Has Poland taken another step toward transparency in reimbursement procedures?

2010-04-21

The incorporation of health technology assessment (HTA) into government funding of drugs was expected to be a significant improvement in pharmaceutical market access in Poland. The process of evidence-based reimbursement decisions, which started as early as 2005 with the establishment of the Health Technology Assessment Agency (the AOTM), has been strengthened recently by further legal regulations which have led to more precise and transparent application procedures. During a seminar held on 24 March 2010 in Warsaw, AOTM representatives presented the most important changes in the function of the agency and the rules pertaining to applications for drug or medical device reimbursement.

The most important step was taken in June 2009, when an amendment to the Publicly-Funded Health Services Act gave the AOTM a new role and significantly augmented its institutional status and powers. More regulations were published at the end of the year. These describe more detailed criteria for reimbursement application procedures. At the same time, the AOTM also updated HTA analysis guidelines – both issues will be discussed later in this article.

Demand for transparency in drug reimbursement
A lack of transparent and coherent rules and timeframes for obtaining drug reimbursement in the Polish healthcare industry used to be cited by drug manufacturers as being one of the main obstacles to the effective running of a pharmaceutical business in Poland. The uncertainty surrounding the decision-making factors involved in the process of reimbursement application evaluation was also considered a potential corruption risk. The introduction of health technology assessment (HTA), a system which summarises the medical, social, economic and ethical aspects of the use of an element of health technology in a systematic, evidence-oriented manner, was expected to be the most appropriate way of overcoming the lack of transparency in state funding of health technologies. Furthermore, the introduction of HTA, a solution which already existed in most Western European countries, was also encouraged by the EU authorities, as Poland was obliged to adopt the requirements of Directive 89/105/EEC, commonly called the Transparency Directive. The first steps toward the implementation of a system of health technology assessment in Poland were taken in September 2005, when the Health Ministry created the Health Technology Assessment Agency (the AOTM). The first HTA guidelines were approved in 2007.

From the creation of the AOTM to the strengthening of its powers
Although the Health Technology Assessment Agency (the AOTM) was created as early as 2005, until mid-2009 it operated as a Health Ministry unit without a separate legal status. During this period the assessment of the quality of HTA analyses, the appraisal of applications by the AOTM’s Consultation Panel and the reimbursement decisions taken by the Health Ministry were completely separate processes. This meant that, although the AOTM’s Consultation Panel carried out evaluations of reimbursement applications, the Ministry was not legally obliged to accept the AOTM’s recommendations when taking the final decision on the state funding of health technologies.
This situation changed significantly in June 2009, when an amendment to the Publicly-Funded Health Services Act rendered the AOTM the key entity in the process of approving health technologies (including medicines, medical supplies and therapeutic programmes). The AOTM became a state unit with a separate legal status, a new structure and more extensive duties and powers. The obtaining of AOTM approval became an essential part of the Health Ministry’s reimbursement decisions.



More precise health technology assessment rules – in step with the EU Transparency Directive
At the end of 2009/beginning of 2010 several new regulations were adopted in order to bring Polish legislation more into line with the EU Transparency Directive requirements. The Directive, adopted by the EU as early as 1989, is designed to ensure the transparency of procedures established by member states to control the cost and reimbursement of medicinal products. It guarantees public access to information on pricing and reimbursement, in particular with regard to the pharmaceutical industry. The Directive spells out four main kinds of requirements pertaining to state administration of pricing and reimbursement. These include: a limited timeframe for the decision-making process, objective and verifiable decision criteria, the possibility of notifying the applicant or publishing the rationale behind the decision and appeal proceedings against a decision.
Work to incorporate the Directive’s requirements into Polish legislation has been underway since the creation of the AOTM. However, the item of legislation with the most profound impact on the transparency of the reimbursement process in Poland was the June 2009 amendment to the Publicly-Funded Health Services Act. In accordance with this, the role of the AOTM in the reimbursement application procedures was clearly determined in law. Furthermore, the obligatory 60-day timeframe for the AOTM’s drug assessment was established and a requirement pertaining to the declaration of any conflict of interest on the part of AOTM experts introduced. The Act also stipulates that information about the status of a reimbursement application must be published on the AOTM website. All of these regulations are designed to render the entire process of obtaining reimbursement more transparent.
With regard to further legislation, the 28 December 2009 Health Ministry ordinance, along with updated HTA guidelines, set up detailed criteria and proceedings pertaining to health technology assessment, in terms of clinical efficacy, cost effectiveness and budget impact. The ordinance also introduced an obligatory fee of PLN 88,437 (€22,709) to be paid by the manufacturer to the AOTM. A fee of PLN 149,000, or €38,477, had previously been suggested. The current fee is based on the calculation of the real cost of AOTM drug evaluation.
Another regulation, a 23 February 2010 decree by the president of the AOTM, introduced a procedure whereby applicant pharmaceutical companies may submit official commentaries on the evaluation report on the Agency’s assessment of a HTA analysis, before the Consultation Panel meets to take the final decision. Communication with industry representatives, which also meets the Transparency Directive requirements, is thus, for the first time, incorporated into a legal regulation and included as part of the reimbursement process.



Room for improvement in reimbursement process
Whereas the new regulations are expected to increase the transparency of the reimbursement process, it is too early to gauge whether they will speed up the reimbursement decision-making process in Poland.
The weak point of the new legislation could still be the lack of precise definitions of some timeframes (including “promptly”), in addition to the lack of legal sanctions in cases in which the administration fails to prepare the drug evaluation on time. Furthermore, as the AOTM is obliged to evaluate applications pertaining to drug reimbursement, medical devices, health services and regional and national therapeutic programmes, there are serious concerns about the agency’s ability to deal with the current workload.

Anna Skoczylas-Ligocka
Business Editor
PMR Publications
anna.skoczylas-ligocka@pmrpublications.com