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. Key highlights The proposed changes introduce uniform reimbursement mechanisms for all medical devices, replacing the three distinct reimbursement groups currently in place. Overview of the current regulations on reimbursement of medical devices Similar to other European countries, Poland operates a public health insurance system. The reason for this is that devices are usually selected to suit individual patients and their needs some may even be personalised, e. 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. Disclosure statement The authors received no funding or benefits to conduct this study, whether from the industry or elsewhere. Your message. 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. 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 ]. Off-label use of drugs Currently, only licensed indications of pharmaceuticals are reimbursed in the outpatient setting i. July 19, 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. According to the Medical Devices Act [ 6 ], a medical device is.
Similarly, a patient attending an accident and emergency department with a broken leg will not be required to pay for the cast as having the leg put in a cast would fall under emergency care , but may subsequently be required to purchase an orthosis, which would fall into the third category of devices, i. Send a copy to your email. Product Data Weight 0. Current exceptions from statutory payback will continue to apply [ 27 ]. PiS is thinking of permitting only pharmacists to own a pharmacy]. The amendment introduces the concept of compassionate use in Poland, allowing patients who have no other treatment options to access innovative products. This change is unlikely to have a substantial effect on the types of special nutritional products reimbursed. Your message. 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 ]. Remember me.
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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. Click to enlarge. Health Policy. Thus, for products priced below the reimbursement limit, patients only cover the co-pay if applicable , while for products priced above the reimbursement limit patients pay the difference between that limit and the actual price, in addition to the co-pay [ 5 , 12 ]. Current regulations Proposed amendment Medical devices Three reimbursement groups: 1. Devices issued based on special prescription — separate reimbursement rules apply e. Patient access to novel medications is often severely restricted and the reimbursement process itself is relatively non-transparent. October 11, Product Data Weight 0. 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. 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.
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- Finally, introducing out-of-pocket payments for devices pieluchomajtki pharma sensitive large 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 ].
- 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 ].
- Similarly to other healthcare systems in Europe and around the world, the Polish healthcare system faces substantial cost constraints.
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.
Diaper pants are especially recommended for people with a severe degree of urinary or fecal incontinence, as well as for people with limited mobility, pieluchomajtki pharma sensitive large. They are completely safe for the skin because they do not cause chafing or skin irritation. Log in. Your name. Your message. Send a copy to your email.
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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 ]. Currently, only licensed indications of pharmaceuticals are reimbursed in the outpatient setting i, pieluchomajtki pharma sensitive large.
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