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Polish pharma industry furious over MoH's warning to HTA agency

09 April 2015 Brendan Melck

The pharmaceutical industry in Poland was in uproar when the contents of a letter from deputy health minister Igor Radziewicz-Winnicki addressed to Poland's Agency for Health Technology Assessment and Tariff System (AOTMiT), and its Transparency Council (TC), was published by the Polish daily Gazeta Wyborcza. In the letter, the deputy minister described the unease of health minister Bartosz Arłukowicz concerning the prioritisation of clinical efficacy above cost-effectiveness in the recommendations of the TC. He stated that in the minister's view, drugs that are effective but very expensive (for which annual treatment costs reach up to PLN1 million (USD264,831)) recommendations should be negative.

As Gazeta Wyborcza reported, it is the 'conditional' positive recommendations that the deputy minister focused on the most. This is when the TC recommends the reimbursement of a drug, based on its clinical efficacy, however, this recommendation is conditional on a price reduction. Reportedly, Radziewicz-Winnicki told the AOTMiT and the TC that in the cases of these drugs the recommendation should be negative. He argues that a positive recommendation of these drugs puts the Ministry of Health (MoH) in a difficult position because patients don't consider economic arguments.

Arłukowicz is reported to have summoned the TC to a meeting to discuss the issue.

Pharma industry hits back
The reaction from the pharmaceutical industry has been swift and highly critical of the intervention. The Employers' Union of Innovative Pharmaceutical Companies (Infarma), in a press release following the revelations, stated that the intervention of the deputy minister posed questions about the very role of the AOTMiT and the TC within the reimbursement system. Infarma emphasised that although the AOTMiT comes under the aegis of the MoH, its function, according to the applicable law, is to offer independent recommendations based on both medical and economic considerations.

Irena Rej, the head of Farmacja Polska, the Polish pharmaceutical chamber of commerce, went further in an interview published by medical news source Termedia, describing the intervention as 'criminal' and accused the minister of breaking the law by trying to influence an independent body. She stated that a strong coalition would be needed to save the TC, but ruled out a legal challenge by Farmacja Polska, saying that she was relying on intervention by Poland's Supreme Audit Office.

Improved transparency
The intervention of the deputy minister was certainly a 'bolt from the blue'. The TC came into existence with the implementation of the Reimbursement Act in 2012, and was a response to the European Commission's complaints over the lack of transparency within the reimbursement system in Poland, and the inability of companies to dispute decisions on reimbursement. There have been significant improvements in the system since then, and pharmaceutical companies have spoken positively of the AOTMiT and their interactions with it. However, the ultimate decision on reimbursement is still taken by the health minister.

Many of the recommendations made by the TC are made conditionally on a price drop. Recently, it made such recommendations for Bayer drug Adempas in the treatment of chronic thromboembolic pulmonary hypertension (CTEPH) and Boehringer Ingelheim's Pradaxa in the treatment of deep-vein thrombosis and pulmonary embolism. In the case of new innovative drugs or recently expanded indications, there is not much likelihood of the producer bringing the price down to a level which the Polish authorities would find acceptable right away.

Nevertheless, these recommendations reflect both medical and economic considerations, as the TC is supposed to by law.

Back to the dark ages?
The intervention of the MoH is worrying because it is consistent with a centralising tendency in the Polish healthcare system which saw the Ministry gain significant powers from the National Health Fund after legal changes last year. As yet, there have been no reports from the anticipated meeting between the minister and the TC. It is to be hoped that the independence of the TC and AOTMiT is maintained and respected - otherwise much of the progress over the past few years would appear to have been for nothing.

Brendan Melck is a life sciences analyst for IHS
Published 9 April 2015

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