The most notable changes and challenges in Poland

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

The panelists:

Marcin Czech, Roman Topór-Mądry, Dominik Dziurda, Ewa Warmińska, Tomasz Bochenek, Agnieszka Pachciarz

The moderator: Jacek Walczak


The role played by the Agency for Health Technology Assessment and Tariff System (AOTMiT)

One of the Agency’s many tasks consists in increasing the healthcare system’s efficiency. The President of AOTMiT underlined that scientific evidence is a key factor in increasing efficiency of the healthcare system. We can assess the quality of the system judging by the how standards have been created, how they have been implemented in practice, and how the best evidence and issues of efficiency have been translated into clinical guidelines. AOTMiT also faces the challenges of expanding the Agency’s competences and tasks by including, i.a.: issuing opinions on clinical guidelines, pricing of healthcare services, emergency access to health technologies (RDTL), as well as binding opinions on projects of health policy programmes.

AOTMiT’s directions of development also include international cooperation, i.e.

  • EUnetHTA – cooperation aimed at developing reliable, up-to-date, transparent and transferable information which will contribute to the use of HTA in European countries.
  • FaAP (Fair and Affordable Pricing) – international cooperation aimed at developing a framework for joint negotiations: Croatia, Lithuania, Slovakia, Slovenia, Hungary.
  • BD4BO (Big Data for Better Outcomes) – it is a research programme which aims at developing important mechanisms supporting the transformation of the healthcare system using large datasets.
  • IMPACT-HTA – an international project aimed at developing a methodology to be used for economic analyses, which will allow the use of other data sources (RWE, non-randomised studies) in the absence of adequate RCTs.
  • PCSI (Patient Classification Systems International) – an organisation focused on aspects related to the case-mix classification (clustering and grouping of clinical and administrative data) for purposes of management and financing of healthcare services.

Performance-based risk-sharing schemes (RSS)

Performance-based (also called outcome-based) RSSs are associated with both opportunities and threats. One opportunity for pharmaceutical companies consists i.a. in verification of the product’s effectiveness in real clinical practice, which is often the only option to provide reimbursement coverage for an expensive therapy. The risks associated with concluding such schemes from the pharmaceutical company’s point of view include, among others, inadequate defining of clinical response points, inappropriate assumptions about the drug’s effectiveness or lack of compliance. However, the risks exist not only on the part of pharmaceutical companies, but also on the part of the payer. The risks include an additional administrative burden and implementation costs, such as the costs of data analysis or audit, or the difficulty in estimating the total expenditure. One undoubted advantage for the payer is the lack of payment in the event of lack of the desired clinical response, while the patient receives access to an innovative, effective therapy.

The main barriers in promoting the use of performance-based risk-sharing schemes on the payer’s side include maladjusted IT systems, hindered monitoring of health effects in the long-term perspective as well as limited administrative and analytical resources. In turn, lack of Polish experience is the barrier from the point of view of pharmaceutical companies. The first pharmaceutical companies to do so will tread into the so-called terra incognita. An additional barrier is the uncertainty of the financial result and the costs of monitoring effectiveness of the treatment, i.e. the costs which will have to be incurred at the very beginning of concluding such an RSS.

The Ministry of Health considers various options for applying outcome-based RSSs. At this moment, due to the existing IT systems, they will most likely be related to drug programmes (perhaps haemato-oncology, although international partners speak in favour of focusing on solid tumours). The Ministry has still not taken a final decision on which areas can be the first ones to be involved with this type of solution.

Joint drug pricing negotiations within the EU

As ordered by the Ministry of Health, AOTMiT is conducting conceptual and analytical work as part of the Fair and Affordable Pricing (FAAP) initiative implemented on the basis of a Memorandum of Understanding dated 3 March 2017. The FAAP initiative was signed by the Ministers of Health of the V4+ Group countries (i.e. Lithuania, Poland, Slovakia Hungary + the Czech Republic and Latvia with an observer status). The objective of the FAAP is to improve and facilitate access to effective and cost-effective medicinal products as well as to develop methods and principles of cooperation and negotiations with the pharmaceutical industry at the regional level. The three main means which are implemented to achieve the intended goals are: expert meetings, exchange of information and organisation of pilot negotiations at the regional level. The tactical goal is to reach a common position on some confidential pricing rules to be applied to medicinal products. In turn, the strategic goal is to develop effective methods of negotiation and identification of elements which should be included in a potential international scheme. The intention behind the FAAP initiative is to implement VBP principles in the economies of scale context. The pilot project should result in the development of recommendations regarding an international scheme which would cover the subject of pricing negotiations. Current conclusions drawn from the process indicate the potential for more flexibility in regulations regarding the international negotiation path.

The most notable changes and challenges in Poland