The Norwegian health care service consists of the primary health care and specialist health care. The system has been established to be applied to New Health Technologies entering the specialist health care.
The purposes of the system
Systematic use of health technology assessments (HTA) to inform decision-making was the main ambition behind the establishment.
- Improve patient safety
- Ensure that patients gain equal access quickly to new methods that have proved to be effective and fulfill safety and cost-effective requirements
- Ensure that new methods that are ineffective and/or harmful are not introduced and that obsolete health technologies are disinvested
- Provide an appropriate decision-making platform for priority setting based on HTAs
- Ensure rational use of resources
- Establish a systematic and predictable process for the introduction of new methods
The Ministry of Health and Care Services (HOD) is the owner of the system and it is based on a broad cooperation between the four regional health authorities (the South-Eastern Norway Regional Health Authority, the Western Norway Regional Health Authority, the Northern Norway Regional Health Authority and the Central Norway Regional Health Authority) including all the hospitals, the Procurement services for Health Enterprises Ltd, the Norwegian Institute of Public Health, the Norwegian Medicines Agency, the Norwegian Directorate of Health and the Norwegian Radiation Protection Authority. In addition, a broad stakeholder group is established consisting of representatives from patient organizations, industry, professional associations and universities to contribute to the development of the system. The continuous dialogue with the industry associations within the pharmaceutical, medical devices and laboratory fields is important.
The principal components of the system
The system has to levels; a national level where decisions based on HTAs are made by the four regional health authorities in concert, and a local/”hospital level” where decisions are made based on the mini-HTAs performed locally in each hospital. The type of method and its designed authorized area of use are guiding to the suitable level for assessment. Certain methods, such as drugs, shall always be processed through the system at the national level. Put simple, both levels are composed of the following principal components:
Submitted proposals and horizon scanning reports complement one and other and feed the system with new methods. It is open to everyone in the specialist health care, patients and patient organizations, industry, authorities and the public in general to submit proposals for STAs (single technology assessment) and full HTAs. The reports from the horizon scanning function provide an increasingly important role. Employees in the specialist health care can initiate a mini-HTA locally at their hospital.
There are three HTAs formats in Norway; mini-HTA, STA and full HTA. The mini-HTAs are limited assessments performed by clinicians and supporting units within the hospitals. The STAs focus on a single method of health technology related to a comparator and are performed by either the Norwegian Medicines Agency (if the method is a medicine) or the Norwegian Institute of Public Health (all other methods). Full HTAs are broad assessments performed at the national level by the Norwegian Institute of Public Health. The full HTAs may for example be used to compare various methods that have been used in clinical practice for some time. When performing assessments the Norwegian Medicines Agency or the Norwegian Institute of Public Health works in close dialogue with clinicians that, among others, have been recruited by the four regional health authorities. The Norwegian Radiation Protection Authority contributes to health technology assessments both at national and local level in issues involving medical radiation.
An Ordering Forum, Bestillerforum RHF, consisting of the four medical directors (one for each regional health authority) and two delegates from the Norwegian Directorate of Health, has the mandate to prioritize the STAs and HTAs to be conducted on the basis of submitted proposals and horizon scanning reports. To optimize the process for introduction of new medicines, it was decided to conduct STAs on all new drugs and indications from October 2015. In this way the system achieved an improved predictability and efficiency aiming to complete STA reports as near in time as possible of the marketing authorization. Each hospital, or the region to which the hospital belong, has procedures for the selection of the methods chosen for mini-HTA.
After completion of STA the Procurement services for Health Enterprises Ltd conducts negotiations. Subsequently a Decision Forum comprised of the four CEOs (one for each regional health authority) make decisions whether to introduce the method or not.
The Norwegian Directorate of Health is responsible for the national clinical guidelines. To reduce and avoid duplication of work the national HTAs are to be used both in decision making and in the work with national guidelines. Whenever there is as decision on a method that is a subject to a national guideline, the decisions made at the national level shall be implemented in it.
Link to a presentation in English (pdf) of the system. The presentation includes a process map.
Further questions about the system can be directed to the secretariat of the system located in the Norwegian Directorate of Health . Secretariat contact details: firstname.lastname@example.org
For the Industry
Submitting documentation for STAs
When Bestillerforum RHF has decided that a single technology assessment (STA) should be performed at the national level, the supplier is asked to prepare and submit documentation for the method.
For the submission of documentation, please use the templates below.
Submission of documentation to The Norwegian Medicines Agency
-when the method is a drug
Submission of documentation to the Norwegian Institute of Public Health
-when the method is a medical device, a diagnostic method or a procedure
All questions regarding calculations and the submission of documentation can be submitted directly to the Norwegian Institute of Public Health or the Norwegian Medicines Agency.