Log in. October 11, The MoH is hoping that introducing the proposed changes will resolve some of the issues, optimising the reimbursement process, improving patient access and ensuring public funds are spent more rationally. The attempt to apply a uniform set of rules to the diverse market of medical devices has sparked considerable criticism [ 17 , 18 ]. Changes in pharmaceutical reimbursement. For instance, a patient having a blood test funded by the NHF will not have to pay for the syringes, swabs and storage vials used, even if the test is conducted at their GP clinic or another outpatient clinic e. Finally, devices such as prostheses, infusion sets for insulin pumps, glasses and hearing aids, among others, require a special prescription from an appropriate specialist, which has to be approved by the NHF regional office 2 before the device can be reimbursed [ 1 , 14 , 15 ]. The reason for this is that devices are usually selected to suit individual patients and their needs some may even be personalised, e. With the reimbursement of medical devices aligned with that of pharmaceuticals, the changes to the reimbursement system are likely to result in closely similar regulations being applied across the market, for pharmaceuticals, medical devices and special nutritional products alike. 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 ]. 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. PLoS One. Disclosure statement The authors received no funding or benefits to conduct this study, whether from the industry or elsewhere.
The reimbursement mechanism for compassionate use programmes is, however, unclear at present. Tenders usually take place at individual hospital level. April 6, The option to limit reimbursement to a specific condition will, however, remain unchanged, thus separating reimbursement from the licensed indications specified in the SPC [ 27 ]. Shopping cart close. For use with Multicare IN. Product Data Weight 0.
Changes to medical device reimbursement
Hoping to improve patient access, the amendment introduces partial reimbursement for vaccines that are recommended, but not mandatory. Current exceptions from statutory payback will continue to apply [ 27 ]. Your message. 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 ]. Related products. 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, such as dressings and test strips for glucose monitoring. Changes to the payback mechanism are criticised by domestic manufacturers, who mostly produce — relatively cheap — generics and therefore do not see themselves as really contributing to the NHF exceeding its reimbursement budget [ 38 ]. 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 ]. Disclosure statement The authors received no funding or benefits to conduct this study, whether from the industry or elsewhere. However, rather than primarily focusing on public health, a Chief Medical Officer is appointed in each medical discipline e. 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 ]. 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 ]. It is worth noting that, in terms of medical device supply, the boundary between inpatient and outpatient care is not clear-cut. At present, the NHF reimburses three broad categories of medical devices [ 1 ]. One-time test for saliva drugs.
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- 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.
- Related products.
- 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 ].
- Published online Sep
- The MoH is hoping that introducing the proposed changes will resolve some of the issues, optimising the reimbursement process, improving patient access and ensuring public funds are spent more rationally.
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.
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The authors received no funding or benefits to conduct this study, whether from the industry or elsewhere.
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