A bit more than one year has passed since Denmark entered the arena of Health Technology Assessment (HTA) for MedTech. The HTA body in Denmark is called “Behandlingsrådet” also known as the Danish Health Technology Council (DHTC). The DTHC evaluates MedTech and is a welcomed addition to the Danish Medicines Council that was established in 2017 to evaluate hospital medicines. Read more about the first year with the DHCT here (link).
During the last 2 years, Partner Anders Mærkedahl has used his vast experience working within HTA for MedTech to support companies in DHTC’s work. Anders has experience with developing HTA submissions for MedTech products to NICE and other Nordic counties. In his role as the chairman of the Health Economics and Market Access Group in the Danish Medico industry, he has used this experience to provide industry feedback on the Method and Process guidelines. Additionally, he has participated in several dialog meetings, and supported several companies in their interactions with DHTC.
Anders has summarized two of his key learnings so far:
- Openness: The DHCT have four basic principles, Openness being one of them, and we are off for a good start. It’s clear that DHTC has prioritized an open dialog with the industry. They have demonstrated this by supporting companies with processes and methods, engaging in early dialog meetings with industry, and support with the actual evaluations. The DHTC understands that it is key to establish a good relationship with the industry and aim to be transparent in their work.
- Companies are hesitant: Considering the ambition to conduct 15-25 evaluations annually, only two products been selected for evaluation. Some key explanatory factors are
- Despite the openness and transparency, companies are insecure about the process. Especially the requirement that they can only apply for a process if they can demonstrate cost neutrality or savings compared to current standard of care (SoC). This naturally eliminates most companies with innovative products, as innovation is often associated higher costs than SoC. However, there is a way of bypassing this requirement that most companies do not seems to be aware of: Healthcare Professionals (HCP) and hospitals do not need to demonstrate this, when applying for a process. Consequently, a company can collaborate with HCPs or hospitals to be subject to an evaluation by the DHCT where there is a Willingness to Pay (WTP) for incremental innovation.
- It is still not clear what the risks and benefits are of submitting to the DHTC as it is unclear how recommendations will be implemented in the Danish Regions. Historically implementation of recommendations and compliance with guidelines have been a major issue in both UK and Sweden. Developing an HTA dossier is a significant investment and consequently it must be clear what the potential benefits are.
- Many companies have not yet generated the necessary evidence to be selected for evaluation by the DHTC and is still considering whether this is worth the investment.
- Finally, negative experiences from HTA process in Norway and Sweden makes some companies hesitant to apply for assessment in Denmark.