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
- For patients with type 2 diabetes mellitus who cannot be treated with the combination of metformin and sulphonylurea derivative, do not use insulin and use this medicinal product as a dual combination with metformin or triple treatment in combination with metformin and/or sulphonylurea derivative.
- For patients aged 18 years or older with symptomatic (NYHA II-IV) chronic heart failure.
- For patients aged 18 years and older with type 2 diabetes mellitus with a very high risk of cardiovascular disease:
a. With previously proven cardiovascular diseases; and/or
b. chronic kidney disease with
- eGFR 30-44 ml/min per 1.73m2 without albuminuria,
- eGFR 30-59 ml/min per 1.73m2 with moderately increased albuminuria (ACR > 3 mg/mmol) or
- eGFR ≥ 60 ml/min per 1.73m2 with severely increased albuminuria (ACR > 30 mg/mmol).
We advise the Minister of Health, Welfare and Sport to adjust the List 2 conditions as follows:
- 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.