This blog summarises an initiative taken by more than 300 health economists and experts in support of the creation of an independent health technology assessment agency in Spain.

Over three hundred academic researchers, professionals, and experts have recently signed a manifesto called ‘For a Hispa-NICE: now or never‘ in support of the creation of an agency for the evaluation of health care practices and policies, analogous to England’s National Institute for Health and Care Excellent (NICE).

The manifesto was signed by prominent experts from a number of sectors, such as Guillem López-Casasnovas (member of the Directors Board of the Bank of Spain since 2005, and former President of the International Health Economics Association, among others); Rafael Bengoa (former Minister of Health of the Basque Country, and member of OHE Policy Committee); Félix Lobo (President of the Spanish National Health System’s Advisory Committee on Pharmaceutical Provision Financing); former presidents of the department of health; presidents of various scientific societies and medical associations, as well as associations such as the Spanish Health Economics Association, and the Spanish Society of Public Health and Health Administration.

The signatories explained that the crisis brought on by COVID-19 has exposed important drawbacks of the Spanish National Health System (SNHS). The document focuses on what is arguably the most critical one: the absence of a structured and systematic implementation of evidence-based decisions related to the administration and financing of medications, diagnostic tests, creation of healthcare infrastructures and prioritisation rules.

The manifesto explains how this is not a need specific to Spain but to all healthcare systems that must objectively assess the safety, effectiveness, and costs of medications and health technologies, especially when some drugs may not be priced according to their true value.

The advocates of the HispaNICE take as a model NICE in England, the institution that carries out systematic evaluations of evidence relating to technologies’ clinical- and cost-effectiveness to advise the National Health Service (NHS) on its adoption of new and existing health technologies. As the English NICE, the HispaNICE would require its own legal identity, functional autonomy, and well-defined procedures and functions, which would be responsible for analysing healthcare services, their technologies, drugs and therapeutic indications, prevention and public health interventions, and other health policies, balancing health results with the costs they entail for the SNHS and for society as a whole. They suggest naming this agency the ‘Independent Authority for the Evaluation of Health Practices and Policies‘.

An innovation of this proposal with respect to similar existing agencies is the upfront inclusion of social benefits, i.e., they propose that its remit includes establishing whether the health and social benefits of a health intervention are worth the cost, based on the analysis of the scientific evidence available at any given time. The running of the institution should be governed by the principles of independence, technical rigor, and good governance, favouring the transparency of the options adopted and contributing to the accountability of public decisions.

This new independent organisation would complement the efficacy and safety assessment carried out by other institutions, such as those currently developed by the Spanish Agency of Medicines and Medical Devices. The new institution would also foster the participation of relevant stakeholders into assessment stages, notably connecting existing centres of expertise at the central and regional levels, academia, patient associations and healthcare and pharmaceutical industry. The main goal of the institution would be to provide evidence to inform healthcare authorities; the creation of such an institution would therefore signal rigour and commitment on the part of healthcare authorities to better manage healthcare services, in line with the evaluation work carried out by the Spanish Network of Agencies for the Evaluation of Healthcare Technologies and Services (RedETS)

Source: Rosa Vivanco Hidalgo (RedETS – Spanish medical device HTA network) presentation at http://www.aes.es/sesion-hispanice/

A combination of factors makes the creation of HispaNICE a pressing issue. First, it is a common belief that the financing of the NextGenerationEU program (the largest stimulus package ever financed through the EU budget) represents an unrepeatable opportunity for it. Second, Spain has an institutional framework established over a number of years, which could facilitate the creation of such an institution at the national level (see an excellent analysis of this landscape in Oliva-Moreno et al., 2020). Finally, it is essential to confront the reality that the SNHS is not sustainable in the long run unless the resources are used efficiently; and the systematic assessment of value for money of new technologies is a necessary condition for this. This is not just the case for Spain: without a regulatory system that makes decisions based on the economic evaluation of health, health care, and health technologies, a universal NHS is not sustainable.

HispaNICE: the time is now. No excuses.