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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. Closely linked to reimbursement decisions for included products, so that any changes need approval of all affected manufacturers. Click to enlarge. Eligible patients will be those suffering from a chronic, serious or life-threatening illness, for whom there are no effective approved treatments [ 2 ]. The amendment introduces the concept of compassionate use in Poland — a change that has been well received by the industry [ 34 ]. The pricing and reimbursement of this device group is regulated in the same manner as that of drugs [ 1 ]. 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. Simple devices sold in pharmacies, reimbursed in the same manner as drugs e. Patients may also choose an appropriate product that is not reimbursed, covering its full cost [ 1 ]. 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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Increased flexibility and efficiency of defining drug programs. Changes in pharmaceutical reimbursement. 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 ]. 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. July 11, The authors received no funding or benefits to conduct this study, whether from the industry or elsewhere.

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Current regulations apply uniform reimbursement rules to all drugs, regardless of the size of their target patient population. Off-label use of drugs Currently, only licensed indications of pharmaceuticals are reimbursed in the outpatient setting i. Thus, the amendment establishes a fixed margin for exporters in an attempt to make pharmaceutical export less profitable and, consequently, limit it [ 3 , 34 ]. 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 ]. 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 ]. Remember me. 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 ]. No account yet? For Urisys Continence pads may become one of the first medical device groups to fall under the new regulations [ 17 ]. Health Policy. April 20, Create an Account. Both amendments are still at a draft stage and many aspects of the new regulations remain unclear.

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Access to orphan drugs: a comprehensive review of legislations, regulations and policies in 35 countries.
For each drug dosage and pharmaceutical form, reimbursed pieluchomajtki pharma sensitive large 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.
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The pricing and reimbursement of this device group is regulated in the same manner as that of drugs [ 1 ].
Remember me.
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 ].

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.

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 pieluchomajtki pharma sensitive large. Log in. Your name. Your message. Send a copy to your email. Click to enlarge.

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