New drugs on reimbursement list by late October? – First special agreements in sight

The Central Drug Committee has adopted the list of priority pharmaceutical drugs and suggested to the National Health Insurance Fund to start negotiating with drug marketing permit holders in order to sign special agreements with them on those drugs.

The list of priority drugs includes drugs for pediatric drugs: Bridion, an agent for reversal of neuromuscular blockade following anaesthesia, Tracleer, used in the treatment of pulmonary artery hypertension, for treating chronic pulmonary infection in patients with cystic fibrosis, Hidrasec, for acute diarrhoea in children, Peyona, for treating primary apnea in prematurely born children, Norditropin, Nordilet, Saizen and Genotropin, biosynthetic human growth hormones, Cathagel with Lidocaine, medical lubricant with an anaesthetic, Enbrel, for treating rheumatism, juvenile rheumatism and psoriatic arthritis, and Exjade, for treating haemochromatosis as a result of transfusion.

Of the drugs used in transplantation, the list includes: Valcyte, preventing diseases caused by the cytomegalovirus, Noxafil, which prevents yeast infections in people with a weakened immunity system following chemotherapy or a transplantation, Mycamine, treating invasive candidiasis and other yeast infections, and Mozobil, used in treating patients with non-Hodgkin lymphoma.

Drugs from the NHIF's haematology memo from the first priority group which are waiting to be imported include: Adcetris (HL), used in treating Hodgkin lymphoma, Revlimid, a drug for multiple myeloma, Jakafi, used for polycythemia vera, Revolade, for patients suffering from thrombocythopenia, Nplate, meant for patients suffering from chronic idiopathic thrombocythopenic purpura, and Gazyva, for chronic lymphocytic leukemia.

Cytotoxic and molecular drugs from the first priority list include: Zelboraf, Keytruda and Tafinlar, used in melanoma therapy, skin cancer, Nexavar, used in patients with renal cell carcinoma, Avastin, used for ovarian carcinoma, and Zytiga, Xtandi and Jevtana, used in prostate cancer treatments, after the Docetaxel therapy.

The managing and Supervisory Boards of the NHIF have formed the Committee in order to negotiate with drug marketing permit holders about signing special agreements. The members of the Committee sent two models of special agreements prepared by the working group of the NHIF to potentially interested companies last Tuesday, and invited them to send a proposition for drugs from the priority list within 8 days of the date of the receipt of the memo.

Following the submission of the proposal, the Committee will negotiate the price and conditions of the agreement, and the special agreements will be signed with drug marketing permit holders, based on the opinion of the Central Drug Committee and the consent of the board of directors of the NHIF. The Central Committee will then put the drugs on the reimbursement list, following which they will be put in the market after the Government gives its consent and the publishing of the decision in the Official Gazette.

These drugs, of everything goes smoothly, can be expected to appear in three weeks at the earliest. This is a huge step up for patients, as Serbia has imported, at the expense of the NHIF, only one of around two hundred innovative drugs registered in the EU since 2010, according to the data by INOVIA, the association of the manufacturers of innovative drugs.

Republički fond za zdravstveno osiguranje Beograd

Central Drug Committee

National Health Insurance Fund

NHIF

bridion

tracleer

bramitob

hidrasec

peyona

norditropin

nordilet

saizen

genotropin

cathegel with lidocaine

enbrel

exjade

valcyte

noxafil

mycamine

mozobil

adcetris

revlimid

jakafi

revolade

nplate

gazyva

zelboraf

keytruda

tafinlar

nexavar

avastin

zytiga

xtandi

jevtana

association of the manufacturers of innovative drugs

INOVIA

new drugs on reimbursement list

innovative drugs