Hungary operates under a state-owned universal National Health Insurance Fund (OEP), completely financed through mandatory tax contributions from employers and employees. “From a drug reimbursement point of view, we have one of the most complex and comprehensive regulatory frameworks in Europe, which aims to cover all medical and medicinal needs for society—even when it comes to aspects like hospital and outpatient care,” declares OEP’s head of pricing support Dr. Judit Bidló.
According to Bidló, one of the primary challenges now, which also extends to every single healthcare market worldwide, is accommodating the growing premiums associated with increasingly innovative therapies and assessing alternative financing methods to introduce them into the system—which is often the root cause of delays for companies seeking reimbursement approval. “Compared to 10 or 15 years ago, the drug mixture has completely changed. The products on the market today are of course much more efficient, but also much higher in price, and correspondingly, it’s become much more challenging for payers to cover them—especially with limited resources. Nowadays its crucial to define specific outcome criteria and appropriate benchmarks to ensure that drugs admitted into reimbursement perform as expected, else we risk the opportunity costs of not covering other therapies that could’ve saved a patient’s life,” explains Bidló.
This trend is especially relevant in the field of oncology, where Dr. György Bodoky, head of clinical oncology at Unified Szent István & Szent László Hospital, uses the expression “financial toxicity” to describe the unsustainable price of innovation, requiring “an urgent need for close collaboration between governments, payers, healthcare professionals and the pharma industry to solve this rapidly emerging issue.”
Janssen has been particularly successful in effectively demonstrating the fair value of innovation through the use of real-world evidence, and in turn, obtaining product reimbursement. “There’s a unique opportunity to access data that encompasses the whole population covered under the OEP,” illustrates Andreas Woitossek, head of strategy and outcomes CEE. “Through this data, you can see how patients are developing through the system, but you can also see the performance of your drugs in market. With studies supported by real-world evidence, you have a much stronger position to show the added value of existing products for the patients, while gaining a much better understanding of which patient population would benefit the most from our new product launches.”
“In an open and transparent way, showing the value and identifying patient groups that can benefit from our innovations, and following up with real-world evidence to demonstrate efficacy before and after launch has been pivotal. For instance, we have an important treatment option for psoriasis, which is administered only 4 times per year. Based on our follow-ups with patients, compared to competitors, our product has been able to boast better patient compliance with fewer side effects, adding to our value proposition and truly demonstrating that our drug goes beyond clinical studies and actually improves real-world health outcomes,” details Woitossek.
In terms of alternative financing avenues, “CSL Behring was the major facilitator in creating a special health insurance fund for patients with primary immune deficiency to increase their access to immunoglobulin therapies. This is the same funding system that has been created in oncology. Now that hospitals do not have to cover the cost of immunoglobulin for the treatment of primary immune deficiency from their own budgets, they are better able to treat patients: patients, doctors and payers all manifestly benefitting. We are now working to establish more of these types of funds to allow reimbursement for the same therapy for patients with other types of immune diseases in neurology and hematology,” promises Dr. Attila Luckács, managing director of CSL Behring.
“The point is that innovation needs to be seen as an innovation, and proven accordingly, whether that’s through mode of action, therapeutic benefits, or efficacy. If you can adequately measure the value of your innovation, then you have something in your hands that everyone would be willing to discuss,” concludes Jan Frederic Kessel, CEO of Servier Hungary.