Reason for request

New indication

Key points

Favourable opinion for reimbursement in the paediatric indication extension, i.e., the treatment of chronic hepatitis C virus (HCV) infection in children aged 3 years and older and weighing at least 12 kg.

Favourable opinion for reimbursement in the new form, MAVIRET (glecaprevir/pibrentasvir) 50 mg/20 mg coated granules in sachet.

What therapeutic improvement?

Therapeutic improvement in the management of the disease.

Role in the care pathway?

The reference treatment for chronic hepatitis C in adults, adolescents and children (from 3 years of age) is now based on direct-acting antiviral combinations. These combinations usually enable a sustained virological response (> 90%) to be obtained, including in cirrhosis patients. The majority of patients can now benefit for 8 to 12 weeks of treatment with ribavirin-free pangenotypic direct-acting antiviral combinations. These pangenotypic regimens are recommended preferentially since they reduce the need for genotyping or resistance tests to guide treatment decisions.

Role of the medicinal product in the care pathway

In children who meet the treatment criteria, MAVIRET (glecaprevir/pibrentasvir) is a reference treatment option, in the same way as EPCLUSA (sofosbuvir/velpatasvir), due to its pangenotypic efficacy, shortening the treatment duration (8 weeks for the majority of patients) and simplifying treatment (reduced need for genotyping or resistance tests).

Special recommendations

The Committee highlights the fact that the decision to treat a chronic HCV infection in children and adolescents should be discussed on a case-by-case basis and should be taken after a documented proposal resulting from a treatment review meeting.

 

 


Clinical Benefit

Substantial

The Committee deems that the clinical benefit of MAVIRET (glecaprevir/pibrentasvir) is substantial in the new MA indication.


Clinical Added Value

minor

Considering:

  • the data available in adults, demonstrating high pangenotypic virological efficacy,
  • the available data (M16-123 study, DORA) in children aged from 3 years, suggesting an efficacy and safety profile comparable to that described in adults,
  • the need to have access to new oral pangenotypic antiviral-based treatment regimens in children that are highly effective and can be administered as short courses,

the Committee considers that, as in adults and adolescents, MAVIRET (glecaprevir/pibrentasvir) provides a minor clinical added value (CAV IV) in the treatment of chronic hepatitis C virus (HCV) infection in children aged 3 years and older and weighing at least 12 kg.


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