ¥19,748,221 in 2020. Overall, the median annual drug expenditure/patient increased from ¥8,723,120 in 2016 to ¥18,051,689 in 2020. Drug expenditure was highest with emicizumab, with an increase in median annual expenditure/patient from 2018 (n = 4, ¥26,030,206) to 2020 (n = 107, ¥45,430,408). Overall, 233 patients (23.9%) switched from an SHL to an EHL product. Although amounts of FVIII prescribed increased in the 3 months after switching, overall, there was no noticeable difference before and after switching. Median total healthcare and FVIII product expenditures increased following switching. Prescribing of EHL products increased over the study and healthcare expenditures increased for patients who switched from SHL to EHL rFVIII products.

Reducing Cancer Drug Cost: 3-Year Analysis of Automated Dose Rounding in Electronic Health Records.

Globally, cancer drug expenditure exceeds $185 in US dollars (USD) billion, with the United States contributing $75 (USD) billion. Many cancer drug doses are calculated on the basis of body weight or body surface area, which often results in leftover drug in partially used single-dose vials (SDVs). The cost of wasted drug is a huge financial burden on the US health care system. We evaluated the cost savings resulting from the reduction of SDV wastage, achieved through the implementation of automated dose rounding rules in electronic health records (EHRs). Mayo Clinic implemented automated dose rounding rules within the EHR. These rules were designed to round calculated doses to the nearest SDV if the vial size closely matched the original calculated dose, within a 10% threshold. We assessed doses administered between January 2019 and December 2021, and computed cost-savings, waste reduction, and cost of waste for chemotherapy drugs. In 3 years, 36.1% of doses were rounded down, 35.8% were rounded up, and 28.1% were exact doses. By rounding doses down to a vial size, we achieved cost-savings of $39.75 (USD) million and prevented 62,065 SDV of cancer drugs from going to waste. By rounding doses up, we avoided wasting $9.95 (USD) million worth of drugs. However, there were still instances where the rounding fell outside of the 10%, resulting in wasted drugs worth $25 (USD) million. The substantial burden imposed on patients and the US health care system because of cancer drug wastage is of significant concern. Although the automated dose rounding system represents a partial solution for this issue, a comprehensive approach involves the imperative development of policy and legislative solutions to effectively mitigate the challenges associated with cancer drug waste.

Management of drug supply chain information based on "artificial intelligence + vendor managed inventory" in China: perspective based on a case study.

To employ a drug supply chain information system to optimize drug management practices, reducing costs and improving efficiency in financial and asset management. A digital artificial intelligence + vendor managed inventory (AI+VMI)-based system for drug supply chain information management in hospitals has been established. The system enables digitalization and intelligentization of purchasing plans, reconciliations, and consumption settlements while generating purchase, sales, inventory reports as well as various query reports. The indicators for evaluating the effectiveness before and after project implementation encompass drug loss reporting, inventory discrepancies, inter-hospital medication retrieval frequency, drug expenditure, and cloud pharmacy service utilization. The successful implementation of this system has reduced the hospital inventory rate to approximately 20% and decreased the average annual inventory error rate from 0.425‰ to 0.025‰, significantly boosting drug supply chain efficiency by 42.4%. It has also minimized errors in drug application, allocation, and distribution while increasing adverse reaction reports. Drug management across multiple hospital districts has been standardized, leading to improved access to medicines and enhanced patient satisfaction. The AI+VMI system improves drug supply chain management by ensuring security, reducing costs, enhancing efficiency and safety of drug management, and elevating the professional competence and service level of pharmaceutical personnel.

Trends in Public Drug Plan Expenditures for Patients With Crohn Disease and Ulcerative Colitis Initiating Targeted Immune Modulator Therapy

The objective of this analysis was to examine the changes in drug expenditures with the initiation of targeted immune modulator (TIM) treatment in patients diagnosed with Crohn disease (CD) and ulcerative colitis (UC). Patient cohorts for CD and UC were identified from hospitalizations in Canada. Expenditure data for TIMs with a Health Canada–approved indication for the treatment of CD or UC were extracted from all provincial drug plans (except Quebec) and Yukon from 2016 to 2021, and a descriptive analysis was performed to assess the expenditure patterns. Annual expenditures on TIMs for patients with CD increased each year from 2016 to 2019 before decreasing in 2020 and 2021, whereas expenditures on TIMs in UC increased each year, generally by a greater percentage than was observed in CD (peak percentage growth of 92.5% for UC versus 15.9% for CD in 2018). Expenditures associated with TIM initiation among patients with CD and UC were driven by infliximab and adalimumab, with the 2 drugs accounting for nearly all expenditures in both indications in 2016 and most expenditures in 2021. In both CD and UC, vedolizumab expenditures increased over time, as did the proportions of TIM expenditures on ustekinumab in CD and tofacitinib in UC, albeit to a lesser extent than vedolizumab.

HPR111 Disease Burden and Medical Insurance Expenditure of National Price-Negotiated Drugs for Multiple Sclerosis Under Dual-Channel Model in China: A Budget Impact Model

HPR111 Disease Burden and Medical Insurance Expenditure of National Price-Negotiated Drugs for Multiple Sclerosis Under Dual-Channel Model in China: A Budget Impact Model

5-year multicenter analysis of clinical trial participation and total cost of care for older adults with cancer.

11013 Background: Clinical trial access particularly for older adults aged 65 years and above with cancer is impacted by multilevel barriers, including cost concerns to payers in the usual models of cancer care delivery. Alternative models recently studied include the Centers for Medicare and Medicaid Innovation’s Oncology Care Model (OCM), a value-based care pilot to enhance quality & reduce costs. Here, we investigated the association between clinical trial participation (CTP) and the total cost of care (TCOC) within this non-traditional model. Methods: We identified prospective longitudinal observational cohort of patients cared for in 11 states within 323 clinics in 14 multi-site community practices participating in OCM, in The US Oncology Network and extracted data (episode claims, medical records, episodes) from OCM performance periods (PP) 3-11 between 7/1/17 and 6/30/22. Propensity score matching by PP, age, gender, date of death, cancer type identified the analysis cohort of matched episodes, then stratified by trial participation (CTP vs usual care) to compare TCOC and drug expenditures. Results: Over 5 years, 121,717 unique patients (94% of whom were aged 65y+) received 282,604 episodes of cancer care in the community, most common cancers being breast, lung, multiple myeloma. Propensity score matching identified 13,260 matched episodes (6630 usual care, 6630 CTP). The actual expenditure differed by $2,341 per episode between CTP & usual care (CTP $43,890 vs usual care $41,548; p < 0.0001), while trial participation had significant savings against the OCM CTP benchmark ($4816 saved per CTP episode), compared to usual care vs its benchmark ($826 saved per usual care episode, p < 0.0001). Drug costs per episode did not differ between the two groups (CTP $29,516 vs usual care $30,553; p 0.54). Further breakdown shows that drug spending on anticancer agents (CTP $28,008 vs usual care $29,139) and other drugs including supportive care meds (CTP $1,511 vs usual care $1,414) did not differ significantly. Conclusions: Clinical trial participation saw relative cost savings against the benchmark compared to usual care, owing largely to the higher benchmark prices for CTP episodes in OCM’s risk-adjusted price prediction model, rather than an absolute cost savings to payers. Drug expenditures remain the largest contributor to total cost of care in this alternative model. The contributors to both drug expenditures as well as the absence of absolute cost savings between the two cohorts represent key areas for further investigation. CMMI Disclaimer: The statements contained in this document are solely those of the authors and do not necessarily reflect the views or policies of CMS. The authors assume responsibility for the accuracy and completeness of the information contained in this document.

Budget impact analysis of participating in sponsored clinical trials in cancer within the Colombian healthcare system: A real-world evidence approach.

e23031 Background: Clinical trials (CTs) are a key element in researching and developing new technologies for cancer. Assessing the economic impact of CTs and the potential savings for healthcare systems in Low- and Middle-Income Countries (LMICs) is vital to guide healthcare decision-making. This research aims to quantify the budget impact for the Colombian Health System of including hematology and oncology patients in sponsored clinical trials. Methods: This study uses real-world data (RWD) from CTIC, a high-complexity cancer center from Bogotá, Colombia. We followed the Budget Impact Analysis methodology defined by the local HTA agency using data for five tumors retrieved from an institutional data lake resource using clinical information and related costs. Tumors were selected based on their prevalence and economic burden. CTIC’s clinical experts validated the cost-generating events for each disease. The eligible population for phase 3 clinical trials was estimated from the literature and CTIC oncology units’ leaders’ opinions. Prevalent and incident population data were obtained from the Colombian High-Cost Account (CAC). Results: There are 7,703 potential patients to be included in CTs, representing a total cost of 217,544,023 for 2023 USD (1 USD = 4,325 COP). If at least 25% of patients with these tumors were included in CTs in 2023, the approximate cost would be 54,386,006 USD. Advanced prostate cancer represented the highest cost, given its prevalence and CT inclusion opportunity. Conclusions: With approximately USD 24 billion spent on healthcare (USD 5 billion in drugs), Colombia could save around 4% of its drug expenditure if all potential candidates were to be included in cancer CTs. Furthermore, assuming similar average costs per patient, inclusion rates, and population growth for 5-years, this could represent savings of around USD 1.1 billion. These savings would ease the reimbursement and access to innovation for Colombian patients, improving health outcomes and enhancing long-term financial sustainability. [Table: see text]

Supporting patient access to pharmaceutical-sponsored assistance programs: Implications for health equity and care delivery at safety-net systems.

e13724 Background: The ever-rising cost of cancer care, driven in large by oncology drugs, has a significant impact on access to care and contributes to disparities. Pharmaceutical-sponsored patient assistance programs (PAPs) are intended to improve access to care; however, vulnerable populations may experience delays, denials, and treatment interruptions due to complexity of the application process and variable qualifying requirements. We present the impact of a pharmacy-run process to facilitate access to PAPs at a safety-net institution. Methods: Parkland Health (PH) is the safety-net system for Dallas County, which has one of the highest uninsured rates in the US. PH provides free health care to uninsured patients below 250% of the federal poverty income level. Hematology-Oncology patients who are prescribed medications with an existing PAP are identified in a work queue within the EHR. A team of licensed pharmacy technicians - Medication Access Technicians (MATs) - screen patients and if eligible, assist in filling and submitting the application, and follow up with PAP sponsors to ensure timely review and approvals. MATs also monitor refills and assist in PAP renewals to prevent interruptions in care. In this study, we used the average wholesale price to quantify the value of the medications provided through PAPs. Data for 10/01/22 through 09/30/23 are presented here. Results: During the study period, MATs enrolled 548 uninsured patients (90% Hispanic/Black) in PAPs for 38 unique clinic-administered drugs, with an estimated value of $45.2 million (M), averaging $78,853 per patient. The highest value and most common clinic-administered PAP drugs were pembrolizumab (96 patients, $8 M) and rituximab (159 patients, $5 M), respectively. For oral agents, MATs enrolled 77 uninsured patients (84% Hispanic/Black) in PAPs for 20 unique medications with an estimated value of $8.8 M, averaging $114,711 per patient. Dasatinib was both the most common and highest value PAP oral drug, with 24 patients and an estimated value of $3.6 M. Of the 38 PAPs for clinic-administered drugs, 25 did not include replacement for dispensed medications. Legal US residence was required by 7 PAPs. The institutional investment by PH (MAT salaries) is estimated at $620,000 annually. Conclusions: A dedicated team of MATs at PH facilitated access to care through PAP enrollments, reduced treatment interruptions by renewing applications, and reduced institutional drug expenditure, allowing investment in other care delivery initiatives. PAPs are philanthropic by nature and requirements such as legal residence and no-replacement for dispensed medications may negatively impact specific segments of our communities, or result in treatment delays. Advocacy by professional organization and patient groups is warranted to expand access to these potentially life-saving programs.

Cancer Treatment Before and After Physician-Pharmacy Integration

Integration of pharmacies with physician practices, also known as medically integrated dispensing, is increasing in oncology. However, little is known about how this integration affects drug use, expenditures, medication adherence, or time to treatment initiation. To examine the association of physician-pharmacy integration with oral oncology drug expenditures, use, and patient-centered measures. This cohort study used claims data from a large commercial insurer in the US to analyze changes in outcome measures among patients treated by pharmacy-integrating vs nonintegrating community oncologists in 14 states between January 1, 2011, and December 31, 2019. Commercially insured patients were aged 18 to 64 years with 1 of the following advanced-stage diagnoses: breast cancer, colorectal cancer, kidney cancer, lung cancer, melanoma, or prostate cancer. Data analysis was conducted from May 2023 to March 2024. Treatment by a pharmacy-integrating oncologist, ascertained by the presence of an on-site pharmacy or nonpharmacy dispensing site. Oral, intravenous (IV), total, and out-of-pocket drug expenditures for a 6-month episode of care; share of patients prescribed oral drugs; days' supply of oral drugs; medication adherence measured by proportion of days covered; and time to treatment initiation. The association between an oncologist's pharmacy integration and each outcome of interest was estimated using the difference-in-differences estimator. Between 2012 and 2019, 3159 oncologists (745 females [27.1%], 2002 males [72.9%]) treated 23 968 patients (66.4% female; 53.4% aged 55-64 years). Of the 3159 oncologists, 578 (18.3%) worked in practices that integrated with pharmacies (with a low rate in 2011 of 0% and a high rate in 2019 of 31.5%). In the full sample (including all cancer sites), after physician-pharmacy integration, no significant changes were found in oral drug expenditures, IV drug expenditures, or total drug expenditures. There was, however, an increase in days' supply of oral drugs (5.96 days; 95% CI, 0.64-11.28 days; P = .001). There were no significant changes in out-of-pocket expenditures, medication adherence, or time to treatment initiation of oral drugs. In the breast cancer sample, there was an increase in oral drug expenditures ($244; 95% CI, $41-$446; P = .02) and a decrease in IV drug expenditures (-$4187; 95% CI, -$8293 to -$80; P = .05). Results of this cohort study indicated that the integration of oncology practices with pharmacies was not associated with significant changes in expenditures or clear patient-centered benefits.

Impact of Socioeconomic Factors and Health Insurance Coverage on Out-of-Pocket Health Expenditure among Ghanaian Women: Implications for Health Financing Policy

Background. The cost of health financing is an age-long social challenge in resource-constrained settings. Out-of-pocket (OOP) health spending adversely affects maternal healthcare provisions and use, making health insurance one of the most effective social interventions. Objective. The purpose of this research was to study the effect of OOP health expenditure on socioeconomic factors and health insurance coverage among Ghanaian women. Materials and Methods. Secondary statistical data pulled out from Ghana Demographic and Health Survey (GDHS)—2014 was investigated. A sample of 9,396 women whose ages ranged from 15 to 49 years was studied. We used marginal predictive model to examine the interaction effect between socioeconomic factors and health insurance coverage on OOP health expenditure. The significance level was determined at 5%. Results. Overall, about 41.9% (95% CI: 39.4%−44.4%) of Ghanaian women reported OOP health expenditure for drugs and services. Amongst those covered by health insurance, this was 37.9% (95% CI: 35.3%−44.4%). The marginal interaction effects of OOP health expenditure were higher for women in the lowest neighborhood socioeconomic disadvantage group (42.6%) than those in the highest neighborhood socioeconomic disadvantage group (26.0%) who were covered by health insurance. In addition, the marginal interaction effects of OOP health expenditure were found to be greater among women who had higher education (43.8%) compared with those who had no formal education (34.0%) who were covered by health insurance. Furthermore, the marginal interaction effects of OOP health expenditure were higher for rural (39.0%), than their urban counterpart (36.6.0%) who were under the covering of health insurance. Conclusion. There is a gap in health insurance coverage, which leads to increased OOP health expenditure. The OOP health expenditure effect was more concentrated among high socioeconomic women with health insurance. The healthcare system’s stakeholders should implement policies aimed at eliminating OOP health expenditure for maternal health services.