GVS advice potassium citrate and potassium hydrogen carbonate (Sibnayal®) for the treatment of distal renal tubular acidosis (dRTA)
TThe National Health Care Institute has assessed whether the combination preparation potassium citrate and potassium hydrogen carbonate (Sibnayal®) can be included in the Medicine Reimbursement System (GVS). This medicinal product can be used in the treatment of patients with distal renal tubular acidosis (dRTA). The National Health Care Institute advises the Minister of Health, Welfare and Sport (VWS) not to include potassium citrate and potassium hydrogen carbonate (Sibnayal®) on List 1B of the GVS.
Indication for which reimbursement is requested
The combination preparation potassium citrate and potassium hydrogen carbonate (Sibnayal®) is registered for the treatment of distal renal tubular acidosis in adults, adolescents and children aged one year and older.
Distal renal tubular acidosis is a disease that causes an excess of acid in the blood because part of the kidney does not work properly. Excess acid can lead to hearing and growth problems, vomiting, kidney stones and lack of alertness. In case of the hereditary form of dRTA, patients also often have an insufficient potassium level in the blood, which can lead to muscle weakness and paralysis.
Recommendations from the National Health Care Institute
The National Health Care Institute advises the Minister of Health, Welfare and Sport not to add the combination preparation potassium citrate and potassium hydrogen carbonate (Sibnayal®) to List 1B of the reimbursement conditions of the basic health care package, as there are no differences in clinical effects between Sibnayal® and already available pharmacy preparations. Also, the costs of Sibnayal® are higher than those of already available pharmacy preparations.
The National Health Care Institute therefore recommends to add Sibnayal® to List 3A of the Health Insurance Regulation. This means that the medicinal product is not reimbursed, but the pharmacy preparation is. This allows dRTA patients to have continued access to potassium citrate therapy.
Medicine Reimbursement System (GVS)
Sibnayal 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.