The VED list commission in August: 9 of 19, a single-indication precedent and a signal on exclusions

The Russian Ministry of Health commission responsible for the drug lists held its quarterly sessions on 5 and 7 August 2026. Of the 22 medicines that had passed the documentary review of second-quarter applications, 19 reached the agenda - the antiretrovirals rilpivirine and cabotegravir, among others, did not. The outcome: nine INNs recommended for the Vital and Essential Drugs (VED) list, ten rejected. The minutes of both sessions were published by the Ministry on 12 and 14 August; the analysis below is based on that primary source.

Who passed, and on what terms

On 5 August the commission backed four INNs: mosunetuzumab (Roche, relapsed or refractory follicular lymphoma; 20 in favour, 0 against; RUB 16,490.70 per 1 mg pack and RUB 494,730 per 30 mg), belumosudil (Sanofi, chronic graft-versus-host disease; 18 to 1; RUB 598,000 per pack of 30), dantrolene (Oncotarget, malignant hyperthermia under anaesthesia; 19 to 0; RUB 5,500 per vial) and ertugliflozin (Life Sciences OHFK, type 2 diabetes; 19 to 0; RUB 1,090 per pack of 30 x 5 mg). Ertugliflozin is a comeback: the product had been on the list and dropped out after MSD left the Russian market in 2022; it now returns with a localised manufacturer.

On 7 August five more were supported: encorafenib and binimetinib (Pierre Fabre; 19 to 1 each; RUB 53,489 and RUB 7,521 per pack respectively), trastuzumab deruxtecan (AstraZeneca; 18 to 2; RUB 55,000 per 100 mg vial), ravidasvir (ChemRar Pharma, chronic hepatitis C; 20 to 0; RUB 16,000 per pack of 28) and verenafusp alfa (Generium, mucopolysaccharidosis type II - Hunter syndrome; 20 to 0; RUB 67,000 per vial). Verenafusp alfa was also unanimously recommended for the 14 High-Cost Nosologies programme - after the decision had been deferred on 5 August to refine the budget-impact modelling and the applicant lowered its price.

Almost every successful dossier shares one feature: the reduced price is fixed on record in the minutes of the session. The commission continues to decide 'as a package' - clinical value plus a specific pricing commitment.

The precedent: inclusion by a single indication

The headline event was trastuzumab deruxtecan (Enhertu). The commission had rejected the application three times, most recently in February 2026, citing budget-impact risk: the label carries five indications, including HER2-low breast cancer, HER2-mutant non-small cell lung cancer, gastric cancer and other solid tumours. On the fourth attempt the applicant proposed a construction with no prior precedent in the commission's practice: narrowing the registered indications to one - HER2-positive unresectable or metastatic breast cancer after anti-HER2 therapy - and cutting the maximum price to RUB 55,000 per vial.

The minutes set out the terms: the marketing authorisation holder is to file for removal of the four indications by 21 August 2026; the Federal Compulsory Medical Insurance Fund is to monitor prescribing under the remaining indication with quarterly reports to the Ministry; professional medical associations are to work on adding the product to the draft 'Breast cancer' clinical guidelines by 15 September 2026.

For applicants this creates a workable route for expensive products with broad labels: the commission is prepared to discuss the target population if it is legally fixed in the label rather than only in the models. In parallel the Ministry is preparing amendments to the list-formation rules that would allow inclusion by individual indication as a matter of course - it signalled support for the approach back in July. For now the precedent has been achieved by narrowing the label, that is, at the cost of giving up the other indications on the Russian market. Whether that step is reversible - whether indications can be restored after inclusion - is a question worth clarifying before filing.

Who failed, and why it matters

The ten rejections fall into several types. Without a single vote in favour: iptacopan (Novartis), datopotamab deruxtecan (AstraZeneca), sotorasib (Amgen) and the ivacaftor + tezacaftor + elexacaftor and ivacaftor combination; near-unanimously, fostemsavir (1 in favour, 19 against). Closer to passing were teclistamab (6 to 14), lumekefamide (6 to 13), luseogliflozin (7 to 12) and ravulizumab (7 to 11); trifluridine + tipiracil received 4 votes out of 20.

Two cases are particularly telling. Luseogliflozin was rejected not on its own shortcomings but because the competing ertugliflozin was recommended the same day at a lower price: the commission compares candidates against each other within a class. The cystic fibrosis combination illustrates that the price is registered per INN and applies to every product under that INN: the distributor of the generic (MIK, Trilexa made by Tuteur) insisted on RUB 597,000 per pack, while the supplier of the originator (Sanofi) said it could not confirm price registration at that level. The risk of supply disruption for patients already on the originator prevailed, and the commission voted against unanimously. According to Vademecum, the INN had already been rejected in autumn 2025.

An easily missed signal: removals from the list

The same 7 August minutes instruct the Ministry to consider removing 11 INNs from the VED list: cefalexin, streptomycin, calcitriol, benzathine benzylpenicillin, amphotericin B, isoniazid + rifampicin, mitoxantrone, procarbazine, BCG vaccine for bladder cancer, strontium ranelate and thiopental sodium. Deadline: 10 November 2026. Alongside this comes a technical revision of dozens of items in the list and the minimum assortment: removal of dosage forms with no valid marketing authorisation, no market release and no stock, plus corrections to ATC codes and names.

The complaint that 'everything gets added and nothing gets removed' has been heard in the industry for years. The instruction shows the regulator starting to work on the tail of the list as well. For holders of authorisations on long-established molecules, it is a reason to check whether their items meet the removal criteria: no valid authorisation, no release into circulation within a year, or no stock on the market.

What comes next and what it means for applicants

A commission recommendation is not inclusion. The draft Government directive is assembled in the autumn; in the last cycle Directive No. 3867-r was signed on 18 December 2025 and came into force on 24 February 2026. Patient organisations expect the document in November, with the products available from early 2027. The last cycle also offers a reminder: of the 12 INNs in the draft directive, eight made it into the signed document.

The 2026 statistics: of 29 dossiers reviewed by the commission in February, April and August, 12 were supported. The August pass rate (9 of 19) is well above the spring one (3 of 10). Three takeaways for those preparing dossiers for the next filing window (applications for the 2027 list are accepted until 10 October 2026). First: the price offer must be ready for discussion at the session, not after it. Second: for products with broad labels it makes sense to model a 'narrow' inclusion scenario in advance, together with its consequences for the other indications. Third: a candidate's competitors are not only the products already on the list but also the other applications in the same class at the same session.

Sources

Minutes of the Russian Ministry of Health drug-list commission sessions of 5 and 7 August 2026 (minzdrav.gov.ru); Government Directive No. 3867-r of 18 December 2025; Vademecum (28 July, 5 and 7 August 2026); Vedomosti (7 August 2026); Medvestnik and PharmMedProm (5 August 2026); Pharmvestnik (2 July 2026 on inclusion by indication; September 2025 on the draft 2026 list); All-Russian Patients' Union (14 August 2026).