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Immunotherapy is one of the experimental methods for tumor treatment. This approach is based on the understanding that a key to the origins, development and outcome of malignant neoplasms is the immune system. In this line of thought, if the functional status of the latter is fortified in the right way, it is likely that it is activated to such an extent that it would control the tumor process.

There are 4 types of antitumor immunotherapy. The first type is called active non-specific immunotherapy. It refers to substances of natural or synthetic origins. They are introduced into the bloodstream and cause the global activation of all immune system components, including those responsible for antitumor protection.

For example, it was shown that the components of the BCG vaccine can activate anti-tumor white blood cells. This effect is used in the experimental treatment of carcinoma of the bladder and of malignant melanoma. The vaccine is injected into tumor masses and directed the activated the immune cells to the neoplastic process. In some patients, however, the effect is contrary to the desired one. This explains why the considered type of immunotherapy has not been a uniform way for treating these tumors.

Another interesting example of non-specific active immunotherapy is the use of viruses for the experimental treatment of certain tumors. The Duke University, USA, has conducted a clinical study in which the cells of malignant brain tumor – glioblastoma, were infected with a modified embodiment of the polio virus. In statistically significant percentage of cases, this lead to both the direct death of the infected tumor cells and the activation of the immune system which fiercely attacked them.

The second type of anti-tumor immunotherapy is active specific immunotherapy. It is implemented through a variety of vaccines containing molecules found in tumor cells. This means that immunotherapy is directed towards this tumor and does not activate the entire immune system, but only the part of it that is responsible for anti-tumor protection. This is the most intensive form of developing immunotherapy and high hopes have been laid on it.

Interesting forms of this type of immunotherapy are DNA vaccines. Through them the tumor cells are inserted in the so called plasmids that make the cells more visible to the immune system. Vaccines with the so called dendritic cells which are pre-activated tumor killers are also being developed.

The third type of anti-tumor immunotherapy is passive humoral immunotherapy. It consists in introducing specific anti-tumor antibodies in the organism. The latter are fastened to the surface of tumor cells and thus direct the immune system thereto. A serious problem here is the significant antigenic variability of malignant tumors. Therefore, in some cases, the antibodies appear to be “outdated” and are not taken where needed.

The last type is gene immunotherapy. This is the most original and highest form of experimental treatment. The idea of this therapy is to achieve the genetic apparatus of the specific tumor and, figuratively speaking, to suppress the “bad” genes, and stimulate the “good” ones. Gene therapy carries risks for normal cells. Therefore it is subject to strict control.

In conclusion, we can say that science is continuously evolving and perhaps every day it takes a step forward towards improvement. The numerous experimental studies in the field of immunotherapy are an embodiment of this statement. Some forms of immunotherapy give encouraging results. Being still an experimental treatment, however, immunotherapy is the last line of treatment in oncology.

The system also allows performing Regional Professionals Search

The new register of the Bulgarian Medical Association (BMA), which allows any citizen to obtain information about a specific physician, was presented to the Healthcare Commission in the National Assembly last Thursday.
The database with public access will allow patients to see where a doctor works, the doctor’s specialty, to get his/her contact information, and to see the location of his/her workplace on the map. The system also enables to perform Regional Professionals Search.

Dr. Julian Yordanov from the BMA said that the register was part of an overall system that turned the BMA into a Medical Chamber with basic functions such as continuing medical education and professional development, which were set out in the European directives.
Each physician will be able to monitor what is posted on his/her profile and when there are inaccuracies, they can be edited. The BMA stated that the information in the register was maintained and updated by the administration of regional collegia, so doctors should turn to them for changes in their status.

Through the system the BMA Accreditation Council will monitor the credits acquired by a doctor participating in conferences and seminars. The database in turn is linked with the European Professional Card for doctors allowing the free movement of physicians in the EU. It has required elements and a chip. So, when a doctor goes to an EU country, he/she will be easily recognized, which would free him/her from the inconvenience to carry a pile of papers along. The BMA registers can be entered directly through the new document. The Accreditation Council has to establish rules for good medical practice by specialty. They will be defending the physicians and if it comes to appeal, they will serve as a criterion whether the doctor has done his/her job well.

It is foreseen that in future the functions of the registers will increase. One of the functions will be the data availability to be used when entering into contracts with the Health Insurance Fund. “Doctors will be able to issue membership certificates. Currently in the months of January and February there formed huge queues at the collegia to issue such certificates. In the future they will be able to print them and they will have a unique code, to be assigned to the NHIF.

Technically this is ready, but there are some problems. One of them is that the Fund has to recognize the legitimacy of these certificates,” explained experts from the BMA.

The NHIF has offered the BMA to begin negotiations to reduce clinical pathway prices. The BMA immediately replied that they disagreed, and instead wanted an update of the NHIF budget by BGN 150 million.

Obviously, the NHIF is facing increasing pressure to pay more than they have. The problem has become more severe over time and a budget revision will be inevitable. The proposed mechanical reduction of pathway prices by a certain percentage is not a good solution.

Instead of figuring out on the calculators how many BGN they can save from each pathway, the NHIF and the BMA can achieve much more in their negotiations. Here are some ideas:

It has long been time for a significant part of the clinical pathways to be transferred to outpatient care. For example, all pathways providing same day surgery, diagnostic and therapeutic pathways that do not necessarily require hospitalization, skin disease pathways ENT, eye care, etc. The National Framework Agreement has now provided 5 pathways for outpatient care, and the analysis shows that their number could increase to 100. If they are implemented in outpatient care, their prices can be reduced and this would not be unfair as the costs would be less.

Another thing the BMA and the NHIF could agree upon is the introduction of price indices in pathways. It makes a difference whether a 25-year-old in his/her prime is treated or an 80 years old patient. It is logical that the costs of treating an elderly person would be higher; therefore, introducing an age factor patient index would be fair. The same applies to the presence or absence of chronic concomitant diseases. Obviously, for the sick person who has received abdominal surgery and has concomitant diabetes there would be more expenses than if there were no diabetes. Therefore, it is only fair to introduce indices in terms of the presence or absence of serious chronic diseases.

The third thing the NHIF and the BMA could negotiate is to allow outsourcing for the clinical pathway activities – their execution by external contractors. These may include laboratory and imaging tests, pathology, etc. This would allow hospitals to avoid unnecessary costs for personnel and equipment, and hence would reduce the pressure for hospital admissions at any cost.

The next thing the NHIF could accomplish even on its own is to review its reimbursement list. Minimum reimbursement for home treatment medicines is proportional to maximum hospitalization. The NHIF should increase the reimbursement of these medicines, particularly antibiotics, and this way it would reduce the “interest” of patients in being hospitalized. The same applies to some difficult tests as CAT, EMG, MRI, EEG, etc. Facilitating the access to them would be cheaper than paying for the same via clinical pathways.

Finally, clinical pathway prices are certainly not inviolable. We do not need a very thorough analysis to see that there are both under evaluated (in most cases) and overpriced pathways. Therefore, individual pathway price negotiations should not be excluded a priori.

Reaching an agreement on these issues is fully achievable trough negotiations, and there is hardly a better time than the present.
This means that the NHIF and the BMA should start negotiations for a National Framework Agreement Annex, as opposed to negotiations under Article 12 of the contract. Such negotiations did not have to not be postponed till the 1^st of June. They could have begun immediately.

The manager of the Health Fund Dr. Glinka Komitov had predicted that “based on the current performance towards the end of April, we could expect a deficit in the Health Insurance Fund budget at the end of 2015.” According to the NHIF representative, the deficit is formed by medicines and hospital care, so therefore the efforts should be directed primarily at reducing precisely these cost elements. The Fund expects the shortages of medicines for home treatment in the country, of medical devices and dietary foods for special medical purposes to be BGN 108-109 million.  The shortage for cancer medicines as of the 30^th of April was BGN 59 million, and for hospital care – about BGN 125 million or in total sum – BGN 292 million. Since there is a reserve of BGN 93 million, however, the shortage would be about BGN 200 million. Dr. Komitov explained that this year the base has been lower for the three items and hence the implementation of the budget has been higher than last year.

In connection with these forecasts, Minister Moskov announced that there will not be a deficit of BGN 200 million in the NHIF budget at the end of the year. He added, however, that if there were no changes made to the healthcare system and it continued to function like before, the deficit may be even larger than BGN 200 million. The Minister noted that at present the public spending on healthcare was BGN 4 billion, but BGN 1 billion were not spent as intended. From his words it became clear that there was resistance from the sphere in question where that one billion was spent. “This is a noisy billion. You know, it can produce a media wave, it can make noise, it can create stress in humans,” he said.

Dr. Moskov also announced that the good intentions for changes were being used before the elections to arouse fears and concerns among people and for political purposes. When asked whether there were contradictions within the coalition regarding his actions he replied that there was a majority behind the management program of the government. According to him, for there to be a change to the situation in the country, the parliament majority has to support the changes. “The conversation takes place inside the coalition, topics are being discussed, better solutions are being considered, and behaviors towards the parliamentary forces that oppose the government are deliberated upon. In other words, this is a conversation within the coalition, within the partnership, which forms the government support. There is no big drama,” he added.

Among the reforms lying ahead, Dr. Moskov indicated the breaking up of the health insurance package into primary and secondary. He noted that one of the main directions of the change was the emergency assistance reform, where there was a 4-year plan for its restructuring. After that he pointed out the structural reform and change in the method of funding where the idea was not to pay for structures, but for treatment: “Because the way of payment will propel hospitals to merge. Because the way of payment will fund the treatment, the outcome, and the complexity, but not who, where and why created the hospital or something else,” said the Minister. He announced that part of this restructuring was the national health card, which would make apparent that one cannot open a new hospital where there were already enough of them. “If you want to invest in hospital infrastructure, then go where there are no hospitals, because there are whole areas in the country where the access to people like you and me in Sofia, is impossible for these people – whether in Deliorman, whether in the Rhodopes, whether somewhere else. And this is state policy – where to direct investment, where to promote investments,” the minister added. He also noted that part of the reform was to improve the control and cost effectiveness. In his words, this was related to e-health.

Dr. Moskov said that the planned hospital and dispensary mergers were part of the transition from structure financing to paying for the treatment. He once again explained that at that time many hospitals did not offer comprehensive treatment and the patient was forced to go back and forth from one place to another.

The Health Minister pointed out that in order for such circling around not to happen, patients should be offered complex treatment. He added that the NHIF would conclude a contract only with those hospitals which offer such comprehensive services. “Starting next year the NHIF will enter into contracts with hospital or hospital groups which can provide one’s full treatment for the major diseases in the basic package. Whether their choice will be to merge, – and this will become clear through the mechanisms of the compulsory health card – to join together in a  functional union or to make a consortium, this will be recorded for each city and for each individual case,” said Moskov. He emphasized that this is done both – in the interest of patients and in the interest of doctors.

The Council of Ministers has lodged an appeal against the ruling of the Supreme Administrative Court for the suspension of the validity of Articles from Decree № 57 of the Council of Ministers, reported the Center for the Protection of Health Rights. On the 13th of May, the SAC ruled that it is suspending several texts from the Decree relating to the limits imposed on hospital budgets, until a conclusion of the proceedings with regard to the case of an effective judicial act is reached.

The court motives are as follows:

“In this case, the contested in the appeal provisions of Annex № 2B from Decree № 57 / 03.16.2015 of the Council of Ministers, limit the possibility to receive payment in full for the work done when providing hospital care.

Due to the obligation of contractors under Article 59 of the Health Insurance Act to provide medical assistance to insured persons, as guaranteed by the provisions of Articles 81 and 85 of the Health Act, and the setting of limits to the preliminary business expenses of hospitals, could lead to a restriction of their activities. Determining the sums for hospital care within the NHIF budget would lead to the non-payment of certain activities carried out by medical institutions, and to property damages for them.

Since the contested provisions would hinder or delay the delivery of medical care, it is likely that this would inflict substantial and irreparable harm to patients. Applicants rightly cited as reasons that the limiting of healthcare activities would limit patients’ rights to benefit from their preferred medical institution inpatient care.

In the light of the facts outlined above, the request for the suspension of the contested secondary legislative normative act provisions is legitimate until a final resolution of the legality of this issue through a court order becomes effective.”

The reasons for which the Council of Ministers  has appealed the decision of the SAC have not yet been announced, so at the moment it is not clear with which of the arguments of the Court the government did not agree, commented from the Center for the Protection of Health Rights.