ALUTARD (Venin d’abeille Apis mellifera et venin de guêpe Vespula) - Immunothérapie allergénique

Opinions on drugs - Posted on Sep 01 2022

Reason for request

First assessment

Key points

Favourable opinion for reimbursement in the treatment of patients with a history of systemic reactions to honey bee (Apis mellifera) and wasp (Vespula spp) venom.

What therapeutic improvement?

No clinical added value compared to ALYOSTAL (honey bee (Apis Mellifera) and wasp (Vespula spp) venom) in the treatment of patients with a history of systemic reactions to honey bee (Apis mellifera) and wasp (Vespula spp) venom.

Role in the care pathway?

According to the European Academy of Allergy and Clinical Immunology (EAACI), venom immunotherapy is indicated in venom-allergic children and adults to prevent further moderate-to-severe systemic sting reactions. Venom immunotherapy is also recommended in adults with only generalised skin reactions as it results in significant improvements in quality of life compared to carrying an adrenaline autoinjector.

Management

The management of insect venom allergy includes:

  • minimisation of the risk of further stings,
  • access to training in the use of self-administered adrenaline,
  • allergy immunotherapy, which is the only preventive treatment for Hymenoptera venom allergy. It reduces mortality and morbidity in the event of further stings. Its efficacy is around 95% for wasps and 80% for bees. The indications for desensitisation depend on the severity of the initial reaction, the risk of recurrence and patients’ risk factors.

Role of the medicinal product in the care pathway

Like all allergy immunotherapies, ALUTARD (honey bee (Apis mellifera) and wasp (Vespula spp) venom) is the first-line treatment in patients with a documented history of generalised and/or systemic IgE-mediated allergic reactions due to sensitisation to honey bee (Apis mellifera) or wasp (Vespula spp) venom. It should be specified that the proprietary medicinal product ALUTARD (honey bee (Apis mellifera) and wasp (Vespula spp) venom) is a preparation adsorbed on aluminium, and is consequently a medicinal product with a more delayed effect and is not suitable for ultra-rush protocols, which are those most commonly used by French allergy specialists. Conversely, aqueous forms like ALYOSTAL (honey bee (Apis mellifera) and wasp (Vespula spp) venom) are rapidly absorbed and are therefore more appropriate for this protocol.


Clinical Benefit

Substantial

The Committee deems that the clinical benefit of ALUTARD (honey bee (Apis mellifera) and wasp (Vespula spp) venom) is substantial in the MA indications.


Clinical Added Value

no clinical added value

ALUTARD (honey bee (Apis mellifera) and wasp (Vespula spp) venom) provides no clinical added value (CAV V) in the care pathway.


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