Patent foramen ovale closure in cryptogenic stroke assessed for funding in Norway

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. If the method concerns only one or two hospitals, the assessment shall be initiated by clinicians and ran at the hospital level. The final report is disseminated via a mini-HTA database. 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).

In April 2019, the Norwegian Institute of Public Health (NIPH) has released a health technology assessment report for patent foramen ovale (PFO) closure, antiplatelet therapy or anticoagulation therapy alone for management of cryptogenic stroke. This assessment was initially commissioned to NIPH by commissioning Forum for the Regional Health Authorities in order to investigate whether PFO closure is an effective and cost-effective alternative to medical treatment.

The following results were obtained by NIPH:

• Patients with cryptogenic stroke due to PFO have a high risk of recurrent strokes with currently recommended treatment (antiplatelet therapy) (moderate severity condition)
• In patients below 60 years, PFO closure probably confers an essential reduction in ischemic stroke recurrence compared with antiplatelet therapy alone (8%) but may make no difference compared with anticoagulation
• PFO closure incurs a risk of persistent atrial fibrillation (2%) and device-related adverse events (3.6%). Compared with alternatives, anticoagulation probably increases major bleeding

• PFO closure is very likely a cost-effective alternative to drug treatment
• The radiation effects are comparable to other cardiac procedures

• The national introduction of PFO closure will implicate organizational consequences in the form of increased need for training, increased capacity for diagnostics and treatment. Organizational consequences should be considered to be investigated further by the Regional Health Authorities before implementation.

Based on this health technology assessment, the RHF Forum will make a decision regarding further implementation of current treatment method.

See the full health technology assessment report in Norwegian here.

See the full information regarding the assessment process in Norwegian here.

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