Press review

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Poland has no comprehensive drug shortages policy - media reports

WARSAW, 4 Oct (APM) - The June drug crisis in Poland, when 500 drugs for diseases including hypertension, thyroid diseases, asthma, allergies and diabetes were unobtainable, showed that Poland has no comprehensive drug policy, Dziennik Gazeta Prawna (pA33) reported on Friday.
It noted that 350 drugs are currently at risk of a lack of availability. Originators and copycat versions including biosimilars were all affected by the June shortages.
The causes of the availability problems are considered to be illegal drug exports, the government’s ineffective attempts to enact legislative amendments and the failure to restructure and invest in the country's Pharmaceutical Inspectorate, the body responsible for dealing with the issues.
Additionally, a very high dependency on active ingredients imported from Asia (70%) proved that, given the recent turmoil of the closure of Chinese pharma plants, the pharma situation in Poland is at risk and needs to be thoroughly revised by the government, the newspaper said.

Polish patients still have a lower life expectancy than other EU citizens

Despite the introduction of fully reimbursable drugs for elderly patients, new therapies on the reimbursable lists and innovative healthcare programmes, Polish citizens still have a lower life expectancy than people in other EU countries, Dziennik Gazeta Prawna (pA32-A33) reported in its government summary on Friday.
New therapies that have been introduced include therapies for patients suffering from multiple sclerosis and spinal muscular atrophy, lung and breast cancers. Innovative healthcare programmes include comprehensive coordinated care after myocardial infarction (KOS-Zawal).
But as reimbursement procedures often last several years, Polish cancer patients have a higher mortality rate than other EU citizens, where those therapies were available much earlier, the newspaper reports. Breast cancer survival in Poland is 74.1% while it is 90% in Cyprus and 86% in Sweden. Poland’s survival rate in the case of lung cancer is 13.4% but over 15% in both Cyprus and Sweden.
However, according to the Supreme Audit Office, the programme reducing drug prices for elderly patients, which is budgeted at 8.3 billion zlotys (€1.9 billion) in 2016-2025, has proved successful. It notes that 61% of patients admit to spending less on drugs, over half of whom admitted to spending 50 zlotys (€11.5) less and a quarter spent 50-100 zlotys (€11.5-€23) less.

Breast cancer patients await clarifications on Perjeta reimbursement in Poland

Roche's Perjeta (pertuzumab), a drug used for treating HER2-positive breast cancer, is still not available to Polish patients despite being added to the reimbursement list at the beginning of September, Dziennik Gazeta Prawna (pA1, pA6) reported on Tuesday.
Both patients and hospitals are waiting for clarifications and eligibility requirements from the Ministry of Health (MoH).
If taken in the early stages of breast cancer, Perjeta significantly increases the efficacy of the treatment and prevents metastases, but the costs of effective treatment are around 50,000 zlotys (€11,418) (one dose costs 11,000 zlotys - €2512), according to the newspaper.
As Perjeta must be taken in the early stages, some patients have bought the drug out of their own pockets or with the help of Alivia, a foundation for breast cancer patients.
The paper added that patients and hospitals are now awaiting clarification from the MoH on whether Perjeta will be eligible for patients who have already started treatment, or solely for new cases. The situation is troubling for patients who cannot delay the decision as to whether to try to buy the drug themselves or wait for the eligibility requirements, it noted.
The MoH is aware of the issue, and announced it would try to add Perjeta to the existing breast cancer drug programmes that might make the therapy available from the beginning of November.

Access blockade for bladder cancer vaccines in Polish hospitals

BCG-Medac and Onco-Tice MSD - bladder cancer vaccinations that can reduce the risk of relapse and prevent full bladder removal for patients - are not available in Polish hospitals, Gazeta Wyborcza (p5) reported on Saturday.
It is estimated that Poland has around 7,000-8,000 bladder cancer patients and, in most cases, in patients with a non-invasive epithelial cancer diagnosis after tumour removal, these vaccinations are used to reduce risk of relapse. Without the vaccinations, the bladder must be removed.
However, neither wholesalers nor hospitals have any vaccines, as both producers - Medac and Merck Sharp & Dohme - claim production of the vaccinations is complicated and costly.
Another problem is the price of the vaccine. In Western Europe, the cost of BCG-Medac is 600-700 zlotys (€137-€160) while Polish hospitals only receive reimbursement of 355 zlotys (€81) from the National Health Fund, so either the producer sells the drug at a lower price, or the hospital suffers losses.
Consequently, Medac claims it cannot assure stable supplies and announced that treatment will be available no sooner than in January 2020.
The MoH will need to increase the reimbursement rate for the treatment to make it available to patients in hospitals, the newspaper reported, but according to the department's official statement, 2,119 packets of BCG-Medac are available in Poland, so there is no reason for intervention.

EMA suspends dozens of ranitidine and pioglitazone drugs on cancer-inducing contaminant fears

The European Medicines Agency (EMA) has suspended dozens of drugs containing heartburn medicine ranitidine and type 2 diabetes therapy pioglitazone Dziennik Gazeta Prawna (pA1, pA8) reported on Monday.
The suspended drugs may have been contaminated with carcinogenic chemical compounds N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA), allegedly originating from active ingredients imported from factories in China or India.
The EMA declared that all drug distributors in the EU need to prepare risk analyses indicating whether the contamination originates from the drug production processes, and to assess the contamination levels.
Drug producers will need to adjust their production processes and apply for changes in their distribution licences on EU markets.
The Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) is trying to establish the reasons for the contamination of certain active ingredients or the use of certain solvents, catalysts or reagents. According to Marek Tomkow, the deputy president of the Polish Pharmaceutical Chamber, the issue is now broader and more serious than previously reported.
In the worst case scenario, entire groups of drugs could disappear from the EU completely and the EMA will then need to assess what will cause more harm - nitrosamine contamination and its potential effects on patient health or leaving patients without medications for their illnesses.
An estimated 800,000 Polish patients are believed to have taken hypertension drugs which were withdrawn from the market by the country's Chief Pharmaceutical Inspector last year.

Increasing number of flu infections in Poland

The National Institute of Public Health in Poland (PZH) warns there are increasingly more cases of flu infections in Poland and the country's chief sanitary inspector recommends improving immunity through flu vaccinations, reported Rzeczpospolita (pA4) on Monday,
The MoH has been reimbursing 50% of the cost of flu vaccinations for patients aged over 65 since 2018, which reduces the cost to 22.88 zlotys (€5.22) per shot. Many local authorities finance the vaccinations in full for their residents.
Nevertheless, it is reported that flu vaccinations were delayed this year because the World Health Organisation (WHO) was a month late with its recommendations on the composition of antigens for the coming flu season.

Pitolisant the first therapy for narcolepsy in Europe

Pitolisant became the first therapy approved in Europe for effectively treating narcolepsy, reported Rzeczpospolita (pA9) on Tuesday.
Pitolisant is the first inverse agonist to histamine H3 receptors that proved effective in patients suffering from both narcolepsy and catalepsy.

Chronic spontaneous urticaria patients are in need of an innovative treatment

The Polish Society of Allergology (PTA) has appealed to the MoH to add Roche/ Novartis' chronic spontaneous urticaria (CSU) treatment Xolair (omalizumab) to the country's reimbursement list, reported Rzeczpospolita (pA9) on Tuesday.
Xolair is currently the only therapy for treating CSU when antihistamines are not effective and other therapies with cyclosporin A or steroids prove to have excessively harmful adverse effects.
The innovative therapy costs 3,000 zlotys (€685) for a monthly dosage, while the recommended treatment period is six months. This makes the therapy unavailable to CSU patients. According to the PTA, 1,000-1,500 patients suffering from CSU do not respond to regular urticaria therapies.

Polish colon cancer patients lack access to innovative therapies

Despite numerous appeals, discussions and petitions, Polish patients suffering from colon cancer, the second largest cause of cancer deaths, are still waiting for reimbursement of innovative drugs for the third and fourth stages of treatment, Rzeczpospolita (pA10) reported on Friday.
Around 1,000 patients look for innovative therapies per year, while 33 patients die from colon cancer per day.

Drug-exporting gang face 10-year jail sentence in Poland

Members of an organised crime group, which was illegally exporting high-demand oncology, cardiology and transplant drugs, have been caught by the Polish police and customs officers, reported Gazeta Wyborcza (p9) on Friday.
The 16 members are currently facing 10-year prison sentences.

Polish patients will only use e-prescriptions from the beginning of 2020

Every prescription issued in Poland from January 2020 will be electronic, and the MoH and the National Centre for Health Information Systems (CSIOZ) are now holding information campaigns for patients on the use of e-healthcare services, reported Dziennik Gazeta Prawna (pA17) on Monday.
During the pilot, which began in mid-2018, 12 million e-prescriptions were issued. They are currently accepted in every Polish pharmacy. The MoH and the CSIOZ are encouraging patients to use an online accounts, where patients can see their prescriptions and the history of their illnesses.
Surveys show 52% of Polish patients aged over 60 have heard about the online account service, but only 5% use it.

Celon Pharma closes the half-year with a decline

Celon Pharma is facing a revenue and profit decline compared to half-year results in 2018 because of sales blockades for Valzek (walsartan) and Salmex (flutykazon), Parkiet Gazeta Giełdy (p03) reported on Tuesday.
The Chief Pharmaceutical Inspector suspended sales of Valzek, significantly reducing its sales from August 2018 to June 2019. Celon was also forced to reduce exports of Salmex to EU countries because of a legal dispute with GlaxoSmithKline. The plan is to resume Salmex sales shortly.
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