New Methods (Nye Metoder)
"The National System for Managed Introduction of New Health Technologies
within the Specialist Health Services in Norway" (a.k.a. New Methods)
"Nasjonalt system for innføring av nye metoder i spesialisthelsetjenesten" (a.k.a. Nye Metoder)
(Implemented 2013)
"The National System for Managed Introduction of New Health Technologies
within the Specialist Health Services in Norway" (a.k.a. New Methods)
"Nasjonalt system for innføring av nye metoder i spesialisthelsetjenesten" (a.k.a. Nye Metoder)
(Implemented 2013)
"The purposes of the system
Systematic use of health technology assessments (HTA) to inform decision-making was the main ambition behind the establishment.
"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 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." (Source: Nye Metoder (English))
"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." (Source: Nye Metoder (English))
"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." (Source: Nye Metoder (English))
"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 a decision on a method that is a subject to a national guideline, the decisions made at the national level shall be implemented in it." (Source: Nye Metoder (English))
"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.
"Why a system like New Methods?
The system is established to:
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"
(Source: Nye Metoder (English); also see: Bakgrunn: Hvorfor har vi Nye metoder? (Background: Why Do We Have 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 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." (Source: Nye Metoder (English))
"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." (Source: Nye Metoder (English))
"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." (Source: Nye Metoder (English))
"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 a decision on a method that is a subject to a national guideline, the decisions made at the national level shall be implemented in it." (Source: Nye Metoder (English))
"Submission of documentation to the Norwegian Institute of Public Health
-when the method is a medical device, a diagnostic method or a procedure
- Template/Guidance for submission of documentation for Single Technology Assessment of medical device, diagnostic methods and procedures (pdf)
- Template/Guidance for submission of documentation for Single Technology Assessment of medical device, diagnostic methods and procedures (word)
"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.
- Short 2017 presentation on New Methods in English: "The National System for Managed Introduction of New Health Technologies within the Specialist Health Service in Norway" (Source: https://nyemetoder.no/Documents/Om%20systemet/New%20health%20technologies%20within%20the%20specialist%20health%20service%20(Nye%20metoder)%20-%20English%20presentation,%202017.pdf)
- Short 2018 presentation on New Methods (Nye Metoder) in Norwegian: "En kort presentasjon om systemet Nye metoder" (Source: https://nyemetoder.no/Documents/Administrativt%20%28brukes%20kun%20av%20sekretariatet%21%29/Nye%20metoder%20%28Norsk%20presentasjon%202018%29_%20v22.02.2018.pdf)
"Why a system like New Methods?
The system is established to:
- Provide patients with confidence that the methods introduced are assessed for efficacy and safety
- Supporting equal and quick access to new and innovative methods
- Demonstrate the added value of new methods compared to existing treatment
- Contribute to phasing out methods that are no longer considered satisfactory
- Provide a quality-assured basis for decisions, priorities and resource use
- Clarify and support decision-making processes and levels.
- Provide transparent decisions"
(Source: New Methods: https://nyemetoder.no/om-systemet/bakgrunn-hvorfor-har-vi-nye-metoder)
Norwegian Ministry of Health & Care Services' approval of Directorate of Health's 2014 Recommendation strains logic, common sense and credulity.
Key Questions:
Again, the "New Methods" system had been implemented in 2013.
Key Questions:
- Why was the Ministry of Health and Care Services' "New Methods" ("Nye Metoder") System not used to assess and compare NCFM eSnurra Group's "method" (i.e., the appropriated, plagiarized, misused Hutchon Method of PDEE) with Bergen Group's Terminhjulet method (internationally recognized for methodological excellence)?
- Why was a full HTA not performed by Norwegian Knowledge Centre for the Health Services (Nasjonalt kunnskapssenter for helsetjenesten)?
- Why were there no Systematic Reviews processes to inform stakeholders and decision makers behind Directorate of Health's 2014 Recommendation?
- Why was Inger Økland's 2012 NTNU dr.philos. Thesis and the 4 NCFM eSnurra Group "studies" included therein not vetted and assessed for academic and scientific integrity, as would have been required if these 4 "studies" were to have been part of a normal NOKC Systematic Reviews process? Why were the important issues of safety and efficacy ignored?
- Why was Directorate of Health's decision-making process not open and transparent?
- Why were Norsk gynekologisk forening (NGF) (Norwegian Society of Gynecology & Obstetrics) and others excluded from the decision-making process behind Directorate of Health's 2014 Recommendation?
- Why were the obvious conflicts of interest among NCFM eSnurra Group and Directorate of Health not disclosed?
Again, the "New Methods" system had been implemented in 2013.
Norwegian Institute of Public Health (Folkehelseinstituttet) and "New Methods" (Nye Metoder)
[Note: Following is an English translation, cut-&-paste from: https://www.fhi.no/prosjekter/nasjonalt-system-for-innforing-av-nye-metoder-i-spesialisthelsetjenesten/]
"PROJECT 9928
National system for introducing new methods in the specialist health service (project description)
The Division of Health Services at the National Institute of Public Health supports New Methods with method assessments.
PUBLISHED 08.04.2014 UPDATED 12.09.2014
New Methods Operated by a Secretariat located in Health South East RHF. You can read more about the system on their web pages.
The national method of method assessment under New Methods will contribute to the evaluation and quality assurance of new and important methods for Norwegian health services for implementation in the Norwegian healthcare sector, both in terms of impact, safety and economics.
FHI, Health Care Area, Cluster for assessment of measures, has overall responsibility for operation, quality and development of:
The national function of method alerting will ensure that new and important methods for Norwegian health services are identified and prioritized for method assessment. All method alerts are publish in the MedNytt database .
The national function of mini-method assessment will provide method support to health enterprises in their work on mini-method assessment. Mini-method assessment is a decision support tool for hospitals when considering a new method. All mini-method assessments are published in the National Database for Mini-Method Assessment
(Source: NIPH: https://www.fhi.no/prosjekter/nasjonalt-system-for-innforing-av-nye-metoder-i-spesialisthelsetjenesten/)
[Note: Following is an English translation, cut-&-paste from: https://www.fhi.no/prosjekter/nasjonalt-system-for-innforing-av-nye-metoder-i-spesialisthelsetjenesten/]
"PROJECT 9928
National system for introducing new methods in the specialist health service (project description)
The Division of Health Services at the National Institute of Public Health supports New Methods with method assessments.
PUBLISHED 08.04.2014 UPDATED 12.09.2014
New Methods Operated by a Secretariat located in Health South East RHF. You can read more about the system on their web pages.
- Contact persons for the project as a whole at the Norwegian Institute of Public Health: Lene Kristine Juvet
- Contact person for method notification : Vigdis Lauvrak
- Contact person for mini-method assessment : Helene Arentz-Hansen
- Contact person for quick method assessment: Lene Kristine Juvet
The national method of method assessment under New Methods will contribute to the evaluation and quality assurance of new and important methods for Norwegian health services for implementation in the Norwegian healthcare sector, both in terms of impact, safety and economics.
FHI, Health Care Area, Cluster for assessment of measures, has overall responsibility for operation, quality and development of:
- Single Health Technology Assistance (Single-HTA) equipment and procedures
- Complete Method Assessment of Medicines, Equipment and Procedures (Health Technology Assements, HTA)
The national function of method alerting will ensure that new and important methods for Norwegian health services are identified and prioritized for method assessment. All method alerts are publish in the MedNytt database .
The national function of mini-method assessment will provide method support to health enterprises in their work on mini-method assessment. Mini-method assessment is a decision support tool for hospitals when considering a new method. All mini-method assessments are published in the National Database for Mini-Method Assessment
(Source: NIPH: https://www.fhi.no/prosjekter/nasjonalt-system-for-innforing-av-nye-metoder-i-spesialisthelsetjenesten/)
Ordering Forum (Bestillerforum RHF)
"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." (Source: Nye Metoder (English))
"Meetings of Ordering Forum for New Methods (Møter i Beslutningsforum for nye metoder)
The Forum consists of the Managing Directors of the four regional health authorities; Helse Nord, Helse Midt-Norge, Helse Vest og Helse Sørøst, with observers from the regional health authorities and the management of the Norwegian Directorate of Health." (Source: New Methods: https://nyemetoder.no/nyheter/beslutningsforum-far-ny-leder)
Norwegian Directorate of Health: Losing Decision-making Control?
On 01 January of 2016, Ministry of Health and Care Services separated Norwegian Knowledge Centre for the Health Services (Nasjonalt kunnskapssenter for helsetjenesten) (NOKC) from Norwegian Directorate of Health to merge NOKC into the Norwegian Institute of Public Health (NIPH). Since then, NOKC has been known as NIPH Division of Health Services. And, on 23 June 2017 Ministry of Health and Care Services made the decision to separate the New Methods Secretariat from Norwegian Directorate of Health effective 01 January 2018 to relocate to the regional health authorities of Helse Sørøst RHF. Consequently, the Ordering Forum is now the Ordering Forum RHF (Bestillerforum RHF). It would appear Directorate of Health have been losing control of key decisions.
"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." (Source: Nye Metoder (English))
"Meetings of Ordering Forum for New Methods (Møter i Beslutningsforum for nye metoder)
The Forum consists of the Managing Directors of the four regional health authorities; Helse Nord, Helse Midt-Norge, Helse Vest og Helse Sørøst, with observers from the regional health authorities and the management of the Norwegian Directorate of Health." (Source: New Methods: https://nyemetoder.no/nyheter/beslutningsforum-far-ny-leder)
Norwegian Directorate of Health: Losing Decision-making Control?
On 01 January of 2016, Ministry of Health and Care Services separated Norwegian Knowledge Centre for the Health Services (Nasjonalt kunnskapssenter for helsetjenesten) (NOKC) from Norwegian Directorate of Health to merge NOKC into the Norwegian Institute of Public Health (NIPH). Since then, NOKC has been known as NIPH Division of Health Services. And, on 23 June 2017 Ministry of Health and Care Services made the decision to separate the New Methods Secretariat from Norwegian Directorate of Health effective 01 January 2018 to relocate to the regional health authorities of Helse Sørøst RHF. Consequently, the Ordering Forum is now the Ordering Forum RHF (Bestillerforum RHF). It would appear Directorate of Health have been losing control of key decisions.
- "Political decision on business transfer of the New Methods Secretariat
On 23 June 2017, the Ministry of Health and Care Services reached a political decision on the relocation of the New Methods Secretariat. The secretariat is moved from the Norwegian Directorate of Health where it has been organizationally located since 2013 to the regional health authorities of Helse Sørøst RHF from 1 January 2018. The Ministry has in its decision assumed that the secretariat is transferred with the resources and posts that confer the secretariat accordingly 4 FTEs."
"Politisk beslutning om virksomhetsoverdragelse av sekretariatet for Nye metoder
Helse- og omsorgsdepartementet fattet den 23. juni 2017 politisk beslutning om flytting av sekretariatet for Nye metoder. Sekretariatet flyttes fra Helsedirektoratet der det har vært organisatorisk plassert siden 2013 til de regionale helseforetak ved Helse Sør-Øst RHF fra 1. januar 2018. Departementet har i sin beslutning lagt til grunn at sekretariatet overføres med de ressurser og stillinger som tilligger sekretariatet tilsvarende 4 årsverk."
(Source "Ney Metoder: Bestillerforum RHF - Årsoppsummering 2017" "New Methods: Ordering Forum RHF - Annual Summary 2017" Dato: 20. mars 2018. p.4-5.)