scholarly journals Adalimumab for the treatment of psoriasis

2009 ◽  
Vol 13 (Suppl 2) ◽  
pp. 49-54 ◽  
Author(s):  
D Turner ◽  
J Picot ◽  
K Cooper ◽  
E Loveman
Keyword(s):  
Cost Effectiveness ◽  
Supportive Care ◽  
Plaque Psoriasis ◽  
Economic Model ◽  
Clinical Evidence ◽  
Single Technology Appraisal ◽  
Utility Values ◽  
Treatment Comparison ◽  
Significant Difference ◽  
Systemic Therapies

This paper presents a summary of the evidence review group (ERG) report into the clinical and cost-effectiveness of adalimumab for the treatment of moderate to severe plaque psoriasis based upon a review of the manufacturer’s submission to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal (STA) process. The submission’s clinical evidence came from three randomised controlled trials comparing adalimumab with placebo, two extension studies and one ongoing open-label extension study. The studies were of reasonable quality and measured a range of clinically relevant outcomes. A higher proportion of patients on 40 mg adalimumab every other week achieved an improvement on the Psoriasis Area and Severity Index (PASI) of at least 75% (PASI 75) compared with placebo groups after 12 or 16 weeks of treatment, and there was a statistically significant difference in favour of adalimumab for the proportion of patients achieving a PASI 50 and a PASI 90. In a mixed treatment comparison, for each PASI outcome the probability of a response was greater for infliximab than for adalimumab, but the probability of response with adalimumab was greater than that with etanercept, efalizumab and non-biological systemic therapies. Adverse event rates were similar in the treatment and placebo arms and discontinuations because of adverse events were low and comparable between groups. The submission’s economic model presents treatment effectiveness for adalimumab versus other biological therapies based upon utility values obtained from two clinical trials. The model is generally internally consistent and appropriate to psoriasis in terms of structural assumptions and the methods used are appropriate. The base-case incremental cost-effectiveness ratio for adalimumab compared with supportive care for patients with severe psoriasis was £30,538 per quality-adjusted life-year. Scenario analysis shows that the model was most sensitive to the utility values used. Weaknesses of the clinical evidence included not undertaking a systematic review of the comparator trials, providing very little in the way of a narrative synthesis of outcome data from the key trials and not performing a meta-analysis so that the overall treatment effect of adalimumab achieved across the trials is unknown. Weaknesses of the economic model included that the assumptions made to estimate the cost-effectiveness of intermittent etanercept used inconsistent methodology for costs and benefits and there were no clear data on the amount of inpatient care required under supportive care. The NICE guidance issued as a result of the STA states that adalimumab is recommended as a treatment option for adults with plaque psoriasis in whom anti-tumour necrosis factor treatment is being considered and when the disease is severe and when the psoriasis has not responded to standard systemic therapies or the person is intolerant to or has a contraindication to these treatments.

scholarly journals Ustekinumab for the treatment of moderate to severe psoriasis

2009 ◽  
Vol 13 (Suppl 3) ◽  
pp. 61-66
Author(s):  
E Gospodarevskaya ◽  
J Picot ◽  
K Cooper ◽  
E Loveman ◽  
A Takeda
Keyword(s):  
Sensitivity Analysis ◽  
Cost Effectiveness ◽  
Adverse Events ◽  
Supportive Care ◽  
Clinical Effectiveness ◽  
Severe Psoriasis ◽  
Base Case ◽  
Mixed Treatment Comparison ◽  
Single Technology Appraisal ◽  
Treatment Comparison

This paper presents a summary of the evidence review group (ERG) report into the clinical effectiveness and cost-effectiveness of ustekinumab for the treatment of moderate to severe psoriasis based upon a review of the manufacturer’s submission to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal (STA) process. The submission’s main evidence came from three randomised controlled trials (RCTs), of reasonable methodological quality and measuring a range of clinically relevant outcomes. Higher proportions of participants treated with ustekinumab (45 mg and 90 mg) than with placebo or etanercept achieved an improvement on the Psoriasis Area and Severity Index (PASI) of at least 75% (PASI 75) after 12 weeks. There were also statistically significant differences in favour of ustekinumab over placebo for PASI 50 and PASI 90 results, and for ustekinumab over etanercept for PASI 90 results. A weight-based subgroup dosing analysis for each trial was presented, but the methodology was poorly described and no statistical analysis to support the chosen weight threshold was presented. The manufacturer carried out a mixed treatment comparison (MTC); however, the appropriateness of some of the methodological aspects of the MTC is uncertain. The incidence of adverse events was similar between groups at 12 weeks and withdrawals due to adverse events were low and less frequent in the ustekinumab than in the placebo or etanercept groups; however, statistical comparisons were not reported. The manufacturer’s economic model of treatments for psoriasis compared ustekinumab with other biological therapies. The model used a reasonable approach; however, it is not clear whether the clinical effectiveness estimates from the subgroup analysis, used in the base-case analysis, were methodologically appropriate. The base-case incremental cost-effectiveness ratio for ustekinumab versus supportive care was £29,587 per quality-adjusted life-year (QALY). In one-way sensitivity analysis the model was most sensitive to the number of hospital days associated with supportive care, the cost estimate for intermittent etanercept 25 mg and the utility scores used. In the ERG’s scenario analysis the model was most sensitive to the price of ustekinumab 90 mg, the proportion of patients with baseline weight > 100 kg and the relative risk of intermittent versus continuous etanercept 25 mg. In the ERG’s probabilistic sensitivity analysis ustekinumab had the highest probability of being cost-effective at conventional NICE thresholds, assuming the same price for the 45-mg and 90-mg doses; however, doubling the price of ustekinumab 90 mg resulted in ustekinumab no longer dominating the comparators. In conclusion, the clinical effectiveness and cost-effectiveness of ustekinumab in relation to other drugs in this class is uncertain. Provisional NICE guidance issued as a result of the STA states that ustekinumab is recommended as a treatment option for adults with plaque psoriasis when a number of criteria are met. Final guidance is anticipated in September 2009.

scholarly journals Romiplostim for the treatment of chronic immune or idiopathic thrombocytopenic purpura: a single technology appraisal

2009 ◽  
Vol 13 (Suppl 2) ◽  
pp. 63-68
Author(s):  
G Mowatt ◽  
C Boachie ◽  
M Crowther ◽  
C Fraser ◽  
R Hernández ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Idiopathic Thrombocytopenic Purpura ◽  
Economic Model ◽  
Clinical Excellence ◽  
Sensitivity Analyses ◽  
Base Case ◽  
Technology Appraisal ◽  
Platelet Response ◽  
Single Technology Appraisal ◽  
Thrombocytopenic Purpura

This paper presents a summary of the evidence review group (ERG) report into the clinical and cost-effectiveness of romiplostim for the treatment of adults with chronic immune or idiopathic thrombocytopenic purpura (ITP) based upon a review of the manufacturer’s submission to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal (STA) process. The submission’s evidence came from two relatively high-quality randomised controlled trials (RCTs). The ERG found no evidence that any important data were missed or that data extraction was inaccurate. In both RCTs more patients in the romiplostim than in the placebo group achieved a durable platelet response [non-splenectomised patients: romiplostim 25/41 (61%), placebo 1/21 (5%), odds ratio (OR) 24.45, 95% confidence interval (CI) 3.34 to 179.18; splenectomised patients: romiplostim 16/42 (38%), placebo 0/21 (0%), OR 8.5 (95% CI 1.15 to 372)] and an overall platelet response [non-splenectomised patients: romiplostim 36/41 (88%), placebo 3/21 (14%), OR 34.74, 95% CI 7.77 to 155.38; splenectomised patients: romiplostim 33/42 (79%), placebo 0/21 (0%), OR 16.6 (95% CI 2.37 to 706]. The difference in mean period with a platelet response was 13.9 weeks (95% CI 10.5 to 17.4) in favour of romiplostim in the RCT of non-splectomised patients and 12.1 weeks (95% CI 8.7 to 15.6) in favour of romiplostim in the RCT of splectomised patients. The manufacturer’s economic model evaluated the cost-effectiveness of romiplostim compared with standard care. The ERG had concerns about the way the decision problem was addressed in the economic model and about the non-adjustment of findings for confounding factors. In non-splenectomised patients, using romiplostim as a first option treatment, the base-case incremental cost-effectiveness ratio (ICER) was £14,840 per quality-adjusted life-year (QALY). In splenectomised patients the ICER was £14,655 per QALY. Additional sensitivity analyses performed by the ERG identified two issues of importance: whether individuals entered the model on watch and rescue or on active therapy in the comparator arm (ICER £21,674 per QALY for non-splenectomised patients, £29,771 per QALY for splenectomised patients); whether it was assumed that any unused medicine would be wasted. Combining all of the separate sensitivity analyses, and assuming that watch and rescue was not the first-line treatment, increased the ICERs further (non-splenectomised £37,290 per QALY; splenectomised £131,017 per QALY). In conclusion, the manufacturer’s submission and additional work conducted by the ERG suggest that romiplostim has short-term efficacy for the treatment of ITP, but there is no robust evidence on long-term effectiveness or cost-effectiveness of romiplostim compared with relevant comparators.

scholarly journals Infliximab for the treatment of adults with psoriasis

2009 ◽  
Vol 13 (Suppl 1) ◽  
pp. 55-60
Author(s):  
E Loveman ◽  
D Turner ◽  
D Hartwell ◽  
K Cooper ◽  
A Clegg
Keyword(s):  
Sensitivity Analysis ◽  
Cost Effectiveness ◽  
Plaque Psoriasis ◽  
Indirect Comparison ◽  
Response To Treatment ◽  
Base Case ◽  
Infliximab Treatment ◽  
Single Technology Appraisal ◽  
Severe Plaque Psoriasis ◽  
Pasi Score

This paper presents a summary of the evidence review group (ERG) report into the clinical and cost-effectiveness of infliximab for the treatment of moderate to severe plaque psoriasis, in accordance with the licensed indication, based on the evidence submission from Schering-Plough to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal (STA) process. The outcomes stated in the manufacturer’s definition of the decision problem were severity [Psoriasis Area and Severity Index (PASI) score], remission rates, relapse rates and health-related quality of life. The main evidence in the submission comes from four randomised controlled trials (RCT) comparing infliximab with placebo and eight RCTs comparing either etanercept or efalizumab with placebo. At week 10, patients on infliximab had a significantly higher likelihood of attaining a reduction in PASI score than placebo patients. There were also statistically significant differences between infliximab and placebo in the secondary outcomes. In the comparator trials both the efalizumab and etanercept arms included a significantly higher proportion of patients who achieved a reduction in PASI score at week 12 than the placebo arms. No head-to-head studies were identified directly comparing infliximab with etanercept or efalizumab. The manufacturer carried out an indirect comparison, but the ERG had reservations about the comparison because of the lack of information presented and areas of uncertainty in relation to the included data. The economic model presented by the manufacturer was appropriate for the disease area and given the available data. The cost-effectiveness analysis estimates the mean length of time that an individual would respond to infliximab compared with continuous etanercept and the utility gains associated with this response. The base-case incremental cost-effectiveness ratio (ICER) for infliximab compared with continuous etanercept for patients with severe psoriasis was £26,095 per quality-adjusted life-year. A one-way sensitivity analysis, a scenario analysis and a probabilistic sensitivity analysis were undertaken by the ERG. The ICER is highly sensitive to assumptions about the costs and frequency of inpatient stays for non-responders of infliximab. The guidance issued by NICE in August 2007 as a result of the STA states that infliximab within its licensed indication is recommended for the treatment of adults with very severe plaque psoriasis, or with psoriasis that has failed to respond to standard systematic therapies. Infliximab treatment should be continued beyond 10 weeks in people whose psoriasis has shown an adequate response to treatment within 10 weeks. In addition, when using the Dermatology Life Quality Index (DLQI), care should be taken to take into account the patient’s disabilities, to ensure DLQI continues to be an accurate measure.

scholarly journals Brentuximab Vedotin for Treating Relapsed or Refractory CD30-Positive Cutaneous T-Cell Lymphoma: An Evidence Review Group Perspective of a NICE Single Technology Appraisal

2020 ◽  
Vol 4 (4) ◽  
pp. 563-574
Author(s):  
Angela Stainthorpe ◽  
Nigel Fleeman ◽  
Rachel Houten ◽  
Marty Chaplin ◽  
Angela Boland ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Clinical Evidence ◽  
Cell Lymphoma ◽  
Evidence Review Group ◽  
Brentuximab Vedotin ◽  
Base Case ◽  
Cutaneous T Cell Lymphoma ◽  
Single Technology Appraisal ◽  
Treatment Pathway ◽  
Evidence Review

AbstractAs part of the single technology appraisal process, the National Institute for Health and Care Excellence invited Takeda UK Ltd to submit clinical- and cost-effectiveness evidence for brentuximab vedotin (BV) for treating relapsed or refractory CD30-positive (CD30+) cutaneous T-cell lymphoma (CTCL). The Liverpool Reviews and Implementation Group at the University of Liverpool was commissioned to act as the evidence review group (ERG). This article summarises the ERG’s review of the company’s submission for BV and the appraisal committee (AC) decision. The principal clinical evidence was derived from a subgroup of patients with advanced-stage CD30+ mycosis fungoides (MF) or primary cutaneous anaplastic large-cell lymphoma (pcALCL) in the phase III ALCANZA randomised controlled trial (RCT). This trial compared BV versus physician’s choice (PC) of methotrexate or bexarotene. Evidence from three observational studies was also presented, which included patients with other CTCL subtypes. The ERG’s main concerns with the clinical evidence were the lack of RCT evidence for CTCL subtypes other than MF or pcALCL, lack of robust overall survival data (data were immature and confounded by subsequent treatment and treatment crossover on disease progression) and lack of conclusive results from analyses of health-related quality-of-life data. The ERG noted that many areas of uncertainty in the cost-effectiveness analysis were related to the clinical data, arising from the rarity of the condition and its subtypes and the complexity of the treatment pathway. The ERG highlighted that the inclusion of allogeneic stem-cell transplant (alloSCT) as an option in the treatment pathway was based on weak evidence and generated more uncertainty in a disease area that, because of its rarity and diversity, was already highly uncertain. The ERG also lacked confidence in the company’s modelling of the post-progression pathway and was concerned that it may not produce reliable results. Results from the company’s base-case comparison (including a simple discount patient access scheme [PAS] for BV) showed that treatment with BV dominated PC. The ERG’s revisions and scenario analyses highlighted the high level of uncertainty around the company base-case cost-effectiveness results, ranging from BV dominating PC to an incremental cost-effectiveness ratio per quality-adjusted life-year gained of £494,981. The AC concluded that it was appropriate to include alloSCT in the treatment pathway even though data were limited. The AC recommended BV as an option for treating CD30+ CTCL after at least one systemic therapy in adults if they have MF, stage IIB or higher pcALCL or Sézary syndrome and if the company provides BV according to the commercial arrangement (i.e. simple discount PAS).

scholarly journals Trabectedin for the treatment of relapsed ovarian cancer

2011 ◽  
Vol 15 (Suppl 1) ◽  
pp. 69-75
Author(s):  
D Papaioannou ◽  
R Rafia ◽  
MD Stevenson ◽  
JW Stevens ◽  
P Evans
Keyword(s):  
Ovarian Cancer ◽  
Overall Survival ◽  
Cost Effectiveness ◽  
Decision Problem ◽  
Single Technology Appraisal ◽  
Treatment Comparison ◽  
Platinum Sensitive ◽  
Platinum Based Chemotherapy ◽  
The Cost ◽  
Sensitive Population

The paper presents a summary of the evidence review group (ERG) report into the clinical effectiveness and cost-effectiveness of trabectedin for the treatment of relapsed platinum-sensitive ovarian cancer, based upon a review of the manufacturer’s submission to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal process. The submission addressed only part of the decision problem and did not provide evidence to compare trabectedin (Yondelis®, PharmaMar) and pegylated liposomal doxorubicin hydrochloride (PLDH) (Caelyx®, Schering-Plough) with key comparators. The submission’s direct comparison evidence came from one reasonable-quality randomised controlled trial (RCT) of trabectedin and PLDH versus PLDH alone (ET743-OVA-301). The results of the RCT were subdivided into the entire platinum-sensitive population (> 6-month relapse after initial platinum-based chemotherapy) and partially platinum-sensitive (≥ 6- to 12-month relapse) and fully platinum-sensitive (> 12-month relapse) populations. The outcomes included were overall survival, progression-free survival measured by three types of assessor, response rates, adverse effects of treatment, health-related quality of life and cost per quality-adjusted-life-year (QALY) gained. A mixed treatment comparison (MTC) meta-analysis comparing trabectedin and PLDH with single-agent PLDH within the entire platinum-sensitive population, with paclitaxel or with topotecan also formed part of the submission. The RCT data showed that trabectedin plus PLDH compared with PLDH monotherapy had a significant effect on overall survival only within the partially platinum-sensitive subgroup. PFS results reported by the independent radiologists showed significant effects in favour of the trabectedin and PLDH arm for the entire and partially platinum-sensitive populations only. Rates of grade 3 and 4 adverse events were mostly higher in the trabectedin and PLDH arm than in the PLDH alone arm. There were several issues regarding the undertaking of the MTC, and thus the data were not considered robust. Furthermore, the ERG did not believe the MTC to be necessary to answer the decision problem. The manufacturer submitted a de novo cost-effectiveness model. The main analysis compared trabectedin in combination with PLDH versus paclitaxel, topotecan and PLDH (each as monotherapy) in the entire platinum-sensitive population, using results estimated from the MTC. Additional analyses were presented comparing trabectedin in combination with PLDH versus PLDH monotherapy using direct evidence from the OVA-301 trial for the fully, partially and entire platinum-sensitive populations. The cost per QALY gained for trabectedin in combination with PLDH versus PLDH monotherapy was estimated to be £70,076 in the main analysis. In the additional analyses, the cost per QALY gained for trabectedin in combination with PLDH versus PLDH monotherapy was £94,832, £43,996 and £31,092 for the entire, partially and fully platinum-sensitive populations, respectively. Additional work was undertaken by the ERG using patient-level data and amending some assumptions to provide a better statistical fit to the Kaplan–Meier data than the exponential distribution assumed by the manufacturer. The ERG base-case estimate of the cost per QALY of trabectedin in combination with PLDH ranged from £46,503 to £54,607 in the partially platinum-sensitive population. At the time of writing, trabectedin in combination with PLDH for the treatment of women with relapsed platinum-sensitive ovarian cancer is not recommended by NICE in the final appraisal determination.

scholarly journals Omalizumab for the treatment of severe persistent allergic asthma

2009 ◽  
Vol 13 (Suppl 2) ◽  
pp. 31-39
Author(s):  
J Jones ◽  
J Shepherd ◽  
D Hartwell ◽  
P Harris ◽  
K Cooper ◽  
...  
Keyword(s):  
Sensitivity Analysis ◽  
Cost Effectiveness ◽  
Allergic Asthma ◽  
Standard Therapy ◽  
Sensitivity Analyses ◽  
Base Case ◽  
Life Questionnaire ◽  
Exacerbation Rate ◽  
Single Technology Appraisal ◽  
Significant Difference

This paper presents a summary of the evidence review group (ERG) report into the clinical effectiveness and cost-effectiveness of omalizumab for the treatment of chronic severe persistent allergic asthma, in accordance with the licensed indication, based upon the evidence submission from Novartis to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal (STA) process. The clinical evidence comes from a randomised controlled trial comparing omalizumab as an add-on to standard therapy with placebo and standard therapy over a 28-week treatment period. For the primary outcome of the rate of clinically significant asthma exacerbations, there was no statistically significant difference between treatment groups. However, after making a post hoc adjustment for a suggested ‘clinically relevant’ imbalance between trial arms in baseline exacerbation rate, the difference became marginally statistically significant. In terms of secondary outcomes, there were statistically significant differences favouring omalizumab over placebo in total emergency visits, Asthma Quality of Life Questionnaire scores, total symptom scores and lung function. Adverse events appeared to be similar between the trial arms. Results from three other publications are included in the manufacturer’s submission as supporting evidence for the effectiveness of omalizumab, despite not meeting the inclusion criteria which adhere strictly to the licensed indication. The ERG checked and provided commentary on the manufacturer’s model using standard checklists as well as undertook one-way sensitivity analysis, scenario analysis and a probabilistic sensitivity analysis. The cost-effectiveness analysis estimates the incremental costs and consequences of omalizumab as an add-on to standard therapy. The base-case analysis of the trial’s primary intention-to-treat population estimates a cost per quality-adjusted life-year of £30,647. The ERG conducted one-way sensitivity analyses for parameters omitted from the manufacturer’s submission sensitivity analysis. The results were most sensitive to variation in the utility values for omalizumab responders, and the unit cost of omalizumab. The guidance issued by NICE in November 2007 as a result of the STA states that omalizumab is recommended as a possible treatment for adults and young people over 12 years with severe persistent allergic asthma when their asthma meets certain conditions. Omalizumab treatment should be given along with the person’s current asthma medicines. It should be prescribed by a doctor who is experienced in asthma and allergy medicine at a specialist centre. If omalizumab does not control the asthma after 16 weeks, treatment should be stopped.

Enrichment of common carp (Cyprinus carpio) diet with Malic acid: Effects on skin mucosal immunity, antioxidant defecne and growth performance

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Roghieh Safari ◽  
Seyed Hossein Hoseinifar ◽  
Maryam Dadar ◽  
Hien Van Doan
Keyword(s):  
Common Carp ◽  
Cyprinus Carpio ◽  
Malic Acid ◽  
Control Group ◽  
Skin Mucus ◽  
Antioxidant Genes ◽  
Treatment Comparison ◽  
Genes Expression ◽  
Significant Difference ◽  
And Control

AbstractThe present study investigated possible effects of dietary malic acid on the expression of immunity, antioxidant and growth related genes expression as well as skin mucus immune parameters in common carp. Common carp (Cyprinus carpio) fingerlings were fed diets supplemented with different levels (0 [control], 0.5%, 1%, 2%) of malic acid (MA) for 60 days. The results revealed highest expression levels of immune-related genes (tnf-alpha, il1b, il8 and lyz) in skin of common carp fed 2% MA (P < 0.05). Regarding 1% MA treatment comparison with control group, significant difference was noticed just in case of lyz (P < 0.05). Evaluation of growth related genes expression revealed no significant difference between treatments (P > 0.05). The study of antioxidant related genes (gsta and gpx) in common carp skin fed with MA, showed significant difference between treated groups and control (P < 0.05). Carps fed with 2% MA had highest alkaline phosphatase activity in skin mucus compared other treated groups and control (P < 0.05). There were no significant difference between 0.5% and 1% and control (P > 0.05). The study of total protein and total immunoglobulin (Ig) in common carp skin musus revealed no alteration following MA treatment (P > 0.05). The present data demonstrated that feeding with MA altered immune and antioxidant genes expression in skin mucus of common carp.

scholarly journals Cost-effectiveness of empagliflozin in patients with type 2 diabetes and established cardiovascular disease in China

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Mafalda Ramos ◽  
Peng Men ◽  
Xu Wang ◽  
Anastasia Ustyugova ◽  
Mark Lamotte
Keyword(s):  
Risk Factors ◽  
Type 2 Diabetes ◽  
Cardiovascular Disease ◽  
Cost Effectiveness ◽  
Willingness To Pay ◽  
Incremental Cost ◽  
Treatment Effects ◽  
Specific Treatment ◽  
Treatment Comparison

Abstract Background In several cardiovascular outcome trials (CVOTs), empagliflozin (SGLT-2 inhibitor), sitagliptin (DPP-4 inhibitor) and liraglutide (GLP-1 receptor agonist) + standard of care (SoC) were compared to SoC in patients with type 2 diabetes and established cardiovascular disease (CVD). This study assessed the cost-effectiveness (CE) of empagliflozin + SoC in comparison to sitagliptin + SoC and liraglutide + SoC based on the respective CVOT. Methods The IQVIA Core Diabetes Model (CDM) was calibrated to reproduce the CVOT outcomes. EMPA-REG OUTCOME baseline characteristics and CVOT specific treatment effects on risk factors for cardiovascular disease (HbA1c, BMI, blood pressure, lipids) were applied. Three-year observed cardiovascular events of empagliflozin + SoC versus sitagliptin + SoC and liraglutide + SoC were derived from EMPA-REG OUTCOME and an indirect treatment comparison. Relative risk adjustments to calibrate the CDM were obtained after a trial and error process to match as closely the observed and CDM-predicted outcomes. The drug-specific treatment effects were considered up until HbA1c reached 8.5% and treatment switch occurred. After this switch, the United Kingdom Prospective Diabetes Study 82 risk equations predicted events based on co-existing risk factors and treatment intensification to basal bolus insulin were applied. The analysis was conducted from the perspective of the Chinese healthcare system applying 3% discounting. The time horizon was lifelong. Results Empagliflozin + SoC provides additional Quality Adjusted Life years (QALY + 0.564) for an incremental cost of 42,497RMB (US$6053) compared to sitagliptin + SoC, resulting in an Incremental Cost Utility Ratio of 75,349RMB (US$10,732), thus below the willingness-to-pay threshold of 212,676RMB, corresponding to three times the Gross Domestic Product in China (2019). Compared to liraglutide + SoC, empagliflozin + SoC use leads to 0.211QALY gained and cost savings of 71,427RMB (US$10,173) and is as such dominant. Scenario and probabilistic sensitivity analyses demonstrated the robustness of the results. Conclusion Results suggest that empagliflozin + SoC is cost-effective compared to sitagliptin + SoC and liraglutide + SoC at a willingness-to-pay threshold of 212,676RMB ($30,292)/QALY.

scholarly journals Cost-Effectiveness of Initial Revision Digit Amputation Performed in the Emergency Department Versus the Operating Room

Hand ◽  
2018 ◽  
Vol 15 (2) ◽  
pp. 208-214 ◽  
Author(s):  
Joseph A. Gil ◽  
Avi D. Goodman ◽  
Andrew P. Harris ◽  
Neill Y. Li ◽  
Arnold-Peter C. Weiss
Keyword(s):  
Emergency Department ◽  
Cost Effectiveness ◽  
Operating Room ◽  
Cost Effective ◽  
Initial Management ◽  
Fingertip Amputation ◽  
Significant Difference ◽  
Initial Procedure ◽  
The Cost ◽  
Cost Effectiveness Threshold

Background: The objective of this study was to determine the comparative cost-effectiveness of performing initial revision finger amputation in the emergency department (ED) versus in the operating room (OR) accounting for need for unplanned secondary revision in the OR. Methods: We retrospectively examined patients presenting to the ED with traumatic finger and thumb amputations from January 2010 to December 2015. Only those treated with primarily revision amputation were included. Following initial management, the need for unplanned reoperation was assessed and associated with setting of initial management. A sensitivity analysis was used to determine the cost-effectiveness threshold for initial management in the ED versus the OR. Results: Five hundred thirty-seven patients had 677 fingertip amputations, of whom 91 digits were initially primarily revised in the OR, and 586 digits were primarily revised in the ED. Following initial revision, 91 digits required unplanned secondary revision. The unplanned secondary revision rates were similar between settings: 13.7% digits from the ED and 12.1% of digits from the OR ( P = .57). When accounting for direct costs, an incidence of unplanned revision above 77.0% after initial revision fingertip amputation in the ED would make initial revision fingertip amputation in the OR cost-effective. Therefore, based on the unplanned secondary revision rate, initial management in the ED is more cost-effective than in the OR. Conclusions: There is no significant difference in the incidence of unplanned/secondary revision of fingertip amputation rate after the initial procedure was performed in the ED versus the OR.

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