WARSAW, 17 May (APM) - Poland will negotiate drug prices in cooperation with Lithuania, the Czech Republic, Slovakia and Hungary to gain leverage over large international pharmas, according to the Fair and Affordable Prices project, reported Rzeczpospolita (pA15) on Friday.
The officials believe their arrangement will help provide greater access for patients to the most innovative drugs sold by the largest international players. This solution should also be acceptable to the pharmas, as, despite potential price cuts, their drugs may become reimbursed in more countries if the negotiations prove successful.
NHF could lose its weapon against hospitals that fix drug tenders
The Ministry of Entrepreneurship and Technology (MoEaT) wants to strip the National Health Fund (NHF) of its right to question drug tenders in hospitals, which is a desirable situation for large pharmas, reports Gazeta Wyborcza (p8) on Friday.
According to the regulations, the NHF is required to fully reimburse hospitals for drugs used in chemotherapy and drug programmes, which is why it wants to ensure that the drug prices are as low as possible.
However, hospitals sometimes use certain tricks to fix tenders, such as announcing one joint tender for drugs that have cheaper equivalents and drugs which do not, in which case the tender rules out manufacturers of generics, as they are unable to meet the demand for originator drugs specified in the order.
Other methods include the organisation of tenders only for drugs that have passed clinical trials, have a specific density, expiry date or can be split into smaller doses, which again favours manufacturers of more expensive originator drugs, while seemingly being in line with the regulations.
Following similar cases in the past, the NHF managed to receive the right to question hospital tenders for medicines in July 2018 and take the questionable practices to court. However, the MoEaT now wants to strip the NHF of its right, which is seen as a way of favouring big international players, and is criticised by the Ministry of Health.
More bureaucracy in clinical trials
Researchers conducting clinical trials are concerned about the new pharmaceutical regulations introducing more bureaucracy, reported Dziennik Gazeta Prawna (pB10) on Wednesday.
According to the regulations, from 1 June researchers will be required to provide personal identity numbers of all clinical trials participants to the NHF within 14 days of enrolment under the risk of fines or even imprisonment for up to two years. This requirement previously only applied to non-commercial trials, which constitute 2-3% of all trials conducted in Poland.
However, neither the researchers nor the institutions organising the clinical trials are sure how to fulfil their new duties, while the NHF unofficially admits the regulations should be more specific. The NHF officially announced the new requirement will only apply to patients enrolled for clinical trials after 1 June.
The Employers' Union of Innovative Pharmaceutical Companies INFARMA admits the changes are needed to make the financing and liability for potential complications of clinical trials more transparent, but adds that the new regulations should primarily benefit patients and not result in problems with access to clinical trials.
Although an increasing number of local authorities have already agreed or are planning to finance HPV vaccinations, which reduce the risk of cervical cancer, access to the vaccines is very limited because of a high global demand and insufficient production capacity of the two suppliers in Poland, GlaxoSmithKline and MSD Polska, reported Dziennik Gazeta Prawna (pA4-A5) on Thursday.
MSD Polska said it has already taken steps to increase the availability of its vaccine, although the product could become available to wholesalers at the end of the year at the earliest. Additionally, the supply of the previous generation product supplied by MSD has already ended, while MSD discontinued its production. Meanwhile, GSK said it should be able to restart deliveries of its vaccine in June and the newspaper confirmed that several thousand doses were recently imported into Poland and are awaiting verification. It is expected that the whole quantity delivered will probably be gone within a few days.
While the availability of HPV vaccines is extremely low, there are also signs that access to hepatitis A, tuberculosis and measles vaccines is also limited.
Expert on the new regulations on prescriptions
Tomasz Zielinski, vice-president of the Polish Chamber of Healthcare IT, says some more improvements could be made to the new regulations intended to simplify the process of writing out prescriptions for reimbursable drugs, reported Dziennik Gazeta Prawna (pB10) on Thursday.
Zielinski said that while the idea of simplifying the process is very good, the solutions offered by the officials still do not satisfy doctors who would like to spend more time treating patients and less time wondering how to prescribe reimbursable drugs in various indications without the risk of the NHF questioning the reimbursement. Zielinski says doctors currently waste time and do not choose the optimal treatment because they are uncertain how to prescribe drugs and specify reimbursement.
Zielinski is hoping that the introduction of e-prescriptions, patient accounts and related IT infrastructure will help simplify and automate the process to the benefit of doctors and patients, but the entire process could last several years in the worst case.
Celon Pharma wants to increase exports
Despite the recent distribution injunction regarding Salmex in Germany, Denmark and Sweden, Celon Pharma believes it should be able to increase its total exports by expanding into other markets, reported Parkiet Gazeta Gieldy (p8) on Wednesday.
Celon is still selling Salmex in Poland, the UK, the Netherlands, Slovakia, the Czech Republic and Norway, and should be able to start sales in France, Ireland, Italy, Luxembourg, Malta, Finland and Spain shortly.
Celon has high hopes for its most advanced project, namely its drug-resistant depression therapy with esketamine, which is currently in Phase II. The company is also continuing Phase I for its PDE10A inhibitor, developing a Phase I study programme for its FGFR kinases inhibitor, and intends to start Phase I for up to three new drug candidates.
Maciej Wieczorek, Celon Pharma’s CEO, said the most important objective in innovative projects for the company in 2019 will be to seal the commercialisation deal for esketamine.
Celon Pharma reported revenues of 27.1 million zlotys (€6.3 million) and a net profit of 6.5 million zlotys (€1.5 million) in the first quarter of the year, which was, respectively, a 4% and a 14% decline over the corresponding period of 2018.
Neuca reported record profits in the first quarter on 2019
Poland’s largest wholesaler, Neuca, improved its first-quarter profit over the same period of 2018, reported Parkiet Gazeta Gieldy (p5) on Wednesday.
Neuca reported a net profit of 37.2 million zlotys (€8.7 million) in the first quarter of 2019, which was 15% more than in the same period of 2018, excluding one-off events.
This was the highest quarterly profit reported by the company since its establishment, even though Neuca’s revenues declined by 1% to 2.14 billion zlotys (€498.8 million) because of the 0.5% decline of the 8.34 billion zloty (€1.9 billion) pharmacy market in that period.
Neuca has a 29% share of the whole of the pharmacy market and a 32% share of the individual pharmacies market.
In addition to distributing medicines, Neuca is currently investing in clinical trials, primarily for cancer research. Neuca recruits patients and organises trials financed by other companies, as it believes this market segment has a good outlook in terms of potential revenues and margins. The company is also continuing to develop its e-commerce platform for ordering drugs, which already has 4.8 million users.