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Thus, for products priced below the reimbursement limit, patients only cover the co-pay if applicable , while for products priced above the reimbursement limit patients pay the difference between that limit and the actual price, in addition to the co-pay [ 5 , 12 ]. However, rather than primarily focusing on public health, a Chief Medical Officer is appointed in each medical discipline e. Remember me. Radical changes to reimbursement policy in Poland. July 19, Related products. This may lead to wider uptake of these vaccines in Poland. Add to wishlist. Manufacturers have raised concerns about the fact that many types of devices — for instance leg prostheses or wheelchairs — vary considerably in their properties and therefore in price [ 19 ]. The MoH is hoping that the proposed changes will allow public spending on medical devices to become both more transparent and more efficient [ 1 ]. Both amendments are still in the relatively early stages of the legislative process, with public consultations completed only in the second half of Disclosure statement The authors received no funding or benefits to conduct this study, whether from the industry or elsewhere.

For each drug dosage and pharmaceutical form, reimbursed indications on- and off-label and prices are available on the reimbursement lists published by the MoH [ 36 ], as are the co-pay and reimbursement limit that apply to each indication see for instance [ 11 ] for an example reimbursement list. J Mark Access Health Policy. Current exceptions from statutory payback will continue to apply [ 27 ]. 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. Conclusion Similarly to other healthcare systems in Europe and around the world, the Polish healthcare system faces substantial cost constraints. Risk-sharing instruments and payback applied to health products The proposed amendment changes the way in which the reimbursement budget is formed to include income from risk-sharing instruments and payback [ 27 ]. The attempt to apply a uniform set of rules to the diverse market of medical devices has sparked considerable criticism [ 17 , 18 ].

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Lost your password? The first category comprises all types of devices used in the inpatient setting, which are supplied to the patient free of charge in line with the Publicly Funded Healthcare Services Act , as are drugs and special nutritional products 1 administered to hospitalised patients [ 1 , 8 ]. In addition to the co-pay, patients will cover any difference between the product price and the reimbursement limit out of pocket [ 1 ]. Other vaccines may be recommended e. When submitting a reimbursement application under the new rules for a device that is already reimbursed under current regulations, manufacturers will not have to pay the application fee or supply the analyses of clinical and pharmacoeconomic data, which would otherwise have to be provided according to the new regulations [ 1 ]. Current regulations apply uniform reimbursement rules to all drugs, regardless of the size of their target patient population. Poland has operated a national vaccination programme since the s [ 30 ]. The reimbursement system in Poland is soon likely to change significantly, with two amendments to the reimbursement act currently under discussion. Simple devices sold in pharmacies, reimbursed in the same manner as drugs e. July 19, However, as the deadlines for the next legislative steps are not fixed, the actual timeline for implementation is hard to predict.

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• The MoH is hoping that the proposed changes will allow public spending on medical devices to become both more transparent and more efficient [ 1 ].
• Parallel import of pharmaceuticals Drug prices in Poland are among the lowest in Europe.
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• The MoH is hoping that, by reducing patient costs, the changes will improve access to vaccines that are currently not mandatory according to the national programme [ 27 ].

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.

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Changes to medical device reimbursement

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Other aspects of the drug pricing and reimbursement process The proposed amendment also includes new regulations on a number of other aspects of pricing and reimbursement in Poland. When applying for reimbursement of different device variants models, versions, sizes, pieluchomajtki pharma sensitive large, etc.