Reason for request

Reevaluation and new indication

Key points

Favourable opinion for reimbursement in the treatment of cytomegalovirus (CMV) infection in hematopoietic stem cell transplant (HSCT) recipients for whom the use of ganciclovir cannot be envisaged.

Favourable opinion for reimbursement in the treatment of disseminated CMV infections in AIDS patients and the induction treatment of mucocutaneous Herpes Simplex Virus (HSV) infections, resistant or unresponsive to aciclovir in immunocompromised patients.

What therapeutic improvement?

A substantial therapeutic improvement in the treatment of the MA indications.

Role in the care pathway? 

In the treatment of cytomegalovirus (CMV) infection in hematopoietic stem cell transplant (HSCT) recipients, FOSCAVIR (foscarnet) is recommended as second-line treatment in the event of resistance to ganciclovir or when treatment with ganciclovir is impossible due to its haematotoxicity.

In the treatment of CMV infection in HIV patients, FOSCAVIR is an alternative to ganciclovir and valganciclovir in the absence of pre-existing renal function impairment and depending on the organ affected. In the event of encephalitis, FOSCAVIR is a treatment of choice, either alone or in combination with ganciclovir.

In immunocompromised patients with mucocutaneous HSV infections, treatment is based on FOSCAVIR in the event of resistance to aciclovir or valaciclovir.

 


Clinical Benefit

Substantial

The clinical benefit of FOSCAVIR is substantial in the MA indication.

 


Clinical Added Value

important

Considering:

  • the high efficacy of foscarnet with a high genetic resistance barrier and its activity in the event of resistance to ganciclovir or valganciclovir,
  • the known and similar safety profile of foscarnet in the initially authorised indications,
  • its already established use when the administration of ganciclovir is impossible, for reasons of resistance or tolerability (due, in particular, to its haematotoxicity),
  • the absence of any alternative to foscarnet that has an marketing authorisation and is well tolerated in the treatment of CMV infection,

FOSCAVIR (foscarnet) provides an important clinical added value (CAV II) in the treatment of CMV infection in hematopoietic stem cell transplant (HSCT) recipients for whom the use of ganciclovir cannot be envisaged.

 


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