The impact of waiting for intervention on costs and effectiveness: the case of transcatheter aortic valve replacement.

OBJECTIVES: The economic crisis in Europe might have limited access to some innovative technologies implying an increase of waiting time. The purpose of the study is to evaluate the impact of waiting time on the costs and benefits of transcatheter aortic valve replacement (TAVR) for the treatment of severe aortic stenosis. METHODS: This is a cost-utility analysis from the perspective of the Spanish National Health Service. Results of two prospective hospital registries (158 and 273 consecutive patients) were incorporated into a probabilistic Markov model to compare quality adjusted life years (QALYs) and costs for TAVR after waiting for 3-12 months, relative to immediate TAVR. We simulated a cohort of 1000 patients, male, and 80 years old; other patient profiles were assessed in sensitivity analyses. RESULTS: As waiting time increased, costs decreased at the expense of lower survival and loss of QALYs, leading to incremental cost-effectiveness ratios for eliminating waiting lists of about 12,500 € per QALY. In subgroup analyses prioritization of patients for whom higher benefit was expected led to a smaller loss of QALYs. Concerning budget impact, long waiting lists reduced spending considerably and permanently. CONCLUSIONS: A shorter waiting time is likely to be cost-effective (considering commonly accepted willingness-to-pay thresholds in Europe) relative to 3 months or longer waiting periods. If waiting lists are nevertheless seen as unavoidable due to severe but temporary budgetary restrictions, prioritizing patients for whom higher benefit is expected appears to be a way of postponing spending without utterly sacrificing patients' survival and quality of life.

Cost-effectiveness of Intrathecal Baclofen Therapy in severe refractory non-focal disabling spasticity: a Spanish hospital perspective.

BACKGROUND: Current knowledge about long-term economic consequences of Intrathecal Baclofen Therapy (ITB Therapy®) is incomplete. METHODS: A markov model was developed to estimate long-term clinical and economic outcomes with ITB Therapy® and conventional medical management of severe refractory non-focal disabling spasticity. Clinical and cost inputs were obtained through a non-interventional, prospective, observational study in a Spanish neurorehabilitation hospital. RESULTS: ITB Therapy® increased remaining lifetime costs by €35,605 and resulted in a gain of 1.06 quality-adjusted life-years (QALYs), thus showing an incremental cost-effectiveness ratio (ICER) of €33,619/QALY gained. In alternative scenarios, reflecting other clinical settings and management options, considerably lower ICER values were obtained. In particular, opportunities were identified to improve efficiency by setting clinically and economically sound targets for post-operation length of stay. CONCLUSION: In the Spanish setting, ITB Therapy® resulted in an ICER close to €30,000/QALY gained; potential ways to reduce costs and further enhance efficiency can be identified.

Cost-effectiveness of Sativex in multiple sclerosis spasticity: new data and application to Italy.

Multiple sclerosis (MS) is a chronic progressive disease that carries a high socioeconomic burden. Spasticity (rigidity and spasms) is common in MS and contributes to MS-related disability. This study aims to evaluate the cost-effectiveness of Sativex(®) (9-delta-tetrahydrocannabinol plus cannabidiol oromucosal spray) when used as add-on therapy for management of resistant MS-related spasticity in the context of the Italian healthcare system. A previously published Markov model-based analysis for the German and Spanish context was replicated, adapting it to the Italian setting. Model parameters were updated to reflect recent findings about MS-related spasticity and use of Sativex in daily clinical practice. The base case incremental cost-effectiveness ratio for Sativex use in Italy over a 5-year period was estimated to be €4968 per quality-adjusted life-year gained (year of costing: 2013). Sativex remained an efficient option in the Italian healthcare context - below the commonly accepted incremental threshold of €30,000 per quality-adjusted life-year gained - when deterministic and probabilistic sensitivity analyses were conducted. Sativex can be regarded as a cost-effective treatment option for patients with MS-related spasticity in Italy.

Transfemoral transcatheter aortic valve replacement compared with surgical replacement in patients with severe aortic stenosis and comparable risk: cost-utility and its determinants.

OBJECTIVE: To evaluate cost-effectiveness of transfemoral TAVR vs surgical replacement (SAVR) and its determinants in patients with severe symptomatic aortic stenosis and comparable risk. METHODS: Patients were prospectively recruited in 6 Spanish hospitals and followed up over one year. We estimated adjusted incremental cost-effectiveness ratio (ICER) (Euros per quality-adjusted life-year [QALY] gained) using a net-benefit approach and assessed the determinants of incremental net-benefit of TAVR vs SAVR. RESULTS: We analyzed data on 207 patients: 58, 87 and 62 in the Edwards SAPIEN (ES) TAVR, Medtronic-CoreValve (MC) TAVR and SAVR groups respectively. Average cost per patient of ES-TAVR was €8800 higher than SAVR and the gain in QALY was 0.036. The ICER was €148,525/QALY. The cost of MC-TAVR was €9729 higher than SAVR and the QALY difference was -0.011 (dominated). Results substantially changed in the following conditions: 1) in patients with high preoperative serum creatinine the ICERs were €18,302/QALY and €179,618/QALY for ES and MC-TAVR respectively; 2) a 30% reduction in the cost of TAVR devices decreased the ICER for ES-TAVR to €32,955/QALY; and 3) imputing hospitalization costs from other European countries leads to TAVR being dominant. CONCLUSIONS: In countries with relatively low health care costs TAVR is not likely to be cost-effective compared to SAVR in patients with intermediate risk for surgery, mainly because of the high cost of the valve compared to the cost of hospitalization. TAVR could be cost-effective in specific subgroups and in countries with higher hospitalization costs.

Sativex® in multiple sclerosis spasticity: a cost-effectiveness model.

BACKGROUND: Multiple sclerosis (MS) is a chronic, progressive disease that carries a high socioeconomic burden. Spasticity (rigidity and spasms) is common in MS and a key contributor to MS-related disability. OBJECTIVES: This study evaluated the cost-effectiveness of Sativex®, a 9-d-tetrahydrocannabinol/cannabidiol-based oromucosal spray that acts as an endocannabinoid system modulator. Sativex was recently approved for the management of resistant MS spasticity as add-on medication. METHODS: A Markov model-based analysis was performed over a 5-year horizon from a German and Spanish healthcare payer perspective. The incremental cost of Sativex was low compared with current spasticity treatments, and provided a quality-adjusted life-year gain over the current standard of care. RESULTS: The base-case incremental cost-effectiveness ratio for Sativex was estimated at €11,214/quality-adjusted life-year in Germany, while the drug was the dominant option in Spain, providing savings of €3496/patient over a 5-year period (year of costing: 2010). This was seen because the lower severity of spasticity in patients who had improved led to reduced resource consumption (e.g., physiotherapy and medications). CONCLUSION: Despite having a relatively high acquisition cost, Sativex was shown to be a cost-effective treatment option for patients with MS-related spasticity.

Cost-effectiveness analysis of early versus non-early intervention in acute migraine based on evidence from the 'Act when Mild' study.

BACKGROUND: In spite of the important progress made in the abortive treatment of acute migraine episodes since the introduction of triptans, reduction of pain and associated symptoms is in many cases still not as effective nor as fast as would be desirable. Recent research pays more attention to the timing of the treatment, and taking triptans early in the course of an attack when pain is still mild has been found more efficacious than the usual strategy of waiting for the attack to develop to a higher pain intensity level. OBJECTIVE: To investigate the cost effectiveness of early versus non-early intervention with almotriptan in acute migraine. METHODS: An economic evaluation was conducted from the perspectives of French society and the French public health system based on patient-level data collected in the AwM (Act when Mild) study, a placebo-controlled trial that compared the response to early and non-early treatment of acute migraine with almotriptan. Incremental cost-effectiveness ratios (ICERs) were determined in terms of QALYs, migraine hours and productive time lost. Costs were expressed in Euros (year 2010 values). Bootstrapping was used to derive cost-effectiveness acceptability curves. RESULTS: Early treatment has shown to lead to shorter attack duration, less productive time lost, better quality of life, and is, with 92% probability, overall cost saving from a societal point of view. In terms of drug costs only, however, non-early treatment is less expensive. From the public health system perspective, the (bootstrap) mean ICER of early treatment amounts to €0.38 per migraine hour avoided, €1.29 per hour of productive time lost avoided, and €14,296 per QALY gained. Considering willingness-to-pay values of approximately €1 to avoid an hour of migraine, €10 to avoid the loss of a productive hour, or €30,000 to gain one QALY, the approximate probability that early treatment is cost effective is 90%, 90% and 70%, respectively. These results remain robust in different scenarios for the major elements of the economic evaluation. CONCLUSIONS: Compared with non-early treatment, a strategy of early treatment of acute migraine with almotriptan when pain is still mild is, with high probability, cost saving from the French societal perspective and can be considered cost effective from the public health system point of view.