Уважаемая Линда, К Вашему сведению

Уважаемая Линда,

К Вашему сведению краткий отчет о настоящей ситуации на рынке и последующие шаги для доступа на рынок.
Как Вы знаете, доступ к фармацевтическому рынку Казахстана осуществляется через включение в списки МЗ.
1) Республиканский лекарственный формуляр имеет 884 ЛС, из них 85 онкологических продуктов.
Регистрация в Казахстане является предварительным основанием для включения.
Документы для подачи –
1. сопроводительное письмо и досье-обоснование, подписанное республиканской медицинской организацией или управлением здравоохранения
Досье должно иметь результаты международных клинических исследований, в том числе опубликованные в PubMed, Cochrane; указание о наличии в Британском национальном формуляре.
Эти документы нужно подать в МЗ, потом МЗ направляет их в ЛИЦ на экспертизу. Затем, на заседании Формулярной комиссии, члены голосуют, учитывая результаты экспертизы ЛИЦ. Периодичность заседания Формулярной комиссии – 1 раз в квартал.
Включение ЛС в РЛФ является основанием для дальнейшего включения в другие списки – список СК-Фармация и амбулаторный список.
Согласно, устному разговору со специалистом МЗ, основанием для отказа на включение Ксалкори и Инлайта в РЛФ, явилась высокая цена.
Учитывая это, для повторной подачи досье необходимо подготовить локальный фармакоэкономический анализ (анализ затраты-эффективности), как обоснование для включения. Такие анализы создаются клиническими фармакологами, которые могут быть членами Формулярной комиссии, длительность работы около 3 недель после подписания контракта. Анализ должен быть опубликован в медицинском издании.

2) Список СК-Фармация содержит ЛС для применения на госпитальном уровне. Список
обновляется 1-2 раза в год. В июне 2014 года был утвержден на три года – 2015-2017 гг, для планирования бюджета, но список будет обновляться каждый год.
Присутствие ЛС в РЛФ и потребность для закупа являются предварительным основанием для включения.
Документы для подачи –
2. заявки из региональных Департаментов здравоохранения, не менее 8 (каждый департамент здравоохранения формирует заявку для закупа ЛС на следующий год, на основании количества больных и соответственно потребности в ЛС),
3. не менее 8 писем-обоснований из Департаментов здравоохранения и республиканских медицинских организацией в МЗ


3) Амбулаторный список создается 1 раз в два года. Выделенный бюджет (местный и республиканский), присутствие ЛС в РЛФ и протоколе диагностике и лечении являются предварительным основанием для включения.
Документы для подачи –
1. заявки из региональных Департаментов здравоохранения, не менее 8 (каждый департамент здравоохранения формирует заявку для закупа ЛС на следующий год, на основании количества больных и соответственно потребности в ЛС),
2. не менее 8 писем-обоснований из Департаментов здравоохранения и республиканских медицинских организацией в МЗ
3. фармакоэкономический анализ
4. адекватная конкурентная цена

Results (English) 1:

Dear Linda, For your information a summary of the present market situation and next steps for access to the market.As you know, the Kazakhstan pharmaceutical market access is provided through the inclusion in the lists of the MOH.1) Republican medicinal form has 884 HP, 85 of them oncology products. Registration in Kazakhstan is a prerequisite for inclusion. Documentation- 1. cover letter and dossier-support, signed by the Republican medical organization or Board of health The dossier should have the results of international clinical studies, including one published in PubMed, Cochrane; indication of British national form. These documents should be submitted to MOH, MOH then directs them to the PARTIES for examination. Then, at a meeting of the Commission, members of the voting Menu, taking into account the results of the examination of PERSONS. The frequency of meetings of the Commission-1 Menu quarterly. Enabling HP to the RLF is grounds for inclusion in other lists-list of SC-Pharmacy and outpatient list. According to oral conversation with a MINISTRY, refused to include Ksalkori and Inlajta in RLF was the high price. With this in mind, for submitting a dossier to prepare a local farmakoèkonomičeskij analysis (cost-efficiency analysis) as justification for inclusion. Such analyses are clinical farmakologami, who may be members of the Commission, the amount of time the Menu about 3 weeks after signing the contract. Analysis to be published in a medical journal. 2) list of SC-Pharmacy contains HP for use at the hospital level. Listupdated 1-2 times a year. In June 2014, was approved for three years-2015-2017 timeframe, budget planning, but the list will be updated every year.The presence of HP in RLF and need to purchase are a prerequisite for inclusion. Documentation- 2. applications of regional health departments, at least 8 (each Health Department forms the application for purchase of the PROPERTY for next year, based on the number of patients and the need for HP), 3. not less than 8 letters of support from health departments and national medical organization in the MINISTRY OF HEALTH3) list is generated 1 Out every two years. Allocated budget (local and national), the presence of HP in RLF and its Protocol of diagnosis and treatment are a prerequisite for inclusion. Documentation- 1. the application of regional health departments, at least 8 (each Health Department forms the application for purchase of the PROPERTY for next year, based on the number of patients and the need for HP), 2. at least 8 letters of support from health departments and national medical organization in the MINISTRY OF HEALTH3. farmakoèkonomičeskij analysis4. adequate competitive price

Results (English) 2:

Dear Linda, Tip brief report on the present market situation and the next steps for access to the market. As you know, access to the pharmaceutical market of Kazakhstan through the inclusion in the lists of the Ministry of Health. 1) Republican medicinal form has 884 HP, 85 cancer products. Join in Kazakhstan is a preliminary basis for inclusion. Documents for submission - 1. cover letter and dossier-justification signed by Republican medical organization or management of health dossier should have the results of international clinical trials, including those published in PubMed, Cochrane; an indication of the presence in the British National Formulary. These documents must be submitted to the Ministry of Health, Ministry of Health and then sends them to the persons for examination. Then, at a meeting of Formulary Committee members vote, given the results of the examination PERSONS. Frequency of meetings Formulary Committee - 1 time per quarter. The inclusion of PM in RIM is the basis for the further inclusion in other lists - the list of SK-Pharmacy and outpatient list. According to, oral communications specialist with the Ministry of Health, the basis for refusal to include Ksalkori and Inlayta in RIM, was the high price. With this in mind, for re-submission of the dossier must prepare local pharmacoeconomic analysis (analysis of cost-effectiveness) as justification for inclusion. Such analyzes are of Clinical Pharmacology, who may be members Formulary Committee, duration of work for about 3 weeks after signing the contract. The analysis should be published in a medical journal. 2) List of SK-Pharmacy contains drugs for use in hospital level. The list is updated 1-2 times per year. In June 2014 was approved for three years - 2015-2017, for budget planning, but the list will be updated every year. The presence of drugs in the RIM and the need for pre-purchase will be the basis for inclusion. Documents for submission - 2. application of the regional health department, at least 8 (each health department generates a request for the purchase of drugs for the next year, based on the number of patients, respectively, and the need for drugs), 3. at least 8 letters of justification from the Department of Health and national medical organization in the Ministry of Health 3) Outpatient list is created one every two years. Allocated budget (local and national), the presence of drugs in the RIM and diagnostic and treatment protocols are preliminary basis for inclusion. Documents for submission - 1. application of the regional health department, at least 8 (each health department generates a request for the purchase of drugs for the next year, based on the number of patients, respectively, and the need for drugs), 2. at least 8 letters of justification from the Department of Health and national medical organization in the Ministry of Health 3. pharmacoeconomic analysis 4. adequate competitive price

Results (English) 3:

Dear Linda,

to your note of the summary report on the present situation in the market and the follow-up steps for access to the market.
as you know,Access to the pharmaceutical market of Kazakhstan is carried out through the inclusion in the lists the MOH.
1) Republican medication (a case is 884 LAN, from them 85 oncology products.
Registration in Kazakhstan is a justification for the inclusion.
Documents to feed -
1. Letter of transmittal and files-justification,Signed on republican health care organization or the office health
files must have the results of the international clinical research studies, including those published in organizations, polyclinics.An indication of the availability in the British national archive.
these documents you need to apply to the MOH, MOH then sends them to the persons at the examination. Then, at the meeting the commission Формулярнои, member voting,Bearing in mind the results of examination. The frequency meeting Формулярнои commission - 1 times in a quarter.
The inclusion in the LAN РЛФ is the basis for the further inclusion in other lists - list BCC-pharmacy and outpatient list.
according to, interpretation conversation with a specialist the MOH,Grounds for refusal to engage the Ксалкори and Инлаита in РЛФ, was a high price.
in the light of this,For re-supply files you need to prepare a local фармакоэкономическии analysis (analysis of cost-effectiveness), as well as the rationale for inclusion. Such analyzes are created clinical фармакологами,That may not be members of the commission Формулярнои, duration of approximately 3 weeks after the signing of the contract. The analysis should be published in medical publications.

(2) The list BCC-pharmacy contains a LAN for use on hospital level. The list
is updated 1-2 times a year. In June 2014, was approved for three years - 2015-2017 gg, for budget planning,But the list will be updated every year.
the presence in РЛФ LAN and the need for purchase are the preliminary basis for inclusion.
Documents to feed -
2.Application of the regional health departments, is not less than 8 (each health department generates a request for purchase LAN for the next year,Based on the number of patients and, consequently, the LAN),
3. not less than 8 letters of justification from the departments of health and of republican health care organization in the MOH


(3) outpatient list is 1 times in two years. The allocated budget (local and national), the presence in LAN РЛФ and protocol diagnosis and treatment are a justification for the inclusion.
Documents for filing -
1. Application of the regional health departments, is not less than 8 (each health department generates a request for purchase LAN for the next year,Based on the number of patients and, consequently, the LAN),
2. not less than 8 letters of justification from the departments of health and of republican health care organization in the MOH
3. фармакоэкономическии analysis
4.An adequate competitive price more multitasking performance