In this Insights series, Around the World in HTAs, we shed light on HTA around the world. In this edition, Athanassios Vozikis and Dimitrios Kourouklis take us to Greece.
The Greek healthcare system
Greece’s healthcare system is a mixed system comprising elements from both the public and private sectors. The National Organisation for the Provision of Health Services (EOPYY) established in 2011, acts as the sole purchaser of healthcare services for patients covered by the publicly financed National Health System (known as “ESY”). The Ministry of Health (MoH) is responsible for the planning and regulation of the ESY, along with the establishment of regional health authorities (YPEs), which are intended to carry out extensive healthcare planning, organisation, and provision (Economou et al., 2017). The healthcare system financing is through a mix of public and private resources, including social health insurance (SHI) and tax, which account for approximately 31% each, with users’ private spending making up the remaining 38% (Hellenic Statistical Authority (ELSTAT), 2023).
The HTA process framework
The value assessments of medicines and medical devices are managed separately.
Assessment of medicines
The regulatory framework for the authorisation, pricing, and reimbursement of pharmaceutical products falls within the scope of Ministerial and Interministerial decisions on pharmaceutical products. It should be noted that the maximum retail, wholesale, hospital, and ex-factory price, as well as any other special sale price of medicinal products – with the exception of non-prescription medicinal products- are defined by the relevant Price Bulletins, which are issued twice a year by the Minister of Health and uploaded to the official website of the MoH, following an opinion provided by the National Organization for Medicines (E.O.F.). Normally, high-cost medications are exclusively provided by EOPYY’s pharmacies and hospitals.
Greece is among the latest adopters of the Health Technology Assessment (HTA) process. HTA was formally introduced as part of the decision-making process on the pricing and reimbursement of medicines in Greece in 2018, together with the establishment of the Committee on the Assessment and Reimbursement of Medicinal Products for Human Use (so-called “HTA Committee”) responsible for the clinical and economic assessment of new prescription medicines; and the Price Negotiation Committee. Also, there is a guide that provides the context of the HTA committee’s rules, processes and general operation (Official Government Gazette, 2018a; b). The main criteria that the HTA committee applies for the evaluation of a treatment in Greece are the following: i) clinical benefit, ii) comparison with existing reimbursed treatments, iii) degree of reliability of clinical study data, iv) cost-effectiveness ratio, v) budget impact. However, the data for the assessment of each product are not publicly available. Patients and scientific associations can be invited or can request to join the committee meeting and share their views. The Price Negotiation Committee negotiates the prices of medicines with a positive assessment by the HTA Committee and provides a recommendation to the HTA Committee regarding the medicines’ budget impact. The HTA Committee issues its final opinion to the Minister of Health, who makes the final decision.
Assessment of medical devices
The current HTA process in Greece does not include medical devices. However, whenever a legally binding HTA organisation is created then it is expected that the assessment and reimbursement for both medicines and medical devices will be under its umbrella. The lack of a formalised process for biomedical technologies (apart from pharmaceuticals) creates significant uncertainty for the providers of medical devices and for pharmaceutical companies (regarding the market entry of the tests and patient access to drugs for which a companion diagnostic is a pre-requisite for administration) as well as for patients (regarding access to testing and sometimes treatment). A Committee for the Negotiation of Medical Devices’ Fees and Prices does exist, operating within the scope of EOPYY. However, it is not involved in the assessment of new technologies, as it only negotiates the prices of technologies that either already exist in the market or are imported through ad hoc decisions, such as ministerial decrees (Naoum, Karampli and Athanasakis, 2022).The National Evaluation Center of Quality and Technology in Health (E.K.A.P.T.Y S.A.), an independent Certification Body of Quality Systems and Products supervised by the Ministry of Health, which is also authorised to evaluate and certify the compliance of medical devices with the requirements of Medical Device Directives is not get involved in any non-formalised and non-systematic process as described above.
Challenges of HTA in Greece
Although there is generally a positive view of the current HTA framework amongst stakeholders, including the pharmaceutical industry, EOPYY, patient and scientific organisations, there are still a few concerns regarding its structure, the assessment criteria in its clinical parameters, and the prioritization of medicines based on specific parameters such as degree of innovation. There are also operational challenges related to inadequate administrative and scientific support. Finally, there is a lack of coordination between the assessment and the negotiation Committees.
Next steps for HTA in Greece
Introduced in 2018, the HTA framework in Greece is a big step forward towards evidence-based resource allocation decisions, as well as patient access to innovative therapies at affordable prices and in a timely manner. Since its establishment, a significant improvement in the performance of the HTA process has been observed by decreasing the backlog of medicinal products as well as the time of HTA clinical assessment.
Finally, there is strong consensus that the creation of a national decisive and legally binding HTA organisation, which will be independent of the MoH, both administratively and financially, might be more credible and effective. Another next step would be the inclusion of assessment and negotiation procedures for medical devices under an HTA organisation.
References
Economou, C., Kaitelidou, D., Karanikolos, M. and Maresso, A., 2017. Greece: Health System Review. Health Systems in Transition, 19(5), pp.1–166.
Naoum, P., Karampli, E. and Athanasakis, K., 2022. HTA191 Health Technology Assessment in Greece: Evaluation of Current Status and Prospects. Value in Health, 25(12), p.S334. 10.1016/j.jval.2022.09.1649.
Hellenic Statistical Authority (ELSTAT), 2023. System of Health Accounts (SHA) of year 2021. Piraeus. ΣΧΕΔΙΟ ΔΕΛΤΙΟ ΤΥΠΟΥ (statistics.gr)
Official Government Gazette, 2018a. Αριθμ. Οικ. 52029/2018 – ΦΕΚ Β 2768/11.07.2018.
Official Government Gazette, 2018b. Αριθμ. Οικ. 63025/2018 – ΦΕΚ Β 3585/23.08.2018.