Four decisions for medical devices and IVD tests from the meeting of the Norwegian Decision Forum on introduction of innovations in September

Norway established in 2013 a framework for the introduction of innovations into the health care system through either a national or hospital-based health technology assessment. This framework is called the “New Method”.

In this framework, all innovations should undergo HTA before being funded. Selection of methods is performed by the Ordering Forum (Bestillerforum). If the method is of national concern, it undergoes Single Technology Appraisal at national level followed by the funding decision by the group of payers (Decision Forum, Beslutningsforum). Decision Forum has regular meetings to review results of assessments to the make funding decisions.

On 25th of September, the Norwegian Decision Forum of “New Methods” had a meeting to review several medical technologies and IVD tests. Decisions were made in relation to the introduction of 2 new newborn screening tests, prehospital emergency thoracotomy, aortic valve replacement using sutureless stent Perceval, and digital breast tomosynthesis.

Two additional newborn screening IVD tests

In August 2017, the Order Forum of “New Method” requested the Norwegian Institute of Public Health (NIPH) in collaboration with the expert group to perform a rapid assessment of the extension of National Service for Screening of Newborns regarding two screening tests for rare diseases:

• Severe combined immune deficiency (SCID) – using TREC (T-Cell Receptor Excision Circles) test
• HMG-CoA lyase deficiency – using mass spectrometry

A systematic literature review was performed within rapid assessment (see the full report here). In accordance with the conclusion of this assessment HMG and SCID tests were considered suitable for inclusion into the program. Additionally, it was stated that implementation of the test of HMG involves very few changes in clinical practice. In the same time, TREC test can be performed within PCR procedure. Studies from other countries have shown that earlier diagnosis with SCID allows patients to receive earlier treatment that can lead to lower costs of healthcare services. Health economics studies demonstrated low overall cost for introducing of newborn screening of SCID via TREC test.

Thus, based on the report of rapid assessment the Decision Forum asked the Directorate of Health to clarify the extension of the newborn screening program with these methods as soon as possible (see full decision here).

Prehospital emergency thoracotomy

A negative decision was released for prehospital emergency thoracotomy in patients with cardiac arrest. This method was not recommended for the national method assessment due to limited evidence. It was noted that this procedure requires a high level of competence of medical staff who need regular experience in using this method. Additionally, there are about 10 patients per year which might require this procedure in Norway. However, professionals considered the need for further follow-up for this technology within “New Method” program in the future (see full decision here)

Aortic valve replacement using sutureless stent Perceval

In October of 2015, the Order Forum commissioned NIPH to perform a single-technology assessment of sutureless aortic valve replacement in the treatment of aortic stenosis. One company, Livanova, Sorin group, provided a submission file for a sutureless prosthetic heart valve (Perceval) (see details of the project here).

The report was dedicated to Perceval device in comparison to traditional aortic valve replacement for the treatment of operable patients with severe aortic stenosis in relation to efficacy, safety and cost-effectiveness. For this purpose, the systematic literature review was performed. No RCTs were identified within the search. Ten studies were comparative and ten studies were non-comparative. None of the studies reported quality of life data. The quality of the available evidence comparing Perceval sutureless aortic valve replacement to traditional aortic valve replacement is low to very low. More robust conclusions will be available upon publication of primary data from an ongoing RCT expected in 2019. Based on the cost-effectiveness and budget impact analyses submitted by the firm Perceval can be cost-saving compared to traditional sutured valves for an isolated full sternotomy or minimally invasive valve replacement surgery, and for concomitant surgeries with full sternotomy. Because the data used in the model were not based on the assessed comparative studies, there remains uncertainty about the likelihood and validity of the results. More robust conclusions will be possible on the publication of the ongoing RCT.

In September, the Decision Forum considered aortic valve replacement using Perceval as the suitable procedure for inclusion in the specialist health service. It was also stated that there is no evidence that sutureless prosthetic aortic valves differ significantly from the prosthetic valves that are already in use in terms of quality, safety and cost-effectiveness.

Digital breast tomosynthesis

In January 2016, the Order Forum commissioned NIPH to perform single technology appraisal for 3D digital breast tomosynthesis (DBT) in screening for breast cancer (see details of the project here).

In September of 2017, the NIPH published the report of the assessment of efficacy, safety and cost-effectiveness (see the full report here). There are several manufacturers of DBT systems, but only Hologic Inc., has submitted a documentation pack. In accordance with results of assessment, there is too little evidence to conclude regarding the effects of the use of Hologic digital breast tomosynthesis in combination with digital mammography or synthesized digital mammography compared to digital mammography alone. Introducing the Hologic Selenia Dimensions DBT-system can allow increasing the rate of screening-detected cancer. In the same time, it was evaluated that implementation of this system into the Norwegian Breast Cancer Screening Programme (NBCSP) will result in an increased radiation dose followed by an increased risk of radiation-induced cancer compared to the current practice with digital mammography. Additionally, DBT could be cost-effective. However, the budget impact analysis showed an increase in expenditure in 5 years after implementation of the procedure.

Therefore, on the meeting in September 2017, the Decision Forum did not recommend 3D digital breast tomosynthesis for routine breast cancer screening in the specialist health service.

See the list of releases decisions in September in Norwegian here.

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