WARSAW, 3 July (APM) - Just before the first round of the presidential elections, President Andrzej Duda presented a bill establishing a new medical fund to improve access to more expensive drugs and to encourage pharma companies to apply for reimbursement of their drugs, reported Dziennik Gazeta Prawna (pA6) on Tuesday.
The bill is designed, among others, to improve access to drugs in the emergency access to drug technologies (RTDL) procedure and offer conditional access to drugs.
According to the bill, university hospitals and clinical hospitals will receive an extra lump sum of 3% of the current reimbursable drug programmes and chemotherapy budget, but the wording is ambiguous and the concern is that the amount would be taken from the existing drugs' budgets. Another disputed point is that the RTDL drugs will undergo price negotiations, which will lead to reductions in drug prices.
One of the medical fund's objectives is to offer access to drugs for patients suffering from diseases which are not included in any drug programmes. However, the conditions and term of inclusion in the RTDL are being questioned by pharma, as the Ministry of Health may withdraw from financing a given treatment for some reason, leaving the pharmas to finance the treatment themselves.
It will now be the Polish Economic Commission (KE) that will decide on drug reimbursement, which, according to Infarma, an organisation associating innovative pharmas, will limit access to innovative drugs, as there will be no way of appealing against its decision, which will be based primarily on price negotiations.
Others expect the price-based selection to lead to Asian drugs monopolising the pharma market, as they will set such a low benchmark price that would be impossible for Polish producers to reach.
Additionally, it is feared that the funding proposed in the bill will be purely an accounting reclassification within the state budget and not additional funding for drugs and that major changes will be introduced into the reimbursement policy without public consultation.
Amendment to pharmaceutical law aims to cut illegal drug exports
The pharmaceutical law outlawed companies running pharmacies and healthcare establishments since 7 July 2018, thereby preventing illegal drug exports by healthcare establishments, established especially for that purpose, reported Dziennik Gazeta Prawna (pB6) on Monday.
All companies running pharmacies and healthcare establishments had to decide by 1 August 2019 on which of these areas of business they would conduct. Poland currently has 12,500 pharmacies, while the Polish pharmacy market is worth 40 billion zlotys (€9 billion) and, until recently, the value of illegal drug exports was estimated at 2 billion zlotys (€450 million).
In the peak period of the drugs crisis, between June and July 2019, 500 drugs were missing from the Polish market.
Polish blood cancer patients need better access to innovative targeted therapies
Despite the recent additions of innovative therapies to the reimbursement lists, Polish blood cancer patients need better access to targeted therapies, reported Rzeczpospolita (pH2) on Tuesday.
The latest additions to the reimbursement lists include daratumumab and carfilzomib for patients suffering from multiple myeloma, blinatumomab for patients with acute lymphoblastic leukaemia, pegylated interferon for patients with myeloproliferative neoplasms (MPNs), a combination of venetoclax with rituximab for patients with
lymphocytic leukaemia with and without 17p detection (TP53 mutation), and obinutuzumab for patients suffering from follicular lymphoma.
Patients suffering from chronic lymphocytic leukaemia (CLL), who are not eligible to join the existing drug programmes, are appealing for the inclusion of ibrutinib, an innovative targeted therapy, in the reimbursement list.
Experts also say patients in the first line of treatment, or those with a recurrence of the disease do not have equal access to therapies. For some, the only chance of receiving treatment is to join clinical trials or apply for individual reimbursement, such as the emergency access to drug technologies (RTDL), but this can be too complicated and time-consuming for patients for whom every second of treatment counts.
Increasing access to innovative therapies is also important in the Covid-19 pandemic, as these drugs are administered orally, so a high-risk patient is not required to visit a hospital and be potentially exposed to the virus.
Over 100,000 patients currently suffer from blood cancer in Poland.
Polpharma's mission is to offer drug safety for Polish patients
Polpharma, Poland's largest pharma, producing 42 original medications, as well as active pharmaceutical ingredients (APIs) domestically is concentrating on assuring Polish patients of drug safety, as well as on research and development activities, reported Rzeczpospolita (pE21) on Monday.
Polpharma produces 400 million packs of drugs each year and offers 750 different types in all major therapeutic classes. The most important products include morphine, adrenaline and acenocoumarol which have no biosimilars on the Polish market.
In terms of APIs, Polpharma produces 73% of global supplies of baclofen and 42% of global supplies of risedronate sodium. Polpharma's APIs account for 30% of the company's export revenue. The company specialises in optical, neurological, pulmonological, cardiological and gastroenterological drugs.
The company is also strong in research and development, in which the company invested 2.3 billion zlotys (€520 million) in 2000-2019 and to which it plans to allocate 235 million zlotys (€55 million) this year. It has three R&D facilities employing over 300 researchers.
Over the last three years, the company has announced 28 innovations, applied for 64 patents and has been granted 18 patents. Polpharma is currently developing 270 new projects. This shows that Polpharma's view of ensuring drug safety for Polish patients is to invest in drug and API production lines, acquisitions, research and development of new therapies and education programmes for both pharma specialists and patients.
Biotech share prices soar on Polish stock market
The first wave of Covid-19 pandemic has boosted the share prices of biotechs on the Polish stock market and they are now expecting another surge during a second wave of the pandemic, reported Rzeczpospolita (pE21) on Monday and Parkiet Gazeta Gieldy (p7) on Saturday, (p10) Monday and (p1, p3) Wednesday.
Experts say the unofficial WIG-covid index, which contains biotechs involved in combating the pandemic, will continue to rise.
Biomed Lublin, a Polish tuberculosis (BCG) vaccine producer, announced it is working on its own anti-Sars-CoV-2 immunoglobulin drug using the plasma of Covid-19 survivors in cooperation with Independent Public Clinical Hospital No. 1 in Lublin Institute of Haematology and Transfusion Medicine and the Regional Blood Centres (RCKiK).
The company claims to focus mainly on the needs of patients in Poland, which will make Polish patients independent of foreign producers.
Ryvu Therapeutics, previously a part of Selvita, is now valued at 1.2 billion zlotys (€270 million). Its flagship project is the SEL120 molecule used in acute myelogenous leukaemia, which has been approved by the U.S. Food and Drug Administration as an orphan drug, reported Puls Biznesu on Monday.
Another pharma with a rising share price is Celon Pharma, which has settled with GlaxoSmithKline on exports of Salmeks. Experts expect a 56% increase in sales and a 186% jump in net revenue year-on-year. The company is also expected to sign a partnership agreement on esketamine in the fourth quarter, reported Parkiet on Saturday.
Another company with record improvements in its results is the pharmaceutical distributor Neuca. It proved to be fully prepared for the increased demand for pharmaceuticals and protective equipment at the beginning of the pandemic in Poland and, together with the rapid development of its telemedicine branch, it is seeing a stable increase in its value, concluded Parkiet on Saturday.
U.S. biotechs are booming on stock markets
The trend of rapid growth of pharmas working on combating the Covid-19 pandemic in the U.S. has also spread to all biotechs in general, reported Parkiet Gazeta Gieldy (p6) on Monday.
The rumours of a Covid-19 vaccine increased share prices, as in case of Moderna, the first company to announce the entry of its vaccine-candidate into Phase I.
Its share price has soared 215% since the start of the year. Meanwhile, Novavax's share price has skyrocketed 2,000%.
Other biotechs, despite some not working on a Covid-19 vaccine, have seen a substantial increase in their share prices.
Forma Therapeutics, specialising in haematology and oncology drugs, has seen a 130% increase in its share price since joining the stock market.
Avidity Biosciences, which works on drugs for muscle disorders, floated on the stock market last month, since when its share price has jumped 60%. Pliant Therapeutics, Repare Therapeutics, Burning Rock Biotech and Vaxcyte, none of which are working on Covid-19 drugs, have seen a significant increase in value.
Two thirds of the companies that debuted on the U.S. stock market in the second quarter of this year were from the biotech sector.