The authors received no funding or benefits to conduct this study, whether from the industry or elsewhere. Simple devices sold in pharmacies, reimbursed in the same manner as drugs e. However, the proposed amendment requires healthcare providers to allow patients access to only one appropriate device priced within the reimbursement limit, although they can offer more options [ 1 ]. 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 ]. However, simplifying the regulations alone seems insufficient, despite the apparent high hopes of the MoH regarding the proposed amendment. Details of innovation-based funding mechanisms will be defined in MoH decrees [ 2 ], drafts of which are currently not publicly available. 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 ]. July 19, The proposed amendment changes the way in which the reimbursement budget is formed to include income from risk-sharing instruments and payback [ 27 ]. September 7, No fixed margin on reimbursable products that are exported, combined with the negotiated manufacturer prices being low compared with many other European countries, result in shortages of some drugs in Polish pharmacies. Access to orphan drugs: a comprehensive review of legislations, regulations and policies in 35 countries. 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. Further details of the reimbursement regulations are available in the literature [ 13 ]. Changes in pharmaceutical reimbursement.
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 manufacturers applying for reimbursement of their devices will have to face a new, complex procedure, which will also involve HTA of novel devices. Poland has operated a national vaccination programme since the s [ 30 ]. For Urisys 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 changes will be introduced gradually to ensure continuity of supply. Drug prices in Poland are among the lowest in Europe.
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April 20, 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. To allow manufacturers to smoothly transfer their currently reimbursed devices to the new system, the MoH will allow them to do so on preferential terms. One-time test for saliva drugs. Current exceptions from statutory payback will continue to apply [ 27 ]. 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 ]. Hoping to improve patient access, the amendment introduces partial reimbursement for vaccines that are recommended, but not mandatory. Patients may also choose an appropriate product that is not reimbursed, covering its full cost [ 1 ]. Product Data Weight 0. Stockholm: ECDC;
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- The MoH will be able to initiate such review under certain conditions.
- Fidelity test to reveal infidelity Detects PSA antigen Incredibly accurate test method The test does not damage the material in any way It leaves no traces on the objects!
- Some devices used in the outpatient setting are included on the reimbursement list for drugs [ 1 ] — these are available in pharmacies [ 11 ] and are generally simple devices that do not require personalisation for each patient, pieluchomajtki pharma sensitive large, such as dressings and test strips for glucose monitoring.
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.
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Published online Sep The combination of free wholesale margins [ 41 ] and manufacturer prices being often substantially lower than in Western Europe [ 42 ] means that pharmaceuticals — especially cardiovascular drugs, anticoagulants and drugs used to treat asthma — are commonly exported, often leading to shortages of those drugs in Polish pharmacies [ 42pieluchomajtki pharma sensitive large, 43 ]. September 21,
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