12 SQ-HDM SLIT (Itulazax®) for the treatment of allergic rhinitis or conjunctivitis induced by pollen from the birch homologous group

Zorginstituut Nederland has completed its assessment whether 12 SQ-HDM SLIT (Itulazax®) is interchangeable with a product that has been included in the Medication Reimbursement System (GVS). The Zorginstituut's advice is to include 12 SQ-HDM SLIT (Itulazax®) in Appendix 1B of the Health Insurance Regulation.

Registered indication

The standardised allergen extract of birch pollen 12 SQ-HDM SLIT (Itulazax®) is indicated for use in adult patients for the treatment of moderate to severe allergic rhinitis or conjunctivitis induced by pollen from the birch homologous group. At indication, the patient has a clinical history of symptoms, despite the use of symptom-relieving medication, and tests positive for sensitivity to a member of the birch homologous group (skin prick test or specific IgE test).

Itulazax® is available as a melting tablet (sublingual tablet; lyophilisate).

Assessment

Zorginstituut Nederland has concluded that Itulazax® has an equal therapeutic value compared to subcutaneous allergen extracts of birch pollen (Alutard® and Pollinex®) for the treatment of moderate to severe allergic rhinitis or conjunctivitis induced by pollen from the birch homologous group in adult patients. 

Based on the current criteria, Itulazax® is not interchangeable with Alutard® or Pollinex® due to a difference in the route of administration.

Zorginstituut's advice

Based on the considerations mentioned in the report, the Zorginstituut advises the Minister for Medical Care to include 12 SQ-HDM SLIT (Itulazax®) in Appendix 1B of the Health Insurance Regulation.