The Ministry of Health cannot purchase some drugs for the treatment of HIV due to lack of requests from suppliers

The Zdravresurs expert group calculated that out of 61 announced auctions for the purchase of drugs for HIV therapy at the beginning of 2024, 17 did not take place due to suppliers not attending the auction. As a result, the Ministry of Health has not yet been able to purchase 107 thousand annual courses of drugs totaling about 1 billion rubles. Activists cite the low starting price offered by the medical department as a likely reason. The Ministry of Health assured Kommersant that the accumulated stocks of drugs for HIV therapy in Russia will be enough for three months, new purchases are underway, and the situation is “under constant monitoring.”

Since December 2023, the Federal Center for Planning and Drug Supply (FCPiLO), subordinate to the Ministry of Health, has been holding auctions for the purchase of antiretroviral drugs (ARVs) for the treatment of HIV in 2024. Experts from the Zdravresurs group (whose goal is to achieve universal access to treatment for socially significant diseases) have calculated that 61 auctions have been announced so far, of which 14 have already been awarded contracts totaling about 7 billion rubles. At the same time, 17 auctions totaling about 1 billion rubles. did not take place due to lack of applications from suppliers. Two of them have been re-announced, the rest have not yet been announced.

Zdravresurs experts cite lack of interest on the part of suppliers as the likely reason for the failure. The initial maximum contract price (IMCP) established by the FKU is 98% lower than it was in 2023. Thus, the NMCC of darunavir 600 mg was fixed at 1.54 rubles. per tablet, whereas a year earlier – 72.56 rubles. Commercial offers for this drug range from 44 to 359 rubles. The NMCC of efavirenz 600 mg decreased by 65.5%, public activists indicate. At the same time, they admit that there are also no applications for auctions where prices have not changed compared to 2023.

Due to failed bidding, it was not possible to purchase 107 thousand annual courses of “third drugs,” of which 66.5 thousand were efavirenz 600 mg, one of the first-line drugs for starting therapy, Zdravresurs calculated. Group expert Natalya Egorova clarified that each regimen, as a rule, consists of two NRTI (nucleoside reverse transcriptase inhibitor) tablets and one tablet of a “third drug”: “It turns out that there is one or another third drug in each regimen, and NRTIs can combine differently. Therefore, to calculate courses, it is more convenient to take third drugs.” In addition, it was not possible to purchase 46 thousand courses of ritonavir 100 mg and 271 thousand courses of lamivudine, which is the most used NRTI in HIV treatment regimens in Russia. Auctions for three pediatric forms of drugs did not take place for 38.3 thousand bottles.

“Failed auctions are cause for concern, since the need to re-conduct procurement procedures with regulated stages may slow down the speed of supply of ARV drugs to the constituent entities of the Russian Federation,” says the Zdravresurs statement. Natalya Egorova believes that the starting low prices are associated with the desire of the financial institution to save money. “This happened a few years ago with lamivudine. The tender was re-announced several times, but until the price was raised, the auction never took place,” says Mrs. Egorova. “The desire of the Ministry of Health to save money is understandable, but this must be correlated with reality.”

Patient Control representative Yulia Vereshchagina said that movement activists are already receiving messages from patients about problems with medications. Now there are interruptions with efavirenz in the Astrakhan region and, according to Ms. Vereshchagina, with ritonavir in the Komi Republic. “The very fact that efavirenz, a cheap drug, became scarce at the beginning of the year speaks to the severity of the situation with the shortage of ARV drugs, which has been going on since 2022. The employees of the Center for Prevention and Control of AIDS, under the leadership of the head physician, are trying to quickly resolve the issue and not leave patients without treatment, seeking additional purchases. This is evidenced by the fact that auctions for ART for funds from the Astrakhan budget began to be announced back in January,” stated Patient Control.

RNC Pharma Development Director Nikolay Bespalov indicates that the initial minimum contract price is determined in accordance with the approved methodology. This “rather complex” mechanism involves several approaches depending on the situation and type of product. “Situations when the NMCP is set too low happen quite often; there were especially many such stories at the stage of system implementation, in particular in 2019, when they began to use the reference price tool. At that time, they were often determined incorrectly, which led to the cancellation of a significant number of tenders,” comments Mr. Bespalov. “Such precedents still happen now, but in a relatively small volume; in addition, regulations for actions in case of such problems have now been formed. It provides for the consistent announcement of a new tender, and if this also does not take place, the purchase will be carried out at state register prices.” This is logical, and, according to Mr. Bespalov, the system is aimed at combating overpricing at government auctions and consistently minimizing these prices. “But, alas, time is wasted, which means there is a risk of interruptions in medical care,” he adds.

The Ministry of Health recalled that, along with the Federal Institution of Public Health, the Federal Center for Epidemiology and Prevention, the powers to provide medications to HIV-infected patients are also assigned to the constituent entities of the Russian Federation. According to the department, the supply of drugs for the treatment of HIV to Russian patients as of February 5, 2024 averages about three months. “For a number of drugs for the provision of drugs to patients with HIV, purchases were made by the federal center at the end of 2023; for other items, procurement procedures continue,” the Ministry of Health assured. “In addition, as part of the monthly monitoring of drug stock in the constituent entities of the Russian Federation, there are free distribution of volumes of these drugs. Such redistribution is carried out by the federal center at the request of the regions. Thus, issues of drug provision for HIV patients are under constant control.”

Natalia Kostarnova