scholarly journals Denosumab, raloxifene, romosozumab and teriparatide to prevent osteoporotic fragility fractures: a systematic review and economic evaluation

2020 ◽  
Vol 24 (29) ◽  
pp. 1-314 ◽  
Author(s):  
Sarah Davis ◽  
Emma Simpson ◽  
Jean Hamilton ◽  
Marrissa Martyn-St James ◽  
Andrew Rawdin ◽  
...  
Keyword(s):  
Systematic Review ◽  
Cost Effectiveness ◽  
Fracture Risk ◽  
Incremental Cost ◽  
Meta Analysis ◽  
Fragility Fractures ◽  
Clinical Effectiveness ◽  
Quality Adjusted Life Year ◽  
Mineral Density ◽  
Quality Adjusted Life

Background Fragility fractures are fractures that result from mechanical forces that would not ordinarily result in fracture. Objectives The objectives were to evaluate the clinical effectiveness, safety and cost-effectiveness of non-bisphosphonates {denosumab [Prolia®; Amgen Inc., Thousand Oaks, CA, USA], raloxifene [Evista®; Daiichi Sankyo Company, Ltd, Tokyo, Japan], romosozumab [Evenity®; Union Chimique Belge (UCB) S.A. (Brussels, Belgium) and Amgen Inc.] and teriparatide [Forsteo®; Eli Lilly and Company, Indianapolis, IN, USA]}, compared with each other, bisphosphonates or no treatment, for the prevention of fragility fracture. Data sources For the clinical effectiveness review, nine electronic databases (including MEDLINE, EMBASE and the World Health Organization International Clinical Trials Registry Platform) were searched up to July 2018. Review methods A systematic review and network meta-analysis of fracture and femoral neck bone mineral density were conducted. A review of published economic analyses was undertaken and a model previously used to evaluate bisphosphonates was adapted. Discrete event simulation was used to estimate lifetime costs and quality-adjusted life-years for a simulated cohort of patients with heterogeneous characteristics. This was done for each non-bisphosphonate treatment, a strategy of no treatment, and the five bisphosphonate treatments previously evaluated. The model was populated with effectiveness evidence from the systematic review and network meta-analysis. All other parameters were estimated from published sources. An NHS and Personal Social Services perspective was taken, and costs and benefits were discounted at 3.5% per annum. Fracture risk was estimated from patient characteristics using the QFracture® (QFracture-2012 open source revision 38, Clinrisk Ltd, Leeds, UK) and FRAX® (web version 3.9, University of Sheffield, Sheffield, UK) tools. The relationship between fracture risk and incremental net monetary benefit was estimated using non-parametric regression. A probabilistic sensitivity analysis and scenario analyses were used to assess uncertainty. Results Fifty-two randomised controlled trials of non-bisphosphonates were included in the clinical effectiveness systematic review and an additional 51 randomised controlled trials of bisphosphonates were included in the network meta-analysis. All treatments had beneficial effects compared with placebo for vertebral, non-vertebral and hip fractures, with hazard ratios varying from 0.23 to 0.94, depending on treatment and fracture type. The effects on vertebral fractures and the percentage change in bone mineral density were statistically significant for all treatments. The rate of serious adverse events varied across trials (0–33%), with most between-group differences not being statistically significant for comparisons with placebo/no active treatment, non-bisphosphonates or bisphosphonates. The incremental cost-effectiveness ratios were > £20,000 per quality-adjusted life-year for all non-bisphosphonate interventions compared with no treatment across the range of QFracture and FRAX scores expected in the population eligible for fracture risk assessment. The incremental cost-effectiveness ratio for denosumab may fall below £30,000 per quality-adjusted life-year at very high levels of risk or for high-risk patients with specific characteristics. Raloxifene was dominated by no treatment (resulted in fewer quality-adjusted life-years) in most risk categories. Limitations The incremental cost-effectiveness ratios are uncertain for very high-risk patients. Conclusions Non-bisphosphonates are effective in preventing fragility fractures, but the incremental cost-effectiveness ratios are generally greater than the commonly applied threshold of £20,000–30,000 per quality-adjusted life-year. Study registration This study is registered as PROSPERO CRD42018107651. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 29. See the NIHR Journals Library website for further project information.

scholarly journals Tumour necrosis factor-α inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis: a systematic review and economic evaluation

2016 ◽  
Vol 20 (9) ◽  
pp. 1-334 ◽  
Author(s):  
Mark Corbett ◽  
Marta Soares ◽  
Gurleen Jhuti ◽  
Stephen Rice ◽  
Eldon Spackman ◽  
...  
Keyword(s):  
Systematic Review ◽  
Cost Effectiveness ◽  
Decision Model ◽  
Axial Spondyloarthritis ◽  
De Novo ◽  
Meta Analysis ◽  
Clinical Effectiveness ◽  
Necrosis Factor ◽  
Quality Adjusted Life

BackgroundTumour necrosis factor (TNF)-α inhibitors (anti-TNFs) are typically used when the inflammatory rheumatologic diseases ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-AxSpA) have not responded adequately to conventional therapy. Current National Institute for Health and Care Excellence (NICE) guidance recommends treatment with adalimumab, etanercept and golimumab in adults with active (severe) AS only if certain criteria are fulfilled but it does not recommend infliximab for AS. Anti-TNFs for patients with nr-AxSpA have not previously been appraised by NICE.ObjectiveTo determine the clinical effectiveness, safety and cost-effectiveness within the NHS of adalimumab, certolizumab pegol, etanercept, golimumab and infliximab, within their licensed indications, for the treatment of severe active AS or severe nr-AxSpA (but with objective signs of inflammation).DesignSystematic review and economic model.Data sourcesFifteen databases were searched for relevant studies in July 2014.Review methodsClinical effectiveness data from randomised controlled trials (RCTs) were synthesised using Bayesian network meta-analysis methods. Results from other studies were summarised narratively. Only full economic evaluations that compared two or more options and considered both costs and consequences were included in the systematic review of cost-effectiveness studies. The differences in the approaches and assumptions used across the studies, and also those in the manufacturer’s submissions, were examined in order to explain any discrepancies in the findings and to identify key areas of uncertainty. A de novo decision model was developed with a generalised framework for evidence synthesis that pooled change in disease activity (BASDAI and BASDAI 50) and simultaneously synthesised information on function (BASFI) to determine the long-term quality-adjusted life-year and cost burden of the disease in the economic model. The decision model was developed in accordance with the NICE reference case. The model has a lifetime horizon (60 years) and considers costs from the perspective of the NHS and personal social services. Health effects were expressed in terms of quality-adjusted life-years.ResultsIn total, 28 eligible RCTs were identified and 26 were placebo controlled (mostly up to 12 weeks); 17 extended into open-label active treatment-only phases. Most RCTs were judged to have a low risk of bias overall. In both AS and nr-AxSpA populations, anti-TNFs produced clinically important benefits to patients in terms of improving function and reducing disease activity; for AS, the relative risks for ASAS 40 ranged from 2.53 to 3.42. The efficacy estimates were consistently slightly smaller for nr-AxSpA than for AS. Statistical (and clinical) heterogeneity was more apparent in the nr-AxSpA analyses than in the AS analyses; both the reliability of the nr-AxSpA meta-analysis results and their true relevance to patients seen in clinical practice are questionable. In AS, anti-TNFs are approximately equally effective. Effectiveness appears to be maintained over time, with around 50% of patients still responding at 2 years. Evidence for an effect of anti-TNFs delaying disease progression was limited; results from ongoing long-term studies should help to clarify this issue. Sequential treatment with anti-TNFs can be worthwhile but the drug survival response rates and benefits are reduced with second and third anti-TNFs. The de novo model, which addressed many of the issues of earlier evaluations, generated incremental cost-effectiveness ratios ranging from £19,240 to £66,529 depending on anti-TNF and modelling assumptions.ConclusionsIn both AS and nr-AxSpA populations anti-TNFs are clinically effective, although more so in AS than in nr-AxSpA. Anti-TNFs may be an effective use of NHS resources depending on which assumptions are considered appropriate.Future work recommendationsRandomised trials are needed to identify the nr-AxSpA population who will benefit the most from anti-TNFs.Study registrationThis study is registered as PROSPERO CRD42014010182.FundingThe National Institute for Health Research Health Technology Assessment programme.

scholarly journals Authors’ Reply: Veganism, vegetarianism, bone mineral density, and fracture risk: a systematic review and meta-analysis

2019 ◽  
Vol 77 (6) ◽  
pp. 452-453
Author(s):  
Isabel Iguacel ◽  
María L Miguel-Berges ◽  
Alejandro Gómez-Bruton ◽  
Luis A Moreno ◽  
Cristina Julian
Keyword(s):  
Bone Mineral Density ◽  
Systematic Review ◽  
Fracture Risk ◽  
Bone Mineral ◽  
Meta Analysis ◽  
Mineral Density

scholarly journals Aspirin and fracture risk: a systematic review and exploratory meta-analysis of observational studies

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e026876 ◽  
Author(s):  
A L Barker ◽  
Sze-Ee Soh ◽  
Kerrie M Sanders ◽  
Julie Pasco ◽  
Sundeep Khosla ◽  
...  
Keyword(s):  
Systematic Review ◽  
Fracture Risk ◽  
Observational Studies ◽  
Meta Analysis ◽  
Large Population ◽  
Mineral Density ◽  
Random Effects Models ◽  
Manual Search ◽  
Relative Risks ◽  
Hip Bmd

ObjectivesThis review provides insights into the potential for aspirin to preserve bone mineral density (BMD) and reduce fracture risk, building knowledge of the risk-benefit profile of aspirin.MethodsWe conducted a systematic review and exploratory meta-analysis of observational studies. Electronic searches of MEDLINE and Embase, and a manual search of bibliographies was undertaken for studies published to 28 March 2018. Studies were included if: participants were men or women aged ≥18 years; the exposure of interest was aspirin; and relative risks, ORs and 95% CIs for the risk of fracture or difference (percentage or absolute) in BMD (measured by dual energy X-ray absorptiometry) between aspirin users and non-users were presented. Risk of bias was assessed using the Joanna Briggs Institute Critical Appraisal Checklists for observational studies. Pooled ORs for any fracture and standardised mean differences (SMDs) for BMD outcomes were calculated using random-effects models.ResultsTwelve studies met the inclusion criteria and were included in the meta-analysis. Aspirin use was associated with a 17% lower odds for any fracture (OR 0.83, 95% CI 0.70 to 0.99; I2=71%; six studies; n=511 390). Aspirin was associated with a higher total hip BMD for women (SMD 0.03, 95% CI −0.02 to 0.07; I2=0%; three studies; n=9686) and men (SMD 0.06, 95% CI −0.02 to 0.13, I2=0%; two studies; n=4137) although these associations were not significant. Similar results were observed for lumbar spine BMD in women (SMD 0.03, 95% CI −0.03 to 0.09; I2=34%; four studies; n=11 330) and men (SMD 0.08; 95% CI −0.01 to 0.18; one study; n=432).ConclusionsWhile the benefits of reduced fracture risk and higher BMD from aspirin use may be modest for individuals, if confirmed in prospective controlled trials, they may confer a large population benefit given the common use of aspirin in older people.

scholarly journals Comparative clinical effects and cost–effectiveness of maximum androgen blockade, docetaxel with androgen deprivation therapy and ADT alone for the treatment of mHSPC in China

2019 ◽  
Vol 8 (11) ◽  
pp. 865-877 ◽  
Author(s):  
Maobai Liu ◽  
Shuli Qu ◽  
Yanjun Liu ◽  
Xingxing Yao ◽  
Wei Jiang
Keyword(s):  
Cost Effectiveness ◽  
Incremental Cost ◽  
Androgen Deprivation Therapy ◽  
Cost Effective ◽  
Quality Adjusted Life Year ◽  
Incremental Cost Effectiveness Ratio ◽  
Clinical Effects ◽  
Cost Effectiveness Ratio ◽  
Quality Adjusted Life ◽  
Androgen Blockade

Aim: To compare the clinical effects and cost–effectiveness of maximum androgen blockade (MAB), docetaxel to androgen deprivation therapy (Doc-ADT) and ADT alone for the treatment of patients with metastatic hormone-sensitive prostate cancer in China. Methods: A network meta-analysis and a Markov model were adopted for effectiveness and economic evaluation. Results: The hazard ratios of overall survival and progression-free survival were 0.782 and 0.628 for Doc-ADT versus ADT alone; 0.897 and 0.824 for MAB versus ADT alone. Doc-ADT was cost-effective compared with MAB and ADT alone, with an incremental cost–effectiveness ratio of CNY 96,848 and CNY 67,758 per quality-adjusted life year, respectively. MAB was cost-effective compared with ADT alone, with an incremental cost–effectiveness ratio of CNY 137,487 per quality-adjusted life year. Conclusion: Doc-ADT is likely the optimal option from the perspective of both clinical outcomes and economic considerations.

Cost-Effectiveness of Primary Prophylaxis with Pegfilgrastim Versus Filgrastim in Non-Hodgkin’s Lymphoma Patients Receiving CHOP-21.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 5166-5166 ◽  
Author(s):  
John Kim ◽  
Jennifer L. Malin ◽  
Quan V. Doan ◽  
Zhimei Liu ◽  
Robert W. Dubois ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Incremental Cost ◽  
Hodgkin’S Lymphoma ◽  
Primary Prophylaxis ◽  
Quality Adjusted Life Year ◽  
Hodgkin's Lymphoma ◽  
Non Hodgkin’S Lymphoma ◽  
Non Hodgkin's Lymphoma ◽  
The Impact ◽  
Quality Adjusted Life

Abstract Prophylaxis with granulocyte colony-stimulating factors (G-CSFs) starting in the first and continuing in subsequent chemotherapy cycles when the risk of febrile neutropenia (FN) is ≥20% is recommended in the 2006 ASCO and EORTC clinical guidelines. Although the daily G-CSF filgrastim (Neupogen®, Amgen Inc.) and the long-acting G-CSF pegfilgrastim (Neulasta®, Amgen Inc.) are both commonly used, in practice filgrastim is often administered for shorter-than-recommended courses, eg, 6 days, which has been shown to be associated with less clinical efficacy. The purpose of this study was to evaluate the cost-effectiveness of primary prophylaxis using pegfilgrastim versus 6-day filgrastim in patients with aggressive non-Hodgkin’s lymphoma (NHL) receiving CHOP-21. Without G-CSF support, CHOP-21 is associated with 17%-50% FN risk. We constructed a decision-analytic model from a payer perspective with a life-time study horizon. Outcomes were measured as incremental cost-effectiveness ratios (ICERs) including cost per FN event avoided, cost per life-year-gained (LYG), or cost per quality-adjusted-life-year (QALY) saved. Model inputs including FN risk, FN case-fatality, relative dose intensity (RDI) of chemotherapy, impact of RDI on survival, and utility scores were obtained from a comprehensive literature review. Drug and drug administration costs were obtained from Center for Medicare and Medicaid Services. Cost for FN-related hospitalizations and subsequent medical costs were obtained from the literature. NHL mortality rates and other-cause mortality were based on data from US Surveillance Epidemiology and End Results and National Vital Statistics Reports. Sensitivity analyses were conducted on key variables. Our model simulated 3 clinical scenarios: Scenario 1 included the impact of prophylaxis with pegfilgrastim or filgrastim on FN risk, Scenario 2 included the impact of a difference in FN risk on FN-related mortality, and Scenario 3 included a differential impact on RDI and long-term survival. Extrapolating from the results of a meta-analysis and observational studies, it was estimated that pegfilgrastim decreased the absolute risk of FN by 12% compared with 6-day filgrastim (13.1% versus 25.1%) for a baseline FN risk of approximately 27.9%. Our results showed that compared with 6-day filgrastim, pegfilgrastim was associated with an ICER of $2,133/FN event avoided in Scenario 1, $4,869/LYG or $5,476/QALY saved in Scenario 2, and $1,805/LYG or $2,029/QALY saved in Scenario 3 (Table 1). Key factors influencing ICER estimates included relative risk of FN, cost of pegfilgrastim and filgrastim, and baseline FN risk. Varying these variables within plausible ranges, the ICERs did not exceed $100,000/QALY saved, a commonly cited threshold for judging cost-effectiveness in oncology. Our study suggested that primary prophylaxis with pegfilgrastim is cost-effective compared with filgrastim used for 6 days in NHL patients receiving CHOP-21. Table 1: Cost-effectiveness of pegfilgrastim versus filgrastim Cost ($) Scenario 1 Scenario 2 (LY) Scenario 2 (QALY) Scenario 3 (LY) Scenario 3 (QALY) ICER, incremental cost-effectiveness ratio; LY, life-year; QALY, quality-adjusted life year; numbers may not match due to rounding errors Pegfilgrastim 15,608 13.1% 9.35 8.13 8.09 7.01 Filgrastim 15,352 25.1% 9.29 8.08 7.95 6.89 ICER --- $2,133 per FN event avoided $4,869/LY $5,476/QALY $1,805/LY $2,029/QALY

scholarly journals Cost-effectiveness of bone-anchored prostheses using osseointegrated fixation: Myth or reality?

2017 ◽  
Vol 42 (3) ◽  
pp. 318-327 ◽  
Author(s):  
Laurent Alain Frossard ◽  
Gregory Merlo ◽  
Brendan Burkett ◽  
Tanya Quincey ◽  
Debra Berg
Keyword(s):  
Cost Effectiveness ◽  
Incremental Cost ◽  
Lower Limb ◽  
Quality Adjusted Life Year ◽  
Incremental Cost Effectiveness Ratio ◽  
Decision Makers ◽  
Evidence Based ◽  
Cost Effectiveness Ratio ◽  
Limb Bone ◽  
Quality Adjusted Life

Background: In principle, lower limb bone-anchored prostheses could alleviate expenditure associated with typical socket manufacturing and residuum treatments due to socket-suspended prostheses. Objective: This study reports (a) the incremental costs and (b) heath gain as well as (c) cost-effectiveness of bone-anchored prostheses compared to socket-suspended prostheses. Study design: Retrospective individual case-controlled observations and systematic review. Methods: Actual costs were extracted from financial records and completed by typical costs when needed over 6-year time horizon for a cohort of 16 individuals. Health gains corresponding to quality-adjusted life-year were calculated using health-related quality-of-life data presented in the literature. Results: The provision of bone-anchored prostheses costed 21% ± 41% more but increased quality-adjusted life-years by 17% ± 5% compared to socket-suspended prostheses. The incremental cost-effectiveness ratio ranged between –$25,700 per quality-adjusted life-year and $53,500 per quality-adjusted life-year with indicative incremental cost-effectiveness ratio of approximately $17,000 per quality-adjusted life-year. Bone-anchored prosthesis was cost-saving and cost-effective for 19% and 88% of the participants, respectively. Conclusion: This study indicated that bone-anchored prostheses might be an acceptable alternative to socket-suspended prostheses at least from a prosthetic care perspective in Australian context. Altogether, this initial evidence-based economic evaluation provided a working approach for decision makers responsible for policies around care of individuals with lower limb amputation worldwide. Clinical relevance For the first time, this study provided evidence-based health economic benefits of lower limb bone-anchored prostheses compared to typical socket-suspended prostheses from a prosthetic care perspective that is essential to clinicians and decision makers responsible for policies.

scholarly journals Prophylactic removal of impacted mandibular third molars: a systematic review and economic evaluation

2020 ◽  
Vol 24 (30) ◽  
pp. 1-116
Author(s):  
Juliet Hounsome ◽  
Gerlinde Pilkington ◽  
James Mahon ◽  
Angela Boland ◽  
Sophie Beale ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Incremental Cost ◽  
Standard Care ◽  
Quality Adjusted Life Year ◽  
Group Model ◽  
Third Molars ◽  
Cost Effectiveness Ratio ◽  
Impacted Mandibular Third Molars ◽  
Mandibular Third Molars ◽  
Quality Adjusted Life

Background Impacted third molars are third molars that are blocked, by soft tissue or bone, from fully erupting through the gum. This can cause pain and disease. The treatment options for people with impacted third molars are removal or retention with standard care. If there are pathological changes, the current National Institute for Health and Care Excellence guidance states that the impacted third molar should be removed. Objective The objective of this study was to appraise the clinical effectiveness and cost-effectiveness of the prophylactic removal of impacted mandibular third molars compared with retention of, and standard care for, impacted third molars. Methods Five electronic databases were searched (1999 to 29 April 2016) to identify relevant evidence [The Cochrane Library (searched 4 April 2016 and 29 April 2016), MEDLINE (searched 4 April 2016 and 29 April 2016), EMBASE (searched 4 April 2016 and 29 April 2016), EconLit (searched 4 April 2016 and 29 April 2016) and NHS Economic Evaluation Database (searched 4 April 2016)]. Studies that compared the prophylactic removal of impacted mandibular third molars with retention and standard care or studies that assessed the outcomes from either approach were included. The clinical outcomes considered were pathology associated with retention, post-operative complications following extraction and adverse effects of treatment. Cost-effectiveness outcomes included UK costs and health-related quality-of-life measures. In addition, the assessment group constructed a de novo economic model to compare the cost-effectiveness of a prophylactic removal strategy with that of retention and standard care. Results The clinical review identified four cohort studies and nine systematic reviews. In the two studies that reported on surgical complications, no serious complications were reported. Pathological changes due to retention of asymptomatic impacted mandibular third molars were reported by three studies. In these studies, the extraction rate for retained impacted mandibular third molars varied from 5.5% to 31.4%; this variation can be explained by the differing follow-up periods (i.e. 1 and 5 years). The findings from this review are consistent with the findings from previous systematic reviews. Two published cost-effectiveness studies were identified. The authors of both studies concluded that, to their knowledge, there is currently no economic evidence to support the prophylactic removal of impacted mandibular third molars. The results generated by the assessment group’s lifetime economic model indicated that the incremental cost-effectiveness ratio per quality-adjusted life-year gained for the comparison of a prophylactic removal strategy with a retention and standard care strategy is £11,741 for people aged 20 years with asymptomatic impacted mandibular third molars. The incremental cost per person associated with prophylactic extraction is £55.71, with an incremental quality-adjusted life-year gain of 0.005 per person. The base-case incremental cost-effectiveness ratio per quality-adjusted life-year gained was found to be robust when a range of sensitivity and scenario analyses were carried out. Limitations Limitations of the study included that no head-to-head trials comparing the effectiveness of prophylactic removal of impacted mandibular third molars with retention and standard care were identified with the assessment group model that was built on observational data. Utility data on impacted mandibular third molars and their symptoms are lacking. Conclusions The evidence comparing the prophylactic removal of impacted mandibular third molars with retention and standard care is very limited. However, the results from an exploratory assessment group model, which uses available evidence on symptom development and extraction rates of retained impacted mandibular third molars, suggest that prophylactic removal may be the more cost-effective strategy. Future work Effectiveness evidence is lacking. Head-to-head trials comparing the prophylactic removal of trouble-free impacted mandibular third molars with retention and watchful waiting are required. If this is not possible, routine clinical data, using common definitions and outcome reporting methods, should be collected. Study registration This study is registered as PROSPERO CRD42016037776. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 30. See the NIHR Journals Library website for further project information.

scholarly journals Oral splints for patients with temporomandibular disorders or bruxism: a systematic review and economic evaluation

2020 ◽  
Vol 24 (7) ◽  
pp. 1-224
Author(s):  
Philip Riley ◽  
Anne-Marie Glenny ◽  
Helen V Worthington ◽  
Elisabet Jacobsen ◽  
Clare Robertson ◽  
...  
Keyword(s):  
Systematic Review ◽  
Cost Effectiveness ◽  
Incremental Cost ◽  
Temporomandibular Disorders ◽  
Temporomandibular Disorder ◽  
Clinical Effectiveness ◽  
Tooth Wear ◽  
Incremental Cost Effectiveness Ratio ◽  
Cost Effectiveness Ratio ◽  
A Value

Background Splints are a non-invasive, reversible management option for temporomandibular disorders or bruxism. The clinical effectiveness and cost-effectiveness of splints remain uncertain. Objectives The objectives were to evaluate the clinical effectiveness and cost-effectiveness of splints for patients with temporomandibular disorders or bruxism. This evidence synthesis compared (1) all types of splint versus no/minimal treatment/control splints and (2) prefabricated versus custom-made splints, for the primary outcomes, which were pain (temporomandibular disorders) and tooth wear (bruxism). Review methods Four databases, including MEDLINE and EMBASE, were searched from inception until 1 October 2018 for randomised clinical trials. The searches were conducted on 1 October 2018. Cochrane review methods (including risk of bias) were used for the systematic review. Standardised mean differences were pooled for the primary outcome of pain, using random-effects models in temporomandibular disorder patients. A Markov cohort, state-transition model, populated using current pain and Characteristic Pain Intensity data, was used to estimate the incremental cost-effectiveness ratio for splints compared with no splint, from an NHS perspective over a lifetime horizon. A value-of-information analysis identified future research priorities. Results Fifty-two trials were included in the systematic review. The evidence identified was of very low quality with unclear reporting by temporomandibular disorder subtype. When all subtypes were pooled into one global temporomandibular disorder group, there was no evidence that splints reduced pain [standardised mean difference (at up to 3 months) –0.18, 95% confidence interval –0.42 to 0.06; substantial heterogeneity] when compared with no splints or a minimal intervention. There was no evidence that other outcomes, including temporomandibular joint noises, decreased mouth-opening, and quality of life, improved when using splints. Adverse events were generally not reported, but seemed infrequent when reported. The most plausible base-case incremental cost-effectiveness ratio was uncertain and driven by the lack of clinical effectiveness evidence. The cost-effectiveness acceptability curve showed splints becoming more cost-effective at a willingness-to-pay threshold of ≈£6000, but the probability never exceeded 60% at higher levels of willingness to pay. Results were sensitive to longer-term extrapolation assumptions. A value-of-information analysis indicated that further research is required. There were no studies measuring tooth wear in patients with bruxism. One small study looked at pain and found a reduction in the splint group [mean difference (0–10 scale) –2.01, 95% CI –1.40 to –2.62; very low-quality evidence]. As there was no evidence of a difference between splints and no splints, the second objective became irrelevant. Limitations There was a large variation in the diagnostic criteria, splint types and outcome measures used and reported. Sensitivity analyses based on these limitations did not indicate a reduction in pain. Conclusions The very low-quality evidence identified did not demonstrate that splints reduced pain in temporomandibular disorders as a group of conditions. There is insufficient evidence to determine whether or not splints reduce tooth wear in patients with bruxism. There remains substantial uncertainty surrounding the most plausible incremental cost-effectiveness ratio. Future work There is a need for well-conducted trials to determine the clinical effectiveness and cost-effectiveness of splints in patients with carefully diagnosed and subtyped temporomandibular disorders, and patients with bruxism, using agreed measures of pain and tooth wear. Study registration This study is registered as PROSPERO CRD42017068512. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 7. See the NIHR Journals Library website for further project information.

Systematic review and meta-analysis of incremental cost-effectiveness ratio (ICER) for new cancer drugs.

2020 ◽  
Vol 38 (29_suppl) ◽  
pp. 66-66
Author(s):  
Fernanda Alves Oliveira ◽  
Eduardo Alves Oliveira ◽  
Gilberto Lopes ◽  
Joao Paulo SN Lima
Keyword(s):  
Systematic Review ◽  
Cost Effectiveness ◽  
Incremental Cost ◽  
Meta Analysis ◽  
Cancer Therapies ◽  
Cancer Drugs ◽  
Middle Income ◽  
Cell Therapies ◽  
Anti Vegf ◽  
Global Issue

66 Background: This systematic review and meta-analysis compared incremental cost-effectiveness ratios (ICERs) of cancer drugs and their relationship with society’s willingness to pay (WTP) across different countries, scenarios and indications. Methods: We sought for cost-effectiveness studies in PubMed, Embase, Cochrane and LILACS published from December 2012 to December 2017. CAR-T cell therapies were excluded given short follow-up. We converted ICERs value and respective annualized 1time the Gross Domestic Product per capita (GDP) - used as a proxy for WTP threshold - into purchase-parity-power dollars (PPP) for better economic reality comparisons. Economics data came from the International Monetary Fund website. Characteristics studied in the distribution of ICERs values were compared using the Mann-Whitney or Kruskal-Wallis U-test with multiple comparison correction and simple linear regression. The chance of ICER being below the 1x GDP threshold was expressed as odds ratio and 95% confidence interval, calculated by logistic regression. Results: We retrieved 354 drug-versus-drug different assessments. PPPconversion increased median ICER of middle-income countries ($32k to $68k;P < 0.001). Median ICER was highest in USA ($154k), followed by other high-income countries ($76k; P < 0.001). In multiple regression, anti-VEGF (P < 0.001) and US-led (P = 0.03) studies had highest ICERs, while curative therapies (p = 0.02) had the lowest ones. 22% of studies were below the WTP bar, none of anti-VEGF, sipuleucel, anti-CD-30, castration-resistant, hepatocarcinoma, and renal cell ones. Immune checkpoint inhibition (OR 8.70; P = 0.045) and middle-income (OR 7.40; P < 0.001) studies were more likely above WTP, whereas curative therapies were more likely below WTP. Conclusions: Cancer therapies’ cost exceeding the WTPs is a worldwide pattern, with some factors related to ICER variation. These findings may foster better understanding and aid stakeholders deal with the global issue of high oncology care costs.

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