The “New Method” is currently developing criteria for which methods other than drugs shall be prioritized for assessment within the framework at the national or local levels. “New method” evaluates three method types: 1) Drugs; 2) Medical equipment, diagnostics, and tests; 3) Procedures and organizational measures. For now, there are no clear criteria for methods other than drugs, and it is partly random which technology will be evaluated within the “New Method” framework.
In January 2021, the Ordering Forum of “New Method” commissioned the project to develop prioritization criteria. Two groups were created to work on the project. The main group consists of the National Institute of Public Health (NIPH), the regional health authorities (RHA), Hospital Procurement HF, Melanor (industry association), Secretariat of the “New Method” and others; the internal group consists of NIPH, Hospital Procurement HF, and Secretariat. Every group had two meetings in 2021.
On January 17, 2022, the project status was presented at the Ordering Forum for “New Method.” It was reported that the project would require more resources and time than initially thought. The assignment concerned “methods other than drugs,” but initially, only medical technology (equipment, diagnostics, and tests) was considered. The internal group now suggests assessing whether the same set of criteria can be used for procedures and organizational measures. Secretariate also asked Ordering Forum to clarify whether criteria for artificial intelligence and digital technologies should also be considered.
On October 04, 2022, the status report “Follow-up of evaluation of the system for New Methods” to the Ministry of Health and Care was published. The development status of prioritization criteria for non-drug methods is reported, and the following recommendations are given:
- The reference group can be considered as a sparring partner for future work on determining the process, including criteria for the method assessment of non-drugs in “New Methods”;
- To support the method notification function, for which NIPH is now responsible, consider “shifting the process to the left” by greater involving the professional environment in identifying relevant methods before method assessment starts.
The proposal is made on how the existing criteria could be used together with the criteria of the regulatory work in HTA. This will not solve all identified problems, and more work is needed. The criteria are not weighted against each other; they must still be considered in the context:
- Is the method currently in the specialist health service?
- Is the method CE marked?
- Does the method deal with an unmet medical need (unmet needs)?
- Does the method deal with technologies that are first of their kind (first in class)?
- Does the method apply to a method that is in use and where there is a need for reassessment?
- Will the method have potentially major consequences for the specialist healthcare service?
- Is there available documentation for the method so that a method assessment can be carried out?
- Is the method associated with high risk? (For medical equipment, enter the risk class).
See more information in Norwegian here.
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