Tenders for the Procurement of Medical Devices: Adapting Cost-Effectiveness Rules to the Requirements of the European Public Procurement Directive.

BACKGROUND: In evaluating 3 or more comparators, pharmacoeconomic analyses can be improved by using the methodology of net monetary benefit (NMB) as opposed to incremental cost-effectiveness ratio (ICER). NMB is particularly suitable for managing competitive tenders that evaluate 3 or more devices in the same lot. For scientific purposes, the methodology of NMB is perfectly adequate. However, when tenders are managed in European countries, the Public Procurement Directive states that the tender score for price should be kept separate from that of clinical benefits. As a result, the traditional mathematical approach of NMB must be rearranged to comply with this administrative requirement. METHODS: In this report, we describe how the classic equations of NMB should be modified to achieve this purpose. The mathematical principle of proportionality, which is typical of the ICER, must be replaced by the principle of mathematical additivity, which is typical of NMB. Furthermore, to rearrange the scale of benefits according to the NMB, an estimate is needed of the minimum acceptable benefit converted into monetary units, which is associated with 0 in the benefit scale. RESULTS: A detailed example is presented to explain the practical application of these mathematical equations. These equations are widely applicable in the field of implantable devices. CONCLUSION: Since the expenditure for medical devices in European hospitals is close to that of hospital medicines, tenders for the in-hospital procurement of devices may represent a decisive tool to manage sustainability and ensure access to innovation. In this context, the methodology for managing clinical outcomes through tenders requires a specific mathematical approach that we have described in the present article.

Biological meshes for abdominal hernia: Lack of evidence-based recommendations for clinical use.

BACKGROUND: In the clinical literature on abdominal hernia repair, no sound criteria have been established to support the use of biological meshes as opposed to synthetic ones. Furthermore, the information on biological meshes is quite scarce, and so their place in therapy has not yet been defined. METHODS: The treatment of primary and incisional ventral hernia was the target intervention evaluated in our analysis. Our study consisted of the following phases: a) Identification of the biologic meshes available on the market; b) Literature search focused on efficacy and safety of these meshes; c) Analysis of the findings derived from the literature search. The information collected this way was reviewed narratively, and presented according to standard meta-analysis. The main end-points of our analysis included infection of surgical wound at 1 month and recurrence at 12 months. RESULTS: Our clinical literature comprised 11 trials that evaluated 5 biological meshes: Permacol (706 patients), Strattice (324 patients), Surgisis (44 patients), Tutomesh (38 patients) and Xenmatrix (22 patients). These studies generally showed a poor methodological quality. Surgical wound infection showed a wide between-study variability (95%CI: from 12.0% to 22.9%). Also the 12-month relapse rate demonstrated a wide 95%CI (from 5.0% to 19.9%). A significantly lower rate of recurrence at 12 months was found for Permacol compared with Strattice (rate difference: -14.2%; 95%CI: -22.1% to -6.2%). DISCUSSION: Our analysis provided an overview of 5 biological meshes currently available on the market. The different types of meshes showed a marked statistical variability in the clinical outcomes. Hence, nearly all comparisons between different meshes in the two clinical end-points did not reach statistical significance. One exception was represented by the finding that cross-linked meshes had a significantly lower recurrence rate at 12 months than non-cross-linked meshes.

Value-based procurement of medical devices: Application to devices for mechanical thrombectomy in ischemic stroke.

OBJECTIVES: In the acute ischemic stroke, endovascular devices have shown promising clinical results and are also likely to represent value for money, as several modeling studies have shown. Pharmacoeconomic evaluations in this field, however, have little impact on the procurement of these devices. The present study explored how complex pharmacoeconomic models that evaluate effectiveness and cost can be incorporated into the in-hospital procurement of thrombectomy devices. PATIENTS AND METHODS: As regards clinical modeling, we extracted outcomes at three months from randomized trials conducted for four thrombectomy devices, and we projected long-term results using standard Markov modeling. In estimating QALYs, the same model was run for the four devices. As regards economic modeling, we firstly estimated for each device the net monetary benefit (NMB) per patient (threshold = $60,000 per QALY); then, we simulated a competitive tender across the four products by determining the tender-based score (on a 0-to-100 scale). Prices of individual devices were obtained from manufacturers. Extensive sensitivity testing was applied to our analyses. RESULTS: For the four devices (Solitaire, Trevo, Penumbra, Solumbra), QALYs were 1.86, 1.52, 1,79, 1.35, NMB was $101,824, $83,546, $101,923, $69,440, and tender-based scores were 99.70, 43.43, 100, 0, respectively. Sensitivity analysis confirmed findings from base-case. CONCLUSION: Our results indicate that, in the field of thrombectomy devices, incorporating the typical tools of cost-effectiveness into the processes of tenders and procurement is feasible. Bridging the methodology of cost-effectiveness with the every-day practice of in-hospital procurement can contribute to maximizing the health returns that are generated by in-hospital expenditures for medical devices.