IHS Global Insight Perspective | |
Significance | New details of the risk-sharing agreements due to be brought into effect in Poland under the recently passed Reimbursement Act have been revealed by the Polish MoH, while the Health Minister Ewa Kopacz has promised to investigate the problem of regional divergence in access to high-cost oncology medicines. |
Implications | Some concerns have already been expressed concerning the fact that the risk-sharing agreements will favour the Polish authorities; meanwhile, Kopacz's commitment to improving the situation for cancer patients is part of the priority status oncology has enjoyed in Poland during recent years. |
Outlook | It seems likely that some drugs that have not been reimbursed in Poland in the past due to excessively high prices could now be reimbursed with the introduction of risk-sharing agreements, although the limit on drug-reimbursement spending means there is unlikely to be any significant growth in expenditure over the coming years. Meanwhile, if regional divergences in access to high-cost cancer drugs are ironed out, it would mean more reimbursement of these medicines, while concerns have been noted that spending growth on these medicines may threaten "conventional" outpatient drug spending. |
Under the new Reimbursement Act, which has already been enacted by parliament and is awaiting a highly likely ratification by the Polish president, a formal, legislatively sanctioned system of risk-sharing agreements is being introduced, details of which are emerging from statements made by representatives of the Polish Ministry of Health (MoH). At the same time, Health Minister Ewa Kopacz has declared her intention to challenge the situation in which access to high-cost oncology drugs through the so-called "non-standard" chemotherapy programme is subject to considerable regional divergence, while she has been praised by eminent oncologists in the country for her work in promoting the importance of the oncology field within the Polish healthcare system.
Risk-Sharing Agreements Will Be "Flexible"
The wording of the section of the Reimbursement Act concerning the shape of the new risk-sharing agreements deliberately avoids any specific types of risk-sharing schemes, allowing for plenty of flexibility, according to Artur Falek, director of the MoH's drug policy and pharmacy department, quoted by Polish pharmaceutical news provider Rynek Aptek. Falek specifies that it will be incumbent on companies to propose risk-sharing agreements, and that these proposed agreements will be the subject of negotiations. Falek emphasises that the MoH will approach each risk-sharing agreement individually.
Drugs Subject to Individual Risk-Shares Are Exempt from Payback
Drugs for which individual risk-sharing agreements are negotiated will not be subject to the payback system, another novelty of the Reimbursement Act, according to which companies and the Polish authorities share the cost of any spending on the reimbursement of drugs in excess of the new 17% limit on drug reimbursement spending as a total proportion of healthcare spending. Falek also emphasises that for a drug that has a risk-sharing agreement, the MoH will endeavour not to treat other drugs in the same limit group (the group of drugs in the same therapeutic area, which are subject to the same price and reimbursement limits) more or less favourably, emphasising that he does not envisage a situation in which only one drug in a limit group would be included within the payback system.
Risk Shares Introduced from January
Falek is reported as saying that in the next drug reimbursement list published by the MoH, the possibility of negotiating risk-sharing agreements will be included, and the results of these will be seen from January 2012. He states that in the case of some drugs that the MoH will not currently reimburse due to their high price, and for which companies will not reduce the price due to their pricing policy, there have already been some declarations from pharmaceutical companies that once these risk-sharing agreements are in place, it will be possible to reduce the cost to the MoH.
Falek states that risk-sharing agreements are very unlikely to be used in the case of older drugs that have been reimbursed for a long time, and that such agreements are only likely to be implemented in cases where there is a substantial risk for the MoH.
Limited Delays Possible in Reimbursement Decision Process
Falek states that in the context of drugs that have risk-sharing agreements proposed by the producers rejected by the Agency for Health Technology Assessment in Poland (Agencja Oceny Technologii Medycznych: AOTM), this will not mean that they will be barred from any further negotiations. However, he emphasises that the negotiations cannot go on for very long, pointing out that there are limits to the delays to which reimbursement decisions can be subject under the transparency directive. Although the Polish legislation does not currently have a "stand-by" option on decision processes, this may be added at a later stage, Falek suggests.
Health Minister to Look into Regional Divergence in Cancer-Drug Access
Separately, Kopacz has stated that the demands of Polish patients for an end to the regional divergence in access to high-cost oncology drugs under the non-standard chemotherapy therapeutic programme will be investigated, reports Rynek Aptek. Currently, whether or not a patient is able to access the drugs under this programme is dependent on the particular policy of the regional branch of the National Health Fund (Narodowy Fundusz Zdrowia: NFZ). Meanwhile, eminent oncologists in Poland have defended Kopacz against calls from the main opposition party for her dismissal in light of the controversy generated by the health reforms that are currently going through Poland's legislature. According to the oncologists, there is no doubt that oncology is a priority of the current Polish government.
Outlook and Implications
Some serious reservations concerning the new risk-sharing-agreement mechanism being introduced have already been expressed by analysts and observers, who have seen it as being too weighted in favour of the MoH (see Poland: 15 February 2011: Problems Identified in Nascent Polish Risk-Sharing Agreement Mechanism). The risk-sharing agreements are, understandably, presented in a quite different light by the representative of the MoH though. From the statements made by Falek, it would appear likely that in the case of drugs that have until now been denied access to the Polish reimbursement system due to their excessive cost could well be included in it under a risk-sharing agreement. Although this is a positive development, it should be emphasised that there will be no growth in spending on reimbursement in Poland over the coming years, with spending to be fixed at 17% of healthcare spending, implying a virtual freeze on spending increases (taking into account overall healthcare spending inflation).
Meanwhile, Kopacz's promise to investigate the demands of cancer patients to unify the policies of regional NFZ branches towards high-cost oncology drugs used in non-standard chemotherapy is a positive development for patients, and potentially for pharmaceutical companies, if it results in a wider use of these medicines in the future. Among the most commonly used oncology medicines in non-standard chemotherapy are Avastin (bevacizumab; Roche, Switzerland), Nexavar (sorafenib; Bayer, Germany), and Sutent (sunitinib; Pfizer, United States). Expenditure on oncology drugs in Poland has risen exponentially in the past few years, and there are concerns that if it continues to rise at such a rate—with the new 17% limit in place—it could increasingly eat into the funds available for the reimbursement of outpatient prescription medicines (see Poland: 28 July 2010: Polish NFZ's Prescription-Drug Reimbursement Increases 11.9% Y/Y in 2009, Chemotherapy Expenditure Rises 96% Y/Y).