Vitaliy  Gordienko

Vitaliy Gordienko, the General...

Vitaliy Gordienko, the General Director of the global research-driven biopharmaceutical company AbbVie, informed LDaily readers about the latest developments of innovative methods of treating complex diseases, which will soon be available in Ukraine. He also covered pressing issues of the healthcare industry in Ukraine and its reform (especially within the coronavirus crisis). According to the professional manager, the pharmaceutical industry plays one of the key roles in it.

Vitaliy  <span>Gordienko</span>

Healthy citizens = healthy economy of Ukraine

23.09.2020 (№ LDaily #15)

Vitaliy Gordienko, the General Director of the global research-driven biopharmaceutical company AbbVie, informed LDaily readers about the latest developments of innovative methods of treating complex diseases, which will soon be available in Ukraine. He also covered pressing issues of the healthcare industry in Ukraine and its reform (especially within the coronavirus crisis). According to the professional manager, the pharmaceutical industry plays one of the key roles in it.

LDaily: Could you please tell us how the coronavirus crisis affects the activities of AbbVie Ukraine?

V. Gordienko: We are committed to helping in any way we can to address the COVID-19 public health crisis. AbbVie is donating >$35 million to help support underserved communities and healthcare systems working to address the impact of the COVID-19 pandemic globally and locally. Along with industry partners, the company has joined the Innovative Medicines Initiative to support research and discovery of targeted medicines against COVID-19. AbbVie has also supplied one of its products as an experimental option for the treatment of COVID-19 to multiple countries (including Ukraine) that have immediate patient needs due to the outbreak.

LDaily: Do you produce medicines for the most serious diseases, such as HIV/AIDS, Hepatitis C? Does the company plan to launch new drugs in 2020 given that we face another serious disease COVID-19? What innovative solutions is the company currently working on?

V. Gordienko: Yes, we do. AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. AbbVie is a strong player in immunology, virology, oncology, neuroscience, and some other therapeutic areas. Oncology is one of the most important HC areas worldwide with no exception for Ukraine. Specifically, from 2019 we made innovative therapy available for CLL patients, with a hope that gradually the treatment will be publicly reimbursed from this year and next year. Additionally, our company has a series of new innovative solutions in rheumatoid arthritis, atopic dermatitis, psoriasis, Crone’s disease, and other immunological diseases which should become available in Ukraine in coming years as well. We also expect that the latest innovations in HCV treatment, allowing a patient to be cured in 8-16 weeks, will be available for Ukraine’s adults and children from the end of this year, contributing to the country’s HCV elimination plan.

LDaily: How do you technologically maintain product quality?

V. Gordienko: We are committed to conducting our research and business with the highest standards of ethics, and to delivering medicines reliably, with the quality and safety patients can trust. We are focused on making medicines that are of high quality and available when patients need them. Our quality processes are reviewed and certified by multiple external parties. We use an integrated enterprise quality management system that complies with applicable standards from the International Organization for Standardization (ISO) and the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). AbbVie manufacturing sites receive dozens of internal audits and outside inspections each year.

To ensure the quality and integrity of our supply chain, we have a supply chain management system that includes criticality assessment, controls, relationship management, and continuous monitoring.

LDaily: How does the state control the pharmaceutical market?

V. Gordienko: The production and circulation of pharmaceuticals in Ukraine are subject to strict control. The framework for the regulation of pharmaceutical products is complex and comprises a network of specific laws and regulations.

LDaily: The reform of state medicine is currently being implemented in Ukraine. Is there anything lacking in it? What do you think is the main problem of health care?

V. Gordienko: The HC reform has been ongoing in Ukraine since 1 July 2018. The main principle of the reform is “Money follows the patient”. That means that payments to healthcare organizations to be conducted for the services provided (patients enrolled at primary level or treated at secondary and tertiary level) and to be based on unified tariffs instead of allocating fixed amounts of financing to each HC organization. The HC reform was launched on the primary care level. As of today, it demonstrated good progress and 1st positive results in increasing access of Ukrainian patients to HC services at the primary level have been achieved. The HC reform at the secondary level was implemented as a pilot project in Poltava region in 2019. Starting from 1 April 2020, it has to be fully implemented on secondary and tertiary levels in a whole country. But it did not happen yet due to different reasons. I would like to stress here just only a few of them. The 1st one – is a lack of appropriate HC sector financing. In accordance with IQVIA data, Ukraine stays far behind the CEE countries in GDP and healthcare expenditures terms – 22 and 7 times less accordingly. The 2nd reason – is a lack of active engagement with leading HCP experts working at secondary and tertiary levels and patient organizations’ involvement to make them true advocates of the reform. And the 3rd one – is that HC reform cannot be effectively implemented alone. For example, HC structure optimization cannot be successful in terms of physical access to care if the availability of respective infrastructure and its quality is not considered simultaneously. But does it mean that HC reform should be stopped? I do not think so, as the abolition of the reform right now will only cause more issues. The positive changes that have already taken place will stop but return to the old system will not be possible anymore. And it is 100% clear that the old system had not worked effectively even before the reform. So, to my mind, there is the only way to change the situation with HC in the country — to reform further, but to correct mistakes in the process and to engage in medical education so that not only each HCP but every Ukrainian understands what the ultimate goal of HC reform is and how it serves their particular needs.

LDaily: What, in your opinion, prevents the active implementation of innovative approaches in the field of health care?

V. Gordienko: Thank you for this very important question. Access to innovative medicines in Ukraine is lower than in East European countries. In accordance with IQVIA data, there are 544 days of delay between market authorization and physical patient access to innovative therapeutic solutions. The share of innovative products in the pharmaceutical market is only 9% vs. 40% in average in CEE countries. And such a modest share could be well explained by very limited State funds allocation on innovative medicines. It is just only 1 EUR per capita vs. 66-172 EUR in CEE. So, the answer to your question is clear.

Firstly, as it was already mentioned above, there is a need for a substantial HC budget increase. It is great that this necessity is supported by the Ukrainian Government now and should be reflected in the 2021 Budget Resolution accordingly. Investment in the health of the community will serve as the accelerator for the country’s macroeconomy/healthy taxpayers to fulfill all needed reforms and sustain economic growth.

Secondly, it is very important to optimize the usage of available resources. For example, 36% of Ukrainian state reimbursement is allocated on so-called “other products”, some of which are of poor efficacy evidence. It could be worth to reevaluate this expenditure and allocate it for innovative medicines. And thirdly, Ukraine is currently lacking modern access mechanisms to innovative products, which are in active use in CEE and other countries. One such mechanism is a Managed Entry Agreement (MEA) — a type of formal institutional arrangement between manufacturers and payers for sharing financial risk surrounding the introduction of new pharmaceutical technologies that have been developed. It is great to mention that the definition of MEA already appeared in recently adopted changes to the Law of State Procurement. But it is vitally important to speed-up the process of sub-law regulations preparation and implementation to make MEA alive in Ukraine as Ukrainian citizens are worth European access to innovative therapies.

LDaily: What prospects for the development of the pharmaceutical market of Ukraine do you see?

V. Gordienko: A lot of important actions to be considered by different stakeholders to improve further the situation with the HC system in Ukraine. AbbVie is highly committed to contribute to HC system improvements and works in close cooperation with other pharma companies under the APRaD umbrella and other partners (AmCham, EBA, USUBC) in advocacy towards efficient HC system to Ukraine’s patients. Such improvements will positively influence the pharmaceutical market in Ukraine as well. Let me summarize just some of the baldly needed actions – further development of reimbursement system and Health Technology Assessment (HTA), ongoing reform of medicines procurement by State via Centralized Procurement Agency (CPA), creation and implementation of modern access mechanisms such as MEA. There are many others, which in case of appropriate governance should help Ukrainian patients to cover their unmet HC needs and ensure further development and economic growth of our country.

Please read: Crisis: a guideline for publicly exposed companies

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