12 SQ-HDM SLIT (Itulazax®) for the treatment of allergic rhinitis or conjunctivitis induced by pollen from the birch homologous group
The National Health Care Institute 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 National Health Care Institute'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
The National Health Care Institute 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.
The National Health Care Institute's advice
Based on the considerations mentioned in the report, the National Health Care Institute advises the Minister for Medical Care to include 12 SQ-HDM SLIT (Itulazax®) in Appendix 1B of the Health Insurance Regulation.