GVS advice on lanadelumab (Takhzyro®) for the prevention of recurrent attacks of hereditary angioedema (HAE)

Indication for which reimbursement is requested

Lanadelumab is used for routine prevention of recurrent attacks of HAE in patients aged 12 and older. People with HAE suffer from sudden swelling of the skin due to extensive fluid accumulation, of which HAE is a hereditary form. 

Lanadelumab is available as a solution for injection. One vial for injection contains 300 mg lanadelumab per 2 ml solution. The recommended starting dose is 300 mg subcutaneously every 2 weeks. Reducing the administration frequency to 300 mg every 4 weeks may be considered if no more seizures occur, especially where the body weight is low.

Recommendations from the National Health Care Institute

Lanadelumab is an extramural drug. Extramural 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 on. Interchangeable medicinal products are clustered in List 1A. These may be subject to a reimbursement limit. Unique medicinal products are listed in 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.

This report is a summary of recommendations by the National Health Care Institute. The original text is in Dutch.