Commercial Payers Research Articles

PCV9 Budget IMPACT Analysis of Vericiguat for the Treatment of Chronic Heart Failure with Reduced Ejection Fraction Following a Worsening Heart Failure Event in the United States

In the United States (US), patients with chronic heart failure (HF) with reduced ejection fraction (HFrEF) following a worsening HF event (WHFE) have significantly increased medical costs. This analysis aimed to estimate the budget impact of vericiguat as add-on therapy to guideline-directed medical therapy (GDMT) in this population from a US commercial payer perspective. A model was developed to estimate the budget impact of adding vericiguat to the formulary by comparing a current scenario (GDMT) and a new scenario (vericiguat plus GDMT) in a hypothetical 10-million-member commercial health plan over a 3-year time horizon. Epidemiology data was obtained from literature. Utilization rates of GDMT and clinical inputs (HF hospitalization [HFH] and cardiovascular [CV] morality) were based on VICTORIA trial (NCT02861534). Costs (2021 US$) included drug acquisition (RED BOOK), HFH, routine care, and mortality (literature). Dosing was based on prescribing information and VICTORIA. Approximately 20,510 prevalent cases in year 1 and 3,109 annual incident cases in subsequent years were estimated to be eligible for treatment with vericiguat. At utilization rates of 5%, 10%, and 15% for vericiguat over years 1-3, the annual per-member-per-month (PMPM) budget impact was estimated to be $0.048, $0.064, and $0.086 on total drug acquisition and medical costs. Vericiguat was associated with 44, 32 and 30 fewer HFHs and 7, 12 and 18 fewer CV deaths, respectively over years 1-3, associated with a reduction of the total 3-year budget impact by 14%. Adding vericiguat to commercial plan formulary was associated with limited budget impact, primarily driven by drug acquisition costs but partially offset by reduced cost of HFHs and CV deaths.

PCN82 Cost-Effectiveness of Once Weekly Selinexor-Bortezomib-Dexamethasone (XVD) in Previously Treated Multiple Myeloma (MM)

To determine the cost-effectiveness of XVd in previously treated MM. The phase III BOSTON trial of once weekly XVd versus twice weekly bortezomib and dexamethasone (Vd) was the basis for this cost-effectiveness analysis (CEA) from a US commercial payer perspective. Comparators to XVd included daratumumab/pomalidomide/dexamethasone (DPd), daratumumab/lenalidomide/dexamethasone (DRd), lenalidomide/dexamethasone (Rd), pomalidomide/bortezomib/dexamethasone (PVd), elotuzumab/pomalidomide/dexamethasone (EPd), carfilzomib/pomalidomide/dexamethasone (KPd), and daratumumab/bortezomib/dexamethasone (DVd). A partitioned survival model enabled the use of direct overall survival (OS) and progression-free survival (PFS) curves from BOSTON to generate four health states for XVd and Vd: PFS on treatment, PFS off treatment, post-progression, and mortality. Using a one-week cycle length, benefits and costs were discounted at 3.0% annually. Cost inputs included primary therapy and administration, secondary therapy, routine medical care, treatment-related adverse events, and mortality. Utility values were obtained from the literature using EQ-5D-5L data. Clinical outcomes for the comparators were based on results from a network meta-analysis. For XVd versus Vd, the base case incremental cost (Δ cost) was $158,368 and the base case incremental cost-effectiveness ratio (ICER) was $471,886/quality-adjusted life year (QALY). The 50% cost-effectiveness probability midpoint was near $470,000/QALY, based on probabilistic sensitivity analysis. XVd showed a higher QALY gain with a lower cost (i.e. was dominant) compared with Rd (Δ cost: $-41,693; ICER: $-70,606/QALY), PVd (Δ cost: $-79,453; ICER: $-5,154,447/QALY), and KPd (Δ cost: $-81,834; ICER: $-59,269/QALY). XVd had lower cost and lower benefit compared with DPd (Δ cost: $-417,591; ICER: $147,482/QALY), DRd (Δ cost: $-974,308; ICER: $345,974/QALY), EPd (Δ cost: $-272,189; ICER: $465,716/QALY), and DVd (Δ cost: $-59,894; ICER: $11,367/QALY). The addition of XVd to the previously treated MM triplet regimen landscape provides a novel, oral treatment option that either was cost-effective (versus Vd, DPd, and DVd) at a willingness-to-pay threshold of $150,000, or dominant (versus Rd, PVd, and KPd).

PMH13 Healthcare Resource Utilization and Costs before and after Long-Acting Injectable Antipsychotic (LAI) Use in Commercially Insured Young Adults with Schizophrenia

This study examined disease burden before and after initiation of LAIs in commercially insured young adults with schizophrenia. This retrospective observational cohort study used IBM MarketScan Commercial Claims and Encounters Database, 1/1/2008-12/31/2019. Patients with ≥1 inpatient or ≥2 outpatient claims with schizophrenia diagnosis were identified; date of first diagnosis was index date. Patients were aged 18-35 years at index date, with continuous enrollment ≥1-year baseline and ≥1-year follow-up, with ≥1 LAI during follow-up. A pre-post analysis was conducted with paired t-tests to compare relapse (defined as hospitalization or emergency department visit), healthcare resource utilization, and costs before (from index date to LAI initiation) and after LAI initiation (to end of follow-up). Outcomes were reported as Per-Patient-Per-Month (PPPM). We identified 2222 patients who initiated LAIs after index date (mean age=22.9, 70.4% male), with 1421 (64.0%) initiating LAIs after post-index oral antipsychotic treatment. Remaining 36.0% initiated LAIs as index treatment. Average time from index date to LAI initiation was 433.1 days (median 243), and from LAI initiation to end of follow up was 744.0 days (median 630). PPPM relapse event rate was 0.109 before LAI initiation, and 0.073 after LAI initiation (p<0.0001). All-cause direct medical costs (excluding medication), medication costs, and total costs were $4587, $311, and $4898 PPPM before and $2535, $542, and $3078 PPPM after LAI initiation, respectively. All these cost numbers were statistically significantly different (P<0.0001) from before to after LAI initiation. In commercially insured young adults with schizophrenia, use of LAIs was associated with decreased relapse event rate vs the period before LAI initiation. Although medication costs increased in the post LAI period, the cost increase was more than offset by the decreased costs associated with total care. This study demonstrated that LAI treatment for young adults with schizophrenia is associated with significant cost savings to commercial payers.

Financial impact of tepotinib for the treatment of adult patients with metastatic non-small cell lung cancer bearing METex14 skipping in the United States.

e21108 Background: MET exon 14 ( METex14) skipping is found in approximately 3% of the non-small cell lung cancer (NSCLC) population and is associated with poor prognoses. We estimated the financial impact to US Medicare and commercial plans of reimbursing the receptor tyrosine kinase inhibitor (TKI) tepotinib for adult patients with metastatic NSCLC bearing METex14 skipping. Methods: We developed an Excel-based economic model to project plan financial outlays with or without tepotinib from 2021-2023. The number of patients eligible for treatment with MET TKIs was estimated from epidemiological data, real-world evidence, and forecasted biomarker testing rates. It was assumed this population has access to other TKIs (capmatinib and crizotinib) and non-targeted standards of care, including immune checkpoint inhibitors, anti–vascular endothelial growth factor (VEGF) medications, and chemotherapy. It was also assumed most patients receiving tepotinib would otherwise be treated with another TKI. Efficacy and safety inputs were obtained from the Phase II VISION study (July 2020 data cut-off), published literature and prescribing information. Resource utilization and costs (2020 US dollars) were informed by online pricing databases, CMS fee schedules, Healthcare Cost and Utilization Project (HCUP) and trial data, expert opinion, and publicly available sources. Results: In hypothetical Medicare and commercial plans with one million members each, an estimated 160 and 32 adult patients with metastatic NSCLC would test positive for METex14 skipping between 2021-2023, respectively. Of these, 26 Medicare and 5 commercial plan members would receive tepotinib. Introducing tepotinib reduced cumulative financial outlays by $661,379 and $151,700 for Medicare and commercial payers respectively, or $0.0061 and $0.0014 per patient per month, primarily due to lower overall drug acquisition and disease management costs relative to a treatment mix without tepotinib. Results are most sensitive to the clinical efficacy of tepotinib and capmatinib. Conclusions: Using tepotinib in adult patients with metastatic NSCLC bearing METex14 skipping is expected to have minimal financial impact on Medicare and commercial payers in the US.[Table: see text]

Potential non-drug cost differences associated with the use of the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (PH FDC SC) in the treatment of HER2-positive early breast cancer patients in Western Europe and the United States.

544 Background: In patients with HER2-positive early breast cancer (BC), pertuzumab (P) added to trastuzumab (T) and chemotherapy has been recognized as a standard-of-care, improving the risk of recurrence. P and T treatments can be given intravenously (PT IV) or, more recently, subcutaneously − via PH FDC SC. Both methods are comparable in terms of efficacy and safety profiles. However, PH FDC SC allows for a faster infusion than that of PT IV, and this can be associated with lower costs. The aim of this study is to estimate the incremental difference in non-drug costs between PH FDC SC and PT IV for a typical patient receiving treatment for HER2-positive early BC in Western Europe and the United States. Methods: A model-based cost-minimization analysis was performed to quantify mean non-drug cost differences per patient over a full course of therapy (18 cycles). Western Europe: costs in the analysis are based on an archetypal country, and explicitly include estimates for costs for patient chair time, active healthcare professional (HCP) time, usage of non-drug consumables, port-a-cath placement surgeries and patients’ productivity losses. Costs are calculated by multiplying the resource use by its corresponding unit price. Costing data were obtained from literature sources on T SC time and cost savings for Western European countries, and assumptions on PH FDC SC and PT IV times and costs. United States: non-drug costs for the two strategies were estimated using average net reimbursement amounts for relevant procedure codes for intravenous and SC therapy administration among commercial payers in the MarketScan databases. Results: PH FDC SC is estimated to reduce non-drug costs by 73% − 80% in Western Europe, and 75% in the United States. Total monetary non-drug savings per patient over 18 cycles of treatment are estimated in the range of €2,474 − €8,975 in Western Europe, and at $10,138 in the United States. In Western Europe, where the analysis allows for a disaggregation by cost category, cost savings related to savings in patient chair time (excluding patients’ productivity losses) are estimated to account for up to 62% of overall non-drug cost savings. Patients’ productivity losses are estimated to explain up to 11% of non-drug cost differences. Conclusions: The use of PH FDC SC for the treatment of HER2-positive BC can potentially result in substantial non-drug cost savings. These savings could easily derive in overall net cost savings to the healthcare system, contributing to the long-term sustainability of the healthcare spending, while still providing a safe and effective therapy.[Table: see text]

Development of AGA’s Policy Agenda During the COVID-19 Pandemic

Development of AGA’s Policy Agenda During the COVID-19 Pandemic

Budget Impact Analysis of Vericiguat for the Treatment of Chronic Heart Failure with Reduced Ejection Fraction Following a Worsening Event.

IntroductionIn the USA, patients with chronic heart failure (HF) with reduced ejection fraction (HFrEF) following a worsening HF event (WHFE) have significantly increased healthcare resource use and medical costs. This analysis aimed to estimate the budget impact of vericiguat as an add-on therapy to guideline-directed medical therapy (GDMT) for the treatment of chronic HFrEF following a WHFE from a US commercial payer perspective.MethodsA model was developed to estimate the budget impact of adding vericiguat to the formulary by comparing a current scenario (GDMT) and a new scenario (vericiguat plus GDMT) to a hypothetical 10-million-member commercial payer over a 3-year time horizon. Epidemiology data was obtained from literature. Treatment utilization rates of GDMT and clinical inputs (HF hospitalization and cardiovascular [CV] morality) were based on the VICTORIA trial in which patients with chronic HFrEF following a WHFE were randomized to GDMT plus placebo or GDMT plus vericiguat. Costs (2020 US$) included drug acquisition, hospitalization, routine care, and mortality.ResultsApproximately 20,510 prevalent cases in year 1 and 3109 annual incident cases in subsequent years were estimated to be eligible for treatment with vericiguat. At a utilization rate of 5%, 10%, and 15% for vericiguat over years 1–3, the per member per month (PMPM) budget impact was estimated to be $0.048, $0.064, and $0.086, respectively, associated with 44, 32, and 30 fewer HF hospitalizations and 7, 12, and 18 fewer CV deaths, respectively. Reduction in HF hospitalizations and CV deaths reduced the budget impact by 14% in total over 3 years.ConclusionAdding vericiguat to commercial plan formulary was associated with limited budget impact, primarily driven by drug acquisition costs but partially offset by reduced cost of HF hospitalizations and CV deaths.Supplementary InformationThe online version contains supplementary material available at 10.1007/s12325-021-01681-2.

Direct-To-Consumer Telemedicine Visits For Acute Respiratory Infections Linked To More Downstream Visits.

Use of direct-to-consumer telemedicine-on-demand virtual care for minor medical issues-is growing rapidly. Although it may yield immediate savings by diverting health care from higher-cost settings, these savings could be countered if direct-to-consumer telemedicine increases follow-up care and, therefore, episode costs. Comparing downstream care utilization data from a large, commercial payer for the period 2016-19, we found that patients with initial visits for acute respiratory infection were more likely to obtain follow-up care within seven days after direct-to-consumer telemedicine visits (10.3percent) than after in-person visits (5.9percent). In both settings approximately 90percent of patients did not obtain additional care. The telemedicine cohort had fewer (0.5percent versus 0.6percent) emergency department visits-a small but statistically significant difference-but more subsequent office, urgent care, and telemedicine visits. Our findings suggest that potential savings from shifting initial care to a direct-to-consumer telemedicine setting should be balanced against the potential for higher spending on downstream care.

Use of Telehealth by Surgical Specialties During the COVID-19 Pandemic

While telehealth use in surgery has shown to be feasible, telehealth became a major modality of health care delivery during the COVID-19 pandemic. To assess patterns of telehealth use across surgical specialties before and during the COVID-19 pandemic. Insurance claims from a Michigan statewide commercial payer for new patient visits with a surgeon from 1 of 9 surgical specialties during one of the following periods: prior to the COVID-19 pandemic (period 1: January 5 to March 7, 2020), early pandemic (period 2: March 8 to June 6, 2020), and late pandemic (period 3: June 7 to September 5, 2020). Telehealth implementation owing to the COVID-19 pandemic in March 2020. (1) Conversion rate defined as the rate of weekly new patient telehealth visits divided by mean weekly number of total new patient visits in 2019. This outcome adjusts for a substantial decrease in outpatient care during the pandemic. (2) Weekly number of new patient telehealth visits divided by weekly number of total new patient visits. Among 4405 surgeons in the cohort, 2588 (58.8%) performed telehealth in any patient care context. Specifically for new patient visits, 1182 surgeons (26.8%) used telehealth. A total of 109 610 surgical new outpatient visits were identified during the pandemic. The median (interquartile range) age of telehealth patients was 46.8 (34.1-58.4) years compared with 52.6 (38.3-62.3) years for patients who received care in-person. Prior to March 2020, less than 1% (8 of 173 939) of new patient visits were conducted through telehealth. Telehealth use peaked in April 2020 (week 14) and facilitated 34.6% (479 of 1383) of all new patient visits during that week. The telehealth conversion rate peaked in April 2020 (week 15) and was equal to 8.2% of the 2019 mean weekly new patient visit volume. During period 2, a mean (SD) of 16.6% (12.0%) of all new patient surgical visits were conducted via telehealth (conversion rate of 5.1% of 2019 mean weekly new patient visit volumes). During period 3, 3.0% (2168 of 71 819) of all new patient surgical visits were conducted via telehealth (conversion rate of 2.5% of 2019 new patient visit volumes). Mean (SD) telehealth conversion rates varied by specialty with urology being the highest (14.3% [7.7%]). Results from this study showed that telehealth use grew across all surgical specialties in Michigan in response to the COVID-19 pandemic. While rates of telehealth use have declined as in-person care has resumed, telehealth use remains substantially higher across all surgical specialties than it was prior to the pandemic.

What is the Level of Evidence Substantiating Commercial Payers’ Coverage Policies for Total Joint Arthroplasty?

BackgroundThe prevalence of total joint arthroplasty (TJA) in the United States has drawn the attention of health care stakeholders. The payers have also used a variety of strategies to regulate the medical necessity of these procedures. The purpose of this study was to examine the level of evidence of the coverage policies being used by commercial payers in the United States. MethodsThe references of the coverage policies of four commercial insurance companies were reviewed for type of document, level of evidence, applicability to a TJA population, and success of nonoperative treatment in patients with severe degenerative joint disease. Results282 documents were reviewed. 45.8% were primary journal articles, 14.2% were level I or II, 41.2% were applicable to patients who were candidates for TJA, and 9.9% discussed the success of nonoperative treatment in patients who would be candidates for TJA. ConclusionMost of the references cited by commercial payers are of a lower level of scientific evidence and not applicable to patients considered to be candidates for TJA. This is relatively uniform across the reviewed payers. The dearth of high-quality literature cited by commercial payers reflects the lack of evidence and difficulty in conducting high level studies on the outcomes of nonoperative versus operative treatment for patients with severe, symptomatic osteoarthritis. Patients, surgeons, and payers would all benefit from such studies and we encourage professional societies to strive toward that end through multicenter collaboration.

Bronchiolitis Obliterans Syndrome Following Lung Transplantation: Economic Burden by Chronic Lung Allograft Dysfunction (CLAD) Stage

<h3>Purpose</h3> Bronchiolitis obliterans syndrome (BOS), affects nearly 50% of lung transplant recipients within 5 years and is the leading cause of death for patients who survive at least one year post transplant. The impact of BOS on healthcare resource use (HRU) and costs is not well understood. The aim is to quantify the economic burden of BOS in the US. <h3>Methods</h3> A retrospective analysis of claims data for commercially insured patients age <65 who underwent lung transplantation between 1/1/2006 and 9/30/2018 was performed. Transplantation was identified using International Classification of Disease (ICD) and Common Procedure Terminology (CPT) codes. Patients were observable 12+ months pre- and post- transplantation. BOS patients were identified using diagnosis codes for severe lung disease 1+ years post-transplant and followed longitudinally. Mean monthly per patient HRU following BOS diagnosis was calculated by CLAD stage. Mean costs, calculated by HRU type, were multiplied by HRU rates to estimate costs by CLAD stage. Costs were those paid by commercial payers in the US. <h3>Results</h3> Among 134 patients who met criteria for BOS following lung transplantation, healthcare costs were substantially higher with CLAD progression. Patients in CLAD 4 had much higher mean per patient monthly costs ($5,042) compared with lower stages (CLAD 1: $554; CLAD 2: $1,080; CLAD 3: $1,724). Inpatient admissions were responsible for most costs for patients in CLAD 3 and 4, while outpatient services accounted for virtually all costs in CLAD 1 and 2. Drug costs were higher for patients in CLAD 2 vs. 1 ($9,917 vs. $6,145). On an annual basis, mean per patient costs increased from $6,658 in CLAD stage 1 to $60,508 in CLAD stage 4 (<b>Figure</b>). <h3>Conclusion</h3> BOS after lung transplantation imposes a large economic burden on healthcare systems and patients that increases substantially in later CLAD stages. Early diagnosis and therapies aimed at slowing disease progression may reduce economic burden associated with BOS.

Cost Analysis of Pediatric Concurrent Care: Commercial vs Medicaid Payer

Cost Analysis of Pediatric Concurrent Care: Commercial vs Medicaid Payer

Adventures in getting paid

Adventures in getting paid

Cost-Effectiveness of Durvalumab After Chemoradiotherapy in Unresectable Stage III NSCLC: A US Healthcare Perspective.

Durvalumab was approved by the FDA in February 2018 for patients with unresectable stage III NSCLC that has not progressed after platinum-based concurrent chemoradiotherapy (cCRT), and this regimen is the current standard of care. The objective of this study was to examine the cost-effectiveness of durvalumab following cCRT versus cCRT alone in patients with locally advanced, unresectable stage III NSCLC. A 3-state semi-Markov model was used. Modeling was performed in a US healthcare setting from Medicare and commercial payer perspectives over a 30-year time horizon. Clinical efficacy (progression-free and post progression survival) and utility inputs were based on PACIFIC study data (ClinicalTrials.gov identifier: NCT02125461; data cutoff March 22, 2018). Overall survival extrapolation was validated using overall survival data from a later data cutoff (January 31, 2019). The main outcome was the incremental cost-effectiveness ratio (ICER) of durvalumab following cCRT versus cCRT alone, calculated as the difference in total costs between treatment strategies per quality-adjusted life-year (QALY) gained. In the base-case analysis, durvalumab following cCRT was cost-effective versus cCRT alone from Medicare and commercial insurance perspectives, with ICERs of $55,285 and $61,111, respectively, per QALY gained. Durvalumab was thus considered cost-effective at the $100,000 willingness-to-pay (WTP) threshold. Sensitivity analyses revealed the model was particularly affected by variables associated with subsequent treatment, although no tested variable increased the ICER above the WTP threshold. Scenario analyses showed the model was most sensitive to assumptions regarding time horizon, treatment effect duration, choice of fitted progression-free survival curve, subsequent immunotherapy treatment duration, and use of a partitioned survival model structure. In a US healthcare setting, durvalumab was cost-effective compared with cCRT alone, further supporting the adoption of durvalumab following cCRT as the new standard of care in patients with unresectable stage III NSCLC.

Comparison of Telemedicine Versus In-Person Visits on Impact of Downstream Utilization of Care.

Background: Telemedicine use has expanded substantially in recent years. Studies evaluating the impact of telemedicine modalities on downstream office visits have demonstrated mixed results. Introduction: We evaluated insurance claims of a large commercial payer, Blue Cross Blue Shield of Michigan (BCBSM), to assess the frequency of follow-up visits following encounters initiated via telemedicine versus in-person. Materials and Methods: We used the BCBSM claim-level data set (2011-2017) to assess encounters in the following places of service: hospital outpatient, doctor's office, patient's home, or psychiatric daycare facility. We identified the primary diagnostic category for 30-day episodes of care using clinical classifications software (CCS) and multilevel clinical classifications software (ML-CCS). Our intervention group consisted of episodes initiated via telemedicine; our control group consisted of episodes initiated in-person. Our primary outcome was the percentage of 30-day episodes with a related visit (encounters occurring within the same period and CCS categories) across CCS categories. Our secondary outcome was the mean related visit rate. Results: The final data set included 4,982,456 patients and 68,148,070 claims, of which 53,853 were telemedicine related. Many episodes did not have related visits (the mean related visit rate was 16%). Telemedicine visits had a higher frequency of related visits across all CCS categories. Discussion: Episodes of care initiated via telemedicine more frequently generate related visits within a 30-day period. This increased health care utilization could represent excessive care or could reflect expanded access to care. Conclusion: Further research should explore the cause of this increased utilization and potential unintended consequences.

Does Biosimilar Bevacizumab Offer Affordable Treatment Options for Cancer Patients in the USA? A Budget Impact Analysis from US Commercial and Medicare Payer Perspectives.

BackgroundBevacizumab remains the most widely used and most thoroughly characterized angiogenesis inhibitor for a range of advanced cancers. Bevacizumab-bvzr (Zirabev®), a biosimilar of bevacizumab, was recently approved by the US Food and Drug Administration (FDA), which provides a less costly option. This study aimed to evaluate the financial impact of introducing bevacizumab-bvzr from US commercial and Medicare payer perspectives.MethodsA Microsoft Excel-based budget impact model was developed over a 5-year time horizon. Target population was patients to be treated with bevacizumab for FDA-approved indications. Drug costs (2020 US$) were based on average sales price and wholesale acquisition cost, accounting for payer-specific reimbursement models and provider settings. Drug dosing and duration were based on prescribing information and pivotal trial publications.ResultsIn a hypothetical 10-million-member health plan, 503 and 723 patients were estimated to be treated with bevacizumab in year 1 and year 5, respectively. Assuming an annual market shift of 1.7%, 3.6%, 6.7%, 9.4%, and 11.9% to bevacizumab-bvzr, an annual cost saving of $313,363 ($0.003 per member per month [PMPM]) was estimated for a commercial payer and $92,880 ($0.001 PMPM) for Medicare in year 1. Cumulative 5-year cost savings were $7,030,924 ($0.012 PMPM) for a commercial payer and $4,059,257 ($0.007 PMPM) for Medicare. More than half of the cost savings was attributed to patients with metastatic colorectal cancer.ConclusionsThe introduction of biosimilar bevacizumab-bvzr was estimated to provide substantial cost savings for US payers, which would allow additional patients access to bevacizumab treatment.

Real-world genomic and treatment landscape in advanced colorectal cancer identifies treatment differences pre- and post-ctDNA genomic profiling.

39 Background: Clinical insights gained from real-world data have led to numerous advances in oncology including new and expanded drug approvals and an understanding of real-world clinical utilization. In this precision oncology age, integrating real-world clinical data with genomic data can lead to further advancements. We aimed to understand the genomic and treatment landscape in advanced colorectal cancer (aCRC) by leveraging a uniquely large and detailed clinical-genomic database. Methods: The GuardantINFORM (Guardant Health) database comprises aggregated commercial payer health claims and de-identified records from over 100,000 individuals with comprehensive ctDNA results (Guardant360). GuardantINFORM was queried for patients (pts) with a diagnosis of CRC. Pts with fewer than two pharmacy claims prior to or after the first ctDNA test were excluded from the regimen analysis. Latest claims data was truncated as of 8/31/2020. Results: 10,845 pts had a total of 13,510 ctDNA tests (1 – 19 tests/pt). The first ctDNA test date was from 06/2014 - 06/2020. The majority of pts had one ctDNA test (86.7%) while 5% had three or more tests. 87.9% of ctDNA tests had at least one genomic alteration identified, with the distribution of alterations consistent with prior reports (Table). 78% of pts had at least two pharmacy claims before and/or after the first ctDNA test. Of those pts with at least one CRC treatment, the most commonly prescribed CRC regimens up to one year prior to the first ctDNA test were FOLFOX +/- bevacizumab (16%, 18%), FOLFIRI +/- bevacizumab (17%, 11%), capecitabine (15%), 5-FU (12%), and regorafenib (5.2%). Anti-EGFR mono and combination therapy was reported in 6% and 16% of pts pre ctDNA testing. Immune checkpoint inhibitor (ICPi) mono and combination therapy was reported in 2% and 0.5% of pts. The most commonly prescribed CRC regimens post first ctDNA test were capecitabine (16%), FOLIRI +/- bevacizumab (15%, 13%), tipiracil and trifluridine (15%), FOLFOX +/- bevacizumab (12%, 14%), 5-FU (11%), and regorafenib (10%). Anti-EGFR mono and combination therapy was reported in 8% and 18% of pts post ctDNA testing. ICPi mono and combination therapy was reported in 5% and 1% of pts. Conclusions: Using a large and uniquely detailed clinical-genomic dataset, we produced results that replicate the observed distribution of ctDNA identified mutations present in aCRC. This genomic information combined with real-world clinical data provides valuable insights into the variety of longitudinal treatments, including before and after comprehensive ctDNA genomic profiling, allowing for detailed outcomes research, especially focused on precision oncology. [Table: see text]

Commercial and public payer opioid analgesic prescribing policies: a case study

BackgroundOne strategy to address the high number of U.S. opioid-related deaths is to restrict high-risk or inappropriate opioid analgesic prescribing and dispensing. Federal and state laws and regulations have implemented restrictions but less is known about commercial and public payers’ policies aside from clinician anecdotal reports that these policies are increasing. To assess the number and types of policies with temporal trends, we examined commercial and public (Medicaid) payer policies in one state, Michigan, that has high opioid-related deaths and implemented opioid analgesic prescribing laws.MethodsPolicies for seven large commercial payers and the public payer for 2012–2018 were reviewed and categorized by actions. Joinpoint regression was used to summarize temporal trends on number of policies for all payers and subgroups.ResultsAcross the 7 years, there were 529 action policies (75.57 (95% confidence intervals (CI) 35.93, 115.22) actions per year) with a range of 36 to 103 actions by payer. Limitations on number of days for initial prescriptions and prior authorizations were the most frequently implemented policy. The temporal trend showed a decline in new policies from 2012 to 2013 but a steady increase from 2014 to 2018 (average annual percent change or AAPC=29.6% (95% confidence intervals 13.2, 48.5%)). The public payer (n=47 policies) showed no increase in number of policies over time (AAPC=2.9% (95% CI -41.6, 61.6%).ConclusionsThe eight commercial and public payers implemented many new policies to restrict opioid analgesic prescribing with a steady increase in the number of such policies implemented from 2014 to 2018. This case study documented that at least in one state with high opioid-related deaths and multiple commercial payers, new and different policies were increasingly implemented creating barriers to patient care. The impact of these policies is understudied, complicating recommendation of best practices.

Biosimilar Perceptions Among Healthcare Professionals and Commercial Medical Benefit Policy Analysis in the United States.

Biosimilars represent a significant cost savings opportunity for the entire healthcare system. Despite efforts from the United States Food and Drug Administration, adoption has not been as successful as originally hoped. Perceived barriers to adoption of biosimilars have been described previously, but more knowledge is needed. Further, increased understanding is needed surrounding commercial payer preferences of biosimilars. A survey to assess perceived barriers to biosimilar adoption was dispersed to healthcare leaders who work in health-systems, physician practices, and the pharmaceutical industry. Policies from the top 15 commercial payers, by covered lives, were reviewed to collect information surrounding coverage and preferred products to assess if perceptions from healthcare leaders align with payer policies. The largest number of responses (n=76) came from health-systems (n=56), followed by pharmaceutical manufacturers (n=12), and physician practices (n=8). Responses from each cohort aligned very closely with the composite results of the group. Responses surrounding safety and efficacy were high amongst all groups, while rebate increases to payers for reference products were of highest concern for adoption. United Healthcare had the most policies preferring biosimilars (6/7, 86%). Filgrastim-sndz (Zarxio), had the most preferred statuses for a biosimilar (10/15, 67%). The infliximab reference product had the most preferred statuses for a reference product (9/15, 60%). Findings from this study outline the greatest perceived barriers to adoption of biosimilars from a variety of different stakeholders. Rebates from reference product manufacturers to payers was the main deterrent for biosimilar use.

Economic value of vaccines to address the COVID-19 pandemic: a U.S. cost-effectiveness and budget impact analysis

Aims The Novel Coronavirus (COVID-19) has infected over two hundred million worldwide and caused 4.4 million of deaths as of August 2021. Vaccines were quickly developed to address the pandemic. We sought to analyze the cost-effectiveness and budget impact of a non-specified vaccine for COVID-19. Materials and Methods We constructed a Markov model of COVID-19 infections using a susceptible-exposed-infected-recovered structure over a 1-year time horizon from a U.S. healthcare sector perspective. The model consisted of two arms: do nothing and COVID-19 vaccine. Hospitalization and mortality rates were calibrated to U.S. COVID-19 reports as of November 2020. We performed economic calculations of costs in 2020 U.S. dollars and effectiveness in units of quality-adjusted life years (QALYs) to measure the budget impact and incremental cost-effectiveness at a $100,000/QALY threshold. Results Vaccines have a high probability of reducing healthcare costs and increasing QALYs compared to doing nothing. Simulations showed reductions in hospital days and mortality by more than 50%. Even though this represents a major U.S. investment, the budget impacts of these technologies could save program costs by up to 60% or more if uptake is high. Limitations The economic evaluation draws on the reported values of the clinical benefits of COVID-19 vaccines, although we do not currently have long-term conclusive data about COVID-19 vaccine efficacies. Conclusions Spending on vaccines to mitigate COVID-19 infections offer high-value potential that society should consider. Unusually high uptake in vaccines in a short amount of time could result in unprecedented budget impacts to government and commercial payers. Governments should focus on expanding health system infrastructure and subsidizing payer coverage to deliver these vaccines efficiently.