Alirocumab in the management of primary hypercholesterolaemia or mixed dyslipidaemia: A budget impact analysis – Italian perspective

Recent evidence suggests that adding protein convertase subtilisin/kexin type 9 inhibitors to current lipid-lowering therapies may result in unprecedented reductions in low-density lipoprotein cholesterol. The objective of this study was to assess the potential pharmaceutical financial impact of including the protein convertase subtilisin/kexin type 9 inhibitor, alirocumab, in the Italian National Health Service budget. The budget impact of adding alirocumab as a lipid-lowering therapy treatment option was assessed among the population defined by the AIFA reimbursement criteria. Data from the IMS/CEGEDIM national electronic database were used to estimate the size of the potentially eligible population. Drug costs were estimated according to dosing schedule and published prices. Alirocumab annual uptake was assumed at 7%, 9% and 10% for years 1, 2 and 3, respectively, considering a 20% treatment drop-out rate. Sensitivity analyses tested the impact of model inputs on the results. The annual estimated incremental cost of alirocumab treatment was €5106/patient. Treating an eligible population of 843 patients with alirocumab in the first year resulted in a total National Health Service budget impact of €4.30 million. Assuming growth of the alirocumab-treated population of 2105 and 2819 patients in the second and third years, the budgetary impact would be €10.75 and €14.10 million, respectively. Sensitivity analysis suggested that financial impact is most sensitive to the uptake of alirocumab in the population. The uptake of alirocumab results in an overall modest budgetary impact to the Italian National Health Service when added to conventional lipid-lowering therapies in a carefully selected population compared to the total lipid-lowering therapy pharmaceutical expenditure in Italy (€1 billion)

Cost-effectiveness of bedaquiline in MDR and XDR tuberculosis in Italy

Objective: To evaluate the cost-effectiveness of bedaquiline plus background drug regimens (BR) for multidrug-resistant tuberculosis (MDR-TB) and extensively drug-resistant tuberculosis (XDR-TB) in Italy. Methods: A Markov model was adapted to the Italian setting to estimate the incremental cost-effectiveness ratio (ICER) of bedaquiline plus BR (BBR) versus BR in the treatment of MDR-TB and XDR-TB over 10 years, from both the National Health Service (NHS) and societal perspective. Cost-effectiveness was evaluated in terms of life-years gained (LYG). Clinical data were sourced from trials; resource consumption for compared treatments was modelled according to advice from an expert clinicians panel. NHS tariffs for inpatient and outpatient resource consumption were retrieved from published Italian sources. Drug costs were provided by reference centres for disease treatment in Italy. A 3% annual discount was applied to both cost and effectiveness. Deterministic and probabilistic sensitivity analyses were conducted. Results: Over 10 years, BBR vs. BR alone is cost-effective, with ICERs of €16,639/LYG and €4081/LYG for the NHS and society, respectively. The sensitivity analyses confirmed the robustness of the results from both considered perspectives. Conclusion: In Italy, BBR vs. BR alone has proven to be cost-effective in the treatment of MDR-TB and XDR-TB under a range of scenarios

Drugs price and reimbursement regulation: comparators, endpoints and role of the cost-effectiveness

This document illustrates the results of a discussion of two multi-disciplinary expert panels on pricing and reimbursement of medicines. Experts work in different organizations. The discussion focused on comparator(s), endpoint(s), negotiation of prices of new medicines and/or indications to include in the List 648, as well as the role of cost-effectiveness in the price and reimbursement negotiation. The debate took place during the fourth edition of the Seminari di Mogliano, organized on the 30th of September/1st of October, 2021. The two panels agreed on a general need to enhance interaction among the different stakeholders, in the early assessment and negotiation phases, and to increase the transparency/reproducibility of the decisions taken. The experts have also emphasized the need (i) to improve clarity in the evaluation of additional therapeutic value and the place in therapy with respect to comparators and how comparators are identified; (ii) to create work groups to identify the most appropriate endpoint(s), for each therapeutic area and level of unmet needs; (iii) to provide for a systematic use of cost-effectiveness when an added therapeutic value is delivered by a new medicine. With regard to the 648 List, the experts advocated for an overall reorganization of the current rules governing the special uses of drugs

Early treatment in HCV : is it a cost-utility option from the Italian perspective?

Our model represents a tool for policy makers and health-care professionals, and provided information on the cost-utility of the early-treatment approach in HCV-infected patients in Italy. Starting innovative treatment regimens earlier keeps HCV-infected patients in better health and reduces the incidence of HCV-related events; generating a gain both in terms of health of the patients and correct resource allocation