COST-UTILITY ANALYSIS OF MULTIPLE SCLEROSIS TREATMENT IN THAILAND

2018 ◽  
Vol 34 (6) ◽  
pp. 584-592
Author(s):  
Chalakorn Chanatittarat ◽  
Usa Chaikledkaew ◽  
Naraporn Prayoonwiwat ◽  
Sasitorn Siritho ◽  
Pakamas Pasogpakdee ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Cost Effective ◽  
Best Supportive Care ◽  
Quality Adjusted Life Year ◽  
Cost Utility ◽  
Outcome Data ◽  
Essential Medicines ◽  
Sensitivity Analyses ◽  
Lifetime Horizon ◽  
Cost Effective Treatment

Objectives:Although interferon beta-1a (IFNß−1a), 1b (IFNß−1b), and fingolimod have been approved as multiple sclerosis (MS) treatments, they have not yet been included on the National List of Essential Medicines (NLEM) formulary in Thailand. This study aimed to evaluate the cost-utility of MS treatments compared with best supportive care (BSC) based on a societal perspective in Thailand.Methods:A Markov model with cost and health outcomes over a lifetime horizon with a 1-month cycle length was conducted for relapsing–remitting MS (RRMS) patients. Cost and outcome data were obtained from published studies, collected from major MS clinics in Thailand and a discount rate of 3 percent was applied. The incremental cost-effectiveness ratio (ICER) was calculated and univariate and probabilistic sensitivity analyses were performed.Results:When compared with BSC, the ICERs for patients with RRMS aged 35 years receiving fingolimod, IFNβ−1b, and IFNβ−1a were 33,000, 12,000, and 42,000 US dollars (USD) per quality-adjusted life-year (QALY) gained, respectively. At the Thai societal willingness to pay (WTP) threshold of USD 4,500 per QALY gained, BSC had the highest probability of being cost-effective (49 percent), whereas IFNβ−1b and fingolimod treatments showed lower chance being cost-effective at 25 percent and 18 percent, respectively.Conclusions:Compared with fingolimod and interferon treatments, BSC remains to be the most cost-effective treatment for RRMS in Thailand based on a WTP threshold of USD 4,500 per QALY gained. The results do not support the inclusion of fingolimod or interferon in the NLEM for the treatment of RRMS unless their prices are decreased or special schema arranged.

scholarly journals Cost-Utility of Acromegaly Pharmacological Treatments in a French Context

2021 ◽  
Vol 12 ◽  
Author(s):  
Thierry Brue ◽  
Philippe Chanson ◽  
Patrice Rodien ◽  
Brigitte Delemer ◽  
Delphine Drui ◽  
...  
Keyword(s):  
Treatment Guidelines ◽  
Meta Analysis ◽  
Cost Effective ◽  
Somatostatin Analogues ◽  
Cost Utility ◽  
Sensitivity Analyses ◽  
Pharmacological Treatments ◽  
Lifetime Horizon ◽  
Efficient Treatment ◽  
The Cost

ObjectiveEfficacy of pharmacological treatments for acromegaly has been assessed in many clinical or real-world studies but no study was interested in economics evaluation of these treatments in France. Therefore, the objective of this study was to estimate the cost-utility of second-line pharmacological treatments in acromegaly patients.MethodsA Markov model was developed to follow a cohort of 1,000 patients for a lifetime horizon. First-generation somatostatin analogues (FGSA), pegvisomant, pasireotide and pegvisomant combined with FGSA (off label) were compared. Efficacy was defined as the normalization of insulin-like growth factor-1 (IGF-1) concentration and was obtained from pivotal trials and adjusted by a network meta-analysis. Costs data were obtained from French databases and literature. Utilities from the literature were used to estimate quality-adjusted life year (QALY).ResultsThe incremental cost-utility ratios (ICUR) of treatments compared to FGSA were estimated to be 562,463 € per QALY gained for pasireotide, 171,332 € per QALY gained for pegvisomant, and 186,242 € per QALY gained for pegvisomant + FGSA. Pasireotide seems to be the least cost-efficient treatment. Sensitivity analyses showed the robustness of the results.ConclusionFGSA, pegvisomant and pegvisomant + FGSA were on the cost-effective frontier, therefore, depending on the willingness-to-pay for an additional QALY, they are the most cost-effective treatments. This medico-economic analysis highlighted the consistency of the efficiency results with the efficacy results assessed in the pivotal trials. However, most recent treatment guidelines recommend an individualized treatment strategy based on the patient and disease profile.

scholarly journals Cost-effectiveness of everolimus for the treatment of advanced neuroendocrine tumours of gastrointestinal or lung origin in Canada

2018 ◽  
Vol 25 (1) ◽  
pp. 32 ◽  
Author(s):  
A. Chua ◽  
A. Perrin ◽  
J.F. Ricci ◽  
M.P. Neary ◽  
M. Thabane
Keyword(s):  
Cost Effectiveness ◽  
Neuroendocrine Tumours ◽  
Locally Advanced ◽  
Cost Effective ◽  
Best Supportive Care ◽  
Quality Adjusted Life Year ◽  
Sensitivity Analyses ◽  
Base Case ◽  
Health States ◽  
The Cost

Background In 2016, everolimus was approved by Health Canada for the treatment of unresectable, locally advanced or metastatic, well-differentiated, non-functional, neuroendocrine tumours (NET) of gastrointestinal (GI) or lung origin in adult patients with progressive disease. This analysis evaluated the cost-effectiveness of everolimus in this setting from a Canadian societal perspective.Methods A partitioned survival model was developed to compare the cost per life-year (LY) gained and cost per quality-adjusted life-year (QALY) gained of everolimus plus best supportive care (BSC) versus BSC alone in patients with advanced or metastatic NET of GI or lung origin. Model health states included stable disease, disease progression, and death. Efficacy inputs were based on the RADIANT-4 trial and utilities were mapped from quality-of-life data retrieved from RADIANT-4. Resource utilization inputs were derived from a Canadian physician survey, while cost inputs were obtained from official reimbursement lists from Ontario and other published sources. Costs and efficacy outcomes were discounted 5% annually over a 10-year time horizon, and sensitivity analyses were conducted to test the robustness of the base case results.Results Everolimus had an incremental gain of 0.616 QALYs (0.823 LYs) and CA$89,795 resulting in an incremental cost-effectiveness ratio of CA$145,670 per QALY gained (CA$109,166 per LY gained). The probability of cost-effectiveness was 52.1% at a willingness to pay (WTP) threshold of CA$150,000 per QALY.Conclusions Results of the probabilistic sensitivity analysis indicate that everolimus has a 52.1% probability of being cost-effective at a WTP threshold of CA$150,000 per QALY gained in Canada.

scholarly journals A Trial-Based Cost-Utility Analysis of Metastasis-Directed Therapy for Oligorecurrent Prostate Cancer

Cancers ◽  
2020 ◽  
Vol 12 (1) ◽  
pp. 132
Author(s):  
Elise De Bleser ◽  
Ruben Willems ◽  
Karel Decaestecker ◽  
Lieven Annemans ◽  
Aurélie De Bruycker ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Cost Effective ◽  
Dominant Strategy ◽  
Quality Adjusted Life Year ◽  
Cost Utility ◽  
Sensitivity Analyses ◽  
Health States ◽  
Government Documents ◽  
Markov Decision ◽  
The Cost

The optimal management of patients with oligorecurrent prostate cancer (PCa) is unknown. There is growing interest in metastasis-directed therapy (MDT) for this population. The objective was to assess cost-utility from a Belgian healthcare payer’s perspective of MDT and delayed androgen deprivation therapy (ADT) in comparison with surveillance and delayed ADT, and with immediate ADT. A Markov decision-analytic trial-based model was developed, projecting the results over a 5-year time horizon with one-month cycles. Clinical data were derived from the STOMP trial and literature. Treatment costs were derived from official government documents. Probabilistic sensitivity analyses showed that MDT is cost-effective compared to surveillance (ICER: €8393/quality adjusted life year (QALY)) and immediate ADT (dominant strategy). The ICER is most sensitive to utilities in the different health states and the first month MDT cost. At a willingness-to-pay threshold of €40,000 per QALY, the cost of the first month MDT should not exceed €8136 to be cost-effective compared to surveillance. The Markov-model suggests that MDT for oligorecurrent PCa is potentially cost-effective in comparison with surveillance and delayed ADT, and in comparison with immediate ADT.

scholarly journals Epidemiological impact and cost-effectiveness of varicella vaccination strategies in the United Kingdom (UK)

2020 ◽  
Author(s):  
E I Hervé Akpo ◽  
Olivier Cristeau ◽  
Manjit Hunjan ◽  
Giacomo Casabona
Keyword(s):  
United Kingdom ◽  
Cost Effectiveness ◽  
Cost Effective ◽  
Quality Adjusted Life Year ◽  
Cost Utility ◽  
Varicella Vaccination ◽  
Lifetime Horizon ◽  
The United Kingdom ◽  
The Uk ◽  
The Impact

Abstract Background Despite the burden of varicella, there is no universal varicella vaccination (UVV) programme in the United Kingdom (UK) due to concerns this could increase herpes zoster (HZ) incidence. This study assessed the cost-utility of a first-dose monovalent (V) or quadrivalent (MMRV) followed by a second-dose quadrivalent (MMRV) UVV programmes. GSK and MSD varicella-containing vaccines (VCVs) were considered. Methods A dynamic transmission and cost-effectiveness models were adapted to the UK. Outcomes measured included varicella and HZ incidences, the incremental cost-utility ratio (ICURs) over a lifetime horizon. The payer and societal perspectives were evaluated. Results The impact of V-MMRV and MMRV-MMRV UVV programmes on varicella incidence was comparable between both VCVs at equilibrium. HZ incidence increased by 1.6%-1.7% over seven years after UVV start, regardless of the strategies, then decreased by >95% at equilibrium. ICURs ranged from £5,665 (100 years) to £18,513 (20 years) per quality-adjusted life year (QALY) gained with V-MMRV; and from £9,220 to £27,101 per QALY gained with MMRV-MMRV (payer perspective). MMRV-MMRV was cost-effective in medium- and long-terms with GSK VCV, and only cost-effective at long-term with MSD VCV at £20,000 per QALY gained threshold. Without the exogenous boosting hypothesis, HZ incidence decreased through UVV implementation. ICURs were most sensitive to discount rates and MMRV price. Conclusions A 2-dose UVV was demonstrated to be a cost-effective alternative to no vaccination. With comparable effectiveness as MSD VCV at lower costs, GSK VCV may offer higher value for money.

scholarly journals The Clinical Effectiveness and Cost-Effectiveness of Rituximab Versus Natalizumab in Patients With Relapsing Remitting Multiple Sclerosis

2021 ◽  
Author(s):  
Mehdi Rezaee ◽  
Mohammad Hossein Morowvat ◽  
Maryam Poursadeghfard ◽  
Armin Radgoudarzi ◽  
Khosro Keshavarz
Keyword(s):  
Multiple Sclerosis ◽  
Cost Effectiveness ◽  
Signs And Symptoms ◽  
Clinical Effectiveness ◽  
Cost Effective ◽  
Cost Utility ◽  
Lifetime Horizon ◽  
Life Years ◽  
Scatter Plots ◽  
Anti Cd20

Abstract Introduction: Multiple sclerosis (MS) is an inflammatory disease in which the myelin sheaths of the nerve cells in the brain and spinal cord, which are responsible for communication, are destroyed and cause physical signs and symptoms. According to studies, anti-CD20 monoclonal antibodies have significant results in the treatment of this disease. Thus, the aim of the present study was to determine the effectiveness and cost-effectiveness of Rituximab against Natalizumab in the patients with MS in southern Iran in 2020. Methods: This is an economic evaluation including cost-effectiveness analysis in which the Markov model with a lifetime horizon was used. The study sample consisted of 120 patients randomly selected from among those referred to the MS Association and the Special Diseases Unit of Shiraz University of Medical Sciences. In this study, the costs were collected from a societal perspective, and the outcomes were obtained in the form of Quality Adjusted Life Years (QALY) and the mean recurrence rate. The TreeAge pro 2020 and Excel 2016 software were used for data analysis. Results: The comparative study of Rituximab and Natalizumab showed that the patients receiving Rituximab had lower costs ($ 58307.931 vs. $ 354174.85) and more QALYs (7.77 vs. 7.65). In addition, the incidence of relapse by Rituximab was lower compared to Natalizumab (1.15 vs. 2.57). The probabilistic one-way sensitivity analysis showed the robustness of the results. The scatter plots also showed that Rituximab was more cost-effective for the patients in 100% of the simulations for the threshold of >$ 37,641. Discussion and Conclusion: According to the results of this study, Rituximab had higher cost-utility and cost-effectiveness than Natalizumab. Therefore, it could be a priority for MS patients compared to Natalizumab because it reduced treatment costs and increased effectiveness.

Ixazomib (IXA), carfilzomib (CAR), elotuzumab (ELO) or daratumumab (DAR) with lenalidomide and dexamethasone (LEN+DEX) versus LEN+DEX only in relapsed/refractory multiple myeloma (R/R MM): A comparative cost-effectiveness analysis.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 8043-8043
Author(s):  
Mavis Obeng-Kusi ◽  
Daniel Arku ◽  
Neda Alrawashdh ◽  
Briana Choi ◽  
Nimer S. Alkhatib ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Cost Effective ◽  
Cost Utility ◽  
Cost Effectiveness Analysis ◽  
The Other ◽  
Sensitivity Analyses ◽  
Treatment Comparison ◽  
Comparative Cost ◽  
Effectiveness Analysis ◽  
Life Years

8043 Background: IXA, CAR, ELO and DARin combination with LEN+DEXhave been found superior in efficacy compared to LEN+DEX in the management of R/R MM. Applying indirect treatment comparisons from a network meta-analysis (NMA), this economic evaluation aimed to estimate the comparative cost-effectiveness and cost-utility of these four triplet regimens in terms of progression-free survival (PFS). Methods: In the absence of direct treatment comparison from a single clinical trial, NMA was used to indirectly estimate the comparative PFS benefit of each regimen. A 2-state Markov model simulating the health outcomes and costs was used to evaluate PFS life years (LY) and quality-adjusted life years (QALY) with the triplet regimens over LEN+DEX and expressed as the incremental cost-effectiveness (ICER) and cost-utility ratios (ICUR). Probability sensitivity analyses were conducted to assess the influence of parameter uncertainty on the model. Results: The NMA revealed that DAR+LEN+DEX was superior to the other triplet therapies, which did not differ statistically amongst them. As detailed in the Table, in our cost-effectiveness analysis, all 4 triplet regimens were associated with increased PFSLY and PFSQALY gained (g) over LEN+DEX at an additional cost. DAR+LEN+DEX emerged the most cost-effective with ICER and ICUR of $667,652/PFSLYg and $813,322/PFSQALYg, respectively. The highest probability of cost-effectiveness occurred at a willingness-to-pay threshold of $1,040,000/QALYg. Conclusions: Our economic analysis shows that all the triplet regimens were more expensive than LEN +DEX only but were also more effective with respect to PFSLY and PFSQALY gained. Relative to the other regimens, the daratumumab regimen was the most cost-effective.[Table: see text]

scholarly journals A one-year cost–utility analysis of REBOA versus RTACC for non-compressible torso haemorrhage

Trauma ◽  
2017 ◽  
Vol 21 (1) ◽  
pp. 45-54 ◽  
Author(s):  
Maxwell S Renna ◽  
Cristiano van Zeller ◽  
Farah Abu-Hijleh ◽  
Cherlyn Tong ◽  
Jasmine Gambini ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Cost Effective ◽  
Quality Adjusted Life Year ◽  
Cost Utility ◽  
Incremental Cost Effectiveness Ratio ◽  
Cost Utility Analysis ◽  
Utility Analysis ◽  
Cost Effectiveness Ratio ◽  
One Year ◽  
Quality Adjusted Life

Introduction Major trauma is a leading cause of death and disability in young adults, especially from massive non-compressible torso haemorrhage. The standard technique to control distal haemorrhage and maximise central perfusion is resuscitative thoracotomy with aortic cross-clamping (RTACC). More recently, the minimally invasive technique of resuscitative endovascular balloon occlusion of the aorta (REBOA) has been developed to similarly limit distal haemorrhage without the morbidity of thoracotomy; cost–utility studies on this intervention, however, are still lacking. The aim of this study was to perform a one-year cost–utility analysis of REBOA as an intervention for patients with major traumatic non-compressible abdominal haemorrhage, compared to RTACC within the U.K.’s National Health Service. Methods A retrospective analysis of the outcomes following REBOA and RTACC was conducted based on the published literature of survival and complication rates after intervention. Utility was obtained from studies that used the EQ-5D index and from self-conducted surveys. Costs were calculated using 2016/2017 National Health Service tariff data and supplemented from further literature. A cost–utility analysis was then conducted. Results A total of 12 studies for REBOA and 20 studies for RTACC were included. The mean injury severity scores for RTACC and REBOA were 34 and 39, and mean probability of death was 9.7 and 54%, respectively. The incremental cost-effectiveness ratio of REBOA when compared to RTACC was £44,617.44 per quality-adjusted life year. The incremental cost-effectiveness ratio, by exceeding the National Institute for Health and Clinical Effectiveness’s willingness-to-pay threshold of £30,000/quality-adjusted life year, suggests that this intervention is not cost-effective in comparison to RTACC. However, REBOA yielded a 157% improvement in utility with a comparatively small cost increase of 31.5%. Conclusion Although REBOA has not been found to be cost-effective when compared to RTACC, ultimately, clinical experience and expertise should be the main factor in driving the decision over which intervention to prioritise in the emergency context.

scholarly journals Cost-utility Analysis of Second-generation Direct-acting Antivirals for Hepatitis C

2021 ◽  
Vol 21 (8) ◽  
Author(s):  
Abdollah Poursamad ◽  
Zahra Goudarzi ◽  
Iman Karimzadeh ◽  
Nahid Jallaly ◽  
Khosro Keshavarz ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Hepatitis C ◽  
Cost Effective ◽  
Sensitivity Analyses ◽  
Genotype 1 ◽  
Medication Regimen ◽  
Lifetime Horizon ◽  
Medication Therapy ◽  
Life Years ◽  
Study Results

Background: Hepatitis C virus (HCV) can lead to increased mortality, disability, and liver transplantation if left untreated, and it is associated with a possible increase in disease burden in the future, all of which would surely have a significant impact on the health system. New antiviral regimens are effective in the treatment of the disease yet expensive. Objectives: The purpose of the present study was to assess the cost-effectiveness of three medication regimens, namely, ledipasvir/sofosbuvir (LDV/SOF), velpatasvir/sofosbuvir, and daclatasvir/sofosbuvir (DCV/SOF) for HCV patients with genotype 1 in Iran. Methods: A Markov model with a lifetime horizon was developed to predict the costs and outcomes of the three mentioned medication therapy strategies. The final outcome of the study was quality-adjusted life-years (QALYs), which was obtained using the previously published studies. The study was conducted from the perspective of the Health Ministry; therefore, only direct medical costs were estimated. The results were provided as the incremental cost-effectiveness ratio (ICER) per QALY. Ultimately, the one-way and probabilistic sensitivity analyses were used to measure the strength of study results. Results: The results showed that the QALYs for LDV/SOF, DCV/SOF, and VEL/SOF were 13.25, 13.94, and 14.61, and the costs were 4,807, 7,716, and 4,546$, respectively. The VEL/SOF regimen had lower costs and higher effectiveness than the LDV/SOF and DCV/SOF regimens, making it a dominant strategy. The tornado diagram results showed that the study results had the highest sensitivity to chronic hepatitis C (CHC) and compensated cirrhosis (CC) state costs. Moreover, the scatter plots showed that the VEL/SOF was the dominant therapeutic strategy in 73% of the simulations compared to LDV/SOF and 66% of the simulations compared to DCV/SOF; moreover, it was in the acceptable region in 92% of the simulations and below the threshold. Therefore, it was considered the most cost-effective strategy. Moreover, the results showed that DCV/SOF was in the acceptable region below the threshold in 69% of the simulations compared to LDV/SOF. Therefore, the DCV/SOF regimen was more cost-effective than LDV/SOF. Conclusions: According to the present study results, it is suggested that the VEL/SOF regimen be used as the first line of therapy in patients with HCV genotype 1. Moreover, DCV/SOF can be the second-line medication regimen.

scholarly journals Cladribine tablets are a cost-effective strategy in high-disease activity relapsing multiple sclerosis patients in Iran

2021 ◽  
Author(s):  
Nayyereh Ayati ◽  
Lora Fleifel ◽  
Mohammad Ali Sahraian ◽  
Shekoufeh Nikfar
Keyword(s):  
Multiple Sclerosis ◽  
Cost Effectiveness ◽  
Disease Activity ◽  
Cost Effective ◽  
High Disease Activity ◽  
Sensitivity Analyses ◽  
Life Years ◽  
Multiple Sclerosis Patients ◽  
The Cost ◽  
Relapsing Multiple Sclerosis

Background: Cladribine tablets are the foremost oral immune-reconstitution therapy for high disease activity relapsing multiple sclerosis (HDA-RMS). We aimed to assess the cost-effectiveness of cladribine tablets compared to natalizumab in patients with HDA-RMS in Iran. Methods: A 5-year cohort-based Markov model was developed with 11 expanded disability status score (EDSS) health states, including patients with HDA-RMS as on and off-treatment. All costs were identified from the literature and expert opinion and were measured in Iranian Rial rates, changed to the 2020 USD rate and were discounted by 7.2%. Quality adjusted life years (QALY), discounted by 3.5%, and life years gained (LYG) were adopted to measure efficacy. The final results were presented as incremental cost-effectiveness ratio that was compared to a national willingness to pay (WTP) threshold of 1 to 3 gross domestic product (GDP) per capita. Deterministic and probabilistic sensitivity analyses (D/PSA) were employed to evaluate uncertainty. Results: Cladribine tablets dominated natalizumab and yielded 6,607 USD cost-saving and 0.003 additional QALYs per patient. LYG was comparable. The main cost component was drug acquisition cost in both arms. DSA indicated the sensitivity of the results to the cost discount rates and also the patients’ body weight; while they were less sensitive to the main clinical variables. PSA indicated that cladribine tablets were cost-effective in Iran, with a probability of 57.5% and 58.6% at lower and higher limits of threshold, respectively. Conclusion: Cladribine tablets yielded higher QALYs and lower costs compared to natalizumab, in patients with HDA-RMS in Iran.

Cost-effectiveness of obeticholic acid for the treatment of non-alcoholic steatohepatitis: an early economic evaluation

2021 ◽  
pp. e20210011
Author(s):  
Chanh-Phong Tran ◽  
John J Kim ◽  
Jordan J Feld ◽  
William WL Wong
Keyword(s):  
Cost Effectiveness ◽  
Drug Cost ◽  
Cost Effective ◽  
Cost Utility ◽  
Sensitivity Analyses ◽  
Decompensated Cirrhosis ◽  
Obeticholic Acid ◽  
Potential Cost ◽  
Alcoholic Steatohepatitis ◽  
Early Results

Background: Currently, there are no pharmacological options available for the treatment of non-alcoholic steatohepatitis (NASH). In the 18-month interim analysis of an ongoing randomized, placebo-controlled phase 3 trial (REGENERATE), early results demonstrated that obeticholic acid (OCA) 25 mg significantly improved fibrosis with no worsening of NASH among patients with NASH and fibrosis compared to placebo (PBO). This study aimed to assess the potential cost-effectiveness of OCA compared to PBO in NASH patients. Methods: A state-transition model was developed to perform a cost-utility analysis comparing two treatment strategies, PBO and OCA 25 mg, from a Canadian public payer perspective. The model time horizon was lifetime with annual cycle lengths. Cost and utility parameters were discounted at 1.5% annually. The efficacy data were obtained from the REGENERATE trial, and costs and utilities were derived from other published literature. Probabilistic and deterministic sensitivity analyses were performed to test the robustness of the model. Results: Treatment with OCA led to reductions of 3.58% in decompensated cirrhosis cases, 3.95% in hepatocellular carcinoma, 7.88% in liver transplant, and 6.01% in liver-related death. However, at an annual price of CDN$36,000, OCA failed to be cost-effective compared to PBO at an incremental cost-effectiveness ratio of $815,514 per quality-adjusted life year (QALY). An 88% reduction in drug price to an annual cost of $4,300 would make OCA cost-effective at a willingness-to-pay threshold of $50,000/QALY. Conclusions: OCA failed to be cost-effective compared to PBO, despite demonstrating clinical benefits due to a high drug cost. A significant price reduction would be needed to make the drug cost-effective.

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