New code: a list of innovative drugs may appear in Russia
The introduction of innovative drugs into the practice of preferential provision in Russia is going too slowly, the Federation Council Committee on Social Policy stated in an appeal to the Ministry of Health (the document is available to Izvestia). And in order to speed up patients' access to them, the Federation Council proposed a special procedure — the appearance of a temporary list of innovative medicines. It could work according to the principle of the list of vital and essential medicines (VED), giving the green light for their purchase at the expense of the state, but in a limited mode — for certain centers and patients. The Ministry of Health promised to consider the initiative. Whether such a list is needed and how it will work is described in the Izvestia article.
What could be the new list?
A special procedure is needed to accelerate the access of Russian patients to innovative drugs, the participants of the round table in the Federation Council came to this conclusion. As a result, the Federation Council Committee on Social Policy sent recommendations to the Ministry of Health, which, according to the authors of the appeal, could significantly speed up the procurement and receipt of such drugs.
"The introduction of innovative drugs into the practice of preferential provision is too slow. The main reason is regulatory gaps: there are no definitions of the concepts of "innovative drug" and criteria for selecting such drugs for public procurement," the letter says.
The idea of a special temporary list is being considered as a solution, the recommendations say.
"A drug that has proven its effectiveness and is registered in Russia will first be included in it, and from there — in the list of vital and essential medicines," the recommendations say. Thus, it will be possible to purchase it at the state expense, as well as drugs from the list of VED.
At the same time, purchases will be carried out "in a limited mode" — for certain medical centers and patients.
"The list will be used to collect clinical practice data, and when the value of the drug is confirmed, it will be included in the list of vital and essential medicines (VED). This measure will reduce the time interval between the appearance of the drug and access to it," the document says.
It is noted that innovative targeted and immunopreparations transfer many previously incurable blood diseases to the category of chronic controlled conditions.
"At the same time, these innovations account for up to 75% of the costs in hematology," the Federation Council noted.
Currently, purchases of innovative medicines are carried out through federal programs for high—cost nosology and high-tech medical care, the Circle of Goodness Foundation, as well as compulsory medical insurance - but only for hospitals. But to a large extent, the burden of purchasing innovative medicines falls on regional budgets.
"It is critically important to apply all mechanisms to reduce the burden on regional budgets, from joint procurement to centralized support for patients whose treatment is beyond the capacity of individual entities," the recommendations say. — Many new hematology drugs are not included in the list of VED and are provided specifically by decisions of medical commissions. Moreover, more than half of the new drugs are tablet forms, meaning that for outpatient patients, the regional benefit remains virtually the only source of their receipt."
In addition, one of the sources of financing purchases from the temporary list may be, for example, a subsidy for the regions, the authors of the document suggest.
The press service of the Russian Ministry of Health, in response to a request from Izvestia, reported that the recommendations of the Federation Council "will be worked out."
Why innovative drugs may not be available
Innovative medicines often get "stuck" after registration and do not become really available to patients, said Yuri Zhulev, co-chairman of the All-Russian Union of Patients.
"Even after obtaining permits, such medicines have not been included in the list of VED or the state guarantee program for years, and people with serious illnesses waste time waiting for them," he stressed.
It is important to consolidate the very concept of an innovative drug and clear criteria for its definition, Yuri Zhulev agreed.
"This will allow us to create a separate track not only for registration, but also for financing such medicines," he believes.
Innovative drugs are becoming available for large-scale government purchases with a long delay, agreed Dmitry Nakhamchen, Director of Government Relations and Market Access at Geropharm.
— To get to the patient, the drug must be included in the list of VED or orphan medicines. It is also advisable to get into the clinical guidelines. And if we are talking about inpatient treatment, then the state guarantees program (determines what is included in free medical care. — Ed.) and the rates of compulsory medical insurance. This is a long and complex sequence of procedures, while patients need to receive therapy promptly," the expert emphasized.
The Federation Council also recommended that the Ministry of Health approve methodological recommendations defining the term "innovative drug", "drug with increased therapeutic value" and develop prioritization criteria: population effect, prevented outcomes, cost-effectiveness, need.
The development of criteria for therapeutically significant innovation is a key issue for bringing new drugs to the market, says Alexander Bykov, Director of Healthcare Economics at R—Pharm.
— These criteria should take into account not only the scientific novelty, but also the added therapeutic value: improved survival, reduced complication rates and improved quality of life. This will make it possible to separate truly breakthrough drugs from those that slightly improve existing therapies," he stressed.
And Yuri Zhulev noted that transparent criteria, long-term procurement mechanisms and sustainable post-registration support are important.
—The sooner innovative drugs become available, the faster their generics appear, which means the wider the coverage of therapy,— he stressed.
In international practice, there is also an approach in which a drug can be given a status of special importance if it solves a medical problem that previously had no effective treatment, Dmitry Nakhamchen reminded Izvestia.
"This status makes it possible to include the drug in state lists faster," he added.
Dmitry Nakhamchen believes that Russia will follow the same path, adapting such experience to its regulatory system.
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