No End Seen to Problems Plaguing Polish Pharma Sector As Shortage of Chemotherapy Drugs Hits Patients

NFZ Willing to Prepare for Transfer to "Drug Programmes"

Poland's National Health Fund (NFZ) has reportedly softened its stance on the request from the Ministry of Health (MoH) to start the process of preparing for hospital contracting on the basis of reimbursement decisions on medicines used in therapeutic programmes, which are due to be replaced by "drug" programmes from the beginning of July, as well as medicines listed by the NFZ for use in chemotherapy. There is concern that there will not be enough time for the NFZ to complete the process before the changeover in July, however, as it requires around three months to complete the contracting process with hospitals.

The NFZ has stated that the basis for issuing regulations on the reimbursement of medicines and announcing competition procedures is a new reimbursement list, and not a reimbursement decision made by the MoH. As the next reimbursement list is only due to be issued on 1 May, however, this would only give the NFZ two months to complete the process, which is insufficient. Thus, as Polish healthcare news provider Rynek Zdrowia reports, the MoH decreed on 21 March that the NFZ may proceed on the basis of a reimbursement decision, prompting a war of words between the MoH and the NFZ.

Rynek Zdrowia reports that the NFZ has now stated its willingness to proceed on the basis requested by the MoH, in order to complete the process within the short time available. The source reports that the NFZ has received data on 531 medicines currently used in chemotherapy and 43 drug programmes, and the NFZ is due to start working on preparing draft regulations concerning the conditions for contracts with hospitals.

In spite of this, concern remains regarding the time limit, particularly considering the many errors reportedly found in the reimbursement decisions issued by the MoH, according to legal expert Lukasz Slawatyniec, quoted by Rynek Zdrowia.

Doctors Threaten to Stop Prescribing Reimbursed Medicines

Additionally, doctors employed in the public healthcare system are threatening to stop prescribing reimbursed medicines completely from July, if the new rules introduced with the Reimbursement Act meaning reimbursement is not provided in the case of off-label uses of medicines (although there are exceptions) are not changed. Polish newspaper Rzeczpospolita reports that doctors want to be able to prescribe medicines according to medical knowledge, and not on the basis of the registered indications of the medicines, and they oppose the fact that this rule means many patients are denied access to reimbursement.

Supply of Ebewe Chemotherapy Drugs Cut

Meanwhile, it has been reported that some essential oncology medicines are in very short supply in Poland; specifically, this refers to cisplatin, doxorubicin, etoposide, and carboplatin. As Polish newspaper Gazeta Wyborcza reports, the shortage in the supply of these medicines is related to supply problems by German generics producer Ebewe, which had warned in 2011 that, as a result of modernisation of its production lines, there would be a temporary shortfall in supply. Although the company stated that this would be resolved by March 2012, it is still continuing. The source reports that Polish television channel TVN carried a report stating that Ebewe had admitted that the real reason for the cut in supply is not production issues, but the fact that sale of these drugs is not profitable, and therefore it is withdrawing them from the market. Poland's MoH has denied this, with Gazeta Wyborcza quoting deputy health minister Jakub Szulc as saying that Ebewe had informed the MoH that the interval in production was ongoing. Szulc also stated that there are equivalents that can be used instead of the Ebewe products; however, according to a report by Rynek Zdrowia, hospitals must rely on direct imports, but these are not sufficient to ensure the continuity of treatment of patients.

MoH spokesperson Agnieszka Golabek is quoted by Gazeta Wyborcza as saying that the same problem has been observed in the case of the drugs mentioned in other European countries, as well as the United States. Golabek added that the official prices of the drugs in question were negotiated with Swiss firm Sandoz, the owner of Ebewe, but that the new, lower price is only set to come into effect from July.

Outlook and Implications

The news that the NFZ has softened its stance to the legal requirements surrounding the transfer from therapeutic to drug programmes allows for some hope that there might not be the huge disruption to the hospital drug sector that has been widely predicted (see Poland: 27 March 2012: Disruption and Delays Expected with Poland's Implementation of New Mechanisms to Control Spending on High-Cost Hospital Drugs). It will require a significant effort and considerable good will all around for this to happen. Whatever the outcome, the sense of a badly managed and poorly executed reform will persist. This is not helped by the news of shortages in the supply of essential oncology medicines, particularly as many of the medicines used in therapeutic/drug programmes are oncology medicines, and the chemotherapy medicines used by the NFZ are also involved in the administrative shake-up. This has already raised fears of potential interruptions in treatment for cancer patients in connection with the changeover; now, news of actual interruptions in treatment, which are being widely reported in the Polish media, are giving commentators and the public more reason to be angry and worried for the future. If reports that Ebewe withdrew the drug because of excessively low prices in Poland are true, then this is likely to be seen as another example of the government's "failed" drug policy.

Meanwhile, doctors' plans to stop prescribing reimbursed drugs from July appear to be a quite serious potential threat to the stability of the Polish healthcare system, and also a probable cause of the continued reduction in the value of the Polish pharmaceutical market. The disruption associated with such a protest, which looks highly likely to happen, will most probably be similar to that the disruption that accompanied doctors' protests earlier in the year against the punishments the new Reimbursement Act imposed on them for inappropriate prescription.