July list of reimbursed drugs is here

In the third list in effect in 2025, 41 new molecule indications were covered by public funding, including:

• 18 molecule - oncology indications,
• 23 molecule - non-oncology indications,
• 12 molecules - indications dedicated to rare diseases.

The reimbursement notice effective July 1, 2025 (No. 79), compared to Notice 78, contains the following changes:

1. A total of 208 products or new indications were added to the list due to positive reimbursement decisions.
2. Net sales price reductions were introduced for 242 products (from PLN 0.01 to PLN 6157.00).
3. Net sales price increases (from PLN 0.03 to PLN 70.00) were introduced for 37 products.
4. For 473 items in the notice, the patient's surcharge will fall (from PLN 0.01 to PLN 24.04).
5. For the 578 items in the notice, the patient surcharge will increase (from PLN 0.01 to PLN 138.63).
6. For 579 products, retail prices will be reduced (from PLN 0.01 to PLN 225.89).
7. For 408 products, retail prices will increase (from PLN 0.01 to PLN 82.34).
8. Due to the receipt of applications to shorten the term of reimbursement decisions, or the expiration of the term of reimbursement decisions or refusal of reimbursement for the next period, the announcement will not include 111 products or indications listed in the previous announcement.

NO CONTINUATION OF REIMBURSEMENT DUE TO WITHDRAWAL FROM THE MARKET

March 28, 2025. The European Commission (EC) has decided to refuse to renew the conditional marketing authorization for the medicinal product "Translarna - ataluren," granted by Decision C(2014)5619 final of July 31, 2014. The withdrawal of the marketing authorization in member countries results in a Europe-wide lack of funding and access to the therapy in question, including preventing further reimbursement of the drug Translarna in Poland.

The wording of the aforementioned decision shows that renewal of the marketing authorization is not possible due to the lack of evidence of a favorable benefit-risk ratio, i.e. taking into account all available data, the efficacy of the drug Translarna in the approved indication has not been demonstrated in any of its subpopulations.

However, the aforementioned EC decision did not provide for restrictions on the remaining on the market of the drug Translarna. Packages placed on the market prior to the date of the EC decision could remain on the market.

Considering the above, and taking into account the fact that the decision to include the drug Translarna in reimbursement under drug program B.130. treatment of patients with Duchenne muscular dystrophy caused by a nonsense mutation in the dystrophin gene (ICD-10: G71.0) was in force on the date of withdrawal of the marketing authorization, the Minister of Health, taking into account the wording of Article 117 (3) of Directive 2001/83/EC, allowed the reimbursement of the treatment of patients continuing therapy with the drug Translarna in program B.130, until 15.06.2025. This concerned packages remaining on the market after the decision of the European Commission.

ONCOLOGY DRUGS WITH WELL-ESTABLISHED EFFICACY

The amended Reimbursement Law has introduced a new pathway for processing reimbursement applications under Article 30a. The provisions set forth in Article 30a of the Reimbursement Law apply to drugs requiring use for more than 30 days for a specific clinical condition, recommended in clinical management guidelines, for which the applicant has not yet submitted a reimbursement application and the period of market exclusivity has expired. On the basis of Article 30a of the Reimbursement Law, the Agency for Health Technology Assessment and Tarification, after consultation with the Transparency Council, National Consultants and the Patient Ombudsman, has prepared a second list of drugs with established efficacy, concerning drugs for oncological indications.

On the basis of the aforementioned list, on May 8, 2025, the Minister of Health published a list of oncology drugs of well-established efficacy, which included 15 active substances in 26 molecular indications (the MZ list contains 17 items, as some of the molecular indications were cumulated into single items), thereby informing the responsible entities whose technologies were included in the aforementioned list of the possibility of submitting reimbursement applications. As a result of the submitted reimbursement applications under the aforementioned list of oncology drugs with established efficacy, as of July 1, 2025, 7 new molecular indications dedicated to oncology disease entities will be covered, which entailed the issuance of 11 additional reimbursement decisions under the chemotherapy catalog.

Source: MZ