Disruption and Delays Expected with Poland's Implementation of New Mechanisms to Control Spending on High-Cost Hospital Drugs

Introduction of "Drug" Programmes: the Next Disaster?

Contrasting views are being expounded by various sources in Poland regarding the changeover from so-called "therapeutic" programmes—the instruments used by the Polish National Health Fund (NFZ) to control spending on high-cost innovative medicines—to "drug" programmes, set to take place at the beginning of July. Polish newspaper Dziennik Gazeta Prawna presents a pessimistic scenario and reports that following the Polish Ministry of Health's (MoH) announcement on 23 March that negotiations on the prices of medicines used in the programmes had been completed, it was revealed by MoH spokesperson Agnieszka Golabek that positive decisions had been given in the case of 547 medicines, with 274 of these decisions being "final". Some 650 medicines are actually included in therapeutic programmes in their present form, however. The source reports that representatives of the MoH have played down any potential problems resulting from this, while in contrast, a legal expert is quoted as stating that removing one medicine from a programme could have the effect of invalidating the use of other medicines in the programme, as the use of one may depend on the results of using the other.

Time Running Out

Dziennik Gazeta Prawna warns that because the reimbursement notice that will include the medicines to be added to the drug programmes is only scheduled to appear on 1 May, and the drug programmes are supposed to come into effect at the beginning of July, there will not be enough time for the NFZ to formulate the new programmes and carry out competition proceedings; sources from the NFZ have been quoted as saying that the process takes around three months, and by then they would only have two. The probable consequence, the source predicts, is disruption in the operation of programmes, with new patients unable to be included on them.

Enough Money to Go Around?

Dziennik Gazeta Prawna highlights another possible problem: the prices negotiated by the MoH with producers, in which the NFZ played no part, but as a result of which it will now have to arrange the funding of care appropriately on the basis of these prices. The source recalls that the budget for medicines used in therapeutic programmes during 2012 is set at 1.57 billion zloty (USD491.73 million), and although the NFZ is not at liberty to change the prices, it may simply sign contracts with fewer hospitals.

Disaster May Never Happen

Contrastingly, Polish newspaper Rzeczpospolita depicts the situation in a much less alarming manner, and in fact dedicates an entire article to playing down the fears of disruption in the treatment of patients included in therapeutic programmes, which include the most seriously ill people under the care of the public healthcare system, notably cancer patients. Rzeczpospolita rejects the idea that it is all but inevitable that there will be disruption, while stating that it would be best for the MoH to publish its regulations regarding the drug programmes by the end of March, to give the NFZ sufficient time to carry out its contracting.

Just a Big Pharmaceutical Lobbying Campaign?

Rzeczpospolita even raises the possibility that the media "campaign" it says is being waged around the therapeutic drug programmes is the result of pharmaceutical companies' lobbying. It presents the idea that pharma companies are using media outlets to put pressure on officials. The source reports that in one Polish tabloid newspaper, a headline was published that read, "In July, hospitals stop treating cancer".

Rzeczpospolita also reports that it is unlikely that the new drug programmes being introduced in July will contain any new innovative medicines that have not been reimbursed yet in Poland, with the MoH reported to be focused on ensuring continuity of treatment, rather than expanding it. The source concedes that it is taking too long for some new, innovative medicines to be placed in the reimbursement system in Poland.

Outlook and Implications

It is hard not to conclude that there is a substantial level of chaos and calamity pervading the implementation of the changes set into law under the Reimbursement Act—the controversial, wide-ranging legal act that came into force on 1 January, of which the change from therapeutic to drug programmes is a part. Recently, concerns have been expressed about the fact that many of the programmes—which in essence are not due to change at the time of the changeover of their name from "therapeutic" to "drug" programmes—are out-of-date in terms of current scientific knowledge and medical practice (i.e. label extensions on medicines are not reflected in them) and such changes are, under the Reimbursement Act, subject to fairly substantial charges to be paid by producers and other applicants (see Poland: 22 March 2012: Poland's New System of Drug Programmes Nears Implementation; MoH Allays Concerns About Access to High-Cost Treatments). Meanwhile, doubts remain over whether, despite assurances from the MoH, there will be problems for hospitals resulting from the use of therapeutic "cluster" style groups in the hospital drug sector, and whether they will have to pay unreasonably high amounts in order to provide patients with the most modern, innovative therapies.

Indeed, although tabloid claims that Polish hospitals will stop treating cancer from July are clearly ridiculous, judging by the manner in which the measures of the Reimbursement Act have been implemented so far, there is unfortunately a very good chance that one or the other of the organisations involved (or, indeed, all of them) will not be able to complete its tasks in connection with the new drug programmes in time, putting in jeopardy their smooth launch in July. Needless to say, this would be bad for patients, as well as all stakeholders in the healthcare system in Poland, including pharmaceutical companies.

Ultimately, too, the question of how the Reimbursement Act was sold to the Polish public also has to be raised. On many occasions, it was stressed that this was an act that was intended to guarantee access to innovation for the greatest number. True, there had been a huge increase in the amount spent on high-cost hospital drugs in the years leading up to the act's passing, and changes needed to be made to manage this. But the current situation, in which many new innovative treatments are available with reimbursement in neighbouring countries, but not yet in Poland, where the need is as great, if not greater (considering the country's population), does not appear to be what the Polish people were promised.