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Innovative therapy reprograms immune cells and cures blood cancer

New drug regulation, enforced on April, 1st, 2019, will further delay the access of Bulgarian patients to new medicines. This was announced by Deyan Denev, Executive Director of the Association of Research-Based Pharmaceutical Manufacturers (ARPharM) at “Drugs of the Future – Scientific discoveries that will change the world” #WeWontRest In The Name of Life Seminar.


Deyan Denev, Executive Director , ARPharM Bulgaria

Bulgaria is among the slowest countries in Europe to include innovative medicines for reimbursement according to the current regulatory framework. With the latest changes, it becomes even more restrictive, and it is expected that 700-800 days the waiting time will be extended from the average delay of about 550 days now. To apply for a new drug, the manufacturer must provide a positive health technology assessment from at least one country among Sweden, UK, France and Germany. A new requirement is that the medicine is already paid by the largest public health insurance fund in 5 out of 17 European countries. The condition has so far been to be publicly funded in 5 out of 27 countries. “This means that if the drug is paid by a specialized fund in some of these countries, it will not be in our country,” Denev explained.


Another new condition is that the National Council on Prices and Reimbursement of Medicinal Products to approve the new medicine by  September, 30th, each year. Medicines beyond this deadline wait for the next year. This year for approval stay new drugs for 7 serious illnesses, including epilepsy. In 2018, pharmaceutical companies had paid around 160 million BGN to NHIF, which means that every 9th or 10th patient is treated with that money, Deyan Denev said. The new regulation introduces another payment for the industry – companies have to reimburse the costs of medicines over the budget. It is expected that the total amount will be about  50 mln BG.

“Companies get a blank check and no one can plan costs. How it should be a sustainable business model and it will probably not survive, it will crack and we will see where”, commented Deyan Denev. “Regulating and assessing effectiveness must undoubtedly have to exist, but poor, inconceivable regulation can lead to complete blockade of new drugs. In 2019, manufacturers have to reimburse all the costs of new medicines to the health care fund”, he added.

Bulgaria spends on medicines as much as other countries in Eastern Europe, Denev said. Total public health expences is about 5 billion BGN, of which about 1.4 billion BGN are for medicines, or 28%. When comparing drug costs, let’s be correct – we have to take into account the VAT that only in our country, Germany and Denmark is in full amount for medicines, in the other countries the rate is lower, said Deyan Denev.

At the same time, technology and science in medicine and pharmacy are developing very rapidly and in the next 5 years there will be a wider introduction of innovative complex therapies for incurable diseases.
One of the most promising new therapies in the world is the CAR-T therapy, which has been applied since 2012 for onco-hematology diseases according to certain medical criteria, said Rossen Dimitrov from Novartis.
It extracts the T-lymphocyte immune cells from the patient’s blood and reprogrammes them to recognize and eliminate the cancer cells, then the blood product is infused back to the patient. The therapy leads to healing, in the world there are already hundreds of cured patients. It is already reimbursed for a number of children in the UK, Deyan Denev said. A technology for the production and application is approved for 2 global companies, and dozens of others are undergoing clinical trials. Some trials target solid tumors.

CAR-T therapy is entirely personalized – the medicinal product is only produced for the particular patient and can not be used for another. Three manufacturing centers are certified in Europe – France, Switzerland and Germany. The other condition is to have prepared clinical centers. It is considered in perspective that such a clinical center should be upgraded in our country.

The new therapies successfully pass the HTA, they are cost-effective, the question is how the patient would have access and by which model, explained Dr. Dimitrov. The health system in our country and globally are not prepared for innovative health technologies, and they are developing extremely fast and the issue of access will become more and more urgent – we have to ask whether Bulgaria will be part of these innovations, he added.

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