Received Jun 6; Accepted Sep 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 ]. Furthermore, issues such as the reimbursement of drugs for orphan diseases are not addressed in the proposed amendments, and some of the new regulations e. Thus, the amendment establishes a fixed margin for exporters in an attempt to make pharmaceutical export less profitable and, consequently, limit it [ 3 , 34 ]. 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 ]. Stockholm: ECDC; The amendment introduces the concept of compassionate use in Poland, allowing patients who have no other treatment options to access innovative products. 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 ]. Set individually during pricing negotiations; up to 5 years. In the long run, this may potentially simplify access to the Polish market by making the pricing and reimbursement regulations more straightforward to interpret. The reimbursement system in Poland is soon likely to change significantly, with two amendments to the reimbursement act currently under discussion. The timeline for the general amendment is also unclear.
However, despite earlier suggestions from MoH officials that the reimbursement changes will apply to both orphan and ultra-orphan products [ 28 ], the proposed amendment focuses solely on ultra-rare diseases [ 29 ]. 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 ]. Another proposed change relates to reimbursement decisions themselves, which are currently valid for two, three or five years, depending on how established the drug is in the given indication [ 5 ]. 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. Related products. Rather than being bundled in a single payment, procedures utilising devices e.
Changes to medical device reimbursement
Sign in close. Manufacturers will need to submit a pricing and reimbursement application, accompanied by a device quality analysis performed by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products [ 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 ]. At present, the amount of payback is determined through a complex mechanism, triggered by the NHF exceeding its total reimbursement budget [ 5 ]. 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. 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 ]. November 15, 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. This universal full reimbursement includes both devices used within a procedure e. For use with Multicare IN. June 27, May 8, Stockholm: ECDC; 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 ]. Thus, products for which risk-sharing instruments are in place — that is, mostly novel, expensive treatments — will be exempt from payback [ 27 ].
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- At present, the NHF reimburses three broad categories of medical devices [ 1 ].
- It will be interesting to see which of the proposed changes are, in fact, implemented, and what exact shape they take.
- Details of innovation-based funding mechanisms will be defined in MoH decrees [ 2 ], drafts of which are currently not publicly available.
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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Current regulations apply uniform reimbursement rules to all drugs, regardless of the size of their target patient population. Indeed, pieluchomajtki pharma sensitive large, 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. 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.
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