Following their introduction, the reimbursement landscape for most devices — with the exception of those already included on the drug reimbursement list — will change completely. The industry considered these changes to be positive; however, they recognised that little detail on innovation-based reimbursement has been provided thus far [ 34 ]. Currently, only licensed indications of pharmaceuticals are reimbursed in the outpatient setting i. 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 ]. Both amendments are still at a draft stage and many aspects of the new regulations remain unclear. Devices issued based on special prescription — separate reimbursement rules apply e. 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 ]. The proposed amendment on reimbursement of medical devices leaves these criteria largely unchanged, but adds the opinion of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products on the quality of the product as a factor influencing maximum manufacturer price. 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. 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. 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 ].
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 ]. This universal full reimbursement includes both devices used within a procedure e. It is worth noting here that Poland uses a broad definition of medical devices. 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 ]. 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 ]. Eligible patients will be those suffering from a chronic, serious or life-threatening illness, for whom there are no effective approved treatments [ 2 ]. Local governments may also support and facilitate group tenders among public hospitals in their area [ 10 ].
Oddychające Pieluchomajtki Pharma Sensitive Large
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. Simple devices sold in pharmacies, reimbursed in the same manner as drugs e. 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 ]. Acknowledgements The authors would like to thank Emna El Hammi, PhD for her helpful review and commentary on the manuscript and Krzysztof Kloc, MSc for help with interpreting some of the regulations outlined in this manuscript. In the long run, this may potentially simplify access to the Polish market by making the pricing and reimbursement regulations more straightforward to interpret. Current regulations Proposed amendment Medical devices Three reimbursement groups: 1. The proposed reimbursement mechanism is similar to that for drugs, requiring an application from the manufacturer, followed by a HTA and pricing negotiations, before the MoH issues a decision [ 27 ]. Thus, with the introduction of compassionate use programmes, patients who need them most will gain access to novel, investigational therapies, providing additional treatment options where no other therapies exist or are effective. Access to orphan drugs: a comprehensive review of legislations, regulations and policies in 35 countries. Such review at the discretion of the MoH is not possible under the current regulations [ 27 ] and this change is likely to raise concerns amongst the pharmaceutical industry [ 3 , 34 ]. 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. 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 ]. 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 [ 42 , 43 ].
Pieluchomajtki dla dorosłych - Sprzęt i wyroby medyczne - Apteka Internetowa Medest
- Increased flexibility and efficiency of defining drug programs.
- 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 pieluchomajtki pharma sensitive large device itself — is necessary for using the device as intended by the manufacturer [ 6 ] e.
- The amendment includes legislation that substantially simplifies payback [ 27 ].
- Simple devices sold in pharmacies, reimbursed in the same manner as drugs e.
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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However, in the private sector, group tenders are commonplace; a single tender may cover supplies for a whole network of private hospitals and outpatient clinics [ 10 ]. Devices used in the inpatient setting — fully reimbursed e.
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