GVS advice empagliflozin (Jardiance®) expansion List 2 conditions for chronic kidney disease

The National Health Care Institute has assessed whether the reimbursement conditions for empagliflozin (Jardiance®) can be expanded. Empagliflozin is already included in the Medicine Reimbursement System (GVS) for certain patients with diabetes or heart failure. The National Health Care Institute advises the Minister of Health, Welfare and Sport (VWS) to expand the reimbursement of the medicinal product empagliflozin for the treatment of patients with chronic kidney disease.

Indication for which reimbursement is requested

The marketing authorisation holder has requested reimbursement for adults with chronic kidney disease (CKD). CKD reduces the ability of the body to remove waste products from the blood through the kidneys. Protein loss in urine can also be an issue. People with CKD may experience fatigue, listlessness, lack of appetite, shortness of breath, swollen legs and itching. Chronic means it does not go away.

Recommendations from the National Health Care Institute

We advise the Minister of Health, Welfare and Sport to adjust the List 2 conditions as follows:

  1. For patients aged 18 years and older with chronic kidney disease.

Medicine Reimbursement System (GVS)

Empagliflozin 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.