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Reimbursement decisions will be issued on request of the manufacturer, but such requests may only be filed for device types covered in the decrees [ 1 ]. 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 ]. Among other changes, the amendment proposes that the descriptions of drug programmes — specifying the conditions under which costly, novel and otherwise paid for out-of-pocket therapies are fully reimbursed for patients meeting the inclusion criteria — are separated from reimbursement decisions for products included in those programmes [ 27 ]. 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 ]. Take 10 minutes, gather courage and test in the comfort of your home for cervical and genital wart cancer. Group tenders are not as common in Poland as they are in many other countries, although public hospital managers have been growing more in favour of them lately [ 10 ]. Creativ-Ceutical is a consulting company that provides pricing and reimbursement-related services worldwide, including Poland. The product manufacturer will have to apply for MoH approval of a compassionate use programme; among other items, the application form should include a description of the target patient group together with an estimate of its size, a description of the disease state, with information on the lack of approved products that could be used in this setting, and criteria for patient inclusion and exclusion into the programme [ 2 ]. Lost your password? Disclosure statement The authors received no funding or benefits to conduct this study, whether from the industry or elsewhere. Novel devices, for which no equivalent device is available, will be subject to health technology assessment HTA and risk-sharing agreements, analogous to those applying to pharmaceuticals [ 1 ]. The timeline for the general amendment is also unclear. The pricing and reimbursement of this device group is regulated in the same manner as that of drugs [ 1 ]. 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.

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 ]. Drug prices in Poland are among the lowest in Europe. July 19, 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. For manufacturers wanting to access the Polish medical devices market, the proposed changes are indeed revolutionary. Radical changes to reimbursement policy in Poland. As such, device choice for patients who cannot afford out-of-pocket payments may be limited. Stockholm: ECDC; An additional, dedicated reimbursement budget will provide funding for the reimbursement of innovative products i.

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Sign in close. One-time test for saliva drugs. April 20, 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. 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 ]. June 27, 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 ]. Similarly to other healthcare systems in Europe and around the world, the Polish healthcare system faces substantial cost constraints. 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 ]. The proposed amendment changes the way in which the reimbursement budget is formed to include income from risk-sharing instruments and payback [ 27 ]. Parallel import of pharmaceuticals Drug prices in Poland are among the lowest in Europe. The first category of medical devices comprises all types of devices that are supplied to patients admitted to hospitals and other providers of inpatient care e. For this device category, the legislation defines the indications in which the product may be reimbursed, the reimbursement limit a cap on the reimbursed amount — if the patient chooses a more expensive product, they will need to cover the difference between the limit and the actual price out-of-pocket, in addition to any co-pay , the applicable patient co-pay, how often a new replacement device can be reimbursed, and a separate reimbursement limit for any necessary repairs of the device [ 15 ]. At present, the NHF reimburses three broad categories of medical devices [ 1 ]. Fixed at 2, 3 or 5 years, based on how long the drug has been reimbursed in that indication.

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• Local governments may also support and facilitate group tenders among public hospitals in their area [ 10 ].
• Local governments may also support and facilitate group tenders among public hospitals in their area [ 10 ].
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• To control innovation-based spending, the risk-sharing instruments will also state that the manufacturer has to pay back any reimbursement exceeding a specified limit [ 27 ].
• 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 ].
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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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Changes to medical device reimbursement

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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 pieluchomajtki pharma sensitive large pampers konowalski co-pay and reimbursement limit that apply to each indication see for instance [ 11 ] for an example reimbursement list. Devices used in the inpatient setting — fully reimbursed e. An additional funding category will be established, with partial NHF funding and patient co-pay.