WARSAW, 4 Jan (APM) - Changes specified in the schedule from Poland’s drugs policy for 2018-2022 have been delayed, reported Rzeczpospolita (pA15) last Thursday (27 December).
The amendments planned for submission to the parliament by the end of 2018 included the major amendment to the Reimbursement Act enabling the submission of reimbursement applications in English, the publication of reimbursement lists every three months (instead of two) and the introduction of a rigid spending level of 17% of the National Health Fund’s budget (rather than ‘up to 17%’).
Additionally, a reimbursement incentives system was to have been introduced promoting production and investments in the Polish pharma industry.
Krzysztof Landa, former deputy minister responsible for drugs policy, is surprised about the delay, as many of the changes were agreed upon at a conference in September 2016. Some experts believe the delay is due to staffing problems caused by harassment by new managers in the drugs policy department, which has lost most of its experienced employees.
New drugs reimbursed from January
Poland's Ministry of Health (MoH) has announced the addition of new drugs to the new reimbursement list for treating lung cancer, leukaemia and spinal muscular atrophy (SMA), reported Gazeta Wyborcza (p6) last Friday (28 December) and Dziennik Gazeta Prawna (pB9) on Monday.
Nusinersen, which stops the development of SMA, is finally to be reimbursed from 1 January. This was a decision made by the MoH as the economic commission objected because of the price. However, no further information was publicised reported both newspapers. The reason for the lack of information is supposedly the introduction of a payback mechanism which automatically makes the agreement confidential for the MoH and the pharma, reported Dziennik Gazeta Prawna.
Furthermore, Roche’s tecentriq (atezolizumab) for treating lung cancer is being added to the reimbursement list, while the indications for Pfizer’s xalkori (crizotinib) are being extended and patients suffering from chronic lymphocytic leukaemia will receive access to venetoclax, reported both newspapers.
A total of 3,100 new reimbursement decisions were made as all the decisions issued three years ago expired at the end of 2018. While the official sales prices of 1,371 drugs were reduced, retail prices declined for 2,382 drugs by between 0.01 zloty and 84.94 zlotys (€0.002-19.8) and increased by 0.01 zloty to 1.11 zlotys (€0.002-0.26) for 296 drugs, reported Dziennik Gazeta Prawna.
Further additions to the list will be drugs for treating chronic lymphocytic leukaemia and Tourette syndrome. However, more drugs are waiting for reimbursement decisions, while some have been removed from reimbursement, reported Dziennik Gazeta Prawna.
Measles outbreak has depleted stocks of vaccines in pharmacies
Polish pharmacies have almost no stock of measles vaccines due to the recent outbreak of the disease, reported Dziennik Gazeta Prawna (A6) last Thursday (27 December).
A demand has been created for the measles vaccines by the increase in the morbidity rate in Germany, France and Italy, as well as the epidemic alert in Ukraine. Not only do the shortages affect children who are to be vaccinated free of charge according to their schedule, but also adults, who need to pay for their vaccinations. Employers are also referring their employees to doctors for vaccinations, as they believe it is cheaper to prevent the disease than to experience downtime later.
The MoH recently ordered 20,000 additional vaccines, but this stock is rapidly being depleted. Furthermore, it is not being distributed evenly throughout the country.
Lung cancer screening programme to start this year
A national early lung cancer screening programme will take off nationally from 2019, reported Gazeta Wyborcza (p11 Tylko Zdrowie supplement) last Friday (28 December).
The programme will be implemented with low-dose computer tomography to detect lung cancer in its early stages. It will be targeted at smokers and former smokers aged 50-74 years. This is expected to reduce the lung cancer mortality rate in Poland.
The current trend in treating lung cancer is the move away from classic chemotherapy in favour of personalised therapy with molecular-targeted drugs that affect specific genetic changes, as well as immunocompetent drugs that help the patient’s own immune system fight cancer. The first group includes EGFR inhibitors (erlotinib, gefitinib, afatinib, ozymertinib) and drugs targeted at the ALK gene (crizotinib). The second group includes nivolumab, pembrolizumab (both of which have been reimbursed in Poland since 1 May 2018) and atezolizumab.
Personalised therapy and ever-newer drugs are currently increasing life expectancy. However, the main problem is availability of the drugs. Crizotinib is currently available to Polish doctors, but only for second line treatment, although it is expected that it will also be used in a drug programme for first line treatment in 2019. Pembrolizumab is also available for first-line treatment, while nivolumab is currently available for second-line treatment, but only for squamous cell carcinoma.
Price of post-transplant drug for children increased for the 11th time
The new reimbursement list will bring a further increase in the price of valganciclovir by 30 zlotys (€7) to 995.80 zlotys (€232), reported Rzeczpospolita (pA15) last Friday (28 December).
Parents will now have to pay almost 2000 zlotys (€465) per month for treatment with the suspension, which generally lasts several months. The MoH claims tablets are much cheaper, whereas doctors and parents argue that the dosage cannot be precisely selected, while an infant could choke on a tablet.
Doctors also argue that the argument that the suspension is free of charge when received from a hospital is inappropriate, as a reduction of post-transplant immunity could pose a threat to the child’s life. However, as all post-transplant drugs for adults are free, the question arises of why financial barriers are created for parents of children.
Falsified drugs directive must be implemented
The government needs to accept the draft amendment to the pharmaceutical law by the end of 2018 to align Polish law to the EU falsified drugs directive, reported Dziennik Gazeta Prawna (B6) on Monday.
The amendment to the law will require all drug packaging to contain a unique code to be read by the pharmacist with a special scanner. The pharmacist may sell a drug that the system confirms originates from a legal source whereas the pharmaceutical inspectorate must be informed of any illegal drugs. The new regulations need to be implemented from 9 February 2019.
Pharmaceutical inspectors to become quasi-police
Pharmaceutical inspectors are expected to carry arms on audits of pharmacies and have quasi-police rights to stop further illegal action and ensure access to around 300 medications in short supply, reported Dziennik Gazeta Prawna (pA1 & pB6) on Monday.
In a letter to Marcin Warchol, deputy minister of justice, Maciej Wasik of the special services council suggested increasing the rights of pharmaceutical auditors and giving them the rights of the intelligence and police services, claiming that they should be able to investigate and pursue entities involved in illegal activities, which would require additional tools.
Dobrawa Biadun, a lawyer and expert from the Polish Confederation Lewiatan objects to this idea, saying that the pharmaceutical authorities already have the powers to conduct dawn raids and enter all premises of a pharmacy if they have reasonable suspicion of a crime being committed. She adds that untrained officials could do more harm than good in a pharmacy and that such legislation would cause problems for the innocent without affecting the real criminals.
Meanwhile, Marek Tomkow of the Supreme Pharmaceutical Council supports the idea, adding that IT experts and former policemen should be employed by the pharmaceutical inspectorates, adding that a good IT expert can often achieve more than six heavily armed officers. He agreed that innocent pharmacists could suffer, but the actions of criminals are currently causing damage to the whole of the pharmaceuticals market.
U.S. ambassador to Poland supports Swiss pharma
U.S. ambassador, Georgette Mosbacher, wrote to the Polish Minister of Health on 30 October 2018 requesting a meeting to clarify concerns about the lack of reimbursement of Roche’s life-saving drugs, reports Gazeta Wyborcza (p4) on Friday.
In the letter that was leaked to the public, Mosbacher claims Roche and its U.S. affiliate, Genentech, were treated unfairly, as the November reimbursement list did not contain Roche’s lung cancer drug, Tecentriq.
She also mentioned that despite Roche’s protests, deputy health minister Marcin Czech agreed to streamline the reimbursement indications for intravenous and subcutaneous forms of Herceptin, seemingly favouring the competition. Furthermore, Mosbacher criticised the National Health Fund’s decision to pay hospitals more for choosing cheaper generics of Herceptin, adding that Roche invests a lot of money around the world, works with Polish scientists and is in the process of establishing a clinical trials centre in cooperation with the oncology centre in Warsaw.
Although Tecentriq appeared on the January reimbursement list, this decision was not directly influenced by Mosbacher’s letter. The officials claim the drug was not included in the November list because Roche refused to make changes to the drug programme in which the medicine is administered to patients.
The newspaper unofficially learned that changes to drug programmes must be confirmed by all pharmas which have drugs in the programme, while one company had not given such consent. Mosbacher’s letter was supposed to encourage the minister to put pressure on that pharma.
The biggest question arising from this letter is why the U.S. ambassador is interested in Roche’s business, as the company is Swiss, while the competition allegedly being favoured is U.S.-based Amgen.
Motion for a vote of no confidence for health minister
The PO (Civic Platform) party intends to file a motion for a vote of no confidence against health minister, Marcin Szumowski, reports Gazeta Wyborcza (p4) and Rzeczpospolita (pA15) on Friday.
This decision is related to the alleged irregularities with the recent announcement of the reimbursement list and reimbursement decisions for drugs produced by Adamed. The controversies arose because the list did not initially include a dozen or so drugs produced by Adamed, but was changed after two days. Meanwhile, senior MoH officials organised a two-day meeting at a luxury hotel owned by Adamed’s owners, reported both newspapers.
The MoH’s officials claim the decision to organise the meeting at the hotel was made long before the announcement of the list, while the changes to the list, even in the case of drugs which had their prices increased in excess of the official limits, were advantageous to patients, reported both newspapers.
Deputies invite anti-vaccination expert from UK
The Sejm’s working party on the safety of Poland’s vaccination programme led by Pawel Skutecki from the Kukiz’15 party invited an opponent of vaccinations from the UK, professor Christopher Exley from Keel University, to discuss the potential complications caused by vaccines, reports Gazeta Wyborcza (p3) on Friday.
Exley, who says there is a clear connection between vaccinations and autism because of increased levels of aluminium in the brains of deceased patients, has been criticised for propagating his theories without applying appropriate research methodology.