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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. The changes will be introduced gradually to ensure continuity of supply. 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. PLoS One. The programme is revised annually and an updated version is published every year by the Chief Sanitary Inspectorate [ 30 ]. As such, device choice for patients who cannot afford out-of-pocket payments may be limited. These off-label indications are established through discussions with the relevant Chief Medical Officers 4 and AOTMiT [ 35 ], allowing the reimbursed indications to be extended beyond those specified in the summary of product characteristics SPC. Health Policy. The amendment includes legislation that substantially simplifies payback [ 27 ]. Following their introduction, the reimbursement landscape for most devices — with the exception of those already included on the drug reimbursement list — will change completely.

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. Currently, only licensed indications of pharmaceuticals are reimbursed in the outpatient setting i. Further, the time period between updates to the list of reimbursed products will also be extended, so that the list is published quarterly [ 27 ], rather than every other month, as is currently the case. 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. When applying for reimbursement of different device variants models, versions, sizes, etc. As a library, NLM provides access to scientific literature. 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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Following their introduction, the reimbursement landscape for most devices — with the exception of those already included on the drug reimbursement list — will change completely. 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. June 27, Access to orphan drugs: a comprehensive review of legislations, regulations and policies in 35 countries. Infidelity test to detect infidelity Detects PSA antigen UV lamp detecting sperm The test does not damage the material in any way It leaves no traces on the objects! As such, device choice for patients who cannot afford out-of-pocket payments may be limited. Among others, these factors include the opinion of the Economic Commission which negotiates prices on behalf of the MoH , Polish HTA Agency AOTMiT recommendation if applicable , importance of the condition, clinical efficacy and effectiveness, safety, budget impact and cost-effectiveness. 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. 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. However, as the deadlines for the next legislative steps are not fixed, the actual timeline for implementation is hard to predict. 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. 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 ]. Changes to medical device reimbursement Definition of medical devices used 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. Poland has operated a national vaccination programme since the s [ 30 ].

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• The reimbursement system in Poland is soon likely to change significantly, with two amendments to the reimbursement act currently under discussion.
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• Finally, the MoH will publish a list of all reimbursement applications received, together with their progress status, in a bid to increase the transparency of the reimbursement process [ 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. 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. Similar to other European countries, Poland operates a public health insurance system.

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Changes to medical device reimbursement

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Local governments may also support and facilitate group tenders among public hospitals in their area [ 10 ]. A brief comparison of the current and proposed regulations.