Are concerns well-founded?
Last week an important dialogue on supplementing lists of vital and essential drugs (VED) was held at the press-centre ITAR-TASS. This subject is particularly important after information in mass media that inclusion into the VED list in 2017 of 24 drugs that passed the expert assessment and recommended for inclusion, was under question.
At the press-briefing held by organizing authorities of Ice Period for patients” a dialogue occured between the representatives of the Ministry of Health on the one part and representatives of patient healthcare and pharmaceutical communities on the other part.
No-one argues that lists should not change. Rotation means exclusion of outdated drugs and replacement of those with innovative, more effective drugs However, according to co-chairman of the Russian National Union of Patients Yan Vlasov, out of the 160 products considered by the Commission of products, the Union defended less than 20 INN from the VED and less than 10 from the essential drugs list. And it was not an easy task: over half of 26 members of the commission were representatives of the Ministry of Health. It is not quite clear what criteria are used for selection.
Executive director of the Russian Community of Clinical Oncology (RUSSCO) Ilya Timofeev voiced a concern, that in case of “freezing” the List cancer patients will be deprived of drugs for treatment of sarcomas, terminal stages of lung cancer, skin melanomas and other disorders.
The decision to “freeze the list” involves both investment and reputation risks. At least, it will decrease the trust to the declared course for import substitution in the Pharma industry. According to that course Russian companies with 100% Russian capital drafted plans and local assessment stages, proposed by the government. Delay of decision to improve the list actually changes the rules of the game.
Director of department of provision of medicines and regulation of medicinal devices, Ministry of Health, Russia, Elena Maximkina, attempted to calm down the audience. She remarked that the list is not going to be frozen, but the approaches to formation of the list have changed a lot recently. Now drugs are selected according to the criterion of clinical efficacy, clinical and economic criterion, ability to include into the treatment protocol, localization etc. “Within the last two years the list included 96 new drugs, and most of them are expensive drugs for treatment of cancer”, she remarked.
Elena Maximkina also noted that the aim of the Ministry of Health is not only to include the drug into the list, but also to ensure its physical and economic affordability for the healthcare system. After refusal to include some of the drugs the Ministry of Health received over 30 applications from companies with a suggestion to reduce the price. Negotiations on reducing prices for drugs for treatment of HIV and hepatitis are ongoing.