A budget impact model and a cost-utility analysis of reducer device (Neovasc) in patients with refractory angina.

Background: Refractory angina (RA) is a chronic condition characterized by the presence of debilitating angina symptoms due to established reversible ischemia in the presence of obstructive coronary artery disease (CAD). Treatments for this condition have undergone major developments in recent decades; however, the treatment for RA remains a challenge for medicine. In this sense, the Coronary Sinus Reducer System (CSRS) stands as the last line of therapy for ineligible patients for revascularization with reversible ischemia. The purpose of this report is to evaluate the potential burden on the National Health Service (NHS) and measure the health effects in terms of both quantity (life years) and quality-of-life aspects related to the reducer. Methods: Two different economic evaluation models were developed as part of the analysis. The budget impact was developed to estimate the potential burden on the NHS from incremental uptake of the use of the reducer in the target population. The utility cost analysis compares and evaluates the quality of life and health resource use and costs between the two alternatives, based on the research of Gallone et al. A deterministic and probabilistic sensitivity analysis was carried out to characterize the uncertainty around the parameters of the model. Results: In the budget impact analysis (BIA), the reducer is shown to be more expensive in the first 2 years of the model, due to the gradual uptake in the market and the cost of the device. Starting from the third year, assuming maintenance of effectiveness, there are savings in terms of resource absorption in direct healthcare costs arising from hospitalizations, emergency department accesses, coronarography, and visits avoided. Conclusion: The BIA and cost-effectiveness model show that the reducer device, despite an increase in resources absorbed in the first years of implementation and use, has the potential to result in increased quality of life in patients with RA. These costs are largely offset in the short term by the improved clinical outcomes achievable leading to savings from the third year onward in the BIA and a dominance ratio in the cost-utility analysis.

Italian Guidelines for the Management of Sporadic Primary Hyperparathyroidism.

AIM: This guideline (GL) is aimed at providing a clinical practice reference for the management of sporadic primary hyperparathyroidism (PHPT) in adults. PHPT management in pregnancy was not considered. METHODS: This GL has been developed following the methods described in the Manual of the Italian National Guideline System. For each question, the panel appointed by Associazione Medici Endocrinology (AME) and Società Italiana dell'Osteoporosi, del Metabolismo Minerale e delle Malattie dello Scheletro (SIOMMMS) identified potentially relevant outcomes, which were then rated for their impact on therapeutic choices. Only outcomes classified as "critical" and "important" were considered in the systematic review of evidence. Those classified as "critical" were considered for the clinical practice recommendations. RESULTS: The present GL provides recommendations about the roles of pharmacological and surgical treatment for the clinical management of sporadic PHPT. Parathyroidectomy is recommended in comparison to surveillance or pharmacologic treatment in any adult (outside of pregnancy) or elderly subject diagnosed with sporadic PHPT who is symptomatic or meets any of the following criteria: • Serum calcium levels >1 mg/dL above the upper limit of normal range. • Urinary calcium levels >4 mg/kg/day. • Osteoporosis disclosed by DXA examination and/or any fragility fracture. • Renal function impairment (eGFR <60 mL/min). • Clinic or silent nephrolithiasis. • Age ≤50 years. Monitoring and treatment of any comorbidity or complication of PHPT at bone, kidney, or cardiovascular level are suggested for patients who do not meet the criteria for surgery or are not operated on for any reason. Sixteen indications for good clinical practice are provided in addition to the recommendations. CONCLUSION: The present GL is directed to endocrinologists and surgeons - working in hospitals, territorial services or private practice - and to general practitioners and patients. The recommendations should also consider the patient's preferences and the available resources and expertise.

Analysis of heterogeneity of the different health technology assessment reports produced on the transcatheter aortic valve implantation in patients with severe aortic valve stenosis at low surgical risk.

Background: Symptomatic severe aortic stenosis is a congenital or acquired aortic valve disease that occurs when the aortic valve of the heart narrows. It represents the most common valvular disease in adults and generally has a degenerative nature. Transcatheter aortic valve implantation (TAVI), due to its non-invasive approach, has become the standard treatment in patients who are ineligible to surgery or at high surgical risk, and it is also increasingly being performed in patients at intermediate to low surgical risk. The aim is to analyze the heterogeneity and explore the limitations of current health technology assessments (HTAs) on TAVI. Methods: For the purpose of this analysis, a review of the literature based on manual research was performed. A population, intervention, comparators, and outcome (PICO) model was used to gather the HTA reports assessing TAVI in the treatment of patients affected by symptomatic severe aortic valve stenosis at low surgical risk. Furthermore, a manual search has been developed to also include assessments from the Haute Autorité de Santé. Results: At the end of the investigation, a certain degree of heterogeneity in the evidence factored and in the recommendations on the technology has emerged. Relative to the clinical domains, the main drivers for the disparity are found in the type of evidence considered and in the use or not of the grading of recommendations, assessment, development, and evaluation (GRADE) methodology to evaluate the quality of the clinical evidence included. Another element concerns the chosen device generation assessed within the evaluation. In order to perform the economic evaluation, a cost-utility analysis and a budget impact model were developed. Despite some elements of heterogeneity, the economic assessments demonstrate a favorable or dominant cost-effectiveness profile for TAVI compared with surgical aortic valve replacement (SAVR). Conclusion: Despite the presence of heterogeneity elements both in clinical and economic domains, HTA agencies reached the same recommendations on the use of TAVI. It emerged the need for a centralized vision on the "strong" domains, which means giving up freedom to local bodies to adapt to their context on the "soft" ones. This approach could have the potential to strengthen the role of HTA in Europe by ensuring faster decision-making and equity of access to health innovations and reduce the heterogeneity in the assessment methods.