MENQUADFI (vaccin méningococcique conjugué des groupes A, C, W et Y)
Reason for request
Key points
Favourable opinion for reimbursement in the active immunisation of individuals from the age of 12 months and older against invasive meningococcal disease caused by group A, C, W and Y strains, only in the populations recommended by the HAS on 11 March 2021.
What therapeutic improvement?
No clinical added value compared to MENVEO and NIMENRIX for the prevention of invasive meningococcal disease caused by serogroup A, C, W 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, W and Y strains: revision of the vaccination strategy and determination of the role of tetravalent meningococcal vaccines.
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 MENQUADFI 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, W and Y strains in individuals from the age of 12 months.
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 MENQUADFI is substantial in the active immunisation of individuals from the age of 12 months and older against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y and only in the populations recommended by the HAS on 11 March 2021. |
Clinical Added Value
no clinical added value |
Considering:
the Committee considers that MENQUADFI meningococcal groups A, C, W and Y conjugate vaccine provides no clinical added value (CAV V) in the prevention of invasive meningococcal disease caused by serogroup A, C, W and Y strains, compared to MENVEO and NIMENRIX (meningococcal groups A, C, W and Y conjugate vaccines). |