WARSAW, 18 Apr (APM) - Polish officials are working on new reimbursement regulations for drugs, potentially making the negotiation process less transparent, reported Gazeta Wyborcza (p5) on Thursday.
The proposals say that all documentation filed by pharma companies applying for reimbursement would be strictly confidential, including data on drug efficacy, comparative analyses or prices.
The confidentiality would have to be respected indefinitely by all employees of the Ministry of Health, Poland's HTA agency and the National Health Fund under the risk of up to five years’ imprisonment.
Critics say this creates a risk of making the process much less transparent and could lead to serious malpractice. However, officials say the objective is to prevent former employees of the institutions with access to sensitive price information from exposing it to the competition.
Additional money for drug programmes
Poland's National Health Fund will spend 62.7 million zlotys (€14.7 million) more on drug programmes in 2019 than previously planned, reported Dziennik Gazeta Prawna (pB10) on Tuesday.
The officials decided to increase spending on non-reimbursable drugs that do not have equivalents in a given indication from 190.7 million zlotys (€44.6 million) to 253.4 million zlotys (€59.2 million) this year.
Multiple myeloma generates unnecessary social cost
Experts believe Polish officials should add innovative multiple myeloma drugs to the country's reimbursement list as they could significantly reduce the social cost of the disease, reported Rzeczpospolita (pA11) on Tuesday.
Polish patients already have access to four out of nine approved multiple myeloma therapies. However, patients and doctors want Poland to consider reimbursing Janssen's Darzalex (daratumumab) and Amgen's Kyprolis (carfilzomib).
Experts say that while the additional therapies are not cheap, there are only about 300 people per year diagnosed with the most severe type of multiple myeloma.
The social cost of multiple myeloma is the third highest among all blood cancer types and was 20 million zlotys (€4.7 million) in 2013, which means that reimbursing innovative drugs that could help mitigate it could actually be cheaper for the state, especially when taking into account special arrangements with pharma companies and risk-sharing mechanisms.
Access to opioid substitution treatment could be easier
Polish officials want to improve access to some drugs used in opioid substitution treatment by making them available on prescription, reported Dziennik Gazeta Prawna (pB11) on Thursday.
Patients undergoing opioid substitution treatment currently receive methadone and buprenorphine in special programmes. However, many patients need to receive their doses every day, which is challenging for geographical and logistical barriers.
Meanwhile, officials are working on new regulations to enable these drugs to be purchased on prescription, thereby making them more accessible throughout Poland. Some experts criticise the idea and say that, as that there will be no national reimbursement for the drugs, the change may only benefit a handful of patients, who can afford to spend 600-800 zlotys (€140-186) per month for treatment.
Reimbursement of a new cardiac drug could improve the situation of many patients
The Polish Cardiac Society believes a new breakthrough drug, which is a combination of two neuroendocrine system blockers, should be reimbursed for patients with the highest risk of cardiac issues, reported Rzeczpospolita (pA11) on Tuesday.
Experts say the treatment increases the life expectancy of patients by several years, reduces the risk of hospitalisation by up to 40% and increases the quality of life of patients. However, without reimbursement, the drug is too expensive for most patients, with monthly therapy costing at 500-600 zlotys (€117-140).
The paper did not name the drug.
New EU regulations could benefit generics producers
The European Parliament has decided that EU pharma companies will be allowed to produce and sell generic drugs outside the EU during the additional five-year supplementary protection certificate (SPC) patent protection period for originator drugs, reported Rzeczpospolita (pA14) and Dziennik Gazeta Prawna (pB4) on Thursday.
The SPC is only valid within the EU and prevents European producers of generics from selling their products even outside the EU. According to the new regulations, the additional five-year period will not apply to drugs exported outside the EU, while generics producers will be able to start producing and storing their equivalents that are to be sold within the EU six months before the SPC certificate expires.
The new regulations are to enable European generics producers to compete with U.S. and Asian companies that are not affected by the SPC certificate on non-EU markets.
Employer union criticises pharmacists association for spreading 'false information'
Marcin Nowacki, vice president of the Union of Entrepreneurs and Employers (ZPP), criticised claims from pharmacy associations that 4,000 pharmacies should be closed to make the market healthier, reported Rzeczpospolita (pA16) on Monday.
According to the association of Polish pharmacy employers (ZAPPA), Poland has too many pharmacies to ensure their profitability and the number should be reduced by around 25%.
ZAPPA's claims is based on a recent ruling from Poland's supreme administrative court, stating that a pharmacist with at least five years’ experience or an academic specialisation and three years’ experience must be present at the pharmacy at all times for it to be open for business, which it says is practically unachievable with the current number of pharmacies in Poland due to the shortage of specialists.
Nowacki criticised ZAPPA for spreading 'misinformation' about the need to close thousands of pharmacies across Poland. He said lobbies of individual pharmacists have long attempted to undermine the position of pharmacy chains, because they are highly price-competitive, with large product portfolios and a good quality of services provided.
He added that the efforts of these lobbies and pressure put on officials means Poland currently has one of the most overregulated pharmacy markets in Europe.
Additional responsibilities for pharmacists
According to new regulations that are in development, pharmacists in Poland could gain additional responsibilities and play a more important role in supervising pharmacotherapy, reported Rzeczpospolita (pA17) on Wednesday.
The vice president of the supreme pharmaceutical council Marek Tomkow said that one in eight patients ending up in hospitals because of drug misuse and that pharmacists could play a key role in improving the system, reducing waiting times and saving money by supervising drug therapies.
Biomed-Lublin’s production is still blocked
Biomed-Lublin announced it should be able to fully resume unimpeded production of its Onko BCG and BCG10 vaccines no earlier than in the third quarter of the year, reported Parkiet Gazeta Gieldy (p4) on Tuesday.
Mabion could soon commercialise its new drug
Polish biotech Mabion is hoping its new drug, MabionCD20, will be registered by the European Medicines Agency (EMA) by the end of the year, reported Parkiet Gazeta Gieldy (p4) on Saturday.
Mabion believes it could report its first revenues from selling MabionCD20 in 2020, but the exact date of market launch will depend on the company’s partner, Mylan. Mabion is also preparing to file all the required documentation with the Food and Drug Administration (FDA) to register the drug in the U.S. The company also expects to sign additional partnership agreements for MabionCD20 and MabionMS by the end of the year, for other regions where it intends to expand with its products.
Alivia organisation claims oncology financing should be increased
The Alivia organisation supporting cancer patients says the additional 971 million zlotys (€226.9 million) the National Health Fund is due to receive in 2019 through public health insurance contributions should be used to improve cancer diagnostics and treatment, reported Dziennik Gazeta Prawna (pB9) on Wednesday.
Neuca branches out
Poland’s largest pharma wholesaler, Neuca, intends to continue investing in new branches of its business in 2019, reported Parkiet (p4) on Wednesday.
Neuca is using its market position and profit generated from drug wholesaling to invest in new activities. It has been investing in diagnostics, telemedicine, its own brands of OTC products and outpatient clinics, while it also recently opened an office in London to branch out into the clinical trials market.