scholarly journals Golimumab for the treatment of psoriatic arthritis

2011 ◽  
Vol 15 (Suppl 1) ◽  
pp. 87-96
Author(s):  
H Yang ◽  
D Epstein ◽  
L Bojke ◽  
D Craig ◽  
K Light ◽  
...  

This paper presents a summary of the evidence review group (ERG) report into the use of golimumab for the treatment of psoriatic arthritis (PsA). The main clinical effectiveness data were derived from a single phase III randomised controlled trial (RCT: GO-REVEAL) that compared golimumab with placebo for treating patients with active and progressive PsA who were symptomatic despite the use of previous disease-modifying antirheumatic drugs or non-steroidal anti-inflammatory drugs. The 14-week data showed that, compared with placebo, golimumab 50 mg significantly improved joint disease response as measured by American College of Rheumatology (ACR) 20 [relative risk (RR) 5.73, 95% confidence interval (CI) 3.24 to 10.56] and Psoriatic Arthritis Response Criteria (PsARC) (RR 3.45, 95% CI 2.49 to 4.87), and skin disease response as measured by the Psoriasis Area and Severity Index (PASI) 75 (RR 15.95, 95% CI 4.62 to 59.11). The 24-week absolute data showed that these treatment benefits were maintained. There was a significant improvement in patients’ functional status as measured by the Health Assessment Questionnaire (HAQ) change from baseline at 24 weeks (–0.33, p < 0.001). The open-label extension data showed that these beneficial effects were also maintained at 52 and 104 weeks. However, PASI 50 and PASI 90 at 14 weeks, and all of the PASI outcomes at 24 weeks, were not performed on the basis of intention-to-treat analysis. Furthermore, analyses of the 24-week data were less robust, failing to adjust for treatment contamination due to patient crossover at week 16. The manufacturer conducted a mixed treatment comparison (MTC) analysis. The ERG considered the assumption of exchangeability between the trials for the purpose of the MTC analysis to be acceptable, and the statistical approach in the MTC analysis to be reliable. Regarding the safety evaluation of golimumab, the manufacturer failed to provide longer-term data or to consider adverse event data of golimumab from controlled studies in other conditions, such as rheumatoid arthritis and ankylosing spondylitis. Although the adverse effect profile of golimumab appears similar to other anti-tumour necrosis factor (TNF) agents, the longer-term safety profile of golimumab remains uncertain. The manufacturer’s submission presented a decision model to compare etanercept, infliximab, golimumab and adalimumab versus palliative care for patients with PsA. In the base-case model, 73% of the cohort of patients were assumed to have significant psoriasis (> 3% of body surface area). Estimates of the effectiveness of anti-TNF agents in terms of PsARC, HAQ change and PASI change were obtained from an MTC analysis of RCT data. The manufacturer failed to calculate incremental cost-effectiveness ratios (ICERs) correctly by comparing golimumab with palliative care instead of the most cost-effective alternative (etanercept). Despite the manufacturer’s claim that golimumab is a cost-effective treatment option, the manufacturer’s own model showed that golimumab is not cost-effective compared with other biologics when the ICERs are correctly calculated. None of the sensitivity analyses carried out by the manufacturer or the ERG regarding uncertainty in the estimates of clinical effectiveness, the acquisition and administration cost of drugs, the cost of treating psoriasis and the utility functions estimated to generate health outcomes changed this conclusion. However, a key area in determining the cost-effectiveness of anti-TNF agents is whether they should be treated as a class. If all anti-TNF agents are considered equally effective then etanercept, adalimumab and golimumab have very nearly equal costs and equal quality-adjusted life-years (QALYs), and all have an ICER of about £15,000 per QALY versus palliative care, whereas infliximab with a higher acquisition cost is dominated by the other biologics.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 43-43
Author(s):  
Rahul Ramesh Khairnar ◽  
Joseph Levy ◽  
Mark Mishra

43 Background: A hydrogel rectal spacer (HRS) is an FDA-approved medical device used to increase the separation between the rectum and the prostate. A recent phase III trial demonstrated a small reduction in the incidence of RT toxicities associated with use of HRS. We conducted a cost-effectiveness analysis of HRS use in PC patients undergoing intensity modulated radiation therapy (IMRT). Methods: A multi-state Markov model was constructed to examine the cost-effectiveness of HRS in men with localized PC receiving IMRT in the US (arms: IMRT alone vs. IMRT + HRS). Subgroups included delivery site of IMRT (hospital vs. ambulatory) and baseline sexual function (SF) (general population vs. those with good SF). Based on previous studies, recurrence and survival were assumed equal for both arms. Data on SF, gastrointestinal and genitourinary toxicities incidence, as well as potential risks associated with HRS implantation were obtained from a recently published clinical trial. Health utilities and costs were derived from the literature and 2018 Physician Fee Schedule. Quality-adjusted life years (QALYs) and costs were modeled for a 5-year period from receipt of RT. Probabilistic sensitivity analysis (PSA) and value-based threshold analysis were conducted. Costs and utilities were discounted at 3% annually. Results: The per-person 5-year incremental cost for HRS administered in a hospital was $4,008 and the incremental effectiveness was 0.0273 QALYs. The incremental cost-effectiveness ratio (ICER) was $146,746 (95% credible interval from PSA $125,638 – $178,049) for PC patients undergoing HRS insertion in a hospital vs. $73,359 ($66,732 – $86,767) for patients undergoing HRS insertion in an ambulatory facility. For men with good SF, the ICER was $55,153 ($46,002 – $76,090) and $26,542 ($17,399 – $46,044) in hospital vs. ambulatory facility. Conclusions: This study is the first to evaluate the cost-effectiveness of HRS based on long-term toxicity data. Based on the current Medicare Physician Fee Schedule, HRS is cost-effective in men with good SF at a willingness to pay threshold of $100,000 and it is marginally cost-effective for the entire population depending on the facility where the HRS is inserted.


2016 ◽  
Vol 34 (7_suppl) ◽  
pp. 23-23
Author(s):  
Sarina Isenberg ◽  
David R Holtgrave ◽  
Chunhua Lu ◽  
John P McQuade ◽  
Brian Weir ◽  
...  

23 Background: The objectives of the study were to determine whether a Palliative Care Unit (PCU) provides benefits not just from a cost perspective, but from a patient and caregiver quality of life (QOL) perspective. Methods: (1) Calculate the total costs of the PCU; (2) Leverage a threshold analysis to estimate the Quality-Adjusted Life Years (QALYs) required for the PCU to be cost effective; and (3) Determine whether it is feasible for the program to yield the required number of QALYs. Setting was the Johns Hopkins Health System Palliative Care Unit (PCU) in Baltimore, MD. Analysis was based on patient volume from March 2013-2014. Results: There were 209 palliative patients. The costs for the societal perspective was $2,044,364 and the required number of QALYs to deem it cost effective were 11.36. The net costs for the hospital perspective was $625,777 (gross cost was $993,528; however, the program generated $367,751 in savings for the hospital through treating patients in the PCU as opposed to other functional units), and the required number of QALYs to deem it cost effective were 3.48. To determine whether the program is able to achieve the number of QALYs required, the study team generated aggregated QALYs based on other studies’ evidence for palliative care’s improvement of quality of life for patients and their caregivers. Combining the QALYs generated from the aggregated calculations for patients (0.12) and caregivers (4.60), the program had the potential to yield a total of 4.73 QALYs. Conclusions: This analysis suggests that the PCU is cost effective from the hospital perspective in the sense that the benefits it provides to patients’ and caregivers’ quality of life outweighs the cost of care. Future studies should continue to evaluate palliative care from a cost effectiveness perspective that incorporates a consideration of the quality of life improvements, rather than just cost-reduction.


2021 ◽  
Vol 37 (S1) ◽  
pp. 35-35
Author(s):  
Gizem Karakuleli ◽  
Leela Barham

IntroductionMyelofibrosis (MF) is a rare (annual incidence estimated to be 1/100,000 in Europe), chronic hematologic disorder associated with morbidity and mortality as well as the risk of evolution to acute myeloid leukemia. Ruxolitinib (Jakavi®, Novartis) is the first JAK 1/2 inhibitor approved by the FDA and EMA in 2011 in treating MF. Ruxolitinib is considered a high-cost and life-time treatment. UK-based estimates of the cost of treatment are in the region of GBP43,000/year/patient (in 2013). Against the background of the challenge of treatments for rare diseases reaching cost-effectiveness thresholds, this study identified, collected, and appraised the available evidence on the cost-effectiveness of ruxolitinib in the treatment of MF.MethodsA systematic approach was taken to conducting the literature review. Databases searched included PubMed, EMBASE, MEDLINE, and the Cochrane Library based on search terms informed by PICO: myelofibrosis, ruxolitinib, best available therapy/standard of care, and cost-effectiveness/cost-utility/pharmacoeconomics. The search was limited to studies published in the English language. A narrative synthesis was used to evaluate studies and the CHEERS checklist to explore the quality of reporting of the cost-effectiveness analysis.ResultsThe narrative synthesis included five studies conducted in the UK, Portugal, Chile, Canada, and Finland. All cost-effectiveness analyses used data from the same two large, randomized controlled, double-blind, phase III studies (COMFORT-I and -II). Ruxolitinib was compared to the best available therapy (BAT), including hydroxyurea, no medication, and prednisone/prednisolone. Perspectives and included costs varied among analyses. Markov models and discrete state cohort models were used to evaluate the cost-effectiveness and clinical benefit was measured in quality-adjusted life years (QALY) or life years (LY) gained.These analyses estimated the base-case incremental cost-effectiveness ratios (ICER) per QALY of (converted into USD, if appropriate, at the historic average annual exchange rate) GBP44,905 in the UK (2013; USD 70,226), EUR40,000 in Portugal (2016; USD44,272), USD54,500 (2016), CAD61,444 in Canada (2012; USD61,474), and EUR42,367 in Finland (2015; USD42,027). Based upon the cost-effectiveness thresholds applied in each of these countries, ruxolitinib was found to be universally cost-effective, albeit with price adjustments as part of the wider pricing and reimbursement processes used in these countries.ConclusionsRuxolitinib was found to be cost-effective in treating MF informed by different types of models and from different perspectives; however, there was some uncertainty around available data due to limited data sources.


Vaccines ◽  
2020 ◽  
Vol 8 (4) ◽  
pp. 707
Author(s):  
Afifah Machlaurin ◽  
Franklin Christiaan Karel Dolk ◽  
Didik Setiawan ◽  
Tjipke Sytse van der Werf ◽  
Maarten J. Postma

Bacillus Calmette–Guerin (BCG), the only available vaccine for tuberculosis (TB), has been applied for decades. The Indonesian government recently introduced a national TB disease control programme that includes several action plans, notably enhanced vaccination coverage, which can be strengthened through underpinning its favourable cost-effectiveness. We designed a Markov model to assess the cost-effectiveness of Indonesia’s current BCG vaccination programme. Incremental cost-effectiveness ratios (ICERs) were evaluated from the perspectives of both society and healthcare. The robustness of the analysis was confirmed through univariate and probabilistic sensitivity analysis (PSA). Using epidemiological data compiled for Indonesia, BCG vaccination at a price US$14 was estimated to be a cost-effective strategy in controlling TB disease. From societal and healthcare perspectives, ICERs were US$104 and US$112 per quality-adjusted life years (QALYs), respectively. The results were robust for variations of most variables in the univariate analysis. Notably, the vaccine’s effectiveness regarding disease protection, vaccination costs, and case detection rates were key drivers for cost-effectiveness. The PSA results indicated that vaccination was cost-effective even at US$175 threshold in 95% of cases, approximating the monthly GDP per capita. Our findings suggest that this strategy was highly cost-effective and merits prioritization and extension within the national TB programme. Our results may be relevant for other high endemic low- and middle-income countries.


2021 ◽  
pp. 019459982110268
Author(s):  
Joseph R. Acevedo ◽  
Ashley C. Hsu ◽  
Jeffrey C. Yu ◽  
Dale H. Rice ◽  
Daniel I. Kwon ◽  
...  

Objective To compare the cost-effectiveness of sialendoscopy with gland excision for the management of submandibular gland sialolithiasis. Study Design Cost-effectiveness analysis. Setting Outpatient surgery centers. Methods A Markov decision model compared the cost-effectiveness of sialendoscopy versus gland excision for managing submandibular gland sialolithiasis. Surgical outcome probabilities were found in the primary literature. The quality of life of patients was represented by health utilities, and costs were estimated from a third-party payer’s perspective. The effectiveness of each intervention was measured in quality-adjusted life-years (QALYs). The incremental costs and effectiveness of each intervention were compared, and a willingness-to-pay ratio of $150,000 per QALY was considered cost-effective. One-way, multivariate, and probabilistic sensitivity analyses were performed to challenge model conclusions. Results Over 10 years, sialendoscopy yielded 9.00 QALYs at an average cost of $8306, while gland excision produced 8.94 QALYs at an average cost of $6103. The ICER for sialendoscopy was $36,717 per QALY gained, making sialendoscopy cost-effective by our best estimates. The model was sensitive to the probability of success and the cost of sialendoscopy. Sialendoscopy must meet a probability-of-success threshold of 0.61 (61%) and cost ≤$11,996 to remain cost-effective. A Monte Carlo simulation revealed sialendoscopy to be cost-effective 60% of the time. Conclusion Sialendoscopy appears to be a cost-effective management strategy for sialolithiasis of the submandibular gland when certain thresholds are maintained. Further studies elucidating the clinical factors that determine successful sialendoscopy may be aided by these thresholds as well as future comparisons of novel technology.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 8043-8043
Author(s):  
Mavis Obeng-Kusi ◽  
Daniel Arku ◽  
Neda Alrawashdh ◽  
Briana Choi ◽  
Nimer S. Alkhatib ◽  
...  

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]


Author(s):  
Nayyereh Ayati ◽  
Lora Fleifel ◽  
Mohammad Ali Sahraian ◽  
Shekoufeh Nikfar

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.


2014 ◽  
Vol 2 (1) ◽  
Author(s):  
Sixten Borg ◽  
Ingmar Näslund ◽  
Ulf Persson ◽  
Knut Ödegaard

Background:The rising trend in the prevalence of obesity has during the past decades become a major public health concern in many countries, as obesity may lead to comorbidities and death. A frequent used marker for obesity is the Body Mass Index (BMI). The cost of treatment for obesity related diseases has become a heavy burden on national health care budget in many countries. While diet and exercise are the cornerstones of weight management, pharmaco­therapy is often needed to achieve and maintain desired weight loss.  In some cases of extreme obesity, bariatric surgery may be recommended. It is expected to increase by 50% in Sweden.Objective: The overall objective was to develop a cost-effectiveness model using the best available evidence to assess the cost-effectiveness of gastric bypass (GBP) surgical treatments for obesity in adult patients, in comparison with conventional treatment (CT), in Sweden from a healthcare perspective. With the model we also seeked to identify the lower cut-off point using BMI criteria, for the surgical intervention to be cost-effective. Methods:A micro-simulation model with an underlying Markov methodology was developed, that simulates individual patients. It simulates the outcomes of the patients in terms of treatment costs, life years, and quality adjusted life years (QALY) over his/her remaining lifetime. The costs are presented in SEK in the year 2006 price level (1 SEK ≈ 0.11 EUR ≈ 0.14 USD).Results: We estimated that the incremental cost per QALY gained will not exceed SEK 33,000 per QALY in patients with BMI < 35. In patients with BMI > 35 kg/m2, gastric bypass surgery has lower costs compared to conventional treatment. Conclusion: Gastric bypass surgery is a cost-effective intervention compared to conventional treatment consisting of watchful waiting, diet and exercise.


2021 ◽  
Author(s):  
Y. Natalia Alfonso ◽  
Adnan A Hyder ◽  
Olakunle Alonge ◽  
Shumona Sharmin Salam ◽  
Kamran Baset ◽  
...  

Abstract Drowning is the leading cause of death among children 12-59 months old in rural Bangladesh. This study evaluated the cost-effectiveness of a large-scale crèche intervention in preventing child drowning. Estimates of the effectiveness of the crèches was based on prior studies and the program cost was assessed using monthly program expenditures captured prospectively throughout the study period from two different implementing agencies. The study evaluated the cost-effectiveness from both a program and societal perspective. Results showed that from the program perspective the annual operating cost of a crèche was $416.35 (95%C.I.: $222 to $576), the annual cost per child was $16 (95%C.I.: $9 to $22) and the incremental-cost-effectiveness ratio (ICER) per life saved with the crèches was $17,803 (95%C.I.: $9,051 to $27,625). From the societal perspective (including parents time valued) the ICER per life saved was -$176,62 (95%C.I.: -$347,091 to -$67,684)—meaning crèches generated net economic benefits per child enrolled. Based on the ICER per disability-adjusted-life years averted from the societal perspective (excluding parents time), $2,020, the crèche intervention was cost-effective even when the societal economic benefits were ignored. Based on the evidence, the creche intervention has great potential for reducing child drowning at a cost that is reasonable.


2018 ◽  
Vol 212 (4) ◽  
pp. 199-206 ◽  
Author(s):  
Stephanie Nobis ◽  
David Daniel Ebert ◽  
Dirk Lehr ◽  
Filip Smit ◽  
Claudia Buntrock ◽  
...  

BackgroundWeb-based interventions are effective in reducing depression. However, the evidence for the cost-effectiveness of these interventions is scarce.AimsThe aim is to assess the cost-effectiveness of a web-based intervention (GET.ON M.E.D.) for individuals with diabetes and comorbid depression compared with an active control group receiving web-based psychoeducation.MethodWe conducted a cost-effectiveness analysis with treatment response as the outcome and a cost-utility analysis with quality-adjusted life-years (QALYs) alongside a randomised controlled trial with 260 participants.ResultsAt a willingness-to-pay ceiling of €5000 for a treatment response, the intervention has a 97% probability of being regarded as cost-effective compared with the active control group. If society is willing to pay €14 000 for an additional QALY, the intervention has a 51% probability of being cost-effective.ConclusionsThis web-based intervention for individuals with diabetes and comorbid depression demonstrated a high probability of being cost-effective compared with an active control group.Declaration of interestS.N., D.D.E., D.L., M.B. and B.F. are stakeholders of the Institute for Online Health Trainings, which aims to transfer scientific knowledge related to this research into routine healthcare.


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