Poland to amend reimbursement laws again, this time for the better?

Anna Wiktorow-Bojska
WKB, Warsaw
anna.wiktorow-bojska@wkb.pl

Poland is processing a draft amendment to the reimbursement law that aims at withdrawing some of the changes that entered into force in 2023 (with the so-called ‘large amendment’ of the reimbursement law) and introducing some of the changes requested by the industry. The law is expected to be adopted in 2026. This article summarises the most significant proposals.

Orphan drugs

The draft law introduces orphan drugs as medicines that should be treated differently in the reimbursement procedure, and introduces a multi-criteria decision to be specified in the Health Minister’s regulation (which is not yet known). Orphan drugs will therefore no longer be assessed based only on their price.

New separate category for medicinal products used in outpatient and inpatient care

The Ministry of Health proposes to create a new reimbursement category is created to cover medicinal products used in non-oncological diseases under outpatient specialist care and/or inpatient treatment. Currently, medicines can be reimbursed only as:

• prescription medicine;
• chemotherapy;
• a drug programme; or
• a medicinal product administered during guaranteed health care services.

There is no intermediate category of reimbursement between medicines available in pharmacies and medicines available under the drug programmes. To remedy this, drug programmes include therapies that could be used outside of hospitals: the costs are increased due to administering them there. Often, these medicines, although they will not be available in pharmacies, could be successfully financed outside the restrictive drug programmes.

Preferences for applicants

Comprehensive change is also coming in the procedure for reimbursement of medicines with established clinical effectiveness. The Ministry of Health wants the right to call on the applicant to submit a reimbursement application for the medicine awaited by patients. If the application is submitted upon such a call, it would benefit from:

• a shorter processing time;
• a lower verification analysis fee; and
• for generic medicines, no obligation to submit an analysis of the impact on the National Health Fund’s budget.

On the other hand, not submitting an application will not result in any sanctions.

We do not know how these preferences will relate to the existing drug technology lists with reimbursement preferences. If a medicinal product is put on the list of drug technologies of high clinical value or with a high level of innovation, the marketing authorisation holder (MAH) can submit a reimbursement application with additional preferences. Will the proposed preferences, therefore, be an addition to these lists? Is this solution deemed by the Ministry of Health to be effective (rumours have it otherwise)?

The draft also removes the requirement to submit a complete set of analyses, and to pay a fee for the preparation of a verification analysis for applications concerning complex prescription medicines whose single-component equivalents are financed to the same extent as requested.

Changes in the reimbursement procedure

Additional obligations in case of applications for reimbursement without equivalents

Marketing authorisation holders who plan to apply for reimbursement of medicines that have no reimbursed equivalent will be obligated to inform the Ministry of Health about a year’s plans between 1 November and 31 December of the preceding year.

Marketing authorisation holders will also have to consult the reimbursement category and indication for which they plan to apply if their product does not have a reimbursed equivalent in a given indication.

General amendments requested by the industry

For many innovative pharmaceutical companies, the current obligation to provide proof of availability of the medicine at the moment of submitting the application is a significant obstacle. Therefore, a declaration of ensuring availability by the time the decision is issued can be provided instead.

Another significant obstacle for MAHs in Poland is that, once the reimbursement decision is issued, they cannot change the limit group or the holder of the reimbursement decision. It means that in case of MAH change, the new MAH has to apply for an entirely new reimbursement decision. The draft remedies this, regulating changing the limit group and the holder of the reimbursement decision.

Currently, reimbursement proceedings are automatically discontinued if the decision is not issued within the year from application. The draft law also proposes to remove this rule.

The draft law proposes to allow reimbursement of medicines in foreign-language packaging that are authorised by the competent authority due to the shortages of medicines in Polish-language packaging. According to the proposal, this would apply to medicinal products that are on the reimbursement list. This does not entirely respond to industry requests but is a step in the right direction.

Health technology assessments

In case the draft law is adopted, the President of the Health Technology Assessment (HTA) Agency would no longer be able to issue ‘conditional’ recommendations. Current regulations lead to discontinuation of proceedings in case the HTA Agency’s recommendations are not met.

Instead of a three-year validity for an HTA analysis (Transparency Council and national consultant) for off-label use, the draft law proposes that they are valid for an indefinite time.

Negotiations – Economic Commission

The draft law rectifies an issue with the previous amendment – it reintroduces the possibility to modify applications and submit new financial offers after an Economic Commission resolution . This allows continued negotiations and does not require the applicants to submit new applications with another financial offer.

The supply volume is also supposed not to be imposed, but is negotiable; this assists applicants in the negotiations.

Pricing rules

The draft law introduces an effective price – the price of the product per pack or per patient borne by the National Health Fund, taking into account risk-sharing instruments. It is a necessary change; however, the proposed wording is too vague and will hopefully be clarified following public consultation.

The reference price is also supposed to change. The Ministry of Health proposes the threshold of the net selling price of the cheapest presentation on the reimbursement list for a given indication (currently we do not refer to an indication).

Price increase

Supposedly, it would be easier to increase the price for the reimbursed medicinal products.

The Ministry of Health proposes to open up the possibility to apply for a price increase during the market exclusivity and patent protection. The draft also presents a list of evidence that can be presented as justification of a price increase as an alternative, not cumulative list (the latter is applicable today). This decreases the formal requirements for the application for the increase.

This is a positive change that encourages innovative companies to introduce medicines on the Polish market. On the other hand, the proposal alone is not enough if the Ministry of Health and the HTA Agency are not open to accepting a price increase. We therefore hope that the inclusion of such a proposal in the draft shows that the authorities are open to appropriate renegotiation.

Price reduction after protection period

The proposal of the Ministry of Health removes the obligation to reduce the price by 25 percentage points when patent protection expires.

The price reduction will still happen but it will take into account the price proposed in the first reimbursement decision and all reductions made in the meantime. It would be a ‘rolling’ reduction mechanism instead of a simple reference to the price at the moment the patent protection expires.

Therefore, if the price has been already reduced by 25 per cent during the patent protection, the price will not have to be reduced more at the expiry of patent protection.

Reimbursement secrecy

The Ministry of Health considers current reimbursement secrecy as too broad and proposes to limit its scope only to information on risk-sharing instruments. The draft law also proposes amendments to the scope of entities covered by secrecy and allowed to receive information covered by secrecy.

Obligations associated with continuity of supply

The last amendment to the reimbursement laws imposed numerous obligations and extended penalties for discontinuity of supply. The current proposal removes the pre-determined algorithm for supply volumes and removes the penalties in case patients’ needs are met – this constitutes a return to the pre-2023 regulations.

The entire supply chain of medicinal products released on the Polish territory will be examined in order to assess compliance with continuity of supply obligations. If the product is available in independent pharmacies and/or pharmaceutical wholesalers, the MAH cannot be sanctioned.

Drug programmes

The draft law proposes several important changes in reference to drug programmes.

First of all, the applicant would be obligated to consult the content of a drug programme before submitting the application. In particular, the consultation concerns compliance with the drug programme, the summary of product characteristics (SmPC) and clinical guidelines.

Secondly, MAHs would be obligated to ensure availability of therapies from the first day of the reimbursement decision in case of medicines without reimbursed equivalents in a given indication. It would be considered a risk-sharing instrument, since the MAHs will have to provide the medicine to the healthcare provider at no cost until the healthcare provider concludes a proper contract with the National Health Fund for a given drug programme. This obligation can last up to three months.

The proposal includes also other changes in this area, such as potential participation of the patient organisations in coordination team meetings on drug programmes without a right to vote, and clarification of the doubts concerning drug programmes with reimbursement decisions from before 1 November 2023.

Financing losses for unused portions of drug packages (wastage)

The Ministry of Health has determined more medicinal products being reimbursed and billed per vial results in higher financial losses and healthcare providers being reluctant to contract them. The Ministry proposes the following solution:

• For reimbursement decisions issued before the effective date of the amendment: coverage of losses resulting from administering the medicine based on a patient’s body weight or body surface area from the therapeutic and innovative sub fund of the Medical Fund.
• For reimbursement decisions issued after the effective date of the amendment: an obligatory risk-sharing instrument obliging the applicant to finance such losses.

The proposed change imposes another financial burden on applicants. Considering the unused funds in the Medical Fund and the desire to make Poland more attractive to medicine manufacturers, partial coverage of losses for all decisions by a public sub fund could be a more favourable solution.

Information systems, data and reports

The draft proposes several solutions in terms of digitalisation. The most important from the MAH perspective are:

• MAHs would be obligated to report each release of a batch of a medicinal product marketed in Poland to the integrated monitoring system for the circulation of medicinal products (ZSMOPL), not just medicines deemed at risk of shortages by the Ministry of Health.
• MAHs would be granted access to aggregated quantitative data on ZSMOPL concerning products covered with their marketing authorisation.

These amendments to the Polish reimbursement law are much needed. Many of the proposed changes have been discussed for many years and are being welcomed with open arms. Therefore, we hope that the draft will go forward and make it easier to place innovative medicines on the Polish market.