Si precisa che gli articoli non sono riproducibili senza l’approvazione dell’editore: per qualsiasi riutilizzo con scopi commerciali o promozionali, è necessario richiedere opportuna quotazione scrivendo a Gli articoli pubblicati sul GIHTAD sono fruibili in base all’attribuzione CCBY NC ND. Visualizza il testo completo della licenza

7 Ottobre 2019

GIHTAD (2019) 12:Suppl. 3

Assessment of the innovation: a challenge for HTA

Iñaki Gutiérrez-Ibarluzea

Director of Managerial and Organisational Innovation
President HTAi
Basque Foundation for Health Innovation and Research
Basque Country – Spain

Corresponding author:
Dr. Iñaki Gutiérrez-Ibarluzea
Basque Foundation for Health Innovation and Research
Torre Bec, Azkue Kalea, 1, 48902 Barakaldo (Bizkaia)
Basque Country – Spain



Innovation is a must in health care systems in order to ensure their continuous improvement to offer enhanced solutions at each level of care. However, there are many factors that are related to innovation, first of all its definition and the evidence that support innovative solutions by themselves. Health Technology Assessment (HTA) considered as a policy analysis that provides information for decision makers is in the “pole position” to aid health systems to: on the one hand, discerning what can be considered innovative and on the other hand, characterizing the degree of maturity and the evidence that support that innovation. HTA should be constructive, supportive and proactive with innovation and innovators and provide creative solutions that while allowing innovation progression, conversely frame the required guarantees to ensure that evidence based safe, effective and efficient solutions and tailored to the context are implemented. Progresses have been made in order to structure the whole process especially on the side of methodologies and frameworks that support evidence generation and risk sharing among innovators and systems. HTA, being a key actor in the whole process of evidence and context analysis and offering recommendations to decision makers, should not be oblivious to these practices and should contribute to their refinement and implementation.

Health care systems are struggling with offers and demands from many sides, among others: professionals, policy makers, pressure groups, patients and their associations, citizens and consumers, industry, capital investors and other non-health related sectors. Thus, the need to do things with quality, efficacy, efficiency, equity, accountability and according to the context in which solutions (health technologies) will be implemented is not under discussion. In this sense, Health Technology Assessment (HTA), whichever definition we use, is in the best place to provide information to decision makers at any level (micro, meso or macro), in order to take informed decisions that enable the best use of resources. This is a consideration that having HTA the role of being a policy exercise [1], other disciplines or methods of analysis are lacking and makes HTA more attractive, if possible. Nevertheless, HTA has been accused of not being able to address in a timely manner the needs of information of innovative or breakthrough health technologies and hindering or obstructing the processes of technological innovation, being ultimately called the 4th hurdle [2].

Having all this in mind, it is arguable that there is a need for a thoughtful analysis of which the factors influencing the introduction of “so called” innovation and its final impact in the health care systems are.


Factors around innovation not related to HTA

First of all, the obvious discussion about what innovation is and what is not and how that applies to health care should be brought to the audience. In this regard, several definitions are available in the literature and some of them differ from each other, it is worth referring to a couple of them. The first one from the Iberoamerican Development Bank states that innovation is: “the development of new services, technologies, but above all, a change of direction in the management of systems towards the promotion of health and disease prevention” [3]; the second promoted by the World Health Organization Innovation Group (WHIG) defines innovation as the process: “to develop and deliver new or improved health policies, systems, products and technologies, and services and delivery methods that improve people’s health” [4]. It can be said that these two definitions are in many senses aligned, however, from the HTA point of view, they are redundant as they include technologies, services, products and systems and all of them are included under health technology definition [5]: “the application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures and systems developed to solve a health problem and improve quality of lives”. If we assume the definition of innovation as such, HTA practices have analysed innovations and anticipated their impact since its inception, and at the early stages of development, through the so-called horizon scanning or early awareness and alert systems and methods have been developed to address those practices [6].

Second, a change in paradigm in technological innovation from blockbuster models in which technological solutions could cover a range of pathologies and patients to a more focused personalised or customized model also named niche-busters [7]. That applied to HTA multiplies the number of pathologies and the group of patients to be addressed and makes the analysis more complex. Personalised or customized solutions require also tailored assessments, including patients’ characteristics, the epidemiological paradigm in each region or country and its related health care system’s features and nuances.

Third, a different regulatory framework that is applicable to the diverse health technologies that can be implemented in systems, this creates a short of miscellaneous scenarios around evidence generation. In fact, the regulatory rules for drugs are well established in most countries, while those related to medical devices and diagnostics are not sufficiently defined and in most cases are inconsistent [8]. Finally, there is no regulatory framework for services or public health interventions, apart from those applicable to science and research. Obviously, these circumstances did not favour the work of those that need to provide information to decision makers and probably did favour the unequal analysis of technologies by HTA units and agencies, in which drugs are analysed more frequently than medical devices, services and interventions.

Fourth, the non-systematic analysis of the innovation’s demand from health care systems and the lack of knowledge of the offer arising from innovators and Small and Medium Enterprises (SMEs) by systems themselves. Meanwhile, the offer from Large companies and the mechanisms to reach to the health systems are better-established. This creates an imbalance between offer and demand and among offer by itself. This affects also the portfolio of activities of HTA units and agencies that are mostly focused on solutions (technologies) and not on questions (health care problems) that require innovation.


Factors related to HTA and its frameworks 

Although there has been a huge effort to harmonise HTA practices, they are diverse around the world and that affects the final results of the assessments and what is more, their credibility. In this respect, the methodological frameworks that have been developed such as the European Network for Health Technology Assessment (EUnetHTA) core model [9] and the networks at the global (International Network of Agencies for Health Technology Assessment, INAHTA or EuroScan, the International Information Network on new or emerging, appropriate use and re-assessment needed Health Technologies) or at the regional basis: REDETSA in the Americas; EUnetHTA in Europe or HTAsialink in Asia-Pacific, have helped a lot in the mentioned harmonisation. Nevertheless, there are still practices derived from Evidence Based Medicine that did not consider the specific factors related to context or the inclusion of domains such as the social, cultural, ethical, legal or environmental that could be crucial in understanding final decisions and the local level [10].

Furthermore, HTA has made a huge effort to address complexity through methods development in European Union funded projects such as INTEGRATE-HTA [11] and give an answer to decision makers around those named breakthrough technologies such as genomic [12] or mhealth [13]. Accordingly, it can not be said that HTA has been oblivious to technological innovations, their implications for evidence needs and their impact in terms of final outcomes in health systems.


What next


In accordance to what has been mentioned before, HTA continues playing a key role in the information around innovative solutions (new and emerging technologies). The first thing that HTA should do is continue informing about which of those innovations fulfil the criteria to be considered as such. It seems to be that when we called a technology to be innovative no further analysis is required and so, decision makers could be confused by that fact and make decisions that contravene the required need of evidence. HTA should help defining: a) which is innovative and improves health, b) which hasn’t proved to change results on health but is promising and thus requires further follow-ups, (e.g. promote monitoring systems to extent the use of innovative solutions) and c) which should be considered as research because the level of maturity of the innovative solution does not meet the criteria and disregards the principle of caution and non-maleficence that any health system should follow. Keeping all this in mind, HTA current role is not to stop possible innovative solutions by stating that no or weak evidence has been found and recommending their rejection. HTA should provide mechanisms that help systems negotiating with innovators around the continuous generation of innovation and risk sharing and thus, make room for improvement that sustains new ways of innovative public procurement (e.g. manage entry agreements or coverage with evidence agreements) [14] (Table 1). At the same time, health systems should implement initiatives that systematically identify innovation demand and defines the questions that should be covered by innovative solutions. Finally, there is a need to bridge the gap between innovators, SMEs and health care systems and continue the dialogue with large companies by establishing early advice and early assessment processes in all cases and aligning demand and offer according to each health systems’ needs.

Table 1. Type of technology and action to be implemented

Technology Action
Innovative* Procurement of innovation including value based health care mechanisms
Innovative but lack or weak evidence Innovative procurement

  • Coverage with evidence development (monitoring systems)
  • Risk sharing agreements
Innovative but not matured and lack of evidence Promote research
Not innovative Recommendation on rejection

* In accordance to innovation definition, it should convincingly improve results on health (evidence).




  1. Banta HD, Luce BR (1993) Health Care Technology and Its Assessment: An International Perspective. Oxford University Press, New York, NY. 
  2. Paul JE, Trueman P (2001) ‘Fourth hurdle reviews’, NICE, and database applications. Pharmacoepidemiol Drug Saf 10:429-438. 
  3. Regalia F. La verdadera innovación en salud. 2015. Available from: [accessed on August 23, 2019].
  4. WHIG. WHO Health Innovation Group, 2019. Available from: [accessed on August 23, 2019].
  5. WHO. What is a health technology?. 2019. Available from: [accessed on August 23, 2019].
  6. EuroScan International Network, A toolkit for the identification and assessment of new and emerging health technologies, 2014, EuroScan International Network: Birmingham A toolkit for the identification and assessment of new and emerging health technologies 2014. Available from: [accessed Sep 01 2019].
  7. Dolgin E (2010) Big pharma moves from ‘blockbusters’ to ‘niche busters’. Nat Med 16:837. 
  8. Eikermann M, Gluud C, Perleth M et al; Signatories of Our Open Letter to the European Union (2013) Commentary: Europe needs a central, transparent, and evidence based regulation process for devices. Br Med J 346:f2771.
  9. EUnetHTA Joint Action 2, Work Package 8. HTA Core Model ® version 3.0 (Pdf); 2016. Available from [accessed on August 23, 2019].
  10. Polisena J, De Angelis G, Kaunelis D, Gutierrez-Ibarluzea I (2018) Environmental impact assessment of a health technology: a scoping review. Int J Technol Assess Health Care 34:317-326. 
  11. Wahlster P, Brereton L, Burns J, et al (2016) Guidance on the integrated assessment of complex health technologies – The INTEGRATE-HTA Model [Online]. Available from: [accessed Sep 01 2019].
  12. Barna A, Cruz-Sanchez TM, Brigham KB et al (2018) Evidence required by Health Technology Assessment and reimbursement bodies evaluating diagnostic or prognostic algorithms that include omics data. Int J Technol Assess Health Care 34:368-377. 
  13. National Horizon Scanning Research & Intelligence Centre. University of Birmingham. New and emerging mobile health interventions that promote behavioural change. 2015. Available from: [accessed Sep 01 2019].
  14. Klemp M, Frønsdal KB, Facey K; HTAi Policy Forum (2011) What principles should govern the use of managed entry agreements? Int J Technol Assess Health Care 27:77-83.
XII Congresso Nazionale della Società Italiana di Health Technology Assessment

Milano, 10-11 ottobre 2019

Sessione plenaria “L’innovazione per una sanità di valore”

L’innovazione per una sanità di valore: un’introduzione 

Carlo Favaretti

Innovazioni dirompenti: quale impatto su salute e sanità? 

Walter Ricciardi

Rivoluzione genetica e medicina di precisione 

Bruno Dallapiccola

Innovazione e problematiche regolatorie nel trasferimento dalla ricerca alla pratica 

Luca Pani, Xhulia Paja

Assessment of the innovation: a challenge for HTA 

Iñaki Gutiérrez-Ibarluzea

Si precisa che gli articoli non sono riproducibili senza l’approvazione dell’editore: per qualsiasi riutilizzo con scopi commerciali o promozionali, è necessario richiedere opportuna quotazione scrivendo a Gli articoli pubblicati sul GIHTAD sono fruibili in base all’attribuzione CCBY NC ND. Visualizza il testo completo della licenza

© 2021 Springer Healthcare Italia s.r.l.

Log in with your credentials

Forgot your details?