Pharmacies report shortage of Trulicity diabetes drug

The hypoglycemic drug Trulicity (dulaglutide) manufactured by Eli Lilly, used by patients with type 2 diabetes, has practically disappeared from Moscow pharmacies. This follows from the data of the websites of pharmacy aggregators and drug discovery services in the capital. Judging by the data of the State Register of Medicinal Products, it has no other analogues for the active substance. In pharmacies where Trulicity was found, its cost is three times the maximum selling price. Patients have to search for Trulicity, as well as another oncology immunotherapy drug, Opdivo (nivolumab from Swix Pharma), in specialized social media groups, while both drugs must be dispensed in pharmacies only by prescription.

In 2022, the Ministry of Health began issuing permits for the temporary circulation of drugs not registered in Russia. This mechanism is used in case of shortage and risks of its occurrence in the supply of medicines registered in the country. Trulicity and Opdivo, although registered in Russia, received such permits, follows from the corresponding register of the ministry. Both drugs are included in the list of essential drugs, the cost of which is regulated by the state.

Last year, almost the same number of Trulicity packages were sold in pharmacy retail as in the state segment – 101,314 versus 75,788 units, respectively. The aggregators “Zdravcity” and “Apteka.ru” (they are owned by large distributors “Protek” and “Quatrain”), as well as “Eapteki” the drug is not on sale. On the ASNA website, Trulicity costs from 8300 rubles. Small non-network pharmacies, according to the search engine “AptekaMos”, offer medicine for 14,500 rubles. at its maximum selling price of 4973 rubles. The Vedomosti correspondent was convinced of the veracity of this cost by talking with the pharmacists of these pharmacies.

As an employee of one of the pharmaceutical companies said, now pharmacy chains do not even see Trulicity in the price lists of suppliers. According to the CEO of the distributor, “Protek» Dmitry Pogrebinsky, the company received the last small batch of the drug in October and there is no data on the prospects for new deliveries from the manufacturer yet.

Trulicity, as prescribed by a doctor, can be replaced with a hypoglycemic drug of the same or another class – liraglutide (Victoza) or semaglutide (Ozempik), says Olesya Gurova, Associate Professor of the Department of Endocrinology at Sechenov University. According to her, the shortage of these drugs is the same as the shortage of Trulicity. Particularly in the November edition RBC reported that about 30 Moscow pharmacies doubled or tripled the price of Ozempik. Gurova believes that the shortage of medicines arises because patients are bought for future use, while pharmacies inflate prices.

Pharmacies cannot purchase unregistered and temporarily put into circulation drugs due to the lack of a maximum selling price for them, Vademecum reported, citing a representative of the self-regulatory organization Association of Independent Pharmacies. Such a problem, according to them, concerns a number of drugs.

A representative of the Federal Antimonopoly Service said that the prices for Trulicity and Opdivo were “registered in packages permitted in the country.” For example, if a drug from Italy with a special barcode on the package has a registered price, then it can be sold in Russia, a source in one of the federal executive authorities (FOIV) said. If the same medicine is imported from Germany and the barcode on the package is different, it will not be possible to sell it, a temporary permit from the Ministry of Health will be required and there will be nuances in price, he continued. Federal executive authorities do not quite understand what to do in this case: whether to allow this drug to be sold and at what cost, he concluded.

If supply problems arose in retail, then they certainly exist in the state segment, says Nikolay Bespalov, development director of the analytical company RNC Pharma. Opdivo is mainly sold in public hospitals. The sales volume of the drug in the state segment last year amounted to 267,102 packs, for 10 months of this year – 117,201 packs, follows from the data of the analytical company DSM Group. In retail – 635 packs in 2021 and 182 packs in 10 months of 2022. Opdivo could not be found in Apteka.ru, Eapteka. The Zdravcity aggregator found one drug in a dosage of 4 ml in a single pharmacy for 36,817 rubles. (maximum selling price – 31076.23 rubles). In a dosage of 10 ml, the medicine is available in a large number of pharmacies, but it costs 92,048 rubles, while its maximum selling price is 77,691.35 rubles.

It appears that the mechanism is not working because the regulators forgot to make a price reservation, Bespalov said. This problem is solved quite quickly by amending the normative documentation, he believes. According to the representative of the Federal Antimonopoly Service, in order to avoid shortages, the service suggested that the Ministry of Health include in the price register information about packages for the sale of which pharmaceutical manufacturers received temporary permits. Requests to Roszdravnadzor and the Ministry of Health, as well as to Eli Lilly and Swix Pharma, remained unanswered.