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<article article-type="research-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="en"><front><journal-meta><journal-id journal-id-type="publisher-id">farmaec</journal-id><journal-title-group><journal-title xml:lang="en">FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology</journal-title><trans-title-group xml:lang="ru"><trans-title>ФАРМАКОЭКОНОМИКА. Современная фармакоэкономика и фармакоэпидемиология</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2070-4909</issn><issn pub-type="epub">2070-4933</issn><publisher><publisher-name>IRBIS LLC</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.17749/2070-4909.2016.9.2.003-010</article-id><article-id custom-type="elpub" pub-id-type="custom">farmaec-142</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>Original Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>Оригинальные статьи</subject></subj-group></article-categories><title-group><article-title>PHARMACOECONOMIC ANALYSIS OF VESOMNI (SOLIFENACIN AND CONTROLLED RELEASE TAMSULOSIN) TREATMENT OF STORAGE SYMPTOMS ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA</article-title><trans-title-group xml:lang="ru"><trans-title>Фармакоэкономическое исследование применения препарата Везомни (тамсулозин с контролируемым высвобождением + солифенацин) при нарушениях мочеиспускания, связанных с доброкачественной гиперплазией предстательной железы</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Авксентьев</surname><given-names>Н. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Avxentyev</surname><given-names>N. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>советник;</p><p>научный сотрудник Института социального анализа и прогнозирования,</p><p>Настасьинский пер. д. 3 стр. 2, Москва, 127006</p></bio><bio xml:lang="en"><p>adviser;</p><p>research fellow of Institute of social analysis and forecasting,</p><p>Nastasyinsky per., 3-2, Moscow, 127006</p></bio><email xlink:type="simple">na@nifi.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Фролов</surname><given-names>М. Ю.</given-names></name><name name-style="western" xml:lang="en"><surname>Frolov</surname><given-names>M. Yu.</given-names></name></name-alternatives><bio xml:lang="ru"><p>к.м.н., доцент курса ФУВ кафедры клинической фармакологии и интенсивной терапии,</p><p>пл. Павших борцов, д. 1, Волгоград, 400131</p></bio><bio xml:lang="en"><p>PHD (candidate of medical sciences), assistant professor (FUV module) of Clinical pharmacology and intensive therapy department</p><p>Pavshih borzov pl., 1, Volgograd, 400131</p></bio><email xlink:type="simple">mufrolov66@gmail.com</email><xref ref-type="aff" rid="aff-2"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru">ФГБУ «Научно-исследовательский финансовый институт» Министерства финансов Российской Федерации;&#13;
ФГБОУ ВПО «Российская академия народного хозяйства и государственной службы при Президенте Российской Федерации»<country>Россия</country></aff><aff xml:lang="en">Research Institute of Finance, Ministry of Finance of the Russian Federation;&#13;
Russian Presidential Academy of National Economy and Public Administration<country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru">ГБОУ ВПО «Волгоградский государственный медицинский университет» Волгоградский государственный медицинский университет Минздрава России;&#13;
МОО «Межрегиональная ассоциация клинических фармакологов»<country>Россия</country></aff><aff xml:lang="en">Volgograd State Medical University of the Ministry of Health Russian Federation;&#13;
Interregional Association for Clinical Pharmacology<country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2016</year></pub-date><pub-date pub-type="epub"><day>31</day><month>08</month><year>2016</year></pub-date><volume>9</volume><issue>2</issue><fpage>3</fpage><lpage>10</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Avxentyev N.A., Frolov M.Y., 2016</copyright-statement><copyright-year>2016</copyright-year><copyright-holder xml:lang="ru">Авксентьев Н.А., Фролов М.Ю.</copyright-holder><copyright-holder xml:lang="en">Avxentyev N.A., Frolov M.Y.</copyright-holder><license license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://www.pharmacoeconomics.ru/jour/article/view/142">https://www.pharmacoeconomics.ru/jour/article/view/142</self-uri><abstract><p>The aim of the current study is pharmacoeconomic evaluation of using combined drug Vesomni (controlled release tablets tamsulosin 0.4 mg + solifenacin 6 mg) for treatment of patients with storage symptoms associated with benign prostatic hyperplasia, who do not respond to first line tamsulosin therapy.</p><sec><title>Materials and methods</title><p>Materials and methods. We consider three therapy options: 1) combined drug Vesomni; 2) combination of tamsulosin (modified release capsules 0.4 mg) and solifenacin (5 mg); 3) combination of tamsulosin (controlled release tablets 0.4 mg) and solifenacin (5 mg). These options are evaluated with cost minimization and budget impact analysis.</p></sec><sec><title>Results</title><p>Results. We found that approx. 250,000 patients in Russia need combined tamsulosin and solifenacin therapy, including 35,400 patients eligible for government reimbursement. Using combined drug is cost saving alternative that annually requires 22,000 rubles per patient, which is 2,000 rubles less than second best option. The overall healthcare annual expenses of using combined drug are 5,7 billion rubles (500 million rubles less than for second best option), and government reimbursement costs are 606 million rubles (74 million less than for second best option).</p></sec><sec><title>Conclusion</title><p>Conclusion. Using combined drug Vesomni for treatment of patients with storage symptoms associated with benign prostatic hyperplasia is cost saving alternative compared to combination of monotheraphy regimens.</p></sec></abstract><trans-abstract xml:lang="ru"><p>Целью настоящего исследования является фармакоэкономический анализ терапии ДГПЖ второй линии комбинированным препаратом Везомни (таблетки с модифицированным высвобождением тамсулозин 0,4 мг + солифенацин 6 мг) у пациентов, не ответивших на терапию первой линии (тамсулозин).</p><sec><title>Материалы и методы</title><p>Материалы и методы. Рассмотрены три варианта терапии: 1) комбинированный препарат Везомни; 2) комбинация монопрепаратов тамсулозин (капсулы с модифицированным высвобождением 0,4 мг) и солифенацин (таблетки 5 мг); 3) комбинация монопрепаратов тамсулозин (таблетки с контролируемым высвобождением 0,4 мг) и солифенацин (таблетки 5 мг). Для проведения исследования использован метод минимизации затрат с последующей оценкой влияния на бюджет системы здравоохранения в целом.</p></sec><sec><title>Результаты</title><p>Результаты. Установлено, что в России около 250 тыс. человек могут претендовать на комбинированную терапию тамсулозином и солифенацином, в т. ч. 35,4 тыс. за счет льготного лекарственного обеспечения, при этом наиболее экономичным является вариант применения комбинированного препарата. В таком случае расходы на одного пациента в год в среднем составляют 22 тыс. руб. (экономия около 2 тыс. руб. по сравнению со вторым наилучшим вариантом), расходы всей системы здравоохранения — 5,7 млрд руб. (экономия около 500 млн руб.), а расходы программы ОНЛС — 606 млн руб. (экономия — 74 млн руб.).</p></sec><sec><title>Заключение</title><p>Заключение. Применение комбинированного препарата Везомни у больных ДГПЖ является ресурсосберегающей альтернативой в сравнении с комбинацией монопрепаратов тамсулозина и солифенацина.</p></sec></trans-abstract><kwd-group xml:lang="ru"><kwd>нарушения мочеиспускания</kwd><kwd>гиперплазия предстательной железы</kwd><kwd>комбинированный препарат</kwd><kwd>Везомни</kwd><kwd>тамсулозин</kwd><kwd>солифенацин</kwd></kwd-group><kwd-group xml:lang="en"><kwd>storage symptoms</kwd><kwd>benign prostatic hyperplasia</kwd><kwd>combined drug</kwd><kwd>Vesomni</kwd><kwd>tamsulosin</kwd><kwd>solifenacin</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Данные Центра демографических исследований РЭШ. URL: http://demogr.nes.ru/index.php/ru/demogr_indicat/data (дата обращения: 23.02.2016).</mixed-citation><mixed-citation xml:lang="en">Data NES Center for Demographic Research (in Russian). URL: http://demogr.nes.ru/index.php/ru/demogr_indicat/data (accessed: 23.02.2016)</mixed-citation></citation-alternatives></ref><ref id="cit2"><label>2</label><citation-alternatives><mixed-citation xml:lang="ru">Заболеваемость населения России в 2014 году: статистические материалы: в X ч. М. 2015.</mixed-citation><mixed-citation xml:lang="en">Incidence of the population of Russia in 2014: statistical data: in X hours [Zabolevaemost' naseleniya Rossii v 2014 godu: statisticheskie materialy: v X ch. (in Russian)] Moscow. 2015.</mixed-citation></citation-alternatives></ref><ref id="cit3"><label>3</label><citation-alternatives><mixed-citation xml:lang="ru">Севрюков Ф. А. Комплексные медико-социальные и клинико-экономические аспекты профилактики и лечения доброкачественной гиперплазии предстательной железы: дис. ... докт. мед. наук. М. 2012; 309 с.</mixed-citation><mixed-citation xml:lang="en">Sevryukov F. A. Complex medical-social and clinico-economic aspects of the prevention and treatment of benign prostatic hyperplasia. Dr. diss. [Kompleksnye mediko-sotsial'nye i kliniko-ekonomicheskie aspekty profilaktiki i lecheniya dobrokachestvennoi giperplazii predstatel'noi zhelezy (in Russian)]. Moscow. 2012; 309 s.</mixed-citation></citation-alternatives></ref><ref id="cit4"><label>4</label><citation-alternatives><mixed-citation xml:lang="ru">Bangalore S. et al. Fixed-dose combinations improve medication compliance: a meta-analysis. The American journal of medicine. 2007; 120 (8): 713-719.</mixed-citation><mixed-citation xml:lang="en">Bangalore S. et al. Fixed-dose combinations improve medication compliance: a meta-analysis. The American journal of medicine. 2007; 120 (8): 713-719.</mixed-citation></citation-alternatives></ref><ref id="cit5"><label>5</label><citation-alternatives><mixed-citation xml:lang="ru">Bruskewitz R. Management of symptomatic BPH in the US: who is treated and how? European urology. 1999; 36 (3): 7-13.</mixed-citation><mixed-citation xml:lang="en">Bruskewitz R. Management of symptomatic BPH in the US: who is treated and how? European urology. 1999; 36 (3): 7-13.</mixed-citation></citation-alternatives></ref><ref id="cit6"><label>6</label><citation-alternatives><mixed-citation xml:lang="ru">Chapple C. R. et al. Tamsulosin oral controlled absorption system (OCAS) in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH): efficacy and tolerability in a placebo and active comparator controlled phase 3a study. European Urology Supplements. 2005; 4 (2): 33-44.</mixed-citation><mixed-citation xml:lang="en">Chapple C. R. et al. Tamsulosin oral controlled absorption system (OCAS) in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH): efficacy and tolerability in a placebo and active comparator controlled phase 3a study. European Urology Supplements. 2005; 4 (2): 33-44.</mixed-citation></citation-alternatives></ref><ref id="cit7"><label>7</label><citation-alternatives><mixed-citation xml:lang="ru">Drake M. J. et al. Long-term safety and efficacy of single-tablet combinations of solifenacin and tamsulosin oral controlled absorption system in men with storage and voiding lower urinary tract symptoms: results from the NEPTUNE Study and NEPTUNE II open-label extension. European urology. 2015; 67 (2): 262-270.</mixed-citation><mixed-citation xml:lang="en">Drake M. J. et al. Long-term safety and efficacy of single-tablet combinations of solifenacin and tamsulosin oral controlled absorption system in men with storage and voiding lower urinary tract symptoms: results from the NEPTUNE Study and NEPTUNE II open-label extension. European urology. 2015; 67 (2): 262-270.</mixed-citation></citation-alternatives></ref><ref id="cit8"><label>8</label><citation-alternatives><mixed-citation xml:lang="ru">Hakimi Z. et al. Drug treatment patterns for the management of men with lower urinary tract symptoms associated with benign prostatic hyperplasia who have both storage and voiding symptoms: a study using The Health Improvement Network UK primary care data. Current medical research and opinion. 2015; 31 (1): 43-50.</mixed-citation><mixed-citation xml:lang="en">Hakimi Z. et al. Drug treatment patterns for the management of men with lower urinary tract symptoms associated with benign prostatic hyperplasia who have both storage and voiding symptoms: a study using The Health Improvement Network UK primary care data. Current medical research and opinion. 2015; 31 (1): 43-50.</mixed-citation></citation-alternatives></ref><ref id="cit9"><label>9</label><citation-alternatives><mixed-citation xml:lang="ru">Homma Y. et al. Epidemiologic survey of lower urinary tract symptoms in Asia and Australia using the international prostate symptom score. International journal of urology. 1997; 4 (1): 40-46.</mixed-citation><mixed-citation xml:lang="en">Homma Y. et al. Epidemiologic survey of lower urinary tract symptoms in Asia and Australia using the international prostate symptom score. International journal of urology. 1997; 4 (1): 40-46.</mixed-citation></citation-alternatives></ref><ref id="cit10"><label>10</label><citation-alternatives><mixed-citation xml:lang="ru">LMMG New Medicine Recommendation. Vesomni for the treatment of Storage Symptoms associated with Benign Prostatic Hyperplasia. URL: http://www.lancsmmg.nhs.uk/wp-content/uploads/sites/3/2014/05/MR140303-VESOMNI-CSU-New-Medicine-ReviewFinal-Recommendation-following-LMMG_WEBSITE.pdf (дата обращения: 23.02.2016).</mixed-citation><mixed-citation xml:lang="en">LMMG New Medicine Recommendation. Vesomni for the treatment of Storage Symptoms associated with Benign Prostatic Hyperplasia. URL: http://www.lancsmmg.nhs.uk/wp-content/uploads/sites/3/2014/05/MR140303-VESOMNI-CSU-New-Medicine-ReviewFinal-Recommendation-following-LMMG_WEBSITE.pdf (accessed: 23.02.2016).</mixed-citation></citation-alternatives></ref><ref id="cit11"><label>11</label><citation-alternatives><mixed-citation xml:lang="ru">Michel M. C. et al. Cardiovascular safety of the oral controlled absorption system (OCAS) formulation of tamsulosin compared to the modified release (MR) formulation. European Urology Supplements. 2005; 4 (2): 53-60.</mixed-citation><mixed-citation xml:lang="en">Michel M. C. et al. Cardiovascular safety of the oral controlled absorption system (OCAS) formulation of tamsulosin compared to the modified release (MR) formulation. European Urology Supplements. 2005; 4 (2): 53-60.</mixed-citation></citation-alternatives></ref><ref id="cit12"><label>12</label><citation-alternatives><mixed-citation xml:lang="ru">Mitropoulos D. et al. Symptomatic benign prostate hyperplasia: impact on partners’ quality of life. European urology. 2002; 41 (3): 240-245.</mixed-citation><mixed-citation xml:lang="en">Mitropoulos D. et al. Symptomatic benign prostate hyperplasia: impact on partners’ quality of life. European urology. 2002; 41 (3): 240-245.</mixed-citation></citation-alternatives></ref><ref id="cit13"><label>13</label><citation-alternatives><mixed-citation xml:lang="ru">National Clinical Guideline Centre. The management of lower urinary tract symptoms in men. National Clinical Guideline Center, 2010. URL: http://www.nice.org.uk/usingguidance/commissioningguides/ luts/LUTS.jsp (дата обращения: 23.02.2016).</mixed-citation><mixed-citation xml:lang="en">National Clinical Guideline Centre. The management of lower urinary tract symptoms in men. National Clinical Guideline Center, 2010. URL: http://www.nice.org.uk/usingguidance/commissioningguides/luts/LUTS.jsp (accessed: 23.02.2016).</mixed-citation></citation-alternatives></ref><ref id="cit14"><label>14</label><citation-alternatives><mixed-citation xml:lang="ru">Nazir J. et al. Cost-effectiveness of a fixed-dose combination of solifenacin and oral controlled adsorption system formulation of tamsulosin in men with lower urinary tract symptoms associated with benign prostatic hyperplasia . BMC urology. 2015; 15 (1): 1.</mixed-citation><mixed-citation xml:lang="en">Nazir J. et al. Cost-effectiveness of a fixed-dose combination of solifenacin and oral controlled adsorption system formulation of tamsulosin in men with lower urinary tract symptoms associated with benign prostatic hyperplasia . BMC urology. 2015; 15 (1): 1.</mixed-citation></citation-alternatives></ref><ref id="cit15"><label>15</label><citation-alternatives><mixed-citation xml:lang="ru">Oelke M. et al. EAU guidelines on the treatment and follow-up of non-neurogenic male lower urinary tract symptoms including benign prostatic obstruction. European urology. 2013; 64 (1): 118-140.</mixed-citation><mixed-citation xml:lang="en">Oelke M. et al. EAU guidelines on the treatment and follow-up of non-neurogenic male lower urinary tract symptoms including benign prostatic obstruction. European urology. 2013; 64 (1): 118-140.</mixed-citation></citation-alternatives></ref><ref id="cit16"><label>16</label><citation-alternatives><mixed-citation xml:lang="ru">Sexton C. C. et al. The overlap of storage, voiding and postmicturition symptoms and implications for treatment seeking in the USA, UK and Sweden: EpiLUTS. BJU international. 2009; 103 (3): 12-23.</mixed-citation><mixed-citation xml:lang="en">Sexton C. C. et al. The overlap of storage, voiding and postmicturition symptoms and implications for treatment seeking in the USA, UK and Sweden: EpiLUTS. BJU international. 2009; 103 (3): 12-23.</mixed-citation></citation-alternatives></ref><ref id="cit17"><label>17</label><citation-alternatives><mixed-citation xml:lang="ru">Toledo A. et al. Cost-Effectiveness Of A Fixed-Dose Combination Of Solifenacin Plus Tamsulosin Ocas For The Treatment Of Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia In Spain. Value in Health. 2015; 18 (7): A510.</mixed-citation><mixed-citation xml:lang="en">Toledo A. et al. Cost-Effectiveness Of A Fixed-Dose Combination Of Solifenacin Plus Tamsulosin Ocas For The Treatment Of Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia In Spain. Value in Health. 2015; 18 (7): A510.</mixed-citation></citation-alternatives></ref></ref-list><fn-group><fn fn-type="conflict"><p>The authors declare that there are no conflicts of interest present.</p></fn></fn-group></back></article>
