For the purpose of financing from public funds, some medicines, foodstuffs for particular nutritional uses and medical devices are grouped into the so-called limit groups, i.e. groups of medicines, foodstuffs for particular nutritional uses or medical devices with a common financing limit, determined by the so-called limit base. In accordance with Article 15(2) of the Act of 12 May 2011 on the reimbursement of medicines, foodstuffs for particular nutritional uses and medical devices (Journal of Laws of 2020, item 357), medicines with the same international name or other international names, but with similar therapeutic effect and similar mechanism of action, as well as and foodstuffs for particular nutritional uses, medical devices, are included into a common limit group, using the following criteria:
- the same indications or uses, for which they are reimbursed;
- similar efficacy.
The manner in which technologies are allocated into limit groups has a direct impact on their cost for the public payer and the patient, as technologies in a common limit group are subject to a common funding limit; the limit for a technology allocated to a separate group will be determined on its basis. Both the Transparency Council and the President of the Agency for Health Technology Assessment and Tariff System i express an opinion on the inclusion of technology in the existing limit group or the creation of a new one in their statements. Taking into consideration the Transparency Council’s opinion, based i.a. on a comparison of the costs of obtaining a similar health effect or an additional health effect, the Minister of Health may create, contrary to the criteria set out in Article 15(2) of the Reimbursement Act:
- a separate limit group, where the route of administration of the medicine or its pharmaceutical form significantly affects the health outcome or additional health benefit;
- a common limit group, where a similar health outcome or a similar additional health benefit is obtained despite the medicines’ different mechanisms of action;
- a separate limit group for foodstuffs for particular nutritional uses, where the nutrient content has a significant effect on the health outcome or additional health benefit
The above-mentioned opinion of the Transparency Council on the qualification for the limit group is issued within the deadline specified by the Minister of Health and is published in the Agency’s Public Information Bulletin.