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HAS issues favorable reimbursement opinion
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HAS issues favorable reimbursement opinion to first diagnostic test to benefit from an innovation package

05/05/2023

In 2015, HAS developed an innovation package, a derogatory and temporary reimbursement scheme to facilitate early access for patients to innovative health technologies in the early phase of development. Since then, 50 applications have been submitted to HAS relating to 35 technologies, among which 45.7% successfully obtained an innovation package from HAS.  

This is the first time that HAS is issuing a favorable opinion for the reimbursement of a technology to have been supported by an innovation package, that is the METAglut1 test. This is a blood test that is used in the diagnosis of glucose transporter deficiency type 1 encephalopathy. HAS’s assessment considered the results reported by the clinical study undertaken as part of the innovation package which confirmed the diagnostic performance of this test (negative and positive predictive value compared to glycorrhachia). 

The HAS has granted the METAglut1 test an expected level II improvement in service, which will lead UNCAM (National Health Insurance Union) to decide on its effective reimbursement within a maximum of six months. 


Sources: 

  1. https://www.has-sante.fr/jcms/p_3432203/en/forfait-innovation-le-dispositif-porte-ses-fruits 
  1. https://www.has-sante.fr/jcms/p_3424746/en/evaluation-du-test-metaglut1-dans-le-diagnostic-de-l-encephalopathie-par-deficit-en-transporteur-de-glucose-de-type-1 
  1. https://www.has-sante.fr/jcms/c_2035788/en/forfait-innovation  

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