News and Media

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.

Prof. Marita Eisenmann predicted that after 10 years the fat grifting method will completely replace breast implants.

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.