Mini-HTA of MitraClip released in Norway

16

Sep 2020

In September 2020, a completed mini-method assessment for the MitraClip for percutaneous mitral valve repair was issued within the New Methods framework, which was established in Norway in 2013. In this framework, all innovations should undergo health technology assessment (HTA) before being funded. The Oslo University Hospital carried out the assessment.

MitraClip is used for percutaneous mitral valve repair in patients with primary and secondary mitral insufficiency (MI), who are technically suitable for the method and have a high risk or are prohibited for open heart surgery. 

MitraClip was compared with current treatment methods - open heart surgery, conventional heart failure treatment, with the focus on safety and effectiveness. Mortality, admissions for heart failure, and degree of residual mitral insufficiency were considered as outcomes.

The following conclusions were made in relation to the effectiveness:

  • In patients with high MI, MitraClip significantly reduces it with a low risk of complications
  • In primary MI, the method is less effective than open heart surgery but has a low risk of complications and is a good treatment alternative for patients who have a high surgical risk and are technically suitable for MitraClip
  • In the case of functional MI insufficiency, MitraClip reduces the mortality risk and readmission for heart failure if patients are technically fit and previously received conventional treatment for their heart failure

Regarding safety, the following statements were provided:

  • The most common undesirable outcomes are failure to reduce mitral leakage due to suboptimal clip implantation or valve apparatus damage
  • The procedural success of placing clips and reducing mitral insufficiency is about 95% in various registry studies
  • Other complications risk is low - 1-3% in various studies (e.g., stroke, cardiac tamponade, bleeding from the injection site, wound infections

The key conclusion is that the MitraClip has a good level of efficacy and safety in comparison with the current treatment, and should be introduced as part of the clinical routine in the hospitals.

See the full details in Norwegian here.

Subscribe to our newsletter delivered every second week not to miss important reimbursement information.

The latest related news

16

Jul 2021

In June 2021, the National Institute for Health Research (NIHR) in England released six MedTech-related reports in its Health Technology Assessment (HTA) Journal, which concerned tibial nerve stimulation for urinary incontinence treatment, imaging in ophthalmology, in-vitro diagnostics, and eHealth. HTA Journal publishes research reports on the effectiveness, costs, and broader impact of health technologies for those who use, manage, and provide care in the NHS, and informs National Institute for Health and Care Excellence (NICE) guidance.

Read more

06

Jul 2021

In June 2021, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (laser lithotripsy for difficult-to-treat bile duct stones and percutaneous insertion of a closure device to repair a paravalvular leak around a replaced mitral or aortic valve), one new Medical Technologies Guidance (Plus Sutures for preventing surgical site infection), and four new Medtech Innovation Briefings (RapidAI for analyzing CT/MRI brain scans, WoundExpress, Magtrace and Sentimag, and SYNE-COV). Also, four clinical guidelines were updated, and two new published.

Read more

21

Jun 2021

On June 16, 2021, the Institute for Quality and Efficiency in Health Care (IQWiG) has opened the submission period for proposals for topics of the health technology assessment (HTA) reports to be developed in 2022.

Read more

18

Jun 2021

In May 2021, the National Institute for Health and Care Excellence (NICE) published five new Interventional Procedure Guidance (ex-situ machine perfusion for extracorporeal preservation of lungs for transplant, transvaginal laser therapy for stress urinary incontinence and for urogenital atrophy, electrohydraulic lithotripsy for difficult-to-treat bile duct stones, and permanent His-bundle pacemaker for heart failure), one new Medical Technologies Guidance (UroLift for benign prostatic hyperplasia), and two new Medtech Innovation Briefings (Axonics sacral neuromodulation system for faecal incontinence and KODEX-EPD for cardiac imaging during ablation of arrhythmias). Also, three clinical guidelines and two Medical Technologies Guidance were updated.

Read more

17

Jun 2021

In late May 2021, the Treatment Council (Behandlingsråd), a new framework for assessing treatments and health technologies in Denmark, started accepting applications for the assessment of health technologies.

Read more