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The arterial hypertension (AH) is a widespread disease, which often occurs in combination with other pathological conditions, worsening prognosis in a patient with metabolic syndrome or type 2 diabetes (DT2), and damage to the target organs, such as microalbuminuria or renal failure (RF).

The combination of arterial hypertension and microalbuminuria or renal puts the patient in the high risk category for the occurrence of adverse cardiovascular events, and accordingly requires from the doctor a more aggressive approach for treatment and for combating the risk factors.

The recommended treatment of patients with hypertension and renal impairment includes blockers of the renin angiotensin aldosterone system (RAAS), angiotensin converting enzyme inhibitors (ACEi) or ARB, because these drug classes prevent onset and/or slow the progression of nephropathy. The side effect profile of RAAS blockers, which determines the tolerability and the compliance with the therapy, provides advantage to angiotensin receptor blockers (ARB).

For treatment of arterial hypertension eight ARBs are available: azilsartan, candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan и valsartan. They differ considerably from one another in terms of their pharmacokinetic and pharmacodynamic properties.

Telmisartan has the longest half-life (approximately 24 hours) and the highest affinity to the type I receptors of angiotensin (AT) II. Furthermore, its lipophilicity is higher compared to the other ARB, which implies a larger volume of distribution and a better penetration into tissues.

An additional effect of telmisartan is its function as a partial agonist of the peroxisome proliferator activated receptor gamma, leading to an advantage of the drug in patients with insulin resistance and impaired glucose regulation (DT2) in association with hypertension.

The specified characteristics of telmisartan are expressed in several clinical advantages (e.g., long-term control of arterial insufficiency – BP and cardiovascular protection), which makes the medication particularly suitable for the treatment of hypertensive patients with DT2.

VIVALDI (VALsartan in hypertensive type II Diabetic patients with overt nephropathy) provides the same degree of Nephroprotection as telmisartan and valsartan in diabetic patients with overt nephropathy, while in the same patient category the ability of telmisartan to reduce proteinuria is higher than that of losartan, despite the similar reduction in the values of BP with both medications.

Telmisartan has proved its efficiency in the absence of hypertension. The study ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) covers 25 620 patients with vascular disease or DT2 and evidence of organ damage that were randomized for treatment with telmisartan, ramipril, or a combination of both medications.

ONTARGET shows that both RAAS blockers are equally effective in influencing the primary endpoint (the combination of cardiovascular death, myocardial infarction, stroke and hospitalization for heart failure), but telmisartan is better tolerated.

Based on the results of ONTARGET, telmisartan is the only ARB with an indication for the prevention of cardiovascular disease regardless of the values of BP, including in patients with DT2 with renal impairment.

Tchaikapharma High Quality Medicines Inc. produces telmisartan under the trade Telsart.

Telsart is in the NHIF list with the following code and price:
Telsart 80 mg x 28 tabl. – CG201
Free sale price – BGN 5.64
Reimbursement – BGN 2.64
Additional payment by the patient – BGN 3.00

Telsart has the lowest price compared to all other competitors on the market – the additional payment under the NHIF is only BGN 3. For other telmisartans the patient has to pay between BGN5.15 and BGN 8.25. Estimated on the number of tablets Telsart again has the lowest price – BGN 0.11 per tablet.

For more information see here:
Telsart

The rating system for assessing of the employers is part of a joint project of the CITUB and the Bulgarian Industrial Association.

Tchaikapharma High Quality medicines Inc. is rated second in one of the most competitive and rapidly growing sectors of the economy – production of medicines. The selection of the companies is based on key economic indicators of the large and medium-sized Bulgarian enterprises – investment and technical conditions, finance, human capital and work climate, corporate social responsibility.

The ranking aims to create an objective public rating and to present to the public, on an annual basis, the leading businesses – those which care for their own development and for their human capital. At the same time the investors and the partners will receive information on the annual turnover, profit and introduction of innovations.

The interview with the Executive Director of the company Mr. Biser Georgiev you can find here.

Рейтингова система

Decades long drought in antibiotic discovery could be over after the announcement of the American scientists which can change the future of these drugs.

The researchers from the Northeastern University in Boston have developed a method for growing bacteria which yielded 25 new antibiotic, and one of them, teixobactin, is “very promising” to combat the so-called superinfections, resistant to existing antibiotics.

The study, in the journal Nature, has been described as a “game-changer” and experts, quoted by the BBC, believe this to be just a small portion of the potential of the new method.

They turned to the source of nearly all antibiotics – soil. Because 99% of the bacteria for antibiotics cannot be grown in the laboratory, they invented a method this to be done in soil in controlled conditions.  The initial data suggests that the teixobactin kills a broad spectrum of microbes resistant to antibiotics by blocking their ability to build cell walls, and thus to develop protection.

Trials on mice show that Staphylococcus aureus and Streptococcus pneumoniae infections, causing life-threatening infections of the blood and lungs, are quickly liquidated. There is also effect against the enterococci, which can cause infections of the heart, prostate, urinary tract and the abdominal cavity.

The vast majority of the discoveries of antibiotic were made in the 50s and 60s and nothing developed after 1987 has reached the doctors. At the same time the microbes become more and more resistant and we have a serious problem with tuberculosis, which is not affected by any of the known means.

Sir Alexander Fleming, who discovered penicillin, warned of the dangers of resistance back in his Nobel prize speech in 1945. Then the massive prescription of antibiotics by the doctors contributed to the problem.

The World Health Organization warned last year that the world probably enters the “Age after antibiotics”.  British experts indicated in December that in the next 20 years, more people will die from infections after surgery, and the infections from antibiotic-resistant germs and bacteria will cost the world economy up to USD 100 billion in 2050.

2014 is yet another year lost for the Health reform

The intentions for changes in health care are serious, stated Minister Petar Moskov

The shadow of the health reform began to appear on the threshold of the new 2015. Obviously discussions on serious reforms have a slow start and this was evident in the last days of the calendar year when the Minister of Health Petar Moskov presented his vision for reforming the sector. A series of legislative measures are expected before April 2015.

What happened in the health sector in 2014?

The year was marked by two updates of the National Health Insurance Fund (NHIF) budget, scandal emergency crisis with baby vaccines and as a whole – year zero for reforms.

The big dispute about the money of the NHIF this year went through two updates. First in the middle of the year, and second – in the end of it. In August, the Fund’s budget was increased by BGN 225 million, and in November – with another BGN 100 million. So this year’s budget of the health care was mended after many comments for and against providing extra money.

The impotence of the authorities to rein the finances of the health care was demonstrated by the raging summer scandal in emergency aid. In the midst of the scandal with the Metropolitan Emergency different positions and suggestions were heard on what should be done so that the system can function normally. The problems of emergency physicians in the capital were demonstrated by protests that exceeded the limits of Sofia and proved the national scale of the problem. It comes to wages of workers in emergency centers, working conditions, lack of people wishing to pursue this profession, insufficient number of teams, ineffective spending, and bad management. Problems which are not new, but remained for the next year.

Another case – the lack of certain vaccines for babies drove doctors and patients up the wall in the autumn. In late September, doctors warned that the 5-valent vaccine, with which all babies born after 1 June this year should be immunized, is missing. Solving this crisis marked the brief quarterly management of the provisional Minister of Health Miroslav Nenkov who resorted to placing public procurement of 6-valent vaccine through negotiation without announcement. After the crisis found a favorable outcome, the Ministry of Health prepared a framework agreement for the supply of vaccines for the next three years. The Agreement provides the producer, who won the contract to provide vaccines for the next three years, not for one year only.

The parallel export of medicines was restricted. Parallel exports of medicinal products subject to medical prescription will be made after notification to the Bulgarian Drug Agency (BDA) and the Director of the Agency will be able to refuse with a reasoned order as long as it is established that the product is in limited amounts in Bulgaria.

The “Moskov’s” reform

By April 2015 the proposals for legislative changes in the health insurance model should be drawn up, and it is expected three health packages for medical care to be introduced – basic, upgraded and emergency. This is set in “Moskov’s reform. According to the experts, the idea actually is a proposal for a complete change of the health insurance model, which is expected to provoke serious discussions. Such as the discussions on the restructuring of health insurance – it should be specified what part of the installment will cover the basic package and what – the upgraded package.

A clear definition of the basic package of services covered by the Health Insurance Fund is expected, i.e. the treatment of the most common diseases that lead to the greatest mortality in the country. According to the intentions of the Health Minister the additional package will cover non emergencies conditions or socially significant diseases, it will give the opportunity for additional payments, for this second pillar insured will be able to choose between installments to the Health Insurance Fund or private funds.

The third, so-called emergency health package actually means developing clear criteria for emergency – something the emergency physicians have long demanded. Clearly regulated criteria for dividing the real emergency patients from those seeking ambulance for everything are expected. Persons without health insurance can use this particular package of services, and the insured persons will have the basic package so that each insured person will be treated for all diseases. The Ministry of Health is expected to define the criteria for emergency and to clarify the question of who pays for the medical service received if the patient does not meet the noted criteria.

The case of people without health insurance, about two million, is about to get a partial solution. Raising the fee for recovery of health care rights, as a way to curb the possibility for easy entry and exit from the health insurance system is proposed. Currently the reentry in the system of one uninsured is about BGN 600. The proposal is the restoration of the health care rights to be BGN 2000.

There will be changes in medicinal policy. The introduction of centralized negotiations of various discounts on medicines by the Health Insurance Fund is prepared. The idea provides that the Fund will not pay for the medicines if the manufacturer does not provide a discount.

Moskov wants the supervision of the NHIF to determine the list of medicines which will be covered by the Fund with public funds.

The introduction of a mechanism for health technology assessment in the application of medicinal products is proposed. When assessment proves the lack of effectiveness in the implementation of a certain drug, the amounts paid by Heath Insurance Funds for it will be refunded to the budget of the Health Insurance Fund.

The changes provide for gradual increase in the contribution from the state for groups provided by it in increments of 5%, and it will start in 2016. The termination of a contract with medical service provider is stipulated, if systematic dissatisfaction of patients is observed, and the termination of a contract in the event that the quality requirements are violated.

Will these measures solve the problem with the draining of the NHIF and will they close the holes in the fund so as to achieve a balance in the system, these are the questions we expect to get an answer to in the new 2015.

The NHIF will pay 100% the covered medicines not to the pharmacies but to the producer
The general practitioners, who treat patients in remote areas of Bulgaria, will be allowed to sell medicinal products to patients – irrespective of whether the medicines are prescription or not.

This is foreseen in the amendments that the parliamentary health committee will begin to consider, announced its chairman Gen. Stoyan Tonev. The idea is the planned reforms in medicinal policy to take effect from April.

Currently many Rhodopean villages or areas in northwestern and northeastern Bulgaria have no pharmacies for tens of kilometers, so patients manage as they can – either someone goes to the city and fulfills the prescriptions for the sick or each seeks relatives and neighbors for help. “Since many years in Switzerland the general practitioners sell medicines” said General Tonev. And from the NHIF reminded that in Germany this practice was introduces in the eighties of the last century.

The remote GPs practices here are around 400, and in some cases the family doctor is responsible for 400 people, in other – for 800 or more. That is, the change in legislature will relieve hundreds of thousands of sick Bulgarians who live in the mountains, at the borders or in the hamlets far from pharmacies.

“With a new text in the Law on Health Insurance we consider to return back the model in place until 2008, according to which health fund paid 100% of covered medicines not to pharmacies, as it is now, but to their manufacturers or distributors”, said General Tonev.

He explained that the idea is, skipping the surplus charges, the NHIF to realize at least 7-12% savings on the annual amount for medicines, and in the best case – 25%. This year, the Health Insurance Fund will provide nearly BGN 720 million for medicines for home treatment and for cancer medicines. That is, if the amendment becomes fact, the Fund will pay between BGN 50.5 million and BGN 180 million less for entirely free medicines. We are talking about 217 medicines from over 2000 which are in the positive list.

About half a million Bulgarians receive through protocol completely covered medicines which are mainly for treatment of cancer, blood diseases, rare diseases, diabetes, multiple sclerosis and others. “The patients will still get their medicines from the pharmacies and if they refuse to provide the expensive therapy because the NHIF will not pay them, then they may be refused a contract with the fund”, said also General Tonev.

According to the distributors, however, the idea is difficult for realization; many questions and problems arise and a lot of legislative changes are required. For example, how, if the Fund does not pay the pharmacy, the distributor will deliver the medicine without invoicing it, which is a violation of the tax laws, or how the Fund will know to which provider to pay (i.e. a serious reporting and electronic system is required).

Pharmacists challenged the idea: Everyone should work what he/she studied

If the changes become a reality, there is no guarantee that the free medicines will reach the pharmacies. The reason is that the distributors will have interest to deliver them to all pharmacies, as the Fund pays for every delivered 100% covered medicine. Secondly – if the distributor does not have money or has not concluded a contract with the manufacturer of a certain product, the distributor also may not make the delivery. At the moment the Ordinance allows doctors to sell medicines, provided they have RHIF permission. The medicines that are provided by them may be prescription or non-prescription, but without those covered by the Health Insurance Fund, the pharmacists clarified.