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For suppliers - information in English
Health technology developers seeking public funding for a new medicinal product, a new indication or an extension of marketing authorisation must submit a request for assessment. Developers of other health technologies may submit proposals. The opportunity to provide input on methods under consideration is open to all.
Health technology developers seeking public funding for a new medicinal product, a new indication or an extension of marketing authorisation (i.e a new pharmaceutical form or a new drug strength), must submit a request for assessment. Developers of other health technologies may submit proposals.
Health technology developers are advised to stay updated on new requests and proposals that have been submitted to the system Nye metoder (“New methods”)– in addition to the assessments commissioned by the Bestillerforum for nye metoder, in short; the Bestillerfourm (“Ordering Forum”).
Nye metoder distinguishes between medicinal products and other methods:
In order to be considered for public funding through the specialist health services in Norway, the supplier of a new medicinal product, a medicinal product with a new indication or an extension of the marketing authorisation (i.e a new pharmaceutical form or a new drug strength) should request an assessment.
In order to be considered for public funding through the specialist health services in Norway, the supplier of a new medicinal product, a medicinal product with a new indication or an extension of the marketing authorisation (i.e a new pharmaceutical form or a new drug strength) must submit the Assessment Request Form to Nye metoder. If the method has previously been assessed and the Beslutningsfourm (“Decision Forum”) has come to a negative decision, the supplier may request a re-assessment 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 (NOMA) and when they expect to submit it.
Generally, until a positive decision has been made by the Beslutningsforum, neither new medicinal products, new indications, new formulations nor new drug strengths should be prescribed in the specialist health services.
Bestillerforum (information in Norwegian) commissions different types of assessments, such as national Single Technology Assessments (STA), Health technology assessments (HTA) and/or price notes. What type of assessment Bestillerforum commissions depends on the information stated in the request form, clinical comparability with other methods, assessment of suitability performed the by the Norwegian Medical Products Agency, and input from for example clinicians.
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 the “Sekretariatet for Nye metoder” (New method's Secretariat) by e-mail: nyemetoder@helse-sorost.no
Two different request forms are available:
Request for assessment of medicinal product. This form must be used when requesting an assessment of either a new medicinal product, or a new indication, pharmaceutical form or strength 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 European Medicines Agency (EMA)approval process. Please note the following: If a supplier hasn’t delivered documentation to NOMA according to the decision in Bestillerforum 12 months after the registration of the request for assessment, Bestillerforum will, unless there are special circumstances, cancel the order and a negative decision will follow.
Suppliers must always request an assessment for the whole indication they either have, or are applying for, a marketing authorization for from EMA. If a supplier suggests a delimitation to a subgroup, the supplier must always submit the necessary documentation for the subgroup in addition to the documentation for the entire indication.
We kindly advise suppliers who have registered with the Norwegian Hospital Procurement Trust (Sykehusinnkjøp HF) that their medicinal product in the request is part of the simplified process for PD-(L)1 inhibitors to inform us about that in the Assessment Request Form.
A supplier who claims that their method is comparable to one or several already introduced medicinal products in Norway, may need to submit confidential data to support their claim. In that case, confidential data must be submitted in a separate attachment. Mark both the attachment and the file name with "confidential".
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 the Nye metoder Secretariat if new clinical data or other important new 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.
The supplier may contact the Norwegian Hospital Procurement Trust (Sykehusinnkjøp HF) directly if an assessment exists and the supplier wants to change the price/their price offer.
A supplier who claims that their method is comparable to one or several already introduced medicinal products in Norway, may need to submit confidential data to support their claim. In that case, confidential data must be submitted in a separate attachment. Mark both the attachment and the file name with "confidential".
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, such as a medical device for a specific indication, may submit proposals for a national HTA.
Bestillerforum can commission different types of assessments.
All suppliers can provide input on methods
Everyone, including suppliers can provide additional information and comment on methods that are being processed by Nye metoder.
Input may be provided using the Nye Metoder Input Form (available in Norwegian). Nye metoder wants your input as early as possible in the process, preferably before the Bestillerfourm discusses commissioning of a specific type of assessment.
Bestillerforum commissions national STAs/HTAs to the relevant assessment body. For most types of assessments, the health technology developer provides the documentation needed.
