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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. Finally, devices such as prostheses, infusion sets for insulin pumps, glasses and hearing aids, among others, require a special prescription from an appropriate specialist, which has to be approved by the NHF regional office 2 before the device can be reimbursed [ 1 , 14 , 15 ]. 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 ]. Access to orphan drugs: a comprehensive review of legislations, regulations and policies in 35 countries. This change is unlikely to have a substantial effect on the types of special nutritional products reimbursed. The programme is revised annually and an updated version is published every year by the Chief Sanitary Inspectorate [ 30 ]. 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. 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 ]. The amendment includes legislation that substantially simplifies payback [ 27 ]. They are completely safe for the skin because they do not cause chafing or skin irritation. This impact will be assessed by the Ministry for Economic Development; their opinion will affect the decision on spending of the investment-based funds and will be taken into account during pricing negotiations [ 27 ]. 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. Devices issued based on special prescription — separate reimbursement rules apply e. This may lead to wider uptake of these vaccines in Poland. Set individually during pricing negotiations; up to 5 years.

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The proposed amendment addresses this issue by linking innovation to pricing and reimbursement decisions. Currently, only licensed indications of pharmaceuticals are reimbursed in the outpatient setting i. January 24, September 21, Briefly, that means prices of reimbursed products are fixed and a reimbursement limit is set, defining the maximum amount that can be reimbursed [ 5 ]. Thus, the amendment establishes a fixed margin for exporters in an attempt to make pharmaceutical export less profitable and, consequently, limit it [ 3 , 34 ]. Increased flexibility and efficiency of defining drug programs. 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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However, as the deadlines for the next legislative steps are not fixed, the actual timeline for implementation is hard to predict. This universal full reimbursement includes both devices used within a procedure e. The decision to recommend a vaccine for inclusion in the national vaccination programme is evidence-based, factoring in disease burden, efficacy, effectiveness and safety of the vaccine, pharmacoeconomic analysis [ 31 ], epidemiological situation in Poland and neighbouring countries, and relevant vaccination policies in other countries [ 30 ]. The proposed amendment changes the way in which the reimbursement budget is formed to include income from risk-sharing instruments and payback [ 27 ]. 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 ]. Access to orphan drugs: a comprehensive review of legislations, regulations and policies in 35 countries. Quick view. Both amendments are still at a draft stage and many aspects of the new regulations remain unclear. An additional funding category will be established, with partial NHF funding and patient co-pay. 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 ]. 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 ]. 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 ]. Further details of the reimbursement regulations are available in the literature [ 13 ].

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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 ].
Changes to reimbursement policy in general Orphan and ultra-orphan drugs Current regulations apply uniform reimbursement rules to all drugs, regardless of the size of their target patient population.
Changes to reimbursement policy in general Orphan and ultra-orphan drugs Current regulations apply uniform reimbursement rules to all drugs, regardless of the size of their target patient population.

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.

Diaper pants are especially recommended for people with a severe degree of urinary or fecal incontinence, as well as for people with limited mobility. They are completely safe for the skin because they do not cause chafing or skin irritation. Log in. Your name. Your message. Send a pieluchomajtki pharma sensitive large to your email. Click to enlarge. Next product. Add to wishlist.

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