The VED list commission: lessons from April and 22 candidates for August

Russia's Vital and Essential Drugs (VED) list for 2026 was approved by Government Directive No. 3867-r of 18 December 2025 and has been in force since 24 February 2026: 827 items, eight new INNs (including capivasertib, camrelizumab, darolutamide, lorlatinib, luspatercept, pretomanid, pegfilgrastim and goflikicept), with twenty items removed. Work on the next cycle is already under way: the Ministry of Health commission responsible for the drug lists met on 28 April, with the next session scheduled for August 2026.

February and April: three approvals out of ten

The 2026 cycle opened with the February session: of two applications, the commission backed only the budesonide + salbutamol combination (Airsupra, AstraZeneca) for the relief of asthma attacks and, for the third time, rejected trastuzumab deruxtecan (Enhertu, AstraZeneca) in breast cancer - citing the absence of the product from approved clinical guidelines and budget-impact risks.

On 28 April the commission reviewed eight VED applications (one of them, mosunetuzumab from Roche, was withdrawn by the applicant before the session) and one application to add lonoctocog alfa to the 14 High-Cost Nosologies programme. Of the applications put to a vote, two were supported: sonidegib (locally advanced basal cell carcinoma, Sun Pharma) and pazufloxacin (an antibiotic, AlPharma). Asciminib, epcoritamab, tremelimumab, finerenone and pegunigalsidase alfa were rejected. The lonoctocog alfa motion was dismissed on procedural grounds: the product is not on the VED list, which is a mandatory precondition for the 14 High-Cost Nosologies programme.

Economics decides - but not always

The voting details are telling. Sonidegib passed comfortably (17 in favour, 2 against) with the backing of the Ministry's chief oncology specialists. Economics was decisive: Sun Pharma cut the price to RUB 170,000 per pack, bringing the annual course (around RUB 2.1 million) roughly 2% below the generic vismodegib made by Promomed. Pazufloxacin passed by the narrowest of margins (10 to 9) after the applicant committed to cutting the price to RUB 580 and RUB 348 per pack depending on strength.

Finerenone (Bayer), by contrast, is the reverse case and key to understanding the commission's logic. The vote against inclusion was unanimous - but price was not the issue: Bayer offered RUB 2,406, some 40% below the lowest price in reference countries. In parallel the company had filed for a new, not-yet-registered indication - chronic heart failure with an ejection fraction above 40% - which would widen the potential population from roughly 80,000 to 500,000-700,000 patients. The commission held that an unregistered indication could not be assessed within the current application. It turned down Bayer's request to be fast-tracked onto the August session and advised the company to register the new indication first (registration was expected around July-August 2026) and then file afresh, aiming at the commission's next quarterly session in November 2026. In other words, this is not an automatic re-review of the April rejection but a new application on a new indication.

August: 22 candidates - but not a decision yet

Following the documentary review of second-quarter applications, the Ministry tabled 22 medicines for the August session. Ten are classified within the oncology block (trifluridine + tipiracil, encorafenib, binimetinib, trastuzumab deruxtecan, teclistamab, datopotamab deruxtecan, sotorasib, plus ravulizumab, belumosudil and iptacopan - the latter used primarily in rare blood disorders); three diabetes treatments (ertugliflozin, luseogliflozin, verenafusp alfa); three HIV medicines (rilpivirine, cabotegravir, fostemsavir); one hepatitis drug (ravidasvir); the triple combination for cystic fibrosis (ivacaftor + tezacaftor + elexacaftor and ivacaftor); as well as dantrolene and an opioid-peptide analgesic. The repeat review of mosunetuzumab has also been moved to August.

An important caveat: these 22 are the outcome of the documentary review stage (a check on the completeness and accuracy of the dossier), not a preliminary approval on the merits. The commission will take its final decision only after a full clinical and economic assessment - clinical efficacy, pharmacoeconomics and budget impact. Judging by the February and April statistics, only a fraction of this list will reach the VED list.

What this means for applicants

The pattern across recent sessions is consistent: only a minority of applications pass - three of the ten dossiers reviewed in February and April 2026 were supported. Several factors prove decisive. First, the quality of the pharmacoeconomic case and budget-impact analysis: the commission consistently rejects dossiers where the additional burden is not offset by clinical value. Second, readiness to make concrete pricing commitments fixed during the session (this is exactly how sonidegib and pazufloxacin passed). Third, certainty of registration status and indication: the finerenone case shows that even a strong price offer will not save an application whose key argument rests on a not-yet-registered indication. Fourth, procedural discipline: lonoctocog alfa was not heard because the sequence was not respected (VED list first, then the 14 High-Cost Nosologies programme).

Resubmission is a normal part of the process: a significant share of medicines are included on the second or third attempt (trastuzumab deruxtecan had been rejected three times by February 2026). Each new application requires updated data and, as a rule, a revised economic offer. Companies whose products did not pass would do well to study the session minutes and plan their next application around the objections raised.

Sources

Government Directive No. 3867-r of 18 December 2025; minutes and materials of the Ministry of Health commission sessions of 10 February 2026 and 28 April 2026; documentary review results for Q2 2026 applications (Russian Ministry of Health). Details of the sessions and pricing offers are drawn from reporting by Kommersant, Vademecum, GxP News, Pharmvestnik, healtheconomics.ru, Katren-Style and PharmZnanie. The primary source for the composition of applications and decisions is the commission's minutes.