Quality of health economic evaluations submitted to the Italian Medicines Agency: current state and future actions

Abstract

Objectives The purpose of this study was to evaluate the current state of health economic evaluations (HEEs) submitted by pharmaceutical companies to the Italian Medicines Agency (AIFA) as part of their pricing and reimbursement (P&R) dossiers, and to explore potential future actions in order to enhance their quality. Methods All company dossiers submitted from October 2016 to December 2018 were reviewed to select those containing pharmacoeconomic studies. The general characteristics of HEEs were described and their quality assessed based on a checklist adapted from Philips et al. (Review of guidelines for good practice in decision-analytic modelling in health technology assessment. Health Technol Assess. 2004;8: 1–158). Results Of the 299 dossiers submitted to AIFA, 105 included one or more pharmacoeconomic studies, of which fifty-three were cost-effectiveness analyses. Overall, the compliance of the HEEs with the quality checklist was highly variable: some studies reached high methodological standards whereas others had serious flaws (mean 59.22 percent, range 19.35–90.32 percent). The main weaknesses were the unjustified exclusion of relevant alternatives, poor description and justification of model data and assumptions, and insufficient exploration of uncertainty and study validity. Non-homogeneity across studies was found in study perspectives, discount rates, methods for costing, estimating quality-adjusted life-years and conducting sensitivity analyses. Conclusions Based on the results of this study, the recommended actions for increasing the quality of HEEs within reimbursement submissions in Italy are twofold: first, to set methodological standards for conducting and reporting HEEs; second, to strengthen the internal assessment process, also through the acquisition of companies' models and re-evaluation of results. These actions will hopefully provide greater contribution to the evidence-based P&R decision making.

Drug Prices and Value of Oncology Drugs in Italy

“…First, other factors that may play a role in the reimbursement process were not considered. On this topic, AIFA published a guideline that identified important parameters in the reimbursement process: (i) the unmet medical need; (ii) the other health benefits over existing alternative therapies (not only in terms of clinical efficacy); (iii) the relative price compared with alternative drugs already available in the market; and (iv) the cost savings in terms of other healthcare resources [39,40]. Future analysis should also explore the impact of these parameters as independent variables in our model.…”

Role of Economic Evaluations on Pricing of Medicines Reimbursed by the Italian National Health Service

“…According to the database structure used in previously published studies [11,16,17,25], a number of independent variables, potentially associated with ΔP, were selected among those variables available from the P&R dossiers/ procedures (Table 1), most of them are regulatory variables (e.g. orphan designation, innovativeness status), while others are related to the expected financial or economic impact on the INHS (e.g.…”

“…Both committees are supported by the AIFA offices involved in P&R procedures. In particular, the AIFA HEE Office suggests the price targets for CPR negotiation, informed on the basis of cost-effectiveness and budget impact analysis considerations submitted by the applicants within the reimbursement dossiers and internally revised according to methods and criteria described elsewhere [ 25 ]. If the negotiations fail, medicines will not be reimbursed by the Italian NHS (INHS).…”

How reliable are ICER’s results published in current pharmacoeconomic literature? The controversial issue of price confidentiality

“…The Health Economic Evaluations Office of the Italian Medicines Agency (AIFA) receives from the pharmaceutical companies the simulation models used for performing CEAs or CUAs of their own products. These models are part of the price and reimbursement dossier submitted for a full technology assessment ( 13 , 14 ). Furthermore, the AIFA’s office also knows both the official transparent price that is published in the Italian official journal, and the net negotiated price in charge to the National Health Service (NHS).…”