Russia Moves to Add 19 Medicines to Essential-Drugs List
Russia’s Health Ministry commission will consider adding 19 medicines to the national essential-drugs list, with nine also seeking inclusion in a federally funded high-cost treatment program. The proposals include cystic fibrosis therapies and the first Russian treatment for Hunter syndrome.
Commission to review 19 medicines
Russia is preparing a significant update to its pharmaceutical reimbursement system as a Health Ministry commission considers applications to add 19 medicines to the national list of vital and essential drugs, known as ZhNVLP. Pravda.ru reports that the commission is due to examine the applications in early August. Nine candidates are also seeking admission to the federal program covering 14 high-cost diseases, through which patients receive some of the most expensive therapies at federal budget expense.
Inclusion in the essential-drugs list subjects a medicine to state price controls and creates a framework for stable government procurement. It also allows eligible patients to receive the product free of charge with a prescription. For manufacturers, listing can provide predictable institutional demand, although regulated maximum prices may limit commercial flexibility.
The applications focus partly on severe chronic and rare diseases. Among the medicines attracting attention is the combination of ivacaftor, tezacaftor and elexacaftor for cystic fibrosis, as well as treatments for myeloma. The commission will also discuss verenafusp alfa, marketed as Clotilia, which Pravda.ru describes as the first Russian-developed medicine for Hunter syndrome.
Domestic suppliers replace withdrawn brands
The review comes as Russian pharmaceutical companies seek substitutes for medicines and brands that have left the market. Promomed is registering the Esperansa trademark for a generic version of molnupiravir, used against COVID-19 and acute respiratory viral infections. According to Pravda.ru, the original US medicine stopped being supplied to Russia in 2023.
Clinical pharmacologist Alexey Ryabtsev told the publication that expanding the list with modern medicines, particularly domestically produced products, concerns the security of patients with serious chronic diseases. He said inclusion can help prevent shortages and make therapies accessible through the compulsory medical insurance system.
A separate access decision concerns Smith-Lemli-Opitz syndrome, a rare genetic disorder affecting cholesterol metabolism. The state-funded Circle of Kindness foundation has added the condition to the diseases it supports. Children with the diagnosis will consequently receive cholic acid treatment.
Patents and clinical research shape the market
Intellectual-property disputes continue to influence competition. Russia’s patent authority rejected Geropharm’s challenge against Danish manufacturer Lundbeck’s patent for the antidepressant vortioxetine, sold as Brintellix. Geropharm argued that the medicine’s formula lacked sufficient novelty, but the regulator maintained Lundbeck’s protection, which runs until 2031.
Litigation has also reached the cosmetics segment. Swedish company Beauty Generation is seeking 60 million rubles from Russian company Almea over use of the Xlash eyelash-serum brand. Claims were also filed against Wildberries, Ozon and Megamarket, the major online marketplaces through which the disputed product was sold.
New clinical research may eventually broaden treatment options, although it is separate from the Russian listing applications. Stanford University researchers reported in JAMA Pediatrics that omalizumab produced sustained tolerance to previously dangerous foods in one-third of children with multiple food allergies and appeared safer than traditional oral immunotherapy. The experimental drug pemvidutide also completed a successful phase two trial: patients receiving injections returned to heavy alcohol consumption significantly less often than the placebo group. Both findings remain tied to controlled clinical settings and do not establish unrestricted use.