For suppliers - information in English

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 an Assessment Request Form to Nye metoder. If the method has previously been assessed and the Decision Forum has come to a negative decision, the supplier may request a reassessment if new clinical data is available. 

Submitted request forms will be published online (nyemetoder.no). In addition to other information, suppliers must state in the Assessment Request Form what type of documentation they plan to submit to the Norwegian Medical Products Agency and when they expect to submit it. 

As a general rule, until a positive decision has been made by the Decision Forum, new medicinal products and indications should not be prescribed in the specialist health services. After an assessment has been commissioned by the Ordering Forum, the medicinal product may be used in accordance with the exemption scheme (information in Norwegian), provided that specific requirements are met.

Bestillerforum commissions different types of assessments, as for example national STAs/HTAs and/or price notes. What type of assessment Bestillerforum commissions depends on the information stated in the request form, clinical comparability with other methods, an assessment of suitability performed the by the Norwegian Medical Products Agency and provided input as for example from clinicians. 

As part of the work being done to further develop Nye Metoder, N 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 information meeting about this transition that was held in Norweigan for supplieres in April 2023 is available (lmi.no).

Nye metoder introduced a simplified process for PD-(L)1 inhibitors in December 2023. Suppliers who consider participating in the process with their PD-(L)1 inhibitor can find more information in Norwegian in the document "Rammer for ordningen «Forenklet vurdering av PD-(L)1 legemidler» (PDF). 

Any questions? Please contact Sekretariatet for Nye metoder by e-mail: nyemetoder@helse-sorost.no

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. 
• Download:  Assessment Request Form Version 1.1 (Editable PDF)
• We kindly advise suppliers who have registered with the Norwegian Hospital Procurement Trust (Sykehusinnkjøp HF) that the method in the request is part of the simplified process for PD-(L)1 inhibitors to inform us about that in the Assessment Request Form.  
• Please send the completed form by e-mail to: nyemetoder@helse-sorost.no
• 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
• A supplier claiming their method to be comparable to another method in Nye metoder and who has a need to submit confidential documentation to support these claims, must include the confidential information in a separate attachment when they submit their request form to nyemetoder@helse-sorost.no. The name of the attachment must include “confidential”, and the confidential information in the attachment must be highlighted.  
• The submitted form will be published on the website.

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.