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NIMENRIX (polyoside de Neisseria meningitidis de groupe W-135)

Opinions on drugs - Posted on Nov 17 2021

Reason for request

New indication

Key points

Favourable opinion for reimbursement in the active immunisation of individuals from the age of 6 weeks to 12 months against invasive meningococcal disease caused by group A, C, W135 and Y strains, only in the populations recommended by the HAS on 11 March 2021.

Maintenance of reimbursement in individuals aged 12 months and older only in the populations recommended following updating of the vaccination recommendations by the HAS on 11 March 2021 incorporating serogroup W meningococcal disease hyperendemic situations.

What therapeutic improvement?

Therapeutic improvement in the indication extension for the active immunisation of individuals from the age of 6 weeks to 12 months against invasive meningococcal disease caused by group A, C, W135 and Y strains.

Role in the care pathway?

In March 2021, the HAS drew up vaccination recommendations for the prevention of invasive meningococcal disease caused by serogroup A, C, W135 and Y strains and defined the role of the meningococcal group A, C, W135 and Yvaccines.

In France, tetravalent meningococcal vaccines are recommended in the following specific populations:

  • individuals with a terminal complement pathway deficiency receiving C5 inhibiting treatment, with a properdin deficiency or with anatomical or functional asplenia and individuals having undergone haematopoietic stem cell transplantation;
  • research laboratory personnel working specifically on Meningococcus;
  • individuals who have been in contact with an individual with serogroup A, C, Y, or W IMD, in the conditions scheduled by the instruction relative to the prophylaxis of invasive meningococcal disease;
  • for IMD W hyperendemic situations.

Role of the medicinal product in the care pathway

The Transparency Committee considers that NIMENRIX (meningococcal groups A, C, W and Y conjugate vaccine) should be used in accordance with its MA and in accordance with current vaccination recommendations for the prevention of invasive meningococcal disease caused by serogroup A, C, W135 and Y strains in infants from the age of 6 weeks.

The Committee highlights the fact that vaccination is the most effective tool for the prevention of meningococcal infection and associated complications (purpura fulminans). Good vaccination coverage of infants and high-risk populations is essential.

 Special recommendations

The Committee highlights that:

  • research laboratory personnel working specifically on Meningococcus can have the costs of their vaccination covered by their employer in accordance with article R4426-6 of French law: “at the suggestion of the occupational health physician, the employer recommends that workers who are not immunised against the biological pathogens to which they are or may be exposed receive the appropriate vaccinations, at the employer’s expense”
  • recourse to vaccination in individuals temporarily exposed due to contact with an individual with invasive meningococcal disease caused by serogroup A, W135 or Y strains is a decision that is up to the regional or national authorities and is funded by regional health agencies as part of their epidemic control strategy.

 

 

 

 


Clinical Benefit

Substantial

The Committee deems that the clinical benefit of NIMENRIX remains substantial in the active immunisation against invasive meningococcal disease caused by group A, C, W and Y strains, in individuals from the age of 12 months and older, only in the populations recommended by the HAS in March 2021.


Clinical Added Value

major

Considering:

  • the medical need to expand the vaccine offer against invasive meningococcal disease caused by serogroup A, C, W and Y strains, particularly in infants,
  • the immunogenicity induced by NIMENRIX (meningococcal groups A, C, W and Y conjugate vaccine) against meningococcal serogroup A, C, W and Y strains in children from six weeks of age,
  • the favourable safety profile,
  • the fact that NIMENRIX is currently the only conjugated tetravalent meningococcal vaccine with an MA in infants from the age of 6 weeks to 12 months,

the Transparency Committee considers that NIMENRIX, meningococcal groups A, C, W and Y conjugate vaccine, provides a major clinical added value (CAV I) in the prevention of invasive meningococcal disease caused by group A, C, W and Y strains in children from the age of 6 weeks to 12 months.


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