Government Authorizes Inclusion of Just Two New Medicines for Treatment of Sexually Transmitted Diseases in the Official Register
Rewritten Article:
Here's the lowdown on this year's initial meeting of the Ministry of Health commission regarding the inclusion of medicinal products in the List of Vital and Essential Medicines (VEDL) and the High-Cost Nosologies (HCN) program. In a unanimous vote, only two drugs were approved for inclusion in the VEDL, with each case receiving a thumbs-up from all commission members.
Medicines within the VEDL and HCN are state-purchased and provided free of charge to patients when faced with specific diseases. Furthermore, the prices of all VEDL-listed drugs are regulated to prevent manufacturers and pharmacies from fluctuating costs.
The first approved drug is lorlatinib, better known as "Lorviqua" from Pfizer. It is used for treating non-small cell lung cancer and was included in clinical guidelines as a second or third-line medication. The N.N. Blokhin National Medical Research Center of Oncology highlights lorlatinib's exceptional results in targeted therapy, the most advanced form of therapy for oncological diseases.
Even though the prevalence of this type of lung cancer doesn't exceed 5%, there are approximately 200 patients in need. Pfizer currently stores 3,000 packs of the drug, pricing it at around 183,000 rubles per 100 mg dosage. Despite the Ministry of Health requesting a lower price, Pfizer representatives claim that it already offers the most competitive price globally. "Last year, we secured the most favorable price for Russia, considering the needs of our patients in this drug, which is 20% cheaper than our closest competitors and 44% cheaper than the lowest price in Hungary," said a Pfizer rep.
If lorlatinib had been approved a year ago, regions could have saved around 300 million rubles in its procurement, according to the FAS, but it was only approved this year.
The second drug approved is pegcetacoplan, also known as "Empaveli" from Swedish Orphan Biovitrum AB. It is utilized in oncology and hematology for treating paroxysmal nocturnal hemoglobinuria. This drug is included in clinical guidelines as a second or third-line treatment when first-line therapies fail. Like Pfizer, SOBI secured the lowest price for Russia - approximately 106,000 rubles.
Pegcetacoplan was initially considered but not approved last year. The public organization "Movement Against Cancer" then petitioned the government, Ministry of Health, and Accounts Chamber to convene an extraordinary meeting of the commission to discuss the inclusion of this and other breakthrough cancer drugs in the VEDL. In Russia, approximately 50 patients require pegcetacoplan therapy.
Despite the request by "Movement Against Cancer" for additional drugs like trastuzumab deruxtecan ("Enhertu" by AstraZeneca) and asciminib ("Scemblix" by Novartis) to be included in the list of vital drugs, they did not make the cut this time. Trastuzumab deruxtecan is used for breast cancer and small cell lung cancer therapy. AstraZeneca has revealed that around 187 patients are currently using the therapy, but the main issue, according to the Ministry of Health, is that the clinical guidelines are still being developed.
Innovative anticancer drugs like tremelimumab by AstraZeneca and teclistamab by Johnson & Johnson were also not included in the list. They were considered for the first time.
Finally, sarilumab, used in rheumatoid arthritis therapy, and peginterferon alpha-2a were removed from the list of vital and essential drugs. A controversial decision was made regarding the drug faricimab ("Vabysmo" by Roche). Its primary indication is neovascular age-related macular degeneration, a condition that can lead to blindness in patients with diabetes. Although ophthalmologists state its high efficacy in resistant forms of the disease, and although Roche representatives have lowered the price to the lowest in the world (35,000 rubles per pack), the commission still refused to approve it. The main reason for the rejection was the large number of people needing the drug, as Olga Tsareva, deputy chair of the FOMC, pointed out, "The patient cohort that requires this drug is in the tens of thousands, making its inclusion in the EML impossible." Only nine commission members voted in favor of the drug, while 11 voted against it.
Experts argued that the exclusion from clinical recommendations had not previously been an insurmountable barrier to EML inclusion. "The main reason for refusal - lack of approved clinical recommendations - is a serious concern, as the approval process for clinical recommendations takes a long time," said Yuri Zhulev, co-chair of the All-Russia Patients' Union. While waiting for drugs to be included in the EML, patients must continue to fight for their right to treatment through medical commissions, the process being "very complex and time-consuming," according to Zhulev.
Key Insights:
The process of inclusion in Russia's Vital and Essential Drugs List (VEDL) and drug price negotiation mechanisms generally follow these key aspects:
- Assessment of Therapeutic Need: Drugs are evaluated based on disease prevalence, clinical guidelines, and public health priorities. Priority is given to medicines treating life-threatening conditions or widespread chronic diseases.
- Expert Committee Review: A specialized body (e.g., the Ministry of Health's Pharmacological Committee) reviews clinical efficacy, safety, and cost-effectiveness.
- Regulatory Approval: Manufacturers must have valid marketing authorization in Russia with demonstrated compliance with Good Manufacturing Practice (GMP) standards.
- Price Submission: Companies submit proposed prices, which are scrutinized against international benchmarks or domestic production costs.
- Government Approval: The finalized VEDL is enacted via government decree, typically updated annually.
Price negotiation mechanisms often involve reference pricing, cost-effectiveness analysis, volume-based agreements, and local production incentives. Global strategies like decentralized drug manufacturing, such as ARPA-H's wheat germ-based production, could potentially influence future VEDL inclusion by lowering costs and ensuring supply chain resilience. In Russia, similar strategies may align with goals to reduce import dependency for essential medicines.
- Lorlatinib, a drug used for treating non-small cell lung cancer, has been included in Russia's Vital and Essential Medicines (VEDL) list and is provided to patients free of charge through the High-Cost Nosologies (HCN) program, thanks to its exceptional results in targeted therapy.
- Despite Pfizer offering the most competitive price globally for lorlatinib, the cost is still high, priced at around 183,000 rubles per 100 mg dosage, leading to concerns about the cost of health care.
- Pegcetacoplan, another drug approved for oncology and hematology, is now included in the VEDL and HCN program for treating paroxysmal nocturnal hemoglobinuria, but its price is approximately 106,000 rubles, also fueling discussions about health care costs.
- The efficacy of science in medical-conditions like cancer is evident from the approval of drugs like lorlatinib and pegcetacoplan, but their high cost and the subsequent burden on pharmacies and patients highlight the need for cost-effective strategies in health and wellness.
- The exclusion of certain innovative anticancer drugs, such as trastuzumab deruxtecan and asciminib, from the VEDL highlights the importance of timely clinical recommendations and the need for an efficient system to ensure that patients have access to essential pharmaceuticals.
