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A commentary from one of the orphan disease patient organisations interpreted this narrowing of the patient population in focus — from orphan to ultra-orphan indications only — as an attempt to control spending, and criticised the lack of proposed means for increasing the reimbursement level of orphan drugs, given that few orphan products are reimbursed in Poland [ 29 ]. November 29, Such review at the discretion of the MoH is not possible under the current regulations [ 27 ] and this change is likely to raise concerns amongst the pharmaceutical industry [ 3 , 34 ]. Current exceptions from statutory payback will continue to apply [ 27 ]. The changes will be introduced gradually to ensure continuity of supply. When applying for reimbursement of different device variants models, versions, sizes, etc. Other vaccines may be recommended e. The project proposes to combine the three different reimbursement categories outlined above using a single approach, whereby the reimbursement of all medical devices would be aligned with that of drugs [ 1 ]. From this definition, it is clear that the proposed changes to medical device reimbursement will affect a wide range of products, including, but not limited to, therapeutic, diagnostic and implantable devices. Briefly, that means prices of reimbursed products are fixed and a reimbursement limit is set, defining the maximum amount that can be reimbursed [ 5 ].

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Click to enlarge. This threshold appears rather stringent, given that reimbursement decisions based on clinical value and measures of innovation — rather than a formal cost-effectiveness analysis — may lead to broader coverage for orphan drugs [ 26 ], thus improving patient access. From this definition, it is clear that the proposed changes to medical device reimbursement will affect a wide range of products, including, but not limited to, therapeutic, diagnostic and implantable devices. Compassionate use of medicines At present, the Polish regulations do not include any guidance on compassionate use of drugs, severely limiting patient access to investigational treatments that show promises in clinical trials but have not yet been granted a marketing authorisation [ 27 ]. The proposed amendment changes the way in which the reimbursement budget is formed to include income from risk-sharing instruments and payback [ 27 ]. At a conference with the Polish pharmaceutical industry, an MoH representative mentioned that the aforementioned opinion from the Ministry for Economic Development will also be taken into account when calculating the incremental cost-effectiveness ratio for innovative products [ 37 ].

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As a library, NLM provides access to scientific literature. At the same time, however, the patient organisation representative noted that the proposed amendment is the first to introduce special provisions for orphan indications, and saw this as a positive change from orphan diseases not being previously considered as a separate entity [ 29 ]. A commentary from one of the orphan disease patient organisations interpreted this narrowing of the patient population in focus — from orphan to ultra-orphan indications only — as an attempt to control spending, and criticised the lack of proposed means for increasing the reimbursement level of orphan drugs, given that few orphan products are reimbursed in Poland [ 29 ]. The proposed amendment also includes new regulations on a number of other aspects of pricing and reimbursement in Poland. November 29, Patients undergoing a procedure will be able to choose from a range of appropriate devices, opting for a product priced within the limit which will be the default option, guaranteed to all those insured or a more expensive device, in which case patients will cover the difference between its price and the reimbursement limit [ 1 ]. Poland has operated a national vaccination programme since the s [ 30 ]. The proposed amendment changes the way in which the reimbursement budget is formed to include income from risk-sharing instruments and payback [ 27 ]. Implementation of the Reimbursement Act in Poland: desired and undesired effects of the changes in reimbursement policy. The MoH is hoping that introducing the proposed changes will resolve some of the issues, optimising the reimbursement process, improving patient access and ensuring public funds are spent more rationally. Drug prices in Poland are among the lowest in Europe. In the long run, this may potentially simplify access to the Polish market by making the pricing and reimbursement regulations more straightforward to interpret.

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For Urisys
Current regulations apply uniform reimbursement rules to all drugs, regardless of the size of their target patient population.
The proposed amendment changes the way in which the reimbursement budget is formed to include income from risk-sharing instruments and payback [ 27 ].
Both amendments are still in the relatively early stages of the legislative process, with public consultations completed only in the second half of
The programme is revised annually and an updated version is published every year by the Chief Sanitary Inspectorate [ 30 ].
However, as the deadlines for the next legislative steps are not fixed, the actual timeline for implementation is hard to predict.

Federal government websites often end in. The site is secure. In Poland, two proposed amendments to the reimbursement act are currently in preparation; these are likely to substantially change the pricing and reimbursement landscape for both drugs and medical devices. Both amendments are still at a draft stage and many aspects of the new regulations remain unclear. Nonetheless, the overall direction of some of the changes is already evident and warrants discussion due to their high expected impact on pharmaceutical and device manufacturers. Here we evaluate the main changes proposed to the reimbursement of drugs, vaccines, and medical devices, and examine the impact they are likely to have on market access and pharmaceutical industry in Poland. The reimbursement system in Poland is soon likely to change significantly, with two amendments to the reimbursement act currently under discussion. The first amendment relates to the reimbursement of medical devices, aligning it with that of pharmaceuticals [ 1 ], while the other one proposes major changes to the overall reimbursement system for drugs and vaccines [ 2 ]. Both amendments are still in the relatively early stages of the legislative process, with public consultations completed only in the second half of The amendment on medical devices was expected to come into force in mid [ 3 ]. Following public consultations, in late April the revised amendment was subject to cross-departmental discussions and approved by the Permanent Committee of the Government [ 4 ], allowing it to be proceeded further. However, as the deadlines for the next legislative steps are not fixed, the actual timeline for implementation is hard to predict. The timeline for the general amendment is also unclear. Major changes to the pricing and reimbursement regulations included in these amendments are listed in Table 1. This article aims to review the key changes proposed to the reimbursement of drugs, vaccines, and medical devices, and assess their potential impact on market access and pharmaceutical industry in Poland. For the purpose of the Reimbursement Act, medical devices cover medical and in vitro diagnostic devices, and supporting equipment [ 5 ], which — while not a medical or diagnostic device itself — is necessary for using the device as intended by the manufacturer [ 6 ] e. It is worth noting here that Poland uses a broad definition of medical devices. According to the Medical Devices Act [ 6 ], a medical device is.

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