National Healthcare System Perspective Research Articles

Economic Evaluation of Once-Weekly Insulin Icodec from Italian NHS Perspective.

Icodec, once-weekly basal insulin, aims to simplify therapy management by reducing injection frequency for diabetic patients. The efficacy and safety of icodec were evaluated in the ONWARDS clinical development program. This study evaluates icodec economic and quality of life impact from the Italian National Healthcare System (NHS) perspective. A pharmacoeconomic study was developed to assess the once-weekly insulin icodec value, highlighting its potential to decrease needle use while improving adherence and quality of life. In the base case, a differential cost and cost-utility analysis over one year compared to once-daily insulin degludec were developed. Based on the comparison with degludec, a scenario analysis was planned between icodec and the mix of basal insulins available on the market. Economic evaluations included drug and administration costs, needles, and impact on adherence. The cost-utility analysis measured the utility associated with the weekly injection compared to the daily ones, resulting in an incremental cost-effectiveness ratio (ICER), measured as Δ€/ΔQALY (Quality Adjusted Life Years). To assess the robustness of the results, a deterministic one-way sensitivity analysis and a probabilistic sensitivity analysis were carried out. At an annual cost 25% higher than degludec, considering the economic benefits generated by the needle use reduction (-€51.10) and adherence improvement (-€54.85), once-weekly icodec grants no incremental cost and even potential savings per patient. Furthermore, icodec reported a utility advantage (0.023). It achieved a dominant incremental cost-effectiveness ratio (ICER) compared to degludec. The comparison with the mix of basal insulins also reported a cost-effectiveness profile. Sensitivity tests conducted confirmed the robustness of the findings, highlighting the key drivers of the analysis. Icodec represents a new therapeutic option to simplify basal insulin treatment. It also improves the patient's management and his quality of life, without increasing the economic burden for the Italian NHS, while guaranteeing an excellent cost-effectiveness profile.

Cost-effectiveness Analysis of Maternal Immunization with RSVpreF Vaccine for the Prevention of Respiratory Syncytial Virus Among Infants in Spain.

Respiratory syncytial virus (RSV) is the leading cause of acute lower respiratory infections (ALRI) in children under one year of age. In high-income countries, RSV infections cause a significant overload of care every winter, imposing a significant burden to the healthcare system, which has made the development of prevention strategies a major global health priority. In this context, a new bivalent RSV prefusion F protein-based vaccine (RSVpreF) has recently been approved. The objective of this study was to evaluate the cost-effectiveness of vaccinating pregnant women with the RSVpreF vaccine to prevent RSV in infants from the Spanish National Healthcare System (NHS) perspective. A hypothetical cohort framework and a Markov-type process were used to estimate clinical outcomes, costs, quality-adjusted life years (QALY) and cost-per-QALY gained (willingness-to-pay threshold: €25,000/QALY) for newborn infants born to RSV-vaccinated versus unvaccinated mothers over an RSV season. The base case analysis was performed from the NHS perspective including direct costs (€2023) and applying a discount of 3% to future costs and outcomes. To evaluate the robustness of the model, several scenarios, and deterministic and probabilistic analyses were carried out. All the parameters and assumptions were validated by a panel of experts. The results of the study showed that year-round maternal vaccination program with 70% coverage is a dominant option compared to no intervention, resulting in direct cost savings of €1.8 million each year, with an increase of 551 QALYs. Maternal vaccination could prevent 38% of hospital admissions, 23% of emergency room visits, 19% of primary care visits, and 34% of deaths due to RSV. All scenario analyses showed consistent results, and according to the probabilistic sensitivity analysis (PSA), the probability of maternal vaccination being cost-effective versus no intervention was 99%. From the Spanish NHS perspective, maternal vaccination with bivalent RSVpreF is a dominant alternative compared with a non-prevention strategy.

Institutional Micro-Cost Comparative Analysis of Reusable vs Single-use Cystoscopes With Assessment of Environmental Footprint

ObjectiveTo conduct a comparative cost analysis between single-use and reusable cystoscopes from a national healthcare system perspective and assess the environmental footprint. MethodsSingle-center micro-cost analysis of reusable versus single-use cystoscopes used institutional data. The cost breakdown included capital, reprocessing, repair, procedure, and environmental impact expenses. Data collection occurred in 2022, utilizing register data, observations, and expert opinions. Depreciation was applied over 5 years for reusable cystoscopes and 8 years for the automated endoscope reprocessor. Deterministic sensitivity analyses gauged result robustness to input variations. Lastly, an assessment of the environmental footprint, focusing on water consumption and waste generation, was conducted. ResultsPer-procedure cost associated with reusable cystoscopes was €332.46 versus €220.19 associated with single-use, resulting in savings of €112.27. When projecting these costs per procedure with the no. procedures performed in 2022 (1186), comparing the costs of procedures performed in one year with reusable endoscopes (€394,295.86) to the costs of the exact no. procedures performed with disposable endoscopes (€261,149.37), a saving of €133,146.49 could be achieved. Additionally, after continuous use of single-use endoscopes, procedures were scheduled every 20 instead of every 30 minutes. This adjustment allowed for 15 daily procedures instead of 10 while maintaining the same shift. This suggests potential advantages in terms of improved organizational impact and reduced waiting lists. Ultimately, the decreased environmental impact favored the adoption of single-use cystoscopes. ConclusionsOur study presents an opportunity for organizational development in response to the evolving external environment, considering user needs, market dynamics, and competition with other facilities.

Cost‑Effectiveness Analysis of Tapentadol PR Versus Oxycodone/Naloxone PR in Patients with Musculoskeletal Pain in Spain

Objetive: Chronic musculoskeletal pain is highly prevalent worldwide and is associated with a huge social and economic burden. Opioids are commonly prescribed to treat chronic pain as recommended by the European Pain Federation. Tapentadol prolonged release (PR), is a strong opioid that has proven being effective in treating chronic musculoskeletal pain with less adverse events than oxycodone/naloxone PR. The aim of this study was to estimate the cost-effectiveness of tapentadol PR compared to oxycodone/naloxone PR from the Spanish National Healthcare System perspective (SNHS). Methods: A Markov model was adapted analysing two arms: patients treated with tapentadol PR and patients treated with oxycodone/naloxone PR. The model assesses a cohort of 1,000 patients over a one-year period. Results: Overall, treating patients with tapentadol PR was less costly than treating patients with oxycodone/naloxone PR (€388,631.70 vs €568,168.85). In terms of cost effectiveness, the incremental cost of tapentadol PR over oxycodone/naloxone PR was -€179,537.15 and the incremental quality-adjusted life year value was 40.05. The incremental cost-effectiveness ratio was estimated at -€4,027.16 per quality-adjusted life year suggesting that tapentadol PR is an economically dominant alternative over oxycodone/naloxone PR. Conclusion: Tapentadol PR represents a cost-effective option to treat musculoskeletal chronic pain patients in Spain. Keywords: Musculoskeletal pain, Opioids, Tapentadol PR, Cost effectiveness, Spain.

Cabotegravir and Rilpivirine Long-Acting Antiretroviral Therapy Administered Every 2Months is Cost-Effective for the Treatment of HIV-1 in Spain.

Current antiretroviral therapies (ARTs) have improved outcomes for people living with HIV. However, the requirement to adhere to lifelong daily oral dosing may be challenging for some people living with HIV, leading to suboptimal adherence and therefore reduced treatment effectiveness. Treatment with long-acting (LA) ART may improve adherence and health-related quality of life. The objective of this study was to evaluate the cost-effectiveness of cabotegravir + rilpivirine (CAB+RPV) LA administered every 2months (Q2M) compared with current ART administered as daily oral single-tablet regimens (STRs) from a Spanish National Healthcare System perspective. A hybrid decision-tree and Markov state-transition model was used with pooled data from three phaseIII/IIIb trials (FLAIR, ATLAS, and ATLAS-2M) over a lifetime horizon, with health states defined by viral load and CD4+ cell count. Direct costs (in €) were taken from Spanish public sources from 2021 and several deterministic and probabilistic analyses were carried out. An annual 3% discount rate was applied to both costs and utilities. Over the lifetime horizon, CAB+RPV LA Q2M was associated with an additional 0.27 quality-adjusted life years (QALYs) and slightly greater lifetime costs (€4003) versus daily oral ART, leading to an incremental cost-effectiveness ratio of €15,003/QALY, below the commonly accepted €30,000/QALY willingness-to-pay threshold in Spain. All scenario analyses showed consistent results, and the probabilistic sensitivity analysis showed cost-effectiveness compared with daily oral STRs in 62.4% of simulations, being dominant in 0.3%. From the Spanish National Health System perspective, CAB+RPV LA Q2M is a cost-effective alternative compared with the current options of daily oral STR regimens for HIV treatment. ATLAS, NCT02951052; ATLAS-2M, NCT03299049; FLAIR, NCT02938520.

EE214 Modelling Cost Determinants for Treating Metastatic Castration-Resistant Prostate Cancer: An Italian National Healthcare System's Perspective Cost Analysis

This study aimed at estimating the healthcare costs and identifying potential drivers associated with metastatic castration-resistant prostate cancer (mCRPC).

Insulin degludec/liraglutide versus its monotherapy on T2D patients: A lifetime cost-utility analysis in China.

Introduction: IDegLira (brand name Xultophy) is a novel fixed ratio combination of insulin degludec and liraglutide for type 2 diabetes (T2D) patients. This study aimed to investigate the lifetime cost-effective value of IDegLira compared with its single component (Degludec or Liraglutide) and to explore the suitable annual cost of IDegLira if necessary. Methods: UKPDS OM2 was applied to determine the long-term quality-adjusted life years (QALYs) and total costs. The efficacy data that were inputted into the model were synthesized from 6 randomized clinical trials (RCTs) that directly assessed the clinical benefit of IDegLira and its components in the treatment of uncontrolled T2D patients. The economic results were examined by one-way sensitivity analysis (OSA) and probabilistic sensitivity analysis (PSA). Further price reduction of IDegLira was investigated by binary search. Results: The IDegLira, IDeg, and Lira yielded 11.79 QALYs, 11.62 QALYs, and 11.73 QALYs and total cost of $20281.61, $3726.76, and $11941.26, respectively. The incremental cost-utility ratio (ICUR) of IDegLira versus IDeg was $99464.12/QALYs, and the ICUR of IDegLira versus Lira was $143348.26/QALYs, which indicated that IDegLira was not a cost-effective therapy for T2D patients compared with its components at the current price from a Chinese national healthcare system perspective. Base case results were robust to OSA and PSA. A further binary search showed that IDegLira appears to only be cost-effective if the annual cost of IDegLira is decreased by 58% when IDeg is considered as a reference, or by 30.57% when Lira is considered as a reference. Conclusion: In conclusion, IDegLira appears to not be cost-effective when compared with the current prices of IDeg or Lira for T2D patients in China. However, after the binary search, IDegLira appears to only be cost-effective if the annual cost of IDegLira is decreased 58% when IDeg is considered as a reference, or by 30.57% when Lira is considered as a reference.

Economic Burden of Non-Alcoholic Steatohepatitis (NASH) Among Diabetic Population in Italy: Analysis and Perspectives.

BackgroundAim of our study is to evaluate the economic impact of NASH among diabetic population in Italy and potential benefits of treatments that can slow the disease progression.MethodsA Markov model was conducted from the Italian National Healthcare System perspective reporting results at 3, 5, 10 and 15 years. The model included NASH and T2DM patients with all stages of fibrosis (F0-F3), compensated cirrhosis (CC), decompensated cirrhosis (DCC), hepatocellular carcinoma (HCC), liver transplant (LT), post-LT and death. A 1-year model cycle length was considered, with each patient passing through the stages and exiting the model when reached one of mortality states. Transition probabilities and annual cost related to health states were derived from published literature. Moreover, the model made it possible to develop a scenario analysis to simulate the impact of treatments capable of slowing the disease progression in phases F0-F4 (CC).ResultsThe results highlighted an economic burden of NASH in T2DM patients of approximately € 1.4 billion, € 3.1 billion, and € 9.4 billion, respectively, after 3, 5 and 10 years, reaching about € 17.3 billion after 15 years. The slowing down of the progression in the early stages of the disease (fibrosis F0-CC) has led to significant savings corresponding to € 2.3 billion at 15 years. These savings were generated by the reduction of the patients in the advanced stages of the disease, which is linked to a reduction in deaths, equal to 92,208 deaths avoided over a 15-year time horizon.ConclusionPatients with NASH and T2DM reported an important burden in Italy. It is important to investigate the potential clinical and economic benefits of antidiabetic drugs that have been shown to be effective in preventing the transition to advanced disease, simultaneously acting on the therapeutic goals of diabetic disease.

The Efficacy and Cost-Effectiveness of Umeclidinium/Vilanterol versus Tiotropium in Symptomatic Patients with Chronic Obstructive Pulmonary Disease.

Both long-acting muscarinic antagonists (LAMAs) and long-acting β2-agonists (LABAs) are widely used in the treatment of chronic obstructive pulmonary disease (COPD). A novel LAMA/LABA combination of umeclidinium/vilanterol (UMEC/VI; 62.5 μg/25 μg) is approved for chronic obstructive pulmonary disease (COPD) treatment. This study aimed to assess the efficacy and cost-effectiveness of UMEC/VI versus tiotropium (TIO) 18 μg in symptomatic patients with COPD from the perspective of the Chinese National Healthcare System. A simple analysis included three studies in the meta-analysis that compared UMEC/VI with TIO. A Markov model was developed to estimate the cost-effectiveness of UMEC/VI compared with TIO treatment in symptomatic patients with COPD. First, utilities, clinical efficacy, and adverse events obtained from the literature were utilized as model inputs. Costs were from Chinese average data, including local data. Costs were expressed in dollars based on 2020 prices. Then, the model outputs including drug costs, other medical costs, and total costs, and quality-adjusted life years (QALYs) were estimated. Costs and outcomes were discounted at a 5% annual rate. Furthermore, incremental cost-effective ratios (ICERs) were analyzed. Finally, the influences of changing parameters on the uncertainty of the results were assessed by means of one-way and probabilistic sensitivity analyses. This study revealed that UMEC/VI treatment had a higher rate of clinical efficacy in comparison with TIO, and the differences in the rate of adverse events between the two treatments were not significant. The results indicated that UMEC/VI was superior to TIO, which provided an increase in QALYs (0.002) and a total cost savings of $765.67 per patient over 3 years. In the base case, the ICER of UMEC/VI is -$397468.04/QALY compared with TIO, suggesting that UMEC/VI may be considered a dominant option over TIO. According to the Chinese medical system, the probability of UMEC/VI being cost-effective was 61.6% at a willingness-to-pay (WTP) of $31554/QALY. Sensitivity analyses confirmed that the results were robust. UMEC/VI could be considered a cost-effective treatment compared with TIO in symptomatic COPD patients from the Chinese National Healthcare System perspective. These results may help decision-makers in China when making judgements on which treatments to administer.

EE254 Biosimilars Impact on the Rheumatoid Arthritis Treatment: A Cost-Effectiveness Model from Spanish National Healthcare System Perspective

Rheumatoid arthritis (RA) is a highly debilitating chronic disease posing significant financial burden to the National Healthcare System (NHS). Whilst options to treat RA patients like conventional synthetic, biologic, or targeted synthetic disease-modifying anti-rheumatic drugs (csDMARDs, bDMARDs, tsDMARDs) exist; anti-tumour necrosis factor’s biosimilars -(anti-TNFb)_ adalimumab (bADA), etanercept (bETN), infliximab (bINF)- have arguably changed the landscape by bringing significant cost reductions and probably early access to biological therapy.

Cost-effectiveness and budget impact analysis of siponimod in the treatment of secondary progressive multiple sclerosis in Italy.

Siponimod is an effective treatment for patients with secondary progressive multiple sclerosis (SPMS), with active disease evidenced by relapses or imaging features characteristic of multiple sclerosis inflammatory activity, however there is a need to evaluate its economic value and sustainability compared to other disease modifying-therapies (DMTs). To estimate the siponimod cost-effectiveness profile and its relative budget impact compared with other DMTs, by using the Italian National Healthcare System perspective. We performed: 1) a cost-effectiveness analysis (CEA) vs interferon beta-1b using an analytical Markov model and a life time-horizon, and 2) a budget impact analysis by using 3-years time-horizon. The results were reported as incremental cost-effectiveness ratio (ICER) and net-monetary benefit (NMB) for CEA, using a willingness to pay threshold of €40,000 per QALY gained, and as difference in the overall budget (Euro) between the scenario with and without siponimod for budget impact. In the base case scenario siponimod resulted cost-effective compared with interferon beta-1b 28,891€ per QALY. Overall, the market access of siponimod was associated to an increased budget of about 3€ millions (+0.9%) in the next 3 years simulated. Compared to interferon beta-1b, siponimod seems to be cost-effective in SPMS patients and sustainable, with less than 1% overall budget increased in the next 3 years. Future studies need to confirm our results in the real word setting and in other countries.

POSC229 Headache Clinical Care Pathway: From Process Mapping to Suggestions of Improvement

To map the clinical pathways of headache patients, stratified for patients’ characteristics, from primary care to hospital setting, analyzing the areas of efficiency and the economic absorption, assuming the National Healthcare System perspective.

Cost-minimization analysis of immunoglobulin treatment of primary immunodeficiency diseases in Spain

Primary immunodeficiency diseases (PID), which are comprised of over 400 genetic disorders, occur when a component of the immune system is diminished or dysfunctional. Patients with PID who require immunoglobulin (IG) replacement therapy receive intravenous IG (IVIG) or subcutaneous IG (SCIG), each of which provides equivalent efficacy. We developed a cost-minimization model to evaluate costs of IVIG versus SCIG from the Spanish National Healthcare System perspective. The base case modeled the annual cost per patient of IVIG and SCIG for the mean doses (per current expert clinical practice) over 1 year in terms of direct (drug and administration) and indirect (lost productivity for adults and parents/guardians of pediatric patients) costs. It was assumed that all IVIG infusions were administered in a day hospital, and 95% of SCIG infusions were administered at home. Drug costs were calculated from ex-factory prices obtained from local databases minus the mandatory deduction. Costs were valued on 2018 euros. The annual modeled costs were €4,266 lower for patients with PID who received SCIG (total €14,466) compared with those who received IVIG (total €18,732). The two largest contributors were differences in annual IG costs as a function of dosage (– €1,927) and hospital administration costs (– €2,688). However, SCIG incurred training costs for home administration (€695). Sensitivity analyses for two dose-rounding scenarios were consistent with the base case. Our model suggests that SCIG may be a cost-saving alternative to IVIG for patients with PID in Spain.

Atrial fibrillation burden of illness: epidemiology and annual economic impact

Abstract Funding Acknowledgements Type of funding sources: None. BACKGROUND The totality of evidence on atrial fibrillation (AF) highlights its role in reducing the quality of life and increasing the risk of developing complications, which are responsible in a considerable increase in the consumption of health resources. PURPOSE Considering the high incidence and prevalence of AF, physicians should be aware of the burden of the disease to provide a timely and effective response. This analysis aims to calculate the annual economic impact of AF in Italy. METHOD A model was developed to assess the economic impact of AF including the probability of the related complications occurring. The number of patients affected by AF was computed by applying to the over-65 years old population residing in Italy on 1th January 2020 the prevalence by the international literature. The separate prevalence of paroxysmal, persistent and permanent AF was considered as well as % of patients with and without symptoms. As according to data coming from literature, the % of patients under treatment is unfortunately very low, thus the general assumption that AF patients were untreated was done. A literature review was then conducted to collect validated relative risk (%RR) for each AF complication. If present in literature, the direct healthcare costs per patient/year were included in the model or, alternatively, the DRG tariffs as a proxy. The actualized costs linked to all complications were then used to estimate the economic impact of AF patients from the Italian National Healthcare System perspective. RESULTS According to this analysis, AF is the most common cardiac arrhythmia and in Italy in 2020 affected approx. 1.018.128 people: 104.942 (65-69 ages); 187.437 (70-74 ages); 223.418 (75-79 ages); 307.406 (80-84 ages); 353.911 (85+ ages). Patients were subdivided by AF conditions: a total of 205.662 patients with paroxysmal AF (82.265 symptomatic), 247.405 patients with persistent AF (113.806 symptomatic) and 565.061 patients with permanent AF (79.109 symptomatic). This economic model estimated the number of events occurred and monetizes the healthcare resource use for the management of complications. The number of events yearly experienced was: 366.526 for any stroke, 1.354.110 for Dementia, 1.130.122 for Heart Failure, 671.964 for Chronic kidney disease,142.538 for Ischemic heart disease, 699.454 for Peripheral arterial disease. The total cost of patients, considering the burden of complications defined before, for 2020 was about 25 billion. This is probably an underestimation, as each patient could experience more than one complication and consequently their annual cost increases. CONCLUSIONS Our data confirm that the costs of AF complications have a considerable impact on resource consumption. Thus, in a context of a cost containment, measures to reduce both the risk of developing AF and the risk of making the disease worse are strongly needed.

New Perspective to Improve Care of Patients with Infected Diabetic Foot Ulcer: Early Economic Impact of the Use of Photodynamic Therapy with RLP068 (Based) System.

ObjectiveTo perform an early economic evaluation of a system based on photodynamic advanced adjuvant therapy with photosensitizer RLP068/CI to facilitate the healing process of foot/leg skin lesions/ulcers with an excellent safety profile.DesignAn early short-term (10 weeks) cost-effectiveness and a budget impact analysis (over 5 years) comparing photodynamic therapy with photosensitizer RLP068/CI based (PDT-RLP068) system added to Standard of Care (SoC) vs SoC alone.SettingThe Italian National Healthcare System perspective considering both the outpatient and the day-hospital regimen.ParticipantsHypothetical patients with diabetic foot infection (DFI) grades I/IIB.InterventionsThe PDT-RLP068 system as an add-on to Standard of Care (SoC) vs SoC alone as the first-line treatment for the management of DFIs.Main OutcomesDays within which the clinical target was achieved and direct health costs for patients’ management.ResultsAdditional costs generated by the use of the PDT-RLP068 system progressively decreased as time to reach the target induced by the novel system decreased. In the outpatient regimen, when time to reach clinical target decreased in the range 7–28 days, ICERs varied from about 1€ to 70€ for each additional day gained with clinical target achieved. The system was dominant when halving time to reach the target in the outpatient regimen and even for modest reduction of time in day-hospital regimen. In terms of budget impact, when considering day-hospital regimen, if the PDT-RLP068 based system allowed a shortened duration to reach the clinical target of between 7–28 days, BI was 8,100,000€ to 700,000€, with saving less than 2,000,000€ with 50% reduction of time. Considering the inpatient setting, the use of the PDT-RLP068 system would result in saving even with the modest impact on the time needed to activate the healing process.ConclusionThe early economic evaluation performed suggested that, if the claimed effectiveness of the technology demonstrated in case reports and in preliminary clinical studies can be confirmed in larger population studies, and allowing for shortening of the time needed to activate the healing process, the PDT-RLP068 system could offer the chance to improve care for DFI patients without compromising the sustainability of the system.

PGI7 Budget IMPACT of Capsule Endoscopy for Crohn's Disease Management in Spain

In Spain, endoscopic evaluation of Crohn’s disease with ileocolonoscopy±magnet resonance enteroscopy is the standard of care (SoC) for surveillance of the mucosa of the colon but not the small bowel (SB). Pan-intestinal video capsule endoscopy (PVCE) allows to visualize both the colon and small bowel in one exam, but the cost impact of introducing PVCE is unknown. From the National Healthcare System perspective, we estimate the budget impact of introducing PVCE in patients diagnosed with SB disease. A patient-level model was developed for describing the care pathway of the disease over a five-year time horizon in a cohort of 4,000 patients who started with CD surveillance at 1-year after diagnosis. A scenario using SoC for all patients was compared to a scenario in which SoC was considered for patients with colonic disease and PVCE (+patency capsule) was used for those patients with diagnosed SB disease. Information about efficacy, resource utilization, and unit costs (€2018) was taken from published sources and validated by Spanish experts. Sensitivity analyses were performed to assess the robustness of the model. Total costs per patient were lower when PVCE (+patency capsule) for SB diagnosed patients was used: €5,413 versus €5,464. Cost associated with monitoring increased by 7.1% (€851 vs €795) whereas pharmacological treatment, complications, and surgery costs all decreased: 1.5% (€3,089 vs €3,137), 4.9% (€577 vs €606), and 3.3% (€896 vs €926), respectively. suggested median total savings of €50 per patient, but it did not reach significance. 47% of patients were switched to PVCE over the time horizon, with the mean saving per switched-patient being €759. This simulation study suggests that using PVCE for patients with diagnosed SB disease is likely to reduce costs in the Spanish setting and could lead to reductions in surgery over a 5-year time period.

Cost-effectiveness analysis of chronic hepatitis C treatment in the prison population in Spain.

ABSTRACTObjectivesTo evaluate the cost-effectiveness of direct-acting antiviral (DAAs) treatment versus non-treatment in prisoners awaiting treatment for chronic hepatitis C (CHC) and to analyse the clinical and economic impact of the treatment on liver complications and mortality.Material and methodA lifetime Markov model was developed to simulate treatment and disease progression from an estimated cohort of 4,408 CHC prisoners treated with DAAs over 2 years (50% of patient each year) versus no treatment. In the treated cohort, a sustained viral response of 95% was associated. Patient characteristics, transition probabilities, utilities and costs (pharmacological and healthcare states) were obtained from published literature. The model estimated healthcare costs and benefits, incremental cost-utility ratio (ICUR) based on total costs and the quality-adjusted life year (QALY) and avoided clinical events. A National Healthcare System perspective was adopted with a 3% annual discount rate for both costs and health outcomes. Sensitivity analyses were performed to assess uncertainty.ResultsIn the DDA treated cohort, the model estimated a decrease of 92% of decompensated cirrhosis and 83% of hepatocellular carcinoma, 88% liver-related mortality cases were reduced, 132 liver transplants were avoided. The treatment achieved an additional 5.0/QALYs (21.2 vs. 16.2) with an incremental cost of €3,473 (€24,088 vs. €20,615) per patient with an ICUR of €690 per QALY gained.DiscussionConsidering the willingness-to-pay threshold used in Spain (€22,000-30,000/QALY), DAAs treatment for prisoners with CHC is a highly cost-effective strategy, reduces infection transmission, increases survival and reduces complications due to liver disease, as well as the cost associated with its management.

PCN117 COST-UTILITY ANALYSIS OF PERTUZUMAB IN COMBINATION WITH TRASTUZUMAB AND CHEMOTHERAPY VERSUS TRASTUZUMAB AND CHEMOTHERAPY FOR THE ADJUVANT TREATMENT OF PATIENTS WITH HER2+ EARLY BREAST CANCER IN SPAIN

Pertuzumab(P), trastuzumab and chemotherapy(HT) for the adjuvant treatment of HER2+ early breast cancer(eBC) significantly improved invasive disease-free survival(iDFS) versus HT in the intention-to-treat population(ITT) and, particularly, in lymph node-positive(N+) and/or hormone receptor-negative(HR-) patients. We performed a study aimed at determining the cost-utility of PHT versus HT as adjuvant treatment in HER2+ eBC for Spain. A six-state Markov model (iDFS, local recurrence, iDFS after local recurrence, metastatic-relapse[1L], metastatic-relapse[2L], and death) was adapted considering the Spanish National Healthcare System perspective, over a lifetime horizon. APHINITY 4 year-iDFS data were fitted with a log-logistic distribution for ITT and N+ populations and with an exponential distribution for HR- patients. Transition probabilities and costs (€ 2019 and list prices of medicines considered) were obtained from national databases/ literature. Utilities were derived from the APHINITY trial. Model inputs were validated by an expert panel. A 3% annual discount rate was applied to effects and costs. Deterministic and probabilistic sensitivity analyses(SA) were performed to explore uncertainties. PHT provided 0.637 additional quality-adjusted life-years(QALYs) and €27,733 cost versus HT in the N+ subgroup (incremental cost-utility ratio[ICUR] of €43,530/QALY). In this subgroup, ICUR were between €19,000 and €27,000 when applying a 20%-30% reduction in pertuzumab and trastuzumab treatment price. In the HR- subgroup, PHT provided 0.405 QALYs and €39,159 cost (ICUR of €96,630/QALY). ICUR were between €58,000 and €71,000 when applying a 20%-30% reduction in treatment price. The ICUR of PHT versus HT was €102,581/QALY in the ITT population, and between €60,000 and €74,000 when considering a 20%-30% treatment price decrease. SA confirmed the robustness of the model. Great controversy currently surrounds cost-effectiveness thresholds. Eighteen cycles of PHT would be an efficient therapeutic alternative in HER2+ N+ eBC with a threshold of €43,530/QALY and in HR- patients with a threshold of €96,630/QALY.

A cost-effectiveness analysis of denosumab for the prevention of skeletal-related events in patients with multiple myeloma in four European countries: Austria, Belgium, Greece, and Italy

Aim: The approved indication for denosumab (120 mg) was expanded in 2018 to include skeletal-related event (SRE) prevention in patients with multiple myeloma (MM). Therefore, a cost-effectiveness analysis was conducted comparing denosumab with zoledronic acid (ZA) for SRE prevention in patients with MM from the national healthcare system perspective in a representative sample of European countries: Austria, Belgium, Greece, and Italy. Methods: The XGEVA global economic model for patients with MM was used to calculate incremental cost-effectiveness ratios (ICERs) for denosumab vs ZA over a lifetime horizon. Clinical inputs were derived from the denosumab vs ZA randomized, phase 3 study (“20090482”) in patients newly-diagnosed with MM, and comprised real-world adjusted SRE rates, serious adverse event (SAE) rates, treatment duration, dose intensity, progression-free survival (PFS), and overall survival (OS). Economic inputs comprised country-specific denosumab and ZA acquisition and administration costs, SRE and SAE management costs, and discount rates. Health utility decrements associated with MM disease progression, SRE and SAE occurrence, and route of administration were included. Results: Estimated ICERs (cost per quality-adjusted life-year [QALY] gained) for denosumab vs ZA in Austria, Belgium, Greece, and Italy were €26,294, €17,737, €6,982, and €27,228, respectively. Using 1–3 times gross domestic product (GDP) per capita per QALY as willingness to pay thresholds, denosumab was 69–94%, 84–96%, 79–96%, and 50–92% likely to be cost-effective vs ZA, respectively. Limitations: Economic inputs were derived from various sources, and time to event inputs were extrapolated from 20090482 study data. Conclusions: Denosumab is cost-effective vs ZA for SRE prevention in patients with MM in Austria, Belgium, Greece, and Italy, based on often-adopted World Health Organization thresholds. This conclusion is robust to changes in model parameters and assumptions. Cost-effectiveness estimates varied across the four countries, reflecting differences in healthcare costs and national economic evaluation guidelines.

Cost-effectiveness analysis of umeclidinium bromide/vilanterol 62.5/25 mcg versus tiotropium/olodaterol 5/5 mcg in symptomatic patients with chronic obstructive pulmonary disease: a Spanish National Healthcare System perspective

BackgroundA head-to-head study demonstrated the superiority of once-daily umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 mcg on trough forced expiratory volume in 1 s (FEV1) versus once-daily tiotropium/olodaterol (TIO/OLO) 5/5 mcg in symptomatic patients with chronic obstructive pulmonary disease (COPD). This analysis evaluated the cost effectiveness of UMEC/VI versus TIO/OLO from a Spanish National Healthcare System perspective, using data from this study and Spanish literature.MethodsThis analysis was conducted from the perspective of the Spanish National Healthcare System with a 3-year horizon as base case. A disease progression model using a linked risk equation approach was used to estimate disease progression and associated healthcare costs, and quality-adjusted life years (QALYs). The Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) study was used to develop the statistical risk equations for clinical endpoints, and costs were calculated using a health state approach (by dyspnea severity). Utilities for QALY calculation were estimated using patient baseline characteristics within a regression fit to Spanish observational data. Treatment effect, expressed as change from baseline in FEV1 was obtained from the head-to-head study and used in the model (UMEC/VI minus TIO/OLO difference: + 52 mL [95% confidence interval: 28, 77]). Baseline patient characteristics were sourced from Spanish literature or the head-to-head study if unavailable. A scenario analysis using only the intent-to-treat (ITT) population from the head-to-head study, and sensitivity analyses (including probabilistic sensitivity analyses), were conducted. Direct healthcare costs (2017 Euro) were obtained from Spanish sources and costs and benefits were discounted at 3% per annum.ResultsUMEC/VI was associated with small improvements in QALYs (+ 0.029) over a 3-year time horizon, compared with TIO/OLO, alongside cost savings of €393/patient. The ITT scenario analysis and sensitivity analyses had similar results. All probabilistic simulations resulted in UMEC/VI being less costly and more effective than TIO/OLO.ConclusionUMEC/VI dominated TIO/OLO (more effective and less expensive). These results may aid payers and decision-makers in Spain when making judgements on which long-acting muscarinic antagonist/long-acting β2-agonist (LAMA/LABA) treatments can be considered cost effective in Spain.