Five important elements to consider before applying to the Danish Health Technology Council
Danske Regioner, the association of Denmark’s five regions, which are responsible for the delivery of health care in Denmark, has recently introduced a Health Technology Assessment (HTA) body called the “Behandlingsrådet” – also known as the Danish Health Technology Council (DHTC). The DHTC is a politically independent organization responsible for evaluating whether medical devices and non-pharmaceutical health technology costs are reasonable in relation to the benefit they provide.
Decisions made by the DHTC are based on documentation, which is primarily developed by the applicant (i.e., the company), and the outcome of an HTA process (i.e., the Council’s decision) will have a significant impact on the product’s market access in Denmark. Consequently, optimal preparation is crucial prior to applying to the DHTC. We have selected five key considerations to consider before applying to the DHTC.
- Cost-neutral or cost-saving?
For a new technology to be considered for an DHTC assessment process, the applicant must be able to demonstrate that the technology is either cost-neutral or cost-saving compared to the current standard treatment. Consequently, both a comprehensive review of the evidence and early modelling are crucial elements to determine the feasibility of being selected for assessment by the DHTC. While it may seem unusual that use of innovative technologies cannot be associated with increased costs compared to current standard treatment in Denmark, this is the current political mandate set out for DHTC.
Important preparation tasks include:
- Conducting a critical risk assessment of the evidence relevant for the submission
- Conducting sub-group analyses
- Obtaining a clear overview of the cost data, model outcomes and feasible price levels
- Think PICO
The decision problem determines how to structure the value story throughout the application. The PICO framework (Population, Intervention, Comparator, Outcome) is a fundamental part of the decision problem and plays a significant role in how your product strategy and claims are interlinked. This affects the application process and decision outcome. Furthermore, the PICO framework must be applied in all systematic literature searches associated with the DHTC application. Consequently, it’s never too late to “think PICO”, since this framework will guide you throughout the DHTC process. Some important consideration to include when formulating the decision problem:
- Inclusion of all relevant alternatives to the technology of interest
- – may include pharmaceuticals
- – may be a mix of treatments
- – may be a mix of new and old standard of care.
- Definition of relevant populations and subpopulations
- Are there any environmental considerations to be made?
- Evidence is key
When applying to DHTC, a systematic approach for reviewing, collecting, and analyzing both clinical and economic evidence must be adopted. However, the methods adopted for evidence synthesis and inclusion criteria may vary depending on the quality and quantity of evidence, as well as the complexity of the decision problem. The DHTC review will follow a structured approach based on both the PICO framework, and GRADE-methodology (systematic grading of evidence). However, in comparison to the high evidence requirements for regulatory approval of pharmaceuticals, evidence limitations within MedTech will result in a higher degree of uncertainty and a broader scope of what qualifies as relevant evidence for DHTC applications in comparison with Danish Medicine Council (DMC) standards.
So, what level of evidence is needed to increase chances of a positive recommendation? A recent study “ASSESSING THE VALUE OF INNOVATIVE MEDICAL DEVICES AND DIAGNOSTICS: THE IMPORTANCE OF CLEAR AND RELEVANT CLAIMS OF BENEFIT” (Campbell et al., 2018) evaluated the first 10 years of MedTech applications submitted to the National Institute for Health and Care Excellence (NICE). The authors found that technologies receiving positive recommendations had a significantly greater total numbers of studies to support the claims than those that were not selected (p < .001). The following types of studies had a significantly positive impact on the selection decisions: cohort studies (p < .05), surveys (p < .05), and cost analyses (p < .05). However, surprisingly, randomized control trails did not have a significant positive influence on NICE’s MedTech decisions. Types of study that were associated with technologies not being selected were pilot studies (p < .05), unpublished studies submitted in confidence (p < .05), and marketing claims without substantiating evidence (p < .001). Further, if all claims were supported by evident evidence, it had a significantly association with positive outcomes by the committee (p < .001).
In conclusion, a well-generated value proposition supported by solid evidence forms the foundation for a successful outcome. If the application is both well planned and executed, claims about the technology can be presented with a greater degree of confidence. This is one key to success when being appraised by DHTC and other HTA bodies.
- State of the art models
The health economic analysis reporting must follow the DHTC health economic application template. The application must explain the methods, all assumptions, justification of the data used in the analyses, as well as source references. A restricted societal perspective (all relevant costs except productivity loses) can be included, and the time horizon in the base case should capture all significant differences in relevant health effects and costs between the alternative treatments. As with applications to the Danish Medicines Council (DMC) for pharmaceuticals, both deterministic and probabilistic sensitivity analyses must be conducted where appropriate, and the application must always explain which elements of the health economic analysis are expected to have significant impact on the result.
For DHTC to accept the health economic model, it needs to reflect both local Danish costs and clinical practice. Further, ensuring that your health economic model is user friendly, transparent, and adaptable will increase the assessor’s confidence in the model. In turn, this will result in a more efficient process, shorter processing time, easier decision making and earlier market access.
- Value based pricing
Where conjoint analyses may be a useful tool to obtain different stakeholders’ willingness to pay (WTP) for the product, acceptable prices levels in an HTA process are affected by the outcomes of the cost-effectiveness (CE) and budget impact (BI) models used in the application. Hence, many device companies must reassess their pricing strategies. The acceptable product price depends on the claims and the level of evidence supporting these. From a healthcare provider’s perspective, high costs drive expectations of large benefits. Consequently, evidence to support the benefits needs to be convincing to increase changes of a recommendation. The study “PROMISE AND PLAUSIBILITY: HEALTH TECHNOLOGY ADOPTION DECISIONS WITH LIMITED EVIDENCE” (Campbell & Knox, 2016) investigated the interaction between promises and claims, the actual risks associated with the used of the device, and the price of the product. They concluded that decisions about adoption of new devices and diagnostics technologies with little evidence are influenced by judgements of their promise and the plausibility of claims providing benefits in a real-world setting. Applicants must also make a robust assessment of whether the technology will lead to a reduction in overall costs or whether a decision on adoption allows for increased benefit at some agreed level of increased cost.
As mentioned, for companies applying to DHTC the new technology must not be associated with additional costs compared to current standard treatment. However, there is a loophole! Doctors and health organizations can apply for health technologies to be assessed by the DHTC, without the requirements cost neutrality. Hence, an applicant can utilize DHTC via a doctor or health organization, resulting in a process with a higher degree of similarity to well know HTA organs like NICE and The Dental and Pharmaceutical Benefits Agency (TLV).
- Campbell B, Campbell M, Dobson L, Higgins J, Dillon B, Marlow M, Pomfrett CJD. ASSESSING THE VALUE OF INNOVATIVE MEDICAL DEVICES AND DIAGNOSTICS: THE IMPORTANCE OF CLEAR AND RELEVANT CLAIMS OF BENEFIT. Int J Technol Assess Health Care. 2018 Jan;34(4):419-424. doi: 10.1017/S0266462318000466. Epub 2018 Jul 20. PMID: 30025548; PMCID: PMC6190073.
- Campbell B, Knox P. PROMISE AND PLAUSIBILITY: HEALTH TECHNOLOGY ADOPTION DECISIONS WITH LIMITED EVIDENCE. Int J Technol Assess Health Care. 2016 Jan;32(3):122-5. doi: 10.1017/S0266462316000234. Epub 2016 Aug 17. PMID: 27530151.