WARSAW, 5 Oct (APM) - With the forthcoming negotiations of reimbursable drug prices between the Ministry of Health (MoH) and pharma companies, there are concerns that some pharmas may not agree to further price cuts, which could result in drug shortages in Polish pharmacies, reports Gazeta Wyborcza on Friday.
Reimbursement agreements for around 3,000 drugs will expire at the end of the year, while their manufacturers warn that aggressive price negotiations by the officials may force them to withdraw their products from reimbursement.
While the Reimbursement Act was supposed to improve access to innovative drugs in Poland, the biggest beneficiary of the changes was the National Health Fund (NHF), which saved several billion zlotys on drug reimbursement, but failed to put the savings back into the system and provide more innovative treatment options as previously promised.
According to a report prepared by IQVIA, the percentage of innovative drugs registered in Poland after 2009 constitutes only 0.3% of all reimbursable drugs available to patients, with the regional average being 0.6%. Additionally, while the NHF is supposed to spend up to 17% of its budget on drug reimbursement, the spending has historically always been lower, with 15.5% of the budget spent in 2017.
Now, even domestic manufacturers of cheaper reimbursable generics say they cannot accept continuing price cuts forever, which could soon result in drug shortages in pharmacies after the pharmas withdraw their products from reimbursement.
MoH wants to reduce spending on HIV/AIDS treatment
According to an analysis conducted by the MoH, spending on HIV/AIDS treatment could be reduced by using cheaper equivalents of currently used originator drugs, reported Rzeczpospolita (pA1 and pA15) and Dziennik Gazeta Prawna (pA2) on Tuesday.
Such treatment performed with combinations of 20 drugs costs the NHF 350 million zlotys (€81.2 million) per year, with an average of 3,100 zlotys (€719) per patient.
Meanwhile, other countries use cheaper generics for treating HIV at a monthly cost of 150-300 zlotys (€35-70) per patient. According to the World Health Organisation, best practices are to treat most patients with cheaper generics and only a small group gaining the greatest benefits with the more expensive originator drugs. However, the officials are concerned that, with the Polish HIV/AIDS treatment system being one of the best in Europe, the percentage of patients from neighbouring countries seeking treatment in Poland could quickly increase, reported both newspapers.
HIV/AIDS drugs are currently bought via a central tender and the MoH cannot negotiate the prices with drug manufacturers. The officials want to reduce the costs of treatment and therefore want the current system to operate only until January 2019. They are considering three solutions, namely to add HIV/AIDS drugs to the reimbursement list, to change the treatment schemes used by doctors, or to change the entire healthcare policy, according to which patients are treated, reported both newspapers.
As the patent protection period for Truvada has ended, generic companies launched their own cheaper products onto the market. Meanwhile, Gilead launched a new HIV product onto the market with milder adverse effects. However, instead of prescribing generics to reduce the costs of treatment, Polish doctors started prescribing the new originator drug, reported Dziennik Gazeta Prawna.
Deputy health minister Slawomir Gadomski claims that switching to equivalents could save several dozens of millions zlotys a year, while including them in the reimbursement list would save up to 50 million zlotys (€11.6 million) a year, reported both newspapers.
MoH wants pharma companies to pay for independent clinical trials
The MoH wants pharmas to provide 5% of their marketing budgets to finance independent clinical trials run by the Medical Research Agency (ABM), reported Rzeczpospolita (pA13) on Monday.
The ABM is to be established shortly with an initial budget of 50 million zlotys (€11.6 million) provided by the state and the NHF in 2019, which is to increase to 466 million zlotys (€108.4 million) in 2020 and to 1.014 billion zlotys (€235.8 million) in 2029. The funds will primarily be used to run clinical trials of innovative molecules and medical devices.
However, the officials are considering supplementing the ABM’s budget with funding obtained from the pharmas through mechanisms similar to the Garattini tax in Italy, according to which pharmas are required to provide 5% of their marketing budgets for running independent clinical trials.
Legal experts are concerned that the changes could result in an increase in over-the-counter drug prices, as only these drugs can be advertised in Poland. Additionally, the definition of advertising would need to be more precise than it currently is in order to make the system work transparently.
Economists add that additional taxes could further discourage major foreign players from investing in Poland, as, despite promises, the officials have yet to introduce the so-called Development Mode Reimbursement, which is supposed to provide exemptions of up to 10% of the reimbursement value to companies starting production in Poland.
Concerns about availability of fulvestrant for cancer
A patent dispute is currently pending between Teva and AstraZeneca regarding a breast cancer drug, with Teva being prohibited from marketing its drug, which was recently added to Poland’s reimbursement list, reported Rzeczpospolita (pA10) on Wednesday.
Teva’s oestrogen receptor antagonist, fulvestrant, was registered in Poland in early 2017 and was added to the reimbursement list on 1 July 2018. AZN’s Faslodex had appeared earlier on the Polish market. Fulverstrant’s reimbursement led to a reduction in the official price from PLN 2700 (€628) to PLN 1215 (€283), which automatically reduced the amount of reimbursement, thereby increasing the price that patients need to pay for Faslodex.
Meanwhile, a patent dispute is pending between Teva and AZN, with the court issuing an injunction preventing Teva from placing its product on the market. Although Teva requested the removal of fulvestrant from the reimbursement list, the request has not been considered to date, which could leave patients without reimbursed treatment.
Large-scale withdrawal of drugs from pharmacies
Some 106 medicinal products have been withdrawn from pharmacies so far this year, which is twice as many as in 2017 and three times more than in 2016, reported Dziennik Gazeta Prawna (pA9) on Wednesday.
Intensified inspections are taking place because of the recent problems with contaminated valsartan being found in hypertension products. However, many of the products are being withdrawn because of errors on the leaflet, for instance the specified dosage, as well as investigations proving the product was out of specification, because of the excessive or insufficient quantity of the active ingredient.
After the product is withdrawn, the marketing authorisation holder needs to present a report on the withdrawal stating what remedial action was taken to prevent the reoccurrence of the cause of the withdrawal.
Pharmas investing in Poland will not be subject to payback mechanism
The new drugs policy, on which the MoH is working, anticipates increasing the amount of payback that pharmas pay from 50% of the overspending on reimbursement to 100%, unless they invest in Poland in production reported Dziennik Gazeta Prawna (pB1) on Thursday.
Krzysztof Kopec, president of the Polish Association of the Pharmaceutical Industry Employers, said the payback mechanism has never been activated, because funding is always added to the reimbursement budget if more medications are needed on the market. He added that, as the health minister is responsible for reimbursement, it is unfair that pharmas have to bear the consequences of decisions over which they have no influence.
Producers of originator drugs are generally exempt from the payback system, as they have risk-sharing agreements, whereas the companies at risk are the pharmas that sell large volumes of the most popular generics. Meanwhile, the new drugs policy will promote innovative companies that invest in Poland, offer jobs and pay taxes.
Officials and Polish pharma companies lobby for EU patent protection changes
The MoH and Polish pharma companies are lobbying for changes to the Supplementary Protection Certificate (SPC), which would enable domestic manufacturers to produce and then sell generic equivalents of originator drugs outside the EU after the extension of their patent protection beyond the standard period, reported Rzeczpospolita (pA17) on Friday.
Pharmas producing originator drugs can currently file for the SPC before the standard 20-year patent protection expires, effectively extending it by up to five years. However, in such a case, manufacturers of generics from the EU are not allowed not only to produce and sell their equivalents in the EU, but also outside it, where the SPC does not operate, for example in India, China or the U.S.
Representatives of generic manufacturers say the SPC puts them at a disadvantage when competing with players from outside the EU and adversely affects patients, as access to more expensive drugs is worse than in the case of cheaper equivalents. Furthermore, the current situation affects the Polish budget, as every 1 zloty (€0.23) spent on drugs produced in Poland contributes 0.78 zlotys (€0.18) to Polish GDP.
The officials and companies involved are hoping the regulations will be ready and accepted within the current term of office of the EU Parliament, as this would enable Polish companies to start selling their equivalents next year in countries where the SPC does not operate.
The proposed solution could also benefit foreign companies deciding to relocate production to Poland, as European standards for drug manufacturing are considered to be among the highest in the world and the U.S. Federal Drug Administration does not require any additional testing before such drugs are launched on its market.
Medical cannabis still not available in Poland
Although the regulations legalising medical cannabis in Poland came into force in November 2017, patients still do not have access to it, reported Gazeta Wyborcza (Duzy Format supplement, p20-22) on Monday.
Medical cannabis is not available at all in Polish pharmacies, as there are no importers of such products, while only a Canadian company applied for an import permit and is still waiting for the application to be processed.
This is creating a situation in which Polish patients have to buy their cannabis from drug dealers, grow it themselves or buy it abroad, all of which is illegal, even if they have the appropriate prescriptions.
Anti-vaccination lobby gaining momentum
Parents of 34,200 children refused to vaccinate their children in the first half of 2018, while the Sejm (the lower house of the parliament), will be considering the anti-vaccination lobby’s bill in the coming days, reported Dziennik Gazeta Prawna (p1 and p4) on Monday.
4.8 of 1,000 people aged up to 19 are refusing vaccination, mostly for ideological reasons. Even the fines imposed on the parents are ineffective, as parents file appeals against them. Meanwhile, many parents pay the fines and still refuse to vaccinate, while only a small percentage vaccinate their children.
Experts claim the establishment of a compensation fund would reduce the impact of the anti-vaccination movement. Therefore, work started on the amendment of the contagious diseases prevention act last year, introducing numerous changes, and is now coming to an end.
These amendments include the establishment of a vaccination compensation fund. It will no longer be necessary to prove there is a causal relationship between the adverse effects and the vaccination, but it will be sufficient to demonstrate symptoms of the adverse effects specified in the literature. This compensation will also not close the door to parents filing for additional compensation in court.
Ruling party wants to change vaccination schedule
Although the ruling party claims it does not support the anti-vaccination movement’s bill, it is still in favour of progressing with the work on the amendment of the law providing for obligatory vaccinations, reported Rzeczpospolita (pA1 and pA17) and Gazeta Wyborcza (p4) on Thursday, as well as Rzeczpospolita (pA17) and Gazeta Wyborcza (p1) on Friday.
The proponents of vaccination claim that making vaccination voluntary will cause an epidemic, giving the example of 123 cases of measles so far this year compared with 46 last year. Meanwhile, the opponents say that despite declining numbers of vaccinations, there were 1,234 fewer cases of whooping cough this year than last year, reported Rzeczpospolita.
During the discussions in the Sejm, the members of the ruling PiS party, Kukiz 15 and the nationalists supported the removal of the word “obligatory” from the current law, reported Gazeta Wyborcza on Thursday.
It is also considering vaccinating children at the age of two years instead of newly-born babies. However, a change in reporting adverse effects is also being considered, whereby it will be the parents who report such cases reported all the newspapers, while Rzeczpospolita added that adverse effects will be subject to the payment of compensation of 70,000 zlotys (€16,250).
During the vote on the bill presented by the STOP NOP anti-vaccination organisation, the PiS and Kukiz 15 parties voted in favour of removing the vaccination obligation, claiming that parents have the right to refuse to vaccinate their children.
This meant that the bill has been passed to the Sejm committees for further legislative work, report both newspapers on Friday. However, this does not mean that the members of parliament are considering lifting the vaccination obligation, but rather to start a debate on the Polish vaccination system adds Rzeczpospolita on Friday.
Biopharma industry pleased with Poland’s plans to increase healthcare spending
Jacek Gralinski, corporate director of Amgen, says the increase in healthcare spending to 6% of GDP in 2024 will create an opportunity for the development of biopharmacy reported Rzeczpospolita (pA23) on Thursday.
While patient co-payment in Poland does not differ from global levels, during an interview with Rzeczpospolita, Gralinski said that co-payment means patients will not hoard medicine unnecessarily, whereas, if the level of co-payment becomes excessive, people will not be able to afford medications and will simply not take their prescribed medications. Therefore, the state needs to monitor the situation to ensure that the threshold of co-payment is never exceeded.