It is unprofitable to treat Russians with Parkinson’s disease – Picture of the Day – Kommersant

Patients with Parkinson’s disease report a shortage of life-saving drugs based on levodopa. According to RNC Pharma, the supply of these drugs has decreased by 49% in a year. At the same time, according to the Movement-Life Foundation, approximately 300,000 out of 350,000 Russians living with Parkinson’s disease need levodopa daily. Citing the unprofitability of production as the reason, following the Israeli Teva and the Swiss Hoffmann-La Roche, the Indian Sun Pharmaceuticals made the “final decision” to leave the Russian market. Even the decision of the Federal Antimonopoly Service to raise the price at which the state purchases levodopa drugs from domestic manufacturers Izvarino Pharma and Canonpharma did not help solve the problem.

In the fund for helping and assisting people with Parkinson’s disease (a severe neurodegenerative disease) “Movement – Life” reported that they had sent more than 400 letters to State Duma deputies with a request to pay attention to the catastrophic situation: in Russia there are “virtually no” drugs with the active ingredient levodopa + benserazide , vital to the wards of the fund.

In April “Kommersant” told about the deficiency of antiparkinsonian drugs based on levodopa, a substance that compensates for the deficiency of dopamine. Nebbiolo, a neurologist and principal investigator at the Nebbiolo Clinical Research Center (Tomsk), Natalya Zhukova, explained to Kommersant that levodopa is the “gold standard” in the treatment of the disease; about 60–70% of patients with Parkinson’s disease take it. According to the representative of the foundation and the head of the informal community of patients with Parkinson’s Elena Shubina, out of about 350 thousand Russians living with Parkinson’s, 300 thousand people need levodopa.

At the end of March, the Ministry of Health of the Russian Federation, at the request of the manufacturer, canceled the state registration of Tremonorm (levodopa + carbidopa) of the Israeli pharmaceutical company Teva. At the end of 2020, Teva stopped importing another drug – Levodopa / Benserazide-Teva.

The Kommersant company explained that the state-registered price for the drug does not now allow covering production and logistics costs.

At the end of 2021, for the same reason, the analogue of Levodopa + Benserazide-Teva left the Russian market – the drug Madopar by Hoffmann-La Roche, the production of the Russian generic Benziel from Canonpharma was reduced several times, and completely disappeared ” Levodopa + Benserazide from Izvarino Pharma.

The Ministry of Health then promised to increase the purchase prices for drugs from Canonpharma, Izvarino Pharma and the Indian company Sun Pharmaceuticals (Sindopa). Other manufacturers, as assured in the department, did not apply for re-registration of prices.

In May, the FAS Russia agreed to increase marginal prices due to the risk of shortages (deficits) of Izvarino Pharma and Canonpharma. The increase ranged from 42% to 83.6%. Companies producing levodopa + carbidopa (Sandoz, Torrent, Sun Pharmaceuticals) were denied re-registration on the same grounds due to a significant decrease in exchange rates against the ruble in April-May compared to March. Sun Pharmaceuticals told Kommersant that after the refusal they made a “final decision” to leave the Russian market.

“In the event of a positive decision from the regulatory authorities and the possibility of increasing the price to a cost-effective level, the company guarantees to resume production of the drug in the period necessary to resume production,” Sun Pharmaceuticals said, without naming what level of the purchase price is considered cost-effective.

Kanonfarm told Kommersant that after the intervention of the FAS, the company began purchasing the substance, but “the moment of rhythmic deliveries was missed.” The only supplier had to wait until August (the Ministry of Health did not approve an alternative supplier due to questions about product quality, which the company agrees with). Now Kanonfarm is waiting for the second delivery and intends to “gradually, in small batches” produce the drug. However, the new price still did not suit the company. “We have a small profitability from the production of the drug, but now, due to changed logistics conditions, we must make an advance payment. And the substance tends to be in global scarcity. We produce as much as we can,” the representative of Canonpharma concluded. Izvarino Pharma did not respond to Kommersant’s request.

In a letter from the fund to parliamentarians, it is indicated that at present a “total” shortage of another drug has been discovered – Nakom (levodopa + carbidopa) manufactured by the Slovenian company Sandoz. “That is, for all 350,000 Russian patients, the only Indian drug, Tidomet Forte, remained from drugs with levodopa. Also, patients are faced with a shortage of other drugs necessary for constant use – dopamine receptor agonists, ”the appeal says. The fund offered the state ways to solve the problem: providing patients with supplies, for example, from Asia-Pacific countries, or parallel imports through neighboring countries, as well as increasing their own production and supporting domestic developments.

Elena Shubina notes that the problem is recognized “in certain regions.” Thus, the Health Committee of the Pskov Region, in response to an appeal from the Movement – Life Foundation, reported that monitoring the availability of drugs for the treatment of Parkinson’s disease indicates their “serious lack” in medical and pharmacy organizations not only in the region, but also in Russia. The committee supports the ideas of the patient community, but indicates that their implementation is possible only at the federal level.

According to Nikolay Bespalov, Development Director of RNC Pharma, the situation is “really very difficult.” He notes that over the year, the supply of all drugs based on levodopa decreased by 49%, and some drugs were not supplied at all. At the same time, according to him, in general, the market for anti-Parkinsonian drugs “feels normal” and sank by about 2%.

Member of the Department of Nervous Diseases and Neurosurgery, PMSMU named after A.I. I. M. Sechenova, dementologist Anastasia Medvedeva confirms that there are “certain difficulties” with levodopa drugs in the pharmacy network. According to her, patients are forced to buy drugs abroad.

Deputy Chairman of the State Duma Health Committee Alexei Kurinny (KPRF) said that the deputies are aware of the problem, but not about ways to solve it. According to him, the committee made a request to the Ministry of Health of the Russian Federation to clarify the reasons for the defect. “We are waiting for their response in order to act depending on the situation,” commented Mr. Kurinny. Kommersant also sent a request to the Ministry of Health, but at the time of publication did not receive a response.

Natalia Kostarnova