Poland’s DNUR Amendment: Transforming Healthcare Reimbursement and Pricing Landscape

A substantial amendment on reimbursement and pricing to Poland’s Reimbursement Act, known as DNUR (Duża Nowelizacja Ustawy Refundacyjnej), officially took effect on November 1, although some of its provisions will only come into force in 2024 and 2025. This amendment is the most significant alteration to the Reimbursement Act since its enactment in 2012. The process of developing DNUR, from the initial draft to its ratification and implementation, took over two years. While there have been previous attempts to draft significant amendments, they did not progress to the parliamentary stage.

The Reimbursement Act laid the groundwork for Poland’s current reimbursement and pricing system, introducing elements such as price negotiations with the Economic Commission and the systematic evaluation of medicines by the Agency for Health Technology Assessment and Tariff System (AOTMiT) as essential components of the reimbursement process. In contrast, DNUR lacks specific headline measures and instead brings about various innovations and adjustments across a wide spectrum of areas.

A Comprehensive Overview of Key Changes in Reimbursement and Pricing

Some of the most notable changes include:

• Introduction of incentives to encourage pharmaceutical manufacturers to invest in medicine production in Poland, offering reductions in co-payments and certain administrative exemptions.
• Extension of the existing requirement to reduce drug prices by 25% upon the expiration of market exclusivity to also apply to the confidential realized (or final) prices, taking into account confidential discounts through risk-sharing agreements. This means that the final negotiated drug price post-market exclusivity must be at least 25% lower than the previous final price.
• Granting the Ministry of Health (MoH) the authority to make decisions regarding the contents of drug programs without requiring consent from manufacturers of drugs already included in these programs.
• Implementation of new price controls for medicines included in national health policy programs subject to reimbursement as part of drug programs.
• The transition from updating the reimbursement list every two months to once every three months, effective from January 1, 2024.
• Introduction of a concept called “reimbursement confidentiality” to enhance the protection of confidentiality related to risk-sharing instruments that allow reductions in the final drug prices. Specific regulations define who is bound by confidentiality in matters related to reimbursement. However, these regulations specify that those generally bound by reimbursement confidentiality may be exempted from it in cases where disclosing confidential information is necessary for international and bilateral agreements regarding drug reimbursement.
• Mandatory requirement for manufacturers to supply a minimum of ten wholesalers in the ambulatory pharmacy market if their products are identified as at risk of becoming unavailable in Poland. The MoH will publish a list of the ten largest full-line pharmaceutical wholesalers, and manufacturers must supply them equally.
• Eligibility for reimbursement of over-the-counter (OTC) medicines, requiring a treatment period of 30 days or more, recommended in clinical guidelines, and off-patent. The MoH can initiate a reimbursement process without manufacturer involvement.

Notably, several proposals were discarded during the lengthy consultation process, including the idea of a price corridor that would have excluded drugs priced over 50% above the reference price from reimbursement, and the introduction of a definitive willingness-to-pay threshold at six times the average GDP per capita per quality-adjusted life year (QALY). Removing these proposals helped mitigate the overall negative impact of DNUR, although several remaining measures continue to be contentious within the industry.

Uncertainties Loom as Poland Implements DNUR Reforms in Drug Policy

Key areas of uncertainty include the new definition of “reimbursement confidentiality” and the potential impact of exemptions on price confidentiality after negotiations. The elimination of the requirement for manufacturer consent when changes are made to drug programs is expected to expedite access to new medicines, but concerns exist that the MoH may make unfavorable financial changes for manufacturers without an opportunity for them to challenge. The decision to introduce reimbursement for certain OTC medications has raised questions, particularly when Poland lags behind many EU counterparts in access to originator drugs. Industry lobbyists anticipate that price controls on OTCs could harm Polish manufacturers and benefit low-cost market producers.

Even changes seen as favorable, such as incentives for manufacturers investing in production in Poland, have faced criticism for not going far enough. Similar responses have been observed in other European countries introducing regulations to enhance supply security amid drug shortages. Offering manufacturers 10-15% lower co-payments for producing finished drugs and/or APIs in Poland is not expected to provide substantial relief.

In recent years, the outgoing government, led by the Law and Justice Party, has made significant strides in improving access to new medicines, particularly in the fields of oncology and orphan drugs. However, DNUR does little to advance this cause. The responsibility for defining the next phase of Poland’s drug policy is expected to fall to the new government, which is likely to be a coalition dominated by the center-right Civic Coalition.

Resource: Pharmaceutical Technology, November 03, 2023

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