Cost-Utility Analysis of TNF-α Inhibitors, B Cell Inhibitors, and JAK Inhibitors Versus csDMARDs for Rheumatoid Arthritis Treatment.

INTRODUCTION: Rheumatoid arthritis (RA) is a progressive and debilitating disease, causing persistent joint pain that limits daily activities requiring long-term treatment. Newer targeted therapies expand RA treatment options, but their high cost necessitates a focus on cost effectiveness. To address this, we aim to conduct a cost-utility analysis of these newer RA pharmacotherapies to support evidence-based policy decision-making. METHODS: We analyzed the cost-utility of sequential treatment with TNF-α, B cell and JAK-inhibitors compared with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) for RA treatment in methotrexate (MTX) nonresponders. We used a Markov model with lifetime horizon and 6-month cycles from an Indian health system perspective. Costs (INR 2022) and quality-adjusted life years (QALYs) were used to determine the incremental cost-effectiveness ratios (ICERs) at a cost-effectiveness threshold of India's gross domestic product (GDP) per capita (2022). We assessed uncertainty using univariate, probabilistic sensitivity, and scenario analyses. RESULTS: Despite additional QALYs, TNF-α, B cell, and JAK inhibitors were not cost-effective for treating moderate-to-severe patients with RA unresponsive to csDMARDs (including MTX) in India, as increased costs outweighed their clinical benefits. ICERs ranged from 10,46,206 to 31,09,207 Indian Rupees in the base case analysis, exceeding three times India's GDP per-capita [approximately USD $13,287 to $39,487 and GBP £10,776 to £32,025]. Sensitivity analyses confirmed the results' robustness. Scenario analysis suggested that a cost reduction of over 75% in drug prices could make most of the interventions cost effective compared with csDMARDs. CONCLUSIONS: TNF-α, B cell, and JAK-inhibitors are not cost-effective compared with csDMARDs for patients with RA who have not responded to MTX in India at the current prices. Cost-effectiveness estimates were highly influenced by drug pricing variations. Therefore, reducing the prices of these interventions could enhance affordability, potentially leading to their inclusion in publicly funded health programs.

Cost-effectiveness of tumor necrosis factor-alpha inhibitors: a systematic review and meta-analysis of cost-utility studies.

OBJECTIVE: To systematically review the cost-utility evidence of TNF-a-i treatment for rheumatoid arthritis (RA) and to estimate the pooled incremental net benefit (INBp). METHODS: We selected economic evaluation studies reporting the cost-utility of TNF-a-i compared to other disease-modifying anti-rheumatic drugs (DMARDs) after a systematic search in PubMed, Embase, Scopus, and Tufts Medical Centers' cost-effective analysis registry. The results were reported as pooled INB in purchasing power parity-adjusted US dollars, along with 95% confidence intervals. We used GRADE quality assessment to present summaries of evidence and random-effects meta-analysis to synthesize cost-utility of TNF-a-i. RESULTS: We included 86 studies for systematic review, of which 27 for meta-analysis. TNF-a-i is not cost-effective [$ -4,129(-6,789 to -1,469)] compared to other DMARDs but with high heterogeneity. There was no evidence of publication bias (p = 0.447). On separate analysis, TNF-a-i is not cost-effective [$ -4,805(-7,882 to -1,728)] compared to conventional synthetic DMARDs for RA treatment. GRADE assessment indicated very low confidence in pooled cost-utility results and likely presence of risk of bias on the overall ECOBIAS checklist in studies. CONCLUSION: Based on the available evidence during the study period, TNF-a-i is not a cost-effective option for treating RA compared to other DMARDs. However, high heterogeneity and low confidence in GRADE quality assessment preclude the results from being generalizable.

Cost-effectiveness of cholecystectomy compared to conservative management in people presenting with uncomplicated symptomatic gallstones or cholecystitis in India.

OBJECTIVES: Gallstone diseases impose a significant economic burden on the health care system; thus, determining cost-effective management for gallstones is essential. We aim to estimate the cost-effectiveness of cholecystectomy compared with conservative management in individuals with uncomplicated symptomatic gallstones or cholecystitis in India. METHODS: A decision-analytic Markov model was used to compare the costs and QALY of early laparoscopic cholecystectomy (ELC), delayed laparoscopic cholecystectomy (DLC), and conservative management (CM) in patients with symptomatic uncomplicated gallstone/cholecystitis from an Indian health system perspective. Incremental cost-effectiveness ratio (ICER) was calculated. One-way and probabilistic sensitivity analyses were performed to test parameter uncertainties. RESULTS: ELC and DLC, compared to CM, incurred an incremental cost of -₹10,948 ($146) and ₹1,054 ($14) for the 0.032 QALYs gained. The ICER was -₹3,42,758 ($4577) for ELC vs. CM, and ₹33,183 ($443) for DLC vs. CM, suggesting ELC and DLC are cost-effective. ELC saved ₹12,001 ($160) for 0.0002 QALYs gained compared to DLC, resulting in an ICER of -₹6,43,89,441 ($8,59,733). The results were robust to changes in the input parameters in sensitivity analyses. CONCLUSION: ELC is dominant compared to both DLC and CM, and DLC is more cost-effective than CM. Thus, ELC may be preferable to other gallstone disease managements.

Safety and feasibility of revisional bariatric surgery following Laparoscopic Adjustable Gastric Band - Outcomes from a large UK private practice.

BACKGROUND: Revisional bariatric surgery is unavoidable in a proportion of patients. Despite its need, the development of this speciality has been hampered by its complexity and preferred delivery in institutional set ups. Although primary bariatric surgery can be delivered in the private sector; safety and feasibility of revisional bariatric surgery remains unexplored in this setting. MATERIALS AND METHODS: Patients undergoing revisional bariatric surgery following previous Laparoscopic Adjustable Gastric Band (LAGB) between 2008 and 2019 at a single private bariatric unit with a minimum follow up of at least 6 months were included. The primary aim was safety outcomes and 30-day morbidity. RESULTS: 178 patients with BMI of 45.6 ± 8.2 kg/m2 underwent revisional bariatric surgery. One stage conversion was performed for 86.5% of the cases. At 9.5 ± 5.3 months follow up, BMI and percentage excess BMI loss were 31.8 ± 6.2 kg/m2 and 62.6 ± 40% respectively. There was no mortality, and the major complication rate was 2.8%. There was no statistically significant difference in the incidence of complications based on one-stage vs. two-stage conversion (p = 0.52). There were no differences in weight loss outcomes post-revisional surgery according to the indication for revision (p = 0.446) or weight loss following primary surgery (p = 0.12). CONCLUSION: Revisional bariatric surgery can be delivered safely in the private sector with good outcomes. One-stage conversions are feasible and do not detrimentally affect the morbidity of the procedure or the weight loss outcomes. More importantly, success following revisional surgery is independent of the indication for revision and weight loss outcomes following primary surgery.

Randomised controlled trial to investigate the effectiveness of thoracic epidural and paravertebral blockade in reducing chronic post-thoracotomy pain (TOPIC): a pilot study to assess feasibility of a large multicentre trial.

OBJECTIVES: Thoracotomy is considered one of the most painful surgical procedures. The incidence of chronic post-thoracotomy pain (CPTP) is up to 50%. Paravertebral blockade (PVB) may be superior to thoracic epidural blockade (TEB) in preventing CPTP. The specific objective of this pilot study was to assess the feasibility of conducting a larger trial to determine whether PVB at thoracotomy is more effective in reducing CPTP compared with TEB. DESIGN: A randomised, parallel, external pilot study was conducted to assess whether a large randomised trial of TEB and PVB with CPTP as the primary outcome is feasible. SETTING: Two adult thoracic centres in the UK. PARTICIPANTS: All adult patients admitted for elective open thoracotomy. Participants were excluded if they were American Society of Anesthesiologists physical status IV or V; or if there is contraindication to local anaesthetics; infection near the proposed puncture site; coagulation/thoracic spine disorders; required chest wall resection or emergency thoracic surgery or had a previous thoracotomy. RESULTS: All patients presenting for thoracotomy were screened over a 12-month period with 194 found to be eligible. Of these, 69 (36%) were randomised (95% CI 29% to 42%). Discounting five participants who died, 54 of 64 participants (84%) returned questionnaire booklets at 6 months. The number of participants indicating at least a moderate level of chest pain at 6 months was lower with PVB but with high levels of uncertainty (RR: 0.7; 95% CI 0.3 to 1.7 for worst pain; RR: 0.3; 95% CI 0.0 to 2.8 for average pain). There were no safety concerns. CONCLUSIONS: A large, multicentre randomised controlled trial of PVB versus TEB is feasible as it is possible to randomise and follow up participants with high fidelity. Pain scores were lower on average with PVB compared with TEB but a much larger trial is required to confirm this reliably. TRIAL REGISTRATION NUMBER: ISRCTN45041624.