Tchaikapharma has won award in the category of solution providers during the Pharm Connect congress which is the most notable meeting of leading pharmaceutical and biotechnology companies for Central Eastern Europe and CIS region.
The excellence award was given for the successful incorporation of the latest running and implementation system. This has been a joint project of Tchaikapharma and Softgroup ,the latter creating the software and providing the technical equipment for the system.
The purpose of all that was to build a running system that meets all the requirements of some of the European directives for falsified medicines. This leads to the fact that production capacity will be connected to the European hub for tracking every package that has been produced and sold.
Tchaikapharma is the fastest growing pharmaceutical manufacturer operating in Bulgaria. The company is focused on making available contemporary therapeutic solutions on the local, regional and European market in accordance with GMP. Tchaikapharma has an annual manufacturing capacity of 500 million tablets and 17 million secondary packaging boxes.
The Financial Supervision Commission (FSC) registered the shares issued by Tchaikapharma High Quality Medicines Inc. as a result of an increase of the company’s capital with a view to trading on a regulated securities market. This is evident from the regulator’s decisions at the meeting held on the 23rd of August.
The equity issue amounts to 7 700 000 ordinary, dematerialized voting shares with a nominal value of BGN 1 each.
You can read the entire article here.
The current capital of the pharmaceutical company is BGN 64.3 million.
Tchaikapharma High Quality Medicines Inc. announced that following the entry in the Commercial Register the capital of the company was increased by BGN 7.7 million, the announcement came through the BSE-Sofia.
The current capital of the pharmaceutical company is BGN 64.3 million, divided into 64.3 million dematerialized shares with a nominal value of BGN 1 each. Each share entitles to one vote at the General Meeting of Shareholders, the right to a dividend and a liquidation share of the company’s assets.
Since the beginning of the year, the shares of Tchaikapharma have appreciated by 8.32% and in the last one year the growth was 20.80% at market capitalization of BGN 427.33 million
You can read the entire article in Bulgarian here.
The voted dividend for 2016 is 7 700 000. The amount of the capital after the increase is BGN 64 300 000.
On June 8, 2017, the Annual General Meeting of Shareholders (GMS) of Tchaikapharma High Quality Medicines Inc. was held with the required quorum. A total of 56,562,089 shares were represented – all with voting rights, namely 99.93. % , or more than ½ of the company’s capital.
The shareholders adopted unanimously the annual report of the Board of Directors on the Company’s activity, the Annual Report on the Activities of the Investor Relations Director, the Auditor’s Report, the Audited Annual Financial Statements and the Audit Committee’s Report on the Company’s Activity in 2016.
The amounts of the monthly remunerations of the Board of Directors and the permanent remuneration of the Executive Director in 2016 remained unchanged.
The newest addition to Tchaikapharma High Quality Medicines Inc. product list is Ivabenor 5 mg and 7,5 mg film-coated tablets. The cardiological medicinal product contains the active substance ivabradine.
Ivabenor is indicated for the treatment of patients with chronic stable angina pectoris and chronic heart failure.
ATC code: C01EB 17
Interview with the production manager at Tchaikapharma’s plant in Plovdiv – Vasil Pavlov.
The requirements for the production of medicinal products resulting from the GMP (good manufacturing practices) enforced around the world approximate (and in many cases exceed) the requirements for operating rooms in hospitals. Medicines are produced in a rigorously monitored environment to ensure that there is absolutely no pollution, especially of the air, so that microorganisms and contamination by other drugs could not be introduced into the finished products.
GMP fully regulates each step: from production of the substance, through mixing with excipients and tabletting, to packaging, storage, transportation. Distribution and sales in pharmacies is regulated by GDP.
Generally the active substances are manufactured in China or India. The synthesis of these essential substances is quite energy intensive and highly polluting, so even large Western pharmaceutical companies buy them from these countries. The quality requirements for the said substances are listed in the current editions of the European Pharmacopeia, which are mandatory for the respective country.
Any substance or excipient comes with a certificate. Nevertheless these products are re-checked in the onsite laboratory. And not only that – subject to verification is even whether the laboratory parameters of the manufacturer of the substance are identical to those that are approved for sale in the country.
“Once the ingredients arrive from the manufacturers, they are placed in an area under quarantine until they pass all laboratory testing”, explained the production manager at Tchaikapharma’s plant in Plovdiv – Vasil Pavlov.
The release from this area takes place only after a complete match between the results from different laboratories and the approved specifications was established.
The laboratory equipment is state of the art, because the quality requirements for the medicinal products are steadily increasing as a result of regulatory pressure in line with the advancement of science. As the plant produces exclusively generics, to market such medicinal product, its manufacturer must have registered in the Bulgarian Drug Agency the dossier which corresponds to the entire dossier of the original drug. And it is full of laboratory and clinical test results that should be met in the generic product. Without achieving these targets, the medicinal product simply could not reach the market because the Bulgarian Drug Agency would not allow it.
We begin the tour from the room where the barrels with substances are received. It is built as a pass box – if the door on one side of this compartment is open and a truck is being unloaded, the other door cannot be opened in order to avoid mixing of flows as from one side external persons have access to this room. Beside the other door is the so called grey area where higher purity requirements are applied. The highest requirements are in the blue zone where the medicinal products are manufactured.
Moreover, the people can move in one direction only – they cannot exit the sterile zone and then re-enter without preparing again for this – they should dress in clothes that tightly cover the entire body, wear mouth mask and head cover cap, shoe covers or special work shoes. On the hands they should wear gloves. And nonetheless they are washed separately with a solution for disinfection.
One cannot move randomly from one room to another, because frequently a certain product is produced in one room and another in the other.
The most important for the production premises where medicines are manufactured is the control of the number of solid particles in the air, since the microorganisms are carried precisely by the solid particles. It is scientifically proven that most microbes are carried by particles with a size between 0.5 and 5 microns. Therefore, ventilation and air conditioning system should not allow infiltration of precisely such particles. This is achieved by circulating and filtering the air. Automatically a temperature of 22 degrees, 45% humidity and a higher air pressure than in the outside area are maintained, which helps blow out the solids through special vents.
Before entering the production premises the personnel passes through another pass box. There the people change clothes. “This is being done because human beings are the biggest polluters that enter the premises”, says Vasil Pavlov.
Before entering the working environment, everyone can see the parameters of the room which is to be entered. They are shown on special screens on every door. They provide information on temperature, pressure and humidity. If the parameters are out of norm, the screen indicates that the person should not enter.
After the pass box there are premises where all the technological processes take place. There are a lot of glass partitions and windows that allows to see what is going on in every room, without having to enter it.
Currently tablet forms are manufactured there. Night shift is avoided even when very busy, because at night more mistakes are made. When there is a lot of work, they work overtime, but during the day.
In the first room is the formulation department. In large machines formulations for various drugs are entered and a software ensures that operators do not make mistakes in the amount or type of material. The addition of materials is performed in strict sequence. A tightly closed container that contains all the ingredients of the medicinal product exits this premise. The mixture is moistened by applying a particular technology with the addition of solutions. Thus granules with different sizes for different medicines are obtained and the most common dimensions are in microns.
In a separate room the so called dry mixing is carried out in order to obtain a homogeneous mixture. The “Mixer” is quite special – it rotates at different speeds for different times and, most notably, spins the mixture in several directions. Thus, it is certain that each tablet will have all the ingredients.
Throughout the technological process for the manufacture of medicines who did what is recorded, who prepared the container, who washed it afterwards, who prepared the tableting press, who then washed the machine parts, etc. There is also a laboratory for intermediate control where the solution and mixtures are tested to check whether all the ingredients are there, to control the moisture, the weighs of each volume of the mixture.
The friability of the tablets is tested – the medicine is rotated and the pressed to see how much of it will be lost.
The works are performed with high precision using analytical scales that measure weight in grams with several digits after the decimal point. Any equipment that enters the separate zones is previously washed and sampled to check whether it is cleaned well.
For washing purified water, alcohol, detergents and disinfectants are used. After this procedure samples are taken from the containers to ensure that every time they were washed in the same way.
We come to the most important machines – those that produce the tablets. The operator has no access to the mixture during the production process – the mixture moves with the help of vacuum and enters the presses that make tablets. Each tableting press can produce up to 150,000 – 200,000 tablets per hour.
Packaging in blisters and cartons is done in a room on another floor and half of the packing line, where the tablets are brought before being closed in blisters, is in a controlled environment.
Some of the tablets are film-coated – this is an additional guarantee that the active substances will not disintegrate. Only medicines with unstable substances are film-coated. Some tablets are pelleted because the taste of the drugs is usually not very pleasant. Very soon the plant will have an installation for the manufacture of capsules.
The walls in manufacturing facilities are cladded with special pharmaceutical panels. They are perfectly smooth, do not retain any particle, and ensure that any dirt will be washed of with detergent only. The silicone which seals joints between the panels is special also and ensures that the preparations will not damage it over time. It is produced for pharmaceutical companies and operating rooms.
Currently at Tchaikapharma 80 % of the distributed medicinal products are in-house manufacture, and 20 % are imported as finished medicinal products or are only packaged at Tchaikapharma.
[The original article was published in the specialized business edition “.bg”, March – May 2017; author Georgi Vasilev. The text should be perceived as an attempt by the author to present in popular intelligible language the high-tech processes which were presented to him by Tchaikapharma’s team during the plant tour in Plovdiv.]
Bortezomib-Tchaikapharma 3.5 mg powder for solution for injection is Tchaikapharma High Quality Medicines’ newest medicinal product which obtained a Marketing Authorisation by the Bulgarian Drug Agency in the beginning of February 2017. The active substance contained is Bortezomib (as a mannitol boronic ester).
The medicinal product is subject to medical prescription.
ATC code: L01XX 32
Tchaikapharma High Quality Medicines Inc. received another Marketing Authorization by the Bulgarian Drug Agency with which the company updated its list of injectable products. The new oncological drug product is called Pemetrexed-Tchaikapharma 500 mg powder for concentrate for solution for infusion and is used in the treatment of malignant pleural mesothelioma and non-small cell lung cancer.
Еаch phial contains the active substance Pemetrexed (Pemetrexed disodium hemipentahydrate) and is subject to medical prescription.
ATC code: L01BA04
Bortezomib-Tchaikapharma 3.5 mg powder for solution for injection is Tchaikapharma High Quality Medicines’ newest medicinal product which obtained a Marketing Authorisation by the Bulgarian Drug Agency in the beginning of February 2017. The active substance contained is Bortezomib (as a mannitol boronic ester).
The medicinal product is subject to medical prescription.
ATC code: L01XX 32
Lidocaine-Tchaikapharma 10 mg and 20 mg solution for injection is Tchaikapharma’s newest product which has obtained a Marketing Authorization issued by the Bulgarian Drug Agency.
ATC code: C01BB 01, N01BB 02
The outgoing 2016 was a wonderful year of continued progress for Tchaikapharma. It was the first full year since Tchaikapharma was listed as a public company on the Bulgarian Stock Exchange (BSE) in Sofia and after share trading started on 21 May 2015. Actually and based on 3Q16 results followed by very good October and November, 2016 was another record-breaking year however sliced, irrespective of the turbulences in the healthcare sector and overall uncertainty. Our patients and their doctors, soon in 9 EU member countries, are enchanted with the therapeutically advanced response of Tchaikapharma’s prescription medicines. Building of shareholders’ value with growing social impact further generates massive appreciation every step of the way every day, nationally and internationally. Innovation both in product development and commercialisation phases makes the difference vis-à-vis the generic medicine and in-licensing industry peers – regionally and across Europe. We remain focused on implementing our strategy with discipline, delivering growth in all segments on top and bottom line and reducing cost wherever possible. Our territorial expansion continued with targeted and timely regulatory advances in 3 more EU countries during 2016.
The full text of the letter to Shareholders is available here.
The renowned business ranking “300 Business Leaders in Bulgaria” for one more year honoured Tchaikapharma High Quality Medicines Inc. as one of the most profitable and influential companies in Bulgaria.
The ranking’s fifth edition prepared by analysts from ICAP Group brings together the most successful companies in the country for the past year 2015, based on the criterion “Earnings before interest, taxes, depreciation and amortization (EBITDA)”.
This year Tchaikapharma marked alike a growth on the paramount indicators ‘profit’ (13%) and ‘equity’ (15%). In 2015, EBITDA-profit of the company rose by nearly 11% over the previous year.
These positive trends determine the high market capitalization of the company amounting to approximately 372.5 million leva (as of 21/11/2016).
The newest product of Tchaikapharma High Quality Medicines Inc., which BDA gave a marketing authorisation for, is Cilapenem 500 mg/500 mg powder for infusion solution.
Each phial contains the following active substances: 530 mg imipenem monohydrate, which is equivalent to 500 mg imipenem anhydrоus, and 532 mg cilastatin sodium, equivalent to 500 mg cilastatin.
The drug is indicated for the treatment of infections in adults and over 1 year-old children:
– Complicated intra-abdominal infections;
– Severe types of pneumonia, including nosocomial pneumonia and ventilator- associated pneumonia;
– Infections during and after birth;
– Complicated urinary tract infections;
– Complicated skin and soft tissue infections
Tsilapenem is also suitable for the treatment of patients with:
– Neutropenia and fever, suspected to be due to bacterial infection;
– Bacteraemia occurring in connection with or presumably associated with any of the above infections.
The medicinal product is subject to medical prescription.
ATC code: J01DH 51
The newest medicinal product placed on the market after having received a marketing authorization from the Bulgarian Drug Agency by the Ministry of Health is the infusion solution Linezolid-Tchaikapharma 2 mg/ml.
Its active substance is linezolid, and a packaging contents 300 ml x 5 pcs. or 10 pcs.
This medicinal product is used in cases of hospital- or community-acquired pneumonias, where they are known or suspected to be caused by sensitive Gram-positive bacteria.
Linezolid-Tchaikapharma is subject to medical prescription.
ATC code: J01XX 08
The decline in the price of shares of Sopharma during the trading session of Wednesday from 3.24% yesterday and the minimum recovery of only 0.24% led to a new leader among the largest public companies in Bulgaria.
Another pharmaceutical company – Tchaikapharma High Quality Medicines Inc. took the forefront place with a market value of BGN 359.9 million versus BGN 358 million for Sopharma.
Since Monday, 12th September, also the shares from the capital increase of Tchaikapharma High Quality Medicines Inc. will be introduced in trade.
We recall that the General meeting of the Shareholders decided BGN 7milion from last year’s profit amounting to 7.78 million to be used for capital increase.
Therefore each shareholder as at July 5th is getting another 0.141129 shares, and as a matter of fact – completely costless.
Starting from Monday, the company’s capital will be totaling BGN 56.6 million versus the current BGN 49.6 million.
For the first six months of 2016 Tchaikapharma High Quality Medicines Inc. reported a net profit of BGN 4.5 million against a positive financial result of BGN 3.9 million.
The company’s stocks were introduced for trading on the Bulgarian stock Exchange on May 21th, 2015. Only 17 ½ months later it is now the largest public company in the country.
The original article is available in Bulgarian at Profit.bg
On the Bulgarian pharmaceutical market the latest addition to constantly growing product list of Tchaikapharma High Quality Medicines Inc. for the treatment of cardiovascular diseases is offered from today.
The product Cardesart-Co x 30 tablets, an international non-proprietary name Candesartan/Hydrochlorothiazide, in concentrations of active ingredients 8 mg/12.5 mg and 16 mg/12,5 mg registered under the decentralized procedure was included in the list of NHIF under the following codes: CG285 and CG284.
Candesartan belongs to a group of medicines called angiotensin II-receptor antagonists and Hydrochlorothiazide belongs to a group of diuretics. Cardesart-Co is indicated for the treatment of essential hypertension in adults whose blood pressure is not optimally controlled with Candesartan or Hydrochlorothiazide monotherapy.
A total of 8 among the 40 companies included in calculating one of the main indicators of the Bulgarian Stock Exchange – BGBX40, rose more than 10%, and nine companies lose between 13 and 58% of its market valuation, according to a check made by Profit.bg.
Here are the details for the best and worst investments on BSE since the beginning of 2016:
Two of the emissions – Albena Invest Holding and Tchaikapharma High Quality Medicines rose by over 30% since the beginning of this year (34.01 and 31.91% respectively).
The growth of that holding company comes after announcement of the impending merger of the company to Albena AD, while the pharmaceutical company reported improved financial results for 2016.
As at the first half of the year Tchaikapharma reported 11% higher sales revenue for the first six months of 2016, as at the end of June they even reached BGN 16.7 million.
Just a little over BGN 13 million of the company’s sales are related to medicinal products for the treatment of cardiovascular diseases. The net profit of the company amounted to BGN 4.5 million versus BGN 3.9 million a year earlier. The growth in this indicator is 14.51%.
A significant increase mark also two of the financial vehicle corporations listed on our stock exchange. These are Real Estate Fund Bulgaria and Sopharma Properties, which added 19.78% and 18.37% respectively, according to data before the start of today’s session.
Double-digit growth there is at Biovet – after the news release that the majority owner of the company is about to make a tender offer to the remaining shareholders at a price of BGN 13.33 per share, which makes stocks more expensive by nearly 16 % since the beginning of the year.
The increase at Neochim of nearly 15 percent is due to the better performance of the company, reported almost twice the profit before tax compared to a year earlier of BGN 29.1 million.
With over 11% since the beginning of 2016 also rose the shares of Hydraulic elements and systems and Sopharma Trading to levels of BGN 3.30 and 5.65 per share.
Investments on the Bulgarian Stock Exchange, besides bringing higher profits, also can cause significant losses. Given that there are shares of Bulgartabac Holding, Yuri Gagarin and Euroins in your portfolio, this year you are already at loss of 58, 44 and 42.9% respectively of these investments.
Serious declines in market capitalization recorded the stocks of Petrol (-39.68%), Sparky Eltos ( -31.25%) and Cereals Bulgaria (-21.62%).
Two-digit decline was reported at other three holding companies – Synergon Holding, Chimimport and Industrial Holding Bulgaria.
The original article is available in Bulgarian at Profit.bg
After successfully completing the third for the company Decentralised Procedure (DCP) Tchaikapharma High Quality Medicines Inc. received Marketing Authorisation for the medicinal product Tamayra 5 mg/5 mg hard capsules and Tamayra 10 mg/5 mg hard capsules, for which Bulgaria is the country of reference
This is the first international procedure for Marketing Authorisation of medicinal products for which our country is the reference country. Concerned are six European countries – the Czech Republic, Romania, Portugal, Slovakia, Greece and Austria.
Tamayra belongs to a group of modern combined drug therapies for cardiovascular diseases based on ACE inhibitors and calcium channel blockers.
ATC code: C09BB 07
Tchaikapharma High Quality Medicines Inc. was granted Marketing Authorisations for the medicinal products Ibodria 6 mg/6 ml concentrate for solution for infusion and Ibodria 3 mg/3 ml solution for injection in pre-filled syringe. The active substance contained is Ibandronic acid (as ibandronate sodium monohydrate).
The medicinal product is indicated for the treatment of osteoporosis in postmenopausal women with increased risk of fracture. A reduction in the risk of vertebral fractures is proven.
Ibodria is subject to medical prescription.
ATC code: M05BA 06
The Bulgarian Pharmaceutical Union awarded Tchaikapharma High Quality Medicines Inc. for cardiological medicinal product Amariton in the category “Medicinal Product Subject to Medicinal Prescription – made in Bulgaria” for 2016. The Awards ceremony took place at the Tenth anniversary edition of the Bulgarian Pharmaceutical Days, held from the 24th to 26th of June 2016 at the National Palace of Culture, Sofia.
By decision of the General Meeting, the company’s capital will be increased by BGN 7 million, which will increase in proportion the number of shares that each shareholder has.
On 23rd June 2016, in the presence of the required quorum, was held the Annual General Meeting (AGM) of shareholders of Tchaikapharma High Quality Medicines AD.
9 shareholders were registered to participate, whereby 49’581’106 shares were personally presented – all with voting rights, or 99.96 % of the company’s capital.
The Annual report of the Board of Directors on the Company’s activities, the Annual report on the activity of the Investor-Relations Director, the Audit report, the audited Annual financial statements and the report of the Audit Committee on its activities in 2015 were adopted unanimously by the shareholders.
With regard to item 6 of the agenda concerning the allocation of the realized profit of the Company in 2015 as well as the unallocated profit from previous periods, the General Meeting took the following decision: from the net profit for 2015 amounted to BGN 7’780’010.40, 10 % to be made available to form a compulsory reserve representing BGN 778’001.04 and the amount of BGN 2009.36 to be qualified as an additional company’s reserve. The decision to increase the capital with the remainder of the profit amounting to BGN 7 million was adopted by majority. Thus, each shareholder will increase the number of their shares in proportion – 14 new shares for every 100 shares held.
AGM gave discharge to the Board of Directors for their activities in 2015 and elected an auditor for the year 2016. The monthly remunerations of the Board of Directors and the Executive Director remain unchanged.
To the questions submitted by some shareholders about how dividends will be allocated in the short term the Investor-Relations Director confirmed that there are discussions underway on the possibilities part of the profit (up to 20%) to be allocated as dividends and the remainder to be capitalized for the purpose of investment in the development of the company’s research activity and the expansion into new markets in the European Union. For the first six months of this year, Tchaikapharma has achieved 8-10 % increase in profits compared to the same quarter of last year.
The company’s Executive Director said in addition that particular consistent steps have been already taken to penetrate the markets of several member states of the European Union, which is a crucial part of the long-term marketing policy of the company. In this connection, real action is planned and undertaken on registering medicinal products in the field of cardiovascular diseases and other socially significant therapeutic fields.
For the past year the company has reported improved results in its financial performance, introducing new products and entering new markets, as well as advancing in the field of its research and development activities
The Public company Tchaikapharma High Quality Medicines Inc. will hold its Annual General Meeting of Shareholders on 23rd of June 2016 at 11:00 a.m. in Sofia.
Only thirteen months after the company was listed on the Bulgarian Stock Exchange, the single share price increased over 75% in comparison with the floated price – from BGN 3.50 to BGN 6.20. The growing trust in the medical and scientific concept of Tchaikapharma has reflected on the increase in the number of shareholders – individual investors and companies.
The audited financial results for the last reporting period include a 14.2% net profit growth up to BGN 7.78 million and a 10.7% increase in EBITDA up to BGN 12.84 million. The projected in 2015 financial results were achieved and surpassed.
During the last twelve months Tchaikapharma strengthened its leadership in the cardiovascular disease treatment in Bulgaria – six new medicines for the treatment of hypertension, ischemic heart disease, heart failure, rhythm and conduction disturbances were registered. The internal company statistics indicates that every tenth Bulgarian or more than 700 000 patients have used the company’s prescription-only medicines at least once a year.
In 2015 Tchaikapharma invested in building its own laboratory and scientific structure for conducting clinical bioequivalence studies. The created system has contributed to the development of the research potential of the pharmaceutical company and obtaining Market Authorisations for three medicines to treat cardiovascular diseases in eight EU countries – Bulgaria, Poland, the Czech Republic, Romania, Greece, Slovakia, Portugal and Austria.
The Research and Development activities of the company have focused on the treatment of diabetes, cancer and neurological diseases, which in the short term are expected to receive new authorisations for EU countries. The European expansion of the company includes creating, testing and registering combined innovative medicines for a range of serious diagnoses.
Tchaikapharma has taken a solid second place in the market capitalisation of the Bulgarian Stock Exchange and continues to climb steadily.
On 10/05/2016, the BDA successfully completed within the specified period the first decentralised procedure (DCP) for marketing authorisation of medicinal products for which Bulgaria is the Reference Member State (RMS).
A team of experts from the BDA assessed the documentation, in connection with the Marketing Authorisation of medicinal products Tamayra 5 mg/5 mg hard capsules and Tamayra 10 mg/5 mg hard capsules, with Marketing Authorisation Holder Tchaikapharma High Quality Medicines Inc., Bulgaria. The procedure was adopted by the other six Concerned Member States (CMSs) as well.
At the end of the trading day (Thursday 7 April) Tchaikapharma’s shares rose most significantly – they increased by 1.21% and the closing price reached BGN 5.85. This represents another appreciation of the emission, which has risen by 6.06% since the beginning of the year.
Your everyday efforts to improve people’s health and save people’s lives are and have always been worthy of respect!
All impediments we face with combined efforts every day to ensure that every Bulgarian has the right of access to the most up-to-date treatment and
quality life make us not only stronger, more united, better professionals, but are also a point of pride!
You are the pride of Bulgarian healthcare!
With best wishes for health, professional success and personal happiness!
Tchaikapharma High Quality Medicines Inc. successfully launched the trading week. On Monday, the company ranked third in traded volume, having trading volume of nearly BGN 33.4 thousand. The transactions were seven, leading to a rise in the share price by 0.7% up to BGN 5.76.
On Tuesday, amid the prevailing unprofitable companies on the Stock Exchange, Tchaikapharma achieved the highest turnover among the profitable companies, as its emissions increased by 0.35%. The closing price reached BGN 5.78, which is the highest closing price in the public history of the company.
This year again, employees of Commercial League assumed the role of Santa Claus and delighted the kids from Konstantsa Lyapcheva orphanage in the town of Dolna Banya.
More than 20 children were asked to send letters with their Christmas wishes, and the team of Commercial League tried to make them true. Besides the dream gift, each child also received a personal message on the occasion, and to the delight of everyone a real table football table was fitted in the common room of the orphanage.
The whole day was filled with wonderful emotions, games and many shared smiles!
The National Health Service in the UK discontinues the coverage of 25 cancer drugs
Twenty five drugs that each year give a last chance to patients with cancer – including breast, prostate and colon cancer will not be funded by the National Health Service in the UK (NHS), which plans to optimize the costs for 2015, and to restructure the budget in an optimal way.
Non-governmental organizations accuse the health authorities in taking “a dramatic step backwards” and destroying the lifeline, which extends the lives of thousands of cancer patients. Annually more than 3000 patients with colon cancer, as well as 1 700 patients with breast cancer will be affected by the decision. Medications that no longer receive funding in some cases, have been increased the life expectancy from eight months to two and a half years, according to the statistics.
In 2011 the center-right coalition in the UK set up a special fund for cancer drugs, following the publicly requested by the conservatives commitment not to deny more treatments because of financial considerations. Although the Fund’s budget was increased from 200 to 280 million pounds, the demand proved to be such that by the end of the financial 2015 it is expected to have spent nearly 380 million.
At the beginning of the year the NHS announced it would increase its annual budget to 340 mln., but even with this increase the fund cannot afford to continue paying for all cancer treatments, which have been financed until now. The patients, who have already received funding approval up to April, will continue receiving their medicines from the NHS.
The Chair of the Fund said that “difficult decisions” had to be taken in order to give priority to the medicines that show best values, and that such a step has been obligatory. From the 84 treatments, examined in the analysis of the fund, 59 continued to be funded after March this year, while 25 were “written off”. Five treatments for colon cancer, four for leukemia, three for breast cancer, three for lymphoma, three for sarcoma, as well as drugs used to treat prostate, ovary, lung, pancreas and kidneys cancer are among those which are no longer financed.
There are three new drugs that will continue to be funded after the analysis – Panitumumab – for treating colon cancer; Ibrutinib – for treating mantle cell lymphoma, non-Hodgkin’s lymphoma type; and Ibrutinib – for treating chronic lymphocytic leukemia.
Professor Peter Clark, Chair of the Fund, said: ” We have been through a robust, evidence-based process to ensure the drugs available offer the best clinical benefit, getting the most for patients from every pound.” “These are difficult decisions, but if we don’t prioritise the drugs that offer the best value, many people could miss out on promising, more effective treatments that are in the pipeline.” The decisions were taken as a result of the analysis of experts on the national level – including oncologists, pharmacists and representatives of patients who independently of each other reviewed the drugs available so far in the Fund, as well as the new applications. Their evaluation included clinical benefit, survival and quality of life, safety and toxicity of treatment, the level of unmet need and the average cost per patient.
Lord Darzi, former Labor health minister, said that the NHS should stop the unnecessary treatment of dying patients in order to help financing and this way – the increase in the cost of new cancer drugs. He told The Times, that the reduction of unnecessary tests and treatments with little chance of success will free up money for expensive modern and better medicines that the health service is struggling to provide for patients.
Tchaikapharma High Quality Medicines Inc. was distinguished among the most profitable and influential companies in Bulgaria for the 2014 business rating “300 Business leaders in Bulgaria”.
In this year’s forth edition the business analysts from the ICAP Group rated the most successful companies in the country accordingto the Earnings Before Interest, Taxes, Depreciation, and Amortization (EBITDA) criterion.
For a consecutive year Tchaikapharma marked a growth in profit and equity. In 2014 the Company’s profit grew by nearly 9 % over previous year, the average value of this indicator of the companies in the rating is only 4.7%.
In its sector “Production of medicines and medicinal products” Tchaikapharma is ranked first based of the criterion “profitability of EBITDA”, i.e. shows the best ratio between profit and the amount of sales revenue. The profitability of Tchaikapharma (40.19 %) significantly exceeded the indicators of other companies in the sector – Sopharma (19.94 %), Balkanpharma – Troyan (19.02 %), Biovet (14.59 %) and Balkanpharma Dupnitsa (10.51 %).
These are the main reasons for the high market capitalization of the company amounting to nearly 255 million BGN (as of 20.10.2015).
The participants in the National Round Table on Reforms and Healthcare without Restrictions insist that the government restores the principle “the funding follows the patient”
“We do not accept and will not accept in the future the activities of the medical institutions to limit and thereby to put bounds on the rights of patients to have access to timely and quality treatment.” So begins the declaration which has been signed by the Center for the Protection of the Rights in Healthcare, the Federation Bulgarian Patients’ Forum and the Bulgarian Association for Patient Rights, the National Association of Private Hospitals, the Association of Municipal Hospitals, and the directors of more than 30 hospitals. The participants were against the norms that lead to the administrative closing down of hospitals, the forced mergers, and the imposing of administrative limitations on the construction of new hospitals. According to them, the success or failure of a hospital should depend entirely on whether the patients are satisfied or not by the treatment provided.
“We insist that the government restores the principle “the funding follows the patient ” and creates the necessary rules for the effective and objective control by the institutions, as well as by the consumers of medical services, over the quality of medical activity,” states the declaration.
According to a reference of the Health Fund, provided to the Medical Association, from March to July the hospitals have exceeded their limits for BGN 31.8 million, which at the end of the year is expected to reach BGN 60-65 million. In a letter to the NHIF the chairman of the BMA Dr. Ventsislav Grozev points out that the healthcare providers are becoming “unpaid donors of the healthcare system.” The Professional Association recalls the legal precedents so far which show that ultimately the NHIF will have to pay the hospitals for the performed activities together with the accrued interest.
Stoycho Katsarov from the Center for the Protection of the Rights in Healthcare stated that all agree that currently the system is not good and needs to change, but he is skeptical whether the reforms undertaken would lead to the desired effect. “The healthcare system would be at its best when it is viewed as a market that offers business services, and not as an administration,” he noted.
The National Association of Private Hospitals commented that the limitations achieve the opposite of what the government claims, namely that the reform works in favor of a higher quality and comprehensive treatment. “The patient goes to the hospital, where he is told he cannot be admitted because of the restrictions. He returnes home and waites to be admitted by this particular doctor at this hospital which he has chosen while his illness is getting worse and his treatment is becoming more expensive. Doctors are beginning to lose confidence in the system and motivation. What this reform achieves is a more expensive treatment, not better quality. ”
Patients’ representatives stressed that the populist statements of politicians that the restrictive policies are in the interest of patients, are not true. “When you undertake reforms in healthcare, it is useful to hear the voice of both – the patient and the professional organizations.”
“If someone steals through clinical pathways, this should be controlled and determined by the NHIF,” said the chairman of the Association for the Protection of Patients and noted that the vicious circle of generating activity that exceeds the limit is due to the planned budget deficit of the NHIF in the recent years .
“We need an urgent discussion on the subject matter of the healthcare budget for 2016,” said the representative of the Supervisory Board of the NHIF Grigor Dimitrov. As an employer, the representative of the Confederation of Employers and Industrialists in Bulgaria in the Supervisory Board was adamant that the limitations are not the way to manage any kind of activity.
The Roundtable participants agreed on the idea that the state should take care to increase the collection of the health insurance contributions, as well as the payment of the full amount. They insisted on increasing the percentage of the GDP for healthcare, which is separated from the budget. The guild accepts the stated intention of the government to provide comprehensive treatment in full, observes that it is available not only through the impoverishment of the structures, but also through organizational and financial mechanisms.
The specialized hospitals of the Bulgarian Cardiac Institute in Varna, Veliko Tarnovo, Shumen and Yambol mark the World Heart Day with an appeal for prevention and free consultations
Every year on the 29th of September the world celebrates the International Heart Day. In connection with this the experts reminded us that according to the “black statistics” every third death in our country is a result of cardiovascular disease, although 80% of the cardiac problems are preventable if detected on time.
“Atherosclerosis and cardiovascular disease are considered to be the largest non-infectious epidemic diseases of our time, in a word – they are the biggest killer of the 21st century,” said the national consultant in Cardiology Assoc. Prof. Ivo Petrov, MD.
“The high level of lipids in the blood is a major risk factor in the early development of cardiovascular disease. The lipids that circulate in our blood come mainly from two sources. One depends on how a person eats and the second, which is even more dangerous, is genetically determined – these are the lipids that our own organism has synthesized. A lot of people have this kind of family history, but it may be less or more risky, depending on the case. In such people the developing of cardiovascular diseases is not potential, it is the rule.
In order to determine whether we are genetically endangered or not it suffices that we know the history of the disease and the cause of the fatal end in our parents or their parents. We, cardiologists, constantly insist on mass screening which should follow simple clinical criteria and laboratory tests. The verification through the lipid profile is widely available throughout the country. But any changes in the electrocardiogram and the echocardiogram should be monitored as well, which, however, are carried out during the second stage. And mainly in people who have cases of early signs of atherosclerosis in their family – either a stroke or myocardial infarction. This is the target group of the Bulgarians who definitely have to be tested, in order to determine if they have a hereditary predisposition to these diseases or not. ”
This year the hospitals of the Bulgarian Cardiac Institute – the Specialized Hospital for Active Treatment in Cardiology in Varna, the Specialized Hospital for Active Treatment in Cardiology in Veliko Turnovo, the Specialized Hospital for Active Treatment in Cardiology in Yambol, and the Specialized Hospital for Active Treatment in Cardiology in Madara – Shumen are joining together in the celebration of the World Heart Day by offering free examinations, taking blood pressure and providing individual consultations.
For the first time clinical trials will be conducted to check if a drug prolonged life, said magazine Sciences et Avenir. The medicine in question is metformin, which is often administered to patients affected by diabetes type 2. In 2008, the study of Russian scientists showed that it prolonged the lives of mice, probably by restricting the calorie intake and controlling the level of glucose. The published in 2014 results from the statistical survey conducted by scientists from the University of Cardiff, UK, included 180 000 people and showed that the treated with metformin diabetics had higher life expectancy than non-diabetics.
This is why, the expert Nir Barzilai at the Albert Einstein College of Medicine in New York launched the TAME / Targeting Aging with Metformin /project. It will monitor the health of 3 000 non-diabetics aged over 70, some of which will be taking metformin for five years, while the other participants will be included in the control group.
Other anti-aging drug – rapamycin, is also being tested. It suppresses the immune response and is often prescribed during transplants. It has been tested on mice and prolongs their lives. Currently, the scientists from the University of Washington in Seattle tested the drug on dogs. Their hopes are that rapamycin will extend the life of the four-legged animal from 2 to 5 years.
Tchaikapharma High Quality Medicines Inc. offers on the Bulgarian market Metformin-Tchaikapharma (metformine), indicated for the treatment of type 2 diabetes mellitus.
According to Minister Moskov, when one has a facility in the big city where people have assets, one has to take responsibility for the system as well. According to the guild, the solution is to permit subsidiaries
Administratively forcible is the method imposed by the state that out of the 4 pharmacies, which an owner is entitled to have, one necessarily has to be located in a small village, the second one – to work round the clock and the other two – whatever the owner considers.
This is what was stated by Nikolay Kostov, chairman of the Association of Pharmacies Owners, in connection with the forthcoming reforms in the Drug Law by the Health Minister Dr. Petar Moskov, which would be the next one to be “repaired”. Kostov predicted that if the idea was implemented, the owners would go around it. For example, a natural or legal person would open up to 2 pharmacies in the cities wherever they decide, and this way the requirement for the other two would be avoided.
The Minister launched his proposal in February this year and then he said:” when one opens a pharmacy in the big city where people have assets, and it is effective, one has to take responsibility for the system, even if this is not a market method”.”Even during post-socialist times there was no such regulation! The opening of pharmacies is encouraged in small towns everywhere in the EU, but only where this is possible. In some places it is a lost cause,” said Kostov.
According to research, in order for a pharmacy to exist in the EU, there should be at least 1200 inhabitants, while in some places a pharmacy serves 15 000. Another determining factor is overcharge. The more it is “suppressed”, the more patients are needed in order for the facility to not go bankrupt. “In our case, although higher overcharge is permitted, it is usually 10-13 to 14%. Of course, if it is 30%, then the pharmacy can function even in a village with 800 people,” said Kostov. He added that people from smaller places have a different income and consumption than in cities. And if the village has no doctor, it is absurd to open a pharmacy, because no one can prescribe medication. And if the patient goes to a big city to see a doctor, it is logical he would to buy his drugs there as well.
Kostov recalled that years ago the state and the municipalities were allowed to open pharmacies, but they all were privatized, as they had debts. “So the state abdicated from this type of activity, and now wants to move it over to us”, he added. While the idea may seem social, it was “wild populism” that protects only the interests of the occupational group. According to the Association of Pharmacies Owners a solution would be to allow the pharmacies in major cities to have branches in small villages which would work 1-2 times a week for several hours, and not only with a master pharmacist, but with an assistant pharmacist as well.
Doctors specializing in Medicine will have a right to a contract with the NHIF was decided by the MPs yesterday, when they accepted the amendments to the Law on Medical Institutions. This way they made the promise of the Health Minister Petar Moskov, which he made to the doctors in the campaign “Young Medic”, become a fact.
Specializing doctors currently do not have the right to work with the Fund and this is the reason why hospitals find it difficult to provide the necessary funds to ensure they have good salaries. However, this will change with the changes and clinics will want to recruit young physicians on staff. Furthermore, the MPs adopted the opportunity for emergency doctors to work more flexible shifts, and in the areas where there are no clinics, physicians are required be on duty at least 10 hours a week.
The Health Insurance Fund will finance hospitals only according to the needs of the population
The Health Insurance Fund will not finance all newfound hospitals and will base its decisions on the National Health Card, which will have an obligatory nature. It will list the needs of the regional population. This was the bottom-line decision of the Parliament when adopting the amendments to the Law on Medical Institutions.
GERB listened to the promise of Prime Minister Borisov to provide support for the health reform of Minister Petar Moskov. The most important changes which concern the funding of hospitals will be solved with the regulations and methodologies of the Health Ministry. It will depend on the Health Minister whether the NHIF will refuse hospital contracts and which hospitals will that be, and whether the government and private hospitals will be forced to unite and for what. Currently Bulgaria has twice as many hospital beds as the EU, and according to the statistics, every fourth Bulgarian is hospitalized once a year, and in practice such people are subjected to treatment not necessarily or even needlessly.
The National Health Card will have an obligatory nature. It will describe by districts the population medical attention needs. How treatment needs in specialties and hospitals will be determined will be recorded in the methodology of the Health Ministry. The Fund will not finance all institutions in the regions where there are more hospitals than population needs. The criteria by which the NHIF will decide with whom to form a contract and who will remain without funding, will be described in an ordinance. Minister Moscow claims that hospitals that provide comprehensive treatment and do not focus only on well-funded activities by the NHIF will receive priority funding.
The law provides that the treatment which paid by the NHIF is divided into two packages – Basic and Additional. For the diseases of the Basic package, a comprehensive treatment of which will be provided, the Health Fund will only enter into contracts with hospitals or groups of hospitals that can provide this. Minister Moskov explained that his idea of comprehensive care will be enacted into an ordinance for cancer, the most common cardiovascular diseases and for some rare diseases starting next year. The aim is to have comprehensive care provide for the whole Basic package within the next 3 years.
The proposal of the Health Minister was the care in question to be provided in one place, i.e. either in a hospital or a group of hospitals. But the majority adopted a softer text according to which hospitals will able to enter into contracts with each other to receive funding from the NHIF for complex care, without merging.
The idea is, for example, in cancer patient treatment to have at any stage a guarantee for surgery, chemotherapy and radiotherapy, and not to receive surgical treatment in one hospital, and infusions – in another, where the person arranges the stay by himself. The NHIF would not pay all hospitals for the reported treatment covering 3 clinical pathways, and would enter into a single contract for all the treatment needed in one. That is, either all pathways would be paid for, or none. Hospitals would have to arrive at an understanding whether to group into holding companies or unions under the Trade Act, or to enter into contracts among themselves and decide who would receive how much funding.
The opposition is concerned that if the state, municipal and private hospitals begin to make associations this would lead to siphoning money. But according to Moskov, the idea is that hospitals, dealing only with chemotherapy, for example, would not be able to receive money directly from the Fund, as well as that consolidating would help downsize the administration.
The idea which caused protests in the summer – that oncology, psychiatric and skin outpatient facilities should merge with the other hospitals – was dropped once and for all. Hospital accreditation will be required in order to land a contract with the NHIF, as it is now, and directors of hospitals are still required to have a qualification in Health Management.
What will the packages contain?
By the 15th of September it should become clear what the Basic package would contain and what the Additional one would contain, said Deputy Health Minister Vanyo Sharkov. The diseases from the Basic package would be the main priority and, according to the promises of Moskov, there would be 100% guaranteed funding for them, while those from the Additional will receive less money than now and the treatment would have to wait. The Basic package would include child and maternal health, strokes, cardiology, cardiac surgery and interventional cardiology, traumatology and neurosurgery. Regarding the Additional package what is clear for the time being is that it would contain the “pimples” in the words of Sharkov – i.e. the non-essential diseases. Most one-day eye surgery would be transferred from hospital to outpatient care. The Basic package was also not defined in a law, and the determining of its contents was left entirely to the Ministry of Health.
For the first time the Republic of Bulgaria, as a Member State of the EU, will be the reference country in the decentralized procedure (DCP) for Marketing Authorisation for a medicinal products with applicant Tchaikapharma High Quality Medicines Inc., Bulgaria. The concerned parties in the procedure are Austria, Greece, Portugal, Romania, Slovakia and the Czech Republic.
As a reference party to the procedure the BDA will assess the dossier for Marketing Authorisation for medicinal products (fixed combination) with active ingredients ramipril and amlodipine. A team of the BDA will prepare evaluation reports, including questions to the applicant at any stage of the procedure. The evaluation will be consistent with the requirements of current Pharmacopoeia (Ph.Eur.), the Guidelines of the International Committee on Harmonization (ICH) and European guidelines on quality, safety and efficacy of medicinal products.
Bulgarian Drug Agency issued a new Marketing Authorisation to Tchaikapharma High Quality Medicines Inc. for the medicinal product for treatment of diabetes mellitus Aroba 100 mg tablets.
Aroba contains the active substance acarbose, and belongs to the group of medicines called alpha-glucosidase inhibitors. It is used as supplement treatment concomitantly with diet in patients with diabetes and for the prevention of type 2 diabetes in patients with demonstrated impaired glucose tolerance. The dosage should be individualized for each patient by the doctor as the efficacy and tolerability vary from individual to individual.
ATC code: A10BF 01
More information about Aroba can be found here.
The Guardian wrote that the Scientists had found that two licensed drugs stopped the degeneration of the brain in mice. The discovery gives hope of success in the search for drugs for the therapy of Alzheimer’s disease.
The results, presented at the annual conference of scientists researching Alzheimer’s disease, were defined as “promising” because the drugs used were already proven safe and well accepted by the human body. This can save years in the process of development and approval of new drugs.
Giovanna Maluchi of Cambridge University said: “This is really exciting. Medicines are licensed. This means that we go directly to the underlying clinical tests on a small group of patients, since no new ingredients, these are known drugs.” The scientists have decided not to disclose the names of the two drugs that are not currently used for the treatment of dementia in order not to cause testing from patients before the clinical trials prove their effectiveness.
The discovery is based on key study conducted two years ago, which proves that the death of brain cells can be stopped in mice by switching off the wrong signal in the brain, stopping the production of new proteins. However, the study had used a composition that causes serious side effects and was not suitable for humans. Both drugs had been identified after Maluchi’s team had examined hundreds of licensed drugs in search of a safe drug with the same protective effect on the brain.
The researchers point out that before the clinical trials a research would be conducted that would confirm that the same error signal, which was treated in mice, caused degeneration and memory loss in Alzheimer’s disease. Maluchi said that if the study would be conducted as soon as possible and would confirm that connection, the clinical trials could begin within a few years.
Three women after mammectomy due to breast cancer undergo reconstructive surgery today in Sofia First Gynecological Hospital “St. Sofia” by a Bulgarian team of specialists, led by the world-renowned plastic surgeon Prof. Marita Eisenmann – Klein. This was announced at a press conference on the opening of a seminar organized by the Cluster for Medical Tourism, International Health Association of Bavaria and the International Confederation for Plastic Reconstructive and Aesthetic Surgery IPRAS. At the meeting with the media became clear that the interventions will be implemented without the placement of implants using the method of autologous fat transfer (fat grafting) and the participation of Prof. Eisenman has a training character, it became clear. The visit of the expert is entirely in good faith, free of charge and aims to help the Bulgarian medics to master this particular methodology, which enjoys more and more supporters in the professional medical community worldwide. The operation will be monitored by a large group of doctors from Sofia and Plovdiv.
The method was extremely sparing the patient, the sessions were short, a great advantage was its universal applicability, one of the indications for its implementation was radiotherapy, said Dr. Mladen Mladenov from the surgical oncology team of Obstetrics and Gynecology Hospital “St. Sofia”. The intervention went in stages between them were provided intervals of not less than 2 months, and the number of individual sessions depended on the individual characteristics of the patient, said Dr. Mladenov.
Prof. Marita Eisenmann predicted that only after 10 years the fat grafting method would be the first choice in reconstructive breast surgery and implants would remain in the past. According to her many hopes were laid on the application of the method in urinary and anal incontinence in orthopedic surgery for arthritis and osteodegenativni diseases. “My dream is to see good results in the treatment with autologous adipose tissue of chronic wounds, especially of decubitus. I am optimistic that this will happen,” added Prof. Eisenman.
At the press conference it became clear that the surgical oncology team of Obstetrics and Gynecology Hospital “St. Sofia” was ready to apply that treatment at that time and every woman who considered that there was a need for thoracic intervention not only because of malignancy might seek consultation at the hospital. For the moment, the intervention is not paid by the NHIF, the individual stages are priced at BGN 1 200.
In the autumn of this year another training workshop with demonstrations of Bulgarian medics is foreseen, it will be dedicated to the topic of the application of new methods of plastic surgery in urology with focus on urinary incontinence.
There are reported cases of serious, sometimes life-threatening cases of diabetic ketoacidosis in patients with type 2 diabetes treated with SGLT2-inhibitors. This is reported by the manufacturers after consultation with the European Medicines Agency (EMA) and the Bulgarian Drug Agency (BDA).
In a number of these reports the clinical presentation of the condition is atypical, as only moderately elevated blood glucose levels are observed. The statement says that such atypical clinical presentation of diabetic ketoacidosis in patients with diabetes could delay diagnosis and treatment.
The patients treated with inhibitors of SGLT2, with symptoms of acidosis should be tested for ketones to prevent the delay in diagnosis and treatment.
Cases of diabetic ketoacidosis have also been reported in patients with type 1 diabetes mellitus, who were given inhibitors of SGLT2. The pharmaceutical companies remind the prescribing physicians that type 1 diabetes is not permitted therapeutic indication for this class of drugs.
In Bulgaria dapagliflozin is registered from this class of inhibitors under the trade name Forxiga 100 mg x 30.
During the past 2014 the NHIF allocated 72 million for rare medicines
The innovations are crucial for achieving better treatment, but they are very expensive. Good examples of this are the so called “orphan drugs”, which treat rare diseases. Treatment of a patient for a year could exceed millions. Because of that the access is problematic for every country. The analysis of the Center for Health Technology Assessment and Analysis and the Institute for Rare Diseases shows – where are we in comparison with EU countries.
The ensuring of access for patients to “orphans drugs” across the EU is different. Although the drugs have Marketing Authorization through the Centralized procedure (simultaneously for each country), the payment from public funds is at a different time. According to the data in the analysis of the Centre for Health Technology Assessment and Analysis and the Institute for Rare Diseases the average delay in the countries is 29.1 to 43 months from the receipt of the Marketing Authorization to funding. The analysis examines all 36 diseases that are covered by the NHIF. Among them are congenital coagulopathies (disturbances in blood clotting), beta thalassemia, idiopathic thrombocytopenic purpura, non familial hipogama-globulinaemia, selective deficit of subclasses of immunoglobulin G, severe combined immunodeficiency with low or normal content of B cells, common variable immunodeficiency, etc.
The delay in Bulgaria for the reimbursement of “orphan drugs” is within a few years. The delay in access to medication for mucopolysaccharidosis II for example was 5 years, as was the reimbursement for another medicine for phenylketonuria. The delay in access to “orphan drug” for hereditary amyloid polyneuropathy was 2 years, while to “orphan drug” for primary pulmonary hypertension – 3 years. “This delay represents a significant obstacle to timely and adequate treatment of patients with rare diseases,” says the analysis.
In the middle of last year registered in the EU “orphan drugs” were 72. Of them in Bulgaria the fund and the hospitals pay only 22. The remaining 50 are not funded with public money and in practice remain inaccessible to patients. For comparison, in other member states on average about 80% of the approved on European level “orphan drugs” are included in the health insurance system. Although many drugs remained inaccessible to the sick people in our country, our country has made great progress in recent years in providing access to rare drugs to patients, says the analysis. The costs of the NHIF for such medicines were increase from BGN 28 million in 2011 to over BGN 72 million in the last. The average cost of treatment per patient per month was about BGN 2 thousand
Although some European countries cover more drugs for patients with rare diseases, they also face many challenges. The establishment of the clinical efficacy of these drugs is number one priority, because the evidence is often insufficient from the standpoint of the health authorities. This is due to the limited number of patients who use them, and the required data can not be accumulated quickly. Furthermore, it is difficult to find for comparison a competitive conventional therapy already covered by public funds and available to patients. These problems, combined with the extremely high cost of most of the treatments for rare diseases, raise the question of finding a partnership between the government and the industry in the financing of the drugs. The mechanisms for the management and sharing of financial risks are many. In Belgium, for example, public expenditure on drugs has a limit. 2/3 of the over-expenditure should be covered by the pharmaceutical industry and the rest by the National Health Insurance Institute. In Australia, as early as 2004, the state agreed to reimburse the medicine provided that a registry of patients with primary pulmonary hypertension will be created and the future price will be consistent with the results. In practice the data on the clinical efficacy of treatment locally is required by the authorities in most countries. This is the main reason for the peculiar boom of the registers for rare diseases in Europe. According to the European portal Orphanet the number of registries for rare diseases in the Member States is 641 as of 2014. In this respect Bulgaria was a kind of best performer in Eastern Europe, says the analysis. However, this is clearly not enough. According to the specialists a better control is needed over funding, reallocation of resources according to the effects of treatment and provision of monitoring network for patients with rare diseases.
There are 8000 rare diseases
A disease is considered rare when it affects less than 5 persons in 10 000 in the EU. According to scientists there are between 5000 and 8000 such diagnoses. They will affect between 29 and 32 million people in the EU, of which 400 000 in Bulgaria.
They are mainly against cancer
More than 72 “orphan drugs” are discovered so far. Only for the last two and a half years 27 new drugs have been approved for marketing, 9 of which in the first half of 2014. Most of the designated drugs are intended for cancer. Lysosomal storage disorder and primary pulmonary hypertension are emerging as the next “most preferred” areas of the industry for development of new drugs.
A new front in the National Assembly against the reduced requirements for managers was formed.
The Health Minister Petar Moskov has proposed a liberalization of the requirements for managers in the Medical Institutions Act and virtually anyone who has a master degree in economics may become head of a hospital. This formed a new front of Members of parliament from different groups against the proposal of the Minister.
According to the current law a manager or executive director of a hospital can only be a person who has a master’s in general or dental medicine and acquired qualification in health management.
The other option is a master degree in economics and management, and board certification in medical informatics and health management or health economics.
Now, however, Moskov has proposed in the draft law to eliminate the requirement for qualification in health management, and for the economists to have knowledge in the field of health. In the health committee he explained that if a young man, a graduate of Cambridge, decided that he wanted to pursue a career as Head of St. Anna Hospital, the Members of the Parliament should not impede him.
The Members of Parliament: We will not draft a law for one person.
“I disagree with this proposal; I believe the current requirements should remain because they provide a guaranteed level of competence in management. We will not make laws for an individual from Cambridge. I think we need to draft a law for those who live in Bulgaria. Moreover, after the New Year there will be enough freelance hospital managers who will seek employment,” said the Member of Parliament from the Reformist Bloc Assoc. Prof. Dimitar Shishkov.
Prof. Georgy Kyuchukov from the Alternative for Bulgarian Revival is also adamant that the criteria should not be lowered. “Receiving his education at Cambridge, he will be better informed about the needs of the British health system, but not of ours. Moreover, the opening of a faculty in health management in each medical university losses its meaning,” said Prof. Kyuchukov.
The Member of Parliament from the PP Citizens for European Development of Bulgaria Dr. Krassimir Petrov is also adamant that his party will not allow the lowering of the standards for hospital executives, provided that the reform aims at better management. They will even propose the requirement of master’s degree in health management, not just qualifications. Of the same opinion is Djevdet Chakarov, his colleague from the Movement for Rights and Freedoms. “It is evident that there is a huge need for effective management. The nature of the medical activities and services should be known. The amendments may have a different interpretation – that the door to change the hospital bosses is opened,” said Chakarov.
The results of a retrospective study published in the Journal of the American College of Cardiology show that the patients with critical limb ischemia who took statins had a significantly lower incidence of major adverse cardiac events (MACE) and amputations.
The register of patients with peripheral arterial disease (PAD) from 2006 to 2012 was analized and 380 cases were selected with at least one episode of critical limb ischemia confirmed by angiography with or without endovascular therapy. The average age in the study group was 69 years and the mean follow-up period – 409 days.
The patients were divided into two groups according to whether they are receiving (65%) or not (35%) statins prior to the episode of critical ischemia. The most commonly used statins in the study were simvastatin and atorvastatin.
In the group on statin the frequency of concomitant diseases (diabetes, hypertension, coronary heart disease, myocardial infarction, carotid stenosis, or stroke) was significantly higher.
Despite the higher comorbidity, after one year of follow up of patients receiving statin, the combined endpoint of myocardial infarction, stroke, and mortality was significantly lower (18%) compared with those who were not taking a statin (23%) before and after the incident of critical limb ischemia.
Interesting here is that the mortality is the main factor that determines the difference in frequency of MACE – 15% mortality in the presence and 21% in the absence of statin therapy
The combined risk of death or amputation of a limb is reduced by half when taking a statin.
The survey results support the recommendations in recent clinical guidelines that the administration of statins is indicated for all patients with PAD, even when the disease is in the final stage.
Despite all the strong evidence of the benefit of statins, only 65% of patients in this retrospective study were taking statins. This indicates that the application of the guidelines for behavior in clinical practice has not yet reached the required level.
Tchaikapharma High Quality Medicines Inc. offers on the Bulgarian market the following statins:
Simvacor (Simvastatin) – CF 710 – 10 mg
Simvacor (Simvastatin) – CF 711 – 20 mg
Simvacor (Simvastatin) – CF 712 – 40 mg
Atorva (Atorvastatin) – CF 996 – 10 mg
Atorva (Atorvastatin) – CF 997 – 20 mg
Scientists from the Edinburgh University announced that they had found the mechanism that allows breast cancer to spread to the lungs, wrote The Guardian.
The team of scientists found that blocking it in mice with the disease reduced the number of secondary tumors in the lungs. The researchers hope that their achievement would lead to new therapies to stop the breast cancer development. The reason for the majority of deaths in this form of cancer is the penetration of malignant cells in other body parts, the lungs being the first organs affected.
The team from the Centre for Reproductive Health at the University has researched the role of an immune cell called a macrophage in relation to the spread of cancerous cells from the primary tumor. Previous studies have shown that cancer cells use macrophages to penetrate into the lungs. The new study found that macrophages communicate with the cancer cells through chemokine signaling molecules. When these signals in mice are blocked, the number of secondary tumors decreases by up to two thirds. Moreover, the suspension of the signal stopped the entry of malignant cells in the lungs through the bloodstream and prevented the already entrenched cells to form new tumors.
Cells in the human body use chemokines signals to communicate with each other, which gives hope that as a result of the discovery new treatments for other body parts can be created.
The party Patriotic Front (PF) would propose a change in the Hospitals Act with which to establish a Register of Medical Errors. This was announced by MP Dr. Sultanka Petrova. Building the system had been discussed for years, leading specialists and the Doctors’ Union had kept demanding that from time to time, but it hadn’t taken place up to that moment. The last to speak of this Register were the new leaders of the professional organization, according to whom this would be finalized in two years’ from that time.
“At the moment we have no idea who goes wrong and how, but when the Register starts running, it will become clear where the problems are rooted – to what extent they are due to the lack of motivation, specialization or professional exhaustion,” indicated Dr. Petrova. She added that the doctors at fault should be removed for a certain period from the system and continue their education. But the details of this process had to be put down in an Ordinance.
The Institution better known as the medical State Agency “National Security” announced: “The creation of the Register is established in the updated Health Strategy 2014 – 2020 as one of the priorities which the Executive Agency ‘Medical Audit’ should work on”. According to it, one first needs to start with a clarification of the terminology in this area – i.e. to adopt a clear and unambiguous concept of what a medical error is and its varieties. The Agency added that it was necessary to classify the errors, so they could be reported. Experts said that if there was a good organization and cooperation between doctors, nurses, patients and control officers for a year and a half or two, the Registers might start working. “And its purpose is to serve as information for all workers in the system. Moreover, the medical community has to regularly get acquainted with the analysis of the results from the Register, to draw the necessary conclusions and to prevent errors’ re-admission”, maintained “Medical Audit”. The public would also be informed.
The Supervisory Board of the National Health Insurance Fund is expecting from the BMA proposals for solving the problem of clinical pathways overspending. This became clear from the words of the member of the Supervisory Board Dr. Evgeni Tasovski. “We look at where the pain is, and this is the spot that is to be treated. And as good diagnosticians, we have let the BMA find the problem, so they should propose the solutions. The doctors themselves have to be analyzed, not the administrative structure, the problems have to be systematized and there has to be an indication what is to be done,” he said.
Dr. Tasovski said that the Medical Association had requested data on which were the most expensive pathways, how much were the overspent funds, and which hospitals had been overspending. He noted that at the meeting between the two parties a few days ago a decision had been reached by the experts of the professional organization and the NHIF to get together and discuss lighter measures than lowering the prices. The situation would be discussed again in two weeks from that time, said the supervisor.
When asked whether the NHIF had not come up with any suggestions to the BMA about which pathways could be transferred from hospital to outpatient services and if analysis had been made on what the savings would come up to, Dr. Tasovski said that no such proposals had been made. According to him, only the Manager of the Health Fund Dr. Glinka Komitov had presented ideas in this regard, but they had not yet been fully formed before the supervisor and the doctors. According to him, Dr. Komitov most likely would be ready the week after. Dr. Tasovski added that at that time there had been no talk about reducing the prices of pathways. “Supervision does not want to display force, but simply wants to show an understanding of the BMA,” he said.
Many people called their personal doctors to enroll for a checkup after the Health Minister Dr. Petar Moskov said that if routine preventive checkups were skipped, there should be a higher health insurance, announced the GPs.
Even now there is a fine of BGN 50 for skipping the annual checkup provided for in the Health Insurance Act. It has not come into practice as no health minister has so far developed a mechanism for its implementation.
“Increasing health contributions is a good step as a disciplinary measure, but all the details have to be taken into consideration,” said Assoc. Prof. Lyubomir Kirov, chairman of the National Association of General Practitioners. He added that everyone had to follow the rules, and the same way doctors were fined for violations, patients should be sanctioned as well. If the raise of health insurance contributions were paid by the insured, not the employer or the state, for example, there would be a real effect. Prof. Kirov explained that the state paid the contributions for pensioners, children, students, the unemployed and if the measures were automatically applied, the sanction would be distributed among all taxpayers.
Over 50% of Bulgarians over 18 do the mandatory annual preventive checkup at their GPs office, according to the Association. In the last Frame Contract the price for the check up had been increased to BGN 10, and the funds set aside for preventive examinations covered just over half of the insured. Separate are the tests that are not provided for independently, but have to be appointed within the common regulatory standard by the GP. If now 2 million people decide to do the examination, for example, this means at least BGN 40 million more, estimated the Association.
Some go on their own initiative, others – due to a particular health problem, and within the visit are done the preventive examinations as well. They include various activities and tests, depending on the age group.
There should be constant awareness campaigns in the media, because things just got forgotten, said Assoc. Prof. Kirov. Despite everything, however, we should not expect that the prophylactics at the GP office could cover the fully insured.
The expectation that preventive examinations could “detect” all diseases is not realistic as well. The point is to get the picture about the risk or the patients with the major diseases: hypertension, diabetes, certain cancers, obesity, etc. They affect more and more young people and it is important to detect them on time – thus preventing complications, improving the quality of life and lengthening the years of working efficiency.
Assoc. Prof. Kirov emphasized that a lot of patients still thought that the GP should look for them for the preventive check-up. This was a delusion left over from previous times. Patients’ health was their personal responsibility, so they had to be the active side. The GP was required only to declare at a noticeable place in his office what kind of preventive examinations and tests are to be done and with what frequency for the insured over the age of 18.
The GPs themselves have remarks on the amount and scope of the planned examinations and tests. Cholesterol and triglycerides tests, for example – a sign of cardiovascular disease and metabolic syndrome – are provided only for men over the age of 40, and then every five years. Women do this test only after the age of 50 and also with a period 5 years in between.
Assoc. Prof. Kirov explained that this did not suffice and did not provide the sought preventive effect. At the initiative of the Association it was accepted in 2009 that all Bulgarians over the age of 18 should undergo such an examination, and a questionnaire for every patient had to be a filled out during the preventive checkups. Assoc. Prof. Kirov added that they had provided the software and that upon filling out the data from the checkup it immediately indicated the percent of patient risk for various diseases.
The goal was for 2-3 years to cover all and to present a complete picture of the health problems of the population, in order to provide the necessary prevention and therapies. This was done for only 1.5 years, and the opportunities for accurate statistics on people with hypertension, metabolic syndrome, diabetes and other socially significant diseases, were missed.
Insulin resistance and beta-cell dysfunction are the two key pathophysiological disorders of diabetes mellitus type 2 (DM T2). The liver, muscle and the adipose tissue are resistant to insulin action. The basal hepatic glucose output is increased, despite the high plasma insulin levels, indicating the presence of hepatic insulin resistance. Increased glucose production by the liver is the primary disorder leading to elevated fasting plasma glucose.
The binding of insulin to the receptor leads to tyrosine phosphorylated insulin receptor and insulin receptor substrate 1 with the subsequent activation of phosphoinositol-3 kinase and Akt. The activation of the insulin-receptor signaling pathway increases the glucose transport into the cell, stimulates glucose phosphorylation and glycogen synthesis, as well as glucose oxidation. The ability of insulin to increase the glucose uptake in peripheral tissues (mainly muscles) is impaired and peripheral insulin resistance is the main cause of postprandial hyperglycemia.
Adipocytes are also resistant to insulin action and the increased lipolysis leads to an increase in plasma free fatty acids. They increase insulin resistance in the liver and muscle, inhibit glycogen synthesis and glucose oxidation, and increase hepatic glucose production. Until DM T2 appears, the insulin resistance of the liver and muscles is compensated by an increased insulin secretion. With time, however, the pancreatic function is affected by reduced beta-cell sensitivity to glucose and beta-cell mass, and plasma glucose concentration rises.
Glucose toxicity and lipotoxicity contribute to the reduced beta-cell secretion. Hyperinsulinemia, by which beta-cells compensate for insulin resistance, stimulates the mitogen-activated protein kinase (MAP) path that suppresses the sensitivity to insulin. The activation of MAP kinase promotes numerous intracellular pathways involved in inflammation, enhances vascular smooth muscle cell growth, and the proliferation and potentiating of atherosclerosis.
Pioglitazone is a medicine from the group of thiazolidinediones (TZDs) – agonists of the peroxisome proliferator activated receptor γ (PPARγ). It is the only thiazolidinedione approved for the treatment of hyperglycemia in DM T2. Pioglitazone is an insulin “sensitizer” which by binding to PPARγ, increases insulin sensitivity of muscle, liver and adipose tissue and decreases plasma glucose in fasting and postprandially.
Pioglitazone is a highly selective PPARγ agonist. PPARγ is a transcription factor, which, when activated by pioglitazone, stimulates the transcription of the insulin-sensitive genes involved in the uptake of fatty acids, as well as of glucose and lipogenesis, and therefore increases or is partially similar to the selective action of insulin. PPARγ is also necessary for normal adipocyte differentiation and proliferation.
PPARγ is expressed in the key target tissues of insulin action, mainly in the adipose tissue, but also in the skeletal muscle, liver, pancreatic β-cells, vascular endothelium, and macrophages. The glucose-lowering effect of TZDs is associated with the increase of the peripheral glucose uptake and the reduction of the hepatic glucose production. TZDs, including pioglitazone, improve insulin signaling and insulin sensitivity in muscle, enhance the production of nitric oxide, a potent vasodilator and anti-atherogenic agent, inhibit the MAP kinase pathway, and reduce the risk of atherosclerosis.
In the liver pioglitazone improves the glucose uptake, decreases the hepatic glucose production by inhibiting gluconeogenesis and reducing fat. Belfort et al. studied 55 people with DM T2 or impaired glucose tolerance with biopsy-confirmed nonalcoholic steatohepatitis. The patients were randomized to a hypocaloric diet or a diet and pioglitazone 45 mg daily. After 6 months of treatment with pioglitazone, the muscle/hepatic insulin sensitivity was improved, the fat content of the liver, objectified by magnetic resonance spectroscopy, was reduced by 54% and the aminotransferase levels were normalized. Liver biopsy showed histological improvement of the steatosis, inflammation, bubble necrosis and fibrosis. Pioglitazone reduces the inflammation expressed by a reduction in the C-reactive protein, the tumor necrosis factor alpha, the transforming growth factor-beta and the increase of adiponectin.
Pioglitazone achieves the positive effects on the metabolism of adipose tissue. By improving the sensitivity to the adipocyte antilipolytic effects of insulin, pioglitazone reduces free fatty acids, which leads to increased insulin sensitivity of the muscle and liver and enhanced insulin secretion. Pioglitazone causes the redistribution of fat from metabolically active visceral fat, associated with increased atherogenesis, to subcutaneous adipose tissue
Miyazaki et al. and studied the effect dose-response to pioglitazone at the doses of 7.5, 15, 30 and 45 mg daily, compared with placebo for 26 weeks in subjects on a poorly controlled diet. Glycated hemoglobin (HbA1c) was significantly decreased at doses of 15 mg (-1.3%), 30 mg (-2.0%) and 45 mg (-3.0%) as compared to placebo (1.2%). The insulin sensitivity, determined by the Matsuda index, improved at all the doses of pioglitazone and the highest – at 45 mg. Hepatic insulin sensitivity index (k/fasting plasma glucose x fasting plasma insulin) was significantly improved. Pioglitazone enhanced the insulin sensitivity of liver, muscle and adipose tissue, which lead to improved glucose and lipid metabolism.
Thiazolidinediones and GLP-1 analogs are the only ones which preserve and enhance the function of beta cells. Pioglitazone was evaluated in a randomized, double-blind, placebo-controlled study of 602 individuals with confirmed through an oral glucose tolerant test / OGTT / impaired glucose tolerance. Observed for 2.6 years, the risk of progression to DM T2 was reduced by 70%.
Pioglitazone significantly improves insulin sensitivity (measured by the Matsuda index and intravenous glucose tolerance test FSIGTT) and the pancreatic beta-cell function as measured by the disposition index (insulin secretion / insulin resistance). In a double-blind, placebo-controlled, 4 month study of poorly controlled patients with DM T2 without medical treatment or who were being treated with a sulfonylurea, pioglitazone significantly improved their beta-cell function. In eight long, > 1.5-year, double-blind placebo-controlled or comparative studies, pioglitazone caused prolonged reduction of HbA1c. This continuous decrease in the glycated hemoglobin could be explained by the storage of the beta-cell function.
Comparative/combination studies with metformin pioglitazone showed equal efficacy in terms of the reduction of glycated hemoglobin and fasting plasma glucose with continuous monitoring. The combination therapy with metformin and pioglitazone had a synergistic effect, leading to significant improvements in the glycemic control by increasing the HDL-cholesterol and decreasing the triglycerides as compared to metformin and placebo.
In comparative studies with sulfonylurea preparation, pioglitazone leads to a similar reduction in HbA1c and fasting plasma glucose. The effect is slower and more prolonged than the earlier effect of the sulfonylurea medicine. Insulin sensitivity, as measured by the homeostasis model (HOMA), shows significant improvement as compared to the treatment with pioglitazone. In combination studies with a sulfonylurea agent, pioglitazone resulted in further significant improvement in the glycemic control, expressed in fasting plasma glucose and HbA1c, as well as in triglycerides and HDL-cholesterol. With a triple combination with metformin, the sulfonylurea preparation achieves further significant improvements of HbA1c. Pioglitazone improves diabetic dyslipidemia, increasing the HDL cholesterol and decreasing the atherogenic small dense LDL-particles and triglycerides.
As monotherapy or in combination with a sulfonylurea agent, metformin or insulin pioglitazone showed a significant reduction in triglycerides and an increase in the HDL-cholesterol. Pioglitazone reduced small dense LDL-particles, regardless of the triglycerides and HDL-cholesterol, which showed that the anti-atherogenic potential of pioglitazone was greater than expected and that it was connected with its effect on the triglyceride, HDL- and LDL-cholesterol alone.
Pioglitazone reduces the total mortality, the nonfatal myocardial infarctions and strokes in people with T2 DM and high risk of macrovascular events.
PROspective pioglitAzone Clinical Trial In macroVascular Events (PROactive) was the first prospective, randomized, double-blind, controlled study in patients with DM T2, treated with a diet and/or oral antidiabetic agents and/or insulin with a history of macrovascular disease. It assessed the impact of Pioglitazone on the secondary prevention of cardiovascular events. 5238 patients, representing the typical population at high risk of future macrovascular events, were randomized to pioglitazone titrated from 15 mg to 45 mg (n = 2605) or placebo (n = 2633), in addition to the antihyperglycaemic and symptomatic agents. The observation took 34.5 months. The primary end output (composite of death, myocardial infarction, stroke, amputation of lower limbs, acute coronary syndrome, cardiac bypass or revascularization of lower limbs) was reduced by 10%. The secondary endpoints output (Kaplan-Meier time to death, nonfatal myocardial infarction or stroke) was reduced by 16%.
In a meta-analysis of 19 randomized, double-blind, placebo-controlled or comparative studies involving 16,390 patients treated with pioglitazone, ranging from 4 months to 3.5 years, Lincoff et al. made a systematic assessment of the effect of pioglitazone on ischemic cardiovascular events. The primary end output was the time to total mortality, myocardial infarction and stroke, and the secondary end output – the frequency of heart failure. Death, myocardial infarction or stroke occurred in 375 of 8554 patients (4.4%) who were receiving pioglitazone and in 450 of 7836 patients (5.7%) in the control group. Pioglitazone was associated with a significantly lower risk of death, myocardial infarction and stroke in patients with DM T2.
Two ultrasound studies showed the anatomical regression of atherosclerotic disease treatment with pioglitazone. In the study CHICAGO (Carotid Intima-Media Thickness in Atherosclerosis Using Pioglitazone) patients with DM T2 were randomized to pioglitazone or glimepiride for 18 months, and the thickness of the carotid intima media (CIMT) was measured before and after randomization. In subjects treated with pioglitazone SІMT had not progressed (-0.001 mm), while those treated with glimepiride showed significant atherosclerotic progression (+0.012 mm).
In conclusion, pioglitazone provides lasting good glycemic control as mono or combined therapy and improves the cardiovascular prognosis of patients with type 2 diabetes mellitus.
Tchaikapharma High Quality Medicines Inc. manufactures Pioglitazone under the trade name of Pizona.