Strontium isotopes as an indicator of human migration : easy questions, difficult answers

Isotope analyses of bones and teeth allow us to study phenomena which occurred in the history of human species and which are difficult to capture by traditional anthropological methods. Measuring oxygen, nitrogen and carbon isotope levels in the skeleton makes it possible to reconstruct climatic changes, diet and/or the weaning process. Among isotopes used in such analyses are strontium isotopes, helpful in analysing migration and studying the mobility of historical and prehistoric human populations. In this respect, the proportion of two isotopes, the heavier 87Sr and the lighter 86Sr, is measured, following their extraction from the bioapatite of the bone mineral. Released from rocks in the weathering process, strontium permeates individual components of inanimate and animate environments, and then finds its way, together with food, to the human body. Thanks to comprehensive environmental studies and the measurement of the strontium ratio 87Sr/86Sr in various animal tissues it is possible to determine the local isotope background for the environment. Values obtained by analysing human skeletons referenced against the range of environmental isotope variability enable researchers to trace back the location inhabited by the individual or group

Use of single pill combinations in the treatment of arterial hypertension in Poland: The current practice and guidelines, the impact on reimbursement spending and patient co-payment

Background: Clinical guidelines recommend using single pill combinations (SPC) when initiating and intensifying the treatment of arterial hypertension (AH), which is not reflected in the Summaries of Product Characteristics (SMPC) for individual preparations. The drug reimbursement system in Poland (with a few exceptions) does not provide for reimbursement outside the indications specified in the SMPC. Therefore, it excludes the use of SPC under reimbursement. In 2020 the share of SPC in the treatment of AH amounted to 12.8% of unit volume and was lower than the 80% based on the guidelines of the Polish Society of Hypertension. Methods: Using the data from a sample of pharmacies in Poland over the period November–December 2020, the potential was assessed of switching from existing AH therapy with monocomponent drugs containing selected combinations of active ingredients to the equivalent SPC. Results: The potential of switching from AH treatment in the analyzed period using monocomponent drugs with the equivalent SPC amounted to 19% of unit volume (a reduction of 212M units), with the highest switch potential (43.9%) for drugs containing amlodipine. The public payer’s savings would be EUR 12.3 million and patient savings would amount to EUR 5.0 million. Conclusions: Enabling reimbursement of SPC in Poland in line with the clinical guidelines can significantly increase the share of SPC in the treatment of AH, which will result in better health outcomes and a significant reduction in the payer’s drug reimbursement spending and will lower the financial barrier for patients to access this type of treatment

Retrospective analysis of eff ectiveness and toleration of treatment with platinum derivative and pemetrexed in patients with advanced (stage IIIB and IV) non-small non-squamous cell lung cancer in a few oncology centers

Wstęp. Badanie Scagliottiego i wsp. zapoczątkowało stosowanie w leczeniu raka płuca schematów chemioterapiistosownie do konkretnego rozpoznania histologicznego: w raku o utkaniu innym niż płaskonabłonkowe — w połączeniuz cisplatyną pojawił się pemetreksed.Cel pracy. Retrospektywna ocena skuteczności i tolerancji paliatywnej chemioterapii z użyciem dwulekowegoschematu zawierającego pochodną platyny i pemetreksed w rutynowej praktyce klinicznej w okresie przed wprowadzeniemprogramu lekowego.Materiał i metody. Do badania włączono 50 chorych na zaawansowanego (stopień kliniczny IIIB lub IV) raka niedrobnokomórkowegoo utkaniu innym niż płaskonabłonkowe. W całej grupie przeprowadzono analizę odpowiedzii tolerancji leczenia. Czas wolny od progresji określono u 45 chorych, u których nie stosowano innego leczenia przedprogresją oraz u których czas do progresji lub zgonu (ewentualnie utraty z obserwacji) był znany.Wyniki. Chorzy otrzymali od 1 do 5 cykli leczenia, a 34 chorych (68%) — zalecane 3–4 cykle. U żadnego chorego nieuzyskano całkowitej remisji pod wpływem leczenia. U 8 chorych (16%) odnotowano częściową remisję, a u 29 chorych(58%) — stabilizację choroby. Progresja w trakcie leczenia wystąpiła u 13 chorych (26%). Korzyść kliniczną odniosło17 chorych (34%). Mediana czasu wolnego od progresji wyniosła w ocenianej grupie 19 tygodni (3–92 tyg.). Wśródchorych leczonych cisplatyną mediana czasu do progresji wyniosła 19,8 tygodnia (3–92 tyg.). Tolerancja leczenia byładobra, nie odnotowano powikłań zagrażających życiu. Wystąpiło 10 przypadków neutropenii, 1 małopłytkowość,niedokrwistość pojawiła się u 7 chorych, odnotowano też 6 przypadków powikłań niehematologicznych.Wnioski. Korzyść kliniczną odniosła około jedna trzecia chorych, a mediana czasu wolnego od progresji była krótszaod uzyskanego we wspomnianym badaniu rejestracyjnym dla pemetreksedu. Leczenie było dobrze tolerowane.Celowe byłoby przeprowadzenie prospektywnego badania obserwacyjnego w celu rzetelnej oceny efektywnościi tolerancji rutynowego leczenia schematem zawierającym pemetrekset.Background. The Scagliotti trial initiated the use of chemotherapy in non-small cell, non-squamous lung cancerchemotherapy with pemetrexed.Purpose. Retrospective analysis of eff ectiveness and toleration of palliative chemotherapy with platinum derivativeand pemetrexed.Materials and methods. The study population was 50 patients with stage IIIB/IV non-small cell non-squamous lungcancer who had been treated with platinum derivate and pemetrexed. Response and toxicity were analyzed in allgroups. Progression-free survival was assessed for 45 patients who had not received any other treatment beforedisease progression and whose date of progression or death was known.Results. Patients received 1 to 5 cycles of chemotherapy, but 34 (68%) had recommended 3 to 4 cycles. No patientachieved complete remission. 8 (16%) had a partial response and stabilization was reached in 29 (58%). Progression ofthe disease occurred in 13 patients (26%). Clinical benefi t was achieved in 17 patients (34%). Median progression-freesurvival was 19 weeks (range 3–92 weeks), and for patients treated with cisplatin 19.8 weeks (3–92 weeks). Treatmenttoleration was good. No life threatening side eff ects were reported. Toxicity was as follows: 10 cases of neutropenia,1 of thrombocytopenia, 7 of anemia, and 6 of non-hematological toxicities were also reported.Conclusions. Clinical benefi t was achieved in one-third of patients. Progression-free survival was shorter than fornon-squamous cell cancer patients treated with cisplatin and pemetrexed in the Scagliotti trial. Treatment was welltolerated. For better assessment of treatment eff ectiveness and toxicity a observational study would be useful

Reimbursement Legislations and Decision Making for Orphan Drugs in Central and Eastern European Countries

BackgroundReimbursement policies influence access of patients to orphan drugs in the European countries.ObjectivesTo provide a comprehensive description of orphan drug reimbursement policies and to assess reimbursement decision-making process in the EU-CEE countries as well as the impact of the type of approval and disease on reimbursement decisions.MethodsFor each drug, the information regarding conditional approval or approval under exceptional circumstances was obtained from the EMA website. The reimbursement status for analyzed drugs was collected in a questionnaire survey performed in a group of experts in reimbursement policy. The agreement between countries was assessed using the κ coefficient, nominal variables tests were compared using the χ2 test or the Fisher exact test. The impact of the EMA’s conditional approval and approval under exceptional circumstances was assessed using logistic regression and presented as an odds ratio (OR).ResultsThe analysis revealed that most orphan drugs were authorized for the treatment of oncological or metabolic diseases [36 drugs (38%) and 22 drugs (23%), respectively]. The shares of reimbursed orphan drugs varied significantly (p = 0.0031) from 6.3% in Latvia to 27.4% in Poland. No correlation (r = 0.02; p = 0.9583) with GDP per capita was observed. The highest agreement in reimbursement decisions was observed between Estonia and Lithuania, and the lowest – between Estonia and Latvia, with kappa of 0.69 and 0.11, respectively. Significant impact of the type of approval and reimbursement status was observed for Czechia, Lithuania and Slovakia where conditional approval and exceptional circumstances negatively influenced reimbursement decision. Type of disease has significant influence on reimbursement decision in 4 out of 10 analyzed countries with significant outweigh of positive decisions for oncological diseases.ConclusionIn considered countries specific regulations on reimbursement of orphan drugs are valid but in Lithuania and Romania no formal HTA process was employed; in case of some countries higher ICER values for orphans are used. The share of reimbursed orphan drugs varied significantly across the countries, but it was not associated with GDP per capita

Studia z Dziejów Państwa i Prawa Polskiego T. XXI Badania nad rozwojem instytucji politycznych i prawnych

Tytuł finansowany przez: Krakowską Akademię im. Andrzeja Frycza Modrzewskiego, Uniwersytet im. Marii Curie-Skłodowskiej w Lublinie, Uniwersytet Gdański, Uniwersytet Warszawsk