GVS advice to include house dust mite extract 300 IR HDM (Actair®)
The National Health Care Institute has completed its assessment whether house dust mite extract 300 IR HDM (Actair®) can be included in the Medicine Reimbursement System (GVS). 300 IR HDM is indicated for adolescents (12 - 17 years) and adults for the treatment of moderate to severe house dust mite-induced allergic rhinitis or rhino conjunctivitis. The National Health Care Institute advises the Minister to include 300 IR HDM (Actair®) in the Medicine Reimbursement System (GVS).
Registered indication
300 IR HDM is available as a sublingual tablet containing 300 IR standardised allergen extract of the house dust mites Dermatophagoides pteronyssinus and Dermatophagoides farinae in equal parts. The recommended dose is one oral tablet daily. A 100 IR HDM tablet is available for dose escalation at the start of treatment.
Based on the data, the administration of 300 IR HDM to the subgroup of patients with a high symptom score at the start of the treatment results in a clinically relevant effect. The National Health Care Institute therefore finds that both sublingually administered house dust mite extracts only meet the established medical science and medical practice in case of severe persistent house dust mite induced allergic rhinitis or rhino conjunctivitis despite adequate medical management.
The National Health Care Institute's advice
The National Health Care Institute advises the Minister to include 300 IR HDM (Actair®) in the Medicine Reimbursement System (GVS) on List 1A of the Health Insurance Regulation in a new to be formed cluster with 12 SQ-HDM (Acarizax®). The standard dose for 300 IR HDM can be set at 300 IR per day and for 12 SQ-HDM at 12 SQ per day. The following compensation conditions be included for both products in this cluster: