Antonio Addis Treatment requirements change over time, together with the provision of care and healthcare services. In recent years we’ve been seeing an accelerated modernisation of the entire healthcare sector, which brings the potential for new opportunities and for improving the health prospects of citizens and patients. In the last few months we’ve had to face the covid-19 pandemic, which caught us unprepared, even though we had the chance not to be. Either way, it was an emergency that forced us to make quick changes to the healthcare system. Did the role of the National Agency for the Regional Health Services (AGENAS) change its evaluation, analysis, assessment and monitoring operations?
Domenico Mantoan I believe that, in order to respect its original purpose, the AGENAS should firstly focus on developing further assessments of organisational systems. This pandemic taught us that the regions that were better able to respond to the emergency, and that did so in a timely manner, were those with a “resilient” organisational model- just to use a very popular word. These types of organisational models are those that aren’t stuck on a rigid and dated structure. We’ve always been used to get everything assessed before doing anything, from the budgets to the number of hospital beds, the hospital standards and so on. Everything had to be completely evaluated and defined with maximum precision. Following our outlook on healthcare management we also planned for emergencies, to avoid getting overwhelmed with a potential epidemic, and we prepared the “National influenza pandemic preparedness and response plan”, which outlined objectives and operations. The plan was approved in 2006 but the last update dates back to 2009, following the last global pandemic caused by H1N1. I remember how at the beginning the prefect used to regularly organise meetings to update the plan but then, over the years, our attention shifted away from the emergency and we organised, defined and structured more and more following standard models. All of this is to say that research should not focus solely on novel treatments but also on the most effective organisational models so that we can compare our processes with those of other countries. The problems we face are the same, even though every country then manages to provide a different- better or worse- solution to them, in line with their culture and organisational framework. That’s what the AGENAS should do in the future: manage to understand, evaluate and define better organisational models and, whenever possible, even anticipate upcoming issues. This pandemic taught us that healthcare models should consider their preparedness to manage emergencies.
Research should not focus solely on novel treatments but also on the most effective organisational models so that we can compare our processes with those of other countries.
Antonio Addis The pandemic highlighted the need for a more technical coordination between the Government and the regions. Theoretically this would be the responsibility of the AGENAS and of the AIFA (Italian Medicines Agency). These two agencies were actually set up as technical structures following the reform of Title V of the Constitution so they were supposed to connect and integrate the central bodies with the regions. In reality both of them viewed this function differently. Might the pandemic push us to recognise these technical organisations as a link between the central Government and the regions? In short, will it be feasible to finally see them as potentially facilitating the decisional process instead of being additional bottlenecks?
Domenico Mantoan Covid-19 confirmed, or at least defined, certain doubts: on one hand there are those who advocate for absolute federalism and on the other there are those who advocate for absolute centralism. I think that the experience of the pandemic made two concepts very clear. Firstly, the regions have an undeniable role when it comes to local healthcare management; the ability of the regions to make independent decisions around the provision and management of healthcare services was essential. Secondly, when it comes to national planning it’s the Government that should have a central role- the need for this function has never been so evident, and even asked for, as it was during the pandemic; the regions themselves requested an increased coordination from the State. While the Ministry of Health, given its political and bureaucratic nature, is responsible to draft the guidelines for planning, the function of the AIFA and the AGENAS- that you correctly described as a link- together with the National Health Institute (or ISS), is to act as technical organisations that help political decision making and that strengthen the connection between the regions and the central bodies. The ISS and the AIFA played important roles in the management of the covid-19 emergency. The ISS monitored the phenomenon and planned interventions. The AIFA, with the CTS (scientific technical committee) assessment, regulated the use of certain off-label drugs, for the treatment of sars-cov-2 patients, as well as clinical trials and the “special” use of potential treatments. We shouldn’t forget that amid the emergency we had to face an infectious disease that we didn’t know how to treat. A simplified and transparent governance of the different clinical trials proposals allowed investigations on, for example, tocilizumab, heparin, cortisone and remdesivir. Even though many treatments turned out to be ineffective, it was still important to be able to test them expeditiously. The Crisis Team instituted by the AIFA was also fundamental to manage the shortages of drugs in the various regions.
Unfortunately, during this crisis, the AGENAS missed the opportunity to cover the reorganisation of primary care and hospitals and to define standards and organisational models. This is the reason why it has become necessary to appoint commissioners to be able to resume operations… In Italy we had 5,300 ICU beds, in line with the reform of the hospital network that followed the DM (Ministerial Decree) n.70, which was strongly criticised once the healthcare structures of the worst hit areas were about to collapse during the covid-19 emergency. The weakness of the DM n.70 wasn’t to underestimate intensive care units- because up till March the bed spaces available were covering 70% of the demand- but rather not planning for the semi-intensive respiratory units that turned out to be essential. The challenges encountered during the first wave should have taught us how to organise so we could face a new one. The AGENAS could have helped those regions that weren’t affected by the pandemic in March to reorganise in order to brace for this second wave.
The AGENAS, the AIFA and the ISS should have a profile that’s highly technical, not political; they should have distinct roles and coordinate among each other.
The pandemic and the way it was managed by the healthcare system clearly confirmed the fundamental roles played by the AGENAS, the AIFA and the ISS as better connectors between the Ministry, the regions and the independent provinces and in assessing and planning processes. These three institutions should have a profile that’s highly technical, not political; they should have distinct roles and coordinate among each other. Furthermore, the Ministry and the regions should guide them by providing clear direction via the boards of directors (CDA). However, there’s also another element that I consider absolutely essential for planning operations: the availability of high quality data, which must be able to circulate freely between these three bodies without any of the hurdles typical of specific data types.
Planning operations require high quality data. The data must be able to circulate freely between the AGENAS, the AIFA and the ISS without any of the hurdles typical of specific data types.
Antonio Addis Data sharing is a substantial issue. In order to overcome this challenge the ISS, for example, developed a common data model approach, which allows each region to share on a platform its data as well as the anonymised results of specific studies. This allows each party to maintain ownership of any data they collected while being able to share them with other territories; it also allows larger scale analysis to happen.
Domenico Mantoan True, but it’s a trick we should resort to if we don’t have any other alternative. If the AGENAS felt the need for this it could make arrangements with the individual regions to utilise their data. The issue is at the source: it’s suicidal not to have a data exchange between the AGENAS, the AIFA and the ISS. The legislator needs to be aware of this. For example, it would be useful if scientific technical committees like yours at the AIFA had all the relevant data available to know how a recently approved drug impacts the territory.
Antonio Addis I completely agree with you. An example of this is a treatment for thalassemia that other countries already valued at thousands of euros per individual patient. In order to evaluate the impact of this treatment doing a health technology assessment we need- among many things- to know precisely what is the target population. Without this data it’s not feasible to plan and assess, not just whether the price is too high or too low, but also what resources the SSN (National Healthcare Service) will need to employ in terms of overall organisation and management of the individual patient. Unfortunately the registration file provides very scarce information to answer these questions and the available data are mostly estimations provided by advisory boards and groups of experts that indicate approximately how many patients might be involved. The obvious question is: how is it possible that, after enormous investments were made to develop a treatment, we don’t have enough resources to complete an adequate and comprehensive analysis so that we can obtain more reliable information on how many and which target populations there are for that specific pathology, and even find out their location?
Domenico Mantoan It’s an absurd situation. Theoretically that’s data that should be obtained in a short period of time. In the case of thalassemia patients they’re even exempt from the charge system so they need to be traceable to receive assistance.
Antonio Addis Going back to the role that the AGENAS could play in the near future, are there other areas you think are important and in which the Agency could help manage what happened and take a lead on the direction of regional healthcare services?
Domenico Mantoan The healthcare emergency caused by the covid-19 pandemic accelerated the applications and the developmental needs of telemedicine and highlighted the need to reorganise the local healthcare system, also utilising the potential of telemedicine. In a state of necessity everything, or almost everything, is allowed. Nevertheless, offering support via electronic means raises a stack of medical-legal issues that can potentially lead to several legal disputes. The AGENAS is dealing with this matter by proposing to develop a complete definition of telemedicine that takes into account clinical aspects such as the importance of remotely diagnosing and controlling devices- for example pacemakers or glucose testing devices- but also how to provide a medical-legal cover, which is currently lacking. Certain aspects of telemedicine practice need to be regulated and codified such as medical-legal and negligence liabilities, data sharing and confidentiality.
Antonio Addis Telemedicine certainly opens a door onto a world of remote control devices but we need to think about things like management of chronic conditions and also all the organisational aspects. The current simplified application of telemedicine consists of the physician contacting the patient via video, but the full version of this would actually require to rethink the diagnostic pathways and the communication between healthcare professionals, and to redesign the relationship between doctor, patient and even the caregiver.
Domenico Mantoan Yes, we need to reorganise the system and can’t just improvise this. We need to plan and regulate each aspect. In the Veneto region, at the peak of the covid-19 emergency, in order to reduce the influx of people into hospitals patients were asked to stay home so someone would contact them remotely. Initially this was done in a primitive way- over the phone- despite knowing that it was not a sustainable system in the long run. Checking remotely for fever or the cardiac rate requires much more than a simple phone call.
Antonio Addis We are going to end with a reflection on the training of healthcare workers, which is a very relevant topic for the AGENAS, as it always works on the education programs with the Ministry of Health. Training has always been centred mostly on residential conventions that nowadays, with covid-19, are just not feasible. This raises the question of how to do in-person training, also thinking about the healthcare workers linked to the SSN. This aspect will definitively need to be explored to identify and trial the best modalities to provide training: remotely or with small groups, perhaps with multiple questionnaires on individual clinical cases instead of wider medical topics that sometimes feel too theoretical. How can the AGENAS redesign the healthcare training of tomorrow?
Domenico Mantoan The old big conventions model won’t certainly be abandoned. For a certain period of time there will only be remote events but then we’ll go back to the in-person ones. What I think is changing is the modality in which we provide training and information- for example through the use of webinars. Webinars are immediate, monothematic and very participated. I was invited to a webinar where I discussed the management plan that the healthcare system adopted to face the covid-19 emergency in Veneto. At the time there was a strong interest and the need to discuss and share different cultures. The webinar allowed to organise in a very short time a meeting that roughly 4,000 people followed. I expect that management training will incorporate this new training model to the classic residential one made of small and big conventions at both national and international levels. Nowadays there is a demand for remote training and also a need to provide expeditious and easily accessible training on specific and very current topics, such us the applications of a drug, how to work in an intensive care unit and how to do swab tests. Therefore covid-19 is certainly changing our approach to training and, also in this case, we need to be ready to apply this with new relevant rules.