Deyan Denev: Stopping life-saving therapies in 2018

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Deyan Denev: Stopping life-saving therapies in 2018
Deyan Denev: Stopping life-saving therapies in 2018

Many new drug therapies that patients in most European countries receive under the He alth Insurance Fund may remain unavailable to Bulgarians in 2018 as well, warned the Association of Research Pharmaceutical Manufacturers in Bulgaria (ARPharM). The reason is a moratorium on their payment by the National He alth Insurance Fund in 2018, adopted by the Supervisory Board of the NHIF. The decision must also be adopted by the parliament. Among the new therapies that the moratorium will affect, there are those that have already been recommended for payment on the basis of he alth technology assessment and for which discount contracts have been concluded with favorable conditions for the NHIF. This is how the chairman of ARPharM, Deyan Denev, commented on the case.“Doctor”

Mr. Deneuve, which patients will be affected by the moratorium on payment for the new drugs?

- These are patients with oncological, respiratory, some rare diseases and many others. They will not have access to new therapies in 2018, despite the fact that most of them have already been assessed as needed by Bulgarian patients based on the he alth technology assessment and have been recommended for reimbursement by the He alth Fund. For some of the medicines, there are already concluded contracts for discounts with favorable conditions for the Treasury. Therapies are either life-saving or for diseases for which there is currently no treatment, and there are also therapies that are more cost-effective than what the Fund currently pays.

Deyan Denev

Do you think that if there is no moratorium, the NHIF will increase its costs for drugs?

- Certainly, the moratorium will not reduce the cost of drugs. Typically, in the first years of inclusion for reimbursement, new therapies do not generate too much cost. The issue here is to manage the system, to sort out the therapies that are needed by Bulgarian patients from those that are not, based on an assessment of he alth technologies. And then the Treasury can negotiate and achieve the most favorable conditions for Bulgaria. There is such a legal basis. It is only a matter of willingness and competence on the part of the institutions to do so. The introduction of the moratorium means in practice a refusal to manage the system.

The head of the Treasury - Prof. Kamen Plochev, explained the moratorium with the severe shortfall in the budget of the NHIF

- Prof. Plochev's statement sounds very strange against the background of the widely publicized increase in the budget of the Treasury by 400 million BGN. Precisely because the Fund has limited financial resources, the pharmaceutical companies give significant amounts of compensation for the cost of medicines every year. This year it is 130 million BGN. Next year, the Fund itself plans to collect BGN 160 million from drug discounts. If these large discounts cannot help to introduce the new therapies assessed as necessary for Bulgarian patients and approved for use in Europe, then the discounts are meaningless.


Obinutuzumab and Venetoclax to treat chronic lymphocytic leukemia (CLL), a cancer of the blood and bone marrow.

Nintedanib and Pirfenidone to treat idiopathic pulmonary fibrosis, a rare, fatal, progressive lung disease. Currently, the NHIF does not provide treatment.

Blinatumomab for the treatment of acute lymphoblastic leukemia, which is a rare and fatal malignancy.

Tofacitinib for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to or are intolerant to prior treatment.

Palbociclib is the first to receive approval from the European Medicines Agency, a new class of medication for the treatment of hormone-positive metastatic breast cancer.

Carfilzomib in combination with dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma.

Trametinib in combination with dabrafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

Pasireotide LAR for the treatment of adult patients with acromegaly in inoperable adult patients.

Everolimus for the treatment of adult patients with renal angiomyolipoma and for the treatment of subependymal giant cell astrocytomas associated with tuberous sclerosis complex.

Mepolizumab to treat severe asthma.

Osimertinib for the treatment of non-small cell lung cancer.

Elena Georgieva: If we are denied medicine in Bulgaria, we will go abroad

Elena Georgieva lives with chronic lymphocytic leukemia. As a representative of the Bulgarian Lymphoma Association, we asked her to comment on the suspension of access to new drugs in 2018, including for her disease

Ms. Georgieva, what therapies have you been through so far?

- I am the youngest living chronic lymphocytic leukemia patient. I was born in 1980. My disease is characteristic of older people, but the age limit is falling more and more. I was 30 years old when I was diagnosed with the disease. In this case, therapy may not be applied for a maximum period of time. But I found a doctor who hastily put me on the most outdated therapy possible, and that's where my problems started. Instead of suppressing leukemia, we developed it. But then I came across doctors in Hematology in Darvenica district. I've been through all the first line drugs. I have been on a second-line inhibitor for a year now and hope to last a long time on it - 2 to 5 years. They voted that this medicine should be used by a limited number of patients because it is really very expensive.

Are you waiting for the medication that has been suspended by the moratorium of the NHSOC?

- I was at a seminar in Madrid on the occasion of the presentation of the medicine in question. His possibilities are very good, because he can put the patient in complete remission within six months. After all, this medicine is part of the therapy officially accepted in the EU, and we as citizens of a member country should have access to it in our own country. Everyone says that we should not be treated abroad, that therapies are also available in Bulgaria. The medication in question should not be prescribed for mass use, but it needs to be available for severe cases, for young patients like me who do not respond to first-line medications, to standard medications. We, the patients for whom the new drug is suitable, are not so many. But if there is no access to it, the doctors see themselves in a miracle. Then we repeat chemotherapy from the first line of treatment, which in most cases does not give any result. In any case, we are looking for ways to heal ourselves, and if it doesn't happen in Bulgaria, it will happen abroad. However, the he alth fund is still obliged to pay for this treatment.

It turns out that the He alth Insurance Fund will not save money from the moratorium because you will go for treatment abroad?

- Yes. She is obliged to pay not only for the treatment abroad, but also for the old therapies, which cost no less than the new ones. In this way, the NHIF does not save money, but aggravates the he alth condition of patients and limits the doctor's ability to treat adequately, and the money goes to waste.

I have seen the list of new drugs that will not be available starting next year and I am convinced that these are therapies for diseases for which there is no other treatment. They cannot deprive people of these therapies because without them their condition will worsen.

Money is not saved this way. I hope that the new Minister of Economics will understand this as quickly as possible. If I am not adequately treated, my alternative is a transplant, and that costs millions.

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