In 2016, Hungary transitioned from a second-tier member to a full member of the EU. As Judit Bidló, deputy director general of pricing and reimbursement for Hungary’s National Institute of Health Insurance Fund Management (NEAK), explains, this has already had a significant impact on patient access to innovative new products. “As soon as there is a new product registered in the EU, within days, patients who are eligible for this treatment are made aware of it,” she outlines. “This has improved transparency within the healthcare ecosystem, and inadvertently, increased the velocity and scale of reimbursement appeals as well.”
Only one-third of products which are submitted into the reimbursement scheme are accepted by NEAK, which is unacceptable
Access to innovation remains the most pressing matter for Hungary’s pharmaceutical ecosystem, and Bidló acknowledges that the “NEAK needs to find solutions to reconcile the number of new products registered with a reimbursement system that can adapt to this new influx of registration.” The current regulatory framework for reimbursement is a bone of contention for innovative industry players who operate in the country.
“Hungary has one of the most bureaucratically clad and complicated systems in Europe which takes up to two years before a new drug is approved for reimbursement. The process requires political decision, as the healthcare budget is not under the State Secretary of Health, but under the Minister of Finance; some decisions even require approval from Prime Minister’s office,” proclaims Peter Holchacker, director general of the AIPM, Hungary’s association of innovative pharmaceutical manufacturers.
Despite being a highly strategic market within CEE, Hungary lags behind its neighbors in terms of market access. “As I manage Bulgaria, Romania, and even Slovenia, I have a benchmark reference for what access conditions are like in these other markets. In these countries, the reimbursement process is faster and more transparent,” laments Dr Attila Lukács, general manager and head of commercial operations EEU for CSL Behring in Hungary, Romania, and Bulgaria.
IBSA’s Anna Wienner concurs, pointing out that “only one-third of products which are submitted into the reimbursement scheme are accepted by NEAK which is unacceptable.” For example, since 2016, 71 and 69 medicinal products have become available for patients in Bulgaria and Slovakia respectively, yet this number is only 48 in Hungary.
Furthermore, the country’s pricing system adds additional complexity to solving the market access equation. CSL Behring’s Lukács points out that that “Hungary has one of the strictest price-referencing systems in the EU, which then plays into how products are analyzed for cost-effectiveness in the country.”
“The EU employs five to six pricing policies, whereas Hungary uses all 11 available. For any new drug, the above and below 20 per cent of price tenders are disregarded and the rest is used to find the right price,” adds Bidló.
Lukács insists that this evaluation system is not effective because “some innovative products cannot be benchmarked to the existing standards of care which have extremely low costs, such as steroids or antibiotics. This limits growth opportunities not only for CSL Behring, but for the entire pharma industry. Because of this, certain brands and products will never be launched in Hungary.”
The AIPM’s Holchacker goes on to clarify that from a legislative perspective, the Hungarian decision-making procedure is quite in line with the European requirements and transparency directives, but adds, “however, the political influence in the decision-making process makes it hard to support improvement efforts.” The question remains of how a fast, effective, and sustainable reimbursement system can be created?
While bureaucracy has hindered the upper levels of Hungary’s regulatory infrastructure, the 2018 appointment of a new director general for the National Institute of Pharmacy and Nutrition (OGYÉI) – the administrative authority for medical product evaluation – offers the possibility of new dynamism in the country’s market access scheme.
Having had a longstanding career in the pharmaceutical industry, Dr Mátyás Szentiványi, OGYEI’s newest leader, aims to bring a fresh and collaborative mindset to the organization. “It has been my goal to streamline regulatory processes in areas where we have sufficient expertise and establish more successful deadlines. Furthermore, I aspire to create a clear regulatory framework for activities such as drug promotion, which are often interpreted differently by government, industry, doctors, etc,” promises Dr Szentiványi.
The industry has made its need for transparency known, and having a regulator with a pharma background who can see both sides of the coin and hopefully deliver win-win solutions is a promising step in the right direction. Looking towards the future, Irma Veberič, general manager of the Hungarian affiliate of Roche, expresses that the pharma companies “hope to see reimbursement publications without limitations and with a higher frequency.”
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