Nine Drugs Nominated for Russia's Vital Medicines List

Russia's Ministry of Health commission has recommended adding nine new medicines to the list of vital and essential drugs (ЖНВЛП), a register whose contents the government directly procures and price-controls. The decisions followed meetings on 5 and 7 August and now require cabinet approval before the expanded list can take effect.

Only four of the nine drugs are produced at Russian facilities, according to the state drug registry. The recommendations include mosunetuzumab (Roche) for lymphoma, belumosudil (Sanofi) for post-transplant complications, the Russian-made dantrolene (OncoTarget) for anaesthesia-related genetic reactions, and ertugliflozin, a diabetes drug previously on the list but removed after MSD’s exit from Russia. Ertugliflozin is now manufactured locally by Life Sciences OHFK using an Indian active ingredient. Also nominated were trastuzumab deruxtecan (AstraZeneca) for breast cancer—after three earlier rejections over budget impact—and a pair of melanoma drugs from Pierre Fabre (encorafenib and binimetinib). Two Russian drugs, ravidasvir (Himrar Pharma) for hepatitis C and verenafusp alfa (Generium) for Hunter syndrome, complete the set.

Patient groups played a role: the 'Oreol zhizni' organization wrote to Deputy Prime Minister Tatiana Golikova in July supporting the AstraZeneca cancer therapy’s inclusion, and the All-Russian Union of Patients expects a government decree by November 2026, with drugs available from early 2027.

Implications for Pharma and Patients

Winners and losers on the list

For the five foreign producers, a place on ЖНВЛП is a major commercial prize. State procurement for hospitals and subsidised patients provides guaranteed demand and visibility, as Pharmedu CEO Tatiana Khodanovich noted. Roche, Sanofi, AstraZeneca and Pierre Fabre stand to gain access to a large, predictable market. Russian firms Generium, Himrar Pharma and OncoTarget also benefit from listing their innovative therapies, while Life Sciences OHFK’s ertugliflozin restores a diabetes option that had disappeared when MSD left.

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The losers are patients waiting for treatments that remain excluded. The commission again declined to include the ivacaftor/elexacaftor/tezacaftor combination for cystic fibrosis, citing missing GMP certification. Khodanovich argues that the system needs faster tools to resolve such technical hurdles so that patients do not wait years.

A precedent for targeted indications

AstraZeneca’s trastuzumab deruxtecan was recommended 'for a specific indication'—a first for a new drug, according to the company’s Maxim Khimich. Previously, the list typically accepted drugs without narrowing their use. This shift could open the door for other high-cost therapies that the budget could not previously accommodate broadly.

The economics of the list

RNC Pharma development director Nikolay Bespalov cautions that the list-based approach is a compromise between fiscal constraints and clinical need. While 81% of the existing 827-drug list is produced in Russia under full cycle, the new additions underscore continued reliance on imported innovation for complex conditions. Bespalov believes that insurance-based reimbursement models will eventually have to replace the current system, which he says raises transparency and efficiency concerns.

What Comes Next for Stakeholders

  • For the government: The cabinet must now decide whether to adopt the commission’s recommendations. The expected decree in November 2026 will set pricing ceilings and procurement volumes for 2027, directly impacting budget planning.
  • For pharmaceutical companies: Manufacturers of the nine recommended drugs should prepare for launch into the state procurement system, ensuring supply chains, local packaging if required, and GMP compliance. Firms that were rejected, particularly the cystic fibrosis combination maker, may need to address technical deficiencies and reapply.
  • For hospitals and pharmacies: The list update will alter formularies and inventory planning. Hospitals treating breast cancer, melanoma and hepatitis C should monitor the final decree to align treatment protocols with newly state-funded options.
  • For patients and patient groups: If approved, patients with the covered conditions could access the medicines free of charge or at regulated, lower prices from early 2027. Advocacy groups may need to press for swift implementation and ensure regional health systems have budget allocations.

Risk & Opportunity Assessment

Commercial RiskMediumFor the recommended drugs, the main risk is that the government does not finalise the decree in time or limits the budget allocation, delaying access and revenue. Domestic producers face lower risk because four of the nine are already locally made.
Competitive RiskMediumInclusion of foreign oncology and rare-disease drugs intensifies competition for state procurement funds, potentially squeezing out domestic alternatives that are not on the list. Russian firms without a place on the list may see their market share constrained.
Regulatory RiskLowThe ministry commission’s recommendations are usually followed by cabinet approval. The main regulatory uncertainty is whether budget concerns could lead to last-minute exclusions, as occurred with AstraZeneca’s three earlier rejections.
Reputation RiskLowFor manufacturers, a refusal to include a drug despite patient lobbying can trigger negative publicity, as seen with the cystic fibrosis combination. However, the reputational impact is limited to specific patient communities and does not threaten broader brand value.
Technology DisruptionLowNo disruptive technology is introduced. The drugs are novel but fit within existing therapeutic classes and procurement systems.
Commercial OpportunityHighFor the nine drugs, ЖНВЛП inclusion guarantees a state-backed market with predictable demand, often for several years. Foreign producers entering the Russian state market gain a foothold they previously lacked, while domestic players secure public reimbursement for their innovations.