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Care is free at point of delivery for those covered by the NHF, although some out-of-pocket payments exist for drugs and medical devices issued in the outpatient sector. Some devices used in the outpatient setting are included on the reimbursement list for drugs [ 1 ] — these are available in pharmacies [ 11 ] and are generally simple devices that do not require personalisation for each patient, such as dressings and test strips for glucose monitoring. The timeline for the general amendment is also 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. Similarly, a patient attending an accident and emergency department with a broken leg will not be required to pay for the cast as having the leg put in a cast would fall under emergency care , but may subsequently be required to purchase an orthosis, which would fall into the third category of devices, i. Indeed, while many of the proposed changes have been well received by the pharmaceutical industry, some — including those related to medical devices — have raised considerable criticism. Currently, only licensed indications of pharmaceuticals are reimbursed in the outpatient setting i. Shopping cart close. Drug prices in Poland are among the lowest in Europe. The combination of free wholesale margins [ 41 ] and manufacturer prices being often substantially lower than in Western Europe [ 42 ] means that pharmaceuticals — especially cardiovascular drugs, anticoagulants and drugs used to treat asthma — are commonly exported, often leading to shortages of those drugs in Polish pharmacies [ 42 , 43 ]. For Urisys Product Data Weight 0. Proposed changes to medical device reimbursement In order to improve access and optimise NHF spending on medical devices, the Ministry of Health MoH proposed a number of changes to medical devices reimbursement [ 1 ]. However, the amendment also introduces another substantial change, as the MoH will be able to initiate a review of reimbursement conditions before the expiry of an existing reimbursement decision e.

Reimbursement of vaccines Poland has operated a national vaccination programme since the s [ 30 ]. Importantly, devices used as part of a procedure — which are currently included in a bundle payment with the procedure itself — will go through their own, separate pricing and reimbursement process [ 1 ]. ABSTRACT 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. Poland has operated a national vaccination programme since the s [ 30 ]. One-time test for saliva drugs. 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 ]. May 8, Although devices will be assigned a reference price group based not only on their target indication and mechanism of action, but also on their effectiveness, technology used, adherence to applicable quality standards and cost-effectiveness, for some devices, it may prove difficult to cluster their myriad different types into reference price groups.

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At the moment, the drug programmes and the relevant reimbursement decisions are linked, so that implementing any changes to the programme itself requires the permission of all manufacturers whose products are included in it [ 27 ]. Similarly, a patient attending an accident and emergency department with a broken leg will not be required to pay for the cast as having the leg put in a cast would fall under emergency care , but may subsequently be required to purchase an orthosis, which would fall into the third category of devices, i. November 28, Key highlights The proposed changes introduce uniform reimbursement mechanisms for all medical devices, replacing the three distinct reimbursement groups currently in place. January 24, 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 ]. Major changes to the pricing and reimbursement regulations included in these amendments are listed in Table 1. 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 ]. Drug prices in Poland are among the lowest in Europe. While the exact shape of the new regulations remains to be seen, their overall direction is clear, likely bringing substantial challenges — especially for smaller device manufacturers, who will now have to face additional bureaucracy associated with reimbursement applications and, in case of novel devices, HTA.

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• Changes to the payback mechanism are criticised by domestic manufacturers, who mostly produce — relatively cheap — generics and therefore do not see themselves as really contributing to pieluchomajtki pharma sensitive large NHF exceeding its reimbursement budget [ 38 ].
• The proposed amendment addresses this issue by linking innovation to pricing and reimbursement decisions.
• Overview of the current regulations on reimbursement of medical devices Similar to other European countries, Poland operates a public health insurance system.
• 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, pieluchomajtki pharma sensitive large, 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 ].
• Thus, products for which risk-sharing instruments are in place — that is, mostly novel, expensive treatments — will be exempt from payback [ 27 ].
• Export margins are, at present, not specified in the Reimbursement Act [ 5 ], and the fixed wholesale margins are not applied to drugs intended for export, leaving wholesalers free to set their own margins [ 40 ].

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. 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.

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Changes to medical device reimbursement

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The proposed amendment also includes pieluchomajtki pharma sensitive large regulations on a number of other aspects of pricing and reimbursement in Poland. The changes will be introduced gradually to ensure continuity of supply. However, rather than primarily focusing on public health, a Chief Medical Officer is appointed in each medical discipline e.