WARSAW, 20 July (APM) - Poland's Ministry of Health (MoH) has decided to artificially increase the prices of two anticoagulants, Pradaxa and Xarelto, at the request of their manufacturers, Boehringer Ingelheim and Bayer, which is in breach of regulations, reported Gazeta Wyborcza (p3) on Monday.
According to the Reimbursement Act, after the patent protection of reimbursable originator drugs expires, their manufacturers must agree to a 25% price reduction.
In the case of Pradaxa, the patent protection of which expired in March, Boehringer Ingelheim asked the MoH to increase the price of the drug in the January reimbursement list from 45 zlotys (€10.4) for ten capsules and 135 zlotys (€31.3) for 30 capsules to, respectively, 60 zlotys (€13.9) and 180 zlotys (€41.7).
That way, after the expiry of patent protection, the manufacturer was able to sell the drug at, respectively, 42 zlotys (€9.7) and 127 zlotys (€29.4), effectively bypassing the obligatory price reduction.
A similar situation applies to Xarelto, as, seeing that the officials agreed to Boehringer’s request, Bayer was allowed to increase the prices of the drug on 1 July from 92 zlotys (€21.3) to 113 zlotys (€26.2) for 10 tablets and from 375 zlotys (€86.8) to 475 zlotys (€110) for 42 tablets.
This practice results in higher spending for both the national health fund (NHF) and patients, because the medicines are available in pharmacies and patients need to co-pay for them, although the MoH claims that its primary concern is to provide access to treatment.
Simultaneously, the officials are rejecting a similar move in the case of Servier and its high blood pressure drug, Co-Prestarium, despite that fact the company did not withdraw the drug from the reimbursement list.
According to unofficial information, the MoH’s legal department issued an opinion that the workarounds to which the officials agreed in case of Boehringer and Bayer are in breach of the Reimbursement Act.
Similar cases have been reported since 2016, but applied to drugs covered in whole by the NHF, such as Myozyme, Evoltra, Nexavar, and Lucentis.
Another price increase for a children’s post-transplant solution
The MoH decided to increase the price again of a post-transplant solution for children, valganciclovir, in the July reimbursement list, reported Rzeczpospolita (pA14) on Wednesday.
The price of the drug was increased by 11.3 zlotys (€2.6) to 870.7 zlotys (€201.6) per pack, while many children need two packs per month for extended periods and that is not the only medication they use.
Professor Tomasz Grodzki, a transplantologist and MP from the PO (Civic Platform) party, said valganciclovir solution does not have reimbursable equivalents and is only used by several hundred children, which is why the officials could consider reducing its price significantly or making it free.
He added that, while the MoH seems to be so concerned about savings, it had been ignoring the national health fund’s requests to include a cheaper intravenous breast cancer drug in the reimbursement list for months. Trastuzumab, was finally introduced in July after the media publicised the issue. This should bring savings of up to 100 million zlotys (€23.2 million) per year.
New state agency for running clinical trials
Experts from the British Medical Research Council will help the MoH establish a Medical Research Agency to be responsible for running clinical trials, reported Rzeczpospolita (pA13) on Thursday.
The new institution will fill the gap between the National Science Centre and the National Centre for Research and Development. It will run clinical trials, as well as population and epidemiology studies commissioned by the MoH, the national health fund and other major state institutions.
The new agency will be financed entirely from the state budget with an initial budget of 100-150 million zlotys (€23.2-34.7 million), which is to increase over time to 1.2 billion zlotys (€277.8 million). One of the reasons for establishing the new institution is to no longer rely on the decisions of pharma companies and improve access to clinical trials in Poland.
New regulations on drug policy could harm domestic pharma
Experts warn that the new regulations on drug policy presented by the MoH favour foreign pharmas and could harm the Polish industry, reported Rzeczpospolita (pA17) on Friday.
The regulations specify priorities for the national drug policy for 2018-2022 and are supposed to be the foundation for further amendments to the Reimbursement Act, Pharmaceutical Law and other regulations regarding, for example, clinical trials.
One area applies to reimbursement incentives for pharma companies investing in Poland. Domestic manufacturers are concerned that the rules are imprecise and do not specify whether the preferential treatment would apply to companies producing drugs in Poland, those running clinical trials or those establishing R&D centres.
They are also afraid of the changes to the payback system, according to which companies not included in the risk sharing system would have to fully refund all spending in excess of the 17% threshold of the budget on drugs to the national health fund.
This would certainly strike at domestic companies, as payback does not currently apply to originator, imported drugs produced by entities using the risk sharing system, which means that it would be Polish manufacturers of generics who would have to cover the cost of any potential overspending.
Officials want to introduce online sales of prescription drugs
The MoH supports the bill opening access to online sales of prescription drugs for patients with disabilities, which concerns pharmacists, reported Dziennik Gazeta Prawna (pB1) and Rzeczpospollita (pA12) on Thursday.
Janusz Cieszynski, the deputy health minister, said the officials want to improve the quality of life of patients with disabilities, but are aware that the final regulations will have to be well-thought-out because of the problem of illegal drug exports, reported Gazeta Prawna.
However, pharmacists warn that the Polish system is not ready to open online sales of prescription drugs and the proposed regulations allow for sales of all drugs that are available in pharmacies, including psychotropics or narcotics.
Furthermore, there are no institutions that would have the jurisdiction and resources to track or manage such sales and there are doubts as to whether external couriers would be authorised to handle deliveries, reported Gazeta Prawna.
The Supreme Pharmaceutical Council has already officially protested against the new regulations, reported Rzeczpospolita.
Experts and patient organisations welcome the idea, but say the change is a rather small quality of life improvement, reported Gazeta Prawna.
Sale of Bioton’s subsidiary could be audited
The CEE Equity fund, indirectly controlling a 13.16% stake in Bioton, requested an audit of the sale of the company’s subsidiary, SciGen, to the Chinese Yifan International, reported Puls Biznesu (p6) and Parkiet Gazeta Gieldy (p6) on Wednesday.
The concerns apply to SciGen’s valuation, specified as $100 million, the fact that Bioton agreed to waive its $28.5 million debt and connections between Bioton’s board and Yifan, reported Puls Biznesu.
Aflofarm strengthens dietary supplements business
Aflofarm, the leading Polish manufacturer of OTC drugs and dietary supplements, is acquiring Trec Nutrition, which produces and sells supplements and substances for athletes, reported Puls Biznesu (p6) on Thursday.
According to market rumours, the transaction could be worth 80-100 million zlotys (€18.5-23.2 million).
Aflofarm reported revenues of 710 million zlotys (€164.4 million) and a net profit of 170 million zlotys (€39.4 million) in 2016. The company was also the biggest pharma advertiser in Poland, with an estimated spend before discounts of 2 billion zlotys (€463 million) in 2017.