Private Payer Perspective Research Articles

RWD179 Resource Utilization and Direct Costs of Diabetes in Relation to Heart Failure Status in Private Payer Perspective in Brazil

RWD179 Resource Utilization and Direct Costs of Diabetes in Relation to Heart Failure Status in Private Payer Perspective in Brazil

Cost-effectiveness analysis of mosunetuzumab for treatment of relapsed or refractory follicular lymphoma after two or more lines of systemic therapy in the United States

Aims Mosunetuzumab has received accelerated approval by the US Food and Drug Administration for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. We evaluated the cost-effectiveness of mosunetuzumab for the treatment of R/R FL from a US private payer perspective. Materials and methods A partitioned survival model simulated lifetime costs and outcomes of mosunetuzumab against seven comparators: axicabtagene ciloleucel (axi-cel), tisagenlecleucel (tisa-cel), tazemetostat (taz, EZH2 wild-type only), rituximab plus lenalidomide (R-Len) or bendamustine (R-Benda), obinutuzumab plus bendamustine (O-Benda), and a retrospective real-world cohort (RW) based on current patterns of care derived from US electronic health records (Flatiron Health). Efficacy data for mosunetuzumab were from the pivotal Phase II GO29781 trial (NCT02500407). Relative treatment efficacy was estimated from indirect treatment comparisons (ITCs). Costs included were related to treatment, adverse events, routine care, and terminal care. Except for drug costs (March 2023), all costs were inflated to 2022 US dollars. Costs and quality-adjusted life-years (QALYs) were used to calculate incremental cost-effectiveness ratios (ICERs). Net monetary benefit (NMB) was calculated using a willingness-to-pay (WTP) threshold of $150,000/QALY. Results Mosunetuzumab dominated taz, tisa-cel, and axi-cel with greater QALYs and lower costs. Mosunetuzumab was projected to be cost-effective against R-Benda, O-Benda, and RW with ICERs of $78,607, $42,731, and $21,434, respectively. Mosunetuzumab incurred lower costs but lower QALYs vs. R-Len. NMBs showed that mosunetuzumab was cost-effective against comparators except R-Len. Limitations Without head-to-head comparative data, the model had to rely on ITCs, some of which were affected by residual bias. Model inputs were obtained from multiple sources. Extensive sensitivity analyses assessed the importance of these uncertainties. Conclusion Mosunetuzumab is estimated to be cost-effective compared with approved regimens except R-Len for the treatment of adults with R/R FL.

Irreversible pulpitis in mature permanent teeth: a cost-effectiveness analysis of pulpotomy versus root canal treatment

IntroductionEvidence-based dentistry suggests pulpotomy as a potential alternative to root canal treatment in mature permanent teeth with irreversible pulpitis. However, the evidence surrounding the cost-valuation and cost-efficacy of this treatment modality is not yet established. In this context, we adopted an economic modeling approach to assess the cost-effectiveness of pulpotomy versus root canal treatment, as this could aid in effective clinical decision-making.MethodsA Markov model was constructed following a mature permanent tooth with irreversible pulpitis in an 18-year-old patient over a lifetime using TreeAge Pro Healthcare 2022. Transition probabilities were estimated based on existing literature. Costs were estimated based on the United States healthcare following a private-payer perspective and parameter uncertainties were addressed using Monte-Carlo simulations. The model was validated internally by sensitivity analyses, and face validation was performed by an experienced endodontist and health economist.ResultsIn the base case scenario, root canal treatment was associated with additional health benefit but at an increased cost (1.08 more years with an incremental cost of 311.20 USD) over a period of an individual’s lifetime. The probabilistic sensitivity analysis revealed pulpotomy to be cost-effective at lower Willingness-To-Pay (WTP) values (99.9% acceptable at 50 USD) whereas increasing the values of WTP threshold root canal treatment was a cost-effective treatment (99.9% acceptable at 550 USD).ConclusionBased on current evidence, pulpotomy was a cost-effective treatment option at lower WTP values for the management of irreversible pulpitis in mature permanent teeth. However, by increasing the WTP threshold, root canal treatment became a more cost-effective treatment option over a period of lifetime of an individual.

Cost-effectiveness of weight-management pharmacotherapies in Canada: a societal perspective

ObjectivesThis study aimed to assess the cost-effectiveness of weight-management pharmacotherapies approved by Canada Health, i.e., orlistat, naltrexone 32 mg/bupropion 360 mg (NB-32), liraglutide 3.0 mg and semaglutide 2.4 mg as compared to the current standard of care (SoC).MethodsAnalyses were conducted using a cohort with a mean starting age 50 years, body mass index (BMI) 37.5 kg/m2, and 27.6% having type 2 diabetes. Using treatment-specific changes in surrogate endpoints from the STEP trials (BMI, glycemic, blood pressure, lipids), besides a network meta-analysis, the occurrence of weight-related complications, costs, and quality-adjusted life-years (QALYs) were projected over lifetime.ResultsFrom a societal perspective, at a willingness-to-pay (WTP) threshold of CAD 50 000 per QALY, semaglutide 2.4 mg was the most cost-effective treatment, at an incremental cost-utility ratio (ICUR) of CAD 31 243 and CAD 29 014 per QALY gained versus the next best alternative, i.e., orlistat, and SoC, respectively. Semaglutide 2.4 mg extendedly dominated other pharmacotherapies such as NB-32 or liraglutide 3.0 mg and remained cost-effective both under a public and private payer perspective. Results were robust to sensitivity analyses varying post-treatment catch-up rates, longer treatment durations and using real-world cohort characteristics. Semaglutide 2.4 mg was the preferred intervention, with a likelihood of 70% at a WTP threshold of CAD 50 000 per QALY gained. However, when the modeled benefits of weight-loss on cancer, mortality, cardiovascular disease (CVD) or osteoarthritis surgeries were removed simultaneously, orlistat emerged as the best value for money compared with SoC, with an ICUR of CAD 35 723 per QALY gained.ConclusionSemaglutide 2.4 mg was the most cost-effective treatment alternative compared with D&E or orlistat alone, and extendedly dominated other pharmacotherapies such as NB-32 or liraglutide 3.0 mg. Results were sensitive to the inclusion of the combined benefits of mortality, cancer, CVD, and knee osteoarthritis.

Cost-effectiveness analysis of full versus selective root canal retreatment.

Selective root-canal retreatment has been proposed as an alternative to full retreatment in multirooted, root-canal-filled teeth with evidence of apical pathology, where only the affected root(s) is retreated. Whilst this option may save costs initially, failures and retreatments may compensate for these initial savings. We assessed the cost-effectiveness of full versus selective root-canal retreatment using data from a recent clinical pilot study, employing a modelling approach. A Markov model was constructed to follow up a previously root-canal treated maxillary molar with apical pathology on a single root (mesio-buccal), receiving either selective or full root-canal retreatment. A private-payer perspective in Dutch health care was adopted. Permanent molar teeth with apical lesions on the mesial root were simulated over the lifetime of initially 50-year-old patients. Teeth could have endodontic complications and require interventions such as retreatment or tooth extraction and replacement. Costs were calculated based on the Dutch dental fee catalogues. Monte-Carlo microsimulations were performed to assess lifetime costs and effectiveness (measured as tooth retention time), and the resulting cost-effectiveness. Probabilistic joint uncertainty and sensitivity analyses were performed, and cost-effectiveness at different willingness-to-pay-thresholds was evaluated. In the base-case scenario, selective retreatment was less costly (2137; 2.5%-97.5% percentiles: 1944-2340 Euro) and more effective (19.6; 18.3-20.8 Years) than full retreatment (2495; 2305-2671 Euro; 16.5; 15.2-17.9 Years) in 100% of the simulations and regardless of the willingness-to-pay threshold. Only in a worst case scenario was selective retreatment more costly, but remained more effective. Selective retreatment, when clinically applicable, is likely to be more cost-effective than full retreatment in endodontically treated molars with persistent apical periodontitis. Our results should be interpreted with caution because the quality of the underlying data is limited.

Cost-Effectiveness Analysis of Regenerative Endodontics versus MTA Apexification.

With the introduction of stem cell engineering in dentistry, regenerative endodontics has emerged as a potential alternative to mineral trioxide aggregate (MTA) apexification in the management of necrotic immature permanent teeth. However, the utility of this modality in terms of cost-effectiveness has not yet been established. Therefore, we performed cost-effectiveness analysis to determine the dominant treatment modality that would influence decision making from the private payer perspective. A Markov model was constructed with a necrotic immature permanent tooth in a 7-y-old patient, followed over the lifetime using TreeAge Pro Healthcare 2022. Transition probabilities were estimated based on the existing literature. Costs were estimated based on United States health care, and cost-effectiveness was determined using Monte Carlo microsimulations. The model was validated internally by sensitivity analyses, and face validation was performed by an experienced endodontist and health economist. In the base-case scenario, regenerative endodontics did not turn out to be a dominant treatment option as it was associated with an additional cost of USD$1,012 and fewer retained tooth-years (15.48 y). Likewise, in the probabilistic sensitivity analysis, regenerative endodontics was again dominated by apexification against different willingness-to-pay values. Based on current evidence, regenerative endodontic treatment was not cost-effective compared with apexification in the management of necrotic immature permanent teeth over an individual's lifetime. The study provides valuable insight regarding the cost valuation and cost-efficacy of regenerative endodontic treatment versus apexification in the management of necrotic immature permanent teeth, as this would aid in effective clinical decision making, allowing for the functional allocation of resources.

Implant or tooth? – A cost-time analysis of managing “unrestorable” teeth✰

ObjectivesRetaining and restoring severely compromised teeth with subcrestal defect extensions or removing and replacing them using implant-supported crowns (ISC) remains controversial, and economic analyses comparing both strategies remain scarce. We performed a cost-time analysis, comparing the expenditures for retaining “unrestorable” teeth using forced orthodontic extrusion and restoration (FOE) versus extraction and ISC, in a clinical prospective cohort study. MethodsForty-two patients (n = 21 per group) were enrolled from clinical routine at a university into this study. Direct medical and indirect costs (opportunity costs) were assessed for all relevant steps (initial care, active care, restorative care, supportive care) using the private payer's perspective in German healthcare based on a micro-costing approach and/or national fee items. Statistical comparison was performed with Mann-Whitney-U test. ResultsPatients were followed up for at least one year after initial treatment (n = 40). The drop-out rate was 5% (n = 2). Total direct medical costs were higher for ISC (median: 3439.05€) than FOE (median: 1601.46€) with p<0.001. We observed a higher number of appointments (p = 0.002) for ISC (median: 14.5) in comparison to FOE (median: 12), while cumulatively, FOE patients spent more time in treatment (median: 402.5 min) in comparison to ISC (median: 250 min) with p<0.001, resulting in comparable opportunity costs for both treatment groups (FOE: 304.50€; ISC: 328.98€). ConclusionsISC generated higher costs than FOE. More in-depth and long-term exploration of cost-effectiveness is warranted. Clinical SignificanceISCs were associated with higher initial medical costs and required more appointments than the restoration of severely compromised teeth after FOE. Treatment time was higher for patients with FOE, resulting in similar opportunity costs for both treatment approaches. Future research needs to investigate long-term cost-effectiveness.

Cost-effectiveness of selective internal radiation therapy with Y-90 resin microspheres for intermediate- and advanced-stage hepatocellular carcinoma in Brazil

AimsHepatocellular carcinoma (HCC) is a severe condition with poor prognosis that places a significant burden on patients, caregivers, and healthcare systems. Selective internal radiation therapy (SIRT) is a treatment available to patients with HCC which addresses some of the limitations of alternative treatment options. A cost-effectiveness analysis was undertaken into the use of SIRT using Y-90 resin microspheres for the treatment of unresectable intermediate- and late-stage HCC in Brazil.Materials and methodsA partitioned-survival model was developed, including a tunnel state for patients downstaged to receive treatments with curative intent. Sorafenib was the selected comparator, a common systemic treatment in Brazil and for which comparative evidence exists. Clinical data were extracted from published sources of pivotal trials, and effectiveness was measured in quality-adjusted life-years (QALYs) and life-years (LYs). The analysis was conducted from the Brazilian private payer perspective and a lifetime horizon was implemented. Comprehensive sensitivity analyses were conducted.ResultsLYs and QALYs were higher for SIRT with Y-90 resin microspheres versus sorafenib (0.27 and 0.20 incremental LYs and QALYs, respectively) and costs were slightly higher for SIRT (R$15,864). The base case incremental cost-effectiveness ratio (ICER) was R$77,602 per QALY. The ICER was mostly influenced by parameters defining the sorafenib overall survival curve and SIRT had a 73% probability of being cost-effective at a willingness-to-pay threshold of R$135,761 per QALY (3-times the per-capita gross domestic product in Brazil). Overall, sensitivity analyses confirmed the robustness of the results indicating that SIRT with Y-90 resin microspheres is cost-effective compared with sorafenib.LimitationsA rapidly evolving treatment landscape in Brazil and worldwide, and the lack of local data for some variables were the main limitations.ConclusionsSIRT with Y-90 resin microspheres is a cost-effective option compared with sorafenib in Brazil.

Artificial Intelligence for Caries Detection: Value of Data and Information

If increasing practitioners’ diagnostic accuracy, medical artificial intelligence (AI) may lead to better treatment decisions at lower costs, while uncertainty remains around the resulting cost-effectiveness. In the present study, we assessed how enlarging the data set used for training an AI for caries detection on bitewings affects cost-effectiveness and also determined the value of information by reducing the uncertainty around other input parameters (namely, the costs of AI and the population’s caries risk profile). We employed a convolutional neural network and trained it on 10%, 25%, 50%, or 100% of a labeled data set containing 29,011 teeth without and 19,760 teeth with caries lesions stemming from bitewing radiographs. We employed an established health economic modeling and analytical framework to quantify cost-effectiveness and value of information. We adopted a mixed public–private payer perspective in German health care; the health outcome was tooth retention years. A Markov model, allowing to follow posterior teeth over the lifetime of an initially 12-y-old individual, and Monte Carlo microsimulations were employed. With an increasing amount of data used to train the AI sensitivity and specificity increased nonlinearly, increasing the data set from 10% to 25% had the largest impact on accuracy and, consequently, cost-effectiveness. In the base-case scenario, AI was more effective (tooth retention for a mean [2.5%–97.5%] 62.8 [59.2–65.5] y) and less costly (378 [284–499] euros) than dentists without AI (60.4 [55.8–64.4] y; 419 [270–593] euros), with considerable uncertainty. The economic value of reducing the uncertainty around AI’s accuracy or costs was limited, while information on the population’s risk profile was more relevant. When developing dental AI, informed choices about the data set size may be recommended, and research toward individualized application of AI for caries detection seems warranted to optimize cost-effectiveness.

Budget Impact and Cost-Effectiveness of Intravenous Meloxicam to Treat Moderate-Severe Postoperative Pain.

This study assesses the budget impact and cost-effectiveness of intravenous meloxicam (MIV) to treat moderate-severe acute postoperative pain in adults. A two-part Markov cohort model captured the pharmacoeconomic impact of MIV versus non-opioid intravenous analgesics (acetaminophen, ibuprofen, ketorolac) among a hypothetical adult cohort undergoing selected inpatient procedures and experiencing moderate-severe acute postoperative pain: Part1 (postoperative hour0 to discharge, cycled hourly), health states were defined by pain level. Pain transition rates, adverse event probabilities, and concomitant opioid utilization were derived from a network meta-analysis. Part2 (discharge to week52, cycled weekly), health states were defined by the presence/absence of pain-related readmission and opioid use disorder as determined by literature-based inputs relating to pain control outcomes. Healthcare utilization and direct medical costs were derived from an administrative claims database analysis. Primary outcomes were the incremental cost per member per month (PMPM) and cost per quality-adjusted life year (QALY) gained. Scenario, univariate, and probabilistic sensitivity analyses were conducted. The model assumed a private payer perspective in the USA (no discounting, 2019 US$). Modeled outcomes indicated MIV was associated with lower accumulated postoperative pain, fewer adverse events, and less opioid utilization for most procedures and comparators, with longer-term outcomes also generally favoring MIV. The budget impact of MIV was - $0.028PMPM. From a cost-effectiveness perspective, MIV had lower costs and better outcomes for all comparisons except against ketorolac in orthopedic procedures where the former was cost-effective but not cost saving ($95,925/QALY). Scenario and sensitivity analyses indicated that modeled outcomes were robust to alternative inputs and underlying input uncertainty. Differences in direct medical costs were driven by reduced costs attributable to length of stay and opioid-related adverse drug events. MIV was associated with modeled clinical and economic benefits compared to commonly used non-opioid intravenous analgesics.

Cost-effectiveness of ribociclib plus letrozole versus palbociclib plus letrozole or letrozole as monotherapy in first-line treatment of postmenopausal women with HR+/HER2- locally advanced or metastatic breast cancer: a Brazilian private payer perspective.

Background:The global burden of breast cancer (BC) is high, especially in advanced stages. CDK 4/6 inhibitors represent a paradigm shift in the treatment of advanced BC HR+/HER2−, given the clinically and statistically significant gain in overall survival associated with this new class of medications. Nevertheless, as an innovation, the incorporation of these drugs impacts healthcare budgets, requiring cost-effectiveness analyses for decision-making. The aim of this study was to evaluate the cost-effectiveness of ribociclib plus letrozole compared with palbociclib plus letrozole or letrozole as monotherapy for first-line treatment of postmenopausal women with HR+/HER2− locally advanced or metastatic BC (aBC) from a Brazilian private healthcare system perspective.Methods:A model including progression-free survival (PFS), progressed disease, and death health states was used to simulate lifetime costs and outcomes. PFS and overall survival were derived from the MONALEESA-2 trial (lifetime horizon). Healthcare costs included drug acquisition and monitoring, subsequent therapies, adverse events, and end-of-life costs. Effectiveness was measured in quality-adjusted life-years (QALYs). Deterministic and probabilistic sensitivity analyses were performed.Results:The total cost of treatment with ribociclib plus letrozole was USD 72,091.82 versus USD 92,749.64 for palbociclib plus letrozole. Total QALYs were 3.30 and 3.16, respectively. Base-case analysis showed ribociclib as dominant over palbociclib in first-line treatment of women with HR+/HER2− aBC, associated with cost savings and QALY gains. The total cost of treatment with ribociclib plus letrozole was USD 83,058.73 versus USD 29,215.10 for letrozole. Total QALYs were 3.84 and 2.61, respectively. Compared with letrozole, ribociclib plus letrozole was associated with an incremental cost of USD 53,843.64 and an incremental QALY gain of 1.23, with incremental cost-effectiveness ratio of USD 43,826.91 per QALY gained.Conclusions:As demonstrated by the cost-effectiveness dominance over palbociclib, ribociclib results in savings when used as first-line treatment in postmenopausal women with HR+/HER2− aBC, warranting incorporation in the private healthcare system.

PGI5 Cost per Responder Analysis of Biologic Treatments for Ulcerative Colitis in Biologic Naïve Patients from the Brazilian Private Healthcare System Perspective

Current clinical practice in managing Ulcerative Colitis (UC) includes biologic treatment with anti-TNF, anti-IL 12/23 and anti-integrin drugs. This study aims to compare cost per responder of each mechanism of action (MoA) for UC biologic naïve patients from the Brazilian private payer perspective through clinical response and remission rates Three drugs with different MoA were compared: adalimumab (anti-TNF), ustekinumab (anti-IL 12/23), and vedolizumab (anti-integrin). A published network metanalysis was accessed to compare each biologic drug clinical outcomes. Clinical response and clinical remission rates were evaluated through changes in total Mayo score and its subscores in biologic naïve patients. Only drug costs were considered, which were obtained on official price lists, and calculated according to label. Cost per patient achieving clinical response and cost per remittent patient were calculated through the ratio of costs (induction and maintenance year for standard and optimized dosing) by the proportion of patients achieving each outcome. For a three-year time horizon, clinical data were considered the same, but costs calculated accordingly Cost per biologic naïve patient achieving clinical response, in induction, maintenance standard and maintenance optimized year costs, were respectively: adalimumab BRL809K, BRL701K, BRL1.40M; ustekinumab BRL 249K, BRL154K, BRL231K; vedolizumab BRL317K, BRL257K, BRL515K. Cost per remittent patient, in induction, maintenance standard and maintenance optimized year costs, were respectively: adalimumab BRL689K, BRL597K, BRL1.19M; ustekinumab BRL 415K, BRL257K, BRL385K; vedolizumab BRL402K, BRL327K, BRL654K. In the 3-years scenario analysis, ustekinumab presented the lowest cost per responder result for clinical response (BRL557K, BRL711K) and remission (BRL 929K, 1.18M) for standard and optimized dosing, respectively. Anti-IL12/23 showed favorable economic results compared to other MoA. Among biologic treatments for UC in bionaïve patients, ustekinumab demonstrated to have the most favorable cost per responder result in the majority of analysis for both outcomes, considering induction, maintenance and 3-year time costs.

Updating the Cost Effectiveness of Oral Anticoagulants for Patients with Atrial Fibrillation Based on Varying Stroke and Bleed Risk Profiles.

Previous investigations into the cost effectiveness of direct oral anticoagulants only considered individual stroke risk but not bleed risk even though bleeding is an important and potentially fatal side effect for anticoagulated patients. This study aimed to evaluate the cost effectiveness of dabigatran, rivaroxaban, apixaban, and edoxaban vs warfarin in patients with atrial fibrillation with varying stroke/bleed risk profiles over a lifetime horizon. A Markov micro-simulation was adapted to examine the lifetime costs and quality-adjusted survival of five anticoagulants from a US private payer's perspective. The study hypothetical cohort consisted of 10,000 patients with atrial fibrillation with age, CHA2DS2-VASc, and HAS-BLED scores similar to a commercially insured patient with atrial fibrillation cohort. Model input parameters including the efficacy and safety of each strategy, utilities, and cost were estimated from public sources, published literature, and analysis conducted in the IBM MarketScan database. Lifetime cost, quality-adjusted life-years, and incremental cost-effectiveness ratios were assessed for each treatment strategy. Subgroup analyses stratified by age, stroke risk score alone, bleed risk score alone and both were performed. Uncertainty was assessed by a deterministic sensitivity analysis and a probabilistic sensitivity analysis. The base-case analysis suggested dabigatran was the optimal treatment with an incremental cost-effectiveness ratio of $35,055 per quality-adjusted life-year relative to warfarin. Subgroup analyses stratified by age, stroke risk score, and bleed risk score alone were largely consistent with the base-case analysis. Subgroup analyses stratified by both stroke and bleed risk score showed edoxaban was the preferred treatment in patients with a low stroke and a low or medium bleed risk, and patients with a high stroke and low bleed risk. Apixaban was the preferred treatment in patients with a medium stroke and high bleed risk. Results of the deterministic sensitivity analysis indicate the model results were most sensitive to the drug cost and hazard ratio for stroke and bleeding event. Results of the probability sensitivity analysis showed dabigatran is cost effective vs. other treatments in 32.8% and 42.4% of iterations at a willingness to pay of $50,000/quality-adjusted life-year and a willingness to pay of $100,000/quality-adjusted life year, respectively. From a US private payer's perspective, dabigatran appears cost effective compared with other anticoagulants. This study indicated risk stratification especially considering both stroke and bleed risk simultaneously is important not only in clinical practice but also in health technology assessment exercises among patients with atrial fibrillation.

PGI17 COST EFFECTIVENESS ANALYSIS OF ENDOSCOPIC CAPSULE FOR DIAGNOSIS OF OBSCURE GASTROINTESTINAL BLEEDING IN THE BRAZILIAN PRIVATE HEALTHCARE SYSTEM

To evaluate the cost-effectiveness of endoscopic capsule (EC) as enteroscopic diagnostic technique, compared to diagnostic procedures currently included in Brazilian private healthcare system, specifically, push enteroscopy using a standard probe and a double-balloon enteroscopy A decision tree model was developed from private payer perspective. The study population was adult patients diagnosed with gastrointestinal bleeding of obscure origin. The primary clinical outcome was diagnostic yield of each comparator; complications were included as a secondary outcome. Clinical data was identified through a literature review and final outcomes were calculated using a meta-analysis. Direct medical costs were included, taken from 2018 private insurance pricing charts (CBHPM) and presented in 2019 BRL and USD. Time horizon adopted was disease diagnosis and complications/adverse events timeframe. There was no discount rate. An univariate sensitivity analysis was conducted. A cost-effectiveness ratio was calculated two scenarios: 1) EC vs push enteroscopy and 2) EC vs double ballon enteroscopy. In the first analysis, EC presents an incremental diagnostic yield of 0.14 and an incremental cost of BRL 1,099 (USD 274), resulting in an ICER of BRL 7,931 (USD 1,982). In comparison to double ballon enteroscopy, EC results in an incremental diagnostic yield of -0.04 and an incremental cost of BRL 2,451 (USD 612). As such, EC is a dominant therapy compared to double balloon enteroscopy. Sensitivity analysis indicated that the results were robust to variations in both cost and effectiveness variables. Cost of EC and push enteroscopy were the varibles with the greatest impact on results. The analysis indicates that enteroscopy with endoscopic capsule has lower costs and a better diagnostic yield when compared to double balloon enteroscopy, making it a dominant alternative. Compared to push enteroscopy, EC may be considered a cost-effectiveness therapy that considerably improves the diagnostic yield.

Cost-effectiveness of diabetes treatment sequences to inform step therapy policies.

Cost-effectiveness estimates are useful to a health plan when they are specific to a utilization management policy question. To help inform a step therapy policy decision, this study assessed the 3-year cost-effectiveness of adding a sodium-glucose cotransporter 2 (SGLT2) inhibitor versus switching to a glucagon-like peptide-1 receptor agonist (GLP-1 RA) in patients with type 2 diabetes who are on metformin and a dipeptidyl peptidase-4 (DPP-4) inhibitor from both private and public payer perspectives in the United States. Cost-effectiveness analysis. A decision-analytic model was built incorporating goal glycated hemoglobin (A1C) achievement as the effectiveness measure, as well as adverse effect and discontinuation rates from clinical trial data. One-way, scenario, and probabilistic sensitivity analyses were performed. In a cohort of 1000 patients, adding an SGLT2 inhibitor led to $3.9 million more in spending and 93 more patients reaching goal A1C compared with switching from a DPP-4 inhibitor to a GLP-1 RA. This resulted in an incremental cost-effectiveness ratio (ICER) of $42,125per patient to achieve goal A1C from the private payer perspective. Using a public payer perspective led to an ICER of $103,829. These results were most sensitive to changes in drug costs and the proportion of patients achieving A1C goal or discontinuing. Assuming a $50,000 willingness-to-pay threshold, adding an SGLT2 inhibitor was cost-effective compared with switching from a DPP-4 inhibitor to a GLP-1 RA from a private payer perspective but not from a public payer perspective. This study highlights how differences in payer reimbursement rates for medications can lead to contrasting results.

Predicting Cost-Effectiveness of Generic vs. Brand Dabigatran Using Pharmacometric Estimates Among Patients with Atrial Fibrillation in the United States.

Generic entry of newer anticoagulants is expected to decrease the costs of atrial fibrillation management. However, when making switches between brand and generic medications, bioequivalence concerns are possible. The objectives of this study were to predict and compare the lifetime cost‐effectiveness of brand dabigatran with hypothetical future generics. Markov microsimulations were modified to predict the lifetime costs and quality‐adjusted life years of patients on either brand or generic dabigatran from a US private payer perspective. Event rates for generics were predicted using previously developed pharmacokinetic‐pharmacodynamic models. The analyses showed that generic dabigatran with lower‐than‐brand systemic exposure were dominant. Meanwhile, generic dabigatran with extremely high systemic exposure was not cost‐effective compared with the brand reference. Cost‐effectiveness of generic medications cannot always be assumed as shown in this example. Combined use of pharmacometric and pharmacoeconomic models can assist in decision making between brand and generic pharmacotherapies.

Cost Comparison of Flash Continuous Glucose Monitoring with Self-monitoring of Blood Glucose in Adults with Type 1 or Type 2 Diabetes Using Intensive Insulin—From a US Private Payer Perspective

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PGI13 COST PER RESPONDER ANALYSIS EVALUATED THROUGH CLINICAL RESPONSE AND REMISSION RATE OF ADALIMUMAB, USTEKINUMAB AND VEDOLIZUMAB FOR THE TREATMENT OF CROHN'S DISEASE FROM THE BRAZILIAN PRIVATE HEALTHCARE SYSTEM PERSPECTIVE

The aim of this study is to compare cost per patient achieving clinical response and cost per remitter patient of adalimumab, ustekinumab and vedolizumab for the treatment of Crohn’s disease (CD) from the Brazilian private payer perspective. Clinical response was evaluated through CD activity index reduction of 100 points (CDAI-100) and remission rate was evaluated through CD activity index score under 150 points (CDAI<150) in patients with CD. Clinical data of one-year treatment comparing adalimumab, ustekinumab and vedolizumab was obtained from a network metanalysis previously published. Only drug acquisition costs were considered in this analysis, which were obtained from official price magazine, and treatment costs were calculated according to approved label. Cost per patient achieving clinical response and cost per remittent patient were calculated dividing the induction and maintenance year costs by the proportion of patients achieving CDAI-100 and CDAI<150, respectively. In case of dose escalated clinical outcomes, costs were considered accordingly. A hypothetical scenario extrapolating clinical data for a three-year’s time horizon was run. Costs per patient achieving clinical response for adalimumab, ustekinumab and vedolizumab were: BRL551K, BRL574K and BRL604K in the induction year; BRL477K, BRL355K, BRL490K considering maintenance year costs; and BRL921K, BRL528K BRL962K in the dose escalation scenario. Cost per remitter patient for adalimumab, ustekinumab and vedolizumab were: BRL575K, BRL648K and BRL664K in the induction year; BRL499K, BRL401K and BRL540K considering maintenance year costs; and BRL960K, BRL584K and BRL1,045K in the dose escalation scenario. In the three-year’s scenario analysis, ustekinumab presented the lowest cost per patient achieving clinical response and remittent patient. The cost per responder in the first year are roughly similar, the advantage for adalimumab is negligible. Ustekinumab demonstrated to have better outcomes in the scenarios of maintenance year costs and dose escalation data, for both clinical response and remission rate outcomes.

PGI12 COST PER RESPONDER ANALYSIS EVALUATED THROUGH CLINICAL RESPONSE AND REMISSION RATE OF ADALIMUMAB, USTEKINUMAB AND VEDOLIZUMAB FOR THE TREATMENT OF CROHN'S DISEASE IN BIOLOGIC NAIVE PATIENTS FROM THE BRAZILIAN PRIVATE HEALTHCARE SYSTEM PERSPECTIVE

The aim of this study is to compare cost per responder of adalimumab, ustekinumab and vedolizumab for the treatment of biologic naïve patients with Crohn’s disease (CD) from the Brazilian private payer perspective, evaluated through clinical response and remission rate. To compare adalimumab, ustekinumab and vedolizumab clinical outcomes, a published network metanalysis was accessed. Clinical response was evaluated through CD activity index reduction of 100 points (CDAI-100) and remission rate was evaluated through CD activity index score under 150 points (CDAI<150) in biologic naïve patients. Only drug acquisition costs were considered, which were obtained from official price magazine and calculated according to label. Cost per patient achieving clinical response and cost per remittent patient were calculated dividing the induction and maintenance year costs by the proportion of patients achieving CDAI-100 and CDAI<150, respectively. In the analysis with dose escalated clinical data, costs were calculated accordingly. For a three-years’ time horizon hypothetical scenario, clinical data was considered the same, but costs were calculated accordingly. Costs per biologic naïve patient achieving clinical response for adalimumab, ustekinumab and vedolizumab were: BRL377K, BRL404K and BRL452K in induction year; BRL327K, BRL250K and BRL367K considering maintenance year costs; and BRL625K, BRL372K and BRL712K in the dose escalation scenario. Cost per remitter patient for adalimumab, ustekinumab and vedolizumab were: BRL373K, BRL449K and BRL421K in induction year; BRL323K, BRL278K and BRL342K considering maintenance year costs; and BRL631K, BRL409K BRL670K in the dose escalation scenario. In the 3 years scenario analysis, ustekinumab presented the lowest cost per responder result for both outcomes. Adalimumab demonstrated slightly favorable cost per responder results in the induction year and ustekinumab demonstrated to have better cost per responder in scenarios of maintenance years, with dose escalation data and in three-years’s time horizon, for both clinical response and remission rate outcomes.

PND3 COST-UTILITY ANALYSIS OF NATALIZUMAB AS FIRST LINE THERAPY FOR HIGHLY ACTIVE RELAPSING-REMITTING MULTIPLE SCLEROSIS FROM A BRAZILIAN PRIVATE PAYER PERSPECTIVE

Natalizumab is covered as second line therapy for relapsing-remitting multiple sclerosis (RRMS) in the Brazilian private healthcare system. Its other label indication, first line therapy for highly active RRMS (HARRMS), does not have mandatory coverage. This study aims at evaluating the cost-utility of natalizumab as first line for HARRMS compared to initiating treatment with platform therapies in the public system and migrating to natalizumab after therapeutic failure. A microsimulation model built in TreeAge® was used to simulate the treatment of a cohort of patients with HARRMS. Two arms were compared: one initiating treatment with natalizumab in the private system and the other initiating treatment with platform therapies in the public system and migrating to natalizumab in the private system. Natural history transition probabilities and relapse rates were derived from the placebo arm of Tysabri’s pivotal trial and drug efficacy data was obtained from each product’s pivotal clinical trial. For Tysabri, efficacy data was specific to the HARRMS population. For comparators, we used efficacy data for overall population. In the comparator arm, and as a conservative assumption, treatment initiation was assumed to have a three-month delay since diagnosis, lower than the observed in real life.Natalizumab’s cost was calculated based on the Brazilian drug price regulator official list. Platform therapies had no cost from the private payer perspective. Disease management costs were obtained through micro-costing based on published burden of illness study. The analysis resulted in greater effectiveness of the treatment being initiated with natalizumab (5.81 vs 4.36). Incremental cost was BRL 115.8 thousand in a 20-year horizon, resulting in an ICER of BRL 79.7 thousand/QALY. Initiating treatment with natalizumab in the private healthcare system is cost-effective vs initiating treatment in the public healthcare system, assuming a three times per capita GDP willingness-to-pay threshold (BRL 90 thousand/QALY).