Health Department Grants Approval for Incorporation of Two Novel Medications in STD Treatment Regimen
Rewritten Article:
In a significant step towards improving the healthcare system, the Ministry of Health held its annual meeting on April 28 to discuss the inclusion of crucial pharmaceuticals in the list of vital and essential medicines (VEDL) and the program of high-cost nosologies (HCN). Despite the tight schedule, only two drugs were greenlit for inclusion, both receiving unanimous approval.
Drugs incorporated into these programs are procured by the government and provided to patients battling specified diseases free of charge. Additionally, the government maintains control over the pricing of all VEDL-listed drugs to prevent arbitrary price increases.
The first approved drug was lorlatinib, commercially known as "Lorviqua" by Pfizer. Used in the treatment of non-small cell lung cancer, it has proven to deliver exceptional results in targeted therapy - the cutting-edge treatment method for cancer patients. With a prevalence of less than 5%, approximately 200 patients in Russia require this medication. Current estimates indicate that Pfizer has 3,000 packages of lorlatinib in storage and has committed to fulfilling all supply obligations. A package of the drug costs around 183,000 rubles, a figure Pfizer maintains as the most favorable price globally.
Despite attempts by the Ministry of Health to further reduce the cost, Pfizer representatives asserted that they have already secured the most advantageous deal for Russia. "We managed to secure the best price for Russia last year, keeping in mind the needs of Russian patients for this vital drug. It is 20% cheaper than our closest competitors and 44% cheaper than the lowest price in the reference country - Hungary," shared a Pfizer representative.
The Federal Antimonopoly Service confirmed that the drug is currently retailing in Russia at a marked-up price of 2 to 2.5 times more than the given cost. If approved last year, regional entities could have saved up to 300 million rubles on its procurement.
The second drug to make the list is the orphan drug pegcetacoplan, commonly marketed as "Empaveli" by Swedish Orphan Biovitrum AB. It is used in oncology and hematology to treat paroxysmal nocturnal hemoglobinuria. Like lorlatinib, pegcetacoplan is also included in clinical guidelines as a second or third-line treatment when initial treatments fail.
Similar to pegcetacoplan, SOBI too managed to secure the most affordable worldwide price for Russia, around 106,000 rubles. Originally considered but rejected last year, the public organization "Movement Against Cancer" petitioned the government, Ministry of Health, and Accounts Chamber to convene an extraordinary meeting of the commission to discuss the incorporation of this and other groundbreaking cancer drugs in the list of vital and essential drugs. Estimates suggest that around 50 patients in Russia require pegcetacoplan therapy.
However, drugs like trastuzumab deruxtecan (Enhertu by AstraZeneca) and asciminib ("Spectrum" by Novartis) remained off the vital drug list. Trastuzumab deruxtecan is employed in the treatment of breast cancer and small cell lung cancer. AstraZeneca reported that around 187 patients are presently receiving this therapy. The company is offering a competitive price of 92,000 rubles per pack but has not managed to secure approval thus far.
The primary hurdle, according to the Ministry of Health, is the continued development of clinical guidelines for the drug. Other innovative anticancer drugs like tremelimumab by AstraZeneca and teclistamab by Johnson & Johnson were also dismissed from the list, making their first appearance this year.
Two other drugs were removed from the list of vital and essential drugs - sarilumab, used in rheumatoid arthritis therapy, and peginterferon alpha-2a.
The debate over faricimab ("Vabysmo" by Roche) and its exclusion from the vital and essential drugs list remains ongoing. Despite its proven high efficacy in addressing resistant forms of blindness related to diabetes, the drug failed to secure a spot on the list. Ophthalmologists argue for its inclusion given the drug's potential to cut down the number of required injections from twelve to three. However, based on current data, the "patient cohort" requiring the drug consists of tens of thousands of patients, preventing its addition to the list.
Exclusion from clinical recommendations did not deter faricimab in the past. "The fact that the drug has yet to be included in clinical recommendations is a significant concern, as this process can take a considerable amount of time," warned Yuri Zhulev, co-chair of the All-Russia Patients' Union. Until the drug is added to the list, patients must navigate complex and time-consuming legal procedures to secure treatment.
Additional Insights:- Regulatory and approval timelines, pricing and reimbursement negotiations, local therapeutic priorities, and market access strategies all play crucial roles in determining whether a drug is included or excluded from a country's vital and essential drugs list, such as Russia's.- Delays in regional trials, non-alignment with reimbursement frameworks, competing drugs, and the drug's impact on a niche patient population could contribute to its exclusion.- Specific examples of drugs like lorlatinib, pegcetacoplan, and faricimab illustrate how pricing negotiations, patient demand, and therapeutic indications impact a drug's inclusion in vital and essential drug lists.
- The pharmaceutical industry is increasingly focusing on treatments for cancer, as demonstrated by the approvals of lorlatinib and pegcetacoplan, both of which are used in oncology.
- The cost of lorlatinib, commercially known as Lorviqua by Pfizer, presents a significant challenge, with a package costing around 183,000 rubles, a figure Pfizer claims is the most favorable price globally.
- The efficacy of faricimab, marketed as "Vabysmo" by Roche, in addressing resistant forms of blindness related to diabetes is well-documented, but its high cost and wide patient cohort have resulted in its exclusion from the vital and essential drugs list.
- Achieving inclusion on a country's vital and essential drugs list, such as Russia's, is a multifaceted process that involves factors like regulatory and approval timelines, pricing and reimbursement negotiations, and local therapeutic priorities.
- For patients in need of treatments like faricimab, navigating complex and time-consuming legal procedures becomes necessary, underscoring the importance of health-and-wellness initiatives that make these drugs more accessible.
