Health technology developers are advised to stay updated on new requests and proposals that have been submitted to Nye metoder – in addition to the assessments commissioned by Bestillerforum for nye metoder (Nye metoder's Ordering Forum).
For an overview of all methods, please search using "Finn metode". You may also subscribe to Nye metoder newsletter.
Requests and proposals
Nye metoder distinguishes between medicinal products (request for assessment) and other methods (proposal of assessment).
In order to be considered for public funding through the specialist health services in Norway, the suppliers of a new medicinal product or a new indication for an existing medicinal product should request an assessment.
Suppliers of non-pharmaceutical methods may submit proposals for health technology assessments. Further information about proposals and the proposal form can be found here (information in Norwegian).
Requests for assessment - Implications for health technology developers
In order to be considered for public funding through the specialist health services in Norway, a supplier of a new medicinal product or a new indication for an existing medicinal product must submit a request for assessment to Nye metoder. If the method has previously been assessed and the Decision Forum has come to a negative decision, the supplier may submit a request for reassessment if new data becomes available.
Please state the expected date for submitting documentation to the Norwegian Medicines Agency on the request form. The supplier must also state the type of documentation it plans to submit.
Submitted request forms will be published online (nyemetoder.no).
As a general rule, until a positive decision has been made by the Decision Forum, new medicinal products and indications cannot be prescribed in the specialist health services. After an assessment has been commissioned by the Ordering Forum, the pharmaceutical may be used in accordance with the exemption scheme (information in Norwegian), provided that specific requirements are met.
Bestillerforum commissions national STAs/HTAs and price notes, and will also process submitted requests (and proposals). Different types of assessments may be commissioned depending on the information stated in the request form as well as as clinical assessment of comparability with other methods, assessment of suitability and other input.
As part of the work being done to further develop Nye Metoder, Nye metoder has transitioned from horizon scanning notifications for medicinal products prepared by the Norwegian Medicines Agency to requests for assessments prepared by the health technology developer.
A recording of the supplier information meeting (13.04.2023) that was held to discuss the transition to requests for assessments is available (lmi.no).
Any questions? Please contact Sekretariatet for nye metoder by e-mail: nyemetoder@helse-sorost.no
Process and request forms for medicinal products
Two different request forms are available:
Request for assessment of medicinal product. This form is to be used when requesting assessment of a new medicinal product/ new indication for an existing medicinal product.
Request for reassessment of medicinal product. This form is to be used when requesting reassessment of a medicinal product/indication previously assessed and where a previous decision in Nye Metoder exists.
Request for assessment of medicinal products
A request for assessment should be submitted to Nye metoder no earlier than Day 120 (day one for extension of indications and for medicinal products in accelerated approval procedures) of the EMA approval process.
Please send the completed form by e-mail to: nyemetoder@helse-sorost.no
Download: Assessment Request Form Version 1.1 (Editable PDF)
The submitted form will be published on the website.
Request for reassessment of medicinal products (new clinical data)
A request for reassessment may be submitted to Nye metoder's Secretariat if new clinical data or other important information is available. Based on the request, Nye Metoder will consider whether there are reasons for commissioning a new assessment.
If there is no new clinical data, a request for reassessment is not warranted. If only the cost of the new method has changed since the previous assessment, the supplier may contact the Norwegian Hospital Procurement Trust (Sykehusinnkjøp HF) directly (nyelegemidler@sykehusinnkjop.no).
Download: Reassessment Request Form Version 1.1 (Editable PDF)
Please send the completed form by e-mail to: nyemetoder@helse-sorost.no
The submitted form will be published on the website.
Suppliers of non-pharmaceutical methods: Submit a proposal
Non-pharmaceutical methods include medical devices, procedures, diagnostics and tests, and organizational measures. Suppliers of non-pharmaceutical methods may submit proposals for a national HTA, such as a medical device for a specific application.
Further information about proposals and the Proposal Form (link to article in Norwegian).
Bestillerforum commissions national STAs/HTAs and price notes, and will also process submitted proposals. Different types of assessment may be commissioned depending on the information stated on the proposal form as well as assessment of suitability and other input.
All suppliers can provide input on methods
Everyone, including suppliers, have the opportunity to provide additional information and comment on methods that are being processed by Nye Metoder.
Input may be provided using Nye Metoder's Input Form (available in Norwegian). We would like your input as early as possible in the process, preferably before the Ordering Forum discusses commissioning of a specific type of assessment.
More information about input and deadlines, along with the Input Form (information in Norwegian).
Documentation and STAs/HTAs
Bestillerforum commissions national STAs/HTAs to the relevant assessment body. For most types of assessments, the health technology developer provides the documentation needed. See more information in the article on HTAs.
For further information concerning methodology, required documentation or the assessment process, please contact the Norwegian Medicines Agency or the Norwegian Institute of Public Health directly. Further information can be found on their websites here:
