The large amendment to Poland’s Reimbursement Act—disappointing, but not disastrous

The large amendment to Poland’s Reimbursement Act (Duża Nowelizacja Ustawy Refundacyjnej, DNUR) finally came into legal force on November 1, although a small number of its regulations will only come into force in 2024 and 2025. It is the most significant amendment to the Reimbursement Act since it became law in 2012. The DNUR took over two years from the publication of its initial draft to reach the stage of ratification and entry into law. It is not the first ‘large’ amendment to be drafted, although previous ones were shelved before reaching parliament.

The Reimbursement Act laid the foundations for Poland’s current pricing and reimbursement system, introducing price negotiations with the Economic Commission, and establishing the systematic evaluation of medicines by the Agency for Health Technology Assessment and Tariff System (AOTMiT), as the central elements of reimbursement procedures. The DNUR, by contrast, has no particular headline measures and instead features novelties and adjustments across a broad range of areas. Some of the most important of these are outlined below:

• Incentives have been introduced for manufacturers to invest in the production of medicines in Poland, including reductions in co-payments, and a selection of administrative exemptions.
• The existing requirement to reduce the price of a medicine by 25% in the first administrative decision after a drug’s market exclusivity expires is extended so that it also applies to the confidential realised (or final) price of drugs, taking their confidential discounts achieved through risk-sharing agreements into consideration. Thus, the final price of a drug negotiated after the expiration of market exclusivity will have to be at least 25% lower than the previous final price.
• The Ministry of Health (MoH) has gained the power to make decisions on the contents of drug programs (the administrative instruments used to manage access to high-cost medicines) without having to gain the consent of manufacturers of drugs already included in the programmes.
• Medicines included in national health policy programs that are subject to reimbursement as part of drug programs will be subject to new price controls.
• From 1 January 2024, the reimbursement list will be updated once every three months, rather than once every two months.
• A new institution of “reimbursement confidentiality” is introduced to strengthen the protection of the confidentiality of risk-sharing instruments allowing for reductions to the final price of medicines, defining precisely who is bound to confidentiality on reimbursement-related matters; however, the regulations state that those who are generally bound by reimbursement confidentiality are not bound by it in cases where revealing confidential information is essential for the purposes of international and bilateral agreements in the exchange of information on drug reimbursement.
• Manufacturers are obliged to supply a minimum of ten wholesalers in the ambulatory pharmacy market, in the case of products identified as being under threat of unavailability in Poland. The MoH will publish a list of the 10 largest full-line pharma wholesalers and manufacturers will be obliged to supply these on an equal basis.
• Over-the-counter (OTC) medicines for which a treatment period of 30 days or more is required, which are recommended in clinical guidance, and are off-patent, will be eligible for reimbursement. The MoH will be able to initiate a reimbursement procedure without the involvement of the manufacturer.

Almost as significant as the measures included in the act are those that have been discarded during the very long consultation process. Plans for a price corridor, which would have seen drugs priced more than 50% above the reference price excluded from reimbursement, were abandoned, as were plans to introduce a new definitive willingness-to-pay threshold of six times the average GDP per capita per quality-adjusted life year (QALY). The removal of these proposals has helped to reduce the overall negative impact of the DNUR. However, there is no shortage of remaining measures that are controversial for the industry.

There are significant uncertainties surrounding the new definition of “reimbursement confidentiality,” and the potential impact the abovementioned exemptions may have on the confidentiality of prices after negotiations. Removing the requirement to gain the consent of manufacturers of drugs already included in drug programs when changes to the programs are made is expected to speed up access to new medicines, but there are concerns that the MoH may make changes that have unfavourable financial consequences for manufacturers, which they then have no chance to challenge. The decision to introduce reimbursement for certain OTCs has been met with bewilderment; when Poland continues to lag behind many of its EU partners in access to originator drugs, many have questioned why reimbursing OTCs should be seen as a priority. Industry lobbyists have predicted that imposing price controls on OTCs will damage Polish manufacturers and benefit producers from low-cost markets. 

Even changes that can be regarded as more favourable, at least to a section of the industry, such as the introduction of incentives for manufacturers investing in production in Poland, have received criticism, for not going far enough; similar responses have been seen in other European countries that have sought to introduce new regulations to strengthen supply security in the face of drug shortages. Offering manufacturers 10–15% lower co-payments for manufacturing their finished drugs and/or APIs in Poland is not expected to provide much relief.

Over the past couple of years, the outgoing government of the Law and Justice Party has overseen a significant advancement in terms of access to new medicines, particularly oncology and orphan drugs. The DNUR, however, does little to advance this cause. It will be for the new government, expected to be formed of a coalition dominated by the centre-right Civic Coalition, to define the next phase in Poland’s drug policy.

This article is produced as part of GlobalData’s Price Intelligence (POLI) service, the world’s leading resource for global pharmaceutical pricing, HTA and market access intelligence integrated with the broader epidemiology, disease, clinical trials and manufacturing expertise of GlobalData’s Pharmaceutical Intelligence Center. Our unparalleled team of in-house experts monitor P&R policy developments, outcomes and data analytics around the world every day to give our clients the edge by providing critical early warning signals and insights. For a demo or further information, please contact us here.