GVS advice avacopan (Tavneos®) for the treatment of certain patients with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA)

Indication for which reimbursement is requested

Avacopan (Tavneos®), in combination with a rituximab regimen or cyclophosphamide regimen, is indicated for the treatment of adult patients with severe active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).

GPA and MPA are forms of inflammation of the walls of the blood vessels; this is called vasculitis. Vasculitis is an autoimmune disease. This means that the immune system gets confused, becomes overactive and aggressively attacks body cells. In this case, they attack the walls of the blood vessels. These get inflamed, which disrupts the blood supply to the underlying organs. Those then deteriorate due to lack of oxygen or even die completely. Some forms of vasculitis can be recognised by the presence of a certain type of antibodies in the blood, called Anti Neutrophil Cytoplasm Antibody (ANCA). This is called ANCA-associated vasculitis. GPA and MPA are forms of ANCA-associated vasculitis. 

Recommendations from the National Health Care Institute

The National Health Care Institute advises the Minister of Health, Welfare and Sport to include avacopan in combination with a rituximab or cyclophosphamide regimen in List 1B of the reimbursement conditions of the basic health care package. This should be done under the conditions that the price is reduced and that an orphan drugs arrangement is set up. Advice from the Insured Package Advisory Committee (ACP) shows that a higher price reduction than the calculated 75% to 80% is needed. The National Health Care Institute recommends a discount of at least 80% of the current price.

In a previous advisory report, the National Health Care Institute advised the Minister of Health, Welfare and Sport not to include avacopan in the GVS. The cost-effectiveness analysis provided by the marketing authorisation holder at the time was of insufficient quality, which prevented us from assessing the cost-effectiveness. 

Medicine Reimbursement System (GVS)

Avacopan is an outpatient medicinal product. Outpatient medicinal products 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 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 in 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.