POLAND Law and Practice Contributed by: Marcin Tomasik, Tomasz Jaworski, Filip Gołba and Jakub Matusiak, Tomasik Jaworski Sp.p.
with a different international name but similar ther- apeutic effects and similar mechanisms of action should be classified in a single group. Medical devices or foodstuffs intended for particular nutritional uses are classified in a single group if they have the same or similar reimbursement indications or uses and similar efficacy. The net disposal price of the first equivalent on the list may not be higher than 75% of the net selling price of the presentation with the lowest cost per defined daily dose, calculated according to the net selling price of the only counterpart reimbursed in a given indication. In the case of subsequent counterparts, the net dis- posal price may not be higher than the price of the counterpart determining the basis of the financing limit or the cheapest counterpart if the basis for the limit in the limit group is a drug that is not equivalent to the subject of the application. After the market exclusivity expires, the new net dis- posal price cannot be higher than 75% of the prod- uct’s price during the previous decision period, sub- ject to the statutory mechanism. 8.2 Price Levels of Pharmaceuticals or Medical Devices External reference pricing is a formal part of the reim- bursement application and pricing framework. As a rule, the applicant must submit information on the minimum and maximum net prices (and reimburse- ment status) of the product in EU/EFTA countries over the preceding year and, where not publicly funded, the market price information. Moreover, in the course of the negotiations, the Eco- nomic Commission typically uses this international price information as one of the inputs when negotiat- ing and assessing price competitiveness and budget impact. The Economic Commission can also consider rebates, discounts or price agreements in these coun- tries. Usually, it is expected that the price will be among the lowest in the EEA member states. An applicant must provide the prices of a product, together with informa- tion on the reimbursement status of the product (level of reimbursement, conditions, restrictions, existence
of risk-sharing schemes, for which indications it is reimbursed) in all EEA member states. 8.3 Reimbursement From Public Funds Polish public health funding includes reimbursement of medicinal products, medical devices and foodstuffs intended for particular nutritional uses that are pro- vided to patients in publicly funded establishments and purchased by them in pharmacies and pharmacy outlets. With regard to medicinal products purchased in pharmacies and pharmacy outlets, virtually only prescription medicines are reimbursed; although the law has allowed the possibility of reimbursing OTC medicines, this possibility has never been used. More- over, the planned amendment to the Reimbursement Act provides for the discontinuation of this option. The levels of reimbursement are as follows. • 100% reimbursement (free of charge) – products with proven efficacy in the treatment of malignant cancer, psychotic disorders, mental disability and development disorders, or contagious diseases posing a special epidemic risk for the population. Also, as a rule, products reimbursed within drug programmes and chemotherapy are provided to (a) products that must be administered for more than 30 days and whose monthly administra - tion cost for the service recipient would, in the case of a payment level of 30% of the financing limit, exceed 5% of the minimum wage; and (b) products that must be administered for no more than 30 days and whose cost for the ser- vice recipient would, in the case of a payment level of 50% of the financing limit, exceed 30% of the minimum wage for work. • Partial reimbursement – 50% of the financing limit, for products that must be administered for not more than 30 days. • Partial reimbursement – 70% of the financing limit, for other products. These patient payment amounts are reduced by 10% if the medicine is made in Poland or if an active sub- stance made in Poland was used in its manufacture. patients free of charge. • Lump sum (PLN3.20):
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