Introduction: There are appreciable concerns among European health authorities with growing expenditure on cancer medicines and issues of sustainability. The enhanced use of low cost generics could help. Aims: Consequently, there is a need to comprehensively document current and future arrangements regarding the pricing of generic cancer medicines across Europe, and whether these are indication specific, as well as how this translates into actual prices to provide future direction. Methodology: Mixed method approach with qualitative research among senior health authority personnel and their advisers. Quantitative research via health authority databases to ascertain current prices for oral cancer medicines that had lost their patent and the influence of population size and economics on prices. Results: 25 European countries participated. Currently we see (a) variable approaches to the pricing of generic cancer medicines, which will continue; (b) no concerns with substitution for oral generic cancer medicines; (c) substantial price reductions versus originators for generic capecitabine (up to-93.1%), generic imatinib (up to-97.8%) and generic temozolomide (up to-80.7%). Prices for oncology medicines are not indication specific, and are not affected by population size although influenced by pricing approaches. There have also been price increases for some nonpatented cancer medicines following manufacturer changes although now stabilising. Conclusion: The considerable price reductions seen for some generics means health authorities should further encourage the use of generic oncology medicines when they become available to fund increased volumes and new valued cancer medicines. Countries are also starting to address price increases for generics following changes in the manufacturer

Background: From October 2018, adalimumab biosimilars could enter the European market. However, in some countries, such as Netherlands, high discounts reported for the originator product may have influenced biosimilar entry.Objectives: The aim of this paper is to provide a European overview of (list) prices of originator adalimumab, before and after loss of exclusivity; to report changes in the reimbursement status of adalimumab products; and discuss relevant policy measures.Methods: Experts in European countries received a survey consisting of three parts: 1) general financing/co-payment of medicines, 2) reimbursement status and prices of originator adalimumab, and availability of biosimilars, and 3) policy measures related to the use of adalimumab.Results: In May 2019, adalimumab biosimilars were available in 24 of the 30 countries surveyed. Following introduction of adalimumab biosimilars, a number of countries have made changes in relation to the reimbursement status of adalimumab products. Originator adalimumab list prices varied between countries by a factor of 2.8 before and 4.1 after loss of exclusivity. Overall, list prices of originator adalimumab decreased after loss of exclusivity, although for 13 countries list prices were unchanged. When reported, discounts/rebates on originator adalimumab after loss of exclusivity ranged from 0% to approximately 26% (Romania), 60% (Poland), 80% (Denmark, Italy, Norway), and 80–90% (Netherlands), leading to actual prices per pen or syringe between €412 (Finland) and €50 – €99 (Netherlands). To leverage competition following entry of biosimilar adalimumab, only a few countries adopted measures specifically for adalimumab in addition to general policies regarding biosimilars. In some countries, a strategy was implemented even before loss of exclusivity (Denmark, Scotland), while others did not report specific measures.Conclusion: Even though originator adalimumab is the highest selling product in the world, few countries have implemented specific policies and practices for (biosimilar) adalimumab. Countries with biosimilars on the market seem to have competition lowering list or actual prices. Reported discounts varied widely between countries.

Objectives: To evaluate the cost-effectiveness of canagliflozin, an active inhibitor of sodium glucose co-transporter -2 (SGLT2) in dual therapy as add-on to metformin compared to sitagliptin and glimepiride. Canagliflozin in clinical trial results showed effective glucose reduction, along with other benefits in diabetes treatment including weight loss and SBP reduction. Cost effectiveness analyses were conducted in the Polish setting from a public perspective in accordance with guidelines of Polish HTA Agency (PolAHTA). MethOds: The IMS CORE Diabetes Model was used to evaluate the cost-effectiveness of canagliflozin versus the aforementioned comparators using Polish-specific data, where available. Direct costs were reported in Polish zloty and an annual discount rate of 5% and 3.5% were applied on costs and effects respectively. Results: In dual therapy as add-on to metformin, canagliflozin 100 mg dominates sitagliptin with average cost savings of 2 811 zł and an average QALY gain of 0.06, canagliflozin 300 mg is cost effective option in comparison to sitagliptin with an incremental cost effectiveness ratio (ICER) of 45 008 zł per QALY and QALY gain of 0.09. As add-on to metformin canagliflozin is a cost effectiveness option in comparison with glimepiride with ICER of 28 454 zł and 73 102 zł, QALY gain 0,112 QALY and 0,140 QALY for canagliflozin 100 mg and 300 mg respectively. All results are below defined in Polish reimbursement act cost-effectiveness threshold. cOnclusiOns: These results suggest that adding Canagliflozin to metformin versus sitagliptin or glimepiride in patients inadequately controlled with metformin would be a more efficient use of health care resources in the Polish setting.Objectives: To evaluate the cost-effectiveness of interventions aimed at decreasing the number of amputations among patients with diabetic foot ulcers (DFU) in Russia. MethOds: We have modeled the changes in the annual outcomes (minor and major amputations) and costs (services provided in outpatient clinics and hospitals, medications, orthopedic shoes and prosthetic devices and services provided in case of amputation) from the perspective of public health and social care. Two interventions were assessed: preventive services for patients with the very high risk of DFU (additional outpatient visits for foot care and orthopedic shoes) and provision of care for DFU patients at hospital by multidisciplinary foot care team (MDT). The current number of amputations and costs among DFU patients in Russia was assessed on the basis of published Russian data and experts' survey. The expected effectiveness of interventions was derived from the international publications. Costs were estimated on the basis on reimbursement rates in public medical insurance and social care. Results: The implementation of hospital care by MDT for cohort of 1000 DFU patients at the current rate of hospitalizations will require additional annual spending of € 532,520, and the expected annual number of major amputations will decrease by 41. The ICER for this...

Cel. Analiza świadczeń psychiatrycznych dla pacjentów z rozpoznaniem schizofrenii, sprawozdanych do Narodowego Funduszu Zdrowia w latach 2009-2018. Metoda. Schizofrenia jest analizowana jako jedna z chorób o najwyższym wskaźniku utraconych lat życia w zdrowiu (Disability Adjusted Life Years - DALY). W badaniu wykorzystano sprawozdawcze dane jednostkowe Narodowego Funduszu Zdrowia (NFZ), które zostały wykazane płatnikowi w latach 2009-2018. Pacjenci byli identyfikowani przy użyciu kodu w Powszechnym Elektronicznym Systemie Ewidencji Ludności (PESEL). Analizowano świadczenia udzielone osobom dorosłym, tj. osobom, które w roku zakończenia udzielania świadczenia miały co najmniej 18 lat, dla których główną chorobą była schizofrenia identyfikowana poprzez kody wg ICD-10: F20 do F20.9. Sprawozdane świadczenia przeanalizowano według warunków udzielania świadczeń oraz kodów produktów rozliczeniowych, określonych w zarządzeniu Prezesa Narodowego Funduszu Zdrowia z dnia 28.06.2019 r. Wyniki. W latach 2009-2018 wzrosła o 5% liczba pacjentów z rozpoznaniem schizofrenii, leczonych w sektorze publicznym. W analizowanych latach liczba pacjentów leczonych stacjonarnie zmniejszyła się o 9%, przy wzroście o 6% liczby osób korzystających ze świadczeń ambulatoryjnych i leczenia środowiskowego. W oddziałach psychiatrii sądowej obserwowano bardzo wysoki wzrost (o 212%) liczby hospitalizowanych pacjentów. W 2018 roku średnia liczba dni hospitalizacji wynosiła 43 dni w oddziale psychiatrycznym ogólnym (podstawowym) oraz 279 dni w oddziale psychiatrii sądowej. Bardzo niski odsetek osób chorujących (poniżej 3%) korzystał z terapii dziennej. W leczeniu ambulatoryjnym zdecydowanie dominującą formą pomocy były porady lekarskie, natomiast mniej niż 10% pacjentów korzystało z innego rodzaju świadczeń. W 2018 roku sprawozdano średnio cztery wizyty / porady na pacjenta.

Value in drugs do not always lies simply in them curing diseases: they may also be used to prolong life, improve its quality, and relieve patients' families. How much these elements matter should weigh on reimbursement decisions. Rare diseases often lack strong clinical evidence; hence, overlooking other elements that society values may lead to suboptimal decisions. We examine the preferences for treatments of non-oncological rare diseases among 16 experts in Poland with PAPRIKA-a choice-based elicitation method. Among seven attributes, clinical effect was found to be the most important, followed by returning the patient's family to normal functioning. Whether a treatment is used in children or any alternative treatment is available were the least important attributes. The respondents have a non-linear, diminishing preference for clinical effects, and an almost linear (negative) preference for cost. We develop a new method of sensitivity analysis that accounts for the non-uniqueness of part-worth utilities and the possibility of respondents answering inattentively to some questions, and we find our results to be robust. When looking at heterogeneity, three types of respondents deviating from mean-preferences emerge, in terms of what particular factors they place emphasis on: (a) cost and effectiveness, (b) to whom technology is offered (prognosis and availability of alternative), (c) the impact on family, safety, and caring for children. The part-worth utilities identified can be used to support multiple criteria decision-making in Poland.