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. 2023 Jun 4;15(6):e39934. doi: 10.7759/cureus.39934

Estimation of Value-Based Price for 48 High-Technology Medical Devices

Giulia Hyeraci 1, Sabrina Trippoli 2, Melania Rivano 3, Andrea Messori 2,✉
Editors: Alexander Muacevic, John R Adler
PMCID: PMC10243399  PMID: 37287820

Abstract

Value-based price is estimated quite frequently for medicines, but its application to medical devices is scarce. While some reports have been published in which this parameter has occasionally been determined for devices, no large-scale application has yet been reported. Our objective was to pursue a systematic analysis of the literature published on value-based prices of medical devices. Pertinent papers were selected upon the criterion that the value-based price was reported for the device examined. The real prices of the devices were compared with their values of value-based price and the ratios between real price versus value-based price were calculated. A total of 239 economic articles focused on high-technology medical devices were selected from a standard PubMed search. Among these, the proportion of analyses unsuitable for value-based price estimation was high (191/239; 80%), whereas adequate clinical and economic information for estimating this parameter was available in 48 cases (20%). Standard equations of cost-effectiveness were applied. The value-based price was determined according to a willingness-to-pay threshold of 60,000 € per quality-adjusted life year. Real prices of devices were compared with the corresponding estimates of value-based prices. From each analysis, we extracted also the value of incremental cost-effectiveness ratio (ICER). Our final dataset included 47 analyses because one was published twice. There were five analyses in which the ICER could be estimated for the treatment, but not for the device. In the dataset of 42 analyses with complete information, 36 out of 42 devices (86%) were found to have an ICER lower than the pre-specified threshold (favorable ICER). Three ICERs were borderline. A separate analysis was conducted on the other three devices that showed an ICER substantially greater than the threshold (unfavorable ICER). Regarding value-based prices, the values of real price were appreciably lower than the corresponding value-based price in 36 cases (86%). For three devices, the real price was substantially higher than the value-based price. In the remaining three cases, real prices and value-based prices were very similar. To our knowledge, this is the first experience in which a systematic analysis of the literature has been focused on the application of value-based pricing in the field of high-technology devices. Our results are encouraging and suggest a wider application of cost-effectiveness in this field.

Keywords: medicine pricing, value-based pricing, pricing, cost-effectiveness analysis, cost-effectiveness, health care outcomes, value in health care

Introduction and background

Value-based pricing represents an approach for managing healthcare products in which the price of the product is assessed according to cost-effectiveness; this implies that the cost-effectiveness ratio of the product is determined and compared with the current standard of willingness-to-pay (WTP) threshold. This concept has been debated in the scientific literature for more than 20 years, and its application has generally been focused on medicines, particularly in the area of innovative agents [1-7]. A number of national regulatory agencies (e.g., in the United Kingdom, France, Germany, and Canada) have formally adopted algorithms that estimate the value-based price for newly introduced medicines [2,7,8]. To our knowledge, no reports can be found in the literature published thus far that describe any systematic analysis of value-based pricing in the field of medical devices [8-12]. A PubMed search conducted from inception to the present date shows a series of sporadic reports of value-based pricing applied to individual devices, particularly high-technology ones; among these, numerous reports reflect a research project sponsored by the manufacturer [8-12].

In a previous article [12], we analyzed a small group of high-technology devices that were consecutively approved in the Tuscany region from January 2020 to December 2021 [13]. In the present work, we describe a more extensive analysis based on literature data and focused on the experiences of value-based pricing published thus far in the field of medical devices. In these studies, the value-based prices were computed according to standard cost-effectiveness methods and were also compared with the current prices obtained from the Italian market (“real prices”).

Review

Literature search

A standard PubMed search was conducted to identify medical devices, that had been the subject of an economic analysis (keywords: medical devices, economic analysis, cost-effectiveness analysis, cost-utility analysis, quality-adjusted life year*, QALY*). In general, to apply the method of value-based pricing, a cost-effectiveness model is needed in which both clinical effectiveness and healthcare cost incurred by the device are interpreted according to standard principles of health technology assessment; this approach requires that the clinical effectiveness is expressed in quality-adjusted life years (QALYs). We accepted such models from studies published in the PubMed database provided that the model was judged to be appropriate by the four authors of this report and a specific reference to a peer-reviewed article was available. Given that PubMed was the source of all eligible articles, a minimum standard, a scientific quality was ensured by the peer-review process to which all PubMed articles are subjected; to go beyond this basic criterion, the four authors were requested to confirm the adequacy of the economic model employed in the article by examination of full texts.

Estimation of value-based price

In comparing two hypothetical treatments denoted as A (novel treatment) and B (comparator or standard of care), the standard formula to determine the incremental cost-effectiveness ratio (ICER) is as follows:

ICER = (costA - costB) / (QALYsA- QALYsB) [Equation 1]

where QALYs are quality-adjusted life years per patient and costs are normalized to a patient as well.

In the estimation of value-based price for A, costA can firstly be split into the price of the device (priceA) plus the other costs incurred in the clinical use of A (denoted as othercostsA). Hence,

costA = priceA+ othercostsA [Equation 2]

It should be noted that also costB includes the same two components (i.e., priceB+ othercostsB); however, splitting costB is not needed if, as in the present case, the calculation is aimed at estimating the value-based price for A. Furthermore, the original analyses are likely to frequently exclude both othercostsA and othercostsB when their two values are identical.

Since ICER is ICER = (priceA+ othercostsA - costB) / gainQALYs and incrementalcostAvsB is incrementalcostAvsB = priceA+ othercostsA - costB, the equation of ICER can be rewritten as follows:

ICER = incrementalcostAvsB / gainQALYs [Equation 3]

where the difference QALYsA- QALYsB has been denoted as gainQALYs.

Finally, the relationship between ICER and incrementalcostAvsB is:

incrementalcostAvsB = ICER x gainQALYs [Equation 4]

and consequently

priceA+ othercostsA - costB = ICER x gainQALYs [Equation 5]

and finally

priceA = ICER x gainQALYs + costB - othercostsA [Equation 6]

If one replaces ICER with the societal value of the willingness to pay threshold (WTPthreshold), the value-based price for A (denoted as valuebasedpriceA) can be estimated as follows:

valuebasedpriceA = WTPthreshold x gainQALYs + costB - othercostsA [Equation 7]

Data sources and selection of devices to be included in our analysis

A simple flowchart (not reported herein) was employed to describe the process by which we verified the presence of a suitable cost-effectiveness model. Regarding the currency used in our analysis, our results were expressed in €; different currencies were converted into € according to the Oanda website (http://www.oanda.com/currency-converter/). In our analysis, Equation 7 was used to estimate value-based prices, while the values of gainQALYs, costA, othercostsA, and costB were drawn from the referenced papers; the value of the WTPthreshold was set at 60,000 €/QALY gained.

Analysis of selected articles

Figure 1 illustrates the flowchart of the selection process that, among the 239 eligible citations, allowed us to select those supported by adequate cost-effectiveness data. Each citation was associated to the device assessed in the analysis; thereafter, our reports presented all results in terms of devices rather than citations. The proportion of analyses unsuitable for value-based price estimation was high (191/239; 80%), whereas adequate clinical and economic information was available in 48 cases (20%). Our final analysis involved 47 devices because one duplicate study was found in our literature search. Of these, 20 referred to the cardiological area, while the remaining 27 referred to other clinical disciplines.

Figure 1. Flow diagram describing our selection of included devices.

Figure 1

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The first PubMed query was based on the following keywords: “medical devices, economic analysis, cost-effectiveness analysis, cost-utility analysis, quality-adjusted life year*, QALY*) with filter set to last 5 years.

Table 1 (in columns 1 through 9) shows the main information about these 48 devices (including the duplicate study) along with the respective sources of cost-effectiveness data. In the dataset of 42 analyses with complete information, four devices (9.5%) were found to have an ICER substantially higher than the threshold; three (7.1%) had a borderline ICER (i.e., ±15% compared with the threshold of 60,000 €/QALY), while the remaining 35 (83.3%) had an ICER clearly lower than the threshold. These values represent the ICER based on the device (not based on the treatment).

Table 1. Detailed information (real price, value-based price, and their ratio) about the devices examined in the 48 economic analyses.

CARDIO, device employed in cardiology; CEA, cost-effectiveness analysis; QALY, quality-adjusted life year; ICER, incremental cost-effectiveness ratio; VBP, value-based price. Exchange rates versus €: GBP, 0.833; Canadian $, 0.7463; Norwegian crown, 0.0956.

Area Device Indication First author Currency used in CEA Gain in QALYs Treatment cost in local currency for experimental group Device cost in local currency Treatment cost in local currency for controls Value-based price in € for device Value-based price in € for treatment ICER in €/QALY Value-based price in local currency for the device Value-based price in local currency for the treatment
CARDIO Amplatzer Patent foramen ovale closure Allou [14] € 0.16 13877 3735 6576 6034 16176 45631 NA NA
CARDIO Barostim neo Heart failure NYHA class III with LVEF <35% Borisenko [15] € 1.19 50856 21000 17671 59215 89071 27887 NA NA
CARDIO HEARTMATE 3 End-stage heart failure Lim [16] GBP 2.3976 141598 80000 28047 91884 143195 39451     110305 171903
CARDIO LVAD (left ventricular assist device) End-stage heart failure Chew [17] Canadian$ 1.08 286942 NA 31984 NA 72230 NA NA 96784
CARDIO Mitraclip Mitral valve regurgitation Shore [18] GBP 1.07 42971 16500 10704   40344 62395 25120 48433 74904
CARDIO Perceval, suture-less valve Severe aortic stenosis Desser [19] Norwegian crown 0.11 453869 32500 650529 22539 62822 -170915 235760 657129
CARDIO Propaten Peripheral Artery Disease Villemoes [20] € 0.06 34446 NA 33856 NA 37456 9833 NA NA
CARDIO Reducer Relief of angina symptoms in refractory angina Gallone [21] € 0.138 15702 7000 6988 6566 15268 63145 NA NA
CARDIO Sapien Aortic stenosis in patients with intermediate surgical risk Goodall [22] € 0.41 34157 NA 54161 NA 75761 NA NA NA
CARDIO SAPIEN 3 Aortic valve stenosis in patients with low-surgical risk Mennini [23] € 1.11 42587 31794 39269 95076 105869 2989 NA NA
CARDIO SAPIEN 3 Inoperable patients with symptomatic severe aortic stenosis Pinar [24] € 1.31 46898 24078 33931 89711 112531 9898 NA NA
CARDIO SAPIEN 3 Symptomatic severe aortic stenosis in patients with high surgical risk Pinar [24] € 0.44 50950 24078 47413 46941 73813 8039 NA NA
CARDIO SAPIEN 3 Symptomatic severe aortic stenosis in patients with intermediate surgical risk Pinar [24] € 0.39 49346 24078 47191 45323 70591 5525   NA NA
CARDIO SAPIEN 3 Relief of severe aortic stenosis (high surgical risk) Gilard [25] € 0.89 38992 15419 51734 81561 105134 14317 NA NA
CARDIO SAPIEN 3 Relief of severe aortic stenosis (intermediate surgical risk) Tarride [26] Canadian$  0.48 70556 25000 57083 30096 64094 20948 40237 85883
CARDIO SAPIEN 3 Relief of severe aortic stenosis (high surgical risk) Tarride [26] Canadian$ 0.43 84348 25000 76986 32417 76709 12777 43438 102786
CARDIO SU-AVR (sutureless aortic valve replacement) Aortic stenosis in low surgical risk patients Povero [27] € 1.14 26679 6000 33250 80971 101650 -5764 NA NA
CARDIO TAVR (transcatheter aortic valve replacement) Aortic valve replacement in severe aortic stenosis Tam [28] Canadian$ 0.14 44299 22000 32994 14251 30892 60654 19095 41394
CARDIO TAVR (transcatheter aortic valve replacement) Aortic stenosis Tam [28] Canadian$ 0.23 46904 24000 36356 20338 37431 34226 27252 50156
CARDIO Tyrx Aortic stenosis Kay [29] GBP   0.03 31261 719 31010 1889 27331 6969 2268 32810
OTHER Gold Anchor Targeting radiotherapy by implanting 22G fiducial markers Lundqvist [30] SEK 0.015 679 confidential 688 NA 152   NA NA 1588
OTHER Y-90 microspheres Patients with hepatocellular carcinoma ineligible for transarterial chemoembolization Muszbek [31] GBP 0.601 29530 8000 30927 37866 55800 -1936 45457 66987
OTHER Yttrium-90 resin microspheres for transarterial radioembolization Locally advanced and inoperable hepatocellular carcinoma Zarca [32] € 0.006 44345 32534 27166 15715 27526 2863167 NA NA
OTHER iStent Inject trabecular bypass stent (TBS) device Mild-to-moderate open-angle glaucoma in Italy Ahmed [33] Canadian$ 0.023 21384 1674 21773 2569 17279 12622     3443   23153
OTHER IStent inject device Non-infectious intermediate uveitis, posterior uveitis and panuveitis Fea [34] € 0.095 8368.51 1300 7134 5766 12835 12995 NA NA
OTHER Argus II Reduced infections after pacemaker or defibrillator implant Health Quality Ontario [35] Canadian$ 2.5688 537734 179850 287458 62467 329556 72712 83702 441586
OTHER OZURDEX Diabetic macular oedema Pesonen [36] € 0.08 9810 1075 5563 1628 10363 53088 NA NA
OTHER ILUVIEN (Fac implant vs usual care) Retinitis pigmentosa in pseudo-phakic pts   Pochopien [37] GBP 0.19 22117 7982 19051 13591 23566 13442 16316 30451
OTHER ILUVIEN (Fac implant vs DEXA implant) Diabetic macular oedema in phakic pts Pochopien [37] GBP 0.71 24425 8078 20340 38812 52429 4793 46593 62940
OTHER ILUVIEN (Fac implant vs usual care) Diabetic macular oedema in phakic pts Pochopien [37] GBP 0.11 24425 8078 21255 9586 23203 24005 11508 27855
OTHER Ozurdex (dexamethasone implant) Non-infectious uveitis Squires [38] GPB This analysis is the same as that published by Squires et al. (coded as S.38).
OTHER DEX-700, dexa- methasone implant (implant + current practice vs current practice alone) Diabetic macular oedema Squires [38] GBP 0.029   40565 870 39992 1698 34763 16459 2037 41732
OTHER OPRA (Osteointegrated Prostheses for the Rehabilitation of Amputees) Trans-femoral amputation Hansson [39] € 0.28 78417 48139 6880 -6598 23680 255489 NA NA
OTHER InSpace Irreparable rotator cuff tears Castagna [40] € 0.05 17327 15000 16805 17478 19805 10440 NA NA
OTHER InSpace Irreparable rotator cuff tears Castagna [40] € 0.06 17327 15000 24312 25585 27912 -116417 NA NA
OTHER InSpace Irreparable rotator cuff tears Castagna [40] € 0.1 17327 15000 31031 34704 37031 -137040 NA NA
OTHER Pathello-femoral arthroplasty (Avon implant by Stryker Orthopaedics, Mahwah, New Jersey, USA) Pathello-femoral arthroplasty in knee osteoarthritis Fredborg [41] € 0.056 6539.5 1603 6867.6 5921 10228 -5859 NA NA
OTHER Triangular titanium implant for sacroiliac joint fusion Patients subjected to minimally invasive sacroiliac joint fusion surgery Blisset [42]     GBP 0.75 8358 3465 6880 39140 43216 1642 46987 51880
OTHER aMACE Revision implant of acetabular arthroplasty Tack [43]   € 0.05 26559 8419 27824 12684 30824 -25300 NA NA
OTHER Biodesign Surgisis (Cook) Trans-sphincteric fistula-in-ano Jayne [44] GBP 0.026 2750 780 2297 1572 3213 14513 1887 3857
OTHER FENIX TORAX Treatment of adult fecal incontinence Jayne [45] GBP 0.01 11360 4000 10913   3459 9590 37235 4153 11513
OTHER AUS (artificial urinary sphincter) Severe post-prostatectomy stress urinary incontinence (PPSUI) Shamout [46] Canadian$ 1.15 14228 8500 18938 61353 65628 -3057 82210 87938
OTHER AUS (artificial urinary sphincter) Severe post-prostatectomy stress urinary incontinence (PPSUI) Shamout [46] Canadian$ 1.15 14228 8500 18938 61353 65628 -3057 82210 87938
OTHER OPTOGENERAPY (Optoferon) Relapsing-remitting multiple sclerosis Visser [47] € 0.45 153621 30395 691 -95535 27691 339844 NA NA
OTHER Inspire Obstructive sleep apnea Pietzsch [48] € 1.02 99,357 NA 54825 NA 116025 NA NA NA
OTHER Propel (bioabsorbable corticosteroid-eluting sinus implant) Chronic rhinosinusitis Javanbakht [49] GBP 0.001 4646 580 4655 541 3928 -7497 649 4715
OTHER Nexplanon (etonogestrel 68 mg implant) Prevention of pregnancy CADTH [50] Canadian$ 0.00851 768 369.30 691 599 897 6753 803 1202
OTHER WavelinQ (incident patients) Endovascular arteriovenous fistula in hemodialysis patients  Rognoni [51] € 0.018 5722 2544 33041 30943 34121 -1517722 NA NA
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Figure 2 summarizes these 42 values of ICER. There were 11 cases in which the ICER was negative because the therapeutic option based on the novel device was dominant.

Figure 2. Values of ICER for the 42 analyses ordered from the lowest to the highest.

Figure 2

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ICER, Incremental cost-effectiveness ratio

Using these cost-effectiveness data, we estimated the values of value-based prices already shown in Table 1 (columns 10, 11, 12, and 14), Figure 3, and Table 2. The calculation of value-based prices was applied separately to the treatment (i.e., all healthcare procedural costs including the device) and to the device. In this framework, the value-based price with respect to the treatment (last column in Table 1) could be estimated in all 47 treatments. On the other hand, the value-based price with respect to the device could not be estimated in five cases because the information needed for this purpose was unavailable; hence, the calculation of value-based price with respect to the device could be performed in 42 cases.

Table 2. Detailed information for each device about real price, value-based price, and their ratio.

DEVICE Real price in € Value-based price in € Ratio real vs. value-based
OPTOGENERAPY (Optoferon) 30395 negative value NR
Triangular titanium implant for sacroiliac joint fusion 2886 39140 0.074
SU-AVR (sutureless aortic valve replacement) 6000 80971 0.074
WavelinQ (incident patients) 2544 30943 0.082
AUS (artificial urinary sphincter) 6344 61353 0.103
AUS (artificial urinary sphincter) 6344 61353 0.103
ILUVIEN (Fac implant vs DEXA implant) 6729 38812 0.173
Y-90 microspheres 6664 37866 0.176
SAPIEN 3 15419 81561 0.189
IStent inject device 1300 5766 0.225
SAPIEN 3 24078 89711 0.268
Pathello-femoral arthroplasty (Avon implant by Stryker Orthopaedics, Mahwah, New Jersey, USA). 1603 5921 0.271
Tyrx 599 1889 0.317
SAPIEN 3 31794 95076 0.334
Mitraclip 13745 40344 0.341
Barostim neo 21000 59215 0.355
Biodesign Surgisis (Cook) 650 1572 0.413
DEX-700, dexa- methasone implant (implant + current practice vs current practice alone), 725 1698 0.427
InSpace 15000 34704 0.432
Nexplanon (etonogestrel 68 mg implant) 276 599 0.460
iStent Inject trabecular bypass stent (TBS) device 1249 2569 0.486
ILUVIEN (Fac implant vs usual care) 6649 13591 0.489
SAPIEN 3 24078 46941 0.513
SAPIEN 3 24078 45323 0.531
SAPIEN 3 18658 32417 0.576
InSpace 15000 25585 0.586
Amplatzer 3735 6034 0.619
SAPIEN 3 18658 30096 0.620
OZURDEX 1075 1628 0.660
aMACE 8419 12684 0.664
ILUVIEN (Fac implant vs usual care) 6729 9586 0.702
HEARTMATE 3 66640 91884 0.725
InSpace 15000 17478 0.858
TAVR (transcatheter aortic valve replacement) 17911 20338 0.881
Propel (bioabsorbable corticosteroid-eluting sinus implant) 483 541 0.893
FENIX TORAX 3332 3459 0.963
Reducer 7000 6566 1.066
TAVR (transcatheter aortic valve replacement) 16419 14251 1.152
OPRA (Osteointegrated Prostheses for the Rehabilitation of Amputees) 48139 41347 1.150
Perceval 32500 22539 1.442
Yttrium-90 resin microspheres for transarterial radioembolization 32534 15715 2.070
Argus II 134222 62467 2.149
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In our comparisons between real prices and value-based prices for the above-mentioned 42 devices (Figure 3), real prices were appreciably lower than value-based prices in 36 cases (86%) and were similar (±15%) in three cases. Three devices showed a real price substantially greater than the value-based price (Perceval for severe aortic stenosis, Yttrium-90 microspheres for hepatocellular carcinoma, and the Argus II retinal prosthesis system). These three devices deserve to be examined in more detail.

Figure 3. Comparison between real price and value-based price for the 42 devices included in the main analysis.

Figure 3

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Detailed information on this analysis is presented in Table 2.

Perceval is a suture-less valve indicated in severe aortic stenosis. The profile of its price (real price, 3107 €; value-based price, 2155 €; ratio, 1.44) is mainly guided by the low incidence of the device cost (irrespective of its nature of real price or value-based price) over the overall cost for treating these patients.

Yttrium-90 microspheres are used for trans-arterial radioembolization in locally advanced and inoperable hepatocellular carcinoma as an alternative to sorafenib; the microsphere treatment was not found to be a cost-effective option at the usually accepted WTP thresholds. The ICER was 2,863,167 € per QALY gained; this unfavorable result was mainly guided by the gain QALYs, which was minimal. Regarding prices, the real price is about twice the value-based price (ratio, 2.07).

Argus II is a retinal prosthesis system for advanced retinitis pigmentosa. This device helps people see better and is generally safe to use. The device is costly (around 180,000 Canadian$), but because retinitis pigmentosa is rare, the budget impact of publicly funding this device in Canada is less than 1 million $ per year (assuming four implants per year per patient). Regarding prices, also for this device the real price is about twice the value-based price (ratio, 2.15). Table 2 shows detailed information about real price, value-based price, and their ratio for each device analyzed in Figure 3.

Discussion

The main finding deriving from our study is that the great majority of economic analyses focused on medical devices show a favorable cost-effectiveness profile, while an unfavorable profile was found in a small minority of cases (3 out of 42, 7.1%). This is a quite unexpected result for which no straightforward explanation can be proposed, but some plausible hypotheses can however be considered. Firstly, it is well known that a remarkable publication bias affects pharmacoeconomic and cost-effectiveness research [6]. Since economic analyses reporting favorable results are more likely to be published than those reporting unfavorable results, our study might simply reflect this well-known tendency. Another hypothesis is that, in the pharmaceutical market, more economic research is being carried out than in the field of devices, and so more efforts are made to claim high prices for medicines than for devices.

Regarding the areas where value-based price deserves to be applied, they include especially the case of innovative devices [52], where innovation can be managed according to recent definitions [9]; also tenders are suitable for the application of value-based pricing [53]. In both cases, value-based prices can be useful either to guide the first purchase of a new device or to determine the starting price of a tender lot.

Our study likely reflects the pros and the cons that are typical to any research conducted in an unexplored area. In the first place, our results suggest the need for a wider application of this type of analysis. On the other hand, since this is a preliminary report, other studies hopefully will follow, likely designed in a different way and more based on real data than on literature data.

In our previous article [12], we emphasized a few points, that are fully confirmed by the present investigation and that we repropose with nearly the same words:

Point 1: When the literature search of cost-effectiveness data is successful, obtaining the value-based price proves to be an easy task.

Point 2: The method proposed herein for value-based price estimation is an approximate one. On this premise, when the reference cost-effectiveness study has been conducted in a foreign country with a health-care system similar to ours, the various items of health-care cost generally remain valid (apart from the mandatory conversion from one currency into another). Much caution is instead needed when the health-care system is substantially different; in such a case, clinical data likely remain valid, but the information on costs needs to be entirely reassessed.

Point 3: The availability of adequate literature data is a critical issue influencing the successful application of value-based pricing. When adequate data are not available, how to fill this gap in information remains an open question.

Conclusions

To summarize the current state of the art concerning the methods for the governance of medical devices, the application of the principles of cost effectiveness is increasingly considered a mandatory objective. There are two main fields of application. Firstly, when tenders are concerned, cost effectiveness can be used both to set the starting price of the various lots and to adjudicate the winner of each lot through a balanced evaluation of costs and benefits; in this balance, the winner is not the product that offers the lowest price, but the product that offers the best ratio between all sources of cost (including the price offered), and all benefits; it should be stressed that, in the evaluation of benefits, all clinical parameters (e.g., the outcomes) must be expressed in monetary units, and reference must explicitly be made to the societal WTP threshold recognized locally. Secondly, also in the assessment of each innovative product, cost-effectiveness is applied but in a different fashion: on the premise that a WTP is recognized, the value-based price of the innovative product needs to be estimated, and a comparison must be made between the price offered and the value-based price calculated separately. In addition, the same analysis can be made though in the opposite direction; the cost effectiveness ratio of the product is calculated, and this ratio is compared with the WTP threshold recognized by the society. This comparison permits to conclude that the economic profile of the new product is favorable, when the ratio remains below the threshold, and instead is unfavorable when the ratio exceeds the threshold. in more general terms, the need to interpret more accurately the available literature is another important point; this implies to use specific investigation methods (e.g., the gap analysis) to understand why the area of devices is so less advanced than that of medicines, and to better differentiate the clinical evidence that emerges from the real world from that generated within formal clinical trials.

All in all, in this framework, the application of cost-effectiveness is important especially for advanced medical devices and therefore needs to be promoted more and more. Regarding the value-based price, when the available data allow for their estimation, the practical relevance of these estimates is extremely high, mainly because its absence would imply to purchase these products with no objective pricing criterion. On the other hand, one should be aware of the unsolved drawbacks of these procurement methods, e.g. when cost data must be transferred from one country to another.

Acknowledgments

ST and AM work in the National Health Care System and act as component of a regional Health Technology Assessment group called "Centro Operativo Regione Toscana" that evaluates the medical devices purchased for the hospitals of the Tuscany Region.

The authors have declared that no competing interests exist.

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