OBJECTIVE: While multiple reversible contraceptives are available, long-acting reversible contraception (LARC) offers multi-year protection with minimal user burden. The etonogestrel implant is the most effective LARC bu...OBJECTIVE: While multiple reversible contraceptives are available, long-acting reversible contraception (LARC) offers multi-year protection with minimal user burden. The etonogestrel implant is the most effective LARC but carries higher upfront acquisition costs. This analysis evaluated whether the acquisition costs for the etonogestrel implant are offset pregnancy prevention and pregnancy-related expenditures. METHODS: A discrete Markov chain model with 5-year time horizon simulated pregnancy outcomes among 1,000 women 18-49 years initiating 1 of 8 hormonal contraceptive methods: branded or generic oral contraception (OC; progestin only and combined), medroxyprogesterone acetate injection, etonogestrel/ethinyl estradiol vaginal ring, norelgestromin/ethinyl estradiol transdermal patch, 3- or ≥5-year levonorgestrel IUD, and the etonogestrel implant. The model specified 28-day cycles. Contraceptive acquisition costs, typical-use failure rates, discontinuation rates, pregnancy outcomes and costs, and healthcare resource use were examined from a United States managed care perspective. Sensitivity analyses were also conducted. RESULTS: The etonogestrel implant followed by IUDs were associated with the fewest pregnancies (60 [etonogestrel implant], 105 [3-year IUD], and 104 [≥5-year IUD], respectively) and the lowest per-woman costs ($3,428 [etonogestrel implant], $5,275 [3-year IUD], and $4,728 [≥5-year IUD], respectively). Cost offsets occurred in Year 1 and increased incrementally through Year 5. In comparison, branded and generic OC resulted in 299 and 323 pregnancies, respectively, and $8,477 and $8,678 per-woman costs; the vaginal ring, injection, and patch resulted in 328, 265, and 327 pregnancies, respectively, with per-woman costs ranging from $8,781 to $13,963. Discontinuation rates, not acquisition costs, were the primary driver impacting overall costs. CONCLUSIONS: The etonogestrel implant was the most cost-effective contraceptive option when modeled over a 5-year period, offering the fewest pregnancies and lowest associated healthcare costs. Policies and practices that support initiation and continuation of the etonogestrel implant can enhance both clinical outcomes and overall cost-effectiveness.
AIMS: Hospitals, in particular intensive care units (ICUs), account for a large proportion of healthcare costs and environmental burden. Preventing unexpected patient transfer to ICU continuous vital sign monitoring (CV...AIMS: Hospitals, in particular intensive care units (ICUs), account for a large proportion of healthcare costs and environmental burden. Preventing unexpected patient transfer to ICU continuous vital sign monitoring (CVSM) may mitigate this burden. Country-specific evidence on the cost-effectiveness of CVSM is missing. This analysis explored the impact of CVSM versus intermittent monitoring in post-surgical patients across France, Germany, the Netherlands, Spain, and the UK. MATERIALS AND METHODS: A health-economic, decision-tree model was developed to compare CVSM versus intermittent monitoring for costs, resources, and environmental consequences up to 30 days after hospital discharge for a hypothetical, 100-patient cohort. Hospital data from the UK were used to populate the initial country model, while data were extracted from the literature for Netherlands, Germany, Spain, and France. Key outcomes were costs (in 2024 currency), days in hospital, and environmental impact (kg of CO and kg of waste). Robustness of results to changes in model inputs were assessed 2,000 Monte Carlo simulations, results being presented reporting the 95% credible interval (95% CrI). RESULTS: For 100 patients, the cost savings with use of CVSM ranged from -€111,381 (95% CrI = -35,164; -159,176) in the Netherlands to -€22,745 (95% CrI = -7,656; -44,134) in France. In no country did the range of the 95% CrI cross zero, indicating significant cost savings with CVSM. Cost savings mainly resulted from reductions of ICU days, which ranged from -25 (95% CrI = 8; -43) in Germany to -9 (95% CrI = -1; -28) in France. Changes in ICU days were not always significant. On average, 3,866 kg of CO and 247 kg of waste were saved per cohort and country. LIMITATIONS: Published data was limited and data was proxied across countries when unavailable. CONCLUSIONS: CVSM is expected to be a cost-saving, sustainable solution for most hospitals of the countries included.
BACKGROUND AND AIM: Bruton tyrosine kinase inhibitors (BTKis) are the standard of care for patients with relapsed/refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Ibrutinib and acalabru...BACKGROUND AND AIM: Bruton tyrosine kinase inhibitors (BTKis) are the standard of care for patients with relapsed/refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Ibrutinib and acalabrutinib are two commonly used BTKis, though hypertension (HTN) and other cardiovascular medical events of interest (CV MEOIs) can impact treatment tolerability and long-term use. This study compared cardiovascular safety and health care resource use (HCRU) of acalabrutinib versus ibrutinib monotherapy for R/R CLL/SLL in real-world community practice. METHODS: This retrospective comparative study included 270 RR CLL/SLL patients (90 acalabrutinib; 180 ibrutinib) treated from January 2017 through December 2023 across the ONCare Alliance Network, comprising 30 US community hematology practices. Endpoints included new or worsening of existing HTN, development of CV MEOIs, and treatment discontinuation due to adverse events. HCRU metrics consisted of emergency department visits, hospital admissions, length of stay, specialist consultations, and related medical procedures. Propensity score weighted multivariable logistic regression was used for the comparative analysis on the tolerability endpoints. RESULTS: At a median follow-up of 33 months, patients treated with acalabrutinib had significantly fewer HTN events (OR = 0.27, 95% CI = 0.074-0.98; = .046) and adverse events leading to treatment discontinuation (OR = 0.39, 95% CI = 0.20-0.73; = .002) compared to those on ibrutinib. Hospital admission rates for MEOIs were lower in the acalabrutinib group (0.20 vs. 0.24 per patient), with a shorter median length of stay (3.0 vs. 6.0 days). Additionally, acalabrutinib patients had fewer specialist consultations (0.11 vs. 0.22 per patient) and associated medical procedures (0.11 vs. 0.18 per patient). CONCLUSIONS: In R/R CLL/SLL, acalabrutinib demonstrated a more favorable cardiovascular safety profile than ibrutinib, with fewer HTN events and CV MEOIs. This translated into reduced hospital admissions and lower HCRU, supporting acalabrutinib as a potentially better tolerated long-term treatment option in community practice.
AIMS: To quantify the clinical and economic burden of Coronavirus disease 19 (COVID-19), and burden potentially avoided with annual vaccination, in German adults in an endemic setting. MATERIALS AND METHODS: A decision t...AIMS: To quantify the clinical and economic burden of Coronavirus disease 19 (COVID-19), and burden potentially avoided with annual vaccination, in German adults in an endemic setting. MATERIALS AND METHODS: A decision tree model was constructed to estimate the clinical and economic impact of COVID-19 and projected burden avoided with BNT162b2, a seasonally adapted mRNA vaccine against severe COVID-19 disease. The majority of cost inputs and clinical event probabilities were informed by German real-world evidence from seasons 2022/23 and 2023/24. Vaccine efficacy was derived from US and German studies. Long/Post COVID impact was assessed in scenario analysis. RESULTS: The model estimated up to 20.8 million symptomatic infections per year in adults, including 7.5 million in people aged 60+, and 6.0 million in comorbid adults. This translates to an estimated 198,598 hospitalizations and 24,626 COVID-attributable deaths, with 93.6% of deaths occurring in people aged 60+. The total economic burden including productivity loss was estimated at €1.4 billion in people aged 60+, €2.0 billion in comorbid adults, and €3.9 billion in all working adults. Long/Post COVID increased the economic burden by 1.7 times. UNLABELLED: Assuming vaccination of 100% of recommended groups, 11.0 million symptomatic infections could be prevented, with the greatest impact in people aged 60+ (estimated 110,362 hospitalizations and 13,685 deaths avoided). For people aged 60+, comorbid adults, and all working adults, the number needed to vaccinate to prevent one symptomatic infection was 7, 4, and 4 people; to prevent one hospitalization, 231, 2,363, and 4,549; and to avoid one death, 1,862, 19,055, and 36,683, respectively. CONCLUSION: COVID-19 imposes a substantial clinical and economic burden on the German population, which could be mitigated with an expanded COVID-19 vaccination program. Further research into Long/Post COVID is needed. Our study presents considerations highlighting the value of broad vaccination especially for working adults.
Montilla PJ, Crisostomo AC, Cunanan E
… +13 more, de Lara-Valenzona MR, de Leon D, Encarnacion PJ, Estabillo AP, Gonzales CJ, Mallari-Catungal M, Perlas Tiongco Ii RH, Taneo MJ, Tan-Lim D, Togonon-Leaño JI, Yu D, Kimwell MJ, Villanueva AR
BACKGROUND AND OBJECTIVE: Chronic kidney disease (CKD) affects a significant proportion of the population leading to a substantial economic burden on healthcare systems and societies. Sodium-glucose co-transporter 2 inhi...BACKGROUND AND OBJECTIVE: Chronic kidney disease (CKD) affects a significant proportion of the population leading to a substantial economic burden on healthcare systems and societies. Sodium-glucose co-transporter 2 inhibitors (SGLT2i) have been shown to slow CKD progression and reduce cardiovascular risks in patients regardless of their diabetes status, leading to cost-savings and health benefits for patients with CKD. Currently, published cost-effectiveness studies in the UK and Southeast Asia demonstrate a significantly high value of adding empagliflozin in CKD management. This study aims to simulate a CKD progression model to assess the cost-effectiveness of adding empagliflozin to the standard of care (SoC) compared to SoC alone for CKD management in the Philippines. METHODS: We conducted an individual microsimulation model of CKD progression and its related complications using annual cycles from a healthcare perspective. The simulation incorporated local costs, life tables, and utility values derived from local and best available evidence from published CKD literature. RESULTS: The addition of empagliflozin to the SoC leads to significant lifetime cost-savings per patient of PHP 8,360,571.52 (USD 146,986.14) for the full cohort of the CKD population, PHP 7,944,677.72 (USD 139,674.36) for the diabetic cohort, and PHP 9,339,394.50 (USD 164,194.70) for the non-diabetic cohort. Patients on empagliflozin also experienced higher quality-adjusted life years (QALYs) of 0.84, 0.90, and 0.78 for the full, diabetic, and non-diabetic cohorts, respectively. Adding empagliflozin to the SoC is economically dominant across willingness-to-pay (WTP) thresholds ranging from 0.5 to 1 times the Philippine gross domestic product (GDP) per capita of 2024. Sensitivity analyses confirmed these findings, demonstrating consistency across varied input parameters. CONCLUSION: Empagliflozin is cost-saving and provides utility benefits when added to SoC among patients with CKD. This finding holds significant value for patients with CKD, regardless of diabetes status.
OBJECTIVE: Several novel therapies have been approved for treatment of generalized myasthenia gravis (gMG). The dosing requirements of certain therapies (efgartigimod intravenous, nipocalimab, ravulizumab, rozanolixizuma...OBJECTIVE: Several novel therapies have been approved for treatment of generalized myasthenia gravis (gMG). The dosing requirements of certain therapies (efgartigimod intravenous, nipocalimab, ravulizumab, rozanolixizumab, zilucoplan) are based on patient's body weight. To determine costs of weight-based gMG treatments to payers, accurate assessment of the body weight distribution of patients with MG is required. However, little is known about these patients' weight profile. The current study aims to provide robust weight data in multiple cohorts of patients with MG and elucidate the cost of gMG therapies based on weight. METHODS: Body weight distribution of patients with MG was analyzed using Optum's de-identified Market Clarity Data and data from the efgartigimod patient support program (PSP). Adult patients with MG with available body weight were included. Additionally, a literature review of clinical trials of gMG therapies that reported patient body weight was conducted. An analysis of the annual cost of weight-based dosing was also performed. RESULTS: Patients from the Optum database ( = 5,033) had mean body weight = 86.6 kg (standard deviation [SD] = 23.1 kg) and median weight = 83.7 kg (interquartile range [IQR] 70.3-99.9 kg). Patients from the PSP ( = 4,539) had mean weight = 92.1 kg (SD = 25.6 kg) and median weight = 89.0 kg (IQR = 74.0-106.1 kg). In each cohort, most patients weighed ≥80 kg (58.0% Optum, 66.2% PSP). Across clinical trials of patients with gMG, mean body weights ranged from 79.1-91.2 kg and median weights from 74.4-90.0 kg. The annual cost of health-care-provider-administered treatment for patients with gMG was estimated at $223,272-$648,960 depending on drug and body weight; annual cost was highest for patients who weighed >80 kg (up to $648,960 versus up to $467,044 for patients who weighed <80 kg). CONCLUSION: Our findings demonstrate that patients with MG may be heavier on average than previously assumed, which may influence the cost-effectiveness of gMG therapies with weight-based dosing.
AIMS: To estimate the societal burden of the US opioid epidemic over the next 15 years and the potential impact of non-opioid pharmacotherapies. METHODS: A published and validated decision analytic dynamic Markov model w...AIMS: To estimate the societal burden of the US opioid epidemic over the next 15 years and the potential impact of non-opioid pharmacotherapies. METHODS: A published and validated decision analytic dynamic Markov model was adapted to project the burden of the US opioid epidemic from 2025-2039, including the portion attributable to incident medical opioid use (IMOU). The model simulated adults with prescription opioid medical use (stratified by use for acute or chronic pain), non-medical prescription opioid use, illicit opioid use, and opioid use disorder (OUD). The annual and cumulative burden (number of OUD cases, overdoses, overdose deaths, and total costs) of the opioid epidemic and the burden attributable to IMOU was estimated from 2025-2039. The potential impact of replacing a portion of IMOU with non-opioid pharmacotherapies each year was evaluated beginning in 2025. RESULTS: The US opioid epidemic is projected to cost $367 billion (B) in 2025, increasing to $412B by 2039. The 15-year cumulative cost is estimated at $5.8 trillion (T), including $1.8 T in healthcare, $3.4 T in lost productivity, and $0.7 T in broader societal costs. IMOU will lead to 3.3 million new OUD cases, 110,000 overdose deaths, and $890B in total costs over the next 15 years. Replacing 10% of IMOU with non-opioid pharmacotherapies from 2025-2039 could prevent 323,000 OUD cases, 11,000 overdose deaths, and save $88B. Increasing IMOU replacement to 25% could prevent 808,000 OUD cases, 27,000 overdose deaths, and save $221B from 2025-2039. LIMITATIONS: As with any mathematical model, these findings represent projections of simulated populations, not precise forecasts. CONCLUSIONS: Findings suggest that the burden of the US opioid epidemic continues to increase, and effective non-opioid pharmacotherapies could reduce the burden by preventing incident OUD and associated downstream consequences.
BACKGROUND AND AIM: Pulmonary arterial hypertension (PAH) is a rare, progressive disease associated with significant morbidity and mortality. Recent clinical studies (STELLAR [NCT04576988] and ZENITH [NCT04896008]) showe...BACKGROUND AND AIM: Pulmonary arterial hypertension (PAH) is a rare, progressive disease associated with significant morbidity and mortality. Recent clinical studies (STELLAR [NCT04576988] and ZENITH [NCT04896008]) showed that adding sotatercept to standard of care improves clinical outcomes in patients with PAH. This study aimed to assess the clinical and economic impact of gradually adding sotatercept to currently available treatments for PAH in Italy. METHODS: A Markov model was developed to simulate the disease pathway of PAH patients. The model consisted of six health states: low risk PAH, intermediate-low risk PAH, intermediate-high risk PAH, high risk PAH, post lung/heart transplant, and death. Using this model, a cost-consequence analysis was performed to calculate the number of PAH related health events and associated costs over a 3-year time horizon assuming a gradual increase in the use of sotatercept. Primary outcomes included number of hospitalizations, lung/heart transplants, PAH-related deaths, and disease management costs. Sensitivity analyses were conducted to examine model robustness. RESULTS: Over a 3-year time horizon, the model predicted a total of 270 deaths, 1 lung/heart transplantation and 430 hospitalizations in the scenario with sotatercept. For the scenario without sotatercept, the model projected a total of 408 deaths, 2 transplants and 720 hospitalizations. Adding sotatercept to background therapy resulted in a reduction of 289 hospitalizations, 1 transplant and 138 deaths. Associated disease management costs were estimated to be €33.8 million in the scenario with sotatercept and €38.2 million in the scenario without sotatercept. Sotatercept plus background therapy was also associated with a reduction in costs of €4.4 million (11.8%). DISCUSSION AND CONCLUSIONS: This cost-consequence analysis showed that the introduction of sotatercept as an add-on therapy for the treatment of patients with PAH in Italy has the potential to reduce mortality, hospitalizations and lung/heart transplants, thereby substantially reducing PAH disease management costs.
AIMS: Cost-effectiveness evidence of chimeric antigen receptor T-cell therapy (CAR-T) for the treatment of relapsed or refractory large B-cell lymphoma (r/r LBCL) remains controversial given the potential CAR-T has to cu...AIMS: Cost-effectiveness evidence of chimeric antigen receptor T-cell therapy (CAR-T) for the treatment of relapsed or refractory large B-cell lymphoma (r/r LBCL) remains controversial given the potential CAR-T has to cure patients coupled with the high cost of therapy. This study aims to synthesize the cost-effectiveness data of CAR-T for the treatment of r/r LBCL in adults using a systematic review and meta-analysis. METHODS: Cost-effectiveness analyses of CAR-T for the treatment of r/r LBCL from inception through November 2024 were identified through database searches (MEDLINE, EMBASE, and CENTRAL). Costs were converted to 2023 US dollars using purchasing power parity. Incremental net benefit (INB) was calculated using country-specific willingness-to-pay thresholds and pooled using a random-effects model. Results were stratified by country income level and line of therapy. The risk of bias was assessed using the ECOBIAS checklist. Protocol registered at PROSPERO #CRD42024602683. RESULTS: Thirty-four studies were included in this systematic review. Twenty-six studies compared CAR-T to platinum-based chemotherapy with autologous stem cell therapy (ASCT) for r/r LBCL and eight studies compared between CAR-T therapies. As 2nd-line therapy for LBCL, CAR-T was found to have an INB of $28,846 (95% Confidence Interval [CI]: -$43,265 to $100,957; = 0%) ( = 9) compared to platinum-based chemotherapy with ASCT in high-income countries (HICs). As 3rd-line therapy against the same comparator, CAR-T had an INB of $48,838 (95% CI: -$156,625 to $254,302; = 79%) ( = 9) for HICs. CONCLUSIONS: Over a lifetime horizon, CAR-T was not significantly cost-effective for the treatment of r/r LBCL, though positive INBs suggest a trend toward cost-effectiveness as 2nd or 3rd-line therapy in HICs. Further cost-effective analyses should be conducted to compare between CAR-T products for the treatment of patients with r/r LBCL, as well as between CAR-T products and emerging novel therapies for r/r LBCL treatment, as this study did not address these comparisons.
AIM: Pembrolizumab has demonstrated significant improvements in clinical outcomes across multiple cancers. This study quantifies health benefits and productivity gains of pembrolizumab as a perioperative/adjuvant treatme...AIM: Pembrolizumab has demonstrated significant improvements in clinical outcomes across multiple cancers. This study quantifies health benefits and productivity gains of pembrolizumab as a perioperative/adjuvant treatment in five earlier-stage cancer indications (melanoma stage IIB-C and III, triple-negative breast cancer, renal cell carcinoma, resectable and resected non-small cell lung cancer) within the US Medicare beneficiary population. MATERIALS AND METHODS: A population-level, multi-indication decision model was developed to project the health and productivity gains of pembrolizumab. Over the 10 year period (2025-2034), a new patient cohort enters the model each year, and every cohort is followed through to 2034. Two scenarios were compared for cohorts of Medicare beneficiaries newly eligible for perioperative/adjuvant pembrolizumab: (1) a world without pembrolizumab, using only historical perioperative/adjuvant treatment options, and (2) a world where pembrolizumab is added as perioperative/adjuvant therapy for FDA-approved cancers. Outcomes included life years (LYs), quality-adjusted LYs (QALYs), number of events or recurrences, number of systemic treatments for metastatic disease, deaths, and caregivers' productive years lost. Inputs include clinical trial efficacy, Medicare and US population data, epidemiology, and market share information. RESULTS: Adding perioperative/adjuvant pembrolizumab is projected to increase recurrence-free LYs by 122,918 (+10%), total LYs by 56,704 (+4%), and QALYs by 55,483 (+4%). This strategy could reduce the number of recurrences by 35,558 (-16%), number of systemic treatments for metastatic disease by 32,962 (-16%), deaths following the first recurrence by 8,962 (-10%), and total deaths by 16,146 (-11%). Caregivers' productive years lost are estimated to decline by 9,392 (-18%) through reduced absenteeism and presenteeism. CONCLUSIONS: Perioperative/adjuvant pembrolizumab in earlier-stage cancers can meaningfully improve clinical outcomes for Medicare patients and reduce caregiver productivity losses. Sustained investment and access to pembrolizumab are critical to fully realize these benefits for patients and society.
AIM: Nirmatrelvir-ritonavir (NMV/r; Paxlovid) treatment reduces COVID-19-related morbidity, mortality, and direct healthcare burdens. To investigate the potential impact of NMV/r on indirect disease burdens, we compared...AIM: Nirmatrelvir-ritonavir (NMV/r; Paxlovid) treatment reduces COVID-19-related morbidity, mortality, and direct healthcare burdens. To investigate the potential impact of NMV/r on indirect disease burdens, we compared workplace productivity between employees diagnosed with COVID-19 who were and were not treated with NMV/r. METHODS: Adult employees with COVID-19 at high-risk of severe disease were identified in the Merative MarketScan Health and Productivity Management Database. Index date was the first COVID-19 diagnosis on or after 12/16/2021; employees were followed over a six-month pre-period and ≥30-day post-period. Individuals treated with NMV/r (claim within 5 days of index) were exactly matched 1:1 to untreated employees based on age, sex, index quarter, Charlson Comorbidity Index, and pre-period acute care visits. Lost workdays per-patient-per-month (PPPM) and associated estimated indirect costs due to absence, short-term disability (STD), or long-term disability (LTD) were compared between matched treated and untreated cohorts over the variable post-period using paired t-tests or Chi-squared tests and two-part hurdle models. RESULTS: Treated and untreated absence, STD, and LTD analyses included = 1,909, = 20,065, and = 20,318 employees respectively. NMV/r treatment was associated with significantly fewer lost workdays PPPM from absence (mean[SD]: 2.06[2.37] vs. 2.22[2.49], < 0.05), STD (0.41[2.17] vs. 0.52[2.42], < 0.001), and LTD (0.02[0.061] vs. 0.04[0.79], < 0.05) in descriptive analyses. Marginal means from combined two-part hurdle models confirmed treated employees had 5% fewer absence days (mean ratio[95% CI]:0.95[0.91, 0.99]), 17% fewer STD days (mean ratio[95% CI]:0.83[0.77, 0.88]), and 27% fewer LTD days (mean ratio[95% CI]:0.73[0.69, 0.78]) compared to untreated patients ( < 0.01). LIMITATIONS: The study sample was derived from large self-insured employers; results may not generalize to small employers or the uninsured and do not reflect other types of productivity loss (e.g. presenteeism). CONCLUSION: Within this sample of high-risk employees, NMV/r therapy was associated with reduced societal burdens following COVID-19 infection.
BACKGROUND: Opioids are commonly used to treat moderate-to-severe acute pain in the United States (US) but are associated with serious and costly outcomes including opioid use disorder (OUD). Suzetrigine is the first ora...BACKGROUND: Opioids are commonly used to treat moderate-to-severe acute pain in the United States (US) but are associated with serious and costly outcomes including opioid use disorder (OUD). Suzetrigine is the first oral nonopioid treatment approved in the US in over 20 years for the treatment of moderate-to-severe acute pain in adults. The objective of this analysis was to estimate the budget impact of adding suzetrigine to a state Medicaid formulary. METHODS: A budget impact model (BIM) compared scenarios before and after suzetrigine was available from the perspective of a hypothetical Medicaid plan with 1 million (M) members. The population consisted of adults with moderate-to-severe acute pain managed with prescription medication. Inputs included drug costs and medical costs of treating nausea/vomiting adverse events (AEs) and OUD/opioid abuse. The budget impact of suzetrigine was calculated as the difference in total costs and costs per member per month (PMPM) between the scenarios. RESULTS: Assuming between 3 and 10 thousand (k) adults with moderate-to-severe acute pain are treated with suzetrigine in place of prescription opioids in the first two years on formulary, suzetrigine was estimated to increase drug costs by $827k to $2.5 M, which was offset by $3.6 M to $10.8 M in savings from avoided nausea/vomiting AEs and OUD/opioid abuse. The addition of suzetrigine to formulary was estimated to result in a budget impact of -$2.8 M to -$8.3 M over two years, or -$0.11 to -$0.34 PMPM, translating to cost savings of $827 per patient treated with suzetrigine rather than an opioid over two years. CONCLUSION: While suzetrigine was estimated to increase drug costs, the associated avoidance of common opioid AEs and OUD/opioid abuse was estimated to result in cost savings for a state Medicaid plan in the first two years on formulary.
OBJECTIVES: Alkaline phosphatase (ALP) is a key biomarker in the management of primary biliary cholangitis (PBC). However, evidence of economic benefits of normal ALP is limited. We evaluated the relationship between ALP...OBJECTIVES: Alkaline phosphatase (ALP) is a key biomarker in the management of primary biliary cholangitis (PBC). However, evidence of economic benefits of normal ALP is limited. We evaluated the relationship between ALP levels and healthcare resource utilization (HCRU) and costs among individuals with PBC in the United States. METHODS: A retrospective analysis was conducted using Komodo's Healthcare Map insurance claims linked with laboratory data of individuals aged ≥18 years diagnosed with PBC between 09/01/2017 and 09/30/2023. At least two ALP tests ≥30 days apart were required, with the second designated as the index date. Continuous enrollment during the 12-month pre- and post-index periods was required. One-year regression-adjusted HCRU and healthcare costs (2024 US dollars) among individuals with persistently mildly elevated (ALP > 1 x upper limit of normal [ULN] ≤ 1.67 x ULN), elevated (ALP > 1.67 x ULN ≤3 x ULN) and highly elevated (ALP > 3 x ULN) were compared to those with persistently normal ALP (ALP ≤1 x ULN). RESULTS: 10,933 individuals with PBC were identified, including 9,544, 904, 297, and 248 with persistently normal, mildly elevated, elevated, and highly elevated ALP, respectively. Median age was 66 years, most were female (86.0%), White (58.2%), Medicare-insured (59.1%), and had ≥2 Charlson comorbidities (59.8%). Only 50.6% received PBC-specific treatment during baseline. Average 1-year healthcare costs were $18,747 (SD=$48,621). Compared to normal ALP, incremental regression-adjusted 1-year costs were $2,128 ( = 0.202), $10,289 ( < 0.001), and $12,229 ( < 0.001) for mildly, elevated, and highly elevated ALP, respectively. CONCLUSION: Effectively treating PBC and lowering ALP may decrease healthcare costs.
OBJECTIVE: To inform potential negotiations under the Medicare Drug Price Negotiation Program, this study evaluates the cost-effectiveness of ribociclib versus palbociclib as first-line (1 L) treatment for patients with...OBJECTIVE: To inform potential negotiations under the Medicare Drug Price Negotiation Program, this study evaluates the cost-effectiveness of ribociclib versus palbociclib as first-line (1 L) treatment for patients with HR+/HER2- advanced breast cancer (aBC) from the Medicare perspective. METHODS: A three-way partitioned survival model with states defined by progression-free survival (PFS) and overall survival (OS) was estimated over a lifetime horizon with a 28-day cycle length using data from Phase III MONALEESA-2 (ribociclib) and PALOMA-2 (palbociclib) trials. Relative treatment efficacy was measured using PFS and OS HRs derived from an anchored matching adjusted indirect comparison. Incremental cost-effectiveness ratios (ICERs) were calculated with costs estimated from a Medicare perspective and effectiveness measured using quality adjusted life years (QALYs), life years (LYs), progression-free life years (PFLYs), equal value life years (evLYs), and health years in total (HYT). All effectiveness and cost measures were discounted at 3%. A willingness-to-pay (WTP) threshold of $150,000 per QALY/evLY was used to assess cost-effectiveness. RESULTS: Measures of effectiveness consistently favoured ribociclib with estimated gains of 1.40 QALYs, 1.83 LYs, 1.08 PFLYs, 1.59 evLYs, and 1.80 HYT relative to palbociclib. Total costs were comparable, with ribociclib associated with a marginal 1.8% lifetime cost increase. ICERs ranged from $4,697 per LY gained to $7,973 per PFLY gained. At a WTP threshold of $150,000 per evLY, ribociclib demonstrated an approximately 100% probability of being cost-effective relative to palbociclib. CONCLUSION: Ribociclib improved health outcomes with a minimal relative cost increase and is therefore a highly cost-effective 1 L treatment option vs. palbociclib in patients with HR+/HER2- aBC from the Medicare perspective.
BACKGROUND: Testing for germline (g) mutations in patients with HER2-negative early breast cancer soon after diagnosis and before surgery (early testing) can influence surgical decisions, targeted adjuvant treatment acc...BACKGROUND: Testing for germline (g) mutations in patients with HER2-negative early breast cancer soon after diagnosis and before surgery (early testing) can influence surgical decisions, targeted adjuvant treatment access, and preventative care for relatives. The objective of this study was to identify evidence gaps in economic analyses of g testing in breast cancer. METHODS: We conducted a targeted literature review using MEDLINE to identify cost-effectiveness analyses (CEAs) of g testing in patients with breast or ovarian cancer published January 2014-April 2024. Ovarian cancer models were included given that status also impacts treatment and family member decisions. To evaluate the comprehensiveness of these studies, we mapped components against value elements relevant to genetic testing, synthesized from published frameworks and literature. RESULTS: A total of 26 CEAs of g testing were identified. Most studies ( = 17) assumed g testing increased risk-reducing surgeries (RRS), eight assumed g testing would guide poly adenosine diphosphate-ribose polymerase inhibitor (PARPi) use, and only one considered both. None assessed the value of early vs. late testing. We identified 21 value elements relevant to genetic testing; 15 CEAs included cascade testing, five included work productivity, and two included patient costs. When comparing g testing to no testing ( = 19), most studies concluded testing was cost-effective ( = 14). CONCLUSION: No CEAs have assessed the value of early g testing or comprehensively modeled downstream impacts to RRS and PARPi use with consideration for broader value elements. Further studies are needed to assess the full value of early g testing strategies.
OBJECTIVE: This study aims to evaluate the cost-effectiveness of ribociclib versus abemaciclib as first-line (1 L) treatment among women with HR+/HER2- advanced breast cancer (aBC) from a Medicare perspective. METHODS: U...OBJECTIVE: This study aims to evaluate the cost-effectiveness of ribociclib versus abemaciclib as first-line (1 L) treatment among women with HR+/HER2- advanced breast cancer (aBC) from a Medicare perspective. METHODS: Using data from the MONALEESA-2 (ribociclib) and MONARCH 3 (abemaciclib) clinical trials and other sources, a partitioned survival model with states defined by progression-free survival (PFS) and overall survival (OS) was estimated over a lifetime horizon with a 28-day cycle length. Relative treatment efficacy was measured using PFS and OS HRs derived through an anchored matching adjusted indirect comparison. Incremental cost-effectiveness ratios (ICERs) were calculated with costs estimated from a Medicare perspective and effectiveness measured in terms of quality-adjusted life years (QALYs), life years (LYs), progression-free life years (PFLYs), equal value life years (evLYs), and health years in total (HYT). All measures of effectiveness and cost were discounted at 3%. A willingness-to-pay (WTP) threshold of $150,000 per QALY/evLY was used to evaluate cost-effectiveness. RESULTS: Measures of effectiveness were consistently higher for ribociclib versus abemaciclib with gains in QALYs (+0.81), LYs (+1.05), PFLYs (+0.65), evLYs (+0.93), and HYT (+1.05). Total costs to Medicare were 14.7% higher with ribociclib vs. abemaciclib ($487,715 vs $425,198, respectively). Ribociclib was cost-effective versus abemaciclib with estimated ICERs of $77,199 per QALY, $59,320 per LY, $96,829 per PFLY, $67,210 per evLY, and $59,624 per HYT gained. At a WTP threshold of $150,000 per evLY, the probability that ribociclib is cost-effective versus abemaciclib, which was 81%. CONCLUSION: Ribociclib improves health outcomes with a modest impact on costs and is likely to be more cost-effective than abemaciclib for postmenopausal women requiring 1 L treatment of HR+/HER2- aBC from a Medicare perspective.
AIMS: The global prevalence of cardio-renal-metabolic (CRM) conditions, including chronic kidney disease, heart failure, type 2 diabetes in interconnected pathophysiology, is rapidly increasing. This presents health/econ...AIMS: The global prevalence of cardio-renal-metabolic (CRM) conditions, including chronic kidney disease, heart failure, type 2 diabetes in interconnected pathophysiology, is rapidly increasing. This presents health/economic consequences for Asia-Pacific (APAC) countries experiencing substantial disease burden. We aimed to forecast the regional clinical/economic burden of comorbid CRM conditions and evaluate the potential impact of sodium-glucose cotransporter 2 (SGLT2) inhibitors on burden reduction, with empagliflozin as the modeled intervention. METHODS: A Markov model (10-year time horizon [2024-2033]; annual cycle length) was developed and adapted for selected Southeast Asian countries (Malaysia/the Philippines/Thailand/Vietnam/Singapore), Australia, and South Korea using published local epidemiological and economic data. Future CRM disease prevalence, as well as the modeled SGLT2 inhibitor empagliflozin's potential in reducing clinical burden (prevalence/mortality) and associated healthcare resource use (HCRU) costs, were estimated. Empagliflozin cost was excluded from HCRU calculations to isolate/evaluate the economic burden of CRM conditions. RESULTS: Projecting the current disease trends (without SGLT2 inhibitors), the total number of patients with comorbid CRM conditions and deaths in Southeast Asia/Australia/South Korea would increase ∼3-fold from 19.0 million/968,000/2.6 million (2024) to 63.4 million/3.1 million/7.1 million (2033). Guideline-recommended use of SGLT2 inhibitor empagliflozin is estimated to prevent 925,000/19,100/105,000 patients from developing comorbid conditions and ∼1.9 million/50,000/174,000 deaths in Southeast Asia/Australia/South Korea by 2033. After excluding empagliflozin cost, these reductions translate to discounted cumulative cost savings for Southeast Asia (Malaysia: RM16.9 billion/the Philippines: ₱775.6 billion/Thailand: ฿973.7 billion/Vietnam: 148.0 trillion ₫/Singapore: S$1.1 billion), Australia (AU$23.2 billion), and South Korea (₩42.4 trillion). Varying the parameters of the deterministic sensitivity analysis resulted in upper and lower estimates of economic burden that differed by no more than 10% from the mean economic burden of each health state across the seven APAC countries. LIMITATIONS: Underreporting/variability in local epidemiological data potentially affected burden projection accuracy. Insufficient available data on comorbid CRM conditions across countries necessitated model input assumptions, which may have introduced uncertainties. CONCLUSIONS: Substantial increases in comorbid CRM disease prevalence and associated healthcare resource strain in APAC are expected over the next decade. Guideline-directed SGLT2 inhibitor use, with empagliflozin as an example, may alleviate regional clinical and economic burden.
BACKGROUND: Timely initiation of appropriate major depressive disorder (MDD) therapy is crucial. Medicaid-insured patients with MDD have higher healthcare resource utilization (HRU) and costs than commercially insured pa...BACKGROUND: Timely initiation of appropriate major depressive disorder (MDD) therapy is crucial. Medicaid-insured patients with MDD have higher healthcare resource utilization (HRU) and costs than commercially insured patients, making this group essential to study. METHODS: Claims in the Merative MarketScan Medicaid Database (2016 to 2022) were used to determine all‑cause and mental health (MH)‑related HRU and healthcare costs of US adults with MDD and ≥ 1 pharmacy claim for cariprazine adjunctive to antidepressant treatment. Outcomes were evaluated in patients initiating cariprazine as their first adjunctive therapy and those initiating cariprazine as a subsequent adjunctive therapy (e.g. after another atypical antipsychotic [AA], non-AA, antidepressant treatment combination). HRU and costs were compared with rate ratios (RRs) and mean cost differences between weighted cariprazine adjunctive therapy cohorts. RESULTS: Among 970 Medicaid beneficiaries meeting inclusion criteria, 392 initiated cariprazine as their first adjunctive therapy and 578 initiated it as a subsequent adjunctive therapy. Patients initiating cariprazine first had significantly lower rates of all‑cause emergency department visits (RR [95% CI] = 0.78 [0.66, 0.94], < .001) and outpatient (OP) visits (0.80 [0.67, 0.92], = .012) per patient‑year than those initiating cariprazine subsequently. This translated to lower annual all‑cause medical costs (-$2,101 [-$5,096, -$7], = .048), driven by lower OP costs (-$2,385, [-$5,251, -$492], = .016) per patient per year. MH‑related HRU and costs were also significantly lower. CONCLUSIONS: Findings from this real‑world study of Medicaid beneficiaries indicate that earlier cariprazine use is associated with potential reduction in the substantial humanistic and economic burden of MDD.