scholarly journals Cost-utility analysis of evolocumab in patients with ASCVD in Italy

Author(s):  
Andrea Marcellusi ◽  
Chiara Bini ◽  
Maria Assunta Rotundo ◽  
Emanuela Arcangeli ◽  
Laura Martinez ◽  
...  

Objective: The aim of this work was to evaluate the cost-effectiveness of evolocumab in addition to standard statin therapy with or without ezetimibe in the treatment of patients with clinically evident atherosclerotic cardiovascular disease (ASCVD) with levels of LDL-C above 100 mg/dL. Method: A theoretical cohort of patients was forecast by a Markov model that includes 11 health states for a lifetime horizon. In the base-case, the standard therapy was characterized by statins with or without ezetimibe. Two sub-populations have been considered, Recent MI (Myocardial Infarction in the last year) and Multiple events (population with multiple MI). The results were also presented for a subset of the Multiple events populations consisting of patients who have experienced a myocardial infarction (MI) in the last year. Results: For the Recent MI and Multiple events populations, ICER values of € 39,547 and € 35,744 respectively were estimated. The value of ICER was lower for the Multiple events with MI < 1 year population (€ 29,949). Considering statins with ezetimibe as standard therapy, ICER values were found to be equal to € 39,781, € 35,986 and € 30,190 respectively for the populations Recent MI, Multiple events and Multiple events with MI < 1 year. Conclusions: The estimated ICER values for the Recent MI, Multiple events and Multiple events populations with MI < 1 year were below the cost-effectiveness threshold of € 40,000, suggesting therefore how the treatment with evolocumab in addition to the standard therapy can be a cost-effective treatment both compared to standard therapy with statins and standard therapy with statins + ezetimibe.

2021 ◽  
Author(s):  
Jefferson Antonio Buendia ◽  
Diana Guerrero Patino

Abstract BackgroundAn important proportion of asthma patients remain uncontrolled despite the use of inhaled corticosteroids and long-acting beta-agonists. Some add-on therapies, as tiotropium bromide have been recommended for this subgroup of patients. The purpose of this study was to assess the cost-effectiveness of tiotropium as add-on therapies to ICS + LABA for patients with severe asthma. Methods A probabilistic Markov model was created to estimate the cost and quality-adjusted life-years (QALYs) of patients with severe asthma in Colombia. Total costs and QALYS of two interventions including standard therapy (ICS + LABA), add-on therapy with tiotropium, were calculated over a lifetime horizon. Multiple sensitivity analyses were conducted. Cost-effectiveness was evaluated at a willingness-to-pay value of $19,000. ResultsThe model suggests a potential gain of 1.06 QALYs per patient per year on tiotropium, with a difference of US$ 478 in favor of tiotropium; showing dominance respect to standard therapy. A position of dominance negates the need to calculate an incremental cost‐effectiveness ratio. In the deterministic sensitivity analyses, our base‐case results were robust to variations of all assumptions and parameters Conclusion Add-on therapy with tiotropium was found to be cost-effective when added to usual care in patients who remain uncontrolled despite treatment with medium or high-dose ICS/LABA. Our study provides evidence that should be used by decision-makers to improve clinical practice guidelines and should be replicated to validate their results in other middle-income countries.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
P Lindgren ◽  
E Hagstrom ◽  
B Van Hout ◽  
G Villa ◽  
M Urbich ◽  
...  

Abstract Background/Introduction Elevated low-density lipoprotein cholesterol (LDL-C) is one of the most important modifiable risk factors for atherosclerotic cardiovascular disease (ASCVD). Evolocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, is indicated for the reduction of CV risk by lowering LDL-C. Purpose Assess the cost-effectiveness of evolocumab added to standard of care (SoC), maximally tolerated lipid-lowering treatment, in two patient populations for which evolocumab is reimbursed in Sweden: (1) patients with ASCVD with LDL-C ≥2.5 mmol/L on SoC, and (2) heterozygous familial hypercholesterolemia (HeFH) patients without ASCVD with LDL-C ≥3.0 mmol/L on SoC. Methods A previously published Markov model was adapted to the Swedish context. The model incorporated real-world CV event (CVE) rates (myocardial infarction, ischemic stroke and CV death). In patients with ASCVD, a CVE rate of 6.3/100 patient-years was obtained from Swedish national registries. In HeFH patients without ASCVD, a CVE rate of 4.5/100 patient-years was obtained from a national screening program in the Netherlands. ASCVD patient characteristics were obtained from Swedish national registries. HeFH patient characteristics were obtained from the RUTHERFORD-2 clinical trial. The model used an evolocumab LDL-C reduction of 59%, as observed in the FOURIER CV outcomes clinical trial, and the relationship between LDL-C lowering and CVE reduction from the Cholesterol Treatment Trialists' Collaboration (CTTC) 2010 meta-analysis (base case) or FOURIER (scenario). An annual evolocumab list price (before discount) of SEK 48,759 [€ 4,632] (1 SEK = € 0.095) was considered. Costs and health outcomes were evaluated over a lifetime horizon from a societal perspective. Results In the base case, for patients with ASCVD with LDL-C ≥2.5 mmol/L on SoC, the addition of evolocumab was associated with: a 0.30 reduction in the lifetime per-patient CVE rate, increased costs of SEK 413,835 and increased quality-adjusted life years (QALY) of 0.67, yielding an incremental cost-effectiveness ratio (ICER) of SEK 615,393 [€ 58,462] per QALY gained. In the base case, for HeFH patients without ASCVD with LDL-C ≥3.0 mmol/L on SoC, the addition of evolocumab was associated with: a 0.57 reduction in the lifetime per-patient CVE rate, increased costs of SEK 701,200 and increased QALY of 1.39, yielding an ICER of SEK 503,710 [€ 47,852] per QALY gained. In the scenario analysis, ICER were SEK 539,846 [€ 51,285] and SEK 462,961 [€ 43,981] per QALY, respectively. Conclusions These results indicate the addition of evolocumab to SoC may be considered cost-effective in Sweden. Indeed, based on these data, the Swedish Dental and Pharmaceutical Benefits Agency (TLV) recently granted expanded reimbursement for evolocumab (submission 2138/2018), which led to a positive national recommendation in the patient populations described above. Acknowledgement/Funding This study was sponsored by Amgen.


2020 ◽  
Vol 15 (1) ◽  
Author(s):  
Thomas M. Best ◽  
Stephanie Petterson ◽  
Kevin Plancher

Abstract Background Patients diagnosed with osteoarthritis (OA) and presenting with symptoms are seeking conservative treatment options to reduce pain, improve function, and avoid surgery. Sustained acoustic medicine (SAM), a multi-hour treatment has demonstrated improved clinical outcomes for patients with knee OA. The purpose of this analysis was to compare the costs and effectiveness of multi-hour SAM treatment versus the standard of care (SOC) over a 6-month timeframe for OA symptom management. Methods A decision tree analysis was used to compare the costs and effectiveness of SAM treatment versus SOC in patients with OA. Probabilities of success for OA treatment and effectiveness were derived from the literature using systematic reviews and meta-analyses. Costs were derived from Medicare payment rates and manufacturer prices. Functional effectiveness was measured as the effect size of a therapy and treatment pathways compared to a SOC treatment pathway. A sensitivity analysis was performed to determine which cost variables had the greatest effect on deciding which option was the least costly. An incremental cost-effectiveness plot comparing SAM treatment vs. SOC was also generated using 1000 iterations of the model. Lastly, the incremental cost-effectiveness ratio (ICER) was calculated as the (cost of SAM minus cost of SOC) divided by (functional effectiveness of SAM minus functional effectiveness of SOC). Results Base case demonstrated that over 6 months, the cost and functional effectiveness of SAM was $8641 and 0.52 versus SOC at: $6281 and 0.39, respectively. Sensitivity analysis demonstrated that in order for SAM to be the less expensive option, the cost per 15-min session of PT would need to be greater than $88, or SAM would need to be priced at less than or equal to $2276. Incremental cost-effectiveness demonstrated that most of the time (84%) SAM treatment resulted in improved functional effectiveness but at a higher cost than SOC. Conclusion In patients with osteoarthritis, SAM treatment demonstrated improved pain and functional gains compared to SOC but at an increased cost. Based on the SAM treatment ICER score being ≤ $50,000, it appears that SAM is a cost-effective treatment for knee OA.


Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 5175-5175
Author(s):  
H. Pilgrim ◽  
K. Jewitt ◽  
S. Ward

Abstract Background: New generation BCR-ABL tyrosine kinase inhibitors are promising treatments for CML patients who are imatinib resistant or intolerant. The objective of this study was to consider the cost-utility of nilotinib in comparison to ‘high dose’ (800 mg) imatinib (the current standard comparator in the UK) for chronic-phase CML patients resistant to standard dose 400 mg imatinib using a lifetime horizon. The analysis is based on a UK NHS perspective. Methods: A Markov model was developed using interim data from the phase II CAMN107A2101 registration study of nilotinib and data from the 39 patients who were dose-escalated, due to a sub-optimal response, to 800 mg imatinib within the IRIS phase III trial of imatinib versus interferon. Based on this evidence, the estimated 18-month survival has been extrapolated over a lifetime using parametric Weibull regression. Since the price of nilotinib in the UK was still to be determined at the time of preparation, the cost was assumed to be £106.94 per day, price parity with high dose imatinib. The costs and utilities associated with adverse events have been incorporated during the first six months following treatment. All costs and utilities were discounted at 3.5%. Results: Nilotinib is estimated to cost an additional £49K and generate an additional 2.18 Quality-Adjusted Life Year’s (QALYs) in comparison to high dose imatinib over a patient’s lifetime. Therefore, the incremental cost-utility of nilotinib versus high dose imatinib is expected to be approximately £22K per QALY gained. This result is subject to uncertainty around data extrapolation. However availability of longer term data from the ongoing nilotinib trial will allow validation at a later date. Conclusions: Our analysis suggests that nilotinib provides a clinically and cost-effective treatment (according to conventionally acceptable thresholds) for CML patients who have become imatinib resistant, in an indication where limited alternative treatment options exist.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19397-e19397
Author(s):  
Eleanor Paul ◽  
Andreas Kuznik ◽  
Sam Keeping ◽  
Chieh-I Chen ◽  
Medha Sasane ◽  
...  

e19397 Background: Cemiplimab is a high-affinity, human, hinge-stabilized, monoclonal antibody that potently blocks the interactions of programmed cell death-1 (PD-1) with programmed cell death ligand-1 (PD-L1) and PD-L2. In September 2018, cemiplimab-rwlc became the first systemic therapy approved by the US Food and Drug Administration for the treatment of patients with advanced CSCC ineligible for curative surgery or radiotherapy. In a single-arm Phase II study (NCT02760498), cemiplimab demonstrated substantial antitumor activity, durable responses, and acceptable safety profile in patients with advanced CSCC. The aim of this analysis was to evaluate the cost-effectiveness of cemiplimab in patients with advanced CSCC from a US payer perspective. Methods: A partitioned survival model was developed to assess the cost-effectiveness of cemiplimab versus historical standard of care (SOC). All inputs were identified based on a systematic literature review (SLR), which was supplemented by expert opinion where necessary. The clinical inputs for cemiplimab were based on the individual patient data from the cemiplimab Phase II trial, whereas for SOC, the analysis was based on a pooled analysis of single-arm clinical trials and retrospective studies evaluating chemotherapy and epidermal growth factor receptor inhibitors (cetuximab, erlotinib, and gefitinib) identified via the SLR (6 of the 27 included studies). Overall survival and progression-free survival were extrapolated over a lifetime horizon using parametric functions consistent with guidance from the National Institute for Health and Care Excellence Decision Support Unit. Costs were included for drug acquisition, drug administration, management of adverse events, subsequent therapy, disease management, and terminal care. Unit costs were based on published 2019 US list prices. Results: In the base case, cemiplimab versus SOC resulted in an incremental cost-effectiveness ratio (ICER) of $99,024 per quality adjusted-life year (QALY), where incremental costs and QALYs were $372,425 and 3.76, respectively. At a willingness-to-pay threshold of USD $150,000 per QALY, the probabilistic sensitivity analysis suggests a 91% probability that cemiplimab is cost-effective when compared to SOC. Scenario analyses resulted in ICERs ranging from $90,326 to $147,944. Conclusions: Compared with historical SOC, cemiplimab is a cost-effective use of US payer resources for the treatment of advanced CSCC and is expected to provide value for money.


2021 ◽  
Author(s):  
Antonio Maria Fea ◽  
Francesco Cattel ◽  
Stefano Gandolfi ◽  
Giorgio Buseghin ◽  
Gianluca Furneri ◽  
...  

Abstract BackgroundGlaucoma is a disease characterized by progressive damage of the optic nerve. Several therapeutic options are available to lower intraocular pressure (IOP). In primary open-angle glaucoma (POAG) patients with inadequate IOP control (or controlled with multiple medical therapies or for whom medical therapy is contraindicated), the implantation of micro-invasive glaucoma surgery devices (MIGS) and concomitant cataract surgery has proved to be more effective in reducing intraocular pressure (IOP), as compared to cataract surgery alone. The objective of this study is to assess the cost-effectiveness of iStent inject® device with concurrent cataract surgery vs. cataract surgery alone, in patients with mild-to-moderate POAG, adopting the Italian National Health Service (NHS) perspective.MethodsSimulation of outcomes and costs was undertaken using a Markov model with 4 health states and one-month cycles, that is used to simulate the prognosis of these patients. Efficacy data were obtained from the randomized clinical trial (RCT). A lifetime horizon was adopted in the analysis. A discount rate of 3.5% was applied to both costs and effects. The Italian National Healthcare Service (NHS) perspective was considered, therefore only healthcare direct costs (acquisition of main interventions and subsequent procedures; medications; monitoring and follow-up; adverse events). Model robustness was tested through sensitivity analyses. ResultsResults of the base-case analysis showed that the total lifetime costs were higher in the iStent inject® + concurrent cataract surgery, compared with the cataract surgery alone group (€8,368.51 vs. €7,134.71 respectively). iStent inject® + concurrent cataract surgery was cost-effective vs. cataract surgery alone, with an incremental cost-effectiveness ratio of €13,037.01 per quality-adjusted life year (QALY) gained. Both one-way deterministic and probabilistic sensitivity analyses confirmed robustness of base-case results. The acceptability curve of cost-effectiveness (CEAC) analysis showed that iStent inject® + cataract surgery would have a 98% probability of being cost-effective, compared to cataract surgery alone, when the willingness to pay (WTP) is equal to €50,000 per QALY gained.ConclusionsThe results of the cost-utility analysis confirm that iStent inject® + cataract surgery is a cost-effective option for the treatment of patients affected by mild-to-moderate POAG, compared with cataract surgery alone, when evaluated from the Italian NHS perspective. Trial registration: Not applicable


2020 ◽  
pp. 096452842092028
Author(s):  
Alex Molassiotis ◽  
Bryony Dawkins ◽  
Roberta Longo ◽  
Lorna KP Suen ◽  
Hui Lin Cheng ◽  
...  

Objective To assess the cost-effectiveness of acupuncture in the management of chemotherapy-induced peripheral neuropathy (CIPN) in Hong Kong. Methods A within trial cost-utility analysis with the primary endpoint for the economic evaluation being the Quality Adjusted Life Year (QALY) and associated Incremental Cost Effectiveness Ratio (ICER) over 14 weeks of treatment. A secondary cost-effectiveness analysis was undertaken with the endpoint being change in pain as measured on the Brief Pain Inventory (BPI). Results Eighty-seven patients were randomised to acupuncture or usual care. Acupuncture resulted in significant improvements in pain intensity (8- and 14-week mean changes compared to usual care of −1.8 and −1.8, respectively), pain interference (8- and 14-week mean changes compared to usual care of −1.5 and −0.9, respectively) and indicators of quality of life and neurotoxicity-related symptoms. However, in the economic evaluation there was little difference in QALYs between the two arms (mean change 0.209 and 0.200 in the acupuncture and usual care arms, respectively). Also, costs yielded deterministic ICERs of HK$616,965.62, HK$824,083.44 and HK$540,727.56 per QALY gained from the health care provider perspective, the societal perspective and the patient perspective, respectively. These costs are significantly higher than the cost-effectiveness threshold of HK$180,450 that was used for the base case analysis. Conclusion While acupuncture can improve symptoms and quality of life indicators related to CIPN, it is unlikely to be a cost-effective treatment for CIPN-related pain in health care systems with limited resources. Trial registration number NCT02553863 (ClinicalTrials.gov) post-results.


2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6558-6558
Author(s):  
K. K. Chan ◽  
K. R. Imrie ◽  
S. M. Alibhai

6558 Background: The 2006 ASCO guideline recommends PP with CSF for elderly patients with diffuse aggressive lymphoma, partially based on previous cost-minimization analyses showing that CSF saved costs when compared with no CSF by reducing hospitalization from febrile neutropenia (FN) when the risk of FN was > 20%. However, these studies examined only one cycle of chemotherapy and did not account for costs of CSF in subsequent cycles, did not consider SP, and did not consider patients’ preferences. Methods: We conducted a cost-utility analysis to compare PP with SP in this setting using a Markov model for a time horizon of 8 cycles of chemotherapy with a government payer perspective. Costs were adjusted to 2006 $CAD. Ontario health economic data were used. The cost of hospitalization for FN was obtained from Ontario Case Costing Initiative. Data for efficacies of CSF, probabilities and utilities were obtained from published literature. Sensitivity analyses were conducted using a threshold of $100,000/QALY. Results: The base case costs for PP and SP were $22,077 and $17,641. The QALYs of PP and SP were 0.254 and 0.248. The incremental cost effectiveness ratio of PP to SP was $739,999/QALY. One-way sensitivity analyses showed that in order for PP to be cost-effective, the cost of hospitalization per episode of FN had to be > $31,138 (i.e. 2.5 times > base case), the cost of CSF per cycle had to be < $896 (base case = $1,960), the risk of FN in the 1st cycle had to be > 48% (base case = 24%), or the relative risk reduction of FN with CSF had to be > 97% (base case = 41%). Our result was robust to all other cost, probability and utility variables. First order microsimulation showed that < 17% of simulations were cost-effective. Conclusions: PP is not cost-effective when compared with SP for this population under most assumptions. PP only becomes attractive in places where the cost of hospitalization for FN is much more than that of Ontario, or the cost of CSF is under $896 per cycle. The costs of CSF and hospitalization in all cycles (instead of just one cycle) should be accounted for in any economic evaluation of CSF. Current guidelines recommending PP in this population should be revisited. No significant financial relationships to disclose.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19369-e19369
Author(s):  
Ambika Parmar ◽  
Narhari Timilshina ◽  
Urban Emmenegger ◽  
Shabbir M.H. Alibhai ◽  
Martin Smoragiewicz ◽  
...  

e19369 Background: The therapeutic landscape for patients with mCSPC has evolved over the last decade given the growing body of evidence demonstrating efficacy for the earlier application of oral androgen receptor signaling inhibitors, such as with abiraterone and enzalutamide. Recently the success of the TITAN trial established the superior efficacy of apalutamide combined with androgen deprivation therapy (ADT), with a 33% reduction in mortality versus ADT alone, and a tolerable toxicity profile. However, with substantially higher costs than ADT alone, the cost-effectiveness of this combination is critical to evaluate. Methods: A cost-utility analysis of apalutamide+ADT versus ADT alone was conducted from the Canadian healthcare perspective. A state-transition model with probabilistic analysis was used to compare the two strategies over a lifetime horizon. Model inputs were informed by the TITAN trial (transition probabilities, adverse events [AE], subsequent therapy), published literature (utilities) and Canadian costing resources (systemic therapy [initial and subsequent], routine care [physician visits, imaging], AE, end-of-life care costs). Primary outcomes included expected life-year gains (LYG), quality-adjusted life-years (QALY), lifetime cost (in 2018 Canadian dollars), and the incremental cost-effectiveness ratio (ICER). Multiple scenario analyses were conducted to assess parameter and model uncertainty. Cost and effectiveness were discounted at 1.5% as per Canadian guidelines. Results: From the base-case analysis expected LYG and QALY for ADT and apalutamide+ADT were 4.11, 5.57 and 3.50, 4.85, respectively. Expected cost over a lifetime horizon was $37,553 and $254,205, respectively. The ICER for apalutamide+ADT as compared to ADT alone was $160,483/QALY. Through scenario analysis, cost-effectiveness of apaluatmide+ADT was achieved with apalutamide price reductions of >50%, relative to a cost-effectiveness threshold (CET) of $100,000/QALY. Scenario analysis of alternative long-term survival expectations with apalutamide+ADT demonstrated cost-effectiveness (relative to CET $100,000/QALY) with expected improvements in the 5-year survival rate of 29% as compared to ADT (versus base-case expected improvement in 5-year survival of 15%). Conclusions: Apalutamide+ADT is unlikely to be cost-effective from the Canadian healthcare perspective at current list prices. Improvement in cost-effectiveness is most likely to be achieved through price reductions in apalutamide drug costs.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e21102-e21102
Author(s):  
Briana Choi ◽  
Nimer S. Alkhatib ◽  
Hala Halawah ◽  
Matthias Calamia ◽  
Dexter Gulick ◽  
...  

e21102 Background: Crizotinib was approved by the FDA (2011) as the first ALK inhibitor for ALK+ NSCLC as the first line drug. This was followed by the approval as second line treatment of ceritinib (2014), alectinib (2015) and brigatinib (2017); and, following more data, now also as first line therapies in ALK+ NSCLC. With varying costs and clinical benefits for progression free survival (PFS), cost effectiveness/utility analyses were conducted. Methods: A 3 state Markov model was built including progression free, progression and death. PFS and overall survival curves were digitized and exponential functions were fit the curves for extrapolation beyond trial follow up. A lifetime horizon, US payer perspective, and a discount rate of 3% were applied. Drug costs were based on Redbook Wholesale Acquisition Cost while costs of adverse events, monitoring, disease progression were from literatures (US$ 2020). Adverse events reported at > 5% were included. Crizotinib was used as reference treatment. PFS life years (PFSLY), quality adjusted life years (PFSQALY), incremental cost-effectiveness and utility ratios (ICER/ICUR) of PFSLY and PFSQALY gained (PFSLYG, PFSQALYG) were estimated in base case (BCA) and probabilistic sensitivity analyses (PSA). Results: Crizotinib was the reference drug in the following estimations. For alectinib, at incremental cost of $7,789 (PSA $7,719), the incremental PFSLY of 1.10 (1.10) and PFSQALY 1.07 (1.07) yielded an ICER of $7,109 ($7,030) / PFSLYG and an ICUR of $7,278 ($7.197) / PFSQALYG. For ceritinib, at incremental cost of $88,688 ($88,450), the incremental PFSLY of 1.02 (1.02) and PFSQALY of 1.01 (1.01) resulted in an ICER of $86,970 ($86,729) / PFSLYG and an ICUR of $87,472 / PFSQALYG. For brigatinib, at incremental cost of $84,680 ($83,986), the incremental PFSLY of 1.01 (1.01) and PFSQALY of 1.02 yielded an ICER of $83,774 ($83,073) / PFSLYG and an ICUR of $82,666 ($81,976) / PFSQALYG. Conclusions: Ceritinib had the highest lifetime cost and comparable PFSLY and PFSQALY to brigatinib. However, alectinib reported the highest PFSLY and PFSQALY gained while having lower costs than ceritinib and brigatinib, therefore being the most cost-effective treatment for naïve ALK+ NSCLC.[Table: see text]


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