This phase takes place
after the Regional Health Authority Forum makes a decision that a Single
Technology Assessment should be carried out at the national level. The Norwegian
Medicines Agency will then require the manufacturer/suppliers to submit
documentation in accordance with the descriptions set forth in the template.
Economic analyses undertaken in the STAs shall be based on the recommendations by the Directorate of Health and NOMA guidelines.
NOMA requires that manufacturers/MAHs present documentation systematically as
proposed in the template. The manufacturer/applicant must provide justification
for any deviation from the template. Documentation can be presented in English
or any of the Scandinavian languages. Documentation shall be submitted
electronically. In cases where a health economic model is used to estimate
cost-effectiveness, then that too shall be submitted.
Confidential material such as trade secrets or data pending publication that
should not be made public will be treated in accordance with current
legislation (The Public Administration act and the Medicinal Products Act). NOMA
then publishes the completed reports on their website.
The template was prepared by NOMA in collaboration with the Knowledge Centre
and the National Working Group for the Introduction of New Methods in the Specialist