GVS advice tezepelumab (Tezspire®) for the treatment of patients 12 years and older with severe asthma
The National Health Care Institute has assessed whether tezepelumab (Tezspire®) can be included in the Medicine Reimbursement System (GVS). This medicinal product can be used to treat certain patients with severe uncontrolled asthma. In August 2023, the National Health Care Institute advised the Minister of Health, Welfare and Sport (VWS) to include tezepelumab on List 1B of the reimbursement conditions. In December 2023, the National Health Care Institute advised the Minister to include an additional reimbursement condition. This additional condition will be placed on List 2 of the GVS.
Download "GVS advice tezepelumab (Tezspire®) for the treatment of patients 12 years and older with severe asthma - August 2023"
Download "GVS advice tezepelumab (Tezspire®) for the treatment of patients 12 years and older with severe asthma - December 2023"
Indication for which reimbursement is requested
Tezepelumab is registered as an add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma who are inadequately controlled despite high dose inhaled corticosteroids in combination with another medicinal product for maintenance treatment. Asthma is a chronic respiratory disease. In asthma, the airways are hypersensitive and the muscles around the alveoli contract due to certain stimuli. Asthma patients will experience shortness of breath, coughing or wheezing. Many asthma patients have periods with few symptoms, but they may develop asthma attacks with considerable shortness of breath. Sometimes, hospitalisation occurs. Severe asthma is difficult to control with medicinal products. By severe asthma, we mean when patients have at least 2 exacerbations (asthma attacks) per year, despite using 1 or more inhalers with respiratory dilators or anti-inflammatory medication.
Recommendations from the National Health Care Institute
The National Health Care Institute advises the Minister of VWS to include tezepelumab on List 1B of the reimbursement conditions. The National Health Care Institute is currently still working on an advisory report for the appropriate use arrangements and the List 2 conditions. This additional advice will follow as soon as possible and at least before 1 January 2024. We are also working on follow-up advice on the inclusion of tezepelumab on List 1B of the Health Insurance Regulation (Rzv) with indication conditions on List 2 of the Rzv. For certain medicinal products, the List 2 conditions of the RVZ are being amended, as per the recommendation of the National Health Care Institute in early 2023. Until the new advice is issued, patients may start treatment with tezepelumab in the hospital.
Medicine Reimbursement System (GVS)
Tezepelumab is an outpatient drug. Outpatient drugs are medicinal products for home use, available at the pharmacy on prescription from a physician. They will only be reimbursed from the basic health care package if they are listed in the GVS. The amount of the reimbursement depends on the list the product is in. Interchangeable medicinal products are clustered on List 1A. These may be subject to a reimbursement limit. Unique medicinal products are listed on List 1B. There is no reimbursement limit for these products. Additional conditions may apply for reimbursement. In that case, a medicinal product is also listed on List 2.
The Scientific Advisory Board (WAR) advises the National Health Care Institute about the assessment. Based on the assessment, the National Health Care Institute sends an advisory report to the Minister of Health, Welfare and Sport. The Minister makes the final decision whether or not to reimburse the medication from the basic health care package.