Add to cart. May 8, It is worth noting here that Poland uses a broad definition of medical devices. April 20, The authors received no funding or benefits to conduct this study, whether from the industry or elsewhere. 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. Thus, patients will no longer have to pay for the procedure to be conducted in the private sector if they wish to use a non-reimbursed device; they will only cover the costs of the device itself. Changes in pharmaceutical reimbursement. 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 ]. Rather than being bundled in a single payment, procedures utilising devices e. No fixed margin on reimbursable products that are exported, combined with the negotiated manufacturer prices being low compared with many other European countries, result in shortages of some drugs in Polish pharmacies. As some patients may be unable to afford out-of-pocket payments for more expensive products [ 18 , 20 , 21 ], care should be taken to provide patients with a reasonable range of high-quality, affordable devices priced within, or only slightly above, the reimbursement limit. 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 ]. 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 the NHF exceeding its reimbursement budget [ 38 ].
May 8, More broadly, aligning reimbursement of all groups of medical devices with that of drugs means relying on out-of-pocket payments for products priced above the reimbursement limit. Sign in close. The option to limit reimbursement to a specific condition will, however, remain unchanged, thus separating reimbursement from the licensed indications specified in the SPC [ 27 ]. Possible implications of the proposed changes The attempt to apply a uniform set of rules to the diverse market of medical devices has sparked considerable criticism [ 17 , 18 ]. In addition to the co-pay, patients will cover any difference between the product price and the reimbursement limit out of pocket [ 1 ]. The remaining two categories encompass devices used in the outpatient setting. To allow manufacturers to smoothly transfer their currently reimbursed devices to the new system, the MoH will allow them to do so on preferential terms.
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Poland has operated a national vaccination programme since the s [ 30 ]. Payback only applies to those products for which the spending on reimbursement has increased since the preceding year, and the amount paid back depends on the reference price group that the product is in [ 5 ]. Lost your password? Access to orphan drugs: a comprehensive review of legislations, regulations and policies in 35 countries. Your name. January 26, 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. Implementation of the Reimbursement Act in Poland: desired and undesired effects of the changes in reimbursement policy. The proposed amendment on reimbursement of medical devices leaves these criteria largely unchanged, but adds the opinion of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products on the quality of the product as a factor influencing maximum manufacturer price. The MoH will be able to initiate such review under certain conditions. 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 ]. To allow manufacturers to smoothly transfer their currently reimbursed devices to the new system, the MoH will allow them to do so on preferential terms.
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- Nonetheless, the fees may come up to a substantial amount when the manufacturer applies, for example, for reimbursement of a family of related devices.
- October 11,
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- The changes will be introduced gradually to ensure continuity of supply.
- An additional, dedicated reimbursement budget will provide funding for the reimbursement of innovative products i.
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.
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Finally, introducing out-of-pocket payments for devices used within a procedure provides patients the opportunity to opt in for a higher-quality product, without having to pay for the entire procedure to be conducted in the private sector [ 21 ].
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