In an interview with SmartTRAK, Dr. Willi Schnorpfeil, managing partner of Value & Dossier and Reimbursement Specialist, provides insights into the scope, impact and potential future developments of changes in Germany’s reimbursement landscape, specifically concerning the Advanced Wound Dressing Market. Dr. Schnorpfeil highlights the challenges faced by the industry in meeting new evidence requirements and the possible implications for patient outcomes. This conversation sheds light on the complex regulatory environment in Germany and its broader implications for the healthcare sector across Europe.
Click on the video below to listen to SmartTRAK’s interview with Dr. Schnorpfeil (24:18 minutes), which was recorded on August 22. A link to download the complete transcript of the interview is also provided below.
SmartTRAK: Hi, this is Anikó Szekér with SmartTRAK and I'm here with Dr. Willi Schnorpfeil, Managing Partner of Value & Dossier and Reimbursement Specialist in Germany. SmartTRAK estimates that the German Advanced Wound Dressing market was over US $500 million in 2023. However, the market and patient care are under threat by the impending reimbursement changes in the country. So, we are here to discuss what's going on, what the situation is, explore a little bit and discuss how it may develop in the future. Thank you very much, Dr. Schnorpfeil, for joining us.
Dr. Willi Schnorpfeil: It's my pleasure.
Thank you. So, let's jump into it. As a start, could you please describe this big change that has happened and has been introduced? What is the scope of the change? What is the background for these changes? Which sector is impacted--statutory, private, home care, or hospital? What is the current situation and background?
WS: Yes, of course. So, this is primarily affecting the wound care market, especially the so-called “other wound care products.” Other wound care products are actually products that are assumed to have a certain pharmacological, metabolic or immunological effect on the patient and on the wounds. This is usually related to risk class III of medical devices. So, that's actually the product class, which is affected by this new law implemented a few years ago. And now, we are approaching the deadline of December 2024. Because these other wound care products will not be reimbursed anymore according to the current law as of December 2024, except, of course, if the companies are able to present new or existing evidence to prove that these products have advantages, actually to the standard of care.
Is it clear what evidence should be submitted for this benefit assessment and what the authority expectations are for this?
WS: Well, we have experience in Germany regarding medical devices, and there's also a product class of medical devices that are perceived as similar to pharmaceuticals, for instance, certain eye drops. It's the same methodology that is applied here to these other wound care products or wound care dressings, which is used now for assessment and evaluation. I would say the methodology is quite clear. We have a history of the requirements we want to see in Germany, RCTs (randomized controlled trials) as the basis for all of the HTA (Health Technology Assessment) procedures. Therefore, one of the requirements is evidence-based on randomized controlled trials. Usually, the German authorities also want to focus on patient-relevant outcomes. So, I would say these are the two main aspects of the evaluation.
When we talk about these changes, which part of the healthcare sector is impacted? Is it only the statutory or the private as well? And what is the percentage-wise split?
WS: Yes, it's really only for the statutory health insurance system, but about 90% of the market is covered by the statutory health insurance. It's roughly 10% for privately insured patients and only in the outpatient sector. So, it's not regarding the hospitals. This is due to the special reimbursement system in the hospitals.
Of course, it's different. So, you talked about the deadline, which is the beginning of December. What kind of scenarios do you see? Is it going to be implemented? Is it going to be postponed potentially again? What do you think about that?
WS: Well, the law is quite clear. The current law says ...
Click the button below to download and read the complete transcript of the interview with Dr. Willi Schnorpfeil, conducted by Anikó Szeker, SmartTRAK Senior Analyst, Wound. The interview took place on Aug 2, 2024.