Third-party Payers Research Articles

Implementing a Bundle to Improve Surgical Site Infection Rates for Patients Undergoing Nonvaginal-Approach Hysterectomy at a Midwestern Teaching Hospital.

Accrediting organizations, third-party payers, and patients review the surgical site infection (SSI) rates of health care organizations. Infection preventionists collaborate with perioperative personnel to decrease SSI rates; they also monitor and report SSI information to national organizations. The standard infection ratio is a comparison of the observed number of SSIs to the predicted number of SSIs based on national benchmark data. Leaders of a midwestern teaching hospital convened an interdisciplinary team (eg, surgeons, perioperative leaders, infection preventionists) to address a standard infection ratio after hysterectomies that was greater than 1.0. The team reviewed national guidelines and published articles on decreasing SSIs (including recommendations for vaginal preparation) before developing and implementing a hysterectomy-specific bundle for SSI prevention. The rate of SSIs decreased 68% after the implementation of the bundle. Perioperative personnel at this facility continue to use the bundle and infection preventionists monitor and report compliance with the bundle's elements.

Access to medication for opioid use disorder supported by telemedicine and healthcare coverage: A web-based survey during the COVID-19 pandemic

Background and AimsMedications for opioid use disorder (MOUD) are highly effective in improving treatment outcomes and reducing overdose. Concerns about interrupted access to critical MOUD services led to expansion of telemedicine services during the COVID-19 pandemic in the US. The current study tested the hypothesis that telemedicine usage and healthcare coverage would be significantly associated with access to MOUD in the early phase of the COVID-19 pandemic. DesignA cross-sectional online survey was administered to a non-probability sample from June 18-July 19, 2020 using the Amazon Mechanical Turk platform. SettingNortheastern United States during the early phase of the COVID-19 pandemic. At the time of the survey, federal regulators had waived the longstanding requirement for in-office visits for MOUD prescription receipt and provided guidance on increasing third-party payer reimbursement rates for telehealth visits in order to mitigate barriers to care associated with COVID-19 safety guidelines. ParticipantsIndividuals 18 years or older residing in Connecticut, Massachusetts, New Jersey, New York, or Rhode Island were eligible to complete the survey. The analytic sample was participants who reported using opioids not as prescribed by a physician in the past seven days. MeasurementsDemographics, telemedicine usage, and healthcare coverage were assessed as explanatory variables. The primary outcome was whether participants reported ability to access MOUD in the past four weeks. FindingsIn this sample of individuals who used illicit opioids in the past week (N = 191), one in two individuals who utilized telehealth or had healthcare coverage were able to access MOUD, whereas only one in five of their respective counterparts who did not have telehealth access or healthcare coverage were able to access these medications. ConclusionsTelemedicine and healthcare coverage were associated with greater MOUD access early in the COVID-19 pandemic, when barriers to care were high. Such findings speak to the importance of not only extending but also formalizing temporary policy changes instituted during the pandemic to allow MOUD prescribing via telemedicine.

Abstract P211: Expedited Versus Standard Postpartum Discharge In Patients With Hypertensive Disorders Of Pregnancy

Background: A hospital stay after an uncomplicated delivery is ~2 days for vaginal birth and ~3 days for cesarean birth. Hospitals and third-party payers have encouraged shorter maternity stays. The safety of earlier discharge is unclear particularly when it comes to patients with hypertensive disorders of pregnancy (HDP). Our aim was to examine whether expedited discharge (1 day after vaginal and 2 days after cesarean birth) has a negative effect on postpartum course and BP after HDP. Methods: A retrospective cohort study of patients with HDP (gestational hypertension, preeclampsia, chronic hypertension) during 2 epochs: 2015-2018, prior to implementation of expedited discharge, and 2019-2020, after implementation of expedited postpartum discharge. The primary outcome was unplanned health care utilization postpartum, defined as emergency room (ER) visits, clinic visits, and hospital readmission. Secondary outcomes were planned postpartum visit attendance and BP control during the 1st year. Bivariate and multiple logistic and linear regressions were run to evaluate the association between expedited discharge and study outcomes. Results: A total of 1441 patients were analyzed. There were no differences in ER or clinic visits or readmission for BP between expedited and standard postpartum discharge (table). Systolic and diastolic BP at 1-2 weeks, 6 weeks, and 1 year postpartum were similar in both groups. Expedited discharge was associated with higher likelihood of attending BP check at 1-2 weeks postpartum (aOR 1.33, 95% CI 1.08-1.77). Conclusion: Expedited discharge after HDP was not associated with BP complications or unplanned healthcare utilization postpartum.

Adverse event costs associated with first-line therapy for advanced non-small cell lung cancer in the United States: An analysis of clinical trials of immune checkpoint inhibitors.

BACKGROUND: Immune checkpoint inhibitors, such as pembrolizumab, nivolumab, and atezolizumab, have demonstrated substantial survival benefits in patients with advanced non-small cell lung cancer (NSCLC). However, there is limited evidence on their relative safety profiles and adverse event (AE)-related cost burden. OBJECTIVE: To compare the AE management costs of nivolumab plus ipilimumab with and without limited chemotherapy with those of chemotherapy, pembrolizumab plus chemotherapy, and atezolizumab plus chemotherapy in a first-line setting among patients with advanced NSCLC. METHODS: The mean per-patient AE costs were estimated using the incidence of all-cause grade 3/4 AEs with any-grade incidence greater than or equal to 15% and the corresponding costs of AE management in the inpatient setting. AE rates were obtained from individual patient data from the CheckMate 227 and CheckMate 9LA trials for nivolumab plus ipilimumab with/without limited chemotherapy and aggregated data from the KEYNOTE-189 and KEYNOTE-407 trials for pembrolizumab plus chemotherapy and the IMpower130 trial for atezolizumab plus chemotherapy. AE management costs from the third-party payer perspective were estimated based on inpatient medical costs from the 2016 United States Healthcare Cost and Utilization Project National Inpatient Sample. All costs were inflated to 2020 US dollars. RESULTS: Nivolumab plus ipilimumab and nivolumab plus ipilimumab plus limited chemotherapy were associated with lower per-patient grade 3/4 AE costs compared with chemotherapy ($1,708 and $624 lower over the treatment course, respectively). Compared with pembrolizumab plus chemotherapy, nivolumab plus ipilimumab was associated with lower grade 3/4 AE costs in patients with nonsquamous histology (difference: -$4,866) and squamous histology (difference: -$3,795), and nivolumab plus ipilimumab with limited chemotherapy also had lower AE costs for both nonsquamous (difference: -$2,800) and squamous (difference: -$2,753) disease. Similarly, nivolumab plus ipilimumab and nivolumab plus ipilimumab plus limited chemotherapy were also associated with lower AE costs ($11,400 and $8,809 lower, respectively) compared with atezolizumab plus chemotherapy among patients with nonsquamous disease. In particular, nivolumab plus ipilimumab without or with limited chemotherapy were associated with much lower AE costs of hematological AEs compared with chemotherapy and other immune checkpoint inhibitor-based treatments in combination with a full course of chemotherapy. CONCLUSIONS: Nivolumab plus ipilimumab with/without limited chemotherapy was associated with lower AE management costs compared with chemotherapy, pembrolizumab plus chemotherapy, and atezolizumab plus chemotherapy as first-line treatment for advanced NSCLC. The AE cost benefits were largely driven by the lower cost burden for hematological AEs for nivolumab plus ipilimumab with/without limited chemotherapy. DISCLOSURES This study was supported by Bristol-Myers Squibb. The sponsor was involved in all aspects of the work and in the decision to submit the manuscript for publication. Dr Stenehjem has received consulting fees from Bristol-Myers Squibb. Dr Lubinga was an employee of Bristol-Myers Squibb at the time of the study's conduct and holds stock/options. Drs Betts and Wu are employees of Analysis Group, Inc., a consulting company that has received funding from Bristol-Myers Squibb for this research.

Cost-Effectiveness Analysis of PET-CT Surveillance After Treatment of Human Papillomavirus-Positive Oropharyngeal Cancer.

To determine the cost-effectiveness of surveillance imaging with PET/CT scan among patients with human papillomavirus-positive oropharyngeal squamous cell carcinoma. Cost-effectiveness analysis. Oncologic care centers in the United States with head and neck oncologic surgeons and physicians. We compared the cost-effectiveness of 2 posttreatment surveillance strategies: clinical surveillance with the addition of PET/CT scan versus clinical surveillance alone in human papillomavirus-positive oropharyngeal squamous cell carcinoma patients. We constructed a Markov decision model which was analyzed from a third-party payer's perspective using 1-year Markov cycles and a 30-year time horizon. Values for transition probabilities, costs, health care utilities, and their studied ranges were derived from the literature. The incremental cost-effectiveness ratio for PET/CT with clinical surveillance versus clinical surveillance alone was $89,850 per quality-adjusted life year gained. Flexible fiberoptic scope exams during clinical surveillance would have to be over 51% sensitive or PET/CT scan cost would have to exceed $1678 for clinical surveillance alone to be more cost-effective. The willingness-to-pay threshold at which imaging surveillance was equally cost-effective to clinical surveillance was approximately $80,000/QALY. Despite lower recurrence rates of human papillomavirus-positive oropharyngeal cancer, a single PET/CT scan within 6 months after primary treatment remains a cost-effective tool for routine surveillance when its cost does not exceed $1678. The cost-effectiveness of this strategy is also dependent on the clinical surveillance sensitivity (flexible fiberoptic pharyngoscopy), and willingness-to-pay thresholds which vary by country.

Estimating the Clinical and Economic Impact of Switching from the 13-Valent Pneumococcal Conjugate Vaccine (PCV13) to Higher-Valent Options in Greek Infants.

In June 2010, Greece introduced the 13-valent pneumococcal conjugate vaccine (PCV13) for pediatric vaccination and has since observed a large decrease in pneumococcal disease caused by these vaccine serotypes, yet the disease prevalence of non-vaccine serotypes has increased. Two higher-valent conjugate vaccines, a 15-valent (PCV15) and a 20-valent (PCV20), were developed to improve serotype coverage and combat serotype replacement. A decision-analytic model was adapted to the Greek setting using historical pneumococcal disease trends from PCV13 to forecast future clinical and economic outcomes of higher-valent PCVs over a 10-year period (2023-2033). The model estimated outcomes related to invasive pneumococcal disease (IPD), hospitalized and non-hospitalized pneumonia, and otitis media (OM) resulting from a switch in vaccination programs to PCV15 in 2023 or switching to PCV20 in 2024. Cost-effectiveness was evaluated from the third-party payer's perspective in the Greek healthcare system. Compared to implementing PCV15 one year earlier, switching from PCV13 to PCV20 in 2024 was estimated to be a cost-saving strategy by saving the Greek health system over EUR 50 million in direct medical costs and averting over 250 IPD cases, 54,800 OM cases, 8450 pneumonia cases, and 255 deaths across all ages over a 10-year period.

The short-term cost-effectiveness of once-weekly semaglutide versus once-weekly dulaglutide for the treatment of type 2 diabetes mellitus in Colombian adults

Background: Type 2 Diabetes Mellitus (T2DM) is a highly prevalent disease worldwide and in Colombia, representing one of the main causes of death and placing a considerable burden on healthcare systems. 13 classes of drugs are approved for the treatment of T2DM, with Glucagon-like Peptide-1 (GLP-1) receptor agonists being a first-line treatment option for patients with or at high risk of certain cardiovascular diseases and chronic kidney disease. The objective of this study is to conduct a short-term cost-effectiveness analysis of once-weekly semaglutide versus once-weekly dulaglutide in Colombian adults with T2DM, from a third-party payer perspective. Methods: Numbers needed to treat were calculated for different single and composite endpoints of the SUSTAIN 7 trial, annual costs for once weekly semaglutide 1.0 mg and dulaglutide 1.5 mg were extracted from the public SISMED database. With these inputs a cost of control model was developed, to obtain the annual cost of bringing one T2DM patient to relevant clinical outcomes by using semaglutide or dulaglutide. Results: Semaglutide was considered cost-effective compared to dulaglutide across all pre-specified endpoints, even in the different scenarios evaluated in the sensitivity analyses, and in a particularly pronounced manner for weight loss outcomes. Semaglutide at a dose of 1.0 mg once-weekly was cost-effective compared to dulaglutide 1.5 mg across all outcomes in the short-term, making it an appropriate first-line choice in the treatment of T2DM when deciding between these two GLP-1 receptor agonists. Conclusions: This is the first short-term cost-effectiveness study of semaglutide and dulaglutide in T2DM Colombian patients. Our modeled results suggest that once-weekly semaglutide represents a cost-effective option for treating individuals with T2DM in Colombia who are not achieving glycaemia control with metformin, and it would be expected to improve HbA1C, promote greater weight loss and reduce costs from a third-payer perspective compared with treatment with dulaglutide.

Cancer Drugs Reimbursed with Limited Evidence on Overall Survival and Quality of Life: Do Follow-Up Studies Confirm Patient Benefits?

Cancer drug costs have increased considerably within healthcare systems, but many drugs lack quality-of-life (QoL) and overall survival (OS) data at the time of reimbursement approval. This study aimed to review the extent of subsequent literature documenting improvements in OS and QoL for cancer drug indications where no such evidence existed at the time of reimbursement approval. Drug indications with claims of added therapeutical value but a lack of evidence on OS and QoL that were reimbursed between 2010 and 2020 in Sweden were included for review. Searches were conducted in PubMed and ClinicalTrial.gov for randomized controlled trials examining OS and QoL. Of the 22 included drug indications, seven were found to have at least one trial with conclusive evidence of improvements in OS or QoL after a mean follow-up of 6.6 years. The remaining 15 drug indications either lacked subsequent randomized controlled trial data on OS or QoL (n = 6) or showed no statistically significant improvements (n = 9). Only one drug demonstrated evidence of improvement in both OS and QoL for its indication. A considerable share of reimbursed cancer drug indications continue to lack evidence of improvement in both OS and QoL. With limited healthcare resources and an increasing cancer burden, third-party payers have strong incentives to require additional post-reimbursement data to confirm any improvements in OS and QoL.

Third Party Payment System In Business Healthcare

Occupational health companies that do not provide products or services directly to patients generally share the same operating environment as companies in other industries. For example, machine tool makers Cincinnati Milicron and GE Medical Systems sell their products in much the same way.Cincinnati sells its machines directly to manufacturers who use them to make other products, and GE Medical sells diagnostic equipment directly to hospitals, clinics and other facilities that use its equipment for diagnostic tests. The prices that both companies charge for their products are set in a competitive marketplace, making it relatively easy for buyers to distinguish between competing products. In general, the more expensive the product, the better the performance, and performance can be judged by more or less objective metrics. For example, in some sectors of occupational health and most other sectors of the economy, consumers of products or services have many suppliers to choose from, distinguish the quality of competing products or services, and Can (probably) act and make decisions rationally. As for the quality and price of the purchase, we will bear the full purchase cost. However, for the most part, the provision of health care in the workplace has its own way of doing things. First, there are often only a few companies offering a particular service in your neighborhood. Moreover, it is very difficult, if not impossible, to assess the quality of competing services.Decisions about which aids to purchase are typically made by physicians or other clinicians, not by the consumer of these aids. Payments to providers are generally made by third-party payers, not by users of the assistance. Finally, for most people, third-party health insurance is fully or heavily subsidized by employers or government agencies, leaving patients largely isolated from professional medical bills.

Health Outcomes and Cost-effectiveness of Monoclonal SARS-CoV-2 Antibodies as Pre-exposure Prophylaxis

Pre-exposure prophylaxis with neutralizing SARS-CoV-2 monoclonal antibodies (mAbs PrEP) prevents infection and reduces hospitalizations and the duration thereof for COVID-19 and death among high-risk individuals. However, reduced effectiveness due to a changing SARS-CoV-2 viral landscape and high drug prices remain substantial implementation barriers. To assess the cost-effectiveness of mAbs PrEP as COVID-19 PrEP. For this economic evaluation, a decision analytic model was developed and parameterized with health care outcome and utilization data from individuals with high risk for COVID-19. The SARS-CoV-2 infection probability, mAbs PrEP effectiveness, and drug pricing were varied. All costs were collected from a third-party payer perspective. Data were analyzed from September 2021 to December 2022. Health care outcomes including new SARS-CoV-2 infections, hospitalization, and deaths. The cost per death averted and cost-effectiveness ratios using a threshold for prevention interventions of $22 000 or less per quality-adjusted life year (QALY) gained. The clinical cohort consisted of 636 individuals with COVID-19 (mean [SD] age 63 [18] years; 341 [54%] male). Most individuals were at high risk for severe COVID-19, including 137 (21%) with a body mass index of 30 or higher, 60 (9.4%) with hematological malignant neoplasm, 108 (17%) post-transplantation, and 152 (23.9%) who used immunosuppressive medication before COVID-19. Within the context of a high (18%) SARS-CoV-2 infection probability and low (25%) effectiveness the model calculated a short-term reduction of 42% ward admissions, 31% intensive care unit (ICU) admissions, and 34% deaths. Cost-saving scenarios were obtained with drug prices of $275 and 75% or higher effectiveness. With a 100% effectiveness mAbs PrEP can reduce ward admissions by 70%, ICU admissions by 97%, and deaths by 92%. Drug prices, however, need to reduce to $550 for cost-effectiveness ratios less than $22 000 per QALY gained per death averted and to $2200 for ratios between $22 000 and $88 000. In this study, use of mAbs PrEP for preventing SARS-CoV-2 infections was cost-saving at the beginning of an epidemic wave (high infection probability) with 75% or higher effectiveness and drug price of $275. These results are timely and relevant for decision-makers involved in mAbs PrEP implementation. When newer mAbs PrEP combinations become available, guidance on implementation should be formulated ensuring a fast rollout. Nevertheless, advocacy for mAbs PrEP use and critical discussion on drug prices are necessary to ensuring cost-effectiveness for different epidemic settings.

Cost-Utility Analysis of Midurethral Sling Timing Among Women Undergoing Prolapse Surgery.

There are no guidelines regarding the ideal timing of midurethral sling (MUS) placement following prolapse repair. The objective of this study was to estimate the cost-utility of concomitant MUS versus staged MUS among women undergoing apical suspension surgery for pelvic organ prolapse. Cost-utility modeling using a decision analysis tree compared concomitant MUS with staged MUS over a 1-year time horizon. The primary outcome was the incremental cost-effectiveness ratio (ICER). Six scenarios were modeled to estimate cost-utilities for women with preoperative overt, occult, or no stress urinary incontinence (SUI) who underwent either minimally invasive sacrocolpopexy or vaginal native tissue apical suspension. Possible complications of de novo overactive bladder, urinary retention requiring sling lysis, mesh exposure, and persistent SUI were included. Costs from a third-party payer perspective were derived from Medicare 2022 reimbursements. One-way sensitivity analyses were performed. Among women without preoperative SUI, staged MUS was the dominant strategy for both surgical routes with higher utility and lower costs. For women with either occult or overt SUI undergoing sacrocolpopexy or vaginal repair, concomitant MUS was cost-effective (ICER = $21,114-$96,536 per quality-adjusted life-year). Therefore, concomitant MUS is preferred for patients with preoperative SUI as higher costs were offset by higher effectiveness. One-way sensitivity analyses demonstrated that ICERs were most affected by probability of cure following MUS. A staged MUS procedure is the dominant strategy for women undergoing apical prolapse repair without preoperative SUI. In women with either overt or occult SUI, the ICER was below the willingness-to-pay threshold of $100,000 per quality-adjusted life-year, suggesting that concomitant MUS surgery is cost-effective.

Creating a Policy for Coverage of Lymphatic Surgery: Addressing a Critical Unmet Need.

This article describes the key stakeholders and process involved in developing an insurance policy in the United States to establish medical necessity criteria for lymphatic surgery procedures. Lymphedema is a chronic health issue that impacts over 1.2 million patients and is associated with lifelong health, economic, and psychosocial costs. Patients affected have been described as "medical nomads," as they often interface with multiple providers before receiving an accurate diagnosis and treatment. This underscores the lack of attention and understanding about this disease across all sectors of the medical system. Unlike nations including Sweden and the United Kingdom, which provide insurance coverage for treatment, the United States has lagged behind. As a country, we have neglected to fully recognize the consequences of inadequate treatment of lymphedema, including chronic morbidities such as loss of mobility, psychosocial sequelae, recurrent infections, and even death. Recently, the authors' lymphatic center had the unique opportunity to help develop a policy that merged their clinical experience, recently established lymphatic care center of excellence criteria, and third-party payer policy expertise. This experience spanned 1 year from June of 2018 to June of 2019. The authors identify how key partnerships helped fill evidentiary gaps that ultimately resulted in policy change.

Cost-Effectiveness of SGLT2 Inhibitors in a Real-World Population: A MICADO Model-Based Analysis Using Routine Data from a GP Registry.

Sodium-glucose cotransporter 2 inhibitors (SGLT2i) have been shown to reduce the risk of cardiovascular complications, which largely drive diabetes' health and economic burdens. Trial results indicated that SGLT2i are cost effective. However, these findings may not be generalizable to the real-world target population. This study aims to evaluate the cost effectiveness of SGLT2i in a routine care type 2 diabetes population that meets Dutch reimbursement criteria using the MICADO model. Individuals from the Hoorn Diabetes Care System cohort (N = 15,392) were filtered to satisfy trial inclusion criteria (including EMPA-REG, CANVAS, and DECLARE-TIMI58) or satisfy the current Dutch reimbursement criteria for SGLT2i. We validated a health economic model (MICADO) by comparing simulated and observed outcomes regarding the relative risks of events in the intervention and comparator arm from three trials, and used the validated model to evaluate the long-term health outcomes using the filtered cohorts' baseline characteristics and treatment effects from trials and a review of observational studies. The incremental cost-effectiveness ratio (ICER) of SGLT2i, compared with care-as-usual, was assessed from a third-party payer perspective, measured in euros (2021 price level), using a discount rate of 4% for costs and 1.5% for effects. From Dutch individuals with diabetes in routine care, 15.8% qualify for the current Dutch reimbursement criteria for SGLT2i. Their characteristics were significantly different (lower HbA1c, higher age, and generally more preexisting complications) than trial populations. After validating the MICADO model, we found that lifetime ICERs of SGLT2i, when compared with usual care, were favorable (<€20,000/QALY) for all filtered cohorts, resulting in an ICER of €5440/QALY using trial-based treatment effect estimates in reimbursed population. Several pragmatic scenarios were tested, the ICERs remained favorable. Although the Dutch reimbursement indications led to a target group that deviates from trial populations, SGLT2i are likely to be cost effective when compared with usual care.

Pharmaceutical policies: effects of policies regulating drug marketing.

The costs of developing new treatments and bringing them to the market are substantial. The pharmaceutical industry uses drug promotion to gain a competitive market share, and drive sale volumes and industry profitability. This involves disseminating information about new treatments to relevant targets. However, conflicts of interest can arise when profits are prioritised over patient care and its benefits. Drug promotion regulations are complex interventions that aim to prevent potential harm associated with these activities. To assess the effects of policies that regulate drug promotion on drug utilisation, coverage or access, healthcare utilisation, patient outcomes, adverse events and costs. We searched Epistemonikos for related reviews and their included studies. To find primary studies we searched MEDLINE, CENTRAL, Embase, EconLit, Global Index Medicus, Virtual Health Library, INRUD Bibliography, two trial registries and two sources of grey literature. All databases and sources were searched in January 2023. We planned to include studies that assessed policies regulating drug promotion to consumers, healthcare professionals or regulators and third-party payers, or any combination of these groups.In this review we defined policies as laws, rules, guidelines, codes of practice, and financial or administrative orders made by governments, non-government organisations or private insurers. One of the following outcomes had to be reported: drug utilisation, coverage or access, healthcare utilisation, patient health outcomes, any adverse effects (unintended consequences), and costs. The study had to be a randomised or non-randomised trial, an interrupted time series analysis (ITS), a repeated measures (RM) study or a controlled before-after (CBA) study. At least two review authors independently assessed eligibility for inclusion of studies. When consensus was not reached, any disagreements were discussed with a third review author. We planned to use the criteria suggested by Cochrane Effective Practice and Organisation of Care (EPOC) to assess the risk of bias of included studies. For randomised trials, non-randomised trials, and CBA studies, we planned to estimate relative effects, with 95% confidence intervals (CI). For dichotomous outcomes, we planned to report the risk ratio (RR) when possible and adjusted for baseline differences in the outcome measures. For ITS and RM, we planned to compute changes along two dimensions: change in level and change in slope. We planned to undertake a structured synthesis following EPOC guidance. MAIN RESULTS: The search yielded 4593 citations, and 13 studies were selected for full-text review. No study met the inclusion criteria. We sought to assess the effects of policies that regulate drug promotion on drug use, coverage or access, use of health services, patient outcomes, adverse events, and costs, however we did not find studies that met the review's inclusion criteria. As pharmaceutical policies that regulate drug promotion have untested effects, their impact, as well as their positive and negative influences, is currently only a matter of opinion, debate, informal or descriptive reporting. There is an urgent need to assess the effects of pharmaceutical policies that regulate drug promotion using well-conducted studies with high methodological rigour.

Older adults (OA) in clinical trials: Where are they? Representation of OA in clinical trials conducted at the national cancer institute (NCI) clinical center.

e18517 Background: Clinical trials are a significant source of evidence for diagnostic and management strategies in cancer patients. Diversity, equity, and inclusion are necessary to provide access to clinical trials and improve care. Despite the increase of OA in the United States (US), OA are still under-represented in clinical trials, with a lack of information on clinical outcomes and safety. The NCI provides oncologic care on research studies conducted at the Clinical Center (CC), the research hospital of the National Institutes of Health (NIH) where third-party payers are neither notified nor invoiced for treatments received. Participants come from all over the US and are primarily referred by their primary oncologists. We sought to evaluate the participation of OA in clinical trials at the NCI-CC. Methods: In this retrospective analysis, OA were defined as participants aged ≥65 years. The demographic data of OA enrolled from 2005 to 2019 were retrieved from the Biomedical Translational Research Information System (BTRIS), the NIH clinical research data repository. Data on the incidence of new cancer diagnoses in the US population for the same period (2005-2019) were obtained from the Surveillance, Epidemiology, and End Results (SEER) program. We compared the proportions of OA enrolled in NCI-CC clinical trials with the corresponding data from SEER program. We further stratified the OA into four age subcategories: from 65 to 69, from 70 to 74, from 75 to 79, and older than 80 years of age. No inferential statistical analyses were performed. Results: A total of 37,326 participants were enrolled from 2005 to 2019 on NCI-CC clinical trials. The number of OA = 7,934 (21.3%). According to the SEER program, 11,017,070 people were diagnosed with cancer from 2005 to 2019, and 5,971,607 (54.2%) were OA. Notably, the proportions of OA enrolled in NCI-CC was lower than the SEER data in all the subcategories. Patients ≥75 years accounted for the most under-represented (Table). Conclusions: OA are under-represented in clinical trials conducted at the NCI-CC from 2005 to 2019, emphasizing the need to “geriatricize” clinical trials. Adaptations of trial design such as expansion of eligibility criteria, utilization of geriatric assessment tools, and inclusion of OA-specific enrollment targets may reduce barriers to enrollment. Outreach initiatives to the oncology community to reinforce the need for increased referral of OA along with incorporation of telehealth for trial screening and assessments could also be considered to expand enrollment and increase the evidence base to guide treatment of OA with cancer. [Table: see text]

EE307 Budget Impact Analysis of Upadacitinib for Moderate-to-Severe Atopic Dermatitis for Social Security and Private Third-Party Payers in Argentina

To estimate the budget impact of upadacitinib 15 and 30 mg for treating adults and adolescent patients with moderate-to-severe atopic dermatitis (AD) and inadequate response to topical and non-targeted systemic immunosuppressive therapies, for social security and private third-party payers in Argentina.

Short-term locally advanced gastric cancer management: A cost-effectiveness analysis.

e16065 Background: Across the nation, patients with locally advanced gastric cancer (LAGC) are managed with modalities including upfront surgery (US), neoadjuvant chemoradiation therapy (NCRT), and perioperative chemotherapy (PCT). Treatment modalities themselves are associated with adverse effects which can lead to difficulty with treatment adherence in the short-term. As preoperative therapies have demonstrated survival benefits over US, long-term outcomes are expected to vary, but it is not known if differences in adherence impacts short-term treatment outcomes. We sought to perform a decision analysis comparing costs and quality-of-life associated with short-term outcomes in the treatment of patients with LAGC to identify the most cost-effective option. Methods: We designed a decision tree model to investigate the survival and costs associated with the three utilized management modalities for T2 or higher gastric cancer in the United States: US, PCT, and NCRT. The tree described costs and treatment strategies over a six-month time horizon to incorporate the complete treatment regimen and various treatment failure points encountered during therapy. Costs were derived from 2022 Medicare reimbursement rates using the third-party payer perspective for physicians and hospitals. Effectiveness was represented using quality-adjusted life months (QALMs). One QALM equates to one month of perfect health, while zero QALMs is equivalent to death. One-way, two-way, and probabilistic sensitivity analyses were utilized to test the robustness of our findings. Results: PCT was the most cost-effective treatment modality for LAGC over US and NCRT with a cost of $40,792.16 with 4.14 QALMs. US had a cost of $55,575.57 with 4.20 QALMs. NCRT was dominated by the other options with a cost of $56,510.64 with 3.70 QALMs. Across 100,000 Monte-Carlo simulations, 55.2% of trials favored PCT and the remainder favored US (44.8%). NCRT was not favored in the probabilistic sensitivity analysis. Finally, one-way and two-way sensitivity analyses did not identify any situations where alternative treatment modalities were preferred over PCT. Conclusions: In our simulated patients with diagnosed gastric cancer, the most cost-effective treatment strategy was PCT. This further confirms the preference of this modality over others in LAGC. While US demonstrated improved QALMs over PCT, the associated cost was too great to justify the benefits. [Table: see text]

Better together? costs of first-line chemoimmunotherapy for advanced non-small cell lung cancer.

Recent advances have created options for first-line (1L) treatment of advanced/metastatic non-small cell lung cancer (aNSCLC). The study objectives were to describe the utilization of 3 classes of 1L treatment-chemotherapy (CT), immunotherapy (IO), and chemoimmunotherapy (IO+CT)-and the total, third-party payer, direct health care costs. Retrospective, administrative claims database analysis of patients with aNSCLC who initiated 1L treatment between January 1, 2017, and May 31, 2019, with IO, CT, or IO+CT. Microcosting enumerated health care resource utilization, including antineoplastic drug costs, using standardized costs. Generalized linear models estimated per-patient per-month (PPPM) costs during 1L treatment, and adjusted cost differences in 1L among treatment cohorts were calculated using recycled predictions. A total of 1317 IO-, 5315 CT-, and 1522 IO+CT-treated patients were identified. Utilization of CT declined from 72.3% to 47.6% between 2017 and 2019, replaced by use of IO+CT, which increased from 1.8% to 29.8%. Total PPPM costs in 1L were highest with IO+CT at $32,436, compared with $19,000 and $17,763 in the CT and IO cohorts, respectively. Adjusted analyses showed that PPPM costs were $13,933 (95% CI, $11,760-$16,105) higher in the IO+CT vs IO cohort (P < .001) and IO costs were $1024 (95% CI, $67-$1980) lower than CT (P = .04). IO+CT accounts for almost one-third of 1L aNSCLC treatment modalities, coinciding with a reduction in treatment with CT. Costs for patients treated with IO were lower than those for patients treated with both IO+CT and CT alone, driven primarily by antineoplastic drug and associated medical costs.

Early access programs for medicines: comparative analysis among France, Italy, Spain, and UK and focus on the Italian case

Early access programs (EAPs) generally refer to patient access to medicines/indications before marketing authorization, possibly extended to price and reimbursement approval. These programs include compassionate use, which is usually covered by pharmaceutical companies, and EAPs reimbursed by third-party payers. This paper aims at comparing EAPs in four European countries (France, Italy, Spain, UK) and providing empirical evidence on EAPs in Italy. The comparative analysis was conducted through a literature review (including scientific and grey literature), complemented by 30-min semi-structured interviews with local experts. The Italian empirical analysis employed data available on the National Medicines Agency website. Although EAPs are very different across countries, they exhibit some common features: (i) eligibility criteria refer to the absence of valid therapeutic alternatives and a presumed favourable risk–benefit profile; (ii) payers do not allocate a pre-determined budget to these programs; (iii) total spending on EAPs is unknown. The French EAPs seem to be the most structured, financed through social insurance, covering pre-marketing, post-marketing and pre-reimbursement phases and providing for data collection. Italy’s approach to EAPs has been varied, with several programs covered by different payers, including the cohort-based 648 List (for both early access and off-label use), the nominal-based 5% Fund, and Compassionate Use. Most applications to EAPs are from the Antineoplastic and immunomodulating drug class (ATC L). Some 62% of indications in the 648 List are either not under clinical development or have never been approved (pure off-label use). For those subsequently approved, most approved indications coincide with those covered through EAPs. Only the 5% Fund provides data on economic impact (€ 81.2 million in 2021; average cost per patient € 61.5K). Diverse EAPs are a possible source of inequalities in access to medicines across Europe. A harmonization of these programs, though difficult to achieve, could be modelled on the French EAPs and provide key advantages, not least of which a common effort to collect real-world data in parallel with clinical trials and clear separation between EAPs and off-label use programs.

Implementation of Clinical Cytochrome P450 3A Genotyping for Tacrolimus Dosing in a Large Kidney Transplant Program.

Tacrolimus is a calcineurin inhibitor with a narrow therapeutic range and is metabolized by cytochrome P450 (CYP) isoenzymes CYP3A4 and CYP3A5. The Clinical Pharmacogenetic Implementation Consortium published evidence-based guidelines for CYP3A5 normal/intermediate metabolizers prescribed tacrolimus, yet few transplant centers have implemented routine testing. The objective of this study was to implement preemptive CYP3A genotyping into clinical practice in a large kidney transplant program and to evaluate workflow feasibility, potential clinical benefit, and reimbursement to identify barriers and determine sustainability. Preemptive pharmacogenetic testing for CYP3A5 and CYP3A4 was implemented in all patients listed for a kidney transplant as part of standard clinical care. Genotyping was performed at the listing appointment, results were reported as discrete data in the electronic medical record, and education and clinical decision support alerts were developed to provide pharmacogenetic-recommended tacrolimus dosing. During this initial phase, all patients were administered standard tacrolimus dosing, and clinical and reimbursement outcomes were collected. Greater than 99.5% of genotyping claims were reimbursed by third-party payers. CYP3A5 normal/intermediate metabolizers had significantly fewer tacrolimus trough concentrations within the target range and a significantly longer time to their first therapeutic trough compared to poor metabolizers. The challenge of tacrolimus dosing is magnified in the African American population. The US Food and Drug Administration drug label recommends increased starting doses in African ancestry, yet only ≈66% of African Americans in our cohort were normal/intermediate metabolizers who required higher doses. Routine CYP3A5 genotyping may overcome this issue by using genotype over race as a more accurate predictor of drug response.