Session Summary from VI HTA Symposium (11-12 June 2018)

The panelists:

Adam Sobantka, Arkadiusz Grądkowski, Dominik Dziurda, Aneta Grunwald-Fitas, Ewa Ściślewska-Jakubiak, Krzysztof Łanda, Mirosław Padjasek, Jakub Pawlikowski

The moderator:
Karolina Skóra

 

Medical devices: quality, safety, scientific evidence – the impact of new legal regulations.

The following questions were among those raised during the Symposium: assessment of compliance and certification of medical devices, reimbursement of medical devices and changes in provisions of law regarding medical devices. In the course of assessing a device’s compliance with substantial requirements, at the phase of registration of the medical device, the manufacturer’s task is to prove effectiveness and safety of the device, whereas its clinical assessment usually is not required. However, in case of active implantable medical devices, implantable medical devices and class III medical devices, the clinical assessment may be carried out on the basis of literature data, provided such data are available.

The planned amendment to the Reimbursement Act includes a provision, where within the reimbursement procedure it is required to submit an application to the President of the Office for Registration of Medicinal Products to obtain an opinion on the quality of the medical device. The Minister for Health would specify minimum quality standards for medical devices, which, according to the speaker, may jeopardise the innovativeness of devices in a situation when manufacturers concentrate only on meeting these standards and give up on searching for new solutions.

The EU Regulation signed in 2017 introduces a series of changes, i.a. extending the definition of a medical device, increasing requirements for notified bodies, creating Eudamed – a publicly available base of medical devices, introducing the UDI system, that is, a system for tracing the origin of a given device. By 2020, changes will have been introduced in regulations which are intended to facilitate the assessment and reimbursement procedure for medical devices, i.a. an obligation of conducting clinical trials for class III medical devices and implantable medical devices will be introduced. Moreover, regardless of the results, the sponsor of clinical trial will submit a report on such a trial to the Member States within a year from its termination.

Revaluation of the Guaranteed Benefits Basket

The structure and current formal and legal status of the guaranteed benefits basket, as well as actions of the Agency for Health Technology Assessment and Tariff System (AOTMiT) taken to revalue the basket were discussed during the session. Current regulations of the Ministry of Health on guaranteed services (benefits) determine the list of guaranteed services defined in different ways, i.e. by diagnosis, procedures, technologies, descriptions – which sometimes causes difficulties in interpretation. The so-called “basket regulations” specify also the conditions required for the provision of services or referential levels understood as an executive potential of the given hospital ward. Unfortunately, current provisions in this regard are somewhat limited, e.g. there is a lack of information necessary for patients about the scope of services to which they are entitled, lack of a consolidated and standardised register of healthcare services, heterogeneous connections between services (i.e. the way of presenting the connection between a given health technology/procedure and recommendation) or unclear connection between provisions of the basket regulations and provisions of the ordinances issued by the National Health Fund.

The Current provisions present an incomplete outline of the system and cause difficulties in reading and understanding guarantees given by the system to the patient within the guaranteed benefits basket. As a result, the actual basket is defined by ordinances of the President of the National Health Fund which reduce the availability of some procedures.

The new approach to defining the basket is based on the definition of a health technology, i.e. what? to whom? on what terms?, that is, defining who is entitled to a given health technology, what is the scope of the service and what are terms of provision of the service. One task of the AOTMiT, set out by the Ministry of Health, is to re-evaluate/verify the guaranteed benefits basket. The objective of this task is to develop procedures and methodology for assessment of health technologies/healthcare services within the scope of the existing guaranteed benefits basket as well as tightening and consolidating the process of including new services into the healthcare system, in particular health technologies into the guaranteed benefits basket. As a result of these actions, in a 4 year-horizon, all services in the following areas are planned to undergo assessment: Primary Health Care, Outpatient Care, Inpatient Care; in the first place (year one), the services in the areas of: oncology, cardiology, ophthalmology as well as orthopaedics and traumatology of the locomotor system will be assessed.

The expected results of the revaluation process include: consolidating the form in which services are described, specifying criteria applied to qualify patients for obtaining specific services, verifying the legitimacy of current quality requirements and limiting spending on services which have been proven to be ineffective.

The most important findings of the Supreme Audit Office’s control regarding medical devices

The Supreme Audit Office’s control regarding implementation of the National Health Fund’s tasks in 2016, including commissioned medical devices, revealed that in the years 2010-2016, costs incurred by the National Health Fund for providing the patients with medical devices increased by 60%, although the total costs of healthcare services financed by the Fund increased by 25% in that period. At the same time, in recent years the number of healthcare providers and places where patients may buy reimbursed medical devices, that is i.a. prosthesis, orthosis, wheelchairs or incontinent briefs, significantly increased. At the end of 2016 there were twice as many agreements regarding the supply of medical devices as in 2012. According to the Supreme Audit Office’s assessment, that situation is due to the fact that the Fund lacks the tools to negotiate price levels of medical devices provided to the patient. The agreements were concluded with all healthcare providers which meet the necessary requirements, and in consequence regional branches of the Fund contracted particular medical devices from the same manufacturer, with the same parameters and characteristics, with differences in unit prices reaching even up to hundreds percent. The Supreme Audit Office requested a change in terms of reimbursement of medical devices released at the order of the beneficiary, by way of amending the Act on reimbursement of drugs, foodstuffs for particular nutritional uses and medical devices, and until the introduction of legal regulations, by way of amendments to legal acts to which Minister for Health has a statutory authorisation in order to eliminate or restrict occurrence of negative developments in this field.

The Supreme Audit Office considers this problem so important that it has undertaken further actions, that is, in May 2018 it commenced an investigation titled “Accessibility of commissioned reimbursed medical devices and their safe use” at its own initiative. This investigation will concern primarily healthcare providers.

Debate: Challenges faced in the market of medical devices

During the discussion participated by speakers and invited experts, the question of assessing non-drug technologies by the Transparency Council was raised. It was stated that such an assessment is conducted very rarely and the Transparency Council bases its decisions mainly on opinions of external experts due to the fact that very often there is not enough clinical evidence allowing for a proper assessment of a given medical device. Attention was drawn to the fact that the conflict of interest policy should be taken into account when the experts who are to issue opinions on the technologies are chosen. It is very difficult in practice because of the limited number of experts. The difference between endpoints assessed in clinical trials and criteria of inclusion of a given technology into the basket was indicated as one of the challenges.

It was pointed out that codification of medical law is necessary, as only this can guarantee easier supervision over particular medical areas. As a result, lack of appropriate regulations results in a situation where the system in Poland forces healthcare providers to use cheaper medical devices or devices characterised by poorer quality. An opinion was also presented that certification of medical devices should be granted within specified scopes, submitted by the medical community to the Minister for Health. In Poland there is a large availability of medical devices characterised by various levels of quality, however very often the higher price of medical devices does not equal their better quality. Recently, many notified bodies around the world have been closed, due to the fact that many of them were selling certificates of quality regarding medical devices without carrying out any assessment. Notified bodies primarily pay attention to the safe use of the medical device, and quality is not as prioritised. An opinion was also presented that the market of medical devices in Poland is not competitive; poor products are not eliminated from the market and at the same time are overpriced. Medical devices characterised by low quality may only be eliminated from the market by the Office for Registration of Medicinal Products, notified bodies, AOTMiT or the payer.

During the debate it was stressed that manufacturers of medical devices are in a more difficult situation than pharmaceutical companies because of the lack of possibility to apply for reimbursement. The Act on guaranteed services in its current form does not take into account manufacturers of health technologies in the process. The lack of statutory deadlines for assessment of services and issuance of the Minister’s decision on financing is the source of additional problems. Therefore, the need for a new and transparent reimbursement procedure which would concern several groups of devices – the most expensive ones from the payer’s perspective – was underlined. Representatives of the Supreme Audit Office emphasised that changes in reimbursement of medical devices should be made as soon as possible, because in the current situation, a large amount of money flows out from the system. The representative of IGWM POLMED pointed out that although there is a large diversity of medical devices, the level of their financing is low. Changes in regard to limit prices are necessary. Also, it was noted that there is a substantial difference between contract and transaction prices of medical devices. Codes in the guaranteed benefits basket also constitute a problem because even hundreds of models of one medical device are allocated to some of them.