Background. Chronic lymphocytic leukemia (CLL) is the most common type of leukemia. Annual incidence rate of CLL is 2 to 6 per 100000 population. CLL is currently a disease which leads to significant social and financial costs. CLL remains an incurable disease up to this date. However, at the moment there is a bunch of drugs available on the pharmaceutical market, which can substantially elongate progression-free survival, increase duration, and improve the patients’ quality of life. One of such drugs is obinutuzumab. Positive evaluation findings of economic feasibility of using obinutuzumab in elderly patients with CLL have been received in some countries of the European Union, but under the conditions of healthcare of Ukraine pharmacoeconomic analysis of obinutuzumab use in the treatment of CLL has not been performed. The purpose of the work is to determine economic feasibility of using obinutuzumab (Gazyva® drug) under the conditions of healthcare system of Ukraine for the treatment of chronic lymphocytic leukemia in patients who did not receive treatment earlier. Materials and methods. An analysis using the Markov analysis model was performed, and it allowed the comparison between life years gained (LYG) and quality adjusted life years (QALY) to be made, which can be obtained when using alternative regimens (O+Clb or R+Clb) and expenditures on these regiments in treating patients with CLL. The analysis modelling was performed on the basis of the results of international randomized multicenter open phase III clinical trial of CLL11. Results. The results of Markov modelling have shown that O+Clb treatment regimen, which consists of obinutuzumab and chlorambucil, provides every patient with CLL with additional 0,1 LYG on average over a period of three years compared to R+Clb regimen. The average lifespan of the patients in whom the disease did not progress was higher in O+Clb group than in R+Clb group by more than a year – 51,2 and 38,1 months respectively. O+Clb regimen not only increases lifespan, but also improves life quality. The patients of R+Clb group have additional 0,14 QALY during the analyzed period compared to O+Clb group. The calculation of expenses on CLL treatment with consideration for time horizon of 3 years has shown that using obinutuzumab in the first line of treatment was almost twice as expensive as the alternative first-line regimen, provided that original pharmaceutical drugs were used. At the same time, due to the greater effectiveness, the high cost of the regimen with obinutuzumab is compensated by reduction in expenses on the second line of chemotherapy. The cost saving on the second line covers the cost difference of the first line of therapy when using obinutuzumab. When using original, as well as generic chemotherapeutic drugs, O+Clb (obinutuzumab + chlorambucil) regimen as a first-line therapy of patients with CLL provides the higher level of effectiveness at smaller cost. Conclusions. The available data of randomized control trials to this date are indicative of high clinical effectiveness of first-line therapy with the use of obinutuzumab + chlorambucil regimen in the patients with CLL. This regimen allows progression-free survival to be substantially elongated. It also increases the number of life years gained and improves the quality of life. Markov modelling shows that obinutuzumab + chlorambucil regimen compared to rituximab + chlorambucil regimen requires bigger expenses as a first-line therapy of the patients with CLL. At the same time, due to the greater effectiveness and longer progression-free survival, this regimen allows the amount of expenses on the next lines of therapy in the patients with CLL to be reduced, consequently total expenses on the treatment of the patients with CLL are also reduced. Pharmacoeconomic analysis based on the Markov analysis model and calculations by the «cost-effectiveness» and «cost-utility» methods allow obinutuzumab + chlorambucil regimen to be considered dominant in comparison with rituximab + chlorambucil regimen as a first-line therapy of the patients with CLL (provided that original pharmaceutical drugs are used).
Background. The incidence of breast cancer tends to be increasing worldwide in recent years. It is characterized by various clinical manifestations and potential treatment approaches. The choice of treatment strategy, its sequence as well as the efficiency of administered chemotherapy is quite relevant these days. Purpose – assessing economic feasibility of targeted therapy with pertuzumab (Perjeta®) in patients with metastatic HER2+ BC from the perspective of the health care system of Ukraine. Materials and methods. The treatment outcomes as well as related costs were determined by means of Markov analytical modelling based on a randomized multicenter open clinical study of CLEOPATRA phase III [2]. The model time horizon was 20 years. The alternative schemes of frontline therapy of metastatic HER2+ breast cancer were compared: PTD regimen pertuzumab + trastuzumab + docetaxel and TD regimen trastuzumab + docetaxel. Based on Markov modelling, pharmacoeconomic analysis by means of cost-effectiveness and cost-utility methods was carried out. As an efficiency criterion, LYG amount was used, as a utility criterion − QALY indicator. Direct medical costs were counted, the structure of which had been determined according to the current Protocol. The cost of drugs was calculated in accordance with the Register of wholesale prices for pharmaceuticals of the Ministry of Health of Ukraine; the cost of treatment procedures was determined in accordance with the available price lists of paid medical services provided by licensed medical institutions. Discounting at the level of 3 % per year was applied. Sensitivity analysis of the outcomes was carried out before pertuzumab price changed. Results. According to the modelling, the average life expectancy of patients with HER2+ BC, receiving PTD scheme is 15.69 years compared to 13.95 years in the TD group. Along with prolonging life, associated with PTD scheme, its quality increases. Patients in the TD group gain 7.8 QALY on average, while in the PTD group it is 9.24. The total expenses for the simulated (involved into modeling) study period in the PTD group averaged UAH 1 970 369.6 per patient, in the TD group − UAH 732 517.7. ICER (cost of 1 additional life year) and ICUR (cost of 1 additional qualityadjusted life year) incremental coefficients amounted to UAH 710924.6 and UAH 861175.4 respectively. Conclusions. 1. Pertuzumab target drug is an effective pharmaceutical when administered to patients with metastatic HER2 + breast cancer. 2. The frontline therapy regimen for patients with metastatic HER2 + breast cancer with pertuzumab being included is more expensive in comparison with trastuzumab + docetaxel regimen; at the same time it makes it possible to achieve better results, i. e. to provide on average extra 1.74 life years and 1.44 QALY in 20-year perspective. 3. Pharmacoeconomic analysis based on Markov model and cost-effectiveness and cost-benefit calculations make it possible to consider pertuzumab (Perjeta®), included into frontline targeted therapy regimen of trastuzumab + docetaxel in patients with metastatic HER2+ breast cancer, as an economically feasible medical technology under current health care conditions in Ukraine.
Національний фармацевтичний університет Харківський національний медичний університет* Фармакоекономічний аналіз ефективності витрат при використанні трастузумабу в ад'ювантній терапії HER2+ раку молочної залози ранньої стадії Рак молочної залози (РМЗ) посідає перше місце серед всіх онкологічних захворювань у жінок і є однією з головних причин жіночої смертності в усьому світі, в тому числі і в Україні. Найбільш поганим прогнозом характеризується HER2+ підтип РМЗ. Таргетний препарат трастузумаб сприяє суттєвому підвищенню 10-річної виживаності пацієнток з HER2+ РМЗ, але одночасно значно збільшує вартість лікування. Мета дослідження. Оцінка фармакоекономічної доцільності ад'ювантної терапії ранньої стадії HER2+ РМЗ трастузумабом (препарат Герцептин ®) з позиції української системи охорони здоров'я. Матеріали та методи. Визначення результатів лікування і пов'язаних з ним витрат виконано на підставі аналітичного моделювання за методом Маркова на ґрунті результатів рандомізованого багатоцентрового відкритого клінічного дослідження III фази HERA. Часовий горизонт моделі-10 років. В якості альтернативи трастузумабу розглядалися стандартні схеми ад'ювантної терапії РМЗ, представлені у чинному Протоколі медичної допомоги хворим на РМЗ. На ґрунті результатів моделювання за Марковим використані методи «витрати-ефективність» і «витрати-корисність». В якості критерію ефективності використовували роки збереженого життя (LYG). В якості критерію корисності використовували показник QALY. Враховували вартість прямих медичних витрат, структура яких була визначена у відповідності до чинного Протоколу. Вартість ЛП визначалась згідно з реєстром МОЗУ станом на 7.08.2019 р. Вартість медичних послуг визначалася згідно з наявними прейскурантами. Також враховували вартість корекції побічних явищ хіміотерапії. Дисконтування визначено на рівні 3 % щорічно. Аналіз чутливості результатів проведено до зміни ціни на трастузумаб та лікарські препарати альтернативних схем ад'ювантної терапії. Результати. Згідно з моделюванням середня очікувана тривалість життя пацієнток з HER2+ РМЗ в групі трастузумабу становить 7,32 років у порівнянні з показником 6,43 років у групі стандартної ХТ, впродовж яких вони отримують відповідно 6,72 та 5,80 QALY. Ад'ювантна терапія трастузумабом забезпечує додатково 0,89 LYG та 0,92 QALY. Загальні витрати за період дослідження у групі трастузумабу склали в середньому 627115,5 грн на одну пацієнтку, в групі стандартної ХТ-501939,6 грн. Інкрементальні коефіцієнти ICER (вартість 1 додаткового року життя) та ICUR (вартість 1 додаткового року якісного життя) склали відповідно 140833,8 грн та 136088,8 грн. Висновки. Таргетний препарат трастузумаб є лікарським засобом з доказаною ефективністю при використанні в якості ад'ювантної терапії HER2+ РМЗ в ранній стадії. Схема ад'ювантної терапії HER2 + РМЗ з використанням трастузумабу у порівнянні зі стандартною схемою ад'ювантної терапії HER2 + потребує більших витрат, в той же час дозволяє досягти кращих результатів-в перспективі 10 років забезпечує в середньому додатково 0,89 ро...
Background. Breast cancer is one of the most widespread malignant diseases among women in the world. For the last few years, its rate has constituted about 20% of all tumor diseases in women. The annual standardized morbidity growth rate in Ukraine was 1,8% in the last decade. The cumulative risk of breast cancer development is 5,4% given that the life duration is 74 years. Treatment of patients with breast cancer. The treatment must be planned by several medical specialists including a surgical oncologist, a radiation therapist, a chemotherapist, and, if possible, a pathologist. This will allow local and systematic tumor therapy methods to be combined in the best way possible. Purpose – to systematize, generalize, and present the research data on modern approaches to diagnostic measures, movement of patients, and sequence of treatment approaches for locally advanced and metastatic breast cancer from the perspective of the Ukrainian healthcare system. Materials and methods. The article covers modern full-text publications, screening, and treatment protocols of patients with breast cancer, which were obtained from international and domestic sources and databases (e-catalog of Vernadsky National Library of Ukraine, Web of Science, Core Collection, Pubmed). Results. Місцево-поширений первинно-неоперабельний інвазивний рак грудної залози РГЗ, в тому числі інфільтративно-набрякова форма є первинно неоперабельними і вимагають призначення медикаментозної терапії на першому етапі лікування. Locally advanced primarily inoperable invasive breast cancer, including infiltrativeedematous form, is primarily inoperable and requires the prescription of drug therapy at the first stage of the treatment. Triple-negative and HER-2-dependent tumors also require presurgical drug therapy. Local treatment (surgery, radiation therapy) at the first stage is not indicated. The main goal of drug therapy in primarily inoperable forms of breast cancer is the reduction in the size of the tumor in order to achieve an operable condition. Presurgical drug therapy in primarily inoperable forms of breast cancer is carried out under the same rules as in primarily operable ones. Therapy of isolated local recurrences is aimed at full recovery and must be performed similarly to the treatment of primary tumor and involve necessary diagnostic and treatment methods (the diagrams are given in article 1). The treatment of advanced, disseminated breast cancer is palliative and intended to improve the quality of life and increase its duration. The main treatment method for metastatic disease is drug therapy. There is no single treatment standard for metastatic breast cancer. Selection of the drug therapy option is performed taking into account biological markers and clinical-anamnestic features of the patient. On the condition that individual approaches to the treatment of patients with breast cancer are used, the following improvements are quite possible: an increase in both recurrence-free and overall survival, a decrease in the number of complications and toxic manifestations, better compliance of the patients and improvement of their life quality. Systematization and individualization of treatment regimens, depending on the stage of the tumor process and biological features of the tumor, allow the practicing physician to plan and predict the types and the sequence of antitumor therapy. Conclusions. The deepening of our knowledge of breast cancer pathogenesis will contribute to the deeper implementation of individual approaches to the treatment of patients with this pathology. Continuous search will certainly lead to the appearance of new groups of drugs which may change the existing standards of treatment. The use of new pathogenetically relevant methods of biological, hormonal, and target therapy in the modern standards of treatment will allow both recurrence-free and overall survival of the patients to be increased.
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