New reimbursement list for drugs, foodstuffs for special nutritional purposes and medical devices – starting March 1, 2023.

Dariusz Marczuk

Dariusz Marczuk

Dyrektor Działu Prawnego

On February 20, 2023. a new list of reimbursable products was announced by the Minister of Health, taking effect on March 1, 2023.

The list (or, more precisely, the index) is announced in the official journal of the minister of health at least 7 days before the day for which the lists of reimbursed products are determined, as specified in Article 37 of the Law of 12.05.2011 on the reimbursement of medicines, dietary foods for special nutritional purposes and medical devices (hereinafter “UoRef” or “the Law”).

According to the statistics provided by the ministry in the Reimbursement Notice (68), it includes the following changes compared to Notice 67:

1. a total of 92 products or new indications were added to the list due to positive reimbursement decisions.

2. reductions in official selling prices were applied for 97 products (from 0.02 PLN to 3,896.40 PLN)

3. official selling prices were increased for 67 products (from 0.38 PLN to 2 160.00 PLN).

4. For 328 items in the announcement, the patient surcharge will decrease (from 0.01 PLN to 452.70 PLN).

5. For 601 items in the announcement, the patient surcharge will increase (from 0.01 PLN to 196.80 PLN).

6. For 385 products, gross retail prices will be reduced (from 0.01 PLN to 4 140.02 PLN).

7. For 180 products, gross retail prices will increase (from 0.01 PLN to 45.55 PLN).

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 36 products or indications listed in the previous announcement.

[Actually, it’s not “The announcement contains changes,” as stated in the summary, but rather “It is announced that (…), changes are made to the lists,” or “The announcement is made to the list (…) containing changes,” but this is a minor semantic detail. {Announcement} (def.) – the making public by a state body of the fact that a certain act has been performed or that a legal act has been announced].

The custom of presenting statistics as part of a notice is relatively new, having first appeared in Refund Notice No. 58 of June 21, 2021 (with the list effective July 1, 2021).

Are the statistics presented having informative and cognitive value, and if so, for whom, how to read them and what do they imply?

In order to properly understand the content of the statistics presented, it is necessary to refer to the text of the UoRef and directly to the definitions contained therein or derive them from the text of the law.

official selling price (“UCZ”) – the selling price of a drug, a foodstuff for special nutritional use, a medical device established in an administrative decision on reimbursement coverage, including the applicable value added tax;

The UCZ, in the terminology and systematics of the law, is, so to speak, the starting price, which before it reaches the patient, will still become the wholesale price (after the UCZ is increased by the official wholesale margin and the applicable value added tax), and then the retail price (after the UCZ is increased by the official wholesale margin and the official retail margin and the applicable value added tax).

Patient’s additional payment – the amount that the patient will be required to pay for the purchase price of the product in the pharmacy (retail price) over the limit of financing, i.e. the amount reimbursed by the National Health Fund.

According to the law, including a specific product in the reimbursement means that it will be available to the patient (depending on the content of the decision):

  • free of charge,
  • for a flat fee (currently 3.20 PLN) or
  • for a 30% or 50% payment of their funding limit
    – up to the amount of the funding limit and with a surcharge in the amount of the difference between the retail price and the amount of the funding limit, where the funding limit means that part of the price that will be covered by the National Health Fund.

Gross retail price – the final price of the product for the patient, in the statutory definition it is simply the retail price, with additional emphasis on its final nature and final for the patient.

Besides, we should compare the terms of decreases and decreases, increases and increases (in their respective forms) with the figures presented, which are supposed to show that statistically the situation of patients will improve (decreases in prices and patient subsidies prevail over their increases).

Is this really the case and does the statistical or mathematical difference presented directly translate into a better situation for patients, greater availability of drugs, drug programs or therapies?

It seems that an affirmative answer would be a controversial simplification, to say the least. Reimbursement is a systemic solution, at the budgetary level, but health matters as much as possible on an individual basis (in this context, for example, it is worth noting the content of point 8) of the Statistics).